diff --git "a/kz_data.jsonl" "b/kz_data.jsonl" new file mode 100644--- /dev/null +++ "b/kz_data.jsonl" @@ -0,0 +1,3869 @@ +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Low Back Pain Must live in the United States Must understand and write English Must have access to a computer with e-mail and expect to have this access for at least 3 years Must be 18 years old Must have seen a doctor for back pain at least once in the past year Pregnancy Back surgery in the past 6 months Expectation of having back surgery in the next 6 months Back pain due to a car accident or other major injury within the last 6 months Back pain or sciatica due to systemic disease (inflammatory rheumatic diseases, tumor, or other) Major physical or mental health condition for which one is currently being treated that severely limits daily activities Terminal illness Receiving disability or workers compensation insurance payments for back pain or sciatica Presently involved in legal proceedings because of back pain or sciatica Difficulty with bladder or bowel control that began with back pain or sciatica", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 30.0-69.0, All Arrhythmia Cardiovascular Diseases Coronary Disease Death, Sudden, Cardiac Heart Diseases Myocardial Infarction Myocardial Ischemia Ventricular Fibrillation Men and women, ages 30 to 69. Documented myocardial infarction ", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 25.0-49.0, All Cardiovascular Diseases Heart Diseases Hypertension Obesity Vascular Diseases Men and women, ages 25 to 49. Diastolic blood pressure between 78 and 89 mm Hg. Free of major disease. Not on a special diet or antihypertensive medication at entry. Some mild to moderately obese subjects ", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-65.0, All Cardiovascular Diabetes Obesity Hypertension Ethnicity: African Americans To enroll participants must self-identify as African Americans and be born in the United States, with American born parents or be born in Africa with African born parents. In the future, we plan to expand the study to other groups which self-identify as African Americans (i.e. AfroCarribeans and Hispanic blacks) Age: The age range of the participants will be between 18 and 50 years Medical History: To participate in the study subjects should identify themselves as healthy Menstrual History: Women must give a history of regular monthly cycles (24-35 days) for at least one year African American Ethnicity other than American or West African ancestry. In the future, we will expand the study to other African American groups such as individuals of Afro-Caribbean and Hispanic blacks Medications: People who take medications that are known to alter the parameters which are under investigation in this study will be excluded. An example would be medications used to treat hyperlipidemia such as statins, niacin, bile acid sequestrants and fibric acid derivatives. Subjects on thyroid hormone replacement will be included if their TSH is normal Diabetes: Because diabetes affects insulin sensitivity and TG levels all people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study Breastfeeding: Women who are breastfeeding or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with breastfeeding or recent childbirth affect the parameters under study Menstrual History: Women with a history of irregular menstrual cycles in the year prior to the study will be excluded. Due to the requirement for regular menses, women in the following categories, regardless of age will be excluded: history of hysterectomy, history of bilateral oophorectomy, use of Norplant or Depo-Provera for contraception History of bleeding diathesis", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 29.0-85.0, All Stroke Cerebral Infarction African Americans are eligible if they had a non-cardioembolic ischemic stroke at lease 7 days, but no more than 90 days before entering the trial African American 85 years of age Non-cardioembolic cerebral infarct Onset of entry stroke at least 7 days but no more than 90 days CT or MRI following entry stroke and consistent with occurrence of entry stroke (i.e., shows entry infarct, shows old infarct, or shows no infarct) Measurable neurologic deficit that correlates with onset of entry stroke Informed consent Able to follow outpatient treatment program Volunteers with transient ischemic attack (TIA) as the potentially qualifying event, intracranial hemorrhage, nonatherosclerotic stroke, sensitivity or major allergy to the study drugs, Modified Barthel Index < 10 or childbearing potential are not eligible Non-qualifying entry events: TIA, subarachnoid hemorrhage, cardiac embolism, iatrogenic stroke, postoperative stroke within 30 days of operation, and carotid endarterectomy as preventive treatment of entry stroke Mean arterial blood pressure > 130mmHg on 3 consecutive days Modified Barthel Index < 10 History of dementia or neurodegenerative disease Severe comorbid condition such as cancer that would limit survival during 2 year follow-up period Concurrent enrollment in another clinical trial Sensitivity or allergy to aspirin or ticlopidine Women of childbearing potential Peptic ulcer disease, active bleeding diathesis, lower gastrointestinal bleeding, platelet or other hematologic abnormality currently active or clinically active in the past year, hematuria, positive stool guaiac, prolonged PT or PTT, BUN > 40mg%, serum creatinine > 2.0mg%, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of > 1800/mm3 required for participation), or > 2 times the upper range of normal on liver function tests (SGOT, SGPT, total bilirubin)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Coronary Disease Hypertension Heart Diseases ", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 35.0-84.0, All Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Disease Hypertension Cerebrovascular Disorders African American ", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Heart Diseases Hypertension ", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure, Congestive In order to be considered an eligible subject, all of the following entry must be met Subjects must be competent to provide informed written consent. Subjects must sign an IRB/IEC approved informed consent form prior to the initiation of any study procedures Subjects must be 18 years of age or older Subjects must have ischemic or nonischemic cardiomyopathy with symptoms of NYHA Class III or IV chronic heart failure Subjects must have a LVEF of less than or equal to 35%, measured within 60 days of the Screening Visit. LVEF must be assessed by radionuclide ventriculography (MUGA). If the subject has experienced any cardiovascular events, has undergone any interventions, or received any changes in treatment that may have affected LV function since the most recent EF measurement, an LVEF measurement must be completed prior to the subject being randomized Subjects must have a left ventricular end diastolic dimension (LVEDD) of >2.7 cm/m2 as measured by 2-D ECHO within 12 months of the Screening Visit Subjects must be on optimal conventional heart failure therapy (with the exception of a beta-blocker), including an ACEI for at least 30 days prior to the Screening Visit, or the subject must have had a trial of an ACEI and proven to be intolerant, or the subject must be taking an ARB for at least 30 days prior to the Screening Visit or proved to be intolerant. Optimal conventional therapy may also spironolactone, digitalis glycosides, diuretics, or other vasodilators Subjects must have failed the initiation, or the up-titration, of a beta-blocker drug due to hemodynamic intolerance within 12 months prior to the Screening Visit. Failure to tolerate beta-blockade for hemodynamic reasons is defined as worsening signs and symptoms of chronic heart failure, hypotension accompanied with symptoms, or evidence of organ hypoperfusion, which in the judgment of the treating physician precluded further treatment with the beta-blocker. This beta-blocker intolerance must have been documented prior to Screening, and a narrative description of the intolerance must be approved by Myogen prior to Randomization Subjects who meet any one of the following will be deemed ineligible for participation in the study Subjects with CHF due to or associated with uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, isolated right-sided heart failure, or primary pulmonary hypertension Subjects who have undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within 60 days prior to the Screening Visit Subjects listed for heart transplantation who are expected to be transplanted within 6 months of randomization Subjects who have had a myocardial infarction within 90 days prior to the Screening Visit Subjects with an ECG recorded at the Screening Visit showing any of the following: 1) evidence of transmural ischemia (dynamic ST elevation or ST elevation associated with ischemic symptoms), or 2) ventricular tachycardia (VT) or premature ventricular complexes (PVCs) associated with symptoms, or 3) VT of greater than or equal to 6 beats Subjects with sustained (>15 seconds) VT, unless precipitated by an event such as an acute myocardial infarction, induction by catheter placement, or by an electrophysiology procedure, or addressed by AICD placement Subjects with an AICD that has fired for any ventricular arrhythmia within 90 days of the Randomization Visit Subjects with a documented diagnosis of angina that meets either of the following 1) angina diagnosed as unstable at any time within the 60 days prior to the Screening Visit or 2) angina is the primary symptom that limits daily physical activity Subjects who have had ventricular reduction surgery or cardiac myoplasty", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-80.0, All Back Pain Chronic back pain for at least 6 months Treatment by medication or physical therapy Acute or life threatening physical illness Current alcohol or substance abuse or dependence Current psychosis or suicidal ideation treatment by anesthesiology, chiropractic care or surgery", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-90.0, All Kidney Failure, Chronic End-stage renal disease Hemodialysis Hypertension Written informed consent Hypotension of less than 90 mmHg systolic High-grade aortic stenosis Heart failure of NYHA stage III and IV Acute myocardial infarction (within the last 4 weeks) Acute heart failure Known allergy to the medicament amlodipine or other constituents of the medicament Severe disorders of liver function Pregnancy and breast-feeding", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 30.0-75.0, All Hypertension Type 2 Diabetes Mellitus Clinical diagnosis of hypertension Clinical diagnosis of type 2 diabetes or impaired glucose tolerance History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months Taking calcium channel blocker for the purpose of angina pectoris Reduced ejection fraction (< 40%) Second or third-degree of atrioventricular block Severe hypertension (> 200/110 mmHg) or secondary hypertension History of stroke in the recent 6 months Serum creatinine > 2.5 mg/dl Estimated survival duration less than 3 years due to other conditions Pregnant woman or possibly pregnant woman", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 65.0-84.0, All Hypertension Cardiovascular Diseases Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex Current antihypertensive treatment with monotherapy SBP \u2265 140mmHg or DBP \u2265 90mmHg in a sitting position on two measurements on two clinic visits At least one of the following risk factors Diabetes mellitus Type 2 History of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (more than 6 months before giving informed consent) Diagnosis of asymptomatic cerebrovascular disease History of myocardial infarction (more than 6 months before giving informed consent) Diagnosis of angina pectoris or heart failure (New York Heart Association [NYHA] functional classification I or II) Diagnosis of left ventricular hypertrophy (thickness of the wall of interventricular septum \u2265 12mm on echocardiography or Sv1+Rv5 \u2265 35mm on electrocardiography before informed consent) Secondary hypertension or malignant hypertension Heart failure (NYHA functional classification III or IV) Required treatment for malignant tumor Serious liver or renal dysfunction (serum creatinine > 2.5mg/dL or with dialysis treatment) Not appropriate for change to the test drugs from current therapy for hypertension or coronary diseases (i.e. calcium channel blockers, \u03b2-blockers, thiazide diuretics, etc.) History of serious adverse drug reactions to angiotensin II receptor blockers or calcium channel blockers Patients with other serious reasons (i.e. illness, significant abnormalities, etc.) that investigators judge inappropriate for the study", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-70.0, All Hypertension Essential Hypertension SBP 140-159 mmHg DBP 90-99 mmHg Intolerance of or allergy to ACE Inhibitors or ARBS Pregnant or Breastfeeding Pre-menopausal women Uncontrolled cardiac or renal failure Diabetes mellitus", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Myocardial Ischemia Outpatients > =18 years of age with diagnosed clinically stable angina pectoris Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-79.0, All Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke Clinical diagnosis of hypertension Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH) Patients who have already been administered ARB Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG) Severe/malignant/secondary hypertensive patients Pregnant women and women of childbearing potential History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block Severe renal impairment (Serum creatinine >3.0 mg/dl) Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-76.0, All Diabetes History of diabetes for at least 5 years, with a least 2 risk factors (i.e. hypertension, elevated cholesterol levels, history of or current smoker, obese, family history of heart disease) & atypical chest pain Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 8.0-18.0, All Chest Pain 18 years of age Pediatric patients with referrals for innocent heart murmurs Pediatric patients experiencing chest pain English speaking Non English speaking patients", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 50.0-999.0, All Coronary Disease Ischemic Heart Disease Heart Failure Patients with HF or IHD who are not currently taking the study medications of interest (ACE inhibitors/angiotensin receptor blockers for HF or statins for IHD) and whose primary care physicians are part of the study population Patients who are unable or unwilling to give informed consent previously taken the study medications according to dispensing records allergy or intolerance to study medications residents of long-term care facilities unable to confirm a diagnosis of either HF or IHD primary care physician has already contributed 5 patients to the study", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Greater than 18 years of age Patients with high blood pressure Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months Type 1 diabetes mellitus", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-75.0, All Breast Cancer Neoplasm Metastasis Hormonal therapy-resistant MBC ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy No anthracyclines for MBC and no prior taxanes At least 6 months from the completion of adjuvant chemotherapy Measurable or evaluable lesions Age: 20 to 75 years PS: 0-3 WBC >= 4,000 /mm3 or ANC >=1,000 /mm3, Platelet >= 100,000 /mm3, SGOT/SGPT <= 1.5 x ULN, T-Bil <= 1.5 mg/dL, Cr <= 1.5 mg/dL normal ECG Written informed consent pregnant malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment Active infection other cancer present within the last 5 years previous stem cell transplantation brain metastasis that requires emergent treatment relapse within 6 months after completion anthracycline or during anthracycline more than 250mg/m2 of anthracyclines hypersensitivity of drug interstitial pneumonitis or pulmonary fibrosis", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Angina Pectoris Chronic stable angina pectoris Documented coronary artery disease Previous treatment with atenolol or other beta-blocker agent Exercise tolerance test positivity and stability Heart rate < 60 bpm Congestive heart failure", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Angina Pectoris Metabolic Syndrome X Chronic stable angina to see if this improves Previous positive exercise tolerance test to ensure that repeating it yields a result Disease not suitable for coronary intervention (Coronary artery bypass grafting or angioplasty) so that best routine care is not withheld Do not have overt diabetes work on this is being undertaken elsewhere Body mass index (BMI) greater than 25 Diabetes mellitus see above Liver failure (ALT>70U/l, AST>80U/l) Renal failure (creatinine > 130mmol/l) Cardiac failure rosiglitazone is contraindicated in those with NYHA 3 and 4 cardiac failure Physical disability if it precludes treadmill testing Women of child bearing capacity Breast feeding mothers", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 50.0-999.0, All Osteoporosis Women aged 50 and older Lumbar spine BMD (L1 to L4) T score between 0 and -2.0 At least 3 years postmenopausal Prior low trauma hip or vertebral fracture Total hip or femoral neck T score of <-2.0 Bone disorders other than osteopenia (e.g., hyperparathyroidism or Paget's disease) Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone or an equivalent at 5 mg/d for 12 months or greater, lithium or anticonvulsants Alendronate or risedronate use for at least four weeks, within the last three years Current treatment with nitrates Systolic blood pressure of =<100 mm Hg or diastolic blood pressure >=100 mm Hg at the baseline screening examination Abnormal electrocardiogram (ECG) at the baseline screening examination history of myocardial infarction, angina, valvular or congenital heart disease Disabling conditions that may interfere with follow-up visits", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 21.0-55.0, All Low Back Pain Age 21 to 55 Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to the greatest proportion of LBP patients that have a favorable natural history of improvement Written Informed Consent A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions) LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis) Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity) Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP Inability to read or verbally comprehend English Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Unstable Angina Myocardial Infarction Age > 18 years or older Admission to the ICCU with ACS (non-ST elevation acute coronary syndrome or 24 hours after ST elevation myocardial infarction) Presence of ischemic symptoms (\u22655 minutes) during hospitalization Pain assessment of 3 out of 10 on Visual Analog Scale (VAS) 1 or dynamic ECG findings (ST segment deviation \u22650.05 mV or T wave inversion \u2265 0.3 mV) Willing and able to provide written informed consent according to the regulations of the Ministry of Health and the Helsinki committee instructions Patient who meet any of the following are excluded from the study Persistent ST-segment elevation \u2265 1 mV in 2 or more contiguous leads or new LBBB Acute pulmonary edema Sepsis Sustained systolic blood pressure < 90 mm Hg or evidence of cardiogenic shock Pregnant women Use at randomization of agents known to enhance the efficacy of nitrates Clinically significant aortic stenosis Cr > 2 mg/dL Participation in another trial of an investigational drug or device on randomization", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Thromboembolic Pulmonary Hypertension Diagnosis of CTEPH and patient consent No patient consent", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 21.0-69.0, All Obesity Participating in the BWHS study Residing in New York, Los Angeles, or Chicago ", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Non-Cardiac Chest Pain Undiagnosed Chest Pain Musculoskeletal Chest Pain Ischemic Heart Disease Acute episode of chest pain of less than 7 days duration as primary reason for admission to a chest pain clinic Admitted to a chest pain clinic, suspected of acute coronary infarction, but with a negative diagnosis confirmed by normal coronary enzymes and normal ECG Pain arising from the thorax and/or neck Able to read and understand Danish Acute coronary syndrome Percutaneous Coronary Intervention Coronary Artery Bypass Grafting Other disease, diagnosed during this admission, which is likely to have caused the acute episode of chest pain No written consent Inflammatory joint disease Diabetes mellitus, type I Fibromyalgia Sharp trauma to the chest Malignant disease", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-60.0, All Prader-Willi Syndrome Obesity Individuals enrolling in the Prader-Willi syndrome group will have a confirmed diagnosis of Prader-Willi syndrome, as confirmed by molecular and cytogenetic testing Individuals enrolling in the Early-onset Morbid Obesity group will have a documented medical history of their weight exceeding 150% of the ideal body weight or a body mass index greater than 97% before the age of 4 years; they will also be under the age of 30 years Known genetic, chromosomal, or hormonal cause of cognitive impairment other than Prader-Willi syndrome", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 10.0-999.0, All Supraventricular Tachycardia More than 10 years old Electrocardiographic diagnosis of SVT SVT not converted by the vagal manoeuvres Signs of impaired cerebral perfusion Signs of pulmonary oedema Subsequent diagnosis of other types of arrythmias rather than SVT pregnancy by history", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 15.0-40.0, All Pneumothorax Male or female Age between 15 and 40 years old First episode of spontaneous pneumothorax Symptomatic (dyspnea or chest pain) or the rim of air is > 2cm on CXR requiring simple aspiration Complete or nearly complete and persistent lung expansion immediately following manual aspiration Organ Function Requirements Adequate hematological function (Hb > 10 g/dl, ANC > 1.5 x 109/L, platelets > 100 x 109/L) Normal renal and hepatic functions: serum creatinine < 1 x ULN, SGPT and SGOT< 2.5 x ULN, alkaline phosphatase < 5 x ULN Written inform consent With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc) With hemothorax or tension pneumothorax requiring chest tube insertion or operation A history of previous pneumothorax A history of previous ipsilateral thoracic operation Allergy to tetracycline or minocycline Pregnant or lactating patients Other serious concomitant illness or medical conditions Congestive heart failure or unstable angina pectoris History of myocardial infarction within 1 year prior to the study entry Uncontrolled hypertension or arrhythmia", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Hypertension Must have completed Visit 14/Week 24 of the NCT00046319 study Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for >=4 weeks following their final study visit Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment Must be stable on conventional therapy for PAH for >=4 weeks prior to the Screening Visit Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit Intravenous inotrope use within 2 weeks prior to the Screening Visit Females who are pregnant or breastfeeding Contraindication to treatment with an endothelin receptor antagonist (ERA)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 65.0-84.0, All Hypertension Cardiovascular Disease Diabetes Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex Systolic blood pressure (SBP) \u2265140 mmHg or diastolic blood pressure (DBP) \u226590 mmHg in a sitting position on two consecutive measurements at clinic during use of 1 or more antihypertensive medications Systolic blood pressure (SBP) \u2265160 mmHg or diastolic blood pressure (DBP) \u2265100 mmHg in a sitting position on two consecutive measurements at clinic without antihypertensive medication Require at least one of the following medical history or risk factors Medical history Cerebrovascular accident: cerebral infarction, brain hemorrhage, subarachnoid hemorrhage\uff086 months or more prior to registration\uff09 Myocardial infarction, coronary revascularization (PCI or CABG) \uff086 months or more prior to registration\uff09 Angina pectoris (except for the patients having history of hospitalization within 6 months prior to registration) Risk factors Male Secondary hypertension or malignant hypertension History of cerebrovascular accident (including TIA) or myocardial infarction within 6 months before registration Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) done within 6 months before registration or scheduled History of hospitalization for angina pectoris or heart failure within 6 months before registration Severe heart failure (New York Heart Association [NYHA] functional class III or more severe) Complications of atrial fibrillation, atrial flutter or severe arrhythmia Severe hepatic or renal dysfunction (including current treatment of dialysis or renal dysfunction with serum creatinine \u2265 2.0mg/dL) Not appropriate for change to the study drugs from current therapy for concurrent disease including coronary diseases (i.e. calcium channel blockers, diuretics, etc) History of serious side effect from study drugs (AT1 subtype angiotensin II receptor antagonist, calcium channel blocker, diuretic) Life threatening condition (malignant tumor, etc)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Musculoskeletal Chest Pain Non-cardiac Chest Pain Undiagnosed Chest Pain To be included in the project the participant must Have chest pain as their primary complaint Have an acute episode of pain of less than 7 days duration before admission Consent to the standardized evaluation program at the chest pain clinic Have pain the in the thorax and/or neck Be able to read and understand Danish. Be between 18 and 75 year of age Be a resident of the Funen County Patients will not be included if any of the following conditions are present ACS Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG) Participants will be excluded following baseline evaluation if any of the following conditions are present Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below) New incidence of any of the above mentioned conditions/pathologies", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 30.0-80.0, All Angina Pectoris Male Stable angina with one of Classical history of exertional angina pectoris Previous diagnostic exercise test Angiographic evidence of CAD Aged 30 to 80 years Weight between 60 and 100 Kg Regular treatment with long-acting nitrates or nicorandil where these cannot be withdrawn 72 hours prior to the study Myocardial infarction, unstable angina, stroke or transient cerebral ischaemia within 3 months Systolic BP > 170 mmHg or diastolic BP > 100 mmHg Systolic BP < 100 mmHg or diastolic BP < 60 mmHg Orthostatic hypotension (> 20 mmHg fall in systolic BP on standing) Diabetes treated with oral hypoglycaemic agents or insulin Any clinically significant disease other than stable angina, excepting other cardiovascular disease risk factors, e.g. smoking, hypercholesterolaemia and diet-controlled diabetes Taking any drug that interacts with sildenafil Evidence of drug abuse", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-999.0, All Neoplasms, Gastrointestinal Tract Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject is provided in the Investigator's Brochure (IB) Pilot Part Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following Signed informed consent Male or female; \u2265 20 years (at the time of giving consent) Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of \u226550% required if normal range of LVEF is not provided by institution) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Able to swallow and retain oral medication Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study Subjects meeting any of the following must not be enrolled in the study Pregnant or lactating female at anytime during the study Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2) Peripheral neuropathy of Grade 2 or greater Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety Life threatening infection Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 30.0-999.0, All Chest Pain At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity) Patients who \"rule-in\" for myocardial ischemia at initial testing Terminally ill (expected to survive less than 3 months) Unavailable for 6-month follow-up Cannot be contacted by telephone Institutionalized persons (prisoners, nursing home residents) Unable to provide informed consent (impaired mental status, unable to speak English)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-999.0, All Hodgkin's Disease Biopsy-proven HL Participation in IRB-approved protocols for the first-line treatment of HL between 1975-2000 (IRB #75-104, #75-103, #79-17, #81-103, #90-44, #91-69) English speaking ", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-65.0, All Anxiety/Depression in Cardiological Unit investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital suffer of chest pain or palpitations do not speak norwegian properly mentally retarded psychosis last 6 month current alcohol or drug misuse", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-80.0, All Active Digital Ulcers Digital gangrene, ulcers in patients with severe secondary Raynaud`s phenomenon Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil Unchanged immunosuppressive therapy 3 months before treatment with sildenafil No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy Therapy with iloprost during the last 4 weeks Sympathectomy during the last 4 weeks TIA, stroke, myocardial infarction during the last 6 months Instable angina pectoris Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia Microangiopathic hemolytic anaemia Azotaemia Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers) Left ventricular ejection fraction< 20% Hypotonus < 80/40 mm Hg", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Metastatic Cancer Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following Histologically proven pleural malignancy Typical features of pleural malignancy seen on direct vision during thoracoscopy Pleural effusion in the context of histologically proven cancer elsewhere No primary lymphoma or small cell lung carcinoma All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible Life expectancy > 1 month Not pregnant or nursing No history of GI bleeding or untreated peptic ulceration No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol ", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Cardiovascular Disease Men and women admitted for an IHD event (acute coronary syndrome or revascularization procedure) who are at low or moderate risk.91 Regular Internet access (home, work or other environment) Over 18 years of age Permission of the attending physician Able to read, write and understand English without difficulty No physical limitations to regular activity Previous experience with a cardiac rehabilitation program Patients with depression, uncontrolled diabetes and other significant co-morbidities that may interfere with effective IHD management Those patients, who in the mind of the attending physician, are unsuitable for participation Those unable to provide informed consent Pregnant women High-risk patients for safety considerations (future studies will high-risk patients)", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Type 2 Diabetes New onset of Type 2 Diabetes BMI>25kg/m2 Antiobesity, oral hypoglycaemic medications or any other prescription medications that may interfere with the study results Pregnancy Unable to converse competently in English as special arrangements would need to be made for such people and this would be impractical in a group setting Attending another weight management programme Patients who would be unable to attend all the programme sessions for medical or other reasons Any patients from groups listed in A24", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-999.0, All Breast Neoplasm Patients with metastatic breast cancer History of hypersensitivity to Caelyx or its components Women who are pregnant or breast-feeding Patients with severe myelosuppression", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease Clinical diagnosis of COPD > 40 years of age > 15 pack year smoking history Contra-indication to beta-blocker use Severe COPD FEV1 < 30% or 1 L Not responsive the methacholine", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-55.0, All Low Back Pain Patients with low back pain between 20 and 55 years old, submitted to a physical therapy treatment Patients with no miofascial low back pain", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-50.0, All HIV Current substance abuse Current high-risk sexual behavior African American racial identification Non resident of Miami-Dade county", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-80.0, All Angina Pectoris Patient must be between the ages of 18 and 80 years Females of childbearing potential must have a negative pregnancy test, not be breast feeding and established on a method of contraception that in the investigator's opinion is acceptable. Females must agree to remain on their established method of contraception through their participation in the study Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes Moderate angina pectoris (Class II or Class III, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System) Naive patient or patient who's Total Exercise Duration (TED) is between 3 to 7 minutes in ETT on Standard Bruce Protocol, and the difference in TED must be no more than 15% between the two screen examinations on day -7 and day 0 All anti-angina regimen (except short-acting nitroglycerin, and one beta-blocker or calcium channel blocker), warfarin or other oral anticoagulants which were used prior to this initial visit can be discontinued Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the verbal rating scales and diary cards Patient must be able to give voluntary written informed consent With contraindication to perform treadmill Exercise Tolerance Test (ETT) Pre-exercise ST-segment depression of at least 1 mm in any lead, left bundle branch block, digoxin therapy, Left Ventricular Hypertrophy (LVH) and Wolff-Parkinson-White (WPW) syndrome or other factors that could interfere with exercise electrocardiograph interpretation Clinically significant arrhythmias or atrioventricular conduction block greater than first degree Clinically significant co-morbidities, including hepatic or renal dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage, or seizure disorders that required anticonvulsant medication History of congestive heart failure, unstable angina, severe valvular disease, severe hypertension, severe anemia, suspected or known dissecting aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism or recent myocardial infarction within three months of study entry History of bleeding diathesis, or is on warfarin Implanted pacemaker Aspirin and/or statins started less than 14 days prior to the signing of informed consent Pregnancy or lactation Inability to discontinue existing chronic nitrate regimen (e.g. long acting nitroglycerin) and allow only short-acting nitroglycerin and one beta-blocker or calcium channel blocker", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-999.0, All Heart Failure Patients eligible for the study had objective evidence of systolic dysfunction (ejection fraction \u226440%), were >18 years of age, and were on stable optimal medical heart failure therapy excluding the use of beta-blockers within the previous 30 days Patients were excluded for active viral myocarditis; hemodynamically significant valvular heart disease; hypertrophic cardiomyopathy, peripartum cardiomyopathy; contra-indications to beta-blockers (asthma or obstructive airway disease requiring scheduled bronchodilators or inhaled steroids), resting heart rate <55; supine blood pressure <85/50; second or third degree heart block); concomitant use of beta-agonists, beta-antagonists, or anti-arrhythmics; unstable angina; myocardial infarction or bypass surgery within 3 months; or significant renal insufficiency (creatinine >2.5 mg/dL), liver disease (transaminase levels > 3 fold above laboratory normal), or anemia", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-65.0, All Obesity, Morbid Ischemic Heart Disease Morbidly obese patients who fulfill the NIH for surgical intervention Patients deemed unfit for surgery Pregnant women, or who are attempting conception Subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion > 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography History of drug or alcohol abuse Chronic liver disease", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Adipose Tissue Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance Obese (BMI >30 kg/m2) subjects also with normal glucose tolerance Obese with impaired glucose tolerance Obese with diet controlled diabetes mellitus Morbid obesity, type diabetes and post bariatric surgery (study part 2) History of severe cardiac, hepatic or renal disease Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction) Current malignant disease Known alcohol misuse Major psychiatric disease (including current use of antidepressants) History of major eating disorder (anorexia or bulimia nervosa)", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-999.0, All Heart Failure Randomised control trials of beta-blocker versus control in patients with documented heart failure Unconfounded trials only (in which one treatment group differed from another only by the beta-blocker therapy of interest) Randomization process precluded prior knowledge of the next treatment (for example trials in which treatment allocation was alternate or based on odd or even dates would not be included) Trial sample size of less than 300 patients", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-999.0, All Acromioclavicular Joint Dislocation Surgical Procedures, Operative Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study A written informed consent Not written informed consent", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-17.0, All Congenital Heart Disease Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect Patients must be taking an ACE inhibitor prior to their operation Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study Pregnancy as ruled out by standard of care screening procedures Individuals whose weight is less than 3.5 kg at the time of enrollment Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 19.0-55.0, All Low Back Pain between the age of 19 and 55 years old able to walk without assistance and /or assistive devices at least 4.7 meters have adequate hearing acuity to detect verbal instructions have adequate visual acuity to walk safely in usual ambient lighting without holding onto objects be able to speak and comprehend English have sufficient cognitive ability to follow instructions, and to provide informed consent, as defined by a Mini Mental Status Examination score of greater than 23 out of 30, performed by the research coordinator have had neurological signs and symptoms, or complications such as tumor or infection are active in a claim pertaining to a motor vehicle accident or work injury or under any litigation for their pain have had previous osteopathic treatment in the last year had more than one abdominal surgery, or spinal fracture, or structural deformity such as scoliosis or spondylolithesis (Hubley-Kozey, 2002) have severe cardiopulmonary disease as determined by a health questionnaire with symptoms such as shortness of breath or chest pain on mild exertion or at rest history of severe neurological disorder that impairs balance and mobility eg stroke, Parkinson's disease, peripheral neuropathy have pain that leads to severe discomfort with minimal movement have significant musculoskeletal impairment e.g. arthritis that leads to severe discomfort with walking that could lead to an abnormal gait have cognitive compromise impairing ability to care for oneself, and ability to provide informed consent have dizziness while standing", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Malignant Pleural Effusion Pleural Effusion Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of Histologically proven pleural malignancy OR Typical features of pleural malignancy seen on direct vision during thoracoscopy OR Pleural effusion in the context of histologically proven cancer elsewhere Expected survival more than 1 month Written informed consent Age < 18 years Primary lymphoma or small cell lung carcinoma Patients who are pregnant or lactating Inability to give informed consent History of GI bleeding or of untreated peptic ulceration Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen Hypercapnic respiratory failure Known intravenous drug abuse Severe renal or liver disease Known bleeding diathesis", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 21.0-999.0, All Diabetes Mellitus, Type 2 Type 2 diabetes for more than 1 year before study entry Insulin therapy Treatment with any beta-blocker in the 30 days before study entry Asthma Chronic obstructive pulmonary disease (COPD) Greater than first degree heart block Heart rate less than 60 bpm Systolic blood pressure less than 90 mm Hg Raynaud's phenomenon Known history of angina, heart attack, heart failure, coronary revascularization, or automatic implantable cardioverter defibrillators Pregnant", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Patients over 18 years of age Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg) Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation) for the control arm (treated by ACEi) Patients over 18 years of age Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg) Patients, who tolerate ACEi treatment Cholestasis, severe hepatic insufficiency Allergy to telmisartan Gravidity or lactation for the arm of patient treated by ACEi Cholestasis, severe hepatic insufficiency Allergy to ACEi Gravidity or lactation", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-49.0, All Low Back Pain Healthy 49 years old Pregnant with a singleton Low back pain began during pregnancy and has lasted more than one week Low back pain is reproducible with palpation Health conditions such as hypertension, diabetes, cancer, thyroid condition etc Pain radiates below knee Cannot read English Plans to move away from Portland area during pregnancy Not willing to be randomized to one of the three arms of the study", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 2.0-999.0, All Sickle Cell Disease for the Observational and Trial Cohorts Hemoglobin diagnosis of SS (two copies of the hemoglobin S gene), SC (one copy of the hemoglobin S gene and one copy of the hemoglobin C gene), or S-\u03b2 thalassemia (\u03b2+ or \u03b20) No clinically apparent ACS No prior participation in either part of the study for the Trial Cohort, in addition to the above sPLA2 level greater than 100 ng/mL within the same 24-hour window that coincides with fever and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window Fever greater than 38.0\u00ba C within the same 24-hour window that coincides with elevated sPLA2 level (greater than 100 ng/mL) and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window Chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window of an abnormal sPLA2 level and fever Hemoglobin levels equal or less than 10 g/dL at time of study entry Informed consent of parent(s) or legal guardian; informed consent or assent of participant as applicable for Observational and Trial Cohorts Existing diagnosis of a new pulmonary infiltrate diagnosed by chest radiography (pleural effusion not obscuring lung parenchyma will not the person from the study) Any coexisting medical condition for which the physician feels that a transfusion may be needed within 24 hours (e.g., severe anemia, stroke) Red Blood Cell (RBC) transfusion in the 60 days before study entry Unwillingness to sign consent form, or if a minor, unwillingness of parent/guardian to sign consent form Treatment with any investigational drug or device in the 30 days before study entry (hydroxyurea is allowable) History of alloimmunization that would prevent the participant from receiving blood within 8 hours of for study entry or history of a life-threatening transfusion reaction Objection to transfusion for religious or other reasons from either the participant or guardian History of treatment with systemic steroids within 1 week of study entry (inhaled steroids are acceptable) Pregnant", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndromes The subject must be 18 years of age or older The subject must present to the Emergency Department with symptoms consistent with acute coronary syndromes (e.g., chest discomfort/pain, squeezing/fullness in the chest, pain radiating to left or both arms, jaw pain, pain in the back/neck/stomach, shortness of breath, cold sweat, nausea/vomiting, lightheadedness) The subject must present to the Emergency Department within 6 hours of the onset of the most recent symptoms that prompted the subject to seek medical attention in the Emergency Department The patient agrees to abide by all aspects of the protocol, including all telephone follow-up The patient is unable to provide consent or understand the consent form The ACS symptoms are clearly not the result of ACS (i.e., penetrating wounds, crush injury, etc.)", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 7.0-13.0, All Obesity Children enrolled in the MEND Programme who are yet to be given a start date for the programme Aged between 7-13 years old Overweight or obese as defined by a BMI which falls above the 91st centile on the boys/girls BMI chart UK cross-sectional reference data:1997/1) Clinically well with no known chronic illness Age less than 7 years or older than 13 Known chronic illness", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 30.0-75.0, All Ischemic Heart Disease Patients with intermediate (>20%, <90%) risk of IHD based on age,gender,symptoms and exercise stress test results Age < 30 Yrs or > 75 yrs Pregnancy (suspected or ascertained) LV Dysfunction (LVEF < 35% by Echo or other method) Low (< =20%) or high (>=90%) probability of CAD Acute Coronary Syndrome Prolonged (> 20 minutes) chest pain De novo or accelerated angina Hemodynamic or electrical instability Recent ST-T segment or T wave changes of ischemic nature Acute myocardial infarction with or without ST segment elevation", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Pain Back Pain Low Back Pain Back Pain With Radiation At Visit 1 (study entry) patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute low back pain that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1 At Visit 1 patients must report qualifying pain intensity scores Patients must be appropriate candidates for treatment with oral opioid pain medication in the investigator's clinical judgment Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening History of back (cervical, thoracic or lumbosacral) pain =50% of the time in the 1 year prior to the first visit History of any low back pain episode, with the exception of the current acute low back pain episode, within 3 months prior to the first visit that was greater than mild in pain intensity, or was associated with disability (e.g., loss of time from work, family, or activities of daily living), or necessitated the use of an opioid (narcotic) analgesic including tramadol Medical history or physical examination results that suggest the acute low back pain or any of the neurological symptoms or signs are caused by a serious medical condition (e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or incontinence, bilateral leg weakness, progressive weakness, paralysis) There is a high probability for surgical intervention for the back pain during the projected time on the study or that there will be an increase in the severity of the leg pain or deficits Had either a surgical procedure involving the spine or intervertebral discs in the lower back region within 1 year prior to Visit 1 or had >1 surgical procedure(s) involving the spine or intervertebral discs in the lower back region has any painful condition that could interfere with the study assessments or with the patient's ability to differentiate the pain associated with the acute low back pain episode from pain associated with another condition History of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis history of epilepsy or recurrent seizures Unable or unwilling to discontinue all prohibited medications at the time of randomization and during the time of their participation in the study Known or suspected history of alcohol or drug abuse based on medical history, physical examination, urine drug screening, or the investigator's clinical judgment", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-90.0, All Adhesive Capsulitis shoulder discomfort for at least one month limited range of motion of the glenohumeral joint in at least two directions systemic inflammatory joint disease radiological evidence of bony abnormality of the shoulder full-thickness rotator cuff tear acute systemic medical illness history of major trauma or surgery involving the shoulder contraindication to intra-articular, local anesthestic injection", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-75.0, All Obstructive Sleep Apnea Hypertension Apnea and hypopnea index of more than 20 /hr, and treated with CPAP Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months Uncontrolled arrhythmia Severe hepatic or renal disorders Having poor prognosis disorders such as malignant disorders", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-80.0, All Resistant Hypertension NIDDM 80 years, informed consent, hypertension, type-II-diabetes mellitus Non-compliance, s-creatinin above 200, AFli", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Atherosclerosis Over 18 years old CCT > 60 ml/min No IHD No hyper/hypoparathyroidism No active malignancy Not taking calcium, phosphate Under 18 years of age Not fulfilling", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All ST Segment Elevation Acute Coronary Syndrome The decision to randomise patients must be made by a qualified physician or paramedic who is present at the time Subjects may be included in the study if they present either via ambulance or to a centre where PCI is not performed and meet all of the following Provide written informed consent before initiation of any study related procedures. Patients randomised in the ambulance may initially sign an abridged version Be aged \u226518 years at the time of randomisation Have a presumed diagnosis of a STE-ACS with onset of symptoms of >20 minutes and <12 hours with one or more of the following ST segment elevation of \u22651 mm in \u22652 contiguous leads Presumably new left bundle branch block An infero-lateral MI with ST segment depression of \u22651 mm in \u22652 of leads V1-3) with a positive terminal T wave All patients must be scheduled for angiography +/ PCI (if indicated) <2 hours after first medical contact Subjects will be excluded from the study if any of the following apply prior to randomisation Any bleeding diathesis or severe haematological disease or history of intra-cerebral mass, aneurysm, arterio-venous malformation, haemorrhagic stroke, intra-cranial haemorrhage or gastrointestinal or genitourinary bleeding within the last 2-weeks Patients who have undergone recent surgery (including biopsy) within the last two weeks Patients on warfarin (not applicable if INR known to be <1.5) Patients who have received UFH, LMWH or bivalirudin immediately before randomisation Thrombolytic therapy within the last 48 hours Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel Contraindications to angiography, including but not limited to severe peripheral vascular disease If it is known pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 10.0-999.0, All Allergic Conjunctivitis Positive bilateral conjunctival allergen challenge(CAC) reaction Known contraindications or sensitivities to the study medication or its components Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters Use of disallowed medications during the period indicated prior to study enrollment or during the study", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 30.0-80.0, All Stable Angina Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI Unstable Angina/NSTEMI patients who completed PCI for main lesions Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs STEMI patients within one month Variant Angina Liver function abnormality or renal failure History of Hypersensitivity to testing drugs Severe heart failure(NYHA class>3) or uncorrectable hematologic disease Woman possible to be pregnant Uncontrolled diabetes Expected life span < one year", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 19.0-55.0, All Healthy Overweight Obesity Subjects with BMI over 25.0 kg/m2 Non-smoker Excessive alcohol consumption Pregnant or lactating women Dyslipidemia, hyperglycemia, or other chronic diseases Subjects who were taking vitamin supplements", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Acute Coronary Syndrome Coronary Artery Disease Diagnosis of unstable angina and non-Q wave myocardial infarction Age 18-75 yr Diameter stenosis of coronary artery<70% diameter stenosis by visual estimation Blood pressure >110/70 mmHg Heart rate 60-~100 bpm, No cardiac arrhythmias St-elevation myocardial infarction Lower blood pressure(<100/70mmHg) Heart rate <60 or >100 bpm, The presence of cardiac arrhythmias Allergy to study drugs Women in pregnancy Liver dysfunction Creatinine >2.5mg/dl Bleeding stroke within 6 months Left ventricular ejection fraction<30% before maximal medication", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-60.0, All Abdominoplasty Bilateral Breast Reduction Bilateral Breast Lift Bilateral Brachioplasty Bilateral Lateral Thigh and Buttocks Lift Subject is >18 years of age or < 60 years old Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof Subject is able to discontinue anticoagulant therapy (including Aspirin) Subject is willing and able to comply with study follow-up procedures Subject is willing to provide written informed consent for their participation in the study Subject has a history of smoking in the last 6 months prior to surgery Subject has a history of type I or type II Diabetes Subject has an active infection of any kind at the time of enrollment Subject has a known coagulopathy", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Ischemic Heart Disease ischemic heart disease patient, and given loading or maintenance dose of clopidogrel and in need of it for 1 or more month and in need of additional drug for optimal BP control (aim blood pressure <130/90) or angina control existing use of amlodipine thrombocytopenia end stage renal failure allergy to clopidogrel/ amlodipine pregnancy/ lactation strong inhibitor or inducer of cytochrome P450 3A4 enzyme within 7 days before start of the study", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension hypertension age > 18 ACE-I related cough Current treatment with telmisartan Cholestatic disorders and severe hepatic failure Allergy to telmisartan Pregnancy and lactation period", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Head and Neck Neoplasms Laryngeal Neoplasms Mouth Neoplasms Pharyngeal Neoplasms Histologically confirmed squamous cell carcinoma (with biopsy on the primary and / or lymph node metastases) of the oral cavity, oropharynx, hypopharynx, larynx supraglottix Locally advanced disease, defined by one of the following any T, N +, M0 (excluding T1, N1), T3-4, N0, M0 Not cancer nasopharynx or paranasal sinuses or salivary glands General conditions and associated diseases which does not allow to perform chemotherapy or radiotherapy in a radical view No other surgical treatments, chemotherapy or radiotherapy for cancer of head and neck or elsewhere, except non-melanoma skin cancer or in situ cervical cancer and other solid tumors for which radical treatment has been completed > three years prior to enrollment in the study and for which the patient has remained continuously free of disease Accessibility to follow-up Signing of informed consent Interval between examinations of local staging and randomization, maximum 3 weeks Interval between randomization and initiation of treatment, maximum 2 weeks Age <18 years ECOG performance status > 0-1 Hemoglobin <9 g / dL Counts of granulocytes, total <1.5 x 10 ^ 9 / L Platelet count <100 x 10 ^ 9 / L Bilirubin> 1.5 times upper limit of normal (ULN) AST or ALT> 3 times ULN Creatinine clearance > 50 mL/min Mg > 0.5 mmol/L Pregnancy or lactation", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Acute Renal Failure all ICU patients requiring renal replacement therapy patient denies informed consent patient not requiring intensive care therapy kidney transplanted patients chronic renal failure (serum creatinine > 3mg/dl)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 35.0-75.0, All Coronary Heart Disease Male or female; age 35-75 years having angina (Canada Cardiovascular Society Class II-IV) Essential Hypertension defined as taking at least 1 anti-hypertensive medication, or average systolic blood pressure \u2265140 mm Hg, or diastolic blood pressure \u226590 mmHg ST-T changes of LVH (Romhilt-Estes or Framingham Heart Study with typical LV strain pattern, or isoelectric, inverted or biphasic T waves) ST-T changes of ischemia in resting ECG (ST depression, isoelectric, biphasic, negative or inverted T-waves) Serum potassium < 5.0 mmol/L prior to randomization Negative pregnancy test in child-bearing potential women Willing to comply with scheduled visits Informed consent form signed by the subject Resistance hypertension despite 3-drugs treatment Myocardial infarction in past 90 days Coronary artery bypass graft surgery in past 90 days Atrial fibrillation with a resting heart rate > 90 bpm Percutaneous coronary intervention in past 30 days Implanted Pacemaker Stroke in past 90 days Left or Right Ventricular Branch Block Aldosterone antagonist or K sparing drug in last 7 days Intolerance to amiloride", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 60.0-85.0, All Low Back Pain Obesity chronic low back pain for >6 months >3 pain episodes per week waist circumferences \u2265102 cm for men waist circumferences \u2265 88 cm for women willing and able to participate in regular exercise for 14 weeks using pain medications to control low back pain free of abnormal cardiovascular responses during a screening graded maximal walk test unable to walk participating in regular resistance exercise training (>3X week) in the past 6 months pain symptoms are too severe and prevent strength testing or walking acute back injury spinal stenosis that precludes walking one block due to neurogenic claudication back surgery within the past 2 years current use of weight loss interventions (drugs; exercise interventions)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-70.0, All Ischemic Heart Disease Obesity obesity Ischemic Heart disease Signed informed consent Visual or manual limitations that preclude reading and writing Unwilling to participate", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Ovarian Cancer Subjects who aged 18 years or older Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-80.0, All Functional Chest Pain Age 18 to 80, male or female Patients must fulfill the Rome III for Functional Chest Pain of Presumed Esophageal Origin for the previous 3 months (with symptom onset at least 6 months before diagnosis), including all of the following Midline chest pain or discomfort that is not of burning quality Absence of evidence that gastroesophageal reflux is the cause of the symptom Absence of histopathology-based esophageal motility disorders Persistent symptoms despite a trial of antidepressant therapy, as defined by either chest pain despite at least a continuous 4-week trial of at least one antidepressant within the last 6 months; or intolerance of at least one antidepressant within the last 6 months Negative cardiac evaluation (negative cardiac stress test or negative coronary angiogram) Negative gastrointestinal evaluation for cause of the pain, defined by absence of Los Angeles grade C or D erosive esophagitis on endoscopy, persistent chest pain on PPI therapy, and no association of chest pain with reflux episodes on an ambulatory pH or pH-impedance study, defined as a symptom index <50% or symptom association probability <95% for chest pain Severe co-morbid illness (cardiac, pulmonary, renal, hematologic, hepatic) Prior treatment with hypnosis/hypnotherapy for a medical condition Prior major thoracic surgery Prior diagnosis of or treatment for dissociative disorders, post-traumatic stress disorder, borderline personality disorder, or other psychiatric disorders that psychotic features Pregnancy or planned pregnancy within the upcoming 3 months Inability or unwillingness to give informed consent", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Atherosclerosis Major Men Obese BMI>30 No aspirin treatment before Coronary exploration: coronary angiography or tomography coronary angiography Chest pain like stable angina Women Severe hepatic insufficiency Inflammatory disease Neoplasia Protein S deficiency Aspirin treatment 10 days before Oral anticoagulant treatment at Heparin or low molecular weight heparin treatment at", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Cystic Fibrosis Back Pain Neck Pain Chest Pain Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene Age > 18 years Patient with chronic chest , neck or back pain Written Informed Consent with health insurance regular follow-up by an osteopathic physician in the previous 3 months patients awaiting lung transplantation history of lung transplantation pregnancy understanding disorders preventing the patient to apply the study participation in another clinical interventional study protocol", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 10.0-999.0, All Allergic Conjunctivitis Positive bilateral conjunctival allergen challenge (CAC) reaction Known contraindications or sensitivities to the study medication or its components Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters Use of disallowed medications during the period indicated prior to the study enrollment or during the study", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-79.0, All Angina Pectoris Coronary Artery Disease Type 2 Diabetes Mellitus Written informed consent Males and females aged 18 to 79 years Able to perform a Sheffield Modified Bruce Treadmill Exercise Protocol At least a 3-months history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin Coronary artery disease documented by one or more of the following Angiographic evidence of \u2265 50% stenosis of one or more major coronary arteries History of myocardial infarction (MI) documented by positive CK-MB enzymes, troponins, or ECG changes Cardiac nuclear scan studies diagnostic of CAD, e.g., thallium scan or ECHO with stress or pharmacologic interventions (adenosine, dipyridamole, etc.) Stable treatment with one of the following antianginal medications for at least 4 weeks prior to Screening beta-blocker (atenolol up to 50 mg daily or metoprolol up to 100 mg daily) Inability to exercise or having exercise limitation due to other co-morbidities that may interfere with ability to perform required ETT (e.g., morbid obesity, significant chronic lung disease, prior hospitalization for acute exacerbation of chronic lung disease or home oxygen use, chronic oral steroid therapy that can limit exercise capacity, osteoarthritis, peripheral artery disease, etc.) Any absolute contraindication to ETT Presence of electrocardiographic or other abnormalities that interfere with ECG interpretation or may cause a false positive stress test (e.g., \u2265 1 mm horizontal or down-sloping ST segment depression at rest in any standard ECG lead, Lown-Ganong-Levine syndrome, Wolff-Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy with repolarization abnormality, ventricular pacemaker, etc.) Decompensated heart failure Clinically significant valvular heart disease or congenital cardiac defects Acute coronary syndrome in the prior 2 months or coronary revascularization within the prior 6 months or planned coronary revascularization during the study period Stroke or transient ischemic attack within 6 months prior to Screening History of serious ventricular dysrhythmias or a history of life-threatening ventricular arrhythmia Atrial fibrillation QTc > 0.5 seconds", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Asthma, Chronic Obstructive Pulmonary Disease (COPD) documented diagnosis of asthma or COPD in accordance with guidelines stable condition, defined as a disease without exacerbation for at least 1 month prior to study enrolment mean HR in holter ECG recording of \u2265 60 bpm disease exacerbation in previous month inability to understand instructions on study procedures", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 25.0-65.0, All Chronic Stable Angina Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes Male and female Age 25 to 65 years Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards Patient must be able to give voluntary written informed consent Hypertension of > 170/100 mm of Hg Valvular heart disease and cardiomyopathy Myocardial infarction in < 6 months Unstable angina Congestive cardiac failure Severe anemia (Hb 7G/dl) Cardiac arrhythmias or II or III degree AV block Significant liver or renal dysfunction IDDM (Type-1 diabetes mellitus) Systolic blood pressure < 100 mm Hg", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 21.0-999.0, All Acute Myocardial Infarction Heart Attack Acute Coronary Syndrome Unstable Angina Acute myocardial infarction, acute coronary syndrome, unstable angina, men & women, all races & ethnicities age < 21 years", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-50.0, All Obesity Subject, male or female, is age 18 to 50 years of age Subject must be able to understand and be willing to sign an informed consent document Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits Subject has a BMI of 40 or 30 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure Subject has a history or is diagnosed with eating disorders Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where plications are to be placed", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 25.0-50.0, All Hypertension essential hypertension ACE inhibitors diabetes mellitus endocrinopathies no smokers", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Breast Cancer TRIAL Patient age 18 years or older who self-identifies as African-American In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer Receiving health care primarily through an health maintenance organization (HMO) Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded PEER At least 25 years of age who self-identifies as African-American Previously participated in any type of research study Has at least high school education ", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-999.0, All Chronic Stable Angina Male or female aged > 20 Patients who had effort-induced angina which was relieved by rest or nitroglycerin, or who had catheterization-documented coronary artery disease or previous myocardial infarction \u2265 3 months before screening Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression \u2265 1 mm compared with at rest, with or without limiting angina) at screening (Day -7) Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression \u2265 1 mm compared with at rest, with or without limiting angina) on the day of enrollment (Day 0). ETT performance between Day -7 and Day 0 were required not differ by >20% in total exercise time Female patient who was in the post-menopausal stage or of childbearing potential who used adequate contraception since last menstruation and no plan for conception during the study was non-lactating had negative pregnancy test (urine) within 14 days prior to the study Able to provide written informed consent Patients with pre-excitation, conduction abnormalities, pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months Patients with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, patients who needed digoxin, isosorbide mononitrate, nitroglycerin sustained release preparation, theophylline, class I antiarrhythmic agents, digitalis, or monoamine oxidase inhibitors, as judged by the investigator Patients with any EKG abnormalities preventing the interpretation of ischemia (complete left bundle branch block) Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators Patients with hepatic failure (defined as aspartate transaminase (AST) and/or alanine transaminase (ALT) > 3X the upper limit of normal values), and/or renal failure (defined as serum creatinine > 3 mg/dL) Patients with severe gastrointestinal illness as judged by the investigator Patient with any conditions that interfered the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stroke)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Acute Coronary Syndrome Age 18 years Ischemic discomfort (ie, ischemic chest pain or equivalent) at rest \u226520 minutes within previous 24 hours Any (new, presumably new, or old) LBBB on the prehospital (ambulance) or admission ECG Urgent coronary angiography (followed, when indicated, by PCI), ideally within 90 minutes after admission all-comers design", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Angina Pectoris Myocardial Infarction Coronary Disease Myocardial Ischemia Acute Coronary Syndrome Patients affected by history of IHD with a non-fatal evolution(angina or AMI as first manifestation),age at the onset of the disease (<50 o >60 years Patients with acute coronary syndrome as first manifestation of coronary disease, admitted to the coronary unit within 6 hours from the onset of symptoms Age>75 Pregnancy Recent(< 6 months) cerebral ischemic attack Active cancer Inability to provide an informed consent", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-65.0, All Low Back Pain unilateral pain near the sacroiliac joint that does not extend pass the knee positive result on 2 of 6 sacroiliac joint provocation tests compression test distraction test posterior shear test Gaenslens' test (left and right) sacral thrust test current pregnancy or pregnancy in the last 6 months history of surgery to lumbar spine, pelvis, chest, abdomen history of congenital lumbar or pelvic anomalies any neurological signs in the lower extremity", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Primary Open Angle Glaucoma Diagnosis of POAG Documented glaucomatous VF damage with mean defect (MD) > 3 dB Progressing glaucomatous damage justifying a DSCI Aged \u226518 years, of either sex Not more than 4 diopters spherical equivalent on the study eye Not more than 2 diopters cylinder equivalent on the study eye Have given written informed consent, prior to any investigational procedures Corneal or conjunctival abnormality precluding contact lens adaptation Severe dry eye syndrome Patients with allergy to corneal anesthetic Patients with contraindications for silicone contact lens wear Patients not able to understand the character and individual consequences of the investigation Participation in other clinical research within the last 4 weeks", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-45.0, All LUMBAR BACK PAIN PELVIC PAIN PREGNANCY Lower back pain and / or posterior pelvic pain when completing the interview. Gestational age greater than or equal to 12 weeks Twin pregnancy. Medical restrictions on the exercise. Be doing physical therapy for the symptom of back pain and / or posterior pelvic", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Inappropriate Sinus Tachycardia Inappropriate sinus tachycardia (HR >100 bpm at rest ECG and/or medium Holter ECG HR >90 bpm) Age > 18 years Secondary causes of sinus tachycardia Structural heart diseases Postural orthostatic tachycardia syndrome Sinus nodal reentrant tachycardia Contraindications to beta-blockers Administration of beta-blockers, non-di-hydropiridinic calcium channels antagonists, class I and III anti-arrhythmic drugs or digitalis at the time of enrollment Age < 18 years Inability of giving informed consent", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Metastatic Breast Cancer age>=18years Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2 and a life expectancy >= 12 weeks histological-proven, HER-2 negative measurable stage IV disease exposure to anthracyclines, taxanes either in the neoadjuvant/adjuvant or in the metastatic setting and had documented disease progression after the firstline or secondline treatment Patients previously treated with radiotherapy were eligible for the study, provided that measurable disease existed outside the radiation field At least 3 weeks from the prior chemotherapy or radiotherapy. At least 2 weeks from the prior endocrine therapy Patients with active infection or other serious underlying medical conditions Patients had prior treatment with 5-FU infusion and/or oxaliplatin therapy Inadequate bone marrow, liver, renal, medullary, and cardiac functions Evidence of spinal cord compression or brain metastasis History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer Pregnant or lactating women Serious uncontrolled intercurrent infection History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding Serious non-bleeding wound, peptic ulcer or bone fracture Prior dihypopyrimidine dehydrogenase deficiency", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 40.0-80.0, All Coronary Disease non-acute chest pain those who underwent CT calcium scoring availability of all relevant risk factor information previous coronary disease i.e., myocardial infarction or revascularization", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-60.0, All Kidney Calculi Well functioning kidney (serum creatinine <1.2 mg/dl) Solitary renal stone Size: 25 mm or less in the largest diameter Contraindications to ESWL Previous surgical treatment of renal stones Congenital renal anomalies Pediatric patients (age <18 years) Patients with Diabetes or hypertension", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-85.0, All Hypertension Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-50.0, All Pregnancy Related Anaesthesia Viable, singleton pregnancy \u2265 37 weeks gestation undergoing EL LSCS Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH, obesity (based on BMI pre pregnancy which is \u2265 30 kg/m2), big baby Ability to provide informed consent Emergency caesarean section Preterm Labour Grandmultipara Multiple Pregnancy Placenta Previa Previous PPH Maternal Obesity ( BMI pre pregnancy \u2265 30 kg/m2)) Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac diseases, history or evidence of liver, renal, vascular, or endocrine disease and bleeding disorder Contraindication to carbetocin and oxytocin Language Barrier", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 45.0-75.0, All Ischemic Heart Disease Obesity Stable Ischemic Heart Disease BMI 28 kg/m2 Known Diabetes Mellitus Repeated Fasting plasma glucose \u2265 7 mmol/L or Hba1c > 7 % Severe or moderate valve disease Main stem stenosis Severe heart failure, Ejection Fraction < 35 % Physical or mental disability which are expected to prevent completion of intervention Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 < 50 % of expected) or asthma Active cancer Severe kidney (GFR < 40 ml/hour) or severe liver disease Severe ischemia or arrhythmias during exercise test", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 16.0-999.0, All Chest Pain All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich Missing informed consent Cardiopulmonary unstable patients No self reported chest pain Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 10.0-50.0, All Breast Cancer Any woman who identifies as African American, Black, or African Currently nursing a baby Able and willing to sign written informed consent Willing to be contacted by study personnel for follow-up to determine whether a biopsy took place Willing to have her milk sample archived for future analyses The woman does not consider herself to be of African American, Black, or African. These women may participate in the other ongoing Breast Milk Study at University of Massachusetts Unable to sign written Informed Consent or Assent Form Unwilling to be contacted by study personnel", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-65.0, All Episodic Tension-Type Headache Male and female patients from 18 years onwards History of ETTH for at least one year. The number of days with such a headache is \u22652 per month Onset of TTH below 65 years of age At least 10 previous headache attacks fulfilling the following four Patients with headache attacks lasting from 30 minutes to 7 days At least two of the following pain characteristics are present Pressing or tightening (non-pulsating) quality Intensity of pain: moderate = unable to ignore (pain may inhibit, but does not prohibit activities) Bilateral location No aggravation by walking stairs or similar routine physical activity Headaches other than TTH: (e.g. migraine, cluster headache, hypertension headache, drug-related headache,analgesic-induced headache,post-traumatic headache; associated migraine attacks are permitted if they are well recognized by the patient and if their frequency during the preceding year has not exceeded one per month) Presence of oromandibular dysfunction History of facial or cranial surgery Use of prophylactic drugs for headache within one month prior to enrolment Use of drugs for acute TTH treatment for \u2265 10 days of headache per month Anticipated problems in adhering to the self-observation procedure (e.g. because of work) Abuse of alcohol, narcotics or other drugs Serious illnesses within the last 3 months (e.g. myocardial infarction, cardiac insufficiency NYHA III and IV, low blood pressure, cerebral insult, diabetes mellitus, neuropathy, changes in the skin or neoplasms in the head) Epilepsy Intake of anti-psychotic, anti-depressant or anti-epileptic medication during the previous month", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndrome Female (post menopausal or surgically sterile) and/or male aged 18 years or older Presenting with ACS fulfilling the following Symptoms or new ECG changes (ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG) Elevation of biomarkers (CK-MB \u22652 ULN or troponin \u2265 ULN) Self-identified as African-American Treatment with 75-100mg ASA daily Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, PE, DVT) for antithrombotic treatment during study period Fibrinolytic therapy within 48 hours before randomization Concomitant therapy with a drug having possible interaction with ticagrelor. (concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer) Increased bleeding risk including: recent (<30 days) GI bleeding, any history of intracranial, intraocular, retroperitoneal, or spinal bleeding, recent (<30 days of dosing) major trauma, sustained uncontrolled hypertension (systolic blood pressure [SBP]>180mmHg or diastolic blood pressure [DBP]>100mmHg), history of hemorrhagic disorders that can increase the risk of bleeding, platelet count less than 100,000 mm3 or hemoglobin <10 g/dL Any history of hemorrhagic stroke Contraindication or other reason that ASA or ticagrelor should not be administered (e.g., hypersensitivity, active bleeding, major surgery within 30 days of dosing) Severe renal failure (creatinine clearance <30mL/min or patient requires dialysis) History of moderate or severe hepatic impairment with aspartate amino transferace, alanine amino transferase or total bilirubin > 1.5 x upper limit of the reference range Pregnant or lactating women Patients receiving any glycoprotein IIb/IIIa inhibitors <8 hours before platelet reactivity testing", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Back Pain Low Back Pain Neuropathic Pain Informed consent signed Male or female 18 years of age or older Women of childbearing potential must have a negative pregnancy test at the Enrollment Visit Women of childbearing potential must practice medically acceptable methods of birth control during the trial Participant must be appropriately communicative and able to differentiate with regard to location and intensity of the pain, and to complete the questionnaires used in this trial Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months prior to enrollment Participant's pain must require a strong analgesic (defined as World Health Organization Step III) as judged by the investigator Participants who require a washout of co-analgesics at enrolment must have an average pain score (NRS-3) of 5 points or higher. Participants who do not require a washout of co-analgesics at enrollment must have an average pain intensity score (NRS-3) during the last 3 days of 6 points or higher The painDETECT diagnostic screening questionnaire must be either \"positive\" (score of 19 to 38 inclusive) or \"unclear\" (score of 13 to 18 inclusive). If the participant is being treated with a stable regimen of centrally acting co-analgesics, a \"negative\" painDETECT score (score 9 points or higher) prior to allocation to treatment Presence of a clinically significant disease or clinical laboratory values that in the investigator's opinion may affect effectiveness, quality of life, or safety/tolerability assessments Presence of active systemic or local infections that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety/tolerability assessments Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members of employees of the investigator Participation in another trial concurrently, or within 4 weeks prior to the Enrollment Visit Known to or suspected of not being able to comply with the protocol and/or appropriate use of the Investigational Medicinal Products Any painful procedures (e.g., major surgery) scheduled during the trial duration (Enrollment Visit until Final Evaluation Visit) that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety assessments Pending litigation or application for insurance/governmental benefits due to chronic pain or disability and/or if the granted benefits might be influenced by a successful participation in the trial Low back pain caused by cancer and/or metastatic diseases History of alcohol or drug abuse, or suspicion thereof in the investigator's judgment Presence of concomitant autoimmune inflammatory conditions", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-80.0, All Pulmonary Arterial Hypertension Signed informed consent prior to any study-mandated procedure Patients with PAH who completed study AC-055-401 Women of childbearing potential must Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation Patients who prematurely discontinued study drug in study AC-055-401 Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study Known hypersensitivity to macitentan or its excipients or drugs of the same class", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 40.0-70.0, All Left Ventriclar Mass They had to have normal glucose tolerance They had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction They were required to have an office BP < 130/80 mm Hg The presence of LVH on echocardiography (American Society of Echocardiography LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women) They were currently prescribed metformin They had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-70.0, All Primary Hypertension Hypertension, Resistant to Conventional Therapy Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included Patients will be excluded for the following conditions: with secondary resistant hypertension because of other disease like renal disease or pheochromocytoma; included in other clinical trial in one month; pregnant or breast-feed or preparing for pregnancy female; combined with disease like stroke, coronary atherosclerotic heart disease, diabetes, chronic renal failure or mental disease", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndrome Provision of subject informed consent Patients hospitalized and diagnosed with STEMI or Hospitalized within 24 hours of onset of symptoms or transferred from another hospital within 24 hours of the onset of symptoms STEMI and precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI STEMI and occurring in patients already hospitalized for other reasons Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances)", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 12.0-24.0, All Obesity \u2265 12 years old Body image concerns Sub-threshold Eating disorder symptomatology Overweight but not obese (BMI between the 85th and 95th percentile for children/adolescents and BMI between 25 and 30 kg/m2 for adults 21-24) Be able to commit to weekly 1-hour sessions for six weeks and 3 separate assessment visits to the MSAHC Current eating disorder (anorexia nervosa, bulimia nervosa or binge eating disorder) absence of body image concerns normal or obese body weight (< 85th or \u2265 95th BMI percentile)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-75.0, All Chest Pain patients undergoing removal of a chest tube after lung surgery patients able to indicate the pain score pregnancy, lactation insulin-dependent diabetes with dysautonomia central or peripheral neurological disease, agitation inability to understand the protocol inability to use the Pain Monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities contra-indication to oral morphine respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations recent administration of neostigmine or of atropine", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 30.0-65.0, All Ischemic Heart Disease healthy men and women aged 30 to 65 years who has one or more self-assessed ischemic heart disease risk factors at screening: physical inactivity, overweight or obese (BMI \u2265 25/m2 ), waist circumference (\u2265 80 cm for women, \u2265 94 cm for men). In addition, the participants should have the motivation and willingness to be randomized to any of the three groups, and to do their best to follow the given protocol no internet access or no access to a computer, smoking, pregnancy, or breast-feeding or planning to become pregnant within the next 12 months, a history of cardiovascular disease, type 2 diabetes, chronic disease / disorders that may affect the results of the study, substance abuse within the past 12 months, regular alcohol consumption > 21 units / week for men or > 14 units/ week for women, allergy or intolerance to food groups in the dietary guidelines, supplements with mega doses of nutrients that can have potential impact on ischemic heart disease risk markers (eg . fish oils)", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-40.0, All Obesity Live in Ribeir\u00e3o Preto, S\u00e3o Paulo Brazil Age between 18 and 40 years old Female gender Regular menses Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity BMI between 18,5 and 24,9 kg/m2, for the group without obesity High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease Psychiatric disorders, alcoholism, smoking or illicit drug abuse Pregnancy or desire to be pregnant Use of medications, excluding contraceptives Contraindication for magnetic resonance imaging Be in treatment for obesity", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Stable Angina Patients aged 18 and over with chronic stable angina (\u22652 months duration) Following screening visit A positive exercise ECG (1mmSTD at J+0.08 seconds) on a modified Bruce protocol treadmill exercise test A positive dobutamine stress echocardiogram and/or a positive myocardial perfusion scan (MPI) and/or a positive coronary angiogram Unable to do exercise test Women of child bearing potential If of a racial origin at risk of glucose-6-phosphate dehydrogenase (G6PD) deficiency, G6PD will be excluded prior to in the study Resting STD>=1mm NYHA 3 or 4 HF or LVEF<45% Myocardial infarction or revascularisation within the last two months Left bundle branch block (LBBB)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Obesity Intra-Abdominal Hypertension years or older Requiring intubation and mechanical ventilation BMI\u226540 kg/m2 or IAP\u226512 mmHg Known presence esophageal varices Recent esophageal trauma or surgery Severe thrombocytopenia (PTL\u226410,000/mm3) Severe coagulopathy (INR\u22652) Presence of pneumothorax Pregnancy Patients with diagnosed moderate to severe ARDS or with poor oxygenation index (PaO2/FiO2 < 200 mmHg)", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 21.0-65.0, All Obesity Subjects aged between 21 -65 years Subjects with BMI > 23 Kg/m2 Subjects aged between 21 -65 years Subjects with BMI > 23 Kg/m2 Diabetes (type 1 and type 2) Known or documented coronary heart disease (CHD) (including ECG consistent with prior myocardial infraction), cerebrovascular accident (including transient ischemic attack), peripheral vascular disease (including symptoms of claudication) Angina or other chest pain that may indicate CHD by history Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable) by history Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, other investigational drugs within 30 days of study entry Pregnancy or planning pregnancy during the study period by history Uncontrolled hypertension Uncontrolled hypothyroidism", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 0.0-999.0, All Chronic Obstructive Pulmonary Disease Information consenting out-patients with a previous physician diagnosis of COPD Clinically stable Ambulatory Subjects who required supplemental oxygen for exercise Subjects with pulmonary hypertension and angina Intolerant to beetroot Insulin dependent diabetes Thyroid disease", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-44.0, All Domestic Violence Domestic Abuse Woman: African American/ African Caribbean/African heritage/Mixed Age 18 \u2010 44 (A.1) Abused (physical, sexual emotional abuse) by an intimate male partner based on responses to screening questions Has had an intimate male partner in the last 2 years Resident of the US Virgin Islands and plans to remain for next two years Woman: Not African American/African Caribbean or African Heritage/Mixed Under or over age limit No intimate partner in the last two years No history of physical, sexual or emotional abuse by an intimate partner Non resident of US Virgin Islands", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Intradialytic Hypotension Must be able to give informed consent for participation in this study Age \u2265 18 years A body weight > 100 lb or a body mass index > 18.5 End-stage renal disease with hemodialysis in-center three times per week Not missing any treatments in the preceding two weeks and in compliance with instructions from the health care provider In the last month had at least two episodes of IDH (defined as having hypotensive symptoms such as dizziness, fainting, headache, nausea, vomiting, cramping, weakness, blurry vision and/or a decrease in systolic blood pressure (SBP) of more than 20 mmHg) Hemoglobin greater than or equal to 9.0 g/dL (hematocrit 27%) to hemoglobin of 15.0 g/dL (hematocrit 45%) \u2022 Pregnancy (self-reported) Allergic to nylon, polyesters and latex Not able to understand the English language Not able to disengage the ACES from compression Having an excessively low systolic blood pressure (SBP which is less than 90 mmHg) Hemoglobin less than 9.0 g/dL or greater than 15 g/dL Excessive intra-abdominal fluid pressure Respiratory distress Bleeding in the chest and abdomen Bleeding dyscrasia causing serious coagulation problem", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Treatment of Acute Coronary Syndrome (ACS). The patient population that will be observed in the NIS must fulfil all of the following Female or male aged \u226518 years A patient information letter has been sent by the Investigator to the patient Patient discharged alive from this hospital to home following ACS (diagnosed with STEMI, or UA) ACS is either UA or myocardial infarction of Type 1 (spontaneous myocardial infarction related to ischemia due to a primary coronary event such as plaque erosion and/or rupture, fissuring, or dissection) ACS after 1st July 2012 and before 1st June 2013 Patient on ticagrelor, prasugrel or clopidogrel treatment at discharge following an ACS Patients will not be eligible to participate if any of the following are present Patient who participated in any interventional clinical study during the observation period Patient with ACS precipitated by or as complication of surgery, trauma, gastrointestinal bleeding or after Percutaneous Coronary Intervention (PCI) Patient with ACS occurring during a stay in the hospital", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Left Ventricular Hypertrophy Insulin Resistance Coronary Artery Disease Aged 18 years or over Participant willing and able to give informed consent Documented Ischaemic Heart Disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina Screening echocardiography based diagnosis of LVH based on ASE (males >115g/m2, females >95g/m2) Fasting insulin resistance index \u2265 2.7 AND/OR HbA1c >5.6 and less than 6.5 at screening Blood pressure < 140/85 mm Hg or 24hr BP <135/85 daytime average in screening Able (in the Investigators opinion) and willing to comply with all study requirements Cognitive impairment Type 1 or 2 Diabetes mellitus Chronic Heart Failure as evidenced by echocardiogram or documented diagnosis of CHF Left Ventricular Ejection Fraction <45% on screening echocardiography Contraindications to cardiac MRI (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention) Malignancy (receiving active treatment) or other life threatening disease, renal disease (CKD class 3B or worse) Pregnancy/lactating females Any other reason considered inappropriate by a study physician Participants who have participated in any other clinical trial within the previous 30 days", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-80.0, All Angina Pectoris Age 18 to 80 years History of stable, exertional angina pectoris (Canadian Cardiovascular Society functional class II to III) for at least 3 months duration prior to enrolment in the study Patients not currently receiving treatment with antianginal medication (other than short-acting nitrates) Between visits 2 and 3 two treadmill exercise tests, demonstrating \u2265 0.1 mV of horizontal or down sloping ST-segment depression, must be carried out. The difference in symptom-limited exercise duration between these two tests must not exceed 20% Total treadmill exercise duration > 3 minutes (i.e. stage 2 or above on a standard Bruce protocol) Coronary artery disease, preferably (not mandatory) documented by a history of proven myocardial infarction and/or coronary angiography indicating \u2265 50% reduction in luminal diameter of one or more coronary arteries or their primary branches Myocardial infarction within 3 months prior to enrolment in the study Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within 6 months Other types of angina (variant, unstable) Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg) Resting heart rate < 50 bpm or > 100 bpm Significant valvular heart disease Heart failure New York Heart Association Class III or IV Chronic obstructive pulmonary disease and/or asthma with clinical symptoms requiring regular medication Significant arrhythmia (since this may interfere with the interpretation of the electrocardiogram) including Wolff Parkinson-White syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, significant Atrio-Ventricular heart block, intraventricular conduction defect (QRS > 0.12 seconds) ventricular pre-excitation, bundle branch block, the presence of a pace-maker, the presence of an implanted automatic defibrillator, uncorrected hypokalaemia (potassium < 3.5 mmol/litre) Insulin dependent diabetes mellitus", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-60.0, All Obesity Metabolic Syndrome Morbid obesity (BMI>30) patients with one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension) Morbid obese patients (BMI>35) Prior bariatric surgery Malignancy (any type) End stage renal disease", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-80.0, All Hypertension Acute Myocardial Infarction Provision of informed consent prior to any study specific procedures Female and/or male aged 18-80 years Patients with ACS, i.e. STEMI, non-STEMI, treated with PCI Medical history of treated (ongoing) hypertension, or hypertension discovered at the time of ACS, and office SBP >140 despite treatment with three antihypertensive drugs Ejection fraction >40% Increased risk of pathological bleedings Office systolic blood pressure <120 Renal artery abnormalities eGFR <30 mL/min ICD or pacemaker, or any other metallic implant not compatible with MRI Estimated survival time <1 year Not oriented to person, place and time Inability to understand given information about the study Fertile female", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 45.0-55.0, All Hypertension Patients operated due to carpal tunnel syndrome under intravenous regional anesthesia betweem January 2009 and January 2010 The patients that the files could not be reached", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation Caucasians \u2265 18 years of age History of typical or lone symptomatic AF AF symptoms present at least once per month ECG that was recorded within 12 months of randomization showing AF Starting a Class I or Class III AAD In sinus rhythm at enrollment Able to give informed consent Permanent AF or isolated atrial flutter Cardiac or thoracic surgery within the previous 6 months Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital) Medical condition that is likely to be fatal in less than one year Received 2 or more AADs in past Creatinine clearance <40 ml/min Contra-indication to a class I AAD e.g., structural heart disease, or history of MI Contra-indication to a class III AAD, e.g., congenital or acquired long QT syndrome with QTc>450 ms at baseline A reversible cause of AF (e.g., thyrotoxicosis) Previously treated with class I and class III antiarrhythmic drugs", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndrome Women age 18 years or older Non-ST-elevation acute coronary syndrome (defined as new onset chest discomfort that occurs at rest or with low levels of activity/or emotion within the preceding 48 hours) with either elevated troponin T (\u2265 0.03 ng per milliliter) elevated creatinine kinase MB-isoenzyme (\u2265 5.0 ng per milliliter) elevated NT-pro-BNP (\u2265 450 pg per milliliter) ST-segment depression (\u2265 0.5 mm) or TIMI risk score (> 2) women who have elevated cardiac enzymes after non-cardiac surgery will also be considered ST-elevation myocardial infarction cardiogenic shock congestive heart failure hemodynamic instability use of fibrinolytic therapy in the last 96 hours current bleeding or bleeding disorder within the last 3 months that required transfusion pregnancy contraindication to any study medication. i.e.heparin, clopidogrel, or glycoprotein IIb/III inhibitor PCI in the last 6 months prior CABG", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-50.0, All Obesity for in main ACE stapling study Subject must be able to understand and be willing to sign an informed consent document Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits Subject has a BMI of 40 or 30 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study Subject must have failed standard obesity therapy of diet, exercise, behaviour modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial Main study Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure Subject has a history or is diagnosed with eating disorders Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where plications are to be placed", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Nerve; Disorder, Sympathetic Patients presenting for sympathetic block of the lower extremity (lumbar sympathetic block) Ages 18-99 Patients with pacemakers or cardiac defibrillators Age <18 IV sedation for anxiolysis or analgesia Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated) Allergy to adhesive tape Patient with diagnosis of: Dysautonomia, Sympathetic dysfunction (e.g.,Raynaud disease, Buerger disease) or Disorders of sweating (e.g.,Acquired idiopathic generalized anhidrosis) Patients on vasoactive drugs", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-85.0, All Postoperative Pain Patients undergoing unilateral THR and TKR who are between the ages of 18 and 85 regardless of the anesthesia and postoperative analgesia type Patients participating in other studies may participate in this study as well Patients with Motor Activity Assessment Scale (MAAS) Score of 3 and 4 Age <18, >85 History of chronic pain as defined by use of long acting opioid medication > 6 months duration MAAS Score of <3 and >4 Anticholinergic agent use Patients with the following conditions Autonomic neuropathy Pacemaker/AICD Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated) Allergy to adhesive tape Communication barriers", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-50.0, All Relapsing Remitting Multiple Sclerosis To be eligible to participate in this study, candidates must meet all the following atthe Screening visit (V0)AND at baseline (V1) Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected information in accordance with local subject privacy regulations Patients with RRMS (McDonald 2010) who do not accept current injectable firstline DMTs Age between 18 and 50 years at the time of informed consent MS onset within one year before enrolment \u2265 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment No previous disease modifying and/or immunosuppressive treatments for MS Must have a baseline EDSS between 0.0 and 5.0, inclusive. \u00b7 Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment Candidates will be excluded from study entry if any of the following exists at Screening OR Baseline/Randomization Visit Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996) Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide Previous treatment with Fumaderm\u00ae, dimethyl fumarate or other fumarates History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment) History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease Angina Symptoms of Angina Pectoris Angiographic evidence of epicardial coronary artery stenosis referred for PCI Flow limiting lesion (Fractional Flow Reserve \u22640.80) in one of following locations (as defined in trial89) Proximal or mid left anterior descending artery (LAD) Proximal or mid dominant right coronary artery (RCA) Proximal left circumflex artery (LCx) or 1ST Obtuse marginal Vessel Existing beta blocker prescription Echocardiogram performed within preceding 12 months Patient consent Previous myocardial infarction (MI) in target vessel myocardial territory or any MI in preceding 12 months (defined by patient history, ECG changes and evidence of regional wall motion abnormalities on echocardiography) FFR>0.80 in target vessel at time of procedure Requirement for Multi-vessel intervention in a single procedure Any chronic total occlusion (100% epicardial occlusion) on angiography Distal coronary artery stenosis or that affecting non-dominant RCA Heart Rate <60 bpm at (assessed by 12 lead ECG after minimum 10 minutes rest period) Any rhythm other than sinus rhythm Sick sinus syndrome or high grade atrio-ventricular block Permanent Pacemaker in situ Congenital QT Syndrome", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-55.0, All Overweight Obesity All participants will be between the ages of 18-55 meeting for overweight, with a BMI between 25 and 45 Participants will provide written informed consent for study participation Participants will possess English language skills at the 5th grade reading level Participants will be free of major medical conditions such as a recent history of coronary heart disease; recent history of myocardial infarction; recent symptoms of angina, diabetes, recent stroke, orthopedic problems that would limit activity during the following twelve months; or any other serious medical condition that would make physical activity unsafe Participants will not have bulimia or anorexia, significant cognitive impairment, a known psychotic disorder, or unstable psychiatric illness (e.g., recent psychiatric hospitalization, acute suicidal ideation) as derived from their intake interview and questionnaires Participants will not be moving out of the San Diego area for the duration of their study enrollment (24 months) Participants will not be pregnant, planning to get pregnant in the 2 year study period or lactating Participants will not be taking medication for weight loss or that may impair physical activity tolerance or performance Participants with medical or psychological problems, or taking medications that could make adherence with the study protocol difficult or dangerous will not be included ", "label": "0"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 20.0-80.0, All Hypertension Eligible subjects were untreated hypertensive men or women aged between 20 and 80 years old with SBP between 130 and 179 mmHg and/or DBP between 85 and 109 mmHg as measured in a sitting position Subjects were excluded if they had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. They were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions", "label": "2"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndrome Subject with compatible symptoms with an acute coronary syndrome, for at least 15 minutes and not older than 3 hours (eg discomfort, tightness or chest pain, pain radiating to the left arm or two arms, pain in the jaw, pain in the back / neck / stomach, breathlessness , cold sweats, nausea / vomiting , dizziness ) Man or woman Patient Did not receive heparin or low molecular weight heparin (LMWH ) before the initial blood sample Patient Agreeing to participate in the study and who signed an informed consent Minor or major patient trust Patient Not having signed informed consent (refusal , physical or mental disability ... ) Patient Who received anticoagulation before carrying blood samples Patient With a progressive septic processes , neoplasia undergoing treatment, dialyzed kidney failure, a history of surgery or coronary angioplasty less than six months Transplanted heart, renal or hepatic heart attack Subject Whose symptoms clearly eliminates acute coronary syndrome ( penetrating trauma, traumatic injury by crushing ... ) Patient Died between the time of and arrival in the cardiology intensive care ( SIC ) Patient Withdrawing consent under study", "label": "1"} +{"topic": "A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes.", "doc": "eligible ages (years): 18.0-999.0, All Abdominal Obesity-Metabolic Syndrome Body mass index more than or equal to 25 kg/m2 Patients with metabolic syndrome Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs Uncontrolled diabetes patients Patients with gastrointestinal abnormalities Patients with cardiovascular diseases Patients with hematologic disorders Patients with Glomerular filtration rate less than 60 ml/min/1.73m2 Patients with drug or alcohol abuse Pregnancy and lactation", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 0.0-0.5, All Thrombosis Parent/legal-guardian has provided written informed consent before initiation of any study related procedures Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram Age less than 6 months Gestational age greater than 35 weeks Expected life expectancy at least 14 days No contraindication to anticoagulation i.e. bleeding complications Active or recent (less than 7 days) bleeding Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment Refusal to undergo blood transfusion should it become necessary Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial Baseline prolonged PT (>18 secs) or aPTT (>55 secs) Platelet count < 50,000 cells/mm3 Birth Trauma Planned or indicated surgery within 30 days Major or minor bleeding event", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 15.0-70.0, All Acquired Bleeding Disorder Spinal Fusion Elective spinal fusion surgery History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis) Any trauma within the last 3 months leading to hospitalization > 24 hours Angina or known coronary artery disease", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-78.0, All Cardiac Arrest Non-traumatic collapsed patients, whose pulsation continues and persists more than 5 minutes after return of spontaneous circulation from cardiopulmonary resuscitation and consciousness level is less than GCS 5 points Age > 78 y/o or < 18 y/o 2. Core temperature< 34\u2103or > 38 \u2103 after resuscitation 3. Pregnancy 4. Underline terminal malignancy disorder or refuse aggressive treatment cancer patient 5. Massive bleeding, known coagulopathy, or received regular anticoagulant medication 6. Persisted hypotension ( mean arterial BP < 60 mmHg) after resuscitation even under inotropic agents 7. No bed available in ICU", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 50.0-75.0, All Hypertension Postmenopausal women Mild to moderate hypertension Statin therapy or LDL\u2264 4.1 mmol/L Severe hypertension LDL > 4.1 mmol/L if not taking anti-hyperlipidemic medication Certain hormonal therapy History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease Diabetes Raynaud's disease or any other significant peripheral vascular disease Allergy to certain medications used to treat high blood pressure Other protocol-defined inclusion/", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Patients >= 18 years of age with pulmonary embolism and cardiogenic shock, defined as a systolic arterial pressure <= 90 mmHg, a drop in systolic arterial pressure >= 40 mmHg for >= 15 minutes, or ongoing administration of catecholamines for systemic arterial hypotension Subtotal or total filling defect in the left and/or right main pulmonary artery due to massive PE, as assessed by chest computed tomography or by conventional pulmonary angiography Right ventricular dysfunction on echocardiography: RV systolic hypokinesis and/or RV dilation (optional) Failed thrombolysis or at least one of the following contraindications to PE thrombolysis present Active bleeding History of intracranial bleeding Surgery, delivery, organ biopsy, puncture of a non-compressible vessel within 10 days History of stroke Gastrointestinal bleeding within 10 days Significant trauma within 15 days Systemic (paradoxical) embolism in the presence of an atrial septal defect or patent foramen ovale Free floating right heart thrombi, left heart thrombi Life expectancy due to underlying disease less than one month", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Healthy Male years and above A negative urine dip-stick Have signed informed written consent to participate The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-79.0, All Hypothermia Heart Arrest Age between 18 and 79 years old Out-of-hospital cardiac arrest (OH-CA) due to a presumed cardiac etiology Delay between OH-CA and return of spontaneous circulation (ROSC) < 60 minutes Delay between ROSC and starting cooling < 240 minutes Patient not obeying verbal command after ROSC and prior to starting cooling Availability of the \"CoolGard\" device (ALSIUS product) Do not reanimate order or terminal disease before Known pregnancy Clinical hemorrhagic syndrome or known coagulopathy Contra-indication to device usage (such as femoral venous access impossible) Hypothermia at admission < 30\u00b0C Etiology of OH-CA thought to be extra-cardiac (trauma, bleeding or anoxia) In hospital cardiac arrest Refractory shock (need for extra-corporeal life support)", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Vascular Disease Written informed consent Age > 18 years If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study Patient is willing and able to comply with the specified follow-up evaluation Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss) Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length \u2264 60 mm Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment Acute limb ischaemia Subacute limb ischaemia which requires thrombolysis as first treatment modality Active bleeding or bleeding diathesis Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure Previous implanted stent at the index site Life expectancy of less than 6 months or other factors making clinical follow-up difficult Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 0.0-999.0, All Asymptomatic Artery Atherosclerosis is the underlying disease Patients with an asymptomatic stenosis >80% (NASCET) with a documented progression of the degree of stenosis to >80% within 6 months with a very tight stenosis \u226590% at initial presentation with a >80% stenosis plus silent ipsilateral ischemia documented by CCT or MRI with ipsilateral >80% stenosis plus contralateral >80% stenosis or occlusion with >80% stenosis plus planned major surgery Neurologist\u00b4s explicit consent to potentially perform CAS Inability to provide informed consent Underlying disease other than atherosclerosis (inflammatory or autoimmune disease) Traumatic or spontaneous carotid dissections Life expectancy <6 months Advanced dementia Advanced renal failure (serum creatinine >2.5 mg/dL) Unstable severe cardiovascular comorbidities (e.g. unstable angina, heart failure) Restenosis after prior CAS or CEA Allergy or contraindications to study medications (clopidogrel, statins, ASA)", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-85.0, All Angioplasty, Transluminal, Percutaneous Coronary Coronary Arteriosclerosis Scheduled for a coronary diagnostic or interventional procedure Able to undergo emergent vascular surgery if a complication requires it arterial puncture located in the common femoral artery Femoral artery has a lumen diameter of at least 5 mm Arterial puncture in the femoral artery of both legs Prior target artery closure with any vascular closure device, or closure with manual compression within 30 days prior to catheterization Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders Acute ST-elevation myocardial infarction within 48 hours prior to catheterization Uncontrolled hypertension at time of vessel closure Elevated Activated Clotting Time at time of vessel closure Ineligible for in-catheterization lab introducer sheath removal Concurrent participation in another investigational device or drug trial Thrombolytic therapy, bivalirudin, other thrombin-specific anticoagulants, or low molecular weight heparin within 24 hours prior to catheterization Preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to femoral artery closure", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Reconstructive Surgical Procedures Tissue Transplantation Adult patients planned to undergo reconstructive surgery using either a pedicle or free tissue transfer flap seen by The Plastic Surgery Service on either an in-patient or outpatient bases Adult patients that are planned to undergo reconstructive surgery as above and able to receive information regarding the study and provide informed consent to enrollment in the study All emergency reconstructive surgery patients Patients planned to undergo radiation therapy in the region of the reconstructive surgery within 6 months after surgery Patients who develop hypotension requiring the administration of vasopressors either intra-operatively or during the post-operative period prior to discharge from the hospital Patients who develop clinical signs of a surgical site infection at the location of the tissue transfer flap(s) Patients with the development of post-operative anemia requiring a blood transfusion during the first 72 hours after surgery Patients with tattooing or pigmented lesions on the tissue transfer flap Patients who incur injury to the flaps secondary to trauma within 6 months of the reconstructive surgery; with trauma defined as either accidental major trauma resulting in injury to the tissue transfer flap or surgical trauma as a result of further oncologic resection of tissues in close proximity to the tissue transfer flap Minor under the age of 18 years of age Patients deemed unable to comprehend and provide informed consent to enrollment into study due to either a cognitive deficit or medical condition", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Vascular Access Complications Cardiac Catheterization Peripheral Vascular Disease Adults age 18 and over Patients undergoing left heart catheterization or peripheral arterial angiography from the retrograde femoral approach Willingness and ability to sign consent form Scheduled to have procedure performed by operator trained in the ultrasound technique Access from a site other than the common femoral artery Nonpalpable femoral pulses Creatinine > 3.0 mg/dl, unless already on dialysis Prisoners Pregnant women Unable or refusal to sign consent form Patients undergoing emergent cardiac catheterization for ST segment elevation myocardial infarction or unstable acute coronary syndrome Equipment unavailable", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 0.0-999.0, All Postoperative Hemorrhages All patients undergoing any percutaneous cardiovascular procedure Patients already enrolled in other clinical trials", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-85.0, All Peripheral Vascular Disease Cardiovascular Disease Subject must be 18-85 Subject must be an acceptable candidate for an elective,non-emergent diagnostic procedure performed percutaneously via the common femoral artery through either a 5F or 6F procedural sheath Subject is an acceptable candidate for emergent vascular surgery Subject agrees to follow-up evaluations to assess for complications related to femoral access site If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an ultrasound of femoral artery performed post-procedure during the 30 \u00b1 7 days follow-up visit Subject or legal representative has been informed of the nature of the study and agrees to provisions and has provided written informed consent as approved by the Institutional Review Board of respective clinical site History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's disease, and/or a current, known platelet count <100,000 cells/mm3, or baseline INR > 1.7 Body Mass Index (BMI) \u00b3 35 kg/m2 Presence of significant anemia (Hgb < 10 g/dL, Hct < 30%) Advanced Subject refusal of blood transfusions, should transfusion become necessary ", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 1.0-18.0, All Hypertension Significant pulmonary arterial hypertension (mean pulmonary artery pressure > 25 mm Hg) Patients aged 4-18 years Routine cardiac catheterization clinically indicated for deciding therapeutic treatment Informed assent/consent from patient/parent Suprasystemic pulmonary artery pressures Evidence of right heart failure History of ventricular arrhythmia Known vascular access arrhythmia Contraindication to Sildenafil Concurrent inotropic / PDE administration Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves No consent/assent Pregnancy or unwillingness to comply with contraceptive advice", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-80.0, All Cardiac Arrest Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min Patients aged between 18 to 80 years Patients who are hemodynamically stable, with a systolic BP > 90 mmHg with or without inotropic support Patients comatose or unresponsive post-resuscitation Hypotension despite fluid and/or vasopressor support Positive pregnancy test in women below 50 years Premorbid status bedbound and uncommunicative", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Cardiac Catheterization All consented pts. over the age of 18 who received sutured mediated femoral vein following catheterization Pt.s who are unable to give consent Pts. whose participation in research is contraindicated for medical reasons are excluded", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 0.0-999.0, All Cardiac Arrest Hypothermia ROSC after SCA due to VF/VT or PEA/Asystolia GCS 3 Non-cardiac SCA Pregnancy Unstable Circulation instead of High-dose Inotropics Life-expectancy reducing concomitant illness", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease, Autosomal Dominant, 1 Patient is > 18 years of age (or minimum age as required by local regulations) The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the \"Patient Informed Consent Form\" All lesions requiring interventions (target lesions one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor\u00ae Zotarolimus Eluting Coronary Stent System Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor\u00ae Zotarolimus Eluting Coronary Stent System. Please check the 'Instructions for Use' that comes with the product. Please be aware that the 'Instructions for Use' may be subject to change during the course of the study The patient is willing and able to cooperate with study procedures and required follow up visits Women with known pregnancy or who are lactating Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen Previous brachytherapy Previous implantation of a drug eluting stent Previous implantation of a bare metal stent in the preceding year Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery Current medical condition with a life expectancy of less than 3 years Manifest acute severe heart failure (Killip class III-IV) The patient is currently, and during the first 3 years of the trial, participating in another investigational device or drug study that clinically interferes with the endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the once", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 19.0-999.0, All Arterial Stiffness The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less All individuals are carefully selected after appropriate clinical evaluation as determined by the treating physicians to possible reversible causes of heart failure Patients with permanent atrial fibrillation and non-palpable carotid and/or femoral pulses will be excluded due to technical limitations of the procedure used for the measurement of arterial stiffness", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Angiography Via Femoral Artery Access The patient must be at least 18 years old Patients undergoing femoral access coronary angiography Patient must be competent for providing informed, written consent Only 6F sheath Percutaneous coronary intervention Intra coronary measurements (FFR, IVUS, OCT, NIR) Groin hematoma before closure Pseudoaneurysm or AV fistula Significant stenosis of ilial or femoral artery Prior peripheral artery surgery INR > 3,0 Platelet count < 120 million per millilitre blood Coagulopathy (bleeding disorder) Thrombolysis in the last 24h", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 30.0-80.0, All Diabetic Foot Ulcer diabetic foot ulcer < = 80 years old diabetic foot ulcer wegnar 2-4 stage Wagner grade 0,1 and grade 5 severe coronary, cerebral, renal vascular as well as severe liver diseases, malignant neoplasms bleeding individuals > 80 years old heart failure (NYHA 3,4) cancer", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-85.0, All Coagulation Therapeutic Uses Pharmacologic Actions patient/legal representative provides written informed consent Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure Target vessel has a lumen diameter \u2265 6 mm Patient must be willing to comply with follow-up requirements Patient has a 5-7F arterial puncture located in the common femoral artery Arterial puncture in the femoral artery of both legs Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks Any closure system has been used on the ipsilateral arterial site within the previous 180 days Any reentry of the ipsilateral site is planned within the next 6 weeks History of surgical repair of blood vessels of the ipsilateral arterial site Patient is unable to ambulate at baseline Significant bleeding diathesis or platelet dysfunction Thrombocytopenia (Plt count \u2264 100,000) Anemia (Hgb \u2264 10mg/dl and/or Hct \u2264 30mg/dl) Hemophilia", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 7.0-18.0, All Pain Ages 7-18 years Scheduled for cardiac catheterization through the femoral artery and/or vein under general anesthetic Ability to speak and understand English No apparent cognitive impairments Known allergies to bupivacaine Impaired renal function Impaired hepatic function", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Critical Limb Ischemia Adult diabetic patients type 1 or 2 Chronic critical ischemia as defined by TASC 2007 (pain at rest, and/or ulcer or gangrene due to arteriopathy: transcutaneous oximetry < 30 mmHg or pressure on the ankle < 70 mmHg) Cancer with adverse prognosis in months, or chemotherapeutic treatment Ongoing or planned pregnancy Lack of consent to participate to the study", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease Age > 19 years Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure Subject must have significant stenosis (>50% by visual estimate) on a native or in-stent coronary artery Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis >75%, evidence of myocardial ischemia does not have to be documented Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.) Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment Subject with non-cardiac co-morbid condition with life expectancy < 2 year or that may result in protocol non-compliance (per site investigator's medical judgment) Subject with cardiogenic shock at presentation Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease Angina Pectoris Myocardial Infarction Age \u226518 years Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with one or multiple stents No limitation on the number of treated lesions, and vessels, and lesion length Pregnancy Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Everolimus or contrast material Inability to provide informed consent Currently participating in another trial before reaching first endpoint Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Critical Care Catheterization Patient admitted in the Intensive Care Unit Requiring Central Venous Catheterization Patients with only one site available", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Severe Sepsis Control group male or female aged at least 18 years, matched on age, sex and cardiovascular risk factors (smoking, hypertension, diabetes and treated dyslipidemia) with septic patients Normal clinical examination and normal 12-lead ECG Routines biological tests in the normal range of the laboratories Body mass index between 18 and 27 kg/m\u00b2 Written informed consent Patients group Male or female aged at least 18 years Severe sepsis defined by the presence of a systemic inflammatory response syndrome Control group legal protection or persons deprived of liberty bacterial or viral infection in the month preceding current medication pregnancy or breastfeeding period stated on the national register for persons who participate to biomedical research Patients group legal protection or persons deprived of liberty vasopressor therapy bacterial or viral infection in the month preceding", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 19.0-90.0, All Carotid Stenosis Femoral Arterial Stenosis Carotid Bruit Asymptomatic Carotid Murmur age 19-90 years having clinical ultrasound evaluation of carotid or femoral artery under age 19; over age 90 years", "label": "2"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Cardiac Disease Coronary Artery Disease Over 18 years of age Each patient, or his or her guardian or legal representative, is willing to give informed consent Clinically indicated for an intra-arterial procedure involving access through the common femoral artery and conducted through an access sheath size of between 6F and 7F inclusive Patients with known allergy to any of the materials used in the device Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year Evidence of systemic bacterial or cutaneous infection, including groin infection Patients suffering with definitive or potential coagulopathy or platelet count <100,000./\u00b5l Use of systemic thrombolytic agents within 24 hours prior to or during the catheterisation procedure which cause the concentration of fibrinogen to be < 100 mg/dl or if post-thrombolytic fibrinogen (in case of thrombolysis within 24 hours or intra-procedural) cannot be measured Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used Currently participating in another investigational device or drug study Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%, or previous bypass surgery or stent placement in the vicinity of the access site If puncture site is via a vascular graft If a palpable haematoma is observed during the procedure", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 16.0-60.0, All Vascular Postoperative Complications Urological System Complication of Procedure Lymphocele Postoperative Infection Patients candidates to renal transplantation Patients with known allergy to products of fibrin seal", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-89.0, All Cardiac Diseases All cardiac surgical patients Non cardiac surgery", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Abdominal Aortic Aneurysm Carotid Atherosclerosis Critical Lower Limb Ischaemia Age greater than 18 years patient willing to give full informed consent for participation Patients undergoing elective carotid endarterectomy or Patients undergoing open abdominal aortic aneurysm repair or Patients undergoing endovascular abdominal aneurysm repair or Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) Patients less than 18 years of age Patients who are unable or unwilling to give full informed consent Pregnancy Significant upper limb peripheral arterial disease Patients on glibenclamide or nicorandil (these medications may interfere with remote ischaemic preconditioning) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with a history of myocarditis, pericarditis or amyloidosis Patients undergoing Fenestrated or branched EVAR", "label": "2"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Acute Ischaemic Stroke Clinical diagnosis of supratentorial acute ischaemic stroke Male or nonpregnant female \u226518 years of age Clinically significant neurological deficit and NIHSS score \u22656 Eligible for IV rtPA according to standard guidelines and able to be commenced on IV treatment <4.5h after symptom onset Enrolment, randomisation and procedure commencement (groin puncture) possible within 90 minutes of the start of IV rtPA treatment (groin puncture maximum 5.5h after stroke onset) Occlusion of the main middle cerebral artery (MCA) trunk, MCA bifurcation or intracranial internal carotid artery(carotidT, M1 or single proximal M2 branch) demonstrated on CTA, MRA, or DSA Interventional device delivery (guide catheter placed beyond aortic arch and angio obtained) can be achieved within 6 hours of onset of the stroke Consent of patient or representative Independent prior to the stroke (estimated mRS 02) Expected to be able to be followed up at 3 months CT evidence of intracranial haemorrhage, or evidence of extensive established hypodensity on CT Clinical history suggestive of subarachnoid haemorrhage even if CT normal Known vascular access contraindications e.g. femoral bypass surgery, tight ipsilateral carotid stenosis, unsuitable proximal vascular anatomy likely to render endovascular catheterisation difficult or impossible Extracranial ICA occlusion or basilar artery occlusion Alternative intracranial pathology potentially responsible for the new symptoms Medical comorbidities which would preclude safe cerebral vessel catheterisation or which are expected to limit life expectancy to <3 months (eg severe cardiac, renal or hepatic failure, significant coagulopathy, metastatic malignancy) Known allergy to radiological contrast", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Cardiovascular Diseases HIV Simultaneous co-enrollment in the START study Signed informed consent Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Hematologic Neoplasm Acute Leukemia Myelodysplastic Syndrome Lymphoma, Multiple Myeloma Potential subjects must satisfy all of the following to be enrolled in the study diagnosis of hematologic neoplasm (acute leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic myeloid leukemia, Ph-negative chronic myeloproliferative neoplasms) independently of the stage of disease or treatment (including transplant procedures) platelet count <50 x109/L at the time of starting antithrombotic prophylaxis or platelet count <50 x109/L at the time of diagnosis of arterial or venous thromboembolism objectively proven or platelet count >50 x109/L at time of thrombosis but subsequent thrombocytopenia <50 x109/L while receiving antithrombotic treatment diagnosis of arterial thrombosis acute coronary syndrome, ischemic stroke (including major and minor stroke), peripheral arterial thrombosis, retinal arterial thrombosis diagnosis of venous thrombosis thrombosis of deep veins of the limbs and the abdomen, superficial veins of limbs, cerebral and splanchnic veins, retinal vein, and pulmonary embolism. Splanchnic venous thrombosis occlusion of hepatic, portal, mesenteric, and splenic veins The following situations will not be of neither outcomes of interest transient ischemic attack without CT and/or NMR signs superficial vein thrombosis without Doppler ultrasound examination showing evidence of thrombosis antithrombotic prophylaxis only local for central venous lines (i.e. CVC flushing with heparin) occlusion of the central venous catheter (notice that CVC-related deep venous thrombosis, i.e. thrombosis of the deep veins where the central line is placed, will be a criterion of or an outcome of antithrombotic prophylaxis)", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 40.0-90.0, All Diabetes Peripheral Arterial Disease Women Diagnosis of diabetes Diagnosis of peripheral arterial disease Regular physical activity Smokers Thrombosis active Severe peripheral arterial disease", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-80.0, All Heart Failure Patients over 18 years of age with chronic heart failure, ischemic and non-ischemic etiology NYHA (New York Heart Association) class II-IV LVEF (Left Ventricular Ejection Fraction) \u2264 35% Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure, who were stable for at least four weeks without acute decompensated heart failure Prior to enrollment, patients must give informed consent Patients with history of acute coronary syndrome or stroke within the last 6 months Significant valvular defects and/or planned cardiac surgery Systolic blood pressure <110 mmHg Advanced renal insufficiency (estimated GFR (Glomerular Filtration Rate) according to MDRD <30 ml/min/1.73 square meters) Unsuitable anatomy of renal arteries (presence of significant renal stenosis, renal artery narrower than 4 mm) Patients who underwent renal angioplasty or stent placement into the renal artery in the past Severe coagulation disorders Pregnancy or lactation Refusal of the patient Other diseases limiting prognosis of the patient to less than 2 years", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Percutaneous Closure of Arteriotomy in Common Femoral Artery Over 18 years of age Each patient, or his or her guardian or legal representative, is willing to give informed consent Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 Females who are not pregnant or lactating, and not planning to become pregnant \u2264 12 months. A pregnancy test may be performed to confirm this There will be no of patients from this trial in respect of race, co-existent disease or concomitant therapy, with the exception of those listed below Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year Evidence of systemic bacterial or cutaneous infection, including groin infection Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation With arterial access other than the common femoral artery.* Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/\u00b5l Patient with a haematocrit of less than 32 % A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal.* If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy.*", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-90.0, All Postcardiac Arrest Pulseless Electrical Activity Asystole Admission to adult ICU (age \u226518 years) at London Health Sciences Centre Primary reason for ICU admission: postcardiac arrest Both in-hospital and out-of-hospital cardiac arrest will be included ICU admission between Jan 2008 and Dec 2012 ICU admissions primarily for reasons other than cardiac arrest", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Vascular Access Complication Comfort CAG or PCI performed via the femoral artery No hematoma in the groin (> 5 cm in diameter) Heparin reversed with protamine after PCI Oozing, bleeding or hematoma Treatment with Integrilin, ReoPro, or Marevan Heparin can not be reversed The patient does not want to participate Systolic blood pressure > 180 mm Hg after the procedure BMI> 35 (can be modified if the groin can be assessed in an upright position) Demented, unconscious patients who do not understand the information for participants", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease patients of both sexes older than 18 years submitted to CABG with CPB, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study intraoperative change of the surgical technique, surgical complications or complications occurring in the ICU, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Abdominal Aortic Aneurysm Carotid Atherosclerosis Critical Lower Limb Ischaemia Age greater than 18 years Patient willing to give full informed consent for participation Patients undergoing elective carotid endarterectomy or Patients undergoing open abdominal aortic aneurysm repair or Patients undergoing endovascular abdominal aneurysm repair or Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) Pregnancy Significant upper limb peripheral arterial disease Previous history of upper limb deep vein thrombosis Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with a known history of myocarditis, pericarditis or amyloidosis Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with severe hepatic disease defined as an international normalised ratio >2 in the absence of systemic anticoagulation Patients with severe respiratory disease (for the trial, defined as patients requiring home oxygen therapy) Patients previously enrolled in the trial representing for a further procedure Patients with previous axillary surgery", "label": "2"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Cardiovascular Disease eligible transplanted patients scheduled for a routine coronary angiography with age >18 years old chronic renal insufficiency (creatinine >2.0 mg/dl) with the potential necessity of using the radial artery as a native fistula will be considered one of the criteria in case of an abnormal or doubtful bilateral Allen's test, a pletysmography will be done. The presence of a type A or B curve will be considered a marker of adequate hand collaterals and the procedure will be able by this access. Only the presence of bilateral type C or D curves will be considered a contraindication to trans radial approach", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndromes Angioplasty, Transluminal, Percutaneous Coronary Unstable angina with an indication for invasive stratification Acute coronary syndrome without ST-segment elevation Acute coronary syndrome with ST-segment elevation Patient informed of the nature of the study and have signed the Informed Consent Patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral Below 18 years of age Pregnancy Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of factor Xa Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance <30 mL / min, platelet count <100,000 mm3) Uncontrolled hypertension Cardiogenic shock Previous coronary artery bypass graft surgery with the use of \u2265 1 graft Patients not candidates for the use of any of the specified vascular access Concomitant severe disease with life expectancy less than 12 months life Medical, geographical, or social conditions that impede study participation", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-80.0, All Hemorrhoids Pain, Postoperative Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or prolapse) that are elegible for surgical treatment with both methods Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure, perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal stenosis Prior anorectal surgery Systemic pathology that could alter the outcome of the surgery as coagulopathies, chronic pain with continued consumption of analgesics Age younger than 18 or older than 80 years, socio-pathology or inability to understand the study objectives", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Disease >18 year Should be able to provide valid informed signed consent CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS) Percutaneous coronary intervention (PCI) procedure and/or implantation of stents ST-Elevations Myocardial Infarction (STEMI) Multiple punctures Active infection Groin haematoma before the closure procedure Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin Cardiogenic shock Prior peripheral arterial surgery in abdomen or lower extremities Sheat size >7 F Life expectancy less than one year", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Endovascular Procedure Requiring an Arteriotomy in the Range of 18 to 24 F, Via the Common Femoral Artery. Over 18 years of age Each patient, or his or her guardian or legal representative, is willing to give informed consent Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 French (F) Females who are not pregnant or lactating, and not planning to become pregnant in \u2264 12 months Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year Evidence of systemic bacterial or cutaneous infection Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation Arterial access other than the common femoral artery Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/\u03bcl Patient with a haematocrit of less than 32 % A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy Circumferential calcification within 20 mm of the arteriotomy", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Renal Failure Chronic Requiring Hemodialysis Central Venous Catheterization Inadequate Hemodialysis Blood Flow Venous Stenosis Venous Thrombosis Infection Due to Central Venous Catheter Central Venous Catheter Thrombosis Chronic renal failure requiring hemodialysis No medical history of central vena catheterization Maintenance hemodialysis after central vena catheterization Signed informed consent Had been performed central venous puncture or catheterization before Can not use heparin Refused to sign the informed consent Advanced cancer patients With or will take arteriovenous fistula surgery in right arm Other inappropriate situation", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 25.0-90.0, All Carotid Artery Thrombosis Carotid Artery Stenosis Stroke Carotid stenosis > 60% Redo carotid surgery Radiation induced carotid stenosis Extensive carotid lesion > 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Artery Disease Critical Limb Ischemia Claudication Age \u2265 18 Patient undergoing vascular surgery that would a groin incision as a standard part of the operation. Infrainguinal bypass including femoral popliteal/tibial/pedal artery bypass with autogenous or prosthetic conduit Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent Any groin incision on index leg within 12 weeks prior to treatment initiation Infrainguinal bypass without a groin incision including popliteal-tibial or pedal bypass Supra inguinal procedures such as open or endovascular abdominal aortic aneurysm repair or aorto-femoral/bi-femoral bypass for occlusive disease Undergoing current chemotherapy or radiation therapy Pregnancy or lactation Inability or refusal to provide informed consent Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days Surgical incision in the groin without primary closure including previously open or infected wounds Sensitivity or allergy to silver Prior enrollment in this randomized controlled trial", "label": "1"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 0.0-17.0, All Intraoperative Complications Postoperative Complications Surgical admission, with a noncardiac surgical interventions Aged between >28 days and <18years on the day of the surgical intervention Non-surgical admission Surgical interventions with <10 per group Cardio-thoracic and interventional cardiology procedures", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All ATRIAL FLUTTER indication for atrial flutter ablation history of recent femoral vein thrombosis (within last 6 months)", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-75.0, All Pain, Postoperative Total Knee Arthroplasty Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement Body-Mass Index >40 Iliac to Patella Distance (IPD) <40cm Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded)", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-75.0, All Vascular Fistula Age from 18 to 75 years Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm Brachial artery diameter \u2265 2 mm Stenosis or thrombosis present in the draining vein A history of peripheral ischemia in upper extremities Active local or systemic infections Inability to consent for the procedure Patients with previous dysfunctional forearm fistula", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Arterial Hypertension Patients with pulmonary artery hypertension (group 1 of the Nice classification of pulmonary hypertension) Aged over 18 years old NYHA class III or IV Not controlled by optimal medical management as defined by dual therapy including a prostacyclin or dual therapy including an endothelin receptor antagonist and a phosphodiesterase inhibitors, in patients with contra-indication of prostacyclin, poor tolerance to this treatment, prostacyclin derivative treatment failure or patient refusal Valid status in the social security system Signed informed consent Patient eligible for pulmonary transplantation Pregnancy or breastfeeding Adults of the age of majority subject to guardianship court order or deprived of liberty Patient with history of radio frequency procedure Known heparin allergy", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Sleep-Disordered Breathing Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension minimum 18 years old diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension diagnosis of PAH based on cardiac catherisation diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before showing AHI above 15) stable clinical condition for at least 3 months before as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months congenital heart disease moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1<60% of the predicted value BMI 35kg/m2 or more patients already treated with CPAP patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 50.0-999.0, All Venous Hypertension Ulcers Venous Stasis Ulcer Venous Ulcer Venous Insufficiency Leg Ulcer Foot Ulcer Varicose Ulcer Diabetic Foot Newly healed leg or diabetic foot ulcer within past 7 days Ankle brachial index 0.8 3mmHg (rule out absence of arterial disease) Willing to wear compression stockings and appropriate footwear Working freezer Open leg or foot ulcers Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog\u2122 for cognitive impairment Chronic inflammatory or vascular conditions where blood flow of skin may be impaired such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy Unable to preform required protocol activities without assistance (return demonstration to study staff)", "label": "0"} +{"topic": "A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Arterial Disease Critical Limb Ischaemia Willing, able, and committed to participate in the procedures for the full length of the study All ethnic groups, male or female above the age of 18 years Diagnosis of non-reconstructable arterial disease and critical limb ischaemia (with a minimum of duplex ultrasound and an MDT discussion to have reached this diagnosis) Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device Blood pressure currently under moderate control (< 160/100mmHg) History of uncomplicated cardiovascular events beyond 3 months No current foot ulceration Patients meeting any of the following are to be excluded Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol Has any metal implants Pregnant Has peripheral neuropathy Has a cardiac pacemaker or defibrillator device Has recent lower limb injury or lower back pain Has current foot ulceration or other skin ulcers Has foot deformities Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study", "label": "2"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-60.0, All Facial Neuropathy 60 years of age Right-handed non-smokers Diagnosed with facial pain Continuous pain for more than 3 months Spontaneous pain greater than 3 of 10 Allodynia to brush greater than 5 of 10 Medications Depression Significant medical problems Claustrophobia Abnormal EKG Significant drug or alcohol history Positive drug screen Weight greater than 285 lbs History of allergy to anticonvulsants Tattoos with metallic ink on upper body", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Neuropathies Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item History of substance abuse or dependence within the past year, excluding nicotine and caffeine Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study Treatment with fluoxetine within 30 days of starting the study Unstable blood sugar control and uncontrolled or poorly controlled hypertension", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 40.0-999.0, All Myocardial Ischemia Documented silent myocardial ischemia type I At least one cardiovascular risk factor History of cardiovascular disease", "label": "1"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 15.0-45.0, All Chronic or Recurrent Appendicitis Patients were eligible if they were between 15 and 45 years of age, and if they suffered from chronic or recurrent right lower abdominal quadrant pain for more than three months. They were to experience continuous pain, or should have endured at least one pain attack in the month prior to inclusion consisted of (a history of) chronic back pain, previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization), specific gastro-intestinal entities (such as inflammatory bowel disease) and gynaecological disease (all female patients consulted a gynaecologist). Routine laboratory investigations included hemoglobin rate, serum leukocyte count and differentiation, C-Reactive Protein concentration, Erythrocyte Sedimentation Rate, faeces cultures and urine sedimentation. Barium contrast studies of the colon were done in all patients, abdominal ultrasound or enteroclysis on discretion. Finally, was possible when diagnostic laparoscopy revealed abnormalities (see below)", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 0.0-999.0, All Brain Trauma Patients of acute moderate brain trauma Patients who are medically unstable or have CT findings that may interfere with the study such as a large hemorrhage or edema encephalomalacia prior neurosurgeries hardware placed in the head or neck prior head trauma history of neurological conditions", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 50.0-75.0, All Type 2 Diabetes Mellitus Age 50-75 years Type 2 diabetes mellitus Angina or anginal equivalent Abnormal rest ECG (Q or ST depression) Known CAD Stress testing within the last 3 years", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-65.0, All Chronic Pain Muscular-skeletal pain in the neck/shoulder region Acute and chronic pain in the neck/shoulder region Restricted range of motion in the neck/shoulder region Fibrosis or scar tissue in the neck/shoulder region Inflammation in the neck/shoulder region Altered function in the neck/shoulder region Muscle strains in the neck/shoulder region Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale 65 years of age Severely herniated disks Pregnancy Taken pain medication within the past 12 hours", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Angina Pectoris Silent Ischemia Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia, all treated with a second generation drug eluting stent Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a Resolute drug eluting stent Patient is > 18 years of age (or minimum age as required by local regulations) The patient has consented to participate by signing the \"Patient Informed Consent Form\"\" The patient is willing and able to cooperate with study procedures and required follow up visits Any type of lesion or number of lesion can be included in this trial unless specifically detailed in the At least one second generation DES implanted in the target lesion in the last 24 hours No other DES implanted before the target procedure No BMS implanted in the 12 months before the target procedure Patients treated for lesions in venous or arterial grafts Patients treated for in-stent restenosis Patients treated for Unprotected Left Main lesions ST elevation myocardial infarction in the 48 hours prior to the procedure Non ST elevation myocardial infarction Patients with LVEF\u226430% Women with known pregnancy or who are lactating", "label": "1"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Inflammatory Demyelinating Polyneuropathy IVIG-untreated subjects Either subjects with newly diagnosed CIDP (developing over at least 2 months) or subjects with an IVIG treatment interruption for at least 1 year with a progressive disease (deteriorating in the last 2 months) prior to enrolment Actual diagnosis (including electrophysiology) of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. for definite or probable CIDP according to EFNS/PNS guideline Age \u226518 years Male or female Written informed consent for study participation obtained before undergoing any study specific procedures IVIG-pretreated subjects Being treated regularly with IVIG on a fixed cycle length of 2 to 6 weeks \u00b1 5 days in the last 6 months, on a fixed dosage of \u00b1 20 % in the last 6 months and deteriorating by at least 1 INCAT score point during the Washout Period of up to 10 weeks (except for an increase from 0 to 1 solely due to upper limb score) Historic diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. for definite or probable CIDP according to EFNS/PNS guideline Age \u226518 years A motor syndrome that fulfils for multifocal motor neuropathy (MMN) with conduction block (i.e., upper limb motor weakness without sensory deficit and with a 50% decrease in action potential amplitude or area on proximal compared with distal stimulation in motor nerves) CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-MGUS antibodies and patients with distal acquired demyelinating symmetric (DADS)neuropathy Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or may interfere with treatment or outcome assessments with the INCAT (e.g., diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with radiculopathy, post-polio-syndrome,M. Parkinson, stroke) Current malignancy History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension History of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident) Migraine associated with IVIG infusion in the last 3 months prior to enrolment Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis) Subjects with serum IgA level less than 50% of the lower normal limit Known hyperprolinemia", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Septic Shock ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment < 18 yr-old pregnancy contra-indication for TEE, non sinus rhythm, aplasia, prior participation to the study, hemodynamic assessment using any other technique than those tested in the study", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Stress Disorders, Post-Traumatic Stress Disorders, Traumatic, Acute Road traffic accident victims hospitalized in surgical department less than 2 weeks Can be called by phone Patient with a coma for more than 15 minutes Patient with a crania traumatism and with loss of consciousness over 15 minutes Homeless", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-90.0, All Hand Foot Syndrome Palmar Plantar Erythrodysesthesia Subjects must meet the following to be eligible for the study Receiving capecitabine or sunitinib as part of routine standard care CTCAE version 4.0, grade 1-3 PPE Adults age \u2265 18 Karnofsky (KPS) performance status of \u226570% Adequate organ and marrow function as defined below ANC > 1000/mL Platelets > 75,000/mL Total bilirubin < 1.5 x UNL AST(SGOT)/ALT(SGPT) < 5 x UNL Subjects meeting any of the following are ineligible for study entry Currently participating in a clinical trial History of hypersensitivity or intolerance to sildenafil or other related products tadalafil (Cialis\u2122), vardenafil (Levitra\u2122) or poloxamer vehicle Currently taking oral sildenafil or other related products tadalafil (Cialis\u2122), vardenafil (Levitra\u2122) Currently taking other treatment for PPE other than standard emollients Using organic nitrates, either regularly and/or intermittently, in any form History of myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months Resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg). Those subjects on alpha-blocker or anti-hypertensive therapy must be hemodynamically stable for at least two weeks before day 1 of study drug Cardiac failure or coronary artery disease causing unstable angina Known retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases)", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Septic Shock or more SIRS according to ACCP/SCCM definition Documented infection or strong suspicion of infection with adequate antibiotic treatment Shock according to ACCP/SCCM definition with the necessity of vasopressor treatment Patients admitted with central nervous diseases ST elevation myocardial infarction Pulmonary embolism Out of hospital cardiac arrest patients Patients with therapy limitations Known pregnancy in other interventional trials", "label": "1"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease The patient is male or female \u2265 18 years of age The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain) The patient is scheduled for coronary angiography, with possible angioplasty The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI) The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent The patient does not present with any form of illness or condition that in the investigator's opinion would impair the results of the study Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment Patients in cardiogenic shock Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI Known history of heparin-induced thrombocytopenia Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study Pregnant women or nursing mothers", "label": "1"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-80.0, All Septic Shock Acute Respiratory Distress Syndrome Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both Shock was defined by the presence 4 Heart rate of at least 90/min A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (\u2264 5 \u03bcg/kg per minute), or dobutamine at least 1 of 3 signs of hypoperfusion (urine output < 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of \u2264 6; plasma lactate higher than the upper limit of the normal value) Acute respiratory distress syndrome\uff1a the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower bilateral pulmonary infiltrates or a chest radiograph consistent with edema no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation Patients were moribund signed do-not-resuscitation odor", "label": "1"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-60.0, All Posttraumatic Stress Disorder Men and women, age 18-60 Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document. We determine whether they have a sufficient understanding of the study procedures and risks by asking them to explain what's involved in the study and to give examples of study risks and benefits Participants must fulfill DSM-IV for current PTSD, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the Clinician-Administered PTSD Scale (CAPS) CAPS score must be at least 40 (moderate PTSD severity) at screening Current, primary Axis I disorders other than PTSD History or current bipolar disorder or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder) Current diagnosis of anorexia nervosa or bulimia nervosa Women who are pregnant or are breast-feeding Drug or alcohol abuse or dependence within the preceding 3 months poorly controlled hypertension (manifest by SBP > 140 and/or DBP > 90); HR < 60 or > 100 at rest at the time of screening and confirmed immediately prior to randomization Evidence of coronary artery disease as evidenced by history, abnormal ECG, typical symptoms History of arrhythmia, cardiac surgery, or family history of sudden death Hepatic dysfunction as defined by AST and ALT > 2x URL, or alkaline phosphatase and bilirubin > 1.5 x URL within X days prior to randomization Chronic renal disease as defined by serum creatinine > 1.9", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 21.0-999.0, All Chagas Disease Heart Diseases Have Chagas disease, confirmed by two serological tests Provide evidence through any of the following diagnosis methods: Rest ECG, 24 hour Holter monitoring, electrophysiological study, stress test or loop monitoring, at least one electrical disorder consistent with sinus bradycardia greater than 45 and lower than 60 bpm, sinus arrest not greater than 2.0 seconds, second degree atrial sinus block, intraventricular conduction disorders such as right branch, left branch or a bifascicular blockage type, first degree A-V blockage, or of type I second degree AV Block without associated bradycardia, atrial and/or ventricular arrhythmias that do NOT constitute an indication for pacemaker implant, ICD or mapping and radio frequency ablation Be asymptomatic or having minimal isolated unspecific symptoms not consistent with cardiac arrest, aborted sudden death, syncope, frequent and recurrent palpitations, cardiac failure, and lower extremity edema Have ejection fraction of left ventricle >35% Be able to give his/her written informed consent Subject should be > 21 years old Be able to return for follow-up visits as required Class I or II (according to AHA/HRS/ESC guidelines) indication for final implantation of pacemaker, ICD, or cardiac resynchronizer Exhibit extrinsic causes of sinus dysfunction or A-V blockage Exhibit infiltrative myocardial diseases such as tumors or associated valvular defects Suffer any concurrent disease that may limit the follow up or evaluation Suffer aftereffects of cerebral embolism Suffer ablation or isolation of pulmonary veins previous to their in the study Not being able or willing to comply with the follow-up schedule Have previous lesions of the spinal cord or aftereffects of skull trauma Have a record of epilepsy Receive pharmacological treatment for other diseases that may modify the autonomic function", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 0.0-999.0, All Pulmonary Thromboembolism Patients with signs or symptoms in favor of PTE who come to Emergency department of Alzahra General Hospital previous history of Allergy to IV contrast Serum creatinin more than 1.8 patients that will not agree to participate in the study pregnancy Body weight more than 120 kg", "label": "2"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 21.0-999.0, All Acute Coronary Syndrome Chest Pain Age greater than or equal to 21 years Chest discomfort or other symptoms consistent with possible ACS The treating physician feels the patient could be discharged home if cardiac disease was excluded New ST-segment elevation in contiguous leads on any electrocardiogram (>/= 1 mV) Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg), tachycardia (HR>120), bradycardia (HR<40), and hypoxemia (<90% pulse-oximetry on room air or normal home oxygen flow rate) Terminal diagnosis with life expectancy less than 1 year A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing Prior enrollment Incapacity or unwillingness to provide consent and comply with study procedures Non-English speaking Sub-study I & II ED attending physicians ED attending physicians who decline to participate", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Anal Incontinence Obstetric Trauma Primiparous women aged 18 years of older Vaginal delivery, vacuum-assisted-vaginal-delivery (VAVD), or forceps-assisted-vaginal-delivery (FAVD) of a neonate of gestational age completed weeks Singleton or vaginal delivery of multiple gestation Able to read and speak the English language Unable to comply with physical therapy or office visits Unreliable transportation Preexisting neurologic, musculoskeletal or neuromuscular disorder rendering them unable to perform physical therapy requirements Cesarean delivery History of prior surgery for anorectal incontinence (i.e. sphincteroplasty", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Acute Pain Reported pain greater than or equal to 3 out of 10 Less than 18 years of age Decreased level of consciousness Inability to answer questions Prisoner", "label": "2"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-70.0, All Dystonia Confirmed diagnosis of focal hand dystonia (patients only) Between age 18 and 70 years Able to give informed consent Right handed Agrees to not drink caffeine or alcohol for 48 hours before study session No open scalp wounds or scalp infections Has used illegal drugs within the past 6 months based on history. The intent is to those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man Abnormal findings on neurologic exam (other than dystonia in patient group) Has had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures Has major depression or any major mental disorders (axis I disorders) Has a neurologic disorder other than dystonia Has had a head injury where there was a loss of consciousness for more than a few seconds Has a pacemaker, intracardiac lines, implanted pumps or stimulators, or has metal objects inside the eye or skull. Dental fillings and dental braces are allowed Has known hearing loss Pregnancy", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-75.0, All Septic Shock Criteria:\u2022 Written informed consent by patient or relative Time in ICU < 48 hours Septic shock Pulmonary artery catheter and radial arterial catheter Age 18 years Sinus rhythm Need for norepinephrine over 0.1 ug/kg/min but otherwise hemodynamically stable i.e no need to change the dose over the last 15min period before the study Mechanical ventilation with sedation Pwcp <18 mmHg Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication ) Contraindication to fluid challenge Contraindication to TEE Previous heart failure, heart valve stenosis of insufficiency", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Hypertension Prospective arm Man or woman aged over 18 With suspicion or diagnosis of pulmonary hypertension Scheduled to undergo right heart catheterization Able and willing to give informed consent Retrospective arm Man or woman aged over 18 With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past Able and willing to give informed consent Both arms Minor (aged < 18) People unable or unwilling to give informed consent Hemodynamically unstable patients Pregnant women Prospective arm only Patients with contra-indication to right heart catheterization Patients incapable of performing a Valsalva maneuver Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Pulmonary Embolus Deep Vein Thrombosis Admitted to the hospital for care of injuries Have a greater than minimal (moderate to highest) level of VTE risk Discharged prior to 24 hours in hospital Minimal VTE risk", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 0.0-17.0, All Septic Shock for 1 and 3 must be answered YES to be eligible for study Age 29 days to less than 18 years of age ) Patient has Persistent Signs of Shock including one or more of the following: i) Vasoactive Medication Dependence ii) Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age) iii) Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output) ) Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause) ) Patient has received initial fluid resuscitation of: Minimum of 40 mL/kg of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 2 hours for patients weighing less than 50 kg, OR Minimum of 2 litres (2000 mL) of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 2 hours for patients weighing 50 kg or more Patient has Fluid Refractory Septic Shock as defined by the Presence of all of 2a, 2b, and 2c Patient located in the Neonatal Intensive Care Unit (NICU) Patient located in the Operating Room (OR) or Post-Anesthetic Care Unit (PACU) Full Active Resuscitative Treatment Not Within the Goals of Care Shock Secondary to Cause other than Sepsis (i.e. obvious signs of cardiogenic shock, anaphylactic shock, hemorrhagic shock, spinal shock)", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 0.0-5.0, All Pneumonia Bronchiolitis Asthma All children below 5 exceeding WHO age-dependent tachypnea criteria ", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-30.0, All Hyperalgesia Asymptomatic subjects who met the criterion of being between 18 and 30 years old rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment development of systemic or degenerative diseases subjects with symptoms of depression according Beck's questionnaire pain in any area between the lower back and head in the last 9 months traumatic event in the past 12 months history of neck or face pain in the last 6 months", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Major Adverse Cardiovascular Events Troponin T GRACE Score patients presenting to the emergency department (\"chest pain unit\") typical angina pectoris absence of symptoms since presentation at least 18 years low GRACE risk score (<140 points) informed consent, signed agreement conditions with need for immediate workup mental disorders dementia pregnancy, breast feeding", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-45.0, All Safety Tolerability Pharmacokinetics Pharmacodynamics Food Interaction Signed informed consent prior to any study-mandated procedure Healthy Caucasian male subjects aged between 18 and 45 years (inclusive) at screening Subjects must agree to use reliable methods of contraception No clinically significant findings on physical examination at screening Body mass index (BMI) between 18.0 and 30.0 kg/m^2 (inclusive) at screening Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate (PR) 45-90 bpm (inclusive) measured at screening lead ECG without clinically relevant abnormalities, measured at screening Body temperature (T\u00b0) 35.5-37.5\u00b0C at screening and prior to (first) dosing Total and differential white blood cell (WBC) count strictly within the normal ranges at screening and on Day \u22121 C-reactive protein (CRP) levels below 5 mg/L Known allergic reactions or hypersensitivity to any excipient of the drug formulation History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug Previous history of recurrent fainting, collapses, syncope, orthostatic hypotension, or vasovagal reactions Veins unsuitable for intravenous (i.v.) puncture on either arm Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening Excessive caffeine consumption Treatment with any prescribed or over-the-counter (OTC) medications within 2 weeks prior to (first) study drug administration or five half-lives of the medication, whichever is longer Any history of immunosuppressive treatment Chronic diseases including those with recurring periods of flare-ups and remission", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 45.0-80.0, All Osteoarthritis Pain Age 45 to 80 years old, inclusive Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) Knee Pain At least 1 of 3 Age > 50 years Morning stiffness lasting < 30 minutes Crepitus on motion Osteophytes on radiograph Symptoms associated with osteoarthritis of the knee (including pain) for \u2265 6 months prior to Screening Knee pain associated with osteoarthritis, which required NSAID or other therapy for \u2265 15 days during the preceding month General Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if They are or intend to become pregnant (including use of fertility drugs) during the study They are nursing They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for \u2265 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.) Body Mass Index (BMI) over 40 A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 1.0-10.0, All Stress, Physiological Patients needing venous blood sampling or insertion of an intravenous canula Normal development according to parents Critically ill children (e.g. shock, respiratory distress or failure) Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections) Known adrenal or pituitary disease Children who have received glucocorticoids during the preceeding six weeks", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Shock healthy volunteers with no assumption of coffee or any other substance with possible action on the autonomic nervous system age < 18 yrs pregnancy assumption of any drugs and existence of any disease intake of any drug/substance with action on the autonomic nervous system during the previous 24 hours", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-85.0, All Common Femoral Artery Injury Other Vascular Adverse Event Patients between 18 and 85 years of age Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI Patients were excluded from the study if the patient has Any procedural complication included prolonged chest pain transient coronary artery closure, no-flow or slow-flow phenomenon hemodynamic instability persistent electrocardiographic changes side-branch occlusion of >1.5 mm, or an angiographically suboptimal result Arterial access other than the right or left femoral artery Vascular perforation, thrombosis during procedure ", "label": "1"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 0.0-999.0, All Basal Cell Carcinoma of the Skin Nevoid Basal Cell Carcinoma Syndrome A diagnosis of basal cell nevus syndrome (BCNS) as defined in the Consensus Statement (Bree et al, American Journal of Medical Genetics [Am J Med Genet] Part A 155:2091-2097) Major are BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type Keratocyst of the jaw prior to age 20 Palmar or plantar pitting Lamellar calcification of the falx cerebri Medulloblastoma First degree relative with BCNS Minor are Rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals Pregnant or nursing Currently participating in another clinical trial Using any systemic treatment for BCC (e.g. vismodegib), or any topical treatment for their BCC tumors, unless discontinued at least one month prior Currently being treated for other cancers with medical or radiation therapy Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material Patients with history of a photosensitivity disease, such as porphyria cutanea tarda Patients with a coexisting skin condition such as scleroderma, psoriasis, or eczema in the skin areas to be treated with PDT, that might interfere with response assessment", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 14.0-16.0, All Adolescent Idiopathic Scoliosis female between 14 and 16 years old normal neurological examination right handed informed consent informed consent form signed by a parent or a holder of parental authority affiliated to medical insurance negative urine pregnancy test For patients (A-STD) : right thoracic scoliosis with a Cobb angle between 20 and 40\u00b0 For healthy volunteers (A-N) : no clinical scoliosis pregnant or lactating woman antecedents of cranial trauma or cranial intervention, of migraine, of spinal trauma, of scoliosis intervention no idiopathic scoliosis contraindications to MRI patient with a legal protection measure", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-65.0, All Tuberculosis of TB (tuberculosis ) subjects Diagnosis TB to 65 years Consent and signed informed consent forms(ICF) Comply with follow-up of TB (tuberculosis ) subjects advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc Taking part in other clinical or within 3 months involved in any other clinical histories of allergy in pregnancy or lactation In a mental illness Any conditions affect the trial evaluation of Non-tuberculosis subjects with lung disease Diagnosis non-tuberculosis subjects with lung disease to 65 years ", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Hypothermia Trauma Trauma patients \u2265 18 years of all severity stages including poly traumatized patients admissioned through the emergency room Patients < 18 years Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Ankle Fractures All patients operated on Nordsj\u00e6llands Hospital, department of Orthopaedic surgery, during the period, for mono-, bi and trimalleolar fracture, according to the AO-principles Age over 18 years Sub study 1 Age under 18 Dementia Need for external fixation Known or suspected DVT or pulmonary embolism Patients without Danish CPR-number, or address in Denmark Patients who doesn\u00b4t want to participate or who are not able to give written or oral consent No palpable pulse in the foot in the affected leg (the posterior tibial or dorsal artery) Multi-traumatized patients and patients with fractures of more than one extremity", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-999.0, All Posttraumatic Stress Disorder Acute Stress Disorder Female, aged 18+ years Had emergency caesarean section within the past 6 hours Have given birth to a live baby at \u2265 37 weeks gestation Do not speak French sufficiently well to participate in assessments Have established intellectual disability or psychotic illness Baby was transferred to intensive care unit after the birth", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 40.0-60.0, All Familial Hypercholesterolemia - Heterozygous For patients with heterozygous form of familial hypercholesterolemia Aged between 40 and 60 years With an identified genetic mutation (LDL-R, ApoB, PCSK9) Asymptomatic With no EKG sign of ischemia No personal history of coronary heart disease Treated or untreated by lipid lowering treatment High cardiovascular risk identified by 1 of the following Current smoking (1 cigarette a day) 2 Family history of very premature onset CHD: first or second-degree male relative onset before age 45, first Non-affiliation to a healthcare system Consent refusal Contra-indication to MRI or to gadolinium injection Claustrophobia, metallic devices, pacemaker, mechanical valve implanted before 1985, pregnancy, nursing Renal failure Technical contra-indication: patient diameter > 70 cm weight > 250 kg Personal history of cardiovascular disease and myocardial infarction Diabetes mellitus Uncontrolled hypertension TG < 4 g/L", "label": "0"} +{"topic": "A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation.", "doc": "eligible ages (years): 18.0-65.0, All Tuberculosis of TB (tuberculosis:include pulmonary tuberculosis and extra pulmonary tuberculosis) subjects judge the pulmonary tuberculosis patient according to Health industry standard of the People's Republic of China WS288-2008:Diagnostic for pulmonary tuberculosis to 65 years old ,no gender limited Consent and signed informed consent forms (ICF) Comply with follow-up of extra pulmonary tuberculosis subjects Diagnosed extra pulmonary tuberculosis by epidemiology, imaging, clinical symptoms, pathological examination and so on Lesions outside the lungs be in unfinished reinforced phase by chemotherapy of TB (tuberculosis) subjects Accompanied by the following severe illness:advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect Taking part in other clinical or within three months involved in any other clinical Severe allergic constitution:allergic to two or more drugs in pregnancy or lactation in a mental illness Any conditions affect the trial evaluation by investigator's judgement of non-TB participants with lung disease A clear lung disease but can pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination to 65 years old, no gender limited", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 25.0-44.0, All Obesity Body Weight Changes Body mass index of 21 through 30 Presence of chronic disease that precludes regular physical activity or changes in dietary intake Currently receiving treatment for psychological disorder Currently pregnant or having given birth within last 12 months Use in last 3 months of weight loss medications or other drugs that affect body weight Participation in a weight loss program in last 12 months Planning to relocate outside the study area in the next 3 years", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Hypothyroidism Male or female subjects >18 years of age Primary hypothyroidism \u22656 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment Thyroxine dose \u2265100 mcg/day No change in thyroxine dose in past 2 months Serum TSH of 0.1-4.8 mU/L Adequate contraceptive measures for women of childbearing age Major systemic illness affecting quality of life or likely to affect participation in the study Treatment with T3 currently or in past 2 months History of thyroid cancer requiring suppression of TSH secretion by thyroxine Ischaemic heart disease \u2013 previous myocardial infarction, angina or coronary artery revascularisation Renal failure: serum creatinine >135 micromol/L Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range Bony fracture in past 3 months or Paget\u2019s disease of bone Secondary (central) hypothyroidism or hypopituitarism", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 25.0-80.0, All Primary Insomnia patients aged 25 with insomnia, will be recruited over a 3-6 month interval All subjects will have a stable sleep/wake schedule with a preferred sleep phase between 10:00 PM and 8:00 AM Must live in the Greater Rochester NY area All subjects will meet diagnostic for Psychophysiological Insomnia according to the International Classification of Sleep Disorders (ICSD). are: the complaint of insomnia and impaired daytime function; an indication of learned sleep-preventing associations and somatized tension; active help seeking. The complaint of disturbed sleep will have one or more of the following characteristics: >30 minutes to fall asleep and/or >2 awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes, problem frequency >4 nights/ week, and problem duration >6 months. In addition, all subjects will complain of fatigue and/or sleepiness at intake As above", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 45.0-75.0, All Obstructive Sleep Apnea Type 2 Diabetes Enrollment in LookAhead Type II Diabetes and Sleep Apnea Determined by parent study, LookAhead", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-50.0, All Obesity Chronic Sleep Deprivation to 50 year old obese men and premenopausal women BMI between 29-55 Chronically (for more than 6 months) sleep-deprived, defined as sleeping on a regular basis less than or equal to approximately 6-1/2 hours/night by history and objective devices (wrist activity monitors and sleep logs) External comparison subjects for extension of Effectiveness Study must meet the above Diagnosed sleep disorders including Chronic insomnia Untreated sleep disordered breathing (sleep apnea at a level of severity [using standardized for measurement], or diagnosed UARS [upper airway resistance syndrome] that would impair the ability to increase sleep duration [Intervention Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in place for 3 months or more and improves sleep is acceptable) Restless leg syndrome or periodic limb movement disorder Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep terrors, sleepwalking, sleep violence) Primary bruxism is allowed as long as it does not interfere with the ability to sleep an additional 90 minutes a night Narcolepsy Central apnea Unstable weight (voluntary losses in BMI greater than 5% over the past 6 months); currently being enrolled in a weight loss program Untreated or uncontrolled diabetes", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Diabetes Mellitus, Type 2 Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months BMI <= 45.0 kg/m2 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 15.0-70.0, All Autoimmune Thyroiditis Hashimotos Thyroiditis Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption", "label": "2"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-75.0, All Secondary Hypothyroidism Hypopituitarism Hyperlipidemias hypopituitarism of at least 3 axes (TSH plus gonadotropin, somatotropin, corticotropin or ADH deficiency) termination of surgical or radiation treatment of pituitary tumors at least six month before study entry BMI of 20 9 kg/m2 non-smoking status history of cardiovascular or pulmonary diseases current thyroxin dosage > 1.6 \u00b5g/kg bw pregnancy epilepsy cerebrovascular diseases nodular goiter", "label": "1"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 0.0-5.0, All Congenital Hypothyroidism L-Thyroxine Follow-Up The diagnostic standard for manifest hypothyroidism and subclinical hypothyroidism was defined as follows Hypothyroidism TSH > 40 mU/L and T3 and T4 below the reference range or TSH > 40 mU/L, T3 normal and T4 below the reference range [2] Subclinical hypothyroidism TSH \u2265 20 mU/L, T3 and T4 normal or low-normal or TSH > 5.6 mU/L and < 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels ", "label": "2"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 0.0-0.077, All Hypothyroxinemia Birth weight: less than 1500g Gestation: 22 weeks 0 day \u2264 Serum free thyroxine level lower than 0.8 ng/dl Serum thyrotropin lower than 10 \u03bcU/ml Age of between 2 and 4 weeks after birth Informed consent any known thyroid disease in mother", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Disorders, Circadian Rhythm Females of childbearing potential who is sexually active must agree to use adequate contraception from screening throughout the duration of the study Must have a diagnosis of Delayed Sleep Phase Syndrome according to International Classification of Sleep Disorders for at least 3 months Based on sleep history, subject's habitual sleep time is more than 3 hours later than the desired sleep time Must have had self reported insomnia which is defined per the sleep history as his or her sleep latency of at least 45 minutes when attempting to sleep at desired sleep time required by his or her work or school schedule The subjective sleep latency via Post sleep questionnaire during outpatient screening period must be greater than or equal to 45 minutes during every working night or school night provided the subject went to bed at their desired sleep time During single blind placebo run-in Polysomnography screening nights, subject is instructed to go to bed at their desired bed time and must demonstrate difficulty in falling asleep based on the following During Polysomnography screening nights when the subject goes to bed at their desired sleep time or The average of total wake time Is in good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology Is able to complete self-rating scales via interactive voice response system, and has a touch tone phone Has a known hypersensitivity to ramelteon or related compounds, including melatonin and melatonin-related compounds or 5-hydroxytryptophan Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives prior to the first dose of study medication, whichever is longer Has flown across greater than 3 time zones within the past 3 months prior to administration of study medication Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of study medication Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of study medication Has a history of alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, or regularly consumes more than 14 alcoholic drinks per week or consumes any alcoholic drinks within 24 hours of Screening Visit Has a history of drug abuse within the past 12 months Has a current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator Has a probable current diagnosis of another circadian rhythm disorder or a sleep disorder other than Delayed Sleep Phase Syndrome that is the primary cause of insomnia Had an apnea hypopnea index greater than 10 on the first night of Polysomnography Screening", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-35.0, All Weight Gain Age 18-35 Body mass index between 23 and 30 Interested in preventing weight gain BMI outside of range specified Age outside of range specified History of or current eating disorder or substance abuse Recent weight loss greater than 5% of weight Currently in another research study that would interfere", "label": "2"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-80.0, All Essential Tremor Subjects must be between the ages of 18 and 80 inclusive Each subject must have current manifestations of ET symptoms based on the Tremor Investigational Group (TRIG) for definite or probable ET Moderate or severe tremor in head or arms for at least 3 years duration No present causes of enhanced physiologic tremor No recent exposure to tremorogenic drugs or drug withdrawal states No direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor No historic or clinical evidence of psychogenic tremor origin Subjects with a history of seizures are eligible Subjects must be in generally good health as evidenced by previous medical history and clinical examination Patients will be allowed to take Beta-blockers but will not be allowed to take any other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening dose of a benzodiazepine to improve sleep is acceptable. They must have been on a stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and will not be allowed to change the dose of that medication throughout the controlled portion of the study. Any medication discontinued during screening in order to comply with these must be stopped for 5 half-lives prior to study initiation Patients do not meet TRIG for probable ET Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement Subjects who have exhibited any psychotic symptomatology Subjects who have known renal deficiencies Subjects who have been intolerant of pregabalin in the past Prior surgical treatment for tremor Patients currently taking more than a single drug for ET Patients taking anti-seizure medications Breast feeding or pregnant females", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 25.0-50.0, All Obesity Weight Gain Body mass index (BMI) 30-39.9 kg/m2 Age 25-50 years No more than 3 kg weight loss during past three months Negative pregnancy test at entry; women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. Women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control BMI < 30 or >40 Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on body weight regulation) Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report History or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease) History of eating disorder Presence of active gastrointestinal disorders such as malabsorption syndromes Pregnancy or lactation Use of obesity pharmacotherapeutic agents within the last 6 months Use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 6 months Recent (past 12 weeks) use of tobacco", "label": "2"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-48.0, All Hypothyroidism Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones Peri and postmenopause Pregnancy Major comorbidity Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations", "label": "2"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-65.0, All Weight Gain Obesity Written informed consent is obtained The subject is English-speaking and 18 through 64 years of age inclusive The subject is currently receiving a serotonergic agent or is scheduled to receive a new or change in serotonergic psychotropic agents for their a psychiatric condition or can document that they have been on a stable regimen without any weight gain in last 3 months as a result The subject must have capacity to obtain and give informed consent The subject must express concern about weight gain as a potential serotonin side effect The patient is in good health as determined by a medical and psychiatric history, medical examination, and cannot have major medical illness that would jeopardize patient health during the study Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate double-barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen) Women must be given a urine pregnancy test (\u00dfHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol The patient must be a voluntary admission inpatient at SUNY Upstate Medical University's Psychiatric department in order to enroll in the study The patient lacks capacity to make medical decisions and ability to receive and utilize the informed consent process due to their mental illness The patient is incapacitated by mental illness The patient is a significant risk of suicide as determined by the study team in this acute setting The patient has recently started a weight loss or exercise program or is taking an insulin resistance improving drug OR plans to start one upon discharge The patient has a co-morbid medical problem thought to induce weight gain or make it difficult to lose weight (ie hypothyroid, hypercortisol, diabetes\u2026) The patient has previously ( in the last 2 months) lost or gained a significant amount of weight from any weight loss program, weight loss agent, or dietary medication The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) The patient is highly unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator The patient has a clinically significant deviation from normal in the physical examination or medical history (renal or hepatic problems) which makes subject medically unstable at time of screening", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 21.0-999.0, All Weight Loss Age range: 21 years and older Body mass index between 25.0-39.9 kg/m2 Weight stable (< 4.5 kg (~10 lbs) weight gain or loss within last 6 months) Body fat >25% (assessed by skinfold and plethysmography (if needed)) Non-smoking (within the last 6 months) Constant habitual activity patterns (within last 3 months) Clinically normal blood profiles (specifically, normal liver and kidney function; fasting blood glucose <110 mg/dl) Not taking medications known to influence appetite or metabolism Non-diabetic Age: <21 years Body mass index: outside of the 25.0-39.9 kg/m2 range Gained or lost > 4.5 kg (10 lbs) within the last 6 months Body fat <25% as assessed by plethysmography Smoker (currently or within the last 6 months) Intermittently been involved in a diet and/or exercise program within the last 3 months Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD Taking medications (currently or within the last 3 months) known to influence appetite or metabolism Clinically diagnosed as diabetic Allergies to eggs", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Fibromyalgia Fibromyalgia using ACR diagnosis Other confounding disease including other inflammatory disease, pain and depression", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 21.0-35.0, All Obesity Healthy normal and obese volunteers serious medical or neurological condition", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-85.0, All Rheumatoid Arthritis Rheumatoid arthritis patients will meet American College of Rheumatology revised (Arnett, Edworthy et al. 1988). This requires at least four of the following seven 1) morning joint stiffness; 2) arthritis in 3 or more joint areas; 3) arthritis of hand joints; 4) symmetric arthritis; 5) rheumatoid nodules; 6) presence of serum rheumatoid factor and 7) changes on posteroanterior hand and wrist radiographs. In addition, 1-4 must be present for at least four weeks. Subjects must be between 18 and 85 years of age If rheumatoid arthritis patients are receiving treatment with traditional disease modifying antirheumatic drugs (DMARD), such as methotrexate, sulfasalazine or hydroxychloroquine, they must be on a stable regime for one month before study and stable throughout study If rheumatoid arthritis patients have received treatment with a TNF antagonist or other biologic medication, they must be drug free for greater than 3 months Steroids Individuals currently taking greater than an equivalent of 10 mg of prednisone will be excluded given the potent anti-inflammatory effects of such medications Opioids Individuals using multiple daily dosage schedule of opioid agents such as oxycodone (Percocet), hydrocodone (Vicodin), morphine, Dilaudid will be excluded Co-morbid medical disorders the presence of active unstable and uncontrolled co-morbid medical conditions such as diabetes, cardiovascular diseases, and cancer will be exclusionary criteria. In particular, individuals with co-morbid inflammatory disorders such as Crohn's disease and ulcerative colitis and other autoimmune disorders will be excluded. Any uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or put the study participant at undue risk will also be considered exclusionary criteria Chronic infections individuals with chronic infections will also be excluded because of effects on immune markers measured in study Co-morbid pain disorders individuals with co-morbid pain disorders such as fibromyalgia will also be excluded. Individuals with fibromyalgia have been found to have sleep abnormalities as well as daytime fatigue and pain (Drewes 1999) and thus could confound findings", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 25.0-999.0, All Obesity Morbid Obesity Obese and morbidly obese women (BMI 30 years and older undergoing laparoscopic gastric bypass surgery Present with at least either metabolic syndrome or diabetes Have smoked in the past 4 weeks Pregnant Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA) There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Neoplasms, Lung Carcinoma, Non-Small Cell Lung Drug Therapy Genes, EGFR Male and female patients aged over 18 years Histologically proven lung adenocarcinoma clinical stage IIIB/IV ECOG performance status 0-2 Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma At least one measurable lesion (according to Provision of written informed consent Life expectancy of at least 12 weeks History of malignant disease Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) Expected life expectancy less than 2 months As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) \u2265 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases) Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study Pregnancy or breast-feeding women (women of child\u00acbearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 35.0-60.0, All Hypothyroidism Recently diagnosed hypothyroid subject (either during the period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor Subject, who has given his/her oral consent for participation Subject included in clinical trial or having participated in a clinical trial during the last 3 months Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) All contraindications to L\u00e9vothyrox", "label": "2"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Major Depressive Disorder Patients must be adult, diagnosed with major depressive disorder and treated with pharmacotherapy Physicians must be either a psychiatrist or a primary care physician, a prescriber of Pristiq, have at least 3 charts representing the 4 identified patient types, have been in clinical practice between 4 and 35 years, primarily office based (50%+), not participated in a research study relating to antidepressants or antidepressant therapy within the past month, not a consultant or have a professional relationship with a pharmaceutical company other than for clinical trials or speaking engagements, and not be employed by of affiliated with an advertising agency, market research company, or pharmaceutical company Patients who have not been treated for depression", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 20.0-999.0, All AITd Patients With Different Polymorphisms Autoimmune thyroid patients patients who cut Nodular Goiter in Wanfang Hospital ", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-90.0, All Central Hypothyroidism Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH Primary hypothyroidism", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Recurrent Melanoma Stage IV Skin Melanoma Patients must have histologically confirmed melanoma with evidence of metastatic disease either by radiologic or physical examination In-transit metastases are allowed Biopsy should be performed to reconfirm the diagnosis in cases of doubt Patients must have measurable disease For computed tomography (CT) imaging, this is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \u2265 20 mm by conventional techniques or as \u2265 10 mm by spiral CT scan For cutaneous lesions, these must be measurable with a ruler and documented photographically with a ruler in place There are no limits on the number of prior therapies; patients must not have received a vaccine containing any of the melanoma antigen peptides, nor previously received daclizumab; at least 4 weeks must have passed since prior chemotherapy or radiation therapy (6 weeks for BCNU [carmustine] or mitomycin C) Life expectancy greater than or equal to 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky \u2265 80%) Leukocytes \u2265 3,000/mcL Patients who have had chemotherapy, biological or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients may not be receiving any other investigational agents Presence of untreated brain metastases; all patients must undergo brain imaging as part of the pre-study evaluation; only patients with no brain metastases, or with brain lesions successfully treated by stereotactic radiation or surgical removal without progression at 28-day follow-up and off corticosteroids for 4 weeks, will be eligible History of allergic reactions attributed to compounds of similar chemical or biologic composition IL-12 or other agents used in the study Concurrent systemic corticosteroids (except physiologic replacement doses) or other immunosuppressive drugs (eg. cyclosporin A) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IL-12; women of child-bearing age must be tested for urinary or serum beta-human chorionic gonadotropin (HCG) Patients with intrinsic immunosuppression, including seropositivity for human immunodeficiency virus (HIV) antibody; patients should be tested for HIV; HIV-positive patients are ineligible Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent; patients with clinical evidence of dementia should have a competent designee participate in decision making Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C; patients should be tested for hepatitis B surface antigen and hepatitis C antibody; patients who are hepatitis C antibody (Ab) positive can be eligible if they are polymerase chain reaction (PCR)-negative", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-70.0, All Androgenetic Alopecia Male, age 18 to 70 year old, in general good health Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale III vertex to VI (See Appendix 1) Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject, has been informed of all pertinent aspects of the trial Willing to maintain the same hairstyle, hair length and hair color throughout the study Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo and other trial procedures Accepting the Information form plus accepting and signing the Informed Consent form Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components Current or 4 weeks dated back use of medical shampoos or solutions which Ketoconazole or the like (e. g. Terzolin\u00ae) in the target region interfering with the CTM or examination method Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens) Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day) Current or 12 months dated back use of Finasteride (Propecia\u00ae, FinaHair\u00ae, etc.), Dutasteride or a similar product Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding Current or 2 months dated back severe diet or presenting a history of eating disorder Any dermatological disorders of the scalp in the target region with the possibility of interfering with the CTM or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-70.0, All Thyroiditis, Autoimmune adults 18-70 years of age having positive antibodies against thyroid peroxidase having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis having evidence of end-stage thyroiditis being a current smoker or smokeless tobacco user be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent", "label": "1"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 0.0-999.0, All Hypopituitarism All patients with pituitary hypopituitarism Unavailability of data", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 0.5-1.5, All Down Syndrome patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21 patient having undergone a cardiac ultrasound not demonstrating any severe heart disease patient aged 6 to 18 months at congenital hypothyroidism hypothyroidism demonstrated by laboratory tests presenting or having presented hyperthyroidism presenting or having presented leukaemia presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis) presenting severe heart disease on cardiac ultrasound, with haemodynamic effects presenting non-controlled cardiac arrhythmia Apgar < 7 to 5 min at birth Gestational age < 245 days (35 weeks)", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-65.0, All Primary Hypothyroidism. Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old Patients scheduled for deployment will be excluded", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Metastatic Breast Cancer OF (MOST for first-line therapy \u2022 Histologically confirmed breast cancer with distant metastases Note A biopsy from the primary tumor or a metastasis can be used for diagnosis Patients with non-measurable lesions are eligible Patients with inoperable, locally advanced breast cancer with lymph node metastases other than ipsilateral locoregional (axillary, infraclavicular, parasternal) or other distant metastases are eligible Patients with bone metastases with or without bone targeted therapy (bisphosphonates, denosumab) are eligible Patients with de-novo Stage IV disease are eligible HER2-positive tumor according to central pathology testing for HER2 for first-line therapy \u2022 Prior chemotherapy for inoperable locally advanced or metastatic breast cancer Note Prior neoadjuvant/adjuvant chemotherapy is allowed if doses for anthracyclines have not exceeded 720mg/m2 and 240mg/m2 for epirubicin and doxorubicin, respectively Re-exposure to paclitaxel is permitted, if the last dose of taxane was given at least 1 year before randomization Re-exposure to vinorelbine is permitted, if the last dose of vinorelbine was given at least 1 year before randomization Prior anti-HER2 treatment for metastatic or inoperable breast cancer Note Prior neoadjuvant/adjuvant anti-HER2 treatment with trastuzumab and/or lapatinib is allowed \u2022 More than one endocrine treatment line for metastatic or inoperable breast cancer exceeding a duration of 1 month", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Thyroid Cancer Differentiated thyroid cancer treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago TSH < 4 imU/L Pregnancy Known metastasis", "label": "1"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 40.0-75.0, All Hypothyroidism Thyroid Diseases Endocrine System Diseases 75 years old Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months Pregnant or lactating women Severe hepatic or renal dysfunction Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism Obviously poor compliance", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 60.0-999.0, All Biomarkers of Stress in Emergency Physicians emergency physician endocrine disease, pregnancy, recent extraprofessional deleterious life event (such as death of a near relative, divorce), any current illness, drugs used to modulate inflammatory diseases (corticosteroids, anti-inflammatory drugs, immunomodulatory drugs), or any drugs with a chronotropic effect taken over the previous six months (beta blockers, diltiazem, verapamil, anxiolytics or antidepressants)", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Breast Cancer Alopecia New diagnosis of breast cancer stage 1-2 Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen Defined as one of the following regimens Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent Docetaxel 100mg/m2 as a single agent Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma) Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale) Subjects with cold agglutinin disease or cold urticaria Subjects who are scheduled for bone marrow ablation chemotherapy Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC) Male gender", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Cancer have stage III or IV cancer diagnosis able to understand English have a Karnofsky Performance Status (KPS) score of 60% (able to care for most of the personal needs) have fatigue and/or two other target symptoms have been cleared by their provider to engage low to moderate intensity physical activities are hospitalized have lesion or metastasis of bone have a cardiac pacemaker have a history of seizure or loss of consciousness have been using a Wii Fit diagnosed cognitive impairment", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 25.0-65.0, All Obesity Prevention of Weight Gain. Men and women between 25 and 65 years of age Overweight or Class I or Class II BMI Walk without assistance Commit to a schedule of assessment visits Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia Enrolled within past year in a formal weight loss program Reported losing greater than 5% of current body weight in the previous 6 months Smoking Plans to move from the area Participating in another research study Clinically judged to be unsuitable for participation or adherence as determined by the participants physician Inability or unwillingness to provide informed consent", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-60.0, All Asthma years of age or older Known Asthma The exacerbation is defined as moderate or severe Not currently enrolled as an active participant in another clinical trial of a medical therapy or device The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy years of age or older Known thyroid disorders Subject where thyrotoxicosis is suspected Known heart disease Heart rate > 140", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-45.0, All Hypothyroidism Consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012 ", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-35.0, All Hashimoto's Thyroiditis Newly diagnosed (within 1 year) Hashimoto's thyroiditis by positive serum anti-TPO antibody or anti-thyroglobulin antibody Euthyroid state by serum free T4 and TSH level within normal limit Pregnant, planning pregnant within 1 year, or lactating women Renal insufficiency, abnormal liver function test Hematologic diseases: anemia, agranulocytosis, thrombocytopenia G6PD deficiency, porphyria cutaneous tarda Allergy to 4-aminoquinoline compounds Known retinopathy or visual field defect disorders Already receive immunosuppression therapy", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-999.0, All Hypothyroidism Subclinical Hypothyroidism Hyperthyroidism Subclinical Hyperthyroidism Graves Disease Hashimoto's Thyroiditis Iodine Deficiency Genetic Susceptibility Aged equal or more than 18 years old at the time of sampling Malaysian citizen Respondents who did not give consent", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 21.0-100.0, All Health Behavior adults age 21 and over referred by primary care physician for health coaching have telephone for follow-up English speaking pregnant or trying to become pregnant", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 21.0-80.0, All Insomnia Primary Insomnia Chronic Insomnia to 80 years of age Insomnia sufferers enrolled, will meet Research Diagnostic for insomnia disorder score > 14 on the Insomnia Severity Index report insomnia for > 3 months have sleep difficulties > 3 nights per week score < 3 on the Epworth Sleepiness Scale (ESS) score > 40 on the Hyperarousal Scale and report an inability to nap in the daytime The normal sleepers enrolled will report general satisfaction with sleep and no sleep/wake complaints, score < 10 on the ESS, score < 35 on the Hyperarousal Scale, and deny a practice of routine daytime napping sleep-disruptive medical condition (e.g., rheumatoid arthritis) current major psychiatric (Axis I) condition on the basis of a Structured Clinical Interview for Psychiatric Disorders (SCID) sedative hypnotic dependence and unwillingness/inability to abstain from these medications while in the study use of anxiolytics, antidepressants, or any other psychotropic medication an apnea/hypopnea index (AHI) > 5 or a periodic limb movement-related arousal index > 5 during on screening PSG that includes a full sleep montage to allow for detection/diagnosis of sleep-disordered breathing and PLMD female participants who have tested positive on urine pregnancy tests or planing on becoming pregnant during the study Additionally, self-described NS who meet for any sleep disorder and those insomnia sufferers who meet for a comorbid sleep disorder in addition to insomnia disorder will also be excluded", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 19.0-999.0, All Post Radiation/Chemotherapy Alopecia Presents With Hair Thinning. Post-burn Alopecia Presents With Hair Thinning. Cicatricial Alopecia Presents With Hair Thinning. Androgenetic Alopecia Presents With Hair Thinning Alopecia Due to Traumatic Injuries Presents With Hair Thinning. Alopecia Due to Skin Disease Presents With Hair Thinning. Subject is \u2265 19 years old Subject has hair thinning of any etiology and has chosen to undergo hair extensions treatment Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, delicate combing, etc.) Subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is NOT suffering from skin problems at planned implantation site around it Subject has Good general health Woman of child bearing potential must have a negative pregnancy test Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol Previous other synthetic hair implants or hair transplantation in the past six months. Subjects with previous Hairstetics' implants implanted less than 6 month prior to screening are allowed, if the implants are located in a different location on the scalp Currently suffering from skin problems at planned implantation site or around it that might affect the procedure and/or success as clinically evaluated by the investigator Currently receiving or have within the past 3 months received radiation and/or chemotherapy Currently using steroid product with Immunosuppressive treatment Impaired coagulation Serious illness that may affect subject compliance to protocol Subject is using illegal drugs Participating in other clinical study Known allergy or hypersensitivity to Nitinol or Nickel or Titanium", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-35.0, All Sleep Pregnancy Stillbirth Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Very Low Birth Weight Fetal Growth Retardation Fetal Hypoxia \u226518 years old low-risk singleton pregnancy entering the last trimester of pregnancy (in range 26-30 weeks of gestation) residing in the Greater Accra Metropolitan Area or area served by the Korle Bu Teaching Hospital fluent in either English, Twi, or Ga BMI \u2265 35 at booking (first antenatal appointment for current pregnancy) pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth]) sleep complicated by medical conditions (known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder]) multiple pregnancy known fetal abnormality maternal age >35", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-45.0, All Diabetes Weight Gain Weight Loss Cardiovascular Disease Obesity Participants will be men of European (self-report of both parents of white European origin) or South Asian (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin) with BMI <25 kg.m-2, who have been weight stable (\u00b1 2 kg) for >6 months will diabetes (physician diagnosed or HbA1c \u22656.5% on screening), history of cardiovascular disease, regular participation in vigorous physical activity, current smoking, taking drugs or supplements thought to affect carbohydrate or lipid metabolism, or other significant illness that would prevent full participation in the study", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 4.0-18.0, All Hashimoto Thyroiditis Graves Disease For HT A positive titers of antithyroid peroxidase (anti-TPO) or antithyroglobulin (anti-Tg) antibodies and at least one of Abnormal thyroid function that requires substitution treatment with L-thyroxine (TSH > 5 \u03bcIU/ml and decreased or normal levels of fT4 or fT3) Increased volume of thyroid gland (goiter) Morphological changes on ultrasound of the thyroid gland For GD A positive titers of thyroid stimulating antibodies (anti-TSI) and Decreased TSH levels and increased levels of fT4 or fT3 For Controls Otherwise healthy children and adolescents, age Not Caucasian origin or affinity among participants Age of diagnosis above 18 years Disease duration below 3 months", "label": "1"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 18.0-80.0, All Hypothyroidism Neoplasms Postoperative Complications Biopsy proven head and neck cancer, as defined by AJCC staging system Treated with surgery in Edmonton, Alberta Treated with curative intent Diagnosis of sub-clinical hypothyroidism after head and neck surgery (TSH 4-10mIU/L, and free T4 10-24pmol/L) Head and neck cancer of the thyroid gland, or other subsite involving the thyroid gland Underwent previous treatment for a different head and neck cancer History of radiation therapy and or chemotherapy to the head and neck History of thyroid disease as follows Hypothyroidism Hyperthyroidism Autoimmune thyroid disease including Grave's disease and Hashimoto's thyroiditis History of thyroiditis History of diabetes mellitus History of long term steroid usage", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 8.0-15.0, All Type 1 Diabetes Stress Informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry Diagnosed with Type 1 DM/Hashimoto thyroiditis prior to signature of Patient Informed Consent (PIC) (for the T1D group) Age between 8-15 years old (inclusive) at signature of PIC Treated by the investigator's centre prior signature of PIC (For the T1D and HT group) Willing to undergo all study procedures Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol (e.g. intellectual disability)", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 20.0-80.0, All Head and Neck Neoplasms Patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck cancer history of coagulation disorders prior radiation to the neck prior neck dissection declined to participate", "label": "0"} +{"topic": "A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline.", "doc": "eligible ages (years): 2.0-18.0, All Pediatric Sleep Apnea children (younger than 18 years old and older than 2 years old) with symptoms of snoring and then were confirmed to having obstructive sleep apnea/hypopnea syndrome by a comprehensive polysomnography patients with substance abuse problems or the long-term usage of medications known to affect sleep, craniofacial abnormalities or neuromuscular disorders, Down syndrome, cerebral palsy, mucopolysaccharidoses, Prader-Willi syndrome, history of psychosis, central sleep apnea syndrome, or previous airway surgery including tonsillectomy and/or adenoidectomy were excluded from the study", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Lung Neoplasms Breast Neoplasms Diagnosis of local or metastatic breast or lung cancer Shortness of breath with onset after cancer diagnosis Life expectancy of at least 4 weeks Prior acupuncture Other conditions suspected of causing shortness of breath, such as congestive heart failure, sarcoid disease, pneumonia, or obesity No chest wall deformity Neuromuscular disorders Pulmonary vascular disease Anemia Uncontrolled pain or infection Heart valve dysfunction", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 40.0-999.0, All Heart Failure, Congestive We plan to all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded", "label": "2"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Right Heart Strain Referred from clinical departments at Odense University Hospital Referred to the Departments of Nuclear Medicine or Radiology for diagnostic evaluation of suspected pulmonary embolism Referred for lung scintigraphy, spiral computer tomography, or pulmonary angiography Age below 18 Contrast allergy Pregnancy S-Creatinine above 200 micromol/L Metformin treatment Fibrinolytic or surgical therapy between examinations No informed consent Withdrawn consent Failed logistics (more than 24 hours between examinations) No conclusive pulmonary angiography", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 16.0-999.0, All Adult Respiratory Distress Syndrome Pulmonary Hypertension After obtaining informed consent the following patients will be included All patients admitted to the ICU with pulmonary hypertension (mean PA > 35 mmHg) All patients in ICU with post operative pulmonary HTN (mean PA > 35 mm Hg) All patients with ARDS (PaO2/FiO2 < 200 arterial hypoxemia, bilateral infiltrates on Chest X-ray infiltrates on CXR and a wedge < 20 mm Hg on swan ganz parameters) or signs of heart failure Patients to be excluded will be those with Pulmonary embolus Cor pulmonale Ejection fraction of < 30%, wedge > 20 mm Hg Non-intubated patients Pediatric patients (< 16 yrs of age)", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Ischemic Stroke Angiographically confirmed large vessel ischemic stroke (occlusion may the following: internal carotid artery (ICA), M1/M2, vertebral, or basilar arteries) Intervention is able to be performed within 8 hours of symptom onset Patients > 18 years of age NIHSS score 8+ Failed IV t-PA treatment or contraindicated for IV t-PA International Normalized Ratio (INR) > 3.0 Platelet count < 30,000 Heparin use in previous 24 hours with PTT > 2X normal Baseline bloog glucose < 50 mg/dL Baseline computed tomography (CT) showing mass effect with midline shift Severe sustained hypertension (SBP > 185 or DBP > 110) that cannot be controlled with medication Patient is pregnant, has anticipated life expectancy < 3 months, or has severe allergy to contrast medium Arterial stenosis > 50% proximal to embolus Excessive arterial tortuosity that precludes the study device from reaching the target area", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-45.0, All Uterine Leiomyoma Participants in the Right From The Start Study must be 18 years old or older, pregnant, enrolled by 10 weeks of gestation, planning to carry pregnancy to term, no plans to move before delivery, and English speaking. Those who are found to have fibroids at either their 7-week, or 22-week ultrasound examination are eligible for this further postpregnancy study A small substudy of 30 women having MRIs to evaluate the sensitivity of the ultrasound imaging will only participants with a single fibroid found at the early pregnancy ultrasound FOR MRI for the MRI are weight greater than 250 pounds, currently pregnant, metal of specific types in the body (an artificial hip, a clip for brain aneurysm, a medical implant in the ear, metal fragment in the eye, or a pacemaker), history of claustrophobia, previous severe reaction to MRI contrast, and chronic kidney disease. A severe reaction would consist of bronchospasm (shortness of breath/difficulty breathing) or shock (sudden loss of blood pressure). Risk is less than 1/100,000 with Gd based contrast material. Any potential subject with a history of kidney disease will be excluded from the study", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 12.0-24.0, All Substance Abuse Native American pregnant teens or young women ages 12-22 years old at the time of conception Women ages 20-22 years at the time of conception must be pregnant for the first time Partners of pregnant teens must be between the ages of 12-24 Pregnant <28 weeks gestation and able to meet the requirements for completing the program in a timely way An enrolled tribal member Reside in the Reservation Service Unit Catchment Area and within 60 mile of the Indian Health Service Unit Headquarters Severe mental illness schizophrenia, bipolar disorder, incapacitating depression, or Substance abuse/dependence in need of intensive and specific treatment Active legal problems \u2013 subjects will not be enrolled if they are incarcerated or if program participation has been made a condition of parole Ongoing social service involvement for abuse and neglect", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-999.0, All Pregnancy Healthy women First trimester of a normal pregnancy Normal baseline echocardiogram Pregnancy with more than one fetus Any hemodynamically significant cardiac condition Any known systemic disease Poor quality echocardiogram", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-0.192, All Development of Control of Breathing Gestational age 23 0/7 6/7 weeks Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg Postnatal age between 21 days and 70 days Informed written consent obtained from at least one of the parents Need for mechanical ventilation, NCPAP or O2 Sepsis or other known causes of apnea", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease Age at least 40 years COPD Dyspnea, determined by Modified Medical Research Council (MMRC) scale of at least 1 Dyspnea and lung disease process dominated by COPD in judgment of the study physician Participant must meet one of the following Post-bronchodilator forced expiratory volume in 1 second (FEV1) percent less than or equal to 70% predicted Post-bronchodilator forced expiratory volume in 1 second (FEV1) percent >70% predicted and LOTT study physician determines that there is radiologic evidence of emphysema Post-bronchodilator FEV1/forced vital capacity (FVC) less then 0.70 Participant must meet either of the following oxygen saturation Oxygen saturation of at least 89% and no greater than 93% after sitting quietly on room air, without hyperventilation and without pursed lips breathing during oximetry Less than 30 days post treatment for acute exacerbation of COPD as of initiating evaluation (less than 30 days from last dose of antibiotics or since a new or increased dose of systemic corticosteroids was initiated); chronic use of systemic corticosteroids while health is stable is not exclusionary COPD exacerbation requiring antibiotics, new or increased dose of systemic corticosteroids, or oxygen treatment after screening starts and prior to randomization (chronic use of corticosteroids while health is stable is not exclusionary) Less than 30 days post discharge from an acute care hospital after acute care hospitalization for COPD or other condition, as of initiating evaluation (participant may be in a rehab hospital at time of screening) New prescription of supplemental oxygen after screening starts and before randomization Thoracotomy, sternotomy, major cardiopulmonary intervention (e.g., lung resection, open heart surgery, etc.), or other procedure in the 6 months before study entry likely to cause instability of pulmonary status Non-COPD lung disease that affects oxygenation or survival Epworth Sleepiness Scale score greater than 15 Desaturation below 80% for at least 1 minute during the 6-minute walk test Disease or condition expected to cause death, inability to perform procedures for the trial, or inability to comply with therapy within 6 months of random assignment, as judged by the study physician Participation in another intervention study", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 50.0-70.0, All Healthy Participants of health check program at our hospital who will receive a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases) Those whose age are under 50 or above 70 year-olds will be excluded", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-999.0, All Postpartum Depression Women after term elective cesarean section age < 16 years, preterm (< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-50.0, All Asthma Hypersensitivity for healthy controls Normal lung function, defined as (Knudson 1976/1984 predicted set) FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > .75 Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score Negative methacholine inhalation challenge as performed in the screening protocol. (Less than a 20% decrease in FEV1 at a maximum methacholine concentration of 10 mg/ml) --Negative pregnancy test for females Negative allergy skin test (AST) for allergic asthmatics also Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) except for use of cromolyn exclusively prior to exercise Use of daily theophylline within the past month Use of tricyclics and MAO inhibitors Pregnancy or nursing a baby Cigarette smoking > 1 pack per month Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Diagnosis of acute PE requires symptoms of PE present <14 days with CT angiography interpreted as positive for acute PE. Initial evaluation for PE must be predicated upon the investigation of new or unexplained cardiopulmonary or chest-related clinical features consistent with PE, including shortness of breath, chest pain, respiratory distress, dizziness, unexplained tachypnea, tachycardia, syncope, cough or hemoptysis. All patients must have CT chest angiography with <2 mm collimation,(36) with or without indirect venography. Pulmonary arterial opacification will be achieved with power injection of non-ionic, low osmolar contrast in an antecubital vein with a timing run; the pitch, voltage, gantry speed and other technical details appropriate for each scanner.(37;38) Images will be interpreted as positive for intrapulmonary arterial filling defect consistent with acute PE using our published definitions(37;38) by a board-certified radiologist with specialty training in body CT or emergency medicine imaging in all cases SBP (SBP)> 89 mm Hg at the time of enrollment. We will allow enrollment for a patient with an SBP < 90 mm Hg prior to enrollment, or a patient with a SBP>80 mm Hg, if the patient has a documented or patient-identified history of low blood pressure and has no symptoms of shock, as described by Jones et al.(39) SaO2% >80% at time of enrollment Patients must have a Borg score greater than 4/10 Altered mental status such that they are unable to provide consent Inability to use a nasal cannula or face mask (e.g., anatomic defect) Supplemental oxygen requirement greater than can be administered via nasal cannula or face mask in order to maintain SaO2 >80% Pregnancy Pneumothorax with decompression A serum mtHb greater than 10% Concurrent therapies including Viagra\u00ae (sildenafil) use within the past 24 hours Levitra\u00ae (vardenafil) use within the past 24 hours Cialis\u00ae (tadalafil) use within the past 72 hours", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-0.019, All Adrenal Insufficiency All preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams.) infants born at AIIMS would be eligible for enrollment in the study. Of these infants, those who meet the following would be enrolled Cases: Preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams with shock in the first week of life requiring vasopressor therapy (dopamine or dobutamine or both in a dose of > 10 mcg/kg/min) Controls: Stable preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams who are matched for gestational age, birth weight, postnatal-age Major congenital malformations Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid) Postnatal corticosteroid treatment Refusal to give consent", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-999.0, All Thromboembolism Venous Thromboembolism Patients who were treated with fondaparinux pre-, peri and/or postpartum for more than 7 days for VTE prophylaxis or treatment, especially those with a history of abortion, and/or stillbirth, VTE, severe fetal and maternal complications during pregnancy, severe inherited or acquired thrombophilias, long-term anticoagulation (e. g. patients with mechanical heart valves) and/or intolerance to heparins or heparinoids or heparin-induced thrombocytopenia (HIT) Patients who were treated with fondaparinux for less than 7 days Patient who were treated with fondaparinux only postpartum", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-18.0, All Mechanical Ventilation Weaning Phase in Children An eligible subject will be considered for into this clinical trial if the attending physician is ready to begin weaning from mechanical ventilation and if the patient fulfils all the following The attending physician thinks that the patient will be able to breathe spontaneously or the patient is already breathing spontaneously No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine or dobutamine (\u2264 5 \u00b5g/kg/min) Slight or no endotracheal tube gas-leakage ((Vti Vte)/Vti \u2264 20%) Mechanical ventilation with a plateau pressure \u2264 25 cmH2O over PEEP PEEP \u2264 8 cmH2O FiO2 \u2264 60% in order to obtain pulse oxymetry \u2265 95% PaCO2 < 70 mmHg on the last blood gases Extubation not expected the day of A patient will be excluded from this study a priori if he/she presents one or many of the following The patient fails the pressure-support test (this test is described below in the section entitled \"Intervention\") Invasive or non invasive mechanical ventilation at home or on hospital ward before PICU admission Child with a tracheotomy Child with an history of mechanical ventilation > 2 months Contemplate withdrawing mechanical ventilation for palliative care Child with tracheobronchomalacia responsible for chronic respiratory failure Child with a severe neuromuscular disease prior to admission or acquired in the PICU and unable to generate a negative pressure of at least cmH20 during inspiration Child with a \"do not resuscitate order\" and/or \"do not reintubate order\" is prescribed", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Must be Age greater than or equal to 18 Obtain informed written consent Diagnosed with acute pulmonary embolism (PE) (< 14 days) Catheter-directed therapy (CDT) was performed to treat acute PE ", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 21.0-999.0, All Sleep Apnea, Obstructive Age greater than 21 years Patients scheduled for a procedure that requires analgesia and/or sedation by any route (intravenous, intramuscular, oral, epidural or intrathecal) Patients with an anticipated length of sedation greater than or equal to one hour Patients in the ASA category I through III Patients who only receive propofol, benzodiazepines, and opioids Age less than 21 years Patients whose room air oxygen saturation is <90% Patients receiving post-operative positive airway pressure support Previous allergic/contact reactions to adhesives CHF Moderate or severe valvular disease TIA/CVA Carotid stenosis or endarterectomy Anemia (HCT if available < 30%) Pulmonary hypertension", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-60.0, All Fetomaternal Hemorrhage Neonatal Anemia Women admitted for term delivery (delivery between 37 0/7 and 41 6/7 weeks from the last menstrual period) to the Mount Sinai Medical Center Women carrying fetuses with known fetal anomaly Women unable to complete the consent process due to likely precipitous delivery, severe labor discomfort, or fetal distress requiring immediate intervention", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-50.0, All Postpartum Hemorrhage All patients planned for elective cesarean delivery under spinal anesthesia All patients who gave written informed consent to participate in this study All patients who refuse to give written informed consent All patients who claim allergy or hypersensitivity to carbetocin or oxytocin All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis All patients with hepatic, renal, and vascular disease All patients requiring general anesthesia prior to the administration of the study drug", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Postpartum Women must be at high risk for thromboembolism for one of the following reasons Known low risk thrombophilia (Known = diagnosed prior to enrollment and low risk thrombophilia includes heterozygous factor V Leiden or prothrombin gene variant or protein C deficiency or protein S deficiency. If not previously tested then assumed not to have thrombophilia) Immobilization (defined as >90% of waking hours in bed, of a week or more at any point in the antepartum period) OR any two of the following reasons Postpartum infection (fever (temperature>38.5oC) and clinical signs/symptoms of infection and elevated neutrophil count (higher than local lab normal)) Postpartum hemorrhage (Estimated blood loss >1000 ml during delivery and postpartum) Pre-pregnancy BMI >25 kg/m2 Emergency cesarean birth (emergency = not planned prior to onset of labour) Smoking >5 cigarettes per day prior to pregnancy Preeclampsia (blood pressure \u2265 140mmHG systolic and/or \u226590 mmHg diastolic on at least one occasion and proteinuria (1+ on urine dipstick or 300mg/dl or total excretion of 300mg/24 hours) or typical end-organ dysfunction Less than 6 hours or more than 36 hours since delivery at the time of randomization Need for anticoagulation as judged by the local investigator, may but not limited to Personal history of previous provoked or unprovoked VTE (DVT or PE) Continuation of LMWH that was started in the antenatal period for VTE prophylaxis Mechanical heart valve Known high-risk thrombophilia (Known = diagnosed prior to enrolment and high-risk thrombophilia includes deficiency of antithrombin (at least 1 abnormal lab result), persistently positive anticardiolipin antibodies (> 30U/ml on two measurements a minimum of six weeks apart), persistently positive Anti B2 glycoprotein antibodies (> 20U/ml on two measurements a minimum of six weeks apart), persistently positive lupus anticoagulant (positive on two measurements a minimum of six weeks apart), homozygous factor V Leiden (FVL), homozygous prothrombin gene mutation (PGM), compound heterozygosity factor V Leiden (FVL) and prothrombin gene mutations (PGM), more than 1 thrombophilia (any combination of 2 or more: FVL, PGM, protein C deficiency, protein S deficiency). If not previously tested then assumed not to have thrombophilia) Contraindication to heparin therapy, including History of heparin induced thrombocytopenia (HIT) Platelet count of less than 80,000 x 106/L on postpartum Complete Blood Count(CBC) Hemoglobin \u2264 75 g/L on postpartum CBC", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-35.0, All Bleeding Venous Thromboembolism Age > 18 years old Delivered by cesarean section (emergency or planned) Signed, informed consent Ready access to a local health service Capable of using Tinzaparin at high risk for thromboembolism (any one of the following) age more than 35 years old obesity (more than 80 kg) parity more than 4 gross varicose veins current infection pre-eclampsia immobility prior to surgery (more than 4 days) Major current disease: including heart or lung disease, cancer,inflammatory bowel disease and nephrotic syndrome Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy)", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-55.0, All Postpartum Hemorrhage All patients planned for elective cesarean delivery under spinal anesthesia All patients who give written informed consent to participate in this study All patients who refuse to give written informed consent All patients who claim allergy or hypersensitivity to carbetocin or oxytocin All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis All patients with hepatic, renal, and vascular disease All patients requiring general anesthesia prior to the administration of the study drug", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Contraception Postpartum Depression Lactation Age > 18 years old and > 24 0/7 weeks pregnant at time of enrollment Planning to deliver at Magee-Womens Hospital and to breastfeed Plans to use DMPA for postpartum contraception for at least 6 months Willing and able to provide informed consent in English and to comply with study protocol Intolerance of irregular vaginal bleeding Severe coagulation disorder Severe liver disease (LFTs >2x upper limits of normal at time of randomization) Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia History of breast cancer, reduction or augmentation surgery History of severe clinical depression Multiple gestation", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Acute Mountain Sickness acute clinically significant inter-current diseases", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-1.5, All Bronchiolitis All children under 18 months of age with a clinical diagnosis of bronchiolitis requiring admission to hospital for observation and oxygen Infants admitted directly to ICU from Emergency Prior positive pressure home ventilation Tracheostomy Nasogastric tubes in situ on admission Upper airway abnormality Congenital heart disease", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 19.0-999.0, All Air Embolism as A Complication of Medical Care Subject is undergoing ERCP as part of their medical care Subject will be of age 19 or older Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE Subject intolerance of the pressure of the TTE probe Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Stress Disorders, Post-Traumatic Anxiety The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 12 months of follow up The patient has given birth this day to a premature child (< 36 weeks of gestation and/or < 2 kg birthweight) Separation of child and mother since birth The patient or baby is participating in another study, excepting the studies \"OASIS\" or \"PROM8736\" The patient or baby is in an period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient or father refuses to sign the consent It is impossible to correctly inform the patient Preexisting maternal psychiatric pathology Major or lethal poly-malformation syndrome Severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain Any emergency situation preventing patient involvement Mother and/or child not hospitalized at the N\u00eemes University Hospital", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-999.0, All Breastfeeding pregnant women (gestational week 35-36) women with known physical, psychological and/or social illness/problem that result in hospitalization more than 50 hours after delivery women with known pregnancy related illness that result in hospitalization more than 50 hours after delivery Women not understanding or speaking Danish women expecting multiple babies women having decided not to breastfeed women expecting to deliver at another hospital than the one she has been visiting during pregnancy", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 19.0-92.0, All COPD Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948) Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years Agrees to volunteers for the study and willing to sign the informed consent form There were negative/normal screening tests for the following Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition \"Normal\" spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69% Impedance oscillometry were within normal limits \"Negative\" physical examination of the chest with absence of wheezing and crackles on auscultation of the chest Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups men of: ages < 18, 31-54 and >92 years old current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years refusal to volunteer for the study and not willing to sign the informed consent form screening test not considered \"normal\" by physician/PI and showing one or more of the following one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.) Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%) \"Positive\" physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest Impulse oscillometry >4 times normal limits Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-50.0, All Healthy Healthy males within the age range of 18 to 50 years A body mass index within 18-25 Kg/m2 Given written informed consent to participate in the study Absence of diseases markers of HIV 1 & 2, Hepatitis B & C virus and RPR Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening A normal 12-lead ECG A normal chest X-Ray Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites Blood pressure Systolic> 140 mm Hg and < 110 mm Hg Diastolic< 70 mm Hg > 90 mm Hg History of seizures History of alcohol consumption for more than 2 units/day High caffeine or tobacco consumption History of difficulty with donating blood or difficulty in accessibility of veins Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Smoking Cessation Pregnancy first or second trimester of pregnancy age 18 or older self-reported tobacco use in the past 90 days or nicotine-dependence in the past year intend to terminate their pregnancy intend to move out of the city within the next 12 months are unable to provide informed consent and participate in English", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-60.0, All Pregnancy Complications Weight Gain Healthy pregnant females > 18 years of age with singleton pregnancies (either nulliparous or multiparous) less than 15 weeks gestation a pre pregnancy BMI < 40 kg/m2 (owing to the fact that severe obesity with BMI> 40 may have limitations with respect to physical activity) plans to deliver at a Hamilton or London regional hospital or by home birth and willing to attend research visits at the community site where they were recruited able to tolerate dairy foods approval of primary care provider able to provide signed informed consent unable to understand some English type 1 or type 2 diabetes breastfeeding during current pregnancy pregnancy resulting from in vitro fertilization known contraindications to exercise as recommended by the Canadian clinical practice guidelines for pregnancy severe gastrointestinal diseases or conditions any significant heart, kidney, liver or pancreatic diseases pre-existing diabetes currently smoking a depression score above 10 on the validated Edinburgh depression questionnaire", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-35.0, All Retinal Oxygenation Retinal Blood Flow Men and women aged between 18 and 35 years Nonsmokers Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, ametropy < 3 Dpt Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive) Symptoms of a clinically relevant illness in the 3 weeks before the first study day Presence of any form of anemia Blood donation during the previous 3 weeks Pregnancy", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis Pulmonary Embolus \u2265 18 years Investigator judges caval filtration clinically indicated for prevention of pulmonary embolism in patient with venous thromboembolic disease or at high risk for venous thromboembolic disease. Patient must meet at least one of the following Anticoagulant therapy is contraindicated, has failed, cannot be achieved or maintained, must be interrupted, resulted in complication, or places the patient at high risk of complication and the patient has Pulmonary embolus Iliocaval deep vein thrombosis (DVT) Severe trauma with high risk of venous thromboembolism including closed head injury, spinal cord injury, or multiple long bone or pelvic fractures Surgery planned with high risk of venous thromboembolism including procedures such as bariatric, orthopedic, or pelvic surgery Past history of thromboembolic disease undergoing surgery Therapeutic anticoagulation can be achieved, but the patient has Venous thromboembolism such as pulmonary embolism or DVT with limited cardiopulmonary reserve Condition that inhibits radiographic visualization of the IVC Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC including occlusion of the SVC or jugular veins Known IVC transverse diameter at target implant site > 28 mm Known obstructing abdominal mass or anatomy that is not suitable for infra-renal placement of IVC filter Known duplication of IVC or left-sided IVC Severe kyphosis or scoliosis Known IVC thrombosis extending to renal veins, or renal or gonadal vein thrombosis Risk for septic pulmonary embolism Confirmed bacteremia Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, or dialysis dependent", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-50.0, All Deep Venous Thrombosis Pulmonary Embolism Age: 18 years or older, and Pregnancy confirmed by urinary pregnancy test, and Gestational age < 14 weeks, and Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma) Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or Inability to provide informed consent, or Any contraindication listed in the local labelling of LMWH", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-6.0, All Transient Tachypnea of the Newborn Late preterm and term infants (post-menstrual age \u2265 34 weeks) delivered by cesarean section or vaginal delivery Diagnosis of TTN Parents signed informed consent Meconium aspiration syndrome Respiratory distress syndrome Congenital heart disease Non respiratory disorders causing tachypnea", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-75.0, All Chronic Obstructive Pulmonary Disease chronic obstructive pulmonary disease (COPD), GOLD grade 2-3 residents at low altitude (<800 m) Unstable condition, COPD exacerbation Mild (GOLD 1) or very severe COPD (GOLD 4) requirement for oxygen therapy at low altitude residence hypoventilation pulmonary hypertension more than mild or unstable cardiovascular disease use of drugs that affect respiratory center drive internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test previous intolerance to moderate altitude (<2600m) Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Multiple Pulmonary Emboli Patients referred for CT pulmonary angiogram to pulmonary embolus Class 3 or 4 Congestive Heart Failure Supraventricular tachycardia History of contrast allergy Unable to give informed consent Patients with serum creatinine >1.28 mg/dl without referring physician approval", "label": "2"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.462-0.846, All Respiratory Distress Syndrome, Newborn Bronchopulmonary Dysplasia Ventilator Induced Lung Injury Infants at 24-36 weeks corrected gestational age Already ventilated with high frequency ventilation Requiring FiO2=21%-70% to maintain adequate oxygen saturation Clinical stable o i.e. ventilated on current settings for more than just a few hours with stable but not necessarily normalized blood gases or transcutaneous values and oxygen requirement Parent(s) or guardian able and willing to provide informed consent Major congenital cardiovascular or respiratory abnormalities The attending neonatologist responsible for the baby considers one of the ventilation modes unsuitable for the infant Poor skin integrity precluding use of transcutaneous monitoring Lack of parental signed written informed consent Parents under 18 years of age", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.462-0.577, All Premature Birth Parental consent 0 to 30+0 weeks(agreed dates) gestation born alive Breathing spontaneously at birth or soon after with minimal resuscitation Oxygen saturations >90% by 5 minutes No parental consent Born in poor condition and unlikely to survive Needing resuscitation including intubation and/or chest compressions Not breathing and thus needing intubation Oxygen saturations <90% by 5 minutes <24 weeks gestation >30 weeks gestation", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Pregnancy aged 18 or above first-time parents able to speak and read the Chinese language; and Hong Kong residents couples with past or family psychiatric history", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-32.0, All Vitamin A Deficiency Pregnant women >-18 years of age with low-risk obstetric Pregnant women expecting a multiple birth Take vitamin A supplements during postpartum apart from study intervention Premature birth Newborn babies with birth defects and / or other serious diseases", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-0.164, All Infant Development Full-term newborns (>37 weeks and <41 weeks gestation) Adequate birth weight for his gestational age (between 3-97 percentiles) age: from 0 to 2 months (60 days) Maximum 30 days of exclusive breastfeeding From 30 days on, exclusive or >70% infant formula Normal Apgar score: 7-10 Umbilical pH \u2265 of 7.10 Availability to continue during the whole study period Informed consent signed ( parent/legal representative) Participating in other studies Nervous system disorders (hydrocephalic, perinatal hypoxia, intraventricular hemorrhage, neonatal meningitis, septic shock, West Sd...) Gastrointestinal disorders (cow's milk protein allergy, lactose intolerance) Mother's disease history or during pregnancy: neurological and metabolic diseases, diabetes mellitus type 1, hypothyroidism, undernutrition, infections TORCH complex Mothers receiving anxiolytic or antidepressant treatment during pregnancy or other potentially harmful drug treatments for infants' neurodevelopment Infant currently participating in another clinical study Infant's family who in the investigators assessment cannot be expected to comply with the protocol", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-75.0, All Precapillary Pulmonary Hypertension Interstitial Lung Disease Precapillary pulmonary hypertension, or interstitial lung disease New York Heart Association class 2-3 Residence at low altitude (<800m) Unstable or exacerbated condition Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4 requirement for oxygen therapy at low altitude residence hypoventilation more than mild or unstable cardiovascular disease use of drugs that affect respiratory center drive internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test previous intolerance to moderate altitude (<2600m) Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study Pregnant or nursing patients", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-45.0, All Postpartum Depressive Mood Postpartum Sexual Function 45 year old women who desire contraception postpartum for at least 6 weeks 45 year old women who choose not to use oral contraceptive medication postpartum for at least 6 weeks for the control group (Medication groups) Breastfeeding (although this may limit participant enrollment, combined oral contraceptives are contraindicated in this population) Delivery by cesarean section Previous history of depression, mood disorders, or psychiatric disorders Any condition (history or presence of) which contraindicates the use of combination OCs, including Thrombophlebitis or thromboembolic disorders, known or suspected clotting disorders, deep vein thrombosis, thrombogenic valvulopathies or rhythm disorders Pulmonary Embolism Cerebrovascular or coronary artery disease or myocardial infarction Diabetes mellitus Migraine headaches with focal, neurological symptoms", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-50.0, All Pregnancy Breastfeeding Contraception Cervical Cancer Postpartum Depression Age 18 or above at time of delivery Delivery of live born infant at estimated gestational age (EGA) \u226537wk Postpartum primiparous patients within the first 48 hours after delivery Patient intent to breastfeed Breastfeeding initiated within the first 48 hours of delivery and/or prior to hospital discharge (whichever occurs first) Infant is continuously rooming in with mother from the time of delivery English-speaking Able to read and complete surveys No anticipated discharge from military system, Tricare benefits, or move planned in the upcoming 6 months Willing to render informed consent Patients delivered by the Family Medicine Department (relatively small number in our population who are not followed postpartum by the Department of Obstetrics and Gynecology) Any condition deemed by patient provider to be an absolute contraindication to breastfeeding Maternal HIV/AIDS Planned use of radioactive or chemotherapeutic medications or medication for other medical problems which is contraindicated for delivery Known fetal factor that would impair breastfeeding Fetal mid-facial defects Known fetal chromosomal abnormality Known fetal conditioning resulting in fetal hypotonia Labor and Delivery complications Maternal separation from infant during the first 48 hours postpartum (such as maternal ICU admission, infant NICU admission)", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode Breathing-Related Sleep Disorder Interval Contact Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort Have pregnancy outcome data from the nuMoM2b study At least 18 years of age (to begin interval contact attempts once nuMoM2b participant reaches age 18) Provision of verbal consent for telephone interview or acknowledgement of consent with completion of the web-based self-administered questionnaire In-clinic Visit Consented for participation in interval contacts and not subsequently withdrawn Between 2 and 3.5 years after the nuMoM2b pregnancy ended Self-report at least 6 months postpartum from any subsequent pregnancy Self-report not currently pregnant Inability or refusal to provide informed consent for the study component", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thrombosis Pulmonary Embolism Lung Neoplasms Patient At least 18 years of age Either gender Diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy Undergoing one of the following surgeries: Segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy Competent to understand and sign consent documents Patient Known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH) Under current anticoagulation for venous thromboembolism or other medical conditions Known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2 as calculated by the Cockroft-Gault method History of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites Pregnant or planning to become pregnant Diagnosed or treated for VTE in the past 3 months prior to surgery Present or previous increase risk of haemorrhage History of previous HIT (heparin induced thrombocytopenia) Platelet count must be below 75,000 Previously inserted Inferior Vena Cava Filter (IVC) filter", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-50.0, All Postpartum Hemorrhage Elective cesarean delivery under spinal anesthesia Written informed consent to participate in this study Term pregnancy Refusal to give written informed consent Allergy or hypersensitivity to carbetocin or oxytocin Conditions that predispose to uterine atony and postpartum hemorrhage, such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis Hepatic, renal, and vascular disease", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 14.0-44.0, All Severe Pre-eclampsia Postpartum. Severe preeclampsia or severe preeclampsia aggregated to chronic hypertension with > 24 weeks of gestation treated with 4-6 grams of magnesium sulfate for impregnation with a minimum of 8 hours continuous of magnesium sulfate before delivery The study begins to terminate pregnancy HELLP syndrome Eclampsia Renal insufficiency Diabetes mellitus Disease of collagen Heart disease", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 16.0-999.0, All Postpartum Period Age 16-18, married, or Age 18+, in a co-habiting relationship Pregnant 24-36 weeks No obstetric risk factors requiring hospital delivery Lives no more than one hour away on foot, not planning to move from the city Gives informed consent Not meeting Declines to participate", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.167-4.917, All Pneumonia Tachypnea History of cough or difficult breathing < 14 days (observed or reported) AND Respiratory rate \u2265 50 breaths per minute in children 2 to <12 months (on two consecutive readings by independent physicians) OR respiratory rate \u2265 40 breaths per minute in children12 months (on two consecutive readings by independent physicians) AND Written informed consent by a legal guardian Previously enrolled in study Pedal edema History of hospitalization in last two weeks With severe lower chest wall in-drawing Known asthmatics,TB or other severe illness Antibiotics taken in last 48 hours Bulging fontanel Congenital heart disease Any surgical condition requiring hospitalization Out of catchment area", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-45.0, All Breastfeeding Maternal age 18-45 years Normal vital signs Contraindications for breastfeeding Significant systemic disease that cause pain or require chronic pain relief", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 21.0-59.0, All Respiratory Failure Healthy male or female volunteers in the age group Any acute or chronic cardiopulmonary disorder including a simple common cold", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Severe Sepsis With Septic Shock Lactate diagnosis in patients with septic shock pregnant women and nursing mothers severe liver failure with child class C using Linezolid pheochromocytoma hematologic malignancy using epinephrine during CVVH treatment", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Postpartum Anemia Women above 18 years old after giving birth Women who suffer from iron deficiency anemia, defined as hemoglobin< 10 g/dl without one of the conditions that are described in the Women who suffer from known allergy for iron supplements Women who suffer from anemia not due to iron deficiency Women who suffer from acute infection Women who suffer from liver failure or viral hepatitis Women who suffer from thalassemia or hemoglobinopathies Women who suffer from renal failure Women who suffer from unbalanced thyroid disorder", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-70.0, All Hypoxemia Trauma Acute Myocardial Infarction to 70 years of age Male and female volunteers ASA physical status I, II and III Capable and willing to provide written informed consent in English Acute cardiopulmonary disease, as defined by blood pressure greater than 150/90, HR greater than 120 and room air oxygen saturation less than 92 Allergy to lidocaine or adhesive tape History or physical exam finding of nasal polyps Currently taking oral or parenteral anticoagulant medications (other than aspirin) History of frequent nose bleeds Current symptoms of nasal congestion Physical examination findings of rales or wheezing Facial hair that prevents forming a seal with an anesthesia mask", "label": "1"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Depression, Postpartum Women who are more than 26 weeks pregnant OR up to 9 months post-birth Outside the limits of the number of weeks pregnant/post birth Living outside England Refusal to participate", "label": "2"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 0.0-999.0, All Thrombophilia Associated With Pregnancy Perioperative/Postoperative Complications Venous Thrombosis Pulmonary Embolism Other Specified Risk Factors in Pregnancy Deep Vein Thrombosis All pregnant women hospitalized Previous use of anticoagulation", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 1.0-18.0, All Noninvasive Ventilation All pediatric patients between one and 18 year of age Requirement for insertion of an endotracheal tube American Society of Anesthesiologists (ASA) class I to III Failure to obtain parental consent or patient assent when appropriate (in general, children over 6 years of age) ASA IV Patients with any cardiac pathology Patients with any respiratory pathology Patients with any form of chest deformity, for example, pectus excavatum, pectus carinatum, scoliosis Patients who had previous cardiac or thoracic surgery", "label": "0"} +{"topic": "A 30-year-old generally healthy woman presents with shortness of breath that had started 2 hours before admission. She has had no health problems in the past besides 2 natural abortions. She had given birth to a healthy child 3 weeks before. On examination, she is apprehensive, tachypneic and tachycardic, her blood pressure is 110/70 and her oxygen saturation 92%. Otherwise, physical examination is unremarkable. Her chest x-ray and CBC are normal.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Thromboembolism Women with clinically suspected pulmonary embolism (PE) during the first 6 weeks postpartum, without any sign of severe PE (shock, hypotension), referred for CT angiography Absence of contraindication to iodinated contrast medium injection Age > 18 years Health insurance Possibility to have 3-month follow-up Obtention of written informed consent (ability to give consent) Anticoagulation at therapeutic dosage for another reason than the suspicion of PE New pregnancy (\u03b2HCG positive before CT angiography) Contrast medium extravasation during injection CTA or CTV not performed according to the study requirements", "label": "1"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 25.0-75.0, All Osteoporosis females 25-75 years of age with no known bone disorders history of vertebral fractures or nonvertebral fractures without trauma prescription medications for prevention of osteoporosis (including vitamin D other than multivitamin and estrogen) history of malignancy other than basal cell or squamous cell cancer of the skin use of steroids or anticonvulsants in the 6 months prior to enrollment", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 60.0-80.0, All Alzheimer's Disease Individuals of either sex, with a high school education, and between the ages of 60 and 80 years living in the New York City metropolitan area Minimum of 12 years education Participants will be classified as within normal limits on medical, psychiatric and neuropsychological examinations (performance that is better than -1.5 sd of the NYU norm based WMS-R delayed memory index) Participants will have a global deterioration scale (GDS)=1 or 2. Those enrolled in the High-Risk group will have a GDS=2 and have a score of >25 on the Memory Complaint Questionnaire (MCQ). In high risk memory loss cases, an informed family member or caregiver will be interviewed to confirm that the participant can perform specific tasks Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder Significant history of alcoholism or drug abuse History of psychiatric illness (e.g., schizophrenia, mania, Post-Traumatic Stress Disorder [PTSD], or depression) Any focal neurological signs or significant neuropathology A score of 4 or greater on the Modified Hachinski Ischemia Scale, indicative of cerebrovascular disease A total score of 16 or more on the Hamilton Depression Scale to possible cases of primary depression Evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions Physical impairment of such severity as to adversely affect the validity of psychological testing Hostility or refusal to cooperate Any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during MRI imaging", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Postoperative Complications Delirium Community-dwelling individuals aged 65 or older Admitted to Methodist Hospital for surgical repair of hip fracture No evidence of delirium at admission to hospital MMSE total score below 24 points after adjustment for education and age Consent to participate in the study Severely demented as defined by MMSE score below 10 Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months Multiple trauma or pathological fractures Aphasic, legally blind, or deaf Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery Allergy to Donepezil", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 30.0-60.0, All Chronic Pain age driving licence driving experience normal vision right-handed fluently Dutch speaking psychological or physical disorder drug or alcohol abuse psychotropic medication use excessive smoking, drinking", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 55.0-999.0, All Multiple Trauma Cardiovascular Diseases Aged All trauma patients admitted to the ICU > 55 years of age with a primary diagnosis of injury will be screened on admission as study candidates Patients will be excluded if they have non-survivable injuries, are receiving comfort care only, have an advanced directive limiting aggressive care, heart block, severe asthma, bradycardia (< 60 bpm), are on beta-blocker therapy, or are having an acute or evolving myocardial infarction", "label": "1"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 16.0-75.0, All Traumatic Brain Injury Cerebral Infarction Cerebral Hemorrhage One week following Traumatic Brain Injury Cerebro Vascular Accident Subsequent brain CT showed cerebral cortex injury A known ailment of the central nervous system Use of medications or illicit drugs that significantly affect the central nervous system tourist or temporary residents not available for follow-up For MRI examinations: heart pacemaker, metal implants, or metal shrapnel", "label": "2"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 0.083-15.0, All Injuries and Wounds All asymptomatic trauma patients from 0 to 15 years old Any pediatric trauma patients with clinical indications for CT scan", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Dementia 65 years of age or older Diagnosed with dementia by a physician Mini-Mental State Examination score of 23 points or less Capable of participating at least once a week for 6 weeks in succession Management of a medical risk required Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis Never having been on a bicycle, and incapable of pedaling well", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-85.0, All Mental Health Geriatrics valid Ontario driver's license active driver (greater than or equal to three times per week) written, informed consent lives in Toronto/Thunder Bay healthy Male between 65-75 years old cognitive impairment psychiatric history sleep disorder history substance abuse neurological history medical illness ophthalmological disease psychoactive medications contra-indications to Donepezil experience car/motion sickness", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Advanced Cancer Delirium Presence of advanced cancer, defined as local recurrent and/or metastatic History of an episode of delirium during the patient's current inpatient admission, diagnosis of delirium will be made by one of the palliative care specialists according to DSM-IV-TR criteria If the patient has a complete recovery from the episode of delirium, the patient must be approached within 3 days for the possibility of in study. \"Complete recovery\" will be defined as diagnosis of complete resolution of all symptoms of delirium according to DSM-IV-TR by one of the palliative care specialists Ability to communicate in the English language Caregiver who is 18 years of age or older (assessments used in this study have not been validated in pediatric population), is able to communicate in English and comprehend the assessment questionnaire, and is at the bedside for a significant length of time (approximately 4 hours) each day during the delirium episode. Both the patient and their caregiver must agree to participate for in the study Written informed consent signed by the patients and the participating caregivers MDAS [Memorial Delirium Assessment Scale] < 13 (Scores of 13 or above likely reflect the presence of delirium) Patients will be recruited from the palliative care mobile team or the inpatient palliative care unit Refusal of both the patient and their caregiver to complete assessments Inability to complete assessment due to sensorial deficits other than cognition; e.g. blindness, deafness, aphasia, etc., that might impact the patient's ability to recall the episode of delirium", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 0.0-999.0, All Accidental Falls At least one fall in the last 6 months Living in their own home or in a home for the aged Availability of a primary caregiver caring for the patient at least once a week Ability to walk 15 meters independently (use of a walking aid is permitted) Life expectancy of more than 6 months, as judged by their geriatrician Dyads of patients and caregivers in whom outcome assessment is highly unlikely to succeed, for example because they proved not to be able to register falls in the three months before randomization, will be excluded MMSE score of less than 15 On the waiting list for a nursing home", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Normal Pressure Hydrocephalus Walking difficulties in both legs which has developed gradually, not explained by other conditions, either in combination with mental impairment and urinary incontinence Brain CT or MRI findings of enlarged ventricles compared to established standards (minimum Evans ratio of 0.30 as measured by reviewing films) Mental impairment must be mild to moderate, emerging with or after the walking difficulties Age > or = 18 years old MMSE (Mini-mental status exam): < or = 10 Urinary incontinence No or only minimal walking difficulties combined with severe dementia Severe medical problems with limited life expectancy (less than six months) Contraindications to surgery Lack of informed consent", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-65.0, All TBI (Traumatic Brain Injury) Post Concussion Syndrome Post Traumatic Stress Disorder Chronic Post Traumatic Stress Disorder Adults, 18-65 years old One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001 Absence of acute cardiac arrest or hemorrhagic shock at time of TBI Absence of intracranial neurosurgery post-TBI Disability Rating Scale of 0-3 Negative Michigan Alcohol Screening Test (MAST) Negative Drug Abuse Screening Test (DAST) Negative urine toxicology screen for drugs of abuse Negative pregnancy test in females Otherwise good health Pulmonary disease that precludes HBOT Unstable medical conditions that are contraindicated in HBOT Severe confinement anxiety Pregnancy Other pre-TBI neurological diagnoses Pre or post TBI history of substance abuse Pre or post TBI history of alcoholism Participation in another experimental trial with active intervention High probability of inability to complete the experimental protocol Previous HBOT", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 10.0-85.0, All Aging Absence of the basic pathology that interferes directly in the balance Neurological changes Cognitive impairment Orthopedic injury Use of orthoses for lower limb Obesity Exercise frequently (more than twice a week) The bearer of any commitment to stay in their standing position", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Intracranial Hemorrhages Spontaneous ICH (intraparenchymal), subdural hematoma (SDH) diagnosed by CT scanning \u2264 12 hours after onset of symptoms. In case of unknown time of symptom onset: time between last seen in healthy condition and first CCT \u2264 12 hours Therapy receiving vitamin K antagonists (VKA) International Normalized Ratio (INR) \u2265 2 Signed informed consent form, or signed informed consent by a legal representative, judicial consent in cases where no legal representative is available in time, or consent of an independent physician familiar with the indication in cases where the first three possibilities can not be realized Patients with ICH not related to vitamin-K antagonist therapy or Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, hemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma Deep Coma (GCS \u2264 5) at the time of admission or before intubation if intubated outside the hospital Known previous disability (mRS > 2 before stroke occurred) Acute myocardial ischemia, acute septicemia, acute crush injury, any history of acute hemorrhagic disseminated intravascular coagulation, acute thrombotic stroke Known history of intermittent claudication Known recent thrombotic event < 30 days Acute or known congestive heart failure (NYHA III, IV) Pulmonary edema Known liver failure (child-pugh-score C)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Post-Traumatic Stress Disorder OEF/OIF Veteran meets DSM-IV for PTSD control group does not meet for PTSD prior history of significant head injury (LOC > 30 minutes) or other neurological disorder (e.g., stroke, seizure, multiple sclerosis), learning disability or confirmed diagnosis of ADHD contraindication to MR imaging, failed malingering tests during testing, or a history of severe mental illness (i.e., Schizophrenia, Bipolar Disorder) individuals will be excluded if in the 30 days prior to the initial interview if they do not have stable housing (i.e., staying in same residence) have medication changes or have had a psychiatric hospitalization participants who meet DSM-IV for substance dependence will be excluded from the study individuals will also receive urine toxicology and Breathalyzer testing as the first procedure on the evaluation day (pre and post treatment and at 3 month follow up); participants who test positive for alcohol or recent substance use (e.g., methamphetamine) or report significant levels of drug or alcohol use if they are unable to abstain from substance use at three consecutive visits veterans who are currently engaged in therapy treatment for PTSD", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Traumatic Brain Injury Post-Traumatic Stress Disorder At least 18 years of age and non-active duty Either Normal (no history of head injury) -OR- TBI (injury since Jan. 1, 2002) Incapable of informed consent or absence of legally authorized representative Incarcerated (or subject to court supervision) Known allergy to protocol contrast/imaging agent (or pregnant and unable to receive agent) MRI incompatible (i.e. implant, metal, > 300 lbs, severe claustrophobia)", "label": "2"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Delirium years of age or greater In the Emergency Department for less than 12 hour at the time of enrollment Severe mental retardation or dementia Baseline communication barriers such as aphasia, deafness, blindness, or who are unable to speak English Refusal of consent Previous enrollment Comatose Out of the hospital before the assessments are completed", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-85.0, All Elderly between the ages of 65-85 independent in activities of daily living able to walk without assistance for at least 10 minutes cognitively intact (Mini Mental State Exam \u226524) reported 2 or more falls within 6 months prior to the beginning of the study any neurological, orthopedic or any other impairment likely to impact gait severe visual impairments major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Traumatic Brain Injury Age 18 or older Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease History of Stroke History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type History of Brain Tumor Status post trauma due to asphyxiation Preexisting contraindications for Magnetic Resonance Imaging (MRI) Active Duty Military Status Police custody or prisoner status Pregnant women", "label": "2"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 75.0-999.0, All Delirium Elderly patient (\u2265 75 years) Patient with planned hip fracture surgery within 48 hours after the hip fracture Patient willing and able to complete the requirements of this study including the signature of the written informed consent Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or distal femur) Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression) Brain trauma within 12 months prior to selection, history of stroke with residuals Patient suffering from delirium (CAM diagnosis) at selection Patient who cannot complete the pre-operative mental tests (CAM and/or MMSE) of this clinical trial Patient with Mini-Mental State Examination (MMSE) score < 24 at selection Patient known to susceptible to malignant hyperthermia Patient with elevated intra-cranial pressure Patient with a risk of high oxygen demand Patient with recent or ongoing myocardial infarction / damage", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Posttraumatic Stress Disorder Involved in or witnessed a car accident at least 6 months ago PTSD or distress or impairment in important areas of functioning following the car accident moderate or severe head injury current mental health treatment for the MVA-related problem severe chronic pre-injury mental health problems", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 75.0-999.0, All Postoperative Delirium Male or female subject aged over 75 years Admission for a scheduled surgery (i.e. all oncologic digestive surgery , ureterostomy, nephrectomy or cystectomy, total hip or knee replacement) Participation agreement Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Aging Decrease in Ambulation Age 65 years and older Must reside in Greve in Chianti or Bagno A Ripoli, Italy Subjects with modertative cognitive problems will be included as long as the consent can be read and signed by by a first-degree relative of the participant or, in absence of first-degree relative, another relative living with or close to the participant Children", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Healthy Japanese healthy elderly male and female \u226565 years old Have a BMI of \u226518 and \u226427 kg/m2 and weigh \u2265 45 kg Be able to understand and comply with the requirements of the study as judged by the investigator(s) History of any clinically significant medical or neurologic disease or disorder History of gastrointestinal surgery or unintentional rapid weight loss Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 75.0-999.0, All Displaced Olecranon Fractures in Elderly Patients Age \u226575 years Minimal, moderate or severe fragmentation of the olecranon Within two weeks of olecranon fracture Patients unable to give informed consent Associated fractures to the coronoid, radial head and/or distal humerus Associated ligamentous injury, dislocation or subluxation Open fractures", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 50.0-999.0, All Head Trauma Traumatic Brain Injury Chronic Subdural Hematoma Completion of informed consent by the patient or a legally appointed guardian Age \u2265 50 years Sustained mild head trauma with visit to the emergency department of the Hadassah-Hebrew University Medical Center within 24 hours after trauma Low-dose aspirin therapy (75-100 mg) at time of head trauma Admission non contrast head CT with no evidence of intracranial hemorrhage or skull fracture, as assessed by the neurosurgical resident on call and confirmed by an attending neuroradiologist Documented or suspected myocardial infarction within the last 12 mo Documented or suspected transient ischemic event or cerebrovascular accident within the last 12 months Coronary intervention within the last 6 mo Vascular stenting or bypass within the last 6 mo End-stage renal failure requiring dialysis Treatment with aspirin dose other than 75-100 mg Concomitant treatment by anti-coagulant or other anti-aggregant (e.g. warfarin, low molecular weight heparin, or clopidogrel)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-85.0, All Contrast Media Induced Nephropathy Subjects of 18 years old or older CKD stage 3 according to GFR-MDRD equation Two consecutive stable plasma Creatinine levels during the last 2months Elective computed tomography (CT) with a nonionic low-osmolality radiographic contrast agent Acute/ chronic renal failure. Acute renal failure is defined as a change in serum creatinine concentration of at least 0.5 mg/dL, or 25% from creatinine measured before the study to that of the day of the procedure Intercurrent illness: e.g. fever\u2026 etc Recent exposure to radiographic contrast media in the last month before enrollment Allergy to contrast agents, PDE inhibitors or NAC Hypotension Pregnancy and lactation Multiple Myeloma Intravenous diuretics therapy Therapy with any of the nephroprotective drugs 2 weeks before enrollment such as N.A.C. PED5 inhibitor or Carnitine for any reason Severe Congestive Heart Failure, Acute Myocardial Infarction, moderate to severe liver failure (Child-Pugh class B or C)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 70.0-999.0, All Delirium \u2265 70 years old Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery > 2 levels MMSE < 15 Delirium at baseline Inability to speak and understand English Severe hearing impairment, resulting in inability to converse Planned use of intraoperative ketamine Planned use of intraoperative remifentanil, except for airway management pre-incision Arterial catheter not planned to be inserted", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Traumatic Brain Injury Trauma all patients with traumatic brain injury patients without traumatic brain injury", "label": "2"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Subdural Hematoma Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours Age 18 years or older Written informed consent from the patient to participate in the study Moribund state of health prohibiting surgery Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) Recurrent hematoma if the first surgery was performed before study start CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa Pregnancy Patient with Metastatic Disease", "label": "2"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 60.0-999.0, All Elderly Delirium of Unknown (Axis III) Etiology Intensive Care (ICU) Myopathy Over 60 year old Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit) informed consent (legal representatives) unable to swallow pills previous allergy to donepezil Atrioventricular block of 2nd and 3nd degree", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Breast Cancer Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER) and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR \u2265 1% positive nuclear staining HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both HER2 is negative if a single test (or all tests) performed in a tumor specimen show IHC negative (0 or 1+) ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+ HER2 equivocal is not eligible Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant ", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Delirium adult patients admitted for cardiac surgery at department of cardiothoracic surgery, Rigshospitalet, denmark patients under age 18 patients that died within 24 hours after admission", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-50.0, All Post Traumatic Stress Disorder Age 18-50 Experienced a traumatic event fitting criterion A1 (stressor), A2 (Reaction) and at least 1 out of the B criterion in the ASD in the DSM-IV-TR Brought to the ER within hours of the traumatic event Signed an informed consent Known psychiatric disorder or current psychiatric medication Complex injury or need for a complex medical treatment, such as operation, Packed RBC or admission extending 36 hours Disorientation, confusion, head injury including intra-cranial bleeding, LOC or a major neurological deficit Known disorder of the HPA axis or use of steroidal medications within the previous 3 years known neurological disease or previous brain surgery Major medical conditions or using medication known to influence the HPA or ANS Axis Baldness or hair shorter than 1cm Using color dyes Pregnancy", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-80.0, All Subarachnoid Hemorrhage, Aneurysmal Intracerebral Hemorrhage (ICH) Traumatic Brain Injury Patients over 18 years onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h indication for implanting a tissue oxygen and intracranial pressure probe A signed informed consent by the patient or legal guardian Persistent epidural, subdural or subcutaneous hematoma in planned area of the NIRS optode Open injuries in the area of the planned optodes Malignant primary disease under chemotherapy pregnancy bleeding disorder In the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils) Patients with pacemakers or where no MRI compatibility is due to non removable metal parts contraindications for contrast media in CT (eg, iodine allergy) Untreated hyperthyroidism", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Stroke Patients with ischemic arteria cerebri media infarct and spontaneous intraparenchymal bleeding Patients with subarachnoidal haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, epilepsy, anti-epileptic treatment, transient ischemic attack, indication for urgent neurosurgical intervention", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Subdural Hematoma Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma Chronic subdural hematoma verified on cranial CT or MRI A subdural drainage cannot be placed due to intraoperative circumstances (e.g. brain unfolds) The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy) Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt) no informed consent", "label": "1"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 50.0-99.0, All Mental Competency Urinary Bladder, Overactive Cognitive Function Female 50 or older Diagnosis of OAB (ICS definition) English literacy Ability to swallow oral medication Cognitive ability to give consent Dementia/Depression/Delirium Current anticholinergic use (requires 2 week washout period) Current cholinesterase Urinary or gastric retention Severe decreased gastrointestinal motility Uncontrolled narrow-angle glaucoma Myasthenia gravis Diagnosis fo renal impairment (creatinine clearance <30 mL/min)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 2.0-999.0, All Venous Thrombosis Pulmonary Embolism Atrial Fibrillation Acute Coronary Syndrome All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017 Patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 55.0-999.0, All Mild Cognitive Impairment Patients who meet the Peterson diagnostic of MCI memory complaints (preferably confirmed by an informant) memory impairment according to age and education preserved general cognitive function intact activities of daily living, absence of dementia head trauma with post-traumatic loss of conscience for 30 minutes during lifespan loss of senses (blindness, deafness) photo-sensitive epilepsy unsuitability for Magnetic Resonance Imaging-examination due to metal foreign bodies or severe claustrophobia drug and/or alcohol abuse", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-75.0, All Delirium Respiratory Failure Adult patients \u2265 18 yrs of age, < 76 yrs of age Admitted to MICU (3B and 3C) or SICU (8C, 8D, 11C) Surrogate present to provide informed consent when patient is not able RASS score of >-3, < +1 CAM positive Enteral access Recent MI (within past 2 weeks) High risk of dysrhythmias (i.e. bundle branch block, QT prolongation, class IV HF, implanted device) Unable to tolerate enteric medication History of stimulant induced mania/psychosis Pre-existing neurologic disease Patients transferred from outside hospital Pregnancy Alcohol withdrawal History of end stage liver disease (Childs-Pugh class B or worse) Prognosis considered hopeless (CMO)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Delirium Cognition Disorders Endotracheally intubated Expected time on ventilator > 24 hours Age \u2265 18 years Informed consent Severe head trauma where therapeutic coma is indicated Therapeutic hypothermia where therapeutic coma is indicated Status epilepticus where therapeutic coma is indicated Patient has participated in the study before Patient is transferred from another ICU with length of stay > 48 hours Patient is comatose at admission PaO2/FiO2 \u2264 9, if sedation is necessary for oxygenation Patient does not speak Danish, swedish or norwegian at a reasonable level", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 16.0-85.0, All Cough Patients will be required to demonstrate significant cough symptoms by a score greater than 20/70 on the Hull Airways Reflux Questionnaire All patients must be current non-smokers Patients must be on stable medication for at least one month Patients must be able to attend the trials unit on at least 3 occasions Patients must have normal lung function patients must be able to give informed consent Subjects who are pregnant, or have pacemakers in situ are excluded from this study Those with a serious comorbid conditions such as cancer, severe COPD, or heart failure will be excluded Those who are non-English speakers and special groups (i.e. mentally ill, children under 16 years of age, and those suffering from dementia) will be excluded No test will be performed on any subject during an acute worsening of asthma or upper airway infection. If the subject has had an upper airway infection in the last three weeks they will be offered another appointment If the subject has taken any over the counter (OTC) cough mixture within the last twelve hours: If the subject is willing to come back another time for challenge testing, another appointment should be made If the subject has had any food or drink products containing caffeine or menthol within the last hour. If the subject is unwilling to wait for 1 hour before starting the test, the subject should return another time. If the subject is unwilling to return another time, testing should proceed and the medication used recorded If the participant is currently involved in research, or within 3 months of participation in any type of research, they will be excluded from this study", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Mild Cognitive Impairment Nursing home residents Surgery on lower limbs Traumatic damage on lower limbs Severe cognitive impairment in order not to complete the assessment", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Delirium Bone Fractures Multiple Trauma Patients with any medical condition with an age of 65 years and older Impossibility to give an informed consent; refusal", "label": "2"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 21.0-999.0, All Alzheimer's Disease Cognitively Normal Subjects Males or females \u2265 21 and \u2264 45 years of age Mini-mental state examination (MMSE) \u2265 29 Clinically Diagnosed AD Subject Males or females \u2265 50 years of age Meet clinical for dementia due to probable AD MMSE \u2265 16 and \u2264 26 Possible AD Subject Males or females \u2265 50 years of age Meet clinical for dementia due to possible AD Have had or currently have a diagnosis of neurodegenerative disorders other than AD Have a current serious or unstable illness that could interfere with completion of the study Subject has a known brain lesion, pathology or traumatic brain injury Have received or participated in a trial with investigational medications in the past 30 days Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 60.0-999.0, All Postoperative Delirium Age >/ 60 years American Society of Anesthesiologists (ASA) physical status 1-3 Undergoing scheduled surgery Giving an informed consent Impaired visual and auditory disturbance Cannot communicate with Thai language Undergoing neurosurgery", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-55.0, All Oxidative Damage Healthy, non-pregnant subjects between 18 and 55 years of age. Apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association http://circ.ahajournals.org/content/97/22/2283/T6.expansion.html Subjects have to achieve a classification of \"local class\" based on age-graded time USA Track & Field. The age-graded time is the finish time adjusted to that of an open division participant using a factor for age and gender. Thus, the times for women and older participants are adjusted downward, while the times for most open division participants (such as 25-year-old men) remain the same. For example, a 55 year old woman has to run 29 minutes 45 seconds or better to be in the study http://www.usatf.org/statistics/calculators/agegrading/ For a man the same age, the equivalent time would be 25 minutes 2 seconds. This is approximately 60% of the speed of the current world record time for that age Subjects who will abstain from taking any nutritional supplements for the duration of the study, including vitamins and mineral supplements (Exception, ferrous sulfate, elemental iron, Vitamin D, Calcium). Subjects will also abstain from taking any over the counter products (herbals, melatonin, St. John's Wort, etc\u2026) for the duration of the study The will be the following Under 18 and over 55 years of age; those who are not apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association Subjects who are not able to run 5-km in the time required for their age and gender Subjects that will continue to take nutritional supplements, including over the counter products, for the duration of the study, including vitamins and mineral supplements (exception: Ferrous sulfate, Elemental iron, Vitamin D, Calcium) Subjects that are taking prescription medications with the exception of birth control Known allergy or sensitivity to milk thistle, Bacopa monnieri, Ashwagandha, turmeric (or ginger), tea, its parts, caffeine, tannins, or members of the Theaceae family", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 25.0-95.0, All Stroke Apraxias Mild-moderate stroke after two month of the cerebrovascular attack Upper limb apraxia lasting at least 2 months Less than 9 points in validated Apraxia Screen of TULIA (AST) following Vanbellingen et al., 2010 Voluntary participation The neurologist, the occupational therapist and the patient judge the intervention to be necessary History of apraxia before current stroke Stroke had occurred less than two months or more than twenty four month ago Cognitive impairment (< 23 in normal school population and < 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)) Severe aphasia Previous brain tumour History of other previous neurologic disorders Mother tongue different to Spanish Drugs addiction Intellectual or learning disorders Brain damage for traumatism or neurodegenerative process", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Post Operative Delirium older patient (\u226565 years) patient with hip fracture and planned hip fracture surgery patient willing to complete this study patient with multiple trauma or multiple fractures, pathological fractures, pelvic fractures, femur fractures contraindication (serious illness or medical conditions) for general anesthesia contraindication (infection at the site of needle insertion, coagulopathy, international normalized ratio >1.4, platelet count <80\u00d7109 litre-1, allergy to local anaesthetics and so on) for regional anesthesia patient who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial patient known to susceptible to malignant hyperthermia known allergy or hypersensitivity to any drugs administered during this clinical trial previous participation in this clinical trial participation in another clinical trial within 4 weeks prior to selection", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Postoperative Delirium Elderly (> 65 years) frail patients undergoing non cardiac surgery under anaesthesia lasting for >60 minutes Patient willing and able to complete the requirements of this study disabling neuropsychiatric or neurological disorders(including severe dementia, Alzheimer's disease, schizophrenia, severe depression) patients suffering from delirium at selection patients who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-55.0, All Post-traumatic Stress Disorder (PTSD) Trauma for patients with PTSD age 18-55 years old currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score > 50 for patients with PTSD any primary Axis I disorder other than PTSD (e.g. psychosis) medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study) current breast feeding use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study general MRI", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 40.0-85.0, All Traumatic Brain Injury Chronic Traumatic Encephalopathy Mild Cognitive Impairment males between 40 to 85 years of age individuals who participated in contact sports (e.g., active and retired NFL players, NHL players, boxers, NCAA athletes) and other individuals (including but not limited to veterans, breachers, or law enforcement officials with multiple blast exposures) who all have a history of one or more concussions and have a memory or cognitive complaint individuals with Mild Cognitive Impairment (MCI) and no history of concussion or TBI healthy controls with no history of head injury and no current cognitive or memory problems all participants require a study partner, who is well acquainted with the participant, to answer questions either in person or over the telephone about the individuals' activities of daily living, and to corroborate cognitive problems and past history of brain injury any significant neurological disease, such as Alzheimer's disease, Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Lewy Body Dementia, frontotemporal dementia, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, or multiple sclerosis any significant systemic illness or unstable medical condition, including: uncontrolled diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer a history of schizophrenia or psychosis, alcohol or substance abuse or dependence within the past 6 months clinically significant impairment of liver or renal function significant cerebrovascular disease impairment of visual or auditory acuity sufficient to interfere with completion of study procedures education level < 10 years any subjects with a history of risk factors for Torsades de Pointes, or subjects taking drugs known to prolong the QT interval subjects who have had 2 or more PET scans within the past year, or other significant exposure to radiation (i.e., radiation therapy)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 60.0-999.0, All Delirium C.Surgical Procedure; Cardiac Postoperative Complications Patients of 60 years or older who are planning to receive cardiac surgery (CABG and/or valve replacement surgery) Patients will be excluded if they meet any of the following Refuse to participate Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier History of brain injury or neurosurgery Preoperative sick sinus syndrome, severe bradycardia (HR < 50 bpm), second-degree or above atrioventricular block without pacemaker Severe hepatic dysfunction (Child-Pugh class C) Severe renal dysfunction (requirement of renal replacement therapy) Other conditions that are considered unsuitable for participation", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 30.0-80.0, All Delirium Postoperative Complications Male or female, between 30 and 80 years of age ASA I , II or III Capable and willing to consent Participants literate in English language ASA IV or V Patients with severe visual or auditory disorder Illiteracy Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia Dementia of Alzheimer's type Parkinson disease Multiple Sclerosis (MS) Vascular dementia", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 75.0-999.0, All Abdominal Pain Elderly patients admitted to the emergency department (aged 75 year old and older) acute abdominal pain informed consent traumatic pain symptom duration of more than a week unability for the patient to give informed consent", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-80.0, All Delirium presence of delirium presence of Alzheimer's disease any mental disorder presence of cancer", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-80.0, All Delirium presence of delirium presence of Alzheimer's disease any mental disorder presence of cancer", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 60.0-999.0, All Delirium years and older Frail Undergoing elective surgery Expected to remain admitted for at least 2 postoperative days No communication possible due to a language barrier or deafness Admission for neurological surgery Participation in this study during a previous hospital admission Practical or logistical reasons hampering the use of the delirium monitor, such as technical failure of the monitor Isolation because of known carrier ship of a resistant bacterium", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Delirium Confusion Intensive care unit patient years of age or older confirmed within 24 hours of admission Positive Confusion Assessment Method score Anticipated intensive care unit stay less than one day Less than 18 years of age Inability to wear a motion sensor watch (ActivPal)", "label": "1"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 2.0-17.0, All Pain Long-bone Fractures children aged 2 through 17 years (17 years included) accompanied by at least one of their parents in the emergency department accompanied by at least one of their parents in the emergency department suspected fracture of a long bone requiring morphine analgesia (VAS \u2265 60/100 or Evendol \u2265 7/15 at the inclusion) within the first 12 hours after the injury at least one signed parental informed consent affiliated to health insurance analgesic treatment within the 6 hours before contraindication to one of the study drug cognitive impairment multiple injuries resuscitation man\u0153uvres open fracture non affiliated to social security parental refusal", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 1.0-3.0, All Children With Mobility Disabilities motor delays (sd>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking aged between 12 months to 36 months old able to tolerate sitting with support for 30 minutes able to reach the objects with either one or two hands consent of the parents to agree to the testing procedures and participate in the training program at their own house or at the hospital children with severe sensory impairments such as blindness, deafness parents/caregivers are not able to make a time commitment for the training phase", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Stroke Atrial Fibrillation (AF) Intracerebral Haemorrhage (ICH) Study I: (AF) Adult (\u226518y; no upper limit) patients with a clinical diagnosis of non-valvular AF (verified by ECG) with intention to treat with best practice oral anticoagulants (e.g. warfarin) Previous ischaemic stroke or TIA diagnosed by treating clinician All patients must be able to have GRE MRI before (or within 1 week) of starting best practice oral anticoagulant Any MRI contraindications Previous use of oral anticoagulation Definite contra-indication to oral anticoagulation Serious head injury (resulting to loss of consciousness) Study II: (ICH) \u2022 Adult (>18y) patients treated at participating centres with confirmed ICH (confirmed on CT or MRI scans) with or without a history of anticoagulant use at the time of the ICH Known underlying structural cause for ICH (e.g arteriovenous malformation, tumour, cavernoma, intracranial aneurysm, haemorrhagic transformation of an infarct) Major head trauma (causing loss of consciousness and though to be sufficient to have caused the ICH) in previous 24 hours", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Delirium ICU patients aged \u226518 years Surgical, medical, neurology/neurosurgical, or trauma patients Delirious at ICU admission Expected ICU stay shorter than 6 hours Unable to reliably assess ICU delirium due to sustained coma during entire ICU stay unable to understand the language spoken severely mentally disabled serious receptive aphasia serious auditory or visual disorders", "label": "1"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 1.0-3.0, All Children With Mobility Disabilities motor delays (sd>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking aged between 12 months to 36 months old able to tolerate sitting with support for 30 minutes able to reach the objects with either one or two hands consent of the parents to agree to the testing procedures and participate in the training program at the hospital children with severe sensory impairments such as blindness, deafness parents/caregivers are not able to make a time commitment for the training phase", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 75.0-999.0, All Acute Dyspnea Admission to the Emergency Department Age \u2265 75 years AND of acute dyspnoea Breathe rate \u2265 25 cycles/minute or PaO2 \u2264 70 mmHg or SpO2 \u2264 92% in room air or PacO2 \u2265 45 mmHg and pH \u2264 7.35 AND Electrocardiogram in sinus rhythm at admission ", "label": "1"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Delirium Patients with an age equal or older than 65 years Hospitalized at the Acute Geriatric Unit of the \"Complejo Hospitalario Universitario of Albacete\" Valid signed informed consent by the patient or legal representative Agonic situation Non-Spanish speaking Severe cognitive decline (Reisberg\u00b4s Global Deterioration Scale = 7) Patients sharing the same room with a previously included participant", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Delirium from designated nursing units ", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Trauma Injury Severe Trauma Population will be All adults (age \u226518) Blunt and/or penetrating trauma patients with hemorrhagic shock, defined by either a systolic BP (SBP) <90 mm Hg or base deficit (BD) <-6 meq Ability to obtain Informed Consent prior to OR repair of injury will be Patients not expected to survive greater than 48 hours Prisoners Pregnancy Transfer from another hospital Patients receiving chronic corticosteroids or immunosuppression therapies Previous bone marrow transplantation Patients with End Stage Renal Disease Patients with any pre-existing hematological disease Elective Hip Repair Population", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Fracture Elderly patients (age \u226555y ears) of any ethnic / sociodemographic background Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring) Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014 Ambulatory before surgery Informed consent for study participation by the patient or legal representatives Refusal of consent by the patient or legal representatives to participate in the study Fractures within the last 3 months before follow-up Suspicion of a pathological fracture in the context of known or unknown malignancy Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 18.0-999.0, All Delirium Intensive Care Unit Syndrome Patients >18 years of age admitted to the ICU at K\u00f8ge Hospital in the study period Richmond Agitation Sedation Score (RASS): -4 or -5 during the whole study period No CAM-ICU scores during the ICU stay Unable to communicate in Danish (aphasic, deaf, non-Danish speaking, severe brain damage) Severe dementia documented in electronic patient charts (OPUS) Patients not receiving active treatment (moribund patients)", "label": "0"} +{"topic": "An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.", "doc": "eligible ages (years): 65.0-999.0, All Postoperative Complications Written informed consent \u2265 65 years of age Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB Both genders Planned deep hypothermic arrest Acute / emergency procedures Surgery without extracorporeal circulation (ECC) Patients with a history of pseudocholinesterase deficiency Employees of the respective study centres Illiteracy Severe communication difficulties and severe vision or hearing problems Patients legally unable to give written informed consent non-fluency in German language Severe psychiatric or neuropsychiatric disorders", "label": "0"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 0.0-999.0, All Good Prognosis Metastatic Gestational Trophoblastic Tumor Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Uterine Corpus Choriocarcinoma Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers Greater than 20% sustained rise in beta HCG titer over two consecutive weeks Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum) Histologically proven nonmetastatic choriocarcinoma Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm) WHO score 0-6 (not including blood group or CT lung) No histologically confirmed placental site pseudotumor Must have undergone at least 1 uterine curettage Previously untreated disease ", "label": "1"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 33.0-50.0, All Leiomyoma Women receiving insulin or thyroid hormone replacement may participate if well-controlled; use of vitamins and calcium under RDA is allowed Female gender-to evaluate effects in the target population for clinical trials In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the counter drugs is acceptable but must be recorded Menstrual cycles of 24 days Hemoglobin greater than 10 g/dL Willing and able to comply with study requirements Age 33 to 50 Using mechanical (condoms, diaphragms), sterilization or abstinence methods of contraception for the duration of the study Negative urine pregnancy test Significant abnormalities in the history, physical or laboratory examination Pregnancy Lactation Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year Unexplained vaginal bleeding History of malignancy within the past 5 years Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations Use of agents known to induct hepatic P450 enzymes; use of imidazoles Current use of GnRH analogs or other compounds that affect menstrual cyclicity FSH greater than 20 IU/mL", "label": "0"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 18.0-999.0, All Uterine Fibroids Leiomyoma Premenopausal women, at least 18 years of age Diagnosis of uterine fibroid(s), confirmed by ultrasound History of menstrual cycles between 17 and 42 days Otherwise in good health Scheduled for a hysterectomy at the end of the treatment period Negative pregnancy test Agrees to double barrier method of contraception Pap test with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder Less than 3 months after having a baby or breast-feeding Any abnormal lab or procedure result the study-doctor considers important Severe reaction(s) to or are currently using any hormone therapy History of cancer or alcohol or drug abuse Diagnosis of Polycystic Ovary Syndrome History of prolactinoma Current use of Intrauterine Device Significant gynecological disorder Uterine size > 32 weeks gestation Current diagnosis of endometriosis", "label": "1"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 18.0-999.0, All Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment Otherwise good health Premenopausal based on Estrogen and Follicle Stimulating Hormone levels Agrees to double-barrier method of contraception Adequate endometrial biopsy with no significant histological disorder Any abnormal lab or procedure result(s) the study-doctor considers important History of a blood-clotting disorder Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away Significant gynecological disorder, such as endometrial polyp", "label": "0"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 20.0-50.0, All Trophoblastic Neoplasms Hydatidiform Mole Choriocarcinoma Gestational Trophoblastic Neoplasms Unwilling to participate in the study", "label": "2"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 20.0-45.0, All Uterine Fibroids Pregnancy Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following Women 20-40 age. Women age < 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test Women undergoing fertility treatment or plan to have sperm donation Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site Able and willing to give consent and able to attend all study visits Able to communicate sensations during the MRgFUS procedure Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone) Tumor(s) are clearly visible on non-contrast MRI Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH Patient is pregnant as confirmed by pregnancy test at time of screening Uterine size >20 weeks as evaluated by US or MR Patients who are considered \"high risk pregnancy\" due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable Patients with adenomyosis Patient is on dialysis Hematocrit is < 25 Patient has hemolytic anemia Patient has unstable cardiac status including: \u00a7 Unstable angina pectoris on medication\u00a7 Documented myocardial infarction within 6 months of protocol entry\u00a7 Congestive heart failure requiring medication (other than diuretic)\u00a7 Currently taking anti-arrhythmic drugs\u00a7 Severe hypertension (diastolic BP>100 on medication)\u00a7 Presence of cardiac pacemaker Patient has an ASA score of >2", "label": "1"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 0.0-999.0, All Trophoblastic Neoplasms Uterine Neoplasms Hydatidiform Mole Choriocarcinoma Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT) WHO score 2-6 (re-evaluated at the time of relapse Histologically confirmed complete or partial moles on initial evacuation Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/ folinic acid) Patients with more than 8 metastatic lesions identified Patients with metastases to liver, spleen, brain, kidney or GI tract", "label": "2"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 18.0-999.0, All Melanoma Male and female subjects above age 18 of any ethnicity will be enrolled in this study Subjects will be excluded from the study if they have significant skin disease which would not allow manipulation of their photographs consistent with the rest of the subjects Since the study instructions are in English, Non-English speakers will be excluded Those with co-morbidity sufficiently severe to prevent them from being able to perform a SSE will be excluded In addition, those with cognitive impairment who are unable to give informed consent, or to understand the study instructions given to them, will be excluded", "label": "0"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 18.0-999.0, All Recurrent Herpes Labialis Patients aged 18 years or older A history typical for recurrent herpes labialis. The subject must have experienced three or more episodes of cold sores in the last 12 months, and have a history of prodromal symptoms, as defined by the patient, preceding at least 50% of these cold sores, and must also have a history of vesicular lesions in at least 50% of the recurrent episodes of cold sores General good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's account of his/her medical history Women of child bearing potential had to use an accepted method of birth control (surgical sterilization; intra-uterine contraceptive device; oral contraceptives; hormone delivery systems such as Norplant\u00ae or Depo-Provera injections; a diaphragm in combination with contraceptive cream, jelly, or foam; or a condom in combination with contraceptive cream, jelly or foam). Patients unable or unwilling to use one of the methods of birth control listed above for the duration of the study could not enter the study For women of child-bearing potential, a negative pregnancy test (urine) at screening was required Signature on the informed consent document Previous herpes vaccination Patients using topical immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) on or near the face or systemic immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) within 30 days of screening Patients known to be immunosuppressed due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy) Recent history of alcohol or drug abuse, which in the opinion of the investigator, could interfere with that study patient's compliance with study requirements Significant skin disease such as atopic dermatitis or eczema that would interfere with the assessment of lesions Allergy or hypersensitivity to formulations containing acyclovir, penciclovir, famciclovir, and/or other nucleoside analogues Women who were lactating or breast feeding Had already been randomized once into the study Patients who had received an investigational drug in the past four weeks", "label": "0"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 30.0-999.0, All Uterine Fibroids Menorrhagia and/or bulk symptoms associated with uterine fibroids Malignancy Current or planned pregnancy Small submucous fibroids suitable for hysteroscopic resection Postmenopausal women Suspected or known adenomyosis Uterus size exceeding the umbilical level Contraindications against laparoscopic surgery", "label": "2"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 5.0-999.0, All Melanocytic Nevi Acquired Melanocytic Nevi Primary Cutaneous Melanoma Infants/Children Must be less than or equal to 5 years Must have large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp Must have outside referring physician Adults Must be greater than 18 years Must have greater than or equal to 100 melanocytic nevi greater than 2 mm in diameter Must have at least one melanocytic nevus greater than or equal to 4 mm in longest dimension Can have prior history of cutaneous or ocular malignant melanoma Must have outside primary physician The patient does not meet the criteria Diagnosis of genetic syndrome associated with multiple lentigines or nevi (Peutz-Jeghers syndrome, Carney complex, turner syndrome, Noonan's syndrome) Two or more first-degree relatives with history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype Diagnosis of cancer-associated syndrome (xeroderma pigmentosum, type I neurofibromatosis, Li-Fraumeni syndrome) Inability to tolerate surgical procedure due to bleeding diathesis or disorder or other cause as determined by principal investigator Patient is unwilling to consider elective biopsy of a melanocytic nevus", "label": "0"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 18.0-999.0, All Uterine Leiomyomas Women included in the study must be at least 18 years if age, premenopausal, speak English, and have one or more uterine leiomyomas at least 2 cm in diameter and the utuerus must be enlarged to the size typical during the 8th week of pregnancy. Note that while the selcetion criteia are set to recruit women in which surgical intervention is a likely outcome, surgery is not a requirement for study inclusion Women will be excluded if they are pregnant because of potential safety concerns associated with imaging and image contrast enhancements. If women become pregnant during the study, they wil have the option to stay in the study, but will have pelvic ultrasound scans in place of MRI scans Women who are taking or likely to start taking GnRH therapy will be excluded because this therapy, which is used as a treatment method for leiomyomas, sometmes induces their regression Women who are greater than 52 inches in circumference or greater than 350 pounds will be excluded because they will be too large to fit in the imaging equipment Women that have an intra-uterine device (IUD) will be excluded because these metal devices create 'shadowing' in MR images, making accurate measurement and interpretation of leiomyomas in the MRIs difficult Women are not excluded if they had a prior myomectomy, or if they are taking oral contraceptives The of only women of premenopausal age (greater than 18 years old) in this study is dictated by the nature of the condition", "label": "1"} +{"topic": "A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.", "doc": "eligible ages (years): 30.0-50.0, All Leiomyoma Leiomyomatosis Uterine Neoplasms Patient chooses to participate and has signed informed consent Age between 30 and 50 years old Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain Patient has fibroids confirmed by MRI Patient has normal kidney function Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility Patients with a history of gynecologic malignancy Patients with known endometrial hyperplasia Patients with adenomyosis Patients with pelvic inflammatory disease Patients with Uteri < 250 ml (cm) calculated volume or > 24 weeks Patients with pedunculated subserosal fibroids with a narrow attachment (<50% diameter of the fibroid) to the uterus Patients with pelvic pain as dominant syndrome Known allergy to contrast media that cannot be adequately pre-medicated Patients not suitable for arterial access", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 0.0-999.0, All Healthy Movement Disorder Any volunteer of any age from birth to old age who is deemed medically fit to participate and is willing to provide their informed consent will be included in the study ", "label": "2"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 0.0-999.0, All Laryngeal Disease Spastic Dysphonia Voice Disorder Symptoms present during speech and not apparent at rest Symptoms less evident during whisper, singing or falsetto Symptoms become worse with prolonged speaking, practice or anxiety Reflexive and emotional aspects of voice function are unaffected, such as coughing, laughter or crying Any patient with a history of airway obstruction will be excluded from the study Structural abnormalities affecting the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or inflammation (laryngitis) Reduction in vocal fold movement range during non-speech tasks such as whistling which would suggest either paralysis or paresis, joint abnormality or neoplasm No smokers or tobacco users will be included in the study Subjects with history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from the study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not a person from participation", "label": "1"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 0.0-999.0, All Essential Tremor Patients with essential tremor affecting the upper limbs who are 21 years of age or older Patients who are not taking medications for essential tremor or any other medical condition for at least 2 weeks Patients who have not consumed alcohol or cold medications containing alcohol for at least 24 hours prior to the day of the study Women must not be pregnant or lactating. Women of childbearing age must use birth control while participating in this study Patients must not have any neurological disease other than tremor (e.g., Parkinson's disease) Patients must not have evidence of thyroid, liver, kidney or chronic lung disease ", "label": "1"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 2.0-6.0, All Cerebral Palsy Motor Deficits Clinical diagnosis of hemiparetic cerebral palsy consistent with in Swaiman and Russman (1999) and Badawi et al. (1998) Recommended for participation in pediatric rehabilitation and/or early intervention Lives within 50 miles of the Civitan Center at University of Alabama at Birmingham or the family is willing to temporarily relocate to the Birmingham area for treatment Profound bilateral hearing loss with the use of hearing aids Severe visual impairment Serious seizure disorder or uncontrolled seizures Genetic and syndromic conditions historically excluded for CP registries Familial Spastic Paraplegia Ataxic Cerebral Palsy Diagnosis of Pervasive Developmental Disability or autism Serious or recurring medical complications Scheduled for surgery within 12 months of study entry", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 21.0-999.0, All Essential Tremor patients with a clinical diagnosis of essential tremor will participate in the study. Selection criterion is essential tremor with a history of ethanol responsiveness. Informed consent will be obtained by any of the co-investigators Patients must be off any medications used to treat essential tremor such as mysoline or propranolol for at least 2 weeks. Patients must withhold ethanol and caffeine 24 hours prior to starting the treatment periods through the end of treatment periods, including alcohol or caffeine containing over the counter medications. Ethanol and caffeine consumption is allowed in the washout period Patients with abnormalities on neurologic exam other than tremor Patients with a history of chronic alcohol dependence Patients with chronic medical conditions such as renal failure, hepatic failure and chronic lung disease Patients on other medications that cannot be temporarily discontinued for the length of the study Patients, who, for moral or religious reasons, do not wish to take a potentially intoxicating drug Patients with abnormalities on their baseline screening laboratory tests Women who are pregnant or lactating Patients under the age of 21 Asians and Pacific Islanders", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 21.0-999.0, All Essential Tremor Patients with alcohol-responsive Essential Tremor Limb involvement should be a prominent feature of the Essential tremor Patients must be willing and able to safely stop and remain off any medications used to treat essential tremor for at least 4 half-lives Patients must be willing to abstain from ethanol and caffeine intake for at least 48 hours prior to starting the study hospitalization until study termination Patients must be willing and able to fast for periods of up to 12 hours during the study Patients with abnormalities other than tremor on neurological exam Patients with active or past alcohol abuse or dependence Patients with acute or chronic severe medical conditions such as renal failure, hepatic failure or lung disease Patients taking primidone Patients on other acute or chronic medications that influence hepatic metabolism or central nervous system (CNS) function and cannot be temporarily discontinued for the length of the study Patients who do not wish to take a potentially intoxicating drug Patients with abnormalities on their baseline screening laboratory tests Women who are pregnant or lactating Patients younger than age 21 The presence of cognitive impairment preventing informed consent or cooperation during the study", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-85.0, All Stroke Cerebrovascular Accident Subjects will be included in the study on the basis of the following They must be at least six months post-stroke years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert) They have voluntary control with a low to medium range of motion function (UE-FT<5) and a muscle tone They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes They report no excessive pain the impaired arm If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel They must not be participating in any experimental rehabilitation or drug therapies If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment They must have driven prior to stroke Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above criteria Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above criteria", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-999.0, All Post-stroke Upper Limb Spasticity Main Female or male patients \u2265 18 years \u2265 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist) Focal spasticity with \u2265 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist Focal spasticity with \u2265 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX\u00ae or 200 Units Dysport\u00ae or 2000 Units Neurobloc\u00ae (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX\u00ae or 240 Units Dysport\u00ae or 2400 Units Neurobloc\u00ae (type B preparation) for flexor carpi radialis Main Spasticity of any other origin than stroke Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7) Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region Previous or planned treatment with phenol or alcohol-injection in the target limb Previous surgical treatment of spasticity in the target muscle(s) Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch Severe atrophy of the target limb muscles", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-70.0, All Upper Extremity Spasticity Stroke Acquired Brain Injury Minimum 6 months post injury/insult with unilateral upper limb spasticity of the elbow, wrist and/or finger flexors Preinjection Modified Ashworth scores > 2 in at least one of the following areas: elbow, wrist, or finger flexors Subjects must meet for CMA Hand Impairment Scale Stage 2 and be able to complete Task 3 (thumb to index finger) of the CMA Hand Impairment Scale Stage 3, or demonstrate 50% gross grasp to be included Botulinum toxin A (Botox\u00ae) stable patients (have received at least two prior doses of the agent with first dose occurring at least 6 months prior to study enrollment) Able to answer reliably to yes/no questions Able to follow reliably 1-step instructions Written informed consent Females enrolled in this study who are of childbearing age will be required to use adequate measures of birth control for the entire study period. Those who do not agree will be excluded Uncontrolled, clinically significant medical condition other than the condition under evaluation Severe, fixed joint contracture in the affected arm. Patients with mild contracture that does not significantly impact function will be included based upon the assessment of the PI Known allergy or sensitivity to any of the components in the study medication Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment Treatment with botulinum toxin of any serotype for any reason in less than 3 months prior to initial date of injection for the study Any medical condition that may put the subject at increased risk with exposure to botulinum toxin type A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function Evidence of recent alcohol or drug abuse Infection or skin disorder at an anticipated injection and/or electrical stimulation sites Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-70.0, All Stroke Male or female, 18 to 70 years of age Written informed consent Written Authorization for Use and Release of Health and Research Study Information has been obtained Medically stable condition in the investigator's opinion History of stroke (hemorrhagic or ischemic) that resulted in a unilateral, upper-limb focal spasticity pattern of the wrist and fingers EMG evidence of volitionary activiation of wrist and finger extensor and flexor muscles Active range of motion (to be repeated 3 times by the patient): The ability to initiate wrist extension of at least 10 degrees from a fully flexed position with the forearm supported and stabilized in a pronated position. Active shoulder flexion and abduction to 45 degrees and no less than -30 degrees of elbow extension Mini-Mental State Exam (MMSE) >24 If on an anti-spasticity medication regiment at the time of qualification, the dose regimen must have been stable 1 month prior to study enrollment Ability to follow study instructions and likely to complete all required visits Time since neurological event resulting in upper limb spasticity less than 3 months or greater than 24 months Previous therapy with BOTOX\u00ae or any other botulinum toxin serotype for any condition within the last 12 months Phenol or alcohol block in the study limb within 6 months of study enrollment visit History (within 3 months of qualification) of or planned (during study period) casting of the study limb Current treatment with an intrathecal baclofen pump In the opinion of the investigator, profound atrophy of the muscles in the study limb that are targeted for injection Previous surgical intervention in the study limb, except for routine orthopedic repair for bone fractures, in the last 6 months Presence of fixed contracture of the study limb impairing functional activity Clinically significant inflammation or condition in the study limb that, in the investigator's opinion, could limit joint movement (other than stroke or spasticity) Clinically significant spasticity or contracture of the elbow (defined as an Ashworth score >3) or shoulder in the study limb, in the investigator's opinion would limit sue of the wrist and fingers", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-999.0, All Alcohol Withdrawal Delirium Meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) for alcohol withdrawal syndrome (AWS) Be an inpatient at St. Mary's Medical Center (SMMC) or Miller Dwan Medical Center (MDMC) at time of study enrollment Have an alcohol withdrawal score as measured by standard SMMC or MDMC inpatient protocol sufficient to trigger the use of benzodiazepine withdrawal therapy Agree to abstain for alcohol for duration of study Be able to provide informed consent The patient must not have any other active drug dependence in addition to alcohol Be unwilling or unable to forgo alcohol for the duration of the study Be using baclofen at the time of study enrollment Be using benzodiazepines for any reason other than acute alcohol withdrawal syndrome at time of study enrollment have known baclofen or benzodiazepine sensitivity Be unable to take oral (PO) meds Be unable to complete one of two consenting procedures Be pregnant or breastfeeding Have a serum creatine level > 2.0 Have a history of non alcoholic withdrawal seizures", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 19.0-65.0, All Rabies Subjects free of obvious health-problems or with stable condition Male or female subjects aged \u226519 to \u226465 years BMI between \u226518 and \u226430 kg/m2 Prior history of active or passive rabies immunization Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator History and/or family history of clinically significant immunodeficiency or auto-immune disease Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 1.0-1.5, All Rabies Male and female 12-18 months old toddlers will be included in the study if they are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator are available for all the visits scheduled in the study have been granted a written informed consent signed by their parents a history of rabies immunization a history of Japanese encephalitis immunization or disease a significant acute or chronic infectious disease at the time of enrollment fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment administration of any vaccine within the past 14 days before enrollment known immunodeficiency or an autoimmune disease known hypersensitivity to neomycin, tetracycline, amphotericin-B planned surgery during the study period being enrolled in any other investigational trial contemporaneously", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 1.0-3.0, All Malaria Malaria Infection Males or females aged greater than or equal to 1 to less than 4 years Known residents of the village of Bancoumana, Mali or its surrounding area Good general health as determined by means of the screening procedure Available for the duration of the trial (24 months from enrollment) Willingness to have child participate in the study as evidenced by parents/legal guardians signing or fingerprinting the informed consent document Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, chronic infectious or renal disease by history, physical examination, and/or laboratory studies including urinalysis Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol Pre-existing known autoimmune diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia Laboratory evidence of possible autoimmune disease determined by anti-dsDNA titer that equals or exceeds 25 IU Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than the upper limit of normal of the testing laboratory) Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing confirmed by repeat testing) Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 14,500/mm(3), absolute lymphocyte count less than 1000/mm(3), platelet count less than 120,000/mm(3), or hemoglobin less than 8.5 g/dL) Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing History of a severe allergic reaction or anaphylaxis", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 4.0-18.0, All Chronic Constipation Less than 2 per week defecation Fecal incontinence Retentive behavior Pain at defecation and Hard stools Medication use (calcium, antacid, diuretic and hematinic) Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental delay neuropsychomotor, kidney disease and metabolic diseases)", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-60.0, All Rabies Aged 18 to 60 years on the day of Provision of a signed Informed Consent Form Able to attend all scheduled visits and comply with all trial procedures For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination) Entitlement to national social security For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test Breast-feeding woman Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response Receipt of any vaccine in the 4 weeks preceding the first trial vaccination", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 21.0-65.0, All Stroke Demographics: 21 to 65 years, within 12 months of first, single clinical stroke (ischaemic or haemorrhagic) Moderate to severe upper extremity (UE) weakness post stroke Fugly-Meyer motor score of the upper limb < 40 Upper limb motor power MRC grade 3 or less /5 in at least 1 arm region Able to give own consent and understand simple instructions and learn through practice Resting brain states determined by FMRI Recurrent stroke Previous brain surgery Spasticity of Modified Ashworth scale > 2 Fixed contracture of any upper limb joint Ataxia, dystonia or tremor of the involved upper limb or previous cervical myelopathy Upper limb pain or painful joints in upper limb Severe cognitive impairment (Abbreviated Mental Test <7/10), or severe aphasia which may affect ability to participate in training . History of seizures in the past 12 months Severe left neglect", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-999.0, All Obesity African American (3 of 4 grandparents are of African Descent) Lives in designated census area No plans to move in the next two years Has no medical condition that would limit participation in moderate intensity exercise including life-threatening illness (e.g., immobile, severely disabled, or bed ridden) Available and able to participate in measures and intervention activities over the next 2 years Extreme Blood Pressure and/or Blood Glucose levels Unable to take a brisk, 30-minute walk", "label": "1"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-999.0, All Rabies Prevention Rabies Exposure Laboratory personnel, epidemiologists, EISOs, veterinary students, interns, and other first responders at CDC; other CDC employees; and healthy volunteer adults. Persons who contact the study coordinator will be assessed for possible occupational exposure to rabies using the risk assessment form (appendix E). The volunteers reporting occupational exposure will be selected to enter the study Male or nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine), aged 18 years and older Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods) for the entire study period Be in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history Able to understand and comply with planned study procedures Provide informed consent prior to any study procedures and be available for all study visits Have health insurance Have a known allergy to PCECV Have a known allergy or sensitivity to eggs or latex (in the stopper) Have a positive urine pregnancy test prior to first vaccine dose (female of childbearing potential age) Are immunosuppressed as a result of an underlying illness or treatment Have active neoplastic disease or a history of any hematologic malignancy Are using oral or parenteral steroids, high-dose inhaled steroids (>800 \u03bcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study Have an acute illness that is accompanied by an oral temperature greater than 100.4\u00b0F, within 1 week of vaccination Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 1st month of the study period Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 0.167-17.0, All Encephalitis Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7 Clinical manifestation or history of any Flavivirus disease Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study History of immunodeficiency or immunosuppressive therapy Known HIV, HBV or HCV infection History of hypersensitivity reactions to other vaccines Acute febrile infection at each visit during which the subject receives a vaccination Active or passive immunization within 1 week before and 1 week after each IC51 vaccination", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-50.0, All Diarrhea Male or female age \u226518 and \u2264 50 years General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI Negative serum pregnancy test before first (visit V0) and before challenge (visit C0) for female subjects of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female subjects unable to bear children must have this documented (e.g. tubal ligation or hysterectomy) or must have negative pregnancy tests Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained Completion of a training session and demonstrated comprehension of the protocol procedures, knowledge of ETEC-associated illness, and by passing a written examination Availability for the study duration, including all planned follow-up visits Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study. Some medical conditions which are adequately treated and stable would not preclude entry into the study. These conditions might stable asthma controlled with inhalers or mild hypertension stably controlled with a single agent Significant abnormalities in screening hematology, serum chemistry or urinalysis as determined by PI or PI in consultation with the MM and sponsor Presence in the serum of HIV antibody, HBsAg, or HCV antibody Evidence of IgA deficiency (serum IgA < 7 mg/dl or limit of detection of assay) Evidence of current excessive alcohol consumption or drug dependence Evidence of impaired immune function BMI <19, >34 Recent vaccination or receipt of an investigational product (within 30 days before vaccination) Intention to donate blood or blood products for one month following the completion of study participation (note: The Red Cross will not allow blood donations for 1 year following participation in an investigational research study) Any other which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study, or the results of the study", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-60.0, All Thyroidectomy Distress Surgery (a) a minimally invasive follicular thyroid carcinoma \u22644 cm in diameter, or (b) a papillary thyroid carcinoma \u22642 cm in diameter (a) previous neck operations (b) age <21 or >65 years (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 21.0-80.0, All Multiple Sclerosis diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS) reduced use of one of the hands because of MS ability to pick up and release a small object with the more-affected hand when requested can travel to the treatment program at the University of Alabama at Birmingham (UAB) can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day can undergo MRI scan any kind of medication used for MS is allowed except spasticity medicine disease relapse in the past 3 months pregnancy marked pain with arm movement severe uncontrolled medical illness simultaneous treatment with another form of physical therapy", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-55.0, All Rabies Male or female subject aged \u226518 to \u226455 years Subjects free of obvious health-problems or with stable conditions or medications Body mass index between \u226518 to \u226430 kg/m2 Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90 Male subjects must agree that they will not donate sperm from the first check-in until Day 90 Subject signed written informed consent Prior history of active or passive rabies immunization Clinically significant acute illness or infection including fever (\u226538 \u00b0C) within 2 weeks before first dosing History and/or family history of clinically significant immunodeficiency or auto-immune disease Planned immunization with live vaccines during the coming 3 months after first dosing Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 4.0-12.0, All Angelman Syndrome Age between 4 years and 12 years (i.e., before the 13th birthday) Molecular confirmation of the diagnosis of AS, which may abnormal methylation studies or UBE3A mutation analyses only subjects with a molecular diagnosis will be allowed to enroll Not on LD, CD, or any dopamine agonists in the 2 weeks prior to participation Co-morbid disorders that may be associated with developmental or cognitive delays Poorly controlled seizures An average of more than 2 clinical seizures per month in the 12 months prior to enrollment Use of medications that may interact with LD/CD including atypical antipsychotics (aripiprazole, asenapine, iloperidone, olanzapine, paliperidone, risperidone, ziprasidone), monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine), or phenytoin within the last 14 days, or other investigational interventions within the past 3 months Presence of cardiovascular disease or instability, respiratory disease, liver disease, peptic ulcer disease, renal impairment, or hematological disorders Pregnancy", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-60.0, All HIV Rabies HIV infected patients 18-60 years of age Ever received primary rabies immunization currently have any active opportunistic infections have received blood or blood product within previous 3 months history of allergy to vaccine or any vaccine components currently received anti-malarial drugs", "label": "1"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 2.0-50.0, All Malaria Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.with consenting parents Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness Severe malnutrition Hypersensitivity to HDCRV History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone History of splenectomy Haemoglobin less than 9.0 g/dL, where judged to be clinically significant in the opinion of the investigator Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator Blood transfusion within one month of enrolment History of vaccination with previous experimental malaria vaccines Administration of any other vaccine or immunoglobulin within two weeks before vaccination", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-999.0, All Muscle Spasticity Adult patients with upper limb spasticity following a stroke Eligible to receive botulinum toxin Type A No previous botulinum toxin Type A therapy ", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 30.0-80.0, All Stroke for patients wth stroke Age 40-80 years sustained a single stroke between 3-24 months prio t study leading to upper limb paresis have at least Stage 3/7 arm control (mild to moderate motor deficits) on the Chedoke-McMaster Scale <81 yrs old to minimize confounding effects of age-related changes in sensorimotor functions for patients wth stroke other neurological or orthopaedic problems that may interfere with interpretation of results significant deficits in attention, constructional skills, neglect and apraxia shoulder subluxation, arm pain lack of endurance as judged by a physician undergoing other therapy, surgery or medical procedures within the study period for healthy control subjects Age 40-80 years for control subjects any neurological or orthopaedic problems that may interfere with interpretation of results", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-60.0, All Meningococcal Disease Meningococcal Meningitis Typhoid Yellow Fever Rabies Japanese Encephalitis Female and male subjects who must be healthy and must be Between 18 and 60 years of age inclusive and who have given their written informed consent Available for all visits and telephone calls scheduled for the study In good health as determined by medical history, physical examination and clinical judgment of the investigator For female subjects, having a negative urine pregnancy test Individuals not eligible to be enrolled in the study are those who are breastfeeding who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection) who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period (Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization) who have received an anti-malaria drug, up to 2 months prior to the study who have experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature \u2265 38\u00b0C) within 3 days prior to enrollment who have any serious acute, chronic or progressive disease such as", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 15.0-60.0, All Efficacy of the New CPRV Healthy Can visit according to the protocol Fever Acute illness History of rabies vaccination Allergic to the vaccines' component Immunosuppressive conditions such as HIV infection, transplantation, chronic renal failure, received steroid or immunosuppressive drugs and anti-malarial drugs within previous two months or any blood products within previous three months Female participant must not be pregnant All female participant must have urine pregnancy test negative prior to participate the study", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 0.417-1.417, All Malaria Healthy infant/child aged 5-17 months at the time of first study vaccination Informed consent of parent/guardian Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness Weight-for-age Z score of less than -3 or other clinical signs of malnutrition History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator Serum Creatinine concentration greater than 70 \u00b5mol/L, where judged to be clinically significant in the opinion of the investigator Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator Blood transfusion within one month of enrolment Previous vaccination with experimental malaria vaccines Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-70.0, All Spinal Cord Injury Muscle Spasticity Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months) Moderate to severe lower-limb spasticity Able to give informed consent and willing to comply with protocol Pregnancy History of seizures Existing or history of frequent Urinary Tract Infections History of drug or alcohol abuse Allergy to pyridine-containing substances Received a botox injection 4 months prior to study Received an investigational drug within 30 days Previously treated with 4-aminopyridine (4-AP) Not on stable medication dosing in 3 weeks prior to study Abnormal ECG or laboratory value at screening", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 20.0-75.0, All Stroke first episode of unilateral stroke time since stroke less than 3 months, i.e., acute or subacute stage initial motor part of upper limb of FMA score ranging from 10 to 40, indicating severe to moderate movement impairment no serious cognitive impairment (i.e., Mini Mental State Exam score > 23) pregnant or breastfeeding women aphasia that might interfere with understanding instructions major health problems or poor physical conditions that might limit participation currently participation in any other research. Potential participants will be also excluded if they have any contraindication to fMRI scanning including claustrophobia, seizures, the presence of pacemaker, mental elements (e.g., steel nails) inside the body or in the eyes, and excessive obesity", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 0.0-999.0, All Rabies Vaccine Allergy Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local \u2265 12 months before injured The man-killer could found and detect whether it carries the virus Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Apply passive immunity preparation", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 2.0-17.0, All Rabies Aged 2 to 17 years on the day of Informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative and by an independent witness, as applicable, and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination Any previous vaccination against rabies (in pre or post-exposure regimen) with either the trial vaccine or another vaccine Bite by a potentially rabid animal in the previous 6 months without post-exposure prophylaxis Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Self-reported seropositivity for Human Immunodeficiency Virus (HIV) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-80.0, All Tremor Essential Tremor Men and women, between 18 and 80 years, inclusive Patients who are able and willing to give consent and able to attend all study visits A diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist Tremor refractory to adequate trials of at least two medications, one of which should be either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated Vim nucleus of thalamus can be target by the ExAblate device. The Vim region of the thalamus must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain Able to communicate sensations during the ExAblate MRgFUS treatment Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the CRST rating scale Stable doses of all medications for 30 days prior to study entry and for the duration of the study May have bilateral appendicular tremor Significant disability due to essential tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities]) have been agreed upon by two members of the medical team Patients with unstable cardiac status including Unstable angina pectoris on medication Patients with documented myocardial infarction within six months of protocol entry Congestive heart failure requiring medication (other than diuretic) Patients on anti-arrhythmic drugs Alcohol or drug abuse within the past 6 months Severe hypertension (diastolic BP > 100 on medication) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 45.0-80.0, All Stroke a history of acute phase of stroke (less than 12 months post onset) first stroke episode no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity no contracture of the affected wrist or fingers (Modified Ashworth<3) no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study for P-ROM patients, the absence of active hand movements for the A-ROM patients, the presence of active hand movements unstable medical disorders active Complex Regional Pain Syndrome (CRPS) severe spatial neglect aphasia cognitive problems", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-45.0, All Malaria Phase Ia Healthy volunteers aged 18-45 years General good health based on history and clinical examination Written informed consent obtained before any study procedure Female volunteers practicing contraception before and up to 13 weeks after the last immunisation Available to participate in follow-up for the duration of study (34 weeks) Reachable by phone during the whole study period Phase Ib Healthy male volunteers aged 18-45 years General good health based on history and clinical examination Phase Ia Positive pregnancy test for females Actively breast feeding females Previous participation in any malaria vaccine trial Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the volunteers Any clinically significant laboratory abnormalities on screened blood samples beyond the normal range, as defined at the clinical trial site Enrolment in any other clinical trial during the whole trial period Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the 13 weeks preceding the screening visit or during the trial period except topical and inhaled steroids Volunteers unable to be closely followed for social, geographic or psychological reasons Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-65.0, All Hyperhidrosis Muscle Spasticity Glabellar Lines Patients treated with BOTOX\u00ae (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines ", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-65.0, All Upper Limb Spasticity Unilaterally in Adults With History of Stroke Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors. Adults with history of stroke that resulted in a unilateral, upper-limb focal spasticity Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by the Ashworth Scale Ability to understand and follow verbal directions At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with a rating of more than 2 on the Disability Assessment Scale (DAS) At least 1 functional task score at Day 0 that met the following nail filing less than 6, hand cleaning less than 6, holding a water bottle less than 4, brushing teeth less than 4, holding fruit (small, medium, or large equals no Stroke within 6 months of the study enrollment visit Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception Previous or current Botox therapy of any type in the study limb Any medical condition that may put the patient at increased risk with Botox exposure or any other disorder that might have interfered with neuromuscular function Presence of fixed contracture of the study limb Limited use of the wrist and fingers", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 40.0-999.0, All Myopic Macular Degeneration Adult male or female over 40 years of age Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment Axial myopia of equal to or greater than -8 diopters and/or axial length equal to or greater than 28 mm Clinical findings consistent with MMD with evidence of one or more areas of >250microns of geographic atrophy (as defined in the Age-Related eye Disease Study [AREDS] study) involving the central fovea GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA No evidence of current or prior choroidal neovascularization The visual acuity of the eye to receive the transplant will be no better than 20/80 The visual acuity of the eye that is NOT to receive the transplant will be no worse than 20/400 The eye with the more advanced disease and worse vision will be the study eye Electrophysiological findings consistent with macula-involving geographic atrophy Negative urine screen for drugs of abuse Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serologies No history of malignancy (with the exception of successfully treated (excised) basal cell carcinoma[skin cancer] or successfully treated squamous cell carcinoma of the skin) Negative cancer screening within previous 6 months complete history & physical examination dermatological screening exam for malignant lesions negative fecal occult blood test & negative colonoscopy within previous 7 years negative chest roentgenogram (CXR) normal CBC & manual differential negative urinalysis (U/A)", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 1.0-999.0, All Rabies Infection Healthy males and females \u2265 1 years of age Individuals/ individual's parents or legal guardians who have given written consent Individuals in good health Individuals who can comply with study procedures Behavioral or cognitive impairment or psychiatric disease Unable to comprehend and to follow all required study procedures for the whole period of the study History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study Individuals \u2265 1 to \u2264 17 years of age, who have or ever had a malignancy Individuals \u2265 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable) Female of childbearing potential who has not used any of the \"acceptable contraceptive methods\" for at least 2 months prior to study entry Female of childbearing potential, refusal to use an \"acceptable birth control method\" through day 50 Female of childbearing potential, with a positive pregnancy test prior to enrollment Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 16.0-999.0, All Cerebral Palsy Spasticity Aged sixteen or older Spastic Cerebral Palsy with stable condition Motor disability unilateral or predominantly unilateral Troubles of speech clinically evident Normal or Slightly sub-normal I.Q No psychiatric disorders Severe cardiac or respiratory troubles Fixed abnormal postures (except if previously corrected by orthopedic surgery) Chronic recurrent bronchial or pulmonary infections Chronic recurrent urinary infections Severe osteoporosis on affected limbs Chronic skin ulcerations", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-40.0, All Rabies Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial Physical examination and laboratory results without clinically significant findings Body Mass Index (BMI) \u2265 18.0 and \u2264 32.0 kg/m2 Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD]); uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for \u2265 3 months e.g., mild hypertension well-controlled with medication, may be enrolled provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease) Major congenital defects", "label": "1"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-40.0, All Rabies Healthy male and female volunteers aged 18 to 40 years inclusive Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9) Physical examination and laboratory results without clinically significant findings Body Mass Index (BMI) \u2265 18.0 and \u2264 32.0 kg/m2 Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment Females of childbearing potential must use acceptable methods of birth control during the trial and Follow-up period (from 6 weeks before the first administration of the test vaccine for the duration of the trial i.e., until the last planned visit (V9)). The following methods of birth control are acceptable when used consistently and correctly: established use of oral, injected or implanted hormonal methods of contraception; intrauterine devices (IUDs) or intrauterine systems (IUSs) with the exception of steel or copper wire; barrier methods of contraception (condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository); true abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and postovulation methods] and withdrawal are not acceptable) Males must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during the trial and Follow-up period i.e., until the last planned visit (V9) Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine Subject has received any investigational or licensed rabies vaccine previously Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infections exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and up to V9 (Day 91/120) Follow-up Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination History of autoimmune disease Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the trial vaccine Subject is taking chloroquine for malaria treatment or prophylaxis Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness or fever \u2265 38 \u00b0C measured orally", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 1.0-15.0, All Dog Bite they are 1-15 years healthy children give signed informed consent from their parents willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded Urine pregnancy test must be done in all female adolescents to the pregnancy in first visit", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-85.0, All Stroke First focal unilateral lesion, ischemic or hemorrhagic Had a stroke less than a month prior to enrollment Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Hand Apraxia Subjects who have other unrelated or musculoskeletal injuries", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-85.0, All Stroke \u2022 First focal unilateral lesion, ischemic or hemorrhagic Had a stroke less than a month prior to enrollment Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Hand \u2022 Apraxia Subjects who have other unrelated or musculoskeletal injuries", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-60.0, All Rabies Male and non-pregnant females aged \u2265 18 to \u2264 60 years on the day of Able to comprehend and give informed consent Able to attend all scheduled visits and to comply with all trial procedures Subject in good health, based on medical history and physical examination Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination) Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Previous history of receiving the rabies vaccine Previous history of receiving rabies immune globulin Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that is well controlled is not an criteria Any history of cardiac arrhythmias, such as: Bradycardia, tachycardia, heart block, SVT, PAC, VF, VT, or any other conduction abnormalities Use of any immunosuppressive drug , including topical steroids of potency groups I, II or III within 30 days of the study period Any immunosuppressive disorder, such as HIV, common variable, active cancers or chemotherapy History of renal insufficiency or requiring dialysis", "label": "1"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-85.0, All Essential Tremor Essential Tremor diagnosed by listed in the Consensus statement of the Movement Disorders Society on Tremor Age 18 years of age Motor skills allowing for capability to complete evaluations Medically cleared for undergoing anesthesia and DBS surgery Dementia per DSM-V Medical or other condition precluding MRI History of supraspinal CNS disease other than Essential Tremor Alcohol use of more than 4 drinks per day Pregnancy History of suicide attempt Currently uncontrolled clinically significant depression (BDI>20) History of schizophrenia, delusions, or currently uncontrolled visual hallucinations", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 2.0-999.0, All Cervical Dystonia clinical diagnosis of cervical dystonia or spasmodic torticollis ages 2-100 no clinical diagnosis of cervical dystonia or spasmodic torticollis symptoms beginning over the age of 40 pregnant women are excluded from Aim 2", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 0.0-999.0, All Complication of Labor and Delivery all midwives and physicians working on labor ward in the participating hospitals all women giving birth in the participating hospitals both genders are included in the staff, and among the newborns the study aim is the education of the staff, and hospitals are compared as units", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 10.0-60.0, All Rabies Aged from 10 to 60 years old Subjects or legal guardians can and will comply with the requirements of the protocol Subjects or legal guardians are able to understand and sign the informed consent Healthy subjects judged from medical history after investigator's inquiry Subjects with temperature <=37.0\u00b0C on axillary setting Female in lactation or pregnancy, or plan to be pregnant during the study period Subject who has allergic history to any vaccine or other medicines Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain Subject with congenital malformation, developmental disorder or serious chronic disease Subject with autoimmune diseases or immunodeficiency Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids Subject with diabetes (Type I or II) excluding gestational diabetes Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease Subject with severe angioedema in the past 3 years or require treatment in the past 2 years", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-60.0, All Rabies HIV infected patients Age 18 years Received primary rabies immunization Have any active opportunistic infections Received blood or blood product within 3 months Allergy to vaccine or any vaccine components Received anti-malarial drugs", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-70.0, All Neck Pain No current history or past history of neck pain; able to lie on back or stomach without difficulty 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc History of neck whiplash injury Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck) Prior surgery to your neck or upper back A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency) Diagnosis from your physician of fibromyalgia syndrome Currently pregnant, or could be pregnant", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-60.0, All Rabies Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Male or female, aged \u2265 18 to \u2264 60 years on day of inclusion In good general health based on medical history and physical exam Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Previous history of receiving the rabies vaccine Previous history of receiving rabies immune globulin Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that are well controlled are not criteria Use of any immunosuppressive drug at the time of the study or 30 days previously. Topical steroids will not be considered an immunosuppressive drug and their use will not be considered an Any immunosuppressive disorder, such as HIV infection, common variable immunodeficiency, active cancers or chemotherapy History of renal insufficiency or requiring dialysis Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator", "label": "0"} +{"topic": "A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.", "doc": "eligible ages (years): 18.0-999.0, All Lateral Epicondylosis Lateral Epicondylitis Tennis Elbow Aged > 18 years old Lateral elbow pain lasting > 3 months Pain induced by direct compression on the lateral epicondyle or common extensor tendon, resistant wrist extension and pronation in the elbow extension position, or static stretching of common extensor tendon through the palmer flexion in wrist pronation and elbow extension position Generalized inflammatory arthritis (e.g., rheumatic arthritis) Pain at the proximal part of involved arm (e.g., shoulder pain, neck pain) Pain other than elbow pain at the involved arm Abnormal neurogenic symptom over the involved arm (e.g., radicular pain, hands numbness, hemiplegia) Wound or skin lesion at the elbow of the involved arm Pregnancy Severe local or systemic infection Malignancy Coagulopathy Cardiac pacemaker", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 0.0-999.0, All Immunologic Deficiency Syndrome Patients with a clinical history or signs and symptoms suggestive of a primary immune deficiency syndrome and their family members are eligible for in this study and they may be referred by their physician or self-referred. If possible, a local physician/clinical immunologist will be identified for self-referred patients to serve as primary reference. If screening of the patients, either by phone interview or review of their medical records indicates that the patient may have a primary immunodeficiency syndrome and is HIV-negative, the patient will be invited to come to the NIH and sign an informed consent. If family history is positive for immunodeficiency, the patients or family members may be asked to invite other relatives to contact the PI to participate in the study Adult patient who are unable to provide informed consent are eligible to participate with permission obtained from their legal guardian or durable power of attorney Inability of the subject or the subject s parent/guardian to provide informed consent Patients infected with the Human Immunodeficiency Virus before enrollment", "label": "2"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 5.0-999.0, All E. Granulosus Cystic Hydatid d Living in study area (Cooperative Tupac Amaru) Older than five-years old Pregnant woman (only for chest X-ray procedure)", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-75.0, All Common Variable Immunodeficiency A subject is eligible for the study if all of the following are met Has given written informed consent prior to screening Is male or female aged 18 through 75 years Has CVID diagnosed definitively prior to screening (based on the IUIS criteria) Has a documented, unintended loss of greater than 5% of their body weight over the last year or requires nutritional supplements to maintain his/her body weight OR has chronic diarrhea defined as a complaint of liquid stools for at least 4 consecutive weeks (and an output of greater than 200 g stool/24hr on a diet of at least 1600 calories with 60 g fat.) If taking oral antibiotics chronically, must have used a stable dose of the antibiotic continuously for at least 2 weeks prior to start of screening period Not taking any potential CYP3A4 inhibitors/inducers (e.g., macrolide antibiotics, HIV protease inhibitors, antifungals, grapefruit juice, St. John's Wort) A subject is excluded from the study if any of the following are met General Has any clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this trial Is a woman who has a positive serum pregnancy test or who is breast-feeding Is a woman of childbearing potential or a man who does not agree to use two forms of contraception during the course of the study and follow-up period Has hypersensitivity to any of the components of STA 5326 mesylate drug product Has any of the following clinical chemistry values AST greater than 2.5 x upper limit of normal (ULN) ALT greater than 2.5 x ULN Serum bilirubin greater than 1.5 x ULN", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 0.0-999.0, All Hyper-IgM Syndrome Ectodermal Dysplasia All patients must have a known or suspected immune defect with hyper-IgM syndrome and/or disorders of immunoglobulin production. There will be no limit on age, sex, race, or disability. Normal volunteers must be healthy adults between the age of 18 and 70 years. All study participants enrolled on to this study must agree to allow PI to store research samples. Refusal to let PI store samples may lead to withdrawal fro this specific study The presence of an acquired abnormality, which leads to immune defects, such as HIV, chemotherapy, and malignancy are general Refusal to let us store samples may lead to withdrawal from this specific study. Other factors, which are in the judgment of the Principal Investigator PI that may interfere with patient evaluation or determine to pose an added risk for study participants are also for exclusion", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-90.0, All Abscess Cysts Female or male, aged between 18 and 90 years Written informed consent Abscess formation or abdominal cyst scheduled to drainage Plasma creatinine <1.5 mg/dL Pregnancy or lactation Hemodialysis or hemofiltration Allergy or hypersensitivity against study drugs Massive edemata or hypernatremia Reduced liver function (Child-Pugh A, B, C) Relevant prolongation of QT-interval CNS-diseases which predispose for cramps", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Diagnosis of cancer of the biliary tract by 1 of the following methods Histologic confirmation Stenosis of the biliary tract by MRI, CT scan, or ECHO Unresectable disease Amenable to radiotherapy No visceral metastases by imaging Hepatic adenopathies that can be included in a radiation field allowed No known ampulla of Vater or pancreatic cancer involving the biliary tract WHO performance status 0-2 Creatinine < 1.5 mg/dL ", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 0.0-18.0, All Ruptured Appendicitis Clinical diagnosis of ruptured appendicitis Inability to have usual follow up care (e.g. transient to area)", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 1.0-70.0, All Common Variable Immunodeficiency Agammaglobulinemia Key Written informed consent, age-adapted Male or female aged 1 to 70 years Diagnosis of primary humoral immunodeficiency No prior immunoglobulin substitution therapy IgG level of <5 g/L at screening Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening Key Evidence of serious infection between screening and first treatment Bleeding disorders that require medical treatments Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-75.0, All Known or Suspected Focal Liver Lesions Patients between 18 and 75 years of age inclusive Patients (men or women) with at least one focal liver lesion, either identified or suspected by ultrasound (US), Computed Tomography (CT)/spiral-CT, conventional angiography, CT-angiography (CTA), CT-arterioportography (CTAP) or unenhanced / contrast-enhanced MRI* within 2 months before entering the study For reference, the following pathologies will meet the definition of 'focal liver lesions' Hepatocellular carcinoma Cholangiole carcinoma Metastasis Focal lymphoma Adenoma Focal nodular hyperplasia Hemangioma Patients who have previously entered this study Patients who have received any contrast material within 24 hours before injection with study drug, or who are scheduled to receive any contrast material within 24 hours after injection Patients who are, or suspected to be, nursing Patients who require emergency treatment Patients with severely impaired hepatic or renal functions (e.g. serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of reference range, acute renal failure) Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery, acute myocardial infarction) Patients with any physical or mental status that interferes with the signing of informed consent Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs Patients with a contraindication for MRI Patients who are scheduled for liver biopsy/surgery or other surgeries within 24 hours after injection with contrast media, or who would have a biopsy within 24 hours before planned injection with contrast media", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Intra-Abdominal Infection Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity) Acute appendicitis: Ruptured or perforated with abscess Acute diverticulitis with perforation and/or abscess Acute cholecystitis (including gangrenous) with either rupture or perforation Acute gastric and duodenal ( > 24 hours) perforation Traumatic (> 12 hours) perforation of the intestines Secondary peritonitis due to perforated viscus Intra-abdominal abscess (including of liver and spleen) Traumatic bowel perforation requiring surgery within 12 hours Perforation of gastroduodenal ulcers requiring surgery within 24 hours other intra-abdominal processes in which the primary etiology was unlikely to be infectious Patients lactating or pregnant Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics Patients with rapidly progressive or terminal illness Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2) Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 16.0-80.0, All Amebic Liver Abscess Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess Both genders Older 15 years Clinically suspected piogenous liver abscess Positive hemoculture Negative ELISA for amoebic antigens Immunosupresion (HIV) Abdominal or biliary surgery antecedents Abdominal neoplasia antecedents", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 0.0-999.0, All Abdominal Pain All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, \"abdominal pain and tenderness\" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 12.0-80.0, All Perforated Appendicitis All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent Age less than 12 years older than 80 years perforated appendicitis was not revealed by pathologic investigation diverticulitis being diagnosed during surgery pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation the patient declining to enroll in this study", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Colon Surgery Consecutive patients undergoing open colonic resection at MSC under the ERAS program Known sensitivity to the local anaesthetic agents Patients who prefer not to participate (no consent gained) ASA greater or equal to 4 Rectal resection Formation of stoma Current use of systemic steroids", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 21.0-80.0, All Abdominal Drainage Laparoscopic Cholecystectomy Gall Stones patients with gallbladder stones and laparoscopic cholecystectomy patients above 80 years old patients with acute cholecystitis patients with history of upper laparotomy patients with a hemorrhagic tendency due to cirrhosis patients refused to give informed consent and patients who were converted to open cholecystectomy", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Stomach Neoplasm patients with operable local gastric adenocarcinoma previous abdominal surgery previous open or blunt abdominal trauma history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity All other gastric malignancies such as lymphomas, GIST, carcinoids", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 15.0-80.0, All Gall Bladder Stone in Cirrhotics patients with liver cirrhosis with symptomatic gall bladder stone patients above 80 years old patients with history of upper laparotomy patients with common bile duct stones and pregnant females", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 21.0-999.0, All Dengue Fever Age \u2265 21years Probable or confirmed dengue a) Confirmed dengue: laboratory confirmation of acute dengue by either i) positive polymerase chain reaction (PCR) for viral ribonucleic acid (RNA), or ii)positive NS1 antigen test with a compatible clinical syndrome b) Probable dengue: Positive acute dengue serology and clinical presentation fulfilling either WHO 1997 or 2009 for probable dengue i) 1997 Acute febrile illness and two or more of the following headache retro-orbital pain myalgia arthralgia rash hemorrhagic manifestations ", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 2.0-18.0, All Appendicitis All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon Consent to participate Uncertainty about the diagnosis The need for laparotomy for another reason Free intraperitoneal air on imaging Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-90.0, All Complicated Intra-abdominal Infection Male or female, from 18 to 90 years of age, inclusive One of the following diagnoses (in which there is evidence of intraperitoneal infection) including:(a) Cholecystitis (including gangrenous cholecystitis) with rupture, perforation, or progression of the infection beyond the gallbladder wall;(b)Diverticular disease with perforation or abscess; (c) Appendiceal perforation or periappendiceal abscess; (d) Acute gastric or duodenal perforation, only if operated on >24 hours after perforation occurs; (e) Traumatic perforation of the intestine, only if operated on > 12 hours after perforation occurs; (f) Peritonitis due to perforated viscus, postoperative or spread from other focus of infection (but not spontaneous [primary] bacterial peritonitis or peritonitis associated with cirrhosis and chronic ascites).Subjects with inflammatory bowel disease or ischemic bowel disease are eligible provided there is bowel perforation; or (g) Intraabdominal abscess (including liver and spleen) Subject requires surgical intervention (e.g. laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug If subject is to be enrolled preoperatively, the subject must have radiographic evidence of bowel perforation or intraabdominal abscess Subjects who failed prior antibacterial treatment for the current cIAI can be enrolled but must: (a) have a positive culture (from an intraabdominal site) and (b) require surgical intervention. Such subjects can be enrolled before the results of the culture are known; however, if the culture is negative, study drug administration must be discontinued Willing and able to comply with all study procedures and restrictions Willing and able to provide written informed consent Women who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control (e.g. condom, oral contraceptive, indwelling intrauterine device, or sexual abstinence) Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours; perforation of gastroduodenal ulcer with surgery within 24 hours (these are considered situations of peritoneal soiling before infection has become established); another intraabdominal process in which the primary etiology is not likely to be infectious Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected, necrotizing pancreatitis, or pancreatic abscess cIAI managed by staged abdominal repair (STAR), open abdomen technique or any situation where infection source control is not likely to be achieved Known prior to randomization to have an IAI or postoperative infection caused by pathogen(s) resistant to meropenem Considered unlikely to survive the 4 to 5-week study period Any rapidly-progressing disease or immediately life-threatening illness (including acute hepatic failure, respiratory failure and septic shock)", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Incidence of Symptomatic Lymphocele After Kidney Transplantation Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks Adult recipients of kidney transplants from deceased donors Former extensive abdominal surgery Participation in other studies", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-70.0, All Colorectal Cancer With a Resected Minimal Synchronous PC or Ovarian Metastases, or Tumour Rupture in the Abdominal Cavity A) Patients presenting with the following history Histologically-proven colorectal adenocarcinoma Presenting at the time of resection of the primary with one of the following 4 (criteria indicating a high risk of developing PC) Minimal PC, resected at the same time as the primary Ovarian metastases Rupture of the primary tumour inside the peritoneal cavity Iatrogenic rupture of the primary tumour during surgery B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified\u2026) Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons\u2026) Cancers of non colorectal origin, particularly, appendiceal cancers are excluded Patients presenting with a detectable recurrent tumour Grade \u2265 3 Peripheral neuropathy History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 14.0-999.0, All Endometritis Wound Infection Abscess Surgical Site Infection Pregnant Women aged 14 years and over at \u2265 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of \u22651cm dilatation or \u226550% effacement), or Membrane rupture (standardized to duration of at least 4 hours prior to randomization) Patient unwilling or unable to provide consent Multiple pregnancy Known azithromycin (or other macrolide) allergy Vaginal delivery Elective or scheduled cesarean prior to labor or membrane rupture Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient) Fetal demise or major congenital anomaly Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 6.0-15.0, All Streptococcal Sore Throat Age of 6 to 15 years old The in clinical examination including objective signs (fever, Erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). Neck tenderness, abdominal pain and pharynx petechia were also considered No antibiotic was used during the week before -Performing throat culture before the initiation of drug administration Positive throat culture indication GABHS No previous history of allergy to penicillin Age of below 6 years old or above 15 years old No signs of pharyngitis in the clinical examination Antibiotic use during the week before Throat culture was not performed before the initiation of drug administration Negative throat culture or the culture indicates a microorganism other than GABHS History of allergy to penicillin Not using drugs or not following the treatment in the field of having the second culture performed", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Polycystic Liver Disease Liver volume \u2265 4 liter \u2265 20 liver cysts Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity Abdominal distention perceived as uncomfortable Frequent abdominal pain Early satiety Nausea (with the of dyspeptic complaints) Dyspnea Diagnosed with ADPKD or ADPLD Male and female patients of 18 years and older Creatinine clearance < 20 ml/min Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year Hormonal replacement therapy Hormonal contraception Pregnant or lactating Presenting with an uncontrolled disease (other than ADPKD/ADPLD) Planned to undergo any surgery of the liver during study participation Planned to undergo any surgery of the during study participation (ADPKD patients only) Patients with known allergies to somatostatin or its analogues or any of its components Patients who received somatostatin analogues in the 6 months preceding study", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Focal Nodular Hyperplasia of Liver Toxic Liver Disease With Focal Nodular Hyperplasia Liver Metastases patients diagnosed with de novo FLL at standard ultrasound age > 18 years, male and female gender informed consent for the contrast enhanced study patients with contraindication for contrast enhanced study: subjects with acute cardiac infarction, with class III/IV cardiac insufficiency, with rhythm disorders and pregnant women Patients diagnosed with simple cysts at standard ultrasound (biliary of hydatid) Patients with known FLL, for example after percutaneous treatment, in which the contrast study is used for the follow up of the patient", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Abdominal Sepsis Patient > 18 years old 30 patients with severe abdominal sepsis in order to form the study group and 30 patients without sepsis undergoing major elective surgery (middle line incision >15cm) to form the control group Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures Patient's Manheim Peritonitis Score < 29 Patient's pre-operative SOFA score < 6 The use of other temporary abdominal closure system Decease before the first VAC dressing change Patient is participating in another clinical trial which may affect this study's outcomes Patients with immune deficiency Documented seropositivity for human immunodeficiency virus (AIDS) Patient receiving steroids treatment for other medical condition Patient receiving chronic anti-inflammatory treatment Patient receiving anti", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-75.0, All End Stage Liver Disease Age >18 years Clinically diagnosed liver cirrhosis by any of the following: ultrasound/MRI/ CT/ + tissue biopsy MELD score \u2265 18 and <35 Ability to sign an informed consent Refused by liver transplant program or labeled as not a liver transplant candidate, decided by at least 3 transplant physicians On a liver transplantation waiting list Questionable diagnosis of cirrhosis Prior history of organ transplantation Past history of malignancy within the 2 years prior to Probable or diagnosis of hepatocellular carcinoma Major hepatic vascular thrombosis (hepatic artery, or portal or hepatic veins) Serious cardiovascular or respiratory disease, or other medical condition with a high anticipated mortality within twelve months Current or recent (within the past 4 weeks) use of vasoactive drugs (Epinephrine, Norepinephrine, Vasopressin, Dopamine, terlipressin) Type-1 (acute) hepatorenal syndrome Levels of serum creatinine >150 \u00b5mol/ml and/or creatinine clearance <30 ml/min (as calculated by MDRD system)", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-65.0, All Acute Appendicitis Without Peritonitis patients between 18 and 65 years old first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound patients with any potential immunodeficiency status assumption of antibiotics for different infectious disease or surgery in the last 30 days allergy to antibiotics established in the study protocol no acceptance of study protocol pregnancy or delivery in the last 6 months ASA IV or V, no Italian or English fluently speakers", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Polycystic Ovary Syndrome Normal Volunteers All Female patients undergoing controlled ovarian hyperstimulation (COH), transvaginal oocyte aspiration (TVA), and Saline Infused Sonography (SIS) with UL collection Age <35 y/o at time of in vitro fertilization (IVF) cycle Normal ovarian function defined Day 3 Follicular Stimulating Hormone (FSH) <8 pg/ml or Anti-Mullerian Hormone (\u2265 1.0 ng/ml) Controls Female patients undergoing COH and TVA donating her oocytes Female patients undergoing COH and TVA for male factor infertility only (i.e. no female causes of infertility) Normal menstrual cycles Lean PCOS Diagnosis of PCOS by Rotterdam Age \u2265 35 y/o Female partners with infertility associated diagnosis (i.e. tubal factor, cervical factor, endometriosis) Unexplained infertility", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-30.0, All Schistosomiasis Bilharziasis Urinary Schistosomiasis All subjects had to meet the study within 21 days prior to treatment Caucasian volunteers No smoker biological parameters (haematological, biochemical, renal and hepatic) in normal range Health Insurance sign inform consent inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) any immunological deficiency any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) current immunosuppressor treatment any other medication use within 2 weeks before the study any vaccination within the last 6 months no antibodies against Sh28GST protein", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 25.0-90.0, All Gastric Cancer Gastric cancer patients who are elegible for curative surgery Age 25-90 Gastric cancer patients who are not elegible for curative surgery", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Liver Transplant Rejection Patients of both sexes aged \u2265 18 years Standard analytical parameters, defined by Leukocytes \u2265 3000 Neutrophils \u2265 1500 Platelets \u2265 100,000 Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \u2264 1.5 standard range institution creatinine \u2264 1.5 mg / dl Patients with liver space occupying lesion (LOE) that require extended hepatic resection Patient selection should be cautious, covering basically 5 types of liver damage which must be submitted prior to liver volumetry Metastatic Disease subsidiary right hepatectomy extended to segment IV Different tumor records current disease or any disease hematologic Patients with uncontrolled hypertension Severe heart failure (NYHA IV) Patients with malignant ventricular arrhythmias or unstable angina Diagnosis of deep vein thrombosis in the previous 3 months Adjunctive therapy including hyperbaric oxygen, vasoactive substances, agents or angiogenesis inhibitors against Cox-II BMI> 40 kg/m2 Patients with alcoholic with active alcoholism Proliferative retinopathy Concomitant disease that reduces life expectancy to less than a year", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 0.0-50.0, All Endometriosis Endometriosis Adnexal finding Laparoscopic sterilization Pregnancy Acute infection Hemoperitoneum Suspicion of a malignancy", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-75.0, All Chronic Granulomatous Disease (CGD) A patient will be included if he or she meets all of the following Has documented chronic granulomatous disease Age 18 Has a liver abscess infected with Staphylococcus aureus, but is not an optimal candidate for curative surgical resection either due to location of disease, multiplicity of disease, or previous surgery or other comorbidities, such as pulmonary insufficiency, or has other contraindications to general anesthesia or perioperative management or refuses surgery Is willing to return to NIH for imaging scans Is willing to undergo testing or procedures associated with this protocol Has failed long term antibiotic treatment and abscess drainage if applicable A patient will be excluded if he or she satisfies 1 or more of the following Positive results for toxin-producing bacteria obtained from liver biopsy in the pertinent abscess Is a good candidate for liver-curative open surgical resection and does not refuse the surgery Is not a candidate for RFA therapy due to lesion size, location, and/or infection with a non staphylococcal bacteria Has a prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 times normal (except in patients who have a known lupus anticoagulant or other condition which a hematologist deems will not cause excessive bleeding despite the abnormal coagulation parameters) Has a platelet count < 50,000/mm(3) which cannot be maintained despite platelet transfusions If you are pregnant Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study Please Note: Co-morbidities in critically ill patients will not themselves constitute because the cause of their illness/condition may require the use of RFA as a less invasive treatment than surgery", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 0.0-999.0, All Acute Cholecystitis Empyema of Gallbladder Abscess of Gallbladder acutely inflamed gallbladder chronic cholecystitis gallbladder polyp or gallbladder cancer the patient who underwent reduced port surgery the patient who underwent common bile duct exploration during the operation the patient who underwent concurrent operation the patient who had past history of upper abdominal surgery the patient who had a immunodeficiency state the case which had a suspicion of delayed bile leakage the case which had a incomplete cystic duct ligation the patient who underwent open conversion surgery during the operation", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Cryptogenic Pyogenic Liver Abscess Pyogenic liver abscess radiologically and bacteriologically diagnosed Amebic liver abscess Other causes of pyogenic liver abscess such as cholangitis, liver cancer, complication of transarterial chemoembolization or radiofrequency ablation to hepatocellular carcinoma Refusal to colonoscopic examination Inadequate general patient status to perform the colonoscopic examination Patient who has had the screening colonoscopic examination within 1 year and showed normal finding or had 1 or 2 colon polyp in adequate exam", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-70.0, All Symptomatic Dominant Liver Cyst All patients who are diagnosed with a dominant liver cyst with an indication for aspiration and sclerotherapy are suitable for in this study In order to be eligible to participate in this study, a subject must meet all of the following Age 18 years Indication for aspiration and sclerotherapy Providing informed consent A potential subject who meets any of the following will be excluded from participation in this study Signs of cyst bleeding on ultrasound Signs of cyst infection (elevated CRP and/or leukocytes or temperature exceeding 38 degrees with the of a different focus) Cyst < 5 cm Coagulopathy (INR > 2 or platelets < 80 x 10^9) Severe co-morbidity contraindicating anesthesia (i.e. ASA 4 classification) Patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR or SQ formulations Pregnant or nursing women Symptomatic cholecystolithiasis QT interval related", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Gastroesophageal-junction Cancer patients with biopsy verified GEJ-cancer referred to the department of surgical gastroenterology, Rigshospitalet, which is considered resectable at MDT-conference >18 years old informed consent < 18 years old Not informed consent", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 21.0-80.0, All Gastric Cancer Patients who have T3 (subserosal) or T4 (serosal) disease based on CT scan and intra-operative inspection with any N staging and M0 gastric cancer Patients planned for open or laparoscopic gastrectomy Patients undergoing gastrectomy with curative intent Lower age limit of research subjects 21 years old and upper age limit of 80 years old Ability to provide informed consent Patients who undergo a palliative gastrectomy Patients who undergo a gastrectomy as emergency Vulnerable persons under age of 21 Patients receiving neoadjuvant therapy Patients presented with life-threatening bleeding from tumour ASA score of 4 & 5 Patients with another primary cancer within last 5 years Patients with gross peritoneal and liver metastasis at surgery", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-75.0, All Hypersplenism Liver Cirrhosis Hypersplenism Patients with bad performance scale Patients with hepatic encephalopathy and tense ascites Patient with active esophageal variceal bleeding Patients with hypocellular bone marrow (BM) Patients with renal failure", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Open Abdomen After Damage Control Laparotomy All admissions of trauma patients who sustain trauma necessitating damage control laparotomy Male and female patients 18 years or older Children (<18 years old), prisoners, or pregnant patients Patients who have more than 1/3 loss of abdominal wall due to trauma Patients with baseline serum sodium of <120 mEq/L or >155 mEq/L", "label": "2"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Breast Neoplasms Bone Neoplasms Be willing and able to provide written informed consent/assent for the trial Be 18 years of age on day of signing informed consent Have histologically or cytologically confirmed breast cancer. Oligometastatic lesions do not need to be biopsied but they must be strongly suspected to represent metastatic disease CT scan (Chest, Abdo + Pelvis), Whole Body Bone scan, and FDG-PET scan evidence of 1 to 5 metastases within 8 weeks of study registration Note: At least 1 of the 5 metastases must be deemed suitable for SABR treatment Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen only upon agreement from the study P.I's Have a performance status of 0-2 on the ECOG Performance Scale Demonstrate adequate organ function Life expectancy > 12 months Be willing and able to comply with all study requirements, including treatment, attending assessments and follow-up Previous high dose radiotherapy (biological equivalent of 20 Gy in 5 fractions to the area to be treated) Evidence of visceral metastases in liver or brain Treatment with any chemotherapy agent within +/ weeks of SABR. Targeted therapy or endocrine therapy is permitted at any stage during the conduct of this study, however is not to be changed during the study period unless due to progression Evidence of Spinal Cord Compression Spinal Instability Neoplastic Score greater than or equal to 7 unless lesion reviewed by a neurosurgical service and considered stable Surgical fixation of lesion required for stability Lytic metastases in a long bone (femur or humerus) that which erodes the cortex Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Single once of doses are acceptable", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 0.25-0.5, All Hernia of Abdominal Wall Incisional Hernia animal model: New Zeeland female rabbits of 3000 gr of body weight - any kind of illness in rabbit subjects", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-40.0, All Fetal Membranes, Premature Rupture singleton pregnancy with a definite history of current PPROM for the study group Suspected fetal growth restriction (IUGR) Any gross fetal anomalies Abnormalities of placentation Uterine structural abnormalities Fetal jeopardy or intrauterine fetal death (IUFD) Women presenting with chorioamniointis with fever over 38 c abdominal tenderness, foul vaginal discharge and/or fetal tachycardia Diabetics, immunocompromized and cardiac patients Women with cervical cerclage Women with drained liquor", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Intracranial Aneurysm Subject \u2265 18 years old Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment Parent vessel with a diameter of \u2265 2.0 mm and \u2264 4 mm Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy) Mycotic or traumatic aneurysm Arteriovenous malformation (AVM) in the territory of the target aneurysm Two or more aneurysms (>2mm) in associated distribution Hunt and Hess Scale (HHS) of IV or V at for subject with ruptured aneurysms Life expectancy of less than 6 months as determined by the treating physician A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions) Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region Unsuitable for the antithrombotic and/or anticoagulant therapies", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 12.0-999.0, All Cystic Fibrosis Immunologic Deficiency Syndrome Turner Syndrome Congenital Hepatic Fibrosis Idiopathic Non-Cirrhotic Portal Hypertension Age 12 years or above, male or female Known diagnosis of NCPH, or to be at the risk for NCPH by virtue of underlying disease processes such as but not limited to; CGD, SCD, Mastocytosis, CVID, CF, and CHF seen at the NIH clinical center or via referral from outside institutions Evidence of other forms of liver disease that typically result in cirrhosis Evidence of active chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (> 10,000 IU/mL) Hepatitis C as defined by the presence of hepatitis C RNA in serum Primary sclerosing cholangitis as defined by liver histology Primary biliary cirrhosis as defined by cholestasis, +/ antimitochondrial antibody positivity and liver histology Wilson s disease as defined by ceruloplasmin below the limits of normal and liver histology and urinary copper consistent with Wilson disease Autoimmune hepatitis as defined by antinuclear antibody (ANA) of 3 EU or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy for autoimmune hepatitis Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y. Patients with iron saturation indices of > 45% and serum ferritin levels of > 300 ng/ml for men and > 250 ng/ml for women will undergo genetic testing for hemochromatosis Bile duct obstruction as suggested by imaging studies done within the previous six months", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Cancer Aged > 18 years old Capable of providing informed consent Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases Evidence of low-volume peritoneal disease defined by a PCI < 10 based on cross-sectional imaging / and / or diagnostic laparoscopy findings ECOG Eastern Cooperative Oncology Group (Zubrod) performance status of 0-2 Patients who are medically fit for surgery defined as the following No parenchymal hepatic metastases No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction No cross sectional imaging findings indicative of multi-segmental (>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity Peritoneal carcinomatosis index (PCI) > 10 Systemic (extraperitoneal) disease, pregnant, incarcerated Pregnant and lactating women. Women of reproductive age must be willing to use contraception during study therapy", "label": "0"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 0.0-999.0, All Immune Deficiency and Early BMF in Childhood Immune Deficiency and early BMF in childhood Common Variable Immunodeficiency (CVID) Genetic patients Refusal to consent", "label": "1"} +{"topic": "A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU.", "doc": "eligible ages (years): 18.0-999.0, All Anal Fistulas \u226518 yrs old Perianal abscess (without spontaneous rupture) Abscess larger than 2 cm in diameter Signed informed consent Malignancy within 5 yrs Previous radiotherapy of the abdomen and pelvis Recurrent abscess within 6 months Immune suppressed patients Pregnant and lactating women Abscess with horseshoe formation Allergy to Clindamycin", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-999.0, All Glomerulonephritis Lupus Nephritis Systemic Lupus Erythematosus Patients must be 18 years of age or older and able to provide informed consent Patients must have at least 4 for SLE as defined by the American Rheumatism Association (ARA) Active glomerulonephritis with Renal biopsy within 1 year with class III or class IV active lupus nephritis, AND Abnormal urine analysis Greater than 10 RBC/hpf and cellular (RBC, WBC or mixed) casts, OR Greater than 10 RBC/hpf and proteinuria greater than 2 g/day, OR Proteinuria greater than 3.5 g/day No patients with severe proliferative lupus nephritis: a. very active renal histology with crescents or necrosis in more than 25% of glomeruli; or b. rapidly progressive glomerulonephritis (doubling of serum creatinine in less than or equal to 3 months); or c. severe impairment of renal function Cr greater than 2.5 mg/dL or GFR less than 50 mL/min measured by inulin clearance Patient has not had previous immunosuppressive therapy ", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-80.0, All Acute Renal Failure ENTRY --Disease Characteristics-- Group 1: Patients on chronic hemodialysis Group 2: Patients at high risk of developing acute renal failure (ARF) after cadaveric renal transplantation Received high risk allograft Cadaveric kidneys with greater than 24 hours of cold ischemia time Donor had rising creatinine before organ procurement Donor over 60 years Group 3: Patients with ischemic ARF due to hypotension, surgery, or trauma ARF severity index 20-60% Creatinine clearance 12-14 mL/min Rising creatinine of at least 0.5 mg/dL per day for 2 days without evidence of recovery despite standard supportive care No drug or contrast induced renal failure No oliguric renal failure (creatinine clearance 3-4 mL/min) No prior chronic renal failure Baseline creatinine greater than 2.5 mg/dL (males) or 2.0 mg/dL (females) No ARF due to bacterial or fungal sepsis, nephrotoxins, acute tubulointerstitial nephritis, cyclosporine toxicity, bilateral renal vascular disease, or systemic diseases (hepatorenal syndrome, glomerulonephritis, renal vasculitis, etc.) --Prior/Concurrent Therapy-- Group 1: No recent immunosuppressive therapy Group 2 and 3: No prior renal transplantation No prior alpha-MSH Group 3: No prior dialysis for this episode of ARF No anticipated need for dialysis for at least 24 hours At least 12 hours since prior diuretics, mannitol, or dopamine At least 14 days since prior immunosuppressive drugs --Patient Characteristics-- No recent infection No known reaction to Terumo T175 dialyzer Not a prisoner Not pregnant or nursing No allergy to drugs used in study Not mentally impaired Group 3: No severe nonrenal medical condition that would interfere with the study (e.g., terminal cancer) ", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-1.0, All Infant, Newborn, Diseases Pain ENTRY --Disease Characteristics-- Infants scheduled for surgery with postoperative inpatient care Must be born after 35 weeks or more gestational age No prenatal opiate exposure Part I patients Less than 12 months of age undergoing surgeries involving major thoracic, abdominal, or cardiac procedures No pneumonectomy, tracheal or bronchial stenosis reconstruction, diaphragmatic hernia repair, or surgeries resulting in high intraabdominal pressure (closure of large gastroschisis or omphalocele defects) No hepatic or renal transplantation Part II patients ", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 13.0-60.0, All IGA Glomerulonephritis Histologically confirmed IgA nephropathy, diagnosed within the past 3 years Clinical presentation of either isolated hematuria/proteinuria for less than 3 years OR Acute nephritic or nephrotic syndrome No secondary forms of IgA nephropathy associated with chronic inflammatory disease of the bowel and liver No end stage renal failure as defined by the following: Glomerular filtration rate less than 15 mL/min AND Extensive glomerulosclerosis and tubulointerstitial damage No systemic lupus erythematosus or systemic (extrarenal) vasculitis (Henoch-Schonlein syndrome) Healthy volunteers will be accrued as a control group No other concurrent medical or psychiatric illness that would preclude study ", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-2.0, All Heart Defects, Congenital Diagnosis of one of the following Ventricular septal defect (VSD) Infant coarctation of the aorta Transposition of the great arteries Tetralogy of Fallot Complete atrioventricular canal defect Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia Patient must be scheduled for surgery Certain additional defects and/or requirement for additional surgery", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.123, All Congenital Heart Defects Criteria:1) scheduled cardiac surgery with hypothermic CPB to repair either D-transposition of the great arteries (D-TGA) with intact ventricular septum (IVS) or ventricular septal defect (VSD), VSD with or without aortic arch obstruction (AAO), tetralogy of Fallot (TOF) with or without pulmonary atresia (PA), truncus arteriosus, total anomalous pulmonary venous return (TAPVR), or double outlet right ventricle (DORV), or to palliate hypoplastic left heart syndrome (HLHS) or other forms of single ventricle (SV) with AAO using the stage I (Norwood) operation, 2) age 1-45 days at surgery, 3) birth weight > 2.3 kg, and 4) a cranial ultrasound < 1 week prior to enrollment showing at most grade II hemorrhage in high risk patients - included the following: 1) need for urgent cardiac surgery, 2) cardiac arrest \u2264 1 week before surgery, 3) prior procedure with hypothermic CPB, 4) acute or chronic infection, 5) major noncardiac congenital anomalies or chromosomal abnormalities, 6) preoperative arterial pH \u2264 7.0, 7) any significant noncardiac organ dysfunction such as renal failure, respiratory failure, seizures, or necrotizing enterocolitis, and 8) use of another investigational drug", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 8.0-12.0, All Hematuria Hydronephrosis children aged 8-12 years All children presenting with macro-haematuria or severe pathology detected by ultrasonography (large masses, pseudo-polyps or hydronephrosis/hydroureter) at the 6 months follow-up examination will be treated with praziquantel and excluded in the data analysis", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-3.0, All Healthy Healthy children, free of medication History of urinary diseases", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Renal Failure Critically Ill cessation of hemofiltration mechanical ventilation written informed consent pre-existent renal failure glomerulonephritis", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Contrast Nephropathy Renal Failure Greater then 18 years of age Referral for coronary angiography Type 1 or type 2 diabetic requiring insulin or oral hypoglycemic agents Stable serum creatinine concentration (140 to 300 \u03bcmol per liter for men or 125 to 300 \u03bcmol per liter for women or a creatinine clearance not greater than 60 ml/min (as calculated by Cockcroft-Gault equation) Non diabetic subjects with a stable serum creatinine concentration of 160 to 300 \u00b5mol per liter for men and 140 to 300 \u00b5mol per liter for women Stable renal function defined as no documented rise or fall in serum creatinine by more then 44 umol/L in the preceding 2 weeks Refusal or inability to give consent Pregnant Non-elective coronary angiography Recent administration (within 21 days) of iodinated intravenous contrast dye Recent administration (within 21 days) of non-steroidal anti-inflammatory drugs (excluding aspirin), aminoglycoside antibiotics or chemotherapeutic agents Severe/unstable diabetics requiring emergency room or inpatient therapy in the previous 21 days Compensated or decompensated hepatic failure Renal transplant", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-40.0, All Escherichia Coli Infections Sign an Institutional Review Board-approved consent prior to any study-related activities Initiate screening 21\u00b1 7 days prior to admission or enrollment Must accomplish all laboratory and diagnostic examinations at 21\u00b1 7 days prior to admission or enrollment Be at least 18 years of age but not older than 40 years of age at the time of enrollment Be otherwise healthy with a stable address and telephone where the volunteer can be contacted Be able to read and write English Possess a social security number in order to receive compensation Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the morning of the challenge and use effective birth control during the entire study period. Methods of effective birth control complete abstinence, the use of a licensed hormonal method, intrauterine device, barrier method plus spermicide, or having sexual relations exclusively with a vasectomized partner. Appropriate barrier methods condoms, cervical sponge, and diaphragm. Females who are not of childbearing potential are defined as those who are physiologically incapable of becoming pregnant, including any female with tubal ligation or who is postmenopausal. For purposes of this study, postmenopausal status will be defined as absence of menses for at least 1 year Be seronegative for antibodies to dispersin Have normal laboratory screening values including a white blood cell (WBC) count, hemoglobin, hematocrit, platelets, blood urea nitrogen, glucose, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), quantitative immunoglobulins, T cell subsets (CD4 and CD8), urinalysis Has acute or chronic medical illness (i.e., renal or hepatic disease, hypertension, diabetes mellitus, coronary artery disease, malnutrition, obesity (body mass index >30 kg/m2), HIV, corticosteroid use, cancer or receiving chemotherapy, chronic debilitating illness, syphilis) Has used antibiotics within 7 days of challenge Has used medications or drugs, including over-the-counter medications such as decongestants, antacids (calcium carbonate or aluminum-based antacids, H2 blockers), anti-diarrheal medications (such as bismuth subsalicylate or loperamide), antihistamines within 7 days of challenge Has a history of chronic gastrointestinal illness, intra-abdominal surgery, chronic functional dyspepsia, chronic gastroesophageal reflux, documented peptic ulcer disease, gastrointestinal hemorrhage, gallbladder disease, inflammatory bowel disease (Crohn's and ulcerative colitis), diverticulitis, irritable bowel syndrome or frequent diarrhea Has a history any of the following psychiatric illness(es) Depression not controlled with current drug therapy or involving institutionalization Schizophrenia or psychosis Suicide attempt Has a history of or current alcohol or illicit drug abuse Is unable to remain as an inpatient in the University Clinical Research Unit for up to 8 days", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.082, All Gastroschisis Diagnosis of Gastroschisis Birth Weight \u2265 1500 grams Gestational Age \u2265 34 weeks Birth Weight < 1500 grams Gestational Age < 34 weeks Presence of Bowel Ischemia or Necrosis Abdominal wall defect too small Major associated anomalies or medical condition Presence of Intracranial Hemorrhage (grade IV) Parent Refusal for Randomization", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-1.0, All Low Cardiac Output Syndrome Age younger than one year corrective open heart surgery with biventricular repair, except tetralogy of fallot Missing written consent of parents Weight less than 3 kg preoperative LCOS gestational age less than 36 weeks preexisting renal failure preexisting thrombopenia preoperative cardiopulmonary resuscitation preoperative use of milrinone or levosimendan", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-70.0, All Immunosuppression in Solid Organ Transplant First time recipient of deceased donor liver transplant Age 18-70 Hepatitis C virus (HCV) positive recipients For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52) Target Disease Exclusions Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age < 12 or > 65 years d) Non heart-beating donors e) Anticipated cold ischemia time > 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative Medical History and Concurrent Diseases Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio > 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR < 40 ml/min/1.73 m^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease [MDRD]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment ", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-90.0, All Kidney Failure, Acute Acute Kidney Insufficiency Age over 18 years planned CABG or valvular surgery with cardiopulmonary bypass Serum creatinine available (within 30 days) Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4) Emergent or urgent surgery (to be performed within the next 36 hours) End stage renal disease, or GFR < 15ml/min (CKD stage 5) Estimated GFR>90ml/min (CKD stage 1 or no CKD) Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR Allergy to minocycline or tetracyclines inability to take oral medications use of preoperative vasopressor agents at therapeutic doses Pregnant or lactating females Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice) Rising creatinine meeting the definition of acute kidney injury prior to surgery", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Acute Renal Failure cardiac surgery at least one risk factor for acute renal failure oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously at least 60 mg furosemide/12 hours iv to maintain diuresis > 1 ml/kg/hour refused or none consent chronic renal failure with chronic renal replacement therapy chronic increase of serum creatinine > 2 mg/dl", "label": "2"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-999.0, All Acute Kidney Injury Families of infants (birthweight >1500g) be asked to participate in the study Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 1.0-16.0, All NEPHROSIS, LIPOID proteinuria over 0.25 g/mmol of creatinine with hypoalbuminemia below 30g/L for the case No history of renal disease Normal C3 and negativity for hepatitis B and C no medical insurance in another study", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.5-3.0, All Distress Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery Neurological impairment Eczema or other skin disorders Nut allergy", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-999.0, All Ileostomy Presence of ileostomy due to any disease or condition (i.e., necrotizing enterocolitis, intestinal atresias, gastroschisis, or intestinal perforations) Minimum birth weight of 500g Likely to survive Dysmotility of the gastrointestinal system Major congenital anomalies, including heart disease Meconium ileus Not expected to survive for at least 2 weeks", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-48.0, All Preterm and Term Infants Infants born at >28 weeks gestation will be eligible for enrollment in this study Infants with fetal malformations, chromosomal anomalies, clinically significant sepsis (retractable hypotension, neutropenia, and thrombocytopenia), or no urine output for the first 48 hours will be excluded", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.5, All Congenital Heart Disease Patient selection will be determined by an assessment of the risk of systemic ventricular dysfunction following open cardiac repair in a population of infants undergoing stage I palliation (Norwood procedure) for the diagnosis of either hypoplastic left heart syndrome or similar left-sided obstructive lesions in the setting of single-ventricle physiology. Eligible neonates and infants those aged 0 days to 6 months. These patients will be evaluated on an individual basis and the decision to give phenoxybenzamine would be determined by the attending surgeon, anesthesiologist, and cardiologist ", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-999.0, All Kidney Failure, Acute Renal Insufficiency for Adults: (must have at least one of the following) Emergent surgery Pre-existing kidney impairment (baseline serum creatinine greater than 2 mg/dL) Ejection fraction less than 35% At least 70 years old Diabetes mellitus Combined CABG and valve surgery Repeat CABG or valve surgery for Adults Pre-operative acute kidney injury Enrolled in a conflicting research study Prior kidney transplantation Baseline serum creatinine level greater than 4.5 mg/dL Nephrotoxic drugs administered pre-operatively Surgery for only left ventricular assist device for Children Undergoing open heart surgery for Children", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-45.0, All Healthy Aged 18-45 years Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases Had voluntarily given written informed consent to participate in this study Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study Had history of allergy or hypersensitivity to hydrochlorothiazide or any other sulphonamide derived drugs Had history of diarrhoea, vomiting or headache within past two weeks Had history of hypotension (systolic BP<100 mmHg) Had history of allergy or bronchial asthma Had history of muscle cramps or muscle weakness Had history of any anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura, Systemic Lupus Erythematoses(SLE) Had history of aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia Had history of anuria or history/evidence of any renal disorder including renal failure, renal dysfunction, interstitial nephritis Had history of erythema multiforme including Stevens Johnson syndrome or exfoliative dermatitis including toxic epidermal necrolysis", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-45.0, All Healthy Be in the age range of 18.45 years Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases Have voluntarily given written informed consent to participate in this study Be of normal health as determined by medical history and physical Examination of the subjects performed .within 28 days prior to the commencement of the study If female and Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or~ Is postmenopausal for at least 1 year; or Is surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) History of allergy to metformin and other related antidiabetic biguanide preparations Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection Female volunteers demonstrating a positive pregnancy screen Female volunteers who are currently breastfeeding Presence of values' which are clinically significantly different from normal reference ranges for hemoglobin, total white blood cells count, differential WBC count and platelet count Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids Presence of values which are significantly different from normal.reference ranges (as defined in Appendix 5) for se rum creatinine, blood urea nitrogen serum aspartate aminotransferase (AST), serum alanine aminotranferase (ALT), serum alkaline phosphatase, serum billrubin, plasma glucose and serum cholesterol Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose, (positive) and protein (positive)", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-80.0, All Acute Kidney Insufficiency Acute Renal Insufficiency Acute Kidney Injury Ischemic Preconditioning Patient undergoing heart surgery on cardiopulmonary bypass Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection End-stage renal disease Inability to give informed consent", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 1.0-17.0, All Purpura, Thrombocytopaenic, Idiopathic Subjects between 1 year and <18 years of age at Day 1 Written informed consent from subject's guardian and accompanying informed assent from subject (for children over 6 years old) Confirmed diagnosis of chronic ITP, according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments Day 1 (or within 48 hours prior) platelet count <30 Gi/L Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1 Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease) Concurrent or past malignant disease, including myeloproliferative disorder Subjects who are not suitable for continuation of their current therapy for at least 7 additional additional weeks Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1 History of platelet agglutination abnormality that prevents reliable measurement of platelet counts Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis) Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders) Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1 Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.082, All Congenital Heart Disease Disorder of Fetus or Newborn Neonates Age or equal to 18 years of age and < or equal to 55 years of age Be in general good health without history of any of the conditions listed in No use of any tobacco products for at least 6 months A woman must agree not to become pregnant from the time of study enrollment until at least 3 months after the completion of the monoclonal antibody infusion. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use hormonal or barrier birth control with spermicidal gel Sexually active male subjects must use a barrier method of contraception during the course of the study Screening laboratory values must meet the following WBC (>3,900 <11,000/mm^3) Platelets(>100,000/mm^3) Hemoglobin (>10.5 gm/dl) Creatinine (<1.1 x ULN) BUN (<1.25 x ULN)", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.019, All Adrenal Insufficiency All preterm (28 to 34 week gestation) very low birth weight (birth weight 750-1500grams.) infants born at AIIMS would be eligible for enrollment in the study. Of these infants, those who meet the following would be enrolled Cases: Preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams with shock in the first week of life requiring vasopressor therapy (dopamine or dobutamine or both in a dose of > 10 mcg/kg/min) Controls: Stable preterm (28 to 34 week gestation) infants with birth weight between 750 and 1500 grams who are matched for gestational age, birth weight, postnatal-age Major congenital malformations Mother receiving anticonvulsant / anti-tubercular drugs (rifampicin, isoniazid) Postnatal corticosteroid treatment Refusal to give consent", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-999.0, All Premature Newborn Necrotizing Enterocolitis Premature infants with gestational age between <32 weeks regardless of birth weight Inborn errors of metabolism Need for exchange transfusion Multiple congenital anomalies Renal failure (defined as urine output <1ml/k/h >24h, creatinine >1.8, or diagnosis of \"non-oliguric renal failure\" as determined by Pediatric nephrology)", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-80.0, All Minimal Change Disease from 18yrs to 80 yrs , man and women Minimal change disease is diagnosed by kidney biopsy On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0 On screening, the patient shows that the serum albumin is below 3.0g/dL the patient sign on the concent form the patient have experience to take tacrolimus or cyclosporin for 1 month If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day steroid dependent or steroid resistant or frequent relapse case uncontrolled hypertension pregnancy or anticipate pregnancy with 6 month hypersensitivity to tacrolimus or macrolide acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Spinal Cord Injury years or older Male signed informed Consent Neg. urine multistix Abnormalities diseases or surgical procedures performed in the lower urinary-tract", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Hepatorenal Syndrome Type 1 Written informed consent by subject or legally authorized representative At least 18 years of age Cirrhosis and ascites Rapidly progressive reduction in renal function characterized by SCr \u2265 2.5 mg/dL Doubling of SCr within 2 weeks (or for observations of shorter duration, SCr values over time meeting slope-based for proportional increases likely to be representative of at least a doubling within 2 weeks No sustained improvement in renal function (< 20% decrease in SCr and SCr \u2265 2.25 mg/dL) 48 hours after both diuretic withdrawal and the beginning of plasma volume expansion with albumin Note: Albumin doses recommended by the IAC are 1 g/kg on the first day (Maximum 100 g) and 20 g/day thereafter as clinically indicated.It is recommended (if clinically appropriate) that the albumin dose is kept constant during the study drug administration period Note: The qualifying SCr value is the SCr value at least 48 hrs after both diuretic withdrawal (if applicable) and the beginning of albumin fluid challenge. The qualifying SCr value must be \u2265 2.25 mg/dL AND at least 80% of the diagnostic (pre-fluid challenge) SCr value Serum creatinine > 7 mg/dL Shock Note: Hypotension (Mean Arterial Pressure < 70 mm Hg or a decrease > 40 mm Hg in systolic blood pressure from baseline) with evidence of hypoperfusion abnormalities despite adequate fluid resuscitation Sepsis or systemic inflammatory response syndrome (SIRS) Note: SIRS: Presence of 2 or more of the following findings Temperature > 38\u00b0C or < 36\u00b0C; heart rate > 90/min; respiratory rate of > 20/min or a PaCO2 of < 32 mm Hg; white blood cell count of > 12,000 cells/\u00b5L or < 4,000/ \u00b5L Note: Sepsis: Documented infection and systemic inflammatory response syndrome < 2 days anti-infective therapy for documented or suspected infection Proteinuria > 500 mg/day Hematuria or microhematuria (> 50 red blood cells per high power field) Clinically significant casts on urinalysis, including granular casts", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-90.0, All Proteinuria Kidney Injury Chronic Kidney Disease Male and females, 18 years to 90 years old Any subject with pre-existing clinical indication of a kidney biopsy including, but not limited to, nephritic syndrome, nephritic syndrome or proteinuric disease state. Additionally, kidney transplant donors will be included for purpose of obtaining control tissue Willing and able to give consent Additionally, kidney transplant donors and patients requiring nephrectomy for removal of renal mass will be included for purpose of obtaining control tissue Subjects on longstanding immunosuppressive agents (empiric initiation of glucocorticoid therapy within 48 hours prior to kidney biopsy is acceptable) Kidney transplant recipient Inability to follow-up for future protocol laboratory evaluation", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-1.0, All Peritoneal Lesion term neonates and infants undergoing heart surgery with cardiopulmonary bypass parents received written information preoperative documented kidney injury parents not informed, opposed", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-50.0, All Polycystic Kidney, Autosomal Dominant Males and females, 18 to 50 years old at the time of consent Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed) Total kidney volume \u2265 750 cc, as measured by centrally evaluated MRI eGFR < 60 mL/min/1.73m2 Uncontrolled hypertension (defined as systolic blood pressure \u2265140 or diastolic blood pressure \u226590 mm Hg) Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-24.0, All Ductus Arteriosus, Patent Gestational age <29 weeks; an echocardiographic evidence of significant PDA; an age of 12 to 24 hours; and RDS necessitating respiratory support Major congenital anomalies; life-threatening infection or hydrops fetalis; pulmonary hypertension; death before the conclusion of the first course of ibuprofen; urine output below 1 ml per kilogram of body weight per hour during the preceding 12 hours (with the exception of the first dose); a serum creatinine concentration of >1.5 mg/dL (129 \u03bcmol per liter); a platelet count of <50,000/mm3; a tendency to bleed, as revealed by hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools, and oozing from puncture sites", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-18.0, All Congenital Heart Disease Cardiopulmonary Bypass Myocardial Injury Acute Kidney Injury Acute Lung Injury Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass Any contraindication to compression of lower extremity/extremities Body weight <2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.167-1.5, All Postoperative Pain in Infants Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, < 6 months Bleeding history in infant or family Coagulopathy Gastrointestinal bleeding history Renal or hepatic disease assessed by history and by pre-drug blood tests Premature birth (<36 weeks gestation)", "label": "2"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 14.0-60.0, All Nephrotic Syndrome Subjects of either sex, 14-60 years of age Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria (> 3.5g/24hr) and secondary Nephrotic syndrome Refractory Nephrotic Syndrome Steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of prednisone Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid eGFR \u2265 60 ml/min/1.73 m2 Provision of written informed consent by subject or guardian Systemic disease eGFR < 60ml/min/1.73m2 Diagnosed DM Malignant tumors (except fully cured basal cell carcinoma) Familial nephritic syndrome History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C Known hypersensitivity or contraindication to tacrolimus, corticosteroids Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening Pregnancy, nursing or use of a non-reliable method of contraception", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-18.0, All Kidney Failure, Acute Age < 18 years, including the newborn Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method Treatment by extra renal replacement therapy for terminal renal failure History of renal transplantation Extra renal replacement therapy for an inborn errors of metabolism without acute renal failure Extra renal replacement therapy in the context of a drug intoxication without acute renal failure Treatment by technique in MARS (Molecular Adsorbent Recirculating System) Modified ultrafiltration during surgery", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 12.0-999.0, All Malaria Patient age >12 years Presence of severe or moderately severe P. falciparum malaria, with and without blackwater fever, confirmed by positive blood smear with asexual forms of P. falciparum Temperature >38 degrees Celsius on admission or fever during the preceding 24hours Written informed consent from patient or attending relative able to and willing to give informed consent. Consent form and information sheets will be translated into Bangla and copies provided to the patient Patient or relatives unable or unwilling to give informed consent History of chronic liver disease History of alcohol use (>3drinks per day) Contraindication or allergy to paracetamol or artesunate therapy Contraindication to nasogastric tube insertion i.e. facial fracture, bleeding diathesis Pregnancy", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-85.0, All Hepatorenal Syndrome, Liver Regeneration Patient with neoplastic liver tumors undergoing elective hepatectomy Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.022, All Prematurity infants born at less than 32 weeks postmenstrual age infants with major malformations deemed incompatible with life disease states characterized by edema renal failure, defined as an increase in serum creatinine by 0.5 mg/dl/day or urine output less than 0.5 ml/kg/hour", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Proliferative Diabetic Retinopathy (PDR) Male or female healthy volunteers will be eligible if the following and none of the are met Ability to provide ethics committee approved written informed consent and comply with study-related procedures/ assessments for the full duration of the study, having age > 18 years Corrected visual acuity >20/25 in both eyes Intraocular Pressure (IOP) <21 mm Hg, with a difference between eyes of < 4 mm Hg Ability to tolerate and self-administer vehicle eye drops to the satisfaction of study staff Tolerance of a commercially available non-preserved, artificial tear solution in one eye Normal slit lamp exam and dilated fundoscopic exam within one week previous to dosing Normal clinical laboratory profiles, defined as complete blood count, serum chemistry and electrolytes, and urinalysis with no clinically significant values Be neither overweight nor underweight for his/her height as per the Body Mass Index (BMI) scale (18.5-24.9) Female of childbearing potential", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 20.0-69.0, All End Stage Renal Disease Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation Donor (1) Refusal of legal guardian Recipient Patient refusal Hypersensitivity to propofol, soybeans or peanuts History of vitamin C or E intake within 5 days before surgery History of acute myocardial infarct within 6 months before surgery Congestive heart failure (NYHA III-IV) Autoimmune disease patients BMI over 30 kg/m2", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery Patients undergoing cardiac surgery (OPS 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an ICU of the anaesthesiology department of the Charit\u00e9 hospital Patients younger 18 Preexisting renal insufficiency", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-65.0, All Urinary Calculi A\u3001B group were enrolled standards: \u2460 aged 18-65 years old; \u2461 comply with percutaneous nephrolithotomy lithotripsy indications for surgery; \u2462 ECT tips ipsilateral normal or mildly impaired renal function Group C patients were enrolled standards: \u2460 aged 18-65 years old; \u2461 normal renal function, not associated with urinary calculi in patients; \u2462 cancer patients met radical nephrectomy indications for surgery; \u2463 emergency trauma patients suffering from kidney resection surgical indications aged <18 years or> 65 years; \u2461 neurological disease or cognitive dysfunction; \u2462 can not be corrected or uncorrected coagulopathy; \u2463 associated with diabetes, hypertension and other metabolic diseases; \u2464 accompanied by tuberculosis, hepatitis, HIV and other infectious diseases; \u2465 poor tolerance to anesthesia and surgery, such as: severe cardiopulmonary disease, coagulation disorders, etc.; \u2466 ultrasound, renal imaging examination revealed renal cortex was significantly thinner (renal cortical thickness <1.5cm), structural variation; \u2467 with severe systemic or urinary tract infection; \u2468 ECT tips ipsilateral renal function is severely impaired or solitary kidney", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-70.0, All Acute Kidney Injury Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled Age < 18 or > 70 years Preexisting Chronic Renal Disease Patients with obstructive uropathy Cirrhosis with HCC (HepatoCellular Carcinoma) Advanced cardiopulmonary disease Pregnancy Patients with extrahepatic malignancy", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-21.0, All Acute Kidney Injury Congenital Heart Disease Subjects age \u226418 years Subjects scheduled for cardiac surgery with cardiopulmonary bypass Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the Schwartz formula Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved) Subjects with known metabolic disorder Premature infants born <30 weeks gestation and <30 days old due to risk of intraventricular hemorrhage Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-10.0, All Patients Undergoing Surgery for Congenital Heart Disease patients who underwent surgery for congenital heart disease between 2009 and 2013 in Samsung Medical Center incomplete data for creatinine, estimated glomerular filtration rate, or urine output required to diagnose acute kidney injury patients who expired within 24 hours after surgery", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 20.0-999.0, All Coronary Artery Bypass Surgery Acute Kidney Injury Creatinine Mortality patients who underwent coronary artery bypass surgery during between 2008 and 2013 in Samsung Medical Center lack of postoperative creatinine or urine output data patients who expired within 24hours after surgery", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-10.0, All Patients Who Underwent Surgery for Congenital Heart Disease pediatric patients who underwent surgery for congenital heart disease with cardiopulmonary bypass between 2009 and 2013 in Samsung Medical Center patients who lack data regarding mortality, creatinine, estimated glomerular filtration rate, or urine output", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Liver Cirrhosis and Acute Kidney Injury Age >18 years Cirrhosis of liver Hospitalization at University of Virginia Medical Center Diagnosis of acute kidney injury based on AKIN Known history of a right to left intracardiac shunt Known history of pulmonary hypertension, including portopulmonary hypertension Pregnancy or lactation History of allergies to Definity\u00ae History of Liver or Kidney Transplant Patient on hemodialysis", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Oliguria Polyuria Patient must \u2265 18 years of age Patient has a Foley catheter and urine collection system is in place per standard clinical decision Estimated length of placement of the Foley is 48 hours minimum Burn injury \u2265 20% and \u2264 80% total body surface area (TBSA) Subject or subject's legally authorized representative is able to give informed consent before entering the study Currently pregnant or breastfeeding Clinical signs or symptoms of a urinary tract infection (UTI) Clinical signs or symptoms of a vaginal infection Currently has bladder or urethral trauma Use of investigational drug/device therapy within the past 4 weeks", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-999.0, All Microscopic Hematuria Post-menopausal women Asymptomatic microscopic hematuria (three or more red blood cells per high powered field on a single urine microscopy) in the absence of urinary tract infection Known urologic disease Presence of gross hematuria Presence of indwelling urologic foreign body (foley catheter, ureteral stent) Inability to obtain intravenous contrast CT scan (elevated creatinine, severe contrast allergy) History of pelvic irradiation or malignancy Not a candidate for vaginal estrogen Allergy to vaginal estrogen Current or prior diagnosis of breast or endometrial cancer History of deep vein thrombosis/pulmonary embolus Hypercoagulable state", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-79.0, All Chronic Kidney Disease patients who had non-cardiac surgery in Seoul Paik Hospital have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase > 2 time of normal level severe lung disease severe heart failure ( Ejection Fraction < 40% ) pregnancy", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.25, All Acute Kidney Injury Neonate < 3 months post natal age Diagnosed with acute kidney injury (AKI) Receiving aminophylline for AKI treatment as per local standard of care Presence of anatomical renal anomaly based on postnatal evaluation of the patient (hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy) Patient on renal replacement therapy Major genetic abnormalities (trisomy 13, 18 or 21)", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Progressive IgA Nephropathy Proteinuria Proteinuria > 1000 mg/24h despite documented ACEi/ARB therapy and adequate blood pressure control for > 3 months Quantified 24h creatinine clearance > 30 ml/min/1.73m2 Blood pressure < 130/80 mmHg at > 75% of the readings Henoch Schoenlein Purpura (HSP): Patients with biopsy proven IgA nephropathy and clinical features consistent with Henoch Schonlein Purpura will be considered eligible for the study Patient must be able to receive injections to be enrolled in the study Patient must have a kidney biopsy slide on file that can be sent to Mayo Clinic Clinical and histologic evidence of IgA predominant Lupus nephritis Patients with greater than 50% glomerular senescence or cortical scarring on renal biopsy Serum Cr > 3.0 mg/dL or creatinine clearance GFR < 30 ml/min at the time of screening ", "label": "1"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 2.0-6.0, All Neonatal Acute Kidney Injury Childhood Chronic Kidney Disease Premature birth UVA NICU admission prior to 7 days of life Birth weight less than 1500 grams Study group: Acute Kidney Injury as defined by KDIGO modified during NICU stay at UVA Control group: No AKI during NICU stay Parental or legal guardian consent obtained Patients with Congenital Anomalies of the Kidney and Urinary Tract SGA patients", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-45.0, All Healthy Volunteers who met the following were included in the study Were in the age range of 18-45 years Were neither overweight nor underweight for their height as per the Life Insurance Corporation of India height/weight chart for non-medical cases Had voluntarily given written informed consent to participate in this study Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study Had a non-vegetarian diet habit History of known hypersensitivity to Felodipine, related drugs and or any other drug Individuals with systolic blood pressure <100 mmHg or >140mmHg diastolic blood pressure < 60 mmHg or >90 mmHg, at the time of admission in period I History of chronic headache, dizziness and syncope History of peripheral edema History of grapefruit juice and / or grapefruit supplements intake in past 48 hours Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids) Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Delayed Graft Function Age \u2265 18 years Patient with ESRD who has been on RRT (Hemodialysis or Peritoneal dialysis) Recipient of deceased donor kidney transplant Urine output less than 0.5 mL/kg/h before transplant Patient consents to the study Patient is not allergic to furosemide or sulfa English or Spanish speaking patient Patient is oliguric (urine output less than 0.5mL/kg/h, as per AKIN criteria) or anuric (urine output less than 10 mL in 6 hours post-transplant or 2 mL/h) in the first 6 hours post kidney transplant Recipients of a living donor kidney transplant Patients who do not consent for the study Patients age <18 years Patients who are allergic to furosemide or sulfa containing medications Non-oliguric patients Patients who require immediate dialysis within 6 hours of the transplant (before enrollment) Patients with renal ischemia due to vascular compromise that has been confirmed with Doppler Ultrasound right after transplant as per standard of care Patients who return to the operating room due to complications within 24 hours Simultaneous multi-organ transplant recipients Hypotensive patients with BP <90/60 or MAP <60 mmHg", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Narrow Band Imaging in Flexible Cystoscopy Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC Patients not fullfilling the above", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 14.0-999.0, All Acute Kidney Injury Critically ill, adult patients AND with acute oliguric renal failure AND within 6 hours of presentation i. Patients with pre-existing chronic renal failure ii. Patients on renal replacement therapy/ Dialysis iii. Patients with poor sonographic windows", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 65.0-90.0, All Total Fluid Volume Increased Old patients scheduled to undergo orthopaedic surgery under a intravertebral anesthesia. (American Society of Anesthesiologists physical status I-\u2162) Allergy and contraindication to HES Infections and malignancies Sepsis History of heart failure or New York Heart Association(NYHA)\uff1e\u2162 Renal failure or Cr>108\u03bcmol/L\uff0cBUN>8.3mmol/L Undergoing dialytic treatments Intracranial hemorrhages Taking non-steroidal antiinflammatory agent for a long time Inability to understand the Study Information Sheet and provide a written consent to take part in the study", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.192, All Postoperative Feeding Following Pyloromyotomy Subjects to be included in the study infants who have a diagnosis of pyloric stenosis who will undergo pyloromyotomy Patients with severe underlying medical conditions including but not limited to hypothermia, sepsis, glycemic instability, or need for care in the intensive care unit/neonatal intensive care unit will not be included in the study", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-0.038, All Acute Kidney Injury All infants born or admitted to a level 2 or 3 NICU will be screened Infants who received intravenous fluids for > 48 hours will be eligible Infants admitted to the NICU at 2 weeks of age or older Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life Infants diagnosed with a lethal anomaly upon admission Infants who die within 48 hours after birth", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Contrast Nephropathy All consecutive patients with chronic kidney disease (CKD) scheduled for coronary and/or peripheral angiography and/or angioplasty with an eGFR <45 ml/min/1.73 m2 and/or At high risk for CI-AKI according to Mehran's score \u226511 and/or Gurm's score >7 Age <18 years Women who are pregnant Acute pulmonary edema Acute myocardial infarction Recent contrast media exposure End-stage CKD on chronic dialysis Multiple myeloma Current enrolment in any other study when enrolment in the III would involve deviation from either protocol Cardiogenic shock Administration of theophilline, dopamine, mannitol and fenoldopam", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.083-1.0, All Postoperative Pain Postoperative Vomiting ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia infection of the orbit increased intraocular pressure(IOP) history of allergy to local anesthetics history of previous eye surgery cardiovascular or clotting disorders full stomach,inner ear disorders or other conditions predisposing to vomiting airway abnormalities compromised sclera", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 3.0-5.0, All Schistosomiasis lifelong residents of the area have provided at least 2 urine and 2 stool for parasitological examination have given a blood sample before and after each treatment episode be negative for schistosomes, hookworm, Trichuris and Ascaris have frequent contact with infective water clinical signs of tuberculosis or malaria presenting with fever have had a recent major operation, illness or vaccination have previously received antihelminthic treatment are infected with any helminths", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-80.0, All Critically Ill Cancer Patients admitted to the ICU in the immediate postoperative period (first 24 hours) of major surgery, defined as involving general anesthesia, ventilation, opening of large cavities (cranial, thoracic, abdominal) Patients with informed consent signed by them or their responsible relative Patients who are likely to survive at least 48 hours after admission to the ICU Patients who have measured \"baseline\" creatinine before UCI admission, in the last three months Patients who have contraindications for enteral medications Patients who have acute kidney injury at the time of admission Patients on renal replacement therapy prior to ICU admission Patients with previous diagnosis of chronic kidney disease G3b stage Patients with plasma potassium greater than 5.1mEq/L Hypersensitivity to spironolactone Septic shock Obstructive uropathy Renal transplantation Postoperative period of nephrectomy", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 18.0-999.0, All Bladder Cancer Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients should be included at the first surveillance cystoscopy after Transurethral Resection of the Bladder (TURB)) History of multiple or recurrent tumors Age 18 or older Written informed consent signed Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy) Patients who cannot undergo in-office cystoscopy Patients who have received Bacillus Calmette-Gu\u00e9rin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure Porphyria Known allergy to hexaminolevulinate hydrochloride or a similar compound Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study and use adequate contraception during the study Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study", "label": "0"} +{"topic": "A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%.", "doc": "eligible ages (years): 0.0-7.0, All Acute Kidney Injury Children aged less than 7 years old American Society of Anesthesiology (ASA) physical status 1-3 Preoperative creatinine > 1.5mg/dl History of dialysis Liver function abnormality Diabetes Mellitus History of allergic reaction Coagulation abnormality", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Cancer Histologically confirmed epidermoid carcinoma or adenocarcinoma of the esophagus eligible for potentially curative radiotherapy Disease in one of the following categories: Newly diagnosed Locoregional failure after prior resection with curative intent Positive microscopic margin after palliative resection of all gross disease Disease clinically limited to esophagus T 1-4, any N, M0 Gastroesophageal junction tumor allowed No positive pleural, pericardial, or peritoneal cytology No tracheobronchial invasion on bronchoscopy, including tracheoesophageal fistula Age: 18 and over Performance status: Karnofsky 60-100% Hematopoietic: WBC more than 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 65 mL/min per 1.73 square meters Cardiovascular: No NYHA class 3/4 status No cerebral vascular disease No hypertension Other: No severe uncontrolled diabetes No uncontrolled infection No other medical condition that precludes treatment No mental status abnormality that precludes comprehension of or compliance with treatment No active cancer arising at another primary site other than basal cell carcinoma of the skin or in situ cervical carcinoma PRIOR No prior chemotherapy or radiotherapy ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-75.0, All Esophageal Cancer Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0 Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix PRIOR No prior chemotherapy or radiotherapy ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Cancer Lung Cancer Histologically confirmed esophageal or non-small cell lung carcinoma Esophageal cancer: Biopsy proven esophageal carcinoma considered acceptable for curative esophageal resection Lung cancer: Stages IA-IIIB, T(any)N(any)M0 disease without pleural effusion, which constitutes locally advanced lung cancer Must be candidates for induction chemotherapy followed by surgical resection Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 65 mL/min Other: Not pregnant Adequate contraception required of all fertile female patients PRIOR Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior surgical mediastinal staging such as prior mediastinoscopy or Chamberlain procedures See Disease Characteristics ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Cancer Histologically confirmed adenocarcinoma, squamous cell, adenosquamous, or undifferentiated carcinoma of the esophagus or gastroesophageal junction Potentially resectable disease No malignant celiac node involvement No cervical esophageal carcinoma Age and over Performance status ECOG 0-2 Life expectancy Not specified ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-60.0, All Smoking Obesity for the smoking cessation studies were: between 18 and 60 years old, a minimum 2-year history of smoking, a current level of smoking > 10 cigarettes per day, and agreement to participate in the study requirements for the weight loss studies were: between 18 and 60 years old, body mass index (weight/height2) > 27.0, 20 percent or more above desirable weight according to medical standards, and consent to participate Smokers and overweight persons were excluded if currently being treated by a physician for a serious physical or psychological disorder (e.g., heart disease, cancer, depression). Women were excluded if currently pregnant, pregnant in the last 6 months, or intending to become pregnant in the next 18 months. People who were overweight and who also smoked were considered eligible for participation in either weight loss or smoking cessation programs. However, they received treatment only for the particular behavior problem targeted by the study they chose to participate in ", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophagus Cancer Biopsy proven Carcinoma of the oesophagus Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. (It should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment) Symptomatic patients with dysphagia scores of \u2265 1 i.e. able to eat only some solids (see Mellow Scale appendix 1) Performance status ECOG \u2264 2 Patients must begin treatment within 2 weeks of randomization Patient is at least 18 years old Adequate haematological function to undergo chemotherapy. Peripheral blood Neutrophils > 1.5 x 10^9/L Platelets > 100 x 10^9/L Adequate renal function, Creatinine Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest Synchronous active malignancies Pregnant or lactating patients Patients unfit for any treatment component Tracheo-oesophageal fistula Stents in situ Previous chemotherapy for Oesophageal Cancer CT scan of thorax and abdomen more than 8 weeks prior to randomization Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomization", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-90.0, All Esophagitis Patients aged 18-90 presenting with dysphagia or food impaction Ability to undergo esophagogastroduodenoscopy and biopsies No significant cardiopulmonary disease, or other contraindication to EGD Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR Inability to provide informed consent Esophageal varices", "label": "2"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-75.0, All Stroke Dysphagia FOR WITH DUE TO BRAIN Inclusive ages of 20 to 90 History of brain injury. No specific localization of brain injury or brain injuyr type will be required for inclusion Evidence of pharyngeal phase dysphagia following the brain injury that places the patient at risk for aspiration Risk for aspiration or frank aspiration will be based on the medical history and evidence from a videofluoroscopic swallowing study. Absence of aspiration is not cause for if the risk for aspiration is deemed present due to impaired pharyngeal phase of swallowing as judged by an expert experienced in the evaluation of dysphagia. The patient may demonstrate evidence of aspiration or the risk for aspiration on any consistency, perhaps secondary to pharyngeal retention. Aspiration is defined as passage of food, liquid, or secretions into the trachea below the level of the vocal folds. If the patient does not demonstrate either aspiration or a risk for aspiration in previous assessment or during preliminary studies, they will be excluded from participation Impaired pharyngeal phase of swallowing may be evidenced by pharyngeal delay, reduced hyolaryngeal elevation, reduced laryngeal closure, and reduced pharyngeal clearance of the bolus. Signs of pharyngeal delay hesitation of the material in the vallecula at times with spill over into the pyriform sinuses. Normally the pharyngeal phase of swallowing should be less than 1 second from onset until the passage of the bolus into the posterior pharynx. Delay will be defined as the time from the entry of the head of the bolus into the oropharynx at the posterior tongue and the lower posterior edge of the angle of the mandible, to the beginning of elevation of the hyoid bone and larynx. Reduced hyolaryngeal elevation will be identified when the larynx is not protected and remains open to the bolus during a swallow on videoendoscopy. Reduced pharyngeal clearance will be seen during videoendoscopy when the bolus remains in the vallecula and/or pyriform sinuses Chronic dysphagia can occur as a result of stroke or other brain injury. Lesions in either hemisphere and/or the brain stem may cause dysphagia and aspiration Duration of 4 months or greater post-onset of brain injury and dysphagia Participants may have other health problems such as diabetes mellitus, arteriosclerotic coronary vascular disease and a history of smoking. These will not be cause for automatic but will be examined on an individual basis by the otolaryngologist in determining the potential risk and benefit to the individual participant Prior history of tracheostomy or current tracheostomy is not a cause for exclusion. The otolaryngologist will determine if an individual with tracheostomy is an appropriate candidate for the study FOR WITH DUE TO BRAIN History of epileptic seizure If subject is participating in TMS, history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia) or a cardiac pacemaker in place History of progressive neurodegenerative disorders, such as progressive dementia, Parkinson's Disease, multiple sclerosis, and amyotrophic lateral sclerosis History of malignant brain tumor Severe oral phase swallowing deficits that prevent bolus retention in the oral cavity Esophageal motility disorder preventing food or liquid from adequately moving through the esophagus into the stomach Pregnant women will be excluded from participation because the study involves radiation exposure and MRI scanning (for anatomical co-registration purposes) Current psychiatric disorder other than depression, as evidenced by being under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, schizophrenia or bipolar disorder Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware) and presence of certain tattoos with ferromagnetic metal or permanent makeup will subjects due to the exposure to high magnetic force through MRI/fMRI/TMS procedures due to the exposure to high magnetic force in both procedures. Subjects who were metal workers as a previous occupation will also be excluded only from MRI/TMS procedures due to the possibility of unknown/undetected metal in their body. Subjects who have MRI-compatible metal implants (e.g. titanium implants) may still be considered as candidates for MRI study, pending review and discussion of documentation regarding the device material and safety of the device in a 3T scanner by the Principal Investigator, LSS staff physician, and an MRI technologist", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-45.0, All Healthy Volunteers Non-pregnant, non-breastfeeding females years old Body mass index between 20 and 32 kg/m2 No alarm indicators on clinical assessment (weight loss of more than 7kg, bleeding, recent recurrent vomiting, progressive dysphagia) No history suggestive of small bowel obstruction ", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine) years or older Ability to understand the protocol and willing to provide written informed consent Membership in one of the following sub-cohorts Histologically proven oral cavity or oropharyngeal cancers planned to receive a full cycle of daily single fraction radiation therapy (with or without boost) or IMRT +/ chemotherapy Histologically proven laryngeal or hypopharyngeal cancers planned to receive a full cycle of daily single fraction radiation (with or without boost) +/ chemotherapy Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of +/ Avastin or Erbitux.1 cycle defined as 2 doses of Histologically proven adenocarcinoma of the colon or rectum planned to receive a minimum of 2 cycles of +/ ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Head and Neck Cancer Lung Cancer Patients with either: a) histologically proven stage I, II, IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy) HNSCC patients:Definitive local treatment = 18 years Performance status of 0 (Zubrod) Patients must have no contraindications for undergoing bronchoscopy Patients must have no active pulmonary infections Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg % Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required) Participants with active pulmonary infections or recent history of pulmonary infection (within one month) Participants with acute intercurrent illness Participants requiring chronic ongoing treatment with NSAIDs except aspirin Participants with history of stroke, uncontrolled hypertension, and/or uncontrolled angina pectoris Patients may not take high dose antioxidants (vitamins E or C) during the study period. \"High dose\" will be determined by the study investigators Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day). \"High dose\" is defined as anything greater than a once-daily multivitamin. Any additional supplementation will be evaluated at the discretion of the treating physician History of biologic therapy", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Head and Neck Cancer years or older Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid All histological types of cancer All tumour stages according to American Joint Committee for Cancer (AJCC) Staging All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers Alert and mentally competent English speaking Unwilling to participate", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Pharyngitis The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis The patient is willing to take \"nothing by mouth\" including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Ovarian Cancer Primary Peritoneal Cavity Cancer Age \u2265 18 years Must have persistent, recurrent or progressive ovarian cancer or primary peritoneal cancer after prior treatment with platinum and taxol compounds. Histologic confirmation of the original primary tumor is required. Prior bilateral oophorectomy is required Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometroid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma NOS The following laboratory values obtained \u22647 days prior to registration ANC \u2265 1500/\u03bcL PLT \u2265 100,000/\u03bcL Total bilirubin \u2264 upper normal limit AST \u2264 2 x ULN Creatinine \u2264 1.5 x ULN Hgb \u2265 9.0 g/dL Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy. Subjects will be excluded if this is their first relapse and they have recurred >6 mo from completion of primary (adjuvant) chemotherapy ECOG performance status (PS) 3 or 4 Active infection \u22645 days prior to registration History of tuberculosis or history of PPD positivity History of other malignancy \u22645 years except for non-melanoma skin cancer or carcinoma in situ of the cervix Any of the following prior therapies Chemotherapy \u2264 3 weeks prior to study entry Immunotherapy \u2264 4 weeks prior to study entry Biologic therapy \u2264 4 weeks prior to study entry", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Oral Cavity Cancer 18 years of age or older Able to provide written informed consent to participate Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment Current treatment plan includes surgical intervention English speaking Previous treatment for malignancy in the head and neck region Significant preexisting facial disfigurement from a previous trauma or congenital defect Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Histological or cytological diagnosis of non-small cell lung cancer Malignant pleural effusion proven by cytological examination Patient must have stage IIIB or IV disease with malignant pleural effusion We plan to recruit 16 patients who have smoked cigarettes of at least 20 pack per year, 16 patients who do not smoke but have been exposed to second hand smoking by living with a person who has smoked 20 pack per year cigarette in the same household and 16 patients who are non-smokers (never smoked) and no second hand smoking exposure in the same household. The accrual will be stopped once the number of patients is reached in each group ECOG PS 0, 1 or 2 Measurable disease (in addition to malignant pleural effusion) No prior chemotherapy for metastatic or recurrent disease. Patient may have surgery or radiation or combined chemoradiation, or neoadjuvant chemotherapy at primary diagnosis. This kind of chemotherapy will not be counted as patient has had prior chemotherapy for metastatic or recurrent NSCLC WBC > 3500/uL and ANC > 2,000/uL, platelet > 100,000/uL AST/ALT < 3 X UNL, bilirubin < 1.5 mg/dL ( or < 35 uM), creatinine < 1.5 mg/dL (or < 125uM for men and 90uM for women) Age > 18 No history of congestive heart failure, myocardial infarction or life-threatening arrthymia (such as ventricular tachycardia, supraventricular tachycardia, brachycardia < 40/min or atrial fibrillation or flutter with ventricular rate > 150/min) within 6 months of entry ECOG performance status 3 or worse Any prior chemotherapy regimen for metastatic or recurrent diseases No measurable disease, even after drainage of pleural effusion ANC < 1,999/uL or Bilirubin > 1.5 mg/dL (or > 35uM) Plt < 100,000/uL or ALT/AST > 3 x UNL Creatinine > 1.5mg/dL (or > 125uM) Patient has history of congestive heart failure, myocardial infarction or life-threatening arrthymia (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation/flutter with ventricular rate > 150/min or bradycardia < 40/min) within 6 months before entry Prior history of breast cancer or ovarian cancer in female patients or any cancer except cured cervical carcinoma in-situ or skin cancer Fasting blood sugar > 200 mg/dL (> 14uM) except in patients on dexamethasone for brain metastases", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 21.0-79.0, All Head and Neck Neoplasms The target population for this study is 125 patients with stages III or IV squamous cell lesions of the oral cavity, oropharynx, pharynx or larynx, or unknown primary No patient will have had prior treatment for head and neck cancer or any otolaryngologic or neurologic disorder affecting swallow and no preexisting swallowing disorder", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 16.0-65.0, All Pharyngitis Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate) First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already Counting of white blood cell in blood routine examination exceeds 10?109/L Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage) Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet Previous and/or existing tumour condition Pregnancy and/or breast-feeding Alcohol, and/or drug abuse ", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Smoking Cessation Patient seeking routine dental care at NYU College of Dentistry and meets medical clearance for routine care Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day) Able to provide a telephone number or collateral contact information where they can be reached over the subsequent 12 months Fluent in English or Spanish History of mouth or throat cancer", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Head and Neck Cancer Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx No histologic diagnosis other than squamous cell carcinoma A primary site must be identified Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0) No stage IVC disease (stage IVB disease allowed) Deemed appropriate for definitive non-operative management with curative intent Resectable disease is not required No primary cancer of the nasopharynx, paranasal sinus, or salivary gland ECOG performance status 0-1 Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible Patients who might be a poor-compliance risk are ineligible Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Colorectal Cancer Esophageal Cancer Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy Not pregnant or nursing No blood disorder Not deprived of freedom or protected by law See Disease Characteristics ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Pharyngitis Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing \u226566 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing Patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides, or acetaminophen were excluded", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Oropharyngeal Cancer Head and Neck Cancer Squamous Cell Carcinoma Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer Must have the ability to understand and provide informed consent Patients must be 18 years and older Ability to read, write, and speak English Resident of the United States Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested Previous cancer diagnosis excluding non-melanoma skin cancer Blood transfusion within the previous 6 months Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids)", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Cancer Willing and able to provide informed consent Willing to comply with follow-up requirements Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less) Indicated for chemotherapy and/or radiation therapy Ability to dilate stricture to 15mm diameter at extent of disease evaluation Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent Patients contraindicated for endoscopy Patients with prior esophageal stent placements Advance stage of disease, greater than T3 tumor or M1 disease", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-75.0, All Muscular Dystrophy, Oculopharyngeal Man or woman <18-75> years old Oculopharyngeal muscular dystrophy confirmed by genetic diagnosis (mutation of the GCG) on the chromosome 14) Oculopharyngeal muscular dystrophy with UES dysfunction salivary or alimentary stasis at fibroscopy of swallowing above the UES decreased opening of the UES at videofluoroscopy of swallowing A decreased of the pharyngeal propulsion may be associated Written consent of the patient History of myotomy of the UES in the context of the Oculopharyngeal muscular Dystrophy HIV, hepatitis B or C tuberculosis) Lupus, rheumatoid polyarthritis, sarco\u00efdosis, collagenosis) Other neuromuscular diseases History of malignant tumor History of neck radiotherapy Renal failure (creatinine clearance <60ml/min) Liver failure Pregnancy ", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All First Line Chemotherapy Capecitabine Plus Cisplatin Versus Capecitabine Plus Paclitaxel Advanced or Recurrent Esophageal Squamous Cell Carcinoma Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma Age > 18 years ECOG performance status 0 At least one measurable lesion(s) by Life expectancy \u2265 3 months Patients may have received prior adjuvant chemotherapy with 5-FU with cisplatin as long as it has been 12 months since completion of regimen No previous palliative chemotherapy Prior radiotherapy must be completed 4 weeks before study entry Adequate bone marrow function (\u2265 ANC 1,500/ul, \u2265 platelet 100,000/ul, \u2265 Hemoglobin 9.0 g/dl) Adequate renal function (\u2264 serum creatinine 1.5 mg/dl or CCr \u2265 50 ml/min) Other tumor types such as adenocarcinoma, small cell carcinoma Evidence of CNS metastasis Contraindication to any drug contained in the chemotherapy regimen Previous adjuvant treatment with 5-FU, cisplatin, capecitabine or paclitaxel finished less than 1 year Evidence of serious gastrointestinal bleeding History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in ECG) or myocardial infarction within the last 6 months Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia) Serious metabolic disease such as severe non-compensated diabetes mellitus History of significant neurologic or psychiatric disorders", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 20.0-80.0, All Esophageal Cancer Histologically confirmed primary cancer of esophagus Must be dysphagia caused by esophageal cancer Without esophageal fistulas Must be an inpatient Life expectancy is over 6 months Esophageal fistulas Tracheal compression with symptoms WBC <2000/mm3 and Platelet count <50,000/mm3 Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Resectable Esophageal Cancer Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained Weight loss < 10% in 0.5 yr WHO performance status 0-1 No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ Inadequate organ function as defined by Inadequate haematology (Hb < 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) neutrophils < 1,5 109/L -platelets <100*109/L) Liver enzyme elevation (bili > 1,5*ULN ASAT > 2,5*ULN ALAT > 2,5*ULN) or Impaired renal function (creatinine clearance by cockcroft < 60 cc/min) Proteinuria >1,0gr/24hr Tumour stage: M1a and/or tumour length > 8 cm and/or > 5 cm radially", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Cancer Histologically proven adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the esophagus Locally advanced disease (any T, N0 or N1, M0 or M1a) No metastatic disease, except for tumor involvement of the upper third of the esophagus or cervical esophageal tumor with regional nodes, or tumor involvement of the lower third of the esophagus with celiac nodes (M1a) Cervical primary tumor with positive supraclavicular or cervical lymph nodes (defined as N1) allowed No radiographic evidence of enlarged (\u2265 1.5 cm) celiac lymph nodes by CT scan or echography No small cell or undifferentiated carcinoma of the esophagus No multiple carcinomas of the esophagus (i.e., > 1 esophageal tumor) No cardia tumor (Siewert II) or gastric tumor extension to the esophagus (Siewert III) Esophageal tumor extension to the cardia (Siewert I) (center of the tumor lying > 1 cm-5 cm above gastroesophageal junction) allowed Inoperable disease OR surgery is contraindicated ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-65.0, All Tobacco Dependence Alcohol Dependence Heavy Smokers/Heavy Drinkers Treatment seeking smokers Age 18 to 65 years Smoke \u2265 10 cigarettes per day Fagerstrom Test of Nicotine Dependence score > 3 Alcohol Use Disorders Identification Test (AUDIT) > 8 Drink > 25 drinks per week for males or > 20 drinks per week for females Able to provide written informed consent (Heavy Smokers/Social Drinkers) Treatment seeking smokers (Heavy Smokers/Heavy Drinkers) Any medical condition requiring immediate investigation or treatment Beck Depression Inventory score >16 Insulin-dependent diabetes Drink > 70 standard alcoholic drinks per week for males or drink > 52 standard alcoholic drinks per week for females Pregnancy or lactation Current DSM-IV Axis 1 psychiatric disorder Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol (Heavy Smokers/Social Drinkers) Any medical condition requiring immediate investigation or treatment", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-75.0, All Suspected Eosinophilic Esophagitis Male and female volunteers \u226518 years old Patients with known or suspected Eosinophilic Esophagitis Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia Use of oral corticosteroids Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety Contraindication to esophageal dilation based on investigator's judgment Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 0.0-999.0, All Lung Cancer Precancerous Condition Meets 1 of the following Smoker with no disease Smoker with airflow obstruction and abnormal sputum cytology Smoker with lung cancer Smoker with various grades of dysplasia Non-smoker Not specified Not specified ", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Cancer Diagnosis of adenocarcinoma of the esophagus Stage I-IV disease Received cisplatin-based treatment on clinical trial ECOG-1201 Not specified Not specified ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-54.0, All Haemophilus Influenzae (NTHI) for Inoculated Volunteers Healthy 18-54 years old (male or female) with no chronic medical conditions with the exception of well-controlled hypertension Availability for study visits over the next 1 month Normal hemoglobin, white blood cell count, creatinine, alanine aminotransferase (ALT), platelet count Signed informed consent form In good health as determined by medical history and physical exam on the screening evaluation [including heart rate 55-100 beats per minute (bpm); blood pressure: systolic 90-140 mm Hg and diastolic 50-90 mm Hg]. If the subject is a well trained athlete by the judgment of the Principal Investigator (PI), heart rate of 40-100 bpm is acceptable Negative urine pregnancy test for women of childbearing potential If the subject is female and of childbearing potential, she agrees to use acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes abstinence, implants, injectables, combined oral contraceptives, effective intrauterine devices, or a vasectomized partner) Negative human immunodeficiency virus (HIV) enzyme linked immunosorbent assay (ELISA) for HIV 1 and 2 or indeterminate Western blot or other assay confirming that the serostatus does not reflect HIV infection, negative hepatitis C and hepatitis B serology or other assay confirming that the serostatus does not reflect active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection Negative urine protein and glucose by dipstick for Inoculated Volunteers Acute illness within the week prior to inoculation Acute febrile illness (oral temperature greater than or equal to 100.4 degrees Fahrenheit) on the day of inoculation Allergic rhinitis requiring therapy in the past year Treatment for sinusitis, otitis, chronic bronchitis, pneumonia, bronchospasm or asthma in the past 5 years Abnormal gag reflex Active drug or alcohol abuse Smoking tobacco within the past year Average ingestion of more than one alcoholic beverage per day for women or two alcoholic beverages per day for men Splenectomy or disease that results in functional asplenism such as sickle cell diseases", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 20.0-70.0, All Tracheal Intubation ASA physical status I-II, aged between 20 and 70 years scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation recent respiratory tract infection or sore throat who were using analgesics or steroid preoperatively who have risk factors for oral cavity infection the surgical duration < 60 minutes or > 300 minutes", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infections Tobacco Dependence HIV-infected patients adults regular smokers (at least 10 cigarettes a day during the last year) motivated to stop smoking followed in one of the participating clinical ward signed written inform consent current co-dependency to another psychoactive substance ongoing depressive episode history of suicidal attempt ongoing treatment by interferon treatment by efavirenz for less than three months or not tolerated previous use of varenicline ongoing treatment by bupropion-SR or nicotinic substitute ongoing pregnancy ongoing breastfeeding hypersensitivity to varenicline or to one of its excipients", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-50.0, All Healthy Age 18-50 years, inclusive Expressed interest and ability to fulfill the study requirements Be in general good health as determined by a screening evaluation within 30 days of the first dose of LGG or placebo Able to ingest the study drug (LGG or placebo) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube) Willing to prevent pregnancy Women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. A woman is eligible if she is monogamous with a vasectomized male. Sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug Willing to comply with protocol and report on compliance and side effects during study period Informed consent obtained and signed prior to screening Consumption of supplements or food products containing LGG or probiotics 30 days prior to the start of the study or consumption of yogurt that has \"live and active cultures\" seal Known or suspected allergies to probiotics, Lactobacillus, microcrystalline cellulose, gelatin, or any antibiotic that may be used to treat LGG bacteremia or infection (Ampicillin, Clindamycin, Moxifloxacin) Received oral or parenteral antibiotics within 4 weeks of enrollment or prescribed antibiotics on day of enrollment Drug or alcohol abuse within previous 12 months Major surgery or endoscopy within last 3 months Daily prescription or over-the-counter medicines except for vitamins, birth control products, and hormone replacement therapy Presence of any of the following Abnormal vital signs or clinically significant physical findings such as murmur (other than functional), hepatosplenomegaly, jaundice, lymphadenopathy, or focal neurological deficit Indwelling catheter or implanted hardware/prosthetic device or feeding tube Febrile illness (oral temperature >37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline visit (first dose of study drug)", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Non-Small Cell Lung Cancer Patients diagnosed with advanced NSCLC stage IIIB/IV who have not received previous chemotherapy Radiotherapy or both and who have tumor tissue embedded in paraffin blocks or formalin-fixed These patients must sign an informed consent letter Patients who refuse to participate in the study or those who decide to withdraw from it Patients without tumor tissue or with a poor quality sample", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-64.0, All Sore Throat Pain Female patients undergoing outpatient laparoscopic gynecologic surgery ASA PS I and II Age between 18 and 64 years Fluent in English History of recent respiratory tract infection Pregnancy, breastfeeding Current treatment with analgesics Current use of corticosteroids Anticipated difficult intubation Risk factors for post-operative aspiration", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 20.0-80.0, All Esophageal Cancer Endoscopically and histologically confirmed cancer of esophagus Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level \u2162 or level \u2163[STOOLER stand] In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction Patients with clear consciousness\uff0cCooperation\uff0cECOG performance status of 0,1 and 3 Informed consent: authorization and signature Poor general status,ECOG performance status of 4 Dysphagia not caused by esophageal cancer Noncooperation or no authorization and signature The superior border of cancer higher than the seventh cervical vertebrae Ulcerative esophageal carcinoma Esophageal fistulas WBC less than 3000/mm3 Severe hepatic inadequacy or renal inadequacy", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 3.0-45.0, All Pharyngitis patients with sore throat, classified 2-3 according to Cantor`s patients on antibiotic treatment suspected carriers of streptococcus", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Neoplasms, Lung Carcinoma, Non-Small Cell Lung Drug Therapy Genes, EGFR Male and female patients aged over 18 years Histologically proven lung adenocarcinoma clinical stage IIIB/IV ECOG performance status 0-2 Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma At least one measurable lesion (according to Provision of written informed consent Life expectancy of at least 12 weeks History of malignant disease Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) Expected life expectancy less than 2 months As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) \u2265 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases) Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study Pregnancy or breast-feeding women (women of child\u00acbearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 0.0-70.0, All Thoracic Esophageal Squamous Cell Carcinoma Age\u226470 years old Karnofsky Performance Status\uff08KPS\uff09\u226580 Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic ultrasonography\uff0cchest and abdomen CT and neck ultrasonic The preoperative evaluation of organ function is tolerant of surgery and chemotherapy The subject can understand and sign the informed consent form (ICF) The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin\uff08HGB\uff09\u22659.0g/L; absolute neutrophils count\uff08ANC\uff09\u22651.5\u00d7109/L; platelet count\uff08PLT\uff09\u2265100\u00d7109/L; total bilirubin\uff08TBIL\uff09\u22641.5N;aspartate aminotransferase (AST)\u22642.5N;alanine aminotransferase(ALT)\u22642.5N;prothrombin time(PT)\u22641.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)\u22641.5N Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer Advanced Esophageal Cancer Prior malignancy in 5 years recently History of previous chest radiotherapy History of cardio-cerebral vascular accident in 6 months lately The subject can not understand and sign the informed consent form(ICF)", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-35.0, All Smoking Body Weight The selection for the clinical trial are designed to a wide range of participants such that the study sample will be representative of the broader U.S. population of the Memphis metropolitan area. Those who might be at risk of adverse outcomes from the study interventions will be excluded (see ). All participants will give voluntary consent at the screening visit by signing an informed consent statement which has been approved by the Institutional Review Board (IRB). We will encourage the participation of women and minorities. The study will be open to all persons of any race or gender who are *18 to 35 years old BMI > 22 kg / m2 Self report smoking > 10 cigarettes each day Have access to a telephone and the internet Demonstrate ability to access a specific web site Demonstrate ability to receive and respond to email Willing to accept random assignment *Intending to be available for a 24 month intervention *At risk for weight gain (e.g. plan to quit smoking)", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Histologically confirmed esophageal cancer or gastroesophageal junction tumor including the following subtypes Adenocarcinoma Squamous cell cancer Poorly differentiated epithelial malignancy Gastroesophageal junction with Siewert type I or II tumors Failure after no more than 2 prior chemotherapy regimens and 1 chemoradiation course Measurable or evaluable disease by CT scan Patients with brain metastases must be stable and have received cranial irradiation prior to entry WHO performance status 0-2 Serum bilirubin \u2264 3 times the upper limit of normal (ULN) ", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Cough Male and female subjects, age 18 years and over History of cough for more than 8 weeks Normal chest x ray Chronic idiopathic cough or chronic cough resistant to treatment of specific triggers Smoking status Current smokers Ex smokers with history of smoking > 20 pack years or those who have given up < 6 months ago Prohibited medications Use of medications likely to suppress / affect cough including codeine, morphine, pregabalin, gabapentin, amitriptylline, angiotensin converting enzyme inhibitors (type 1) and baclofen Use of any anti-arrhythmic medication Use of cimetidine, beta blockers, or diuretics Cardiovascular conditions Sinoatrial disease, bradycardia or all types of heart blocks History of ischaemic heart disease or heart failure", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 21.0-90.0, All Dysphagia Stroke identified by neurological and radiological examination Oropharyngeal dysphagia as confirmed by clinical and radiological examination No prior history of oropharyngeal dysphagia by patient and/or caregiver report No previous head/neck surgery or trauma that may impact swallowing ability No other/concomitant neurological disorders (e.g. Parkinson's disease) that would impact oropharyngeal swallowing ability. This does not post-stroke deficits Physician and patient/family agreement to participate Exposed to previous behavioral or NMES swallowing therapy within 6 months of admission Presence of progressive neurological disorder, such as ALS; Parkinson's or other neurologic disorders within the last 6 months History of neurosurgery (either ablative or stimulatory), encephalitis or significant head trauma History of a significant medical condition such as heart, liver, or renal disease; history or evidence of malignancy within the past 5 years other than excised basal cell carcinoma Because of FDA Warnings, patients with cardiac demand pace makers will be excluded Patients with evidence of significant cognitive impairment or dementia as reflected in a Mini-Mental test less than 23 and/or a score of 50% or less on the comprehension quotient on the Western Aphasia Battery", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 70.0-85.0, All Esophageal Cancer Histologically documented diagnosis of esophageal Cancer Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible age:70-85 years Written informed consent Performance status of 0 to 2 Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) Prior systemic chemotherapy or radiation therapy for esophageal cancer", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Neoplasms Patients with a confirmed diagnosis of advanced, measurable or evaluable, nonresectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months as demonstrated by serial imaging Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options Tumour tissue must be available for the determination of E-cadherin expression (archived tissue or fresh biopsy) Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (CTCAE grade < 2) Age = 18 years Life expectancy = 3 months Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation, including consent for PK samples, for using an archived tumour sample for determination of Ecadherin status, for reviewing previous tumour scans (and for providing skin biopsies, in patients in dose finding phase enrolled before protocol amendment 03) Eastern Cooperative Oncology Group (ECOG), R01-0787) performance score 0-1 Additional in the expansion phase Patients must have measurable progressive disease within the last 6 months, according to Response Evaluation in Solid Tumours (RECIST) (version 1.1, R09-0262) Serious concomitant non-oncological disease/illness Active/symptomatic brain metastases Second malignancy Pregnancy or breastfeeding Women or men who are sexually active and unwilling to use a medically acceptable method of contraception Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Metastatic Gastric Cancer Adenocarcinoma of the Gastro-oesophageal Junction Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease not amenable to curative therapy Measurable disease, according to the Response Evaluation in Solid Tumours (RECIST), assessed using imaging techniques (CT or MRI) ECOG Performance status 0, 1 or 2 (see Appendix 2) Life expectancy of at least 3 months Male or female age \u2265 18 years Signed informed consent Assessment of HER2 status (primary tumour or metastasis) by the central laboratory prior to initiation of study treatment (see section 9.1) Able to swallow and retain oral medication LVEF \u2265 50% assessed by multigated radionucleotide angiography (MUGA) or cardiac ultrasound Any of the following will the patient from the study Previous chemotherapy for advanced/metastatic disease (prior peri-operative chemotherapy is allowed if at least 6 months has elapsed between completion of this therapy and enrolment into the study) Previous radiotherapy on the abdomen Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma Patients with active (significant or uncontrolled) gastrointestinal bleeding Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity \u2265 grade 2 NCI-CTCAE Creatinin clearance <50 mL/min Neutrophil count <1.5 \u00d7 109/L, or platelet count <100 \u00d7 109/L Serum bilirubin >1.5 \u00d7 upper limit of normal (ULN); or, AST or ALT >2.5 \u00d7 ULN (or >5 \u00d7 ULN in patients with liver metastases); or, alkaline phosphatase >2.5 \u00d7 ULN (or >5 \u00d7 ULN in patients with liver metastases, or >10 \u00d7 ULN in patients with bone but no liver metastases); or, albumin <25 g/L Known dihydropyrimidine dehydrogenase (DPD) deficiency", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Malignant Dysphagia Esophageal Cancer Age \u226518 years Confirmed esophageal/gastroesophageal (GEJ) cancer (Siewert Type I and Type II only) of any histology on biopsy Dysphagia score \u22652 Stage IV cancer/Metastatic disease Expected life expectancy < 3 months Inability to undergo stent insertion Siewert Type III gastroesophageal cancer Esophageal-Airway fistula", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 20.0-999.0, All Metastatic or Recurrent Gastric Adenocarcinoma Her-2 Positive Gastric Cancer Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy Measurable disease, according to the Response Evaluation in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI) HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2 ECOG Performance status 0, 1 or 2 Life expectancy of at least 3 months Male or female. Age over 20 year Signed informed consent Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed) Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube) Patients with active (significant or uncontrolled) gastrointestinal bleeding Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma Neutrophil count < 1.5 \u00d7 109/L, or platelet count < 100 \u00d7 109/L Serum bilirubin > 1.5 \u00d7 upper limit of normal (ULN); or, AST or ALT > 2.5 \u00d7 ULN (or > 5 \u00d7 ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 \u00d7 ULN (or > 5 \u00d7 ULN in patients with liver metastases, or > 10 \u00d7 ULN in patients with bone but no liver metastases); or, albumin < 25 g/L Creatinine clearance < 60 mL/min. Other Study Drug-Related History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias Baseline LVEF < 50% (measured by echocardiography or MUGA)", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 12.0-75.0, All Laryngopharyngeal Reflux Patients with age of 12-75 years old (inclusive) Patients with at least one symptom consistent with LPR, including hoarseness, throat clearing, throat pain, globus sensation in the throat, or chronic cough \u2267 4 weeks before entering study Patients with a total reflux symptom index (RSI) >10 (based on a self-administered 9-item questionnaire of voice/throat complaints) Patients with a total reflux finding score (RFS) >5 (based on a laryngoscopic examination by investigators) Patients or their legal representatives have signed the informed consent form Patients with viral or bacterial laryngitis, or occupational exposures causing laryngitis Patients with erosive GERD as evidenced by upper GI endoscopy Patients with laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, , or with history of neck radiation therapy Patients with history of uncontrolled hypertension or moderate to severe renal impairment Patients with history of esophageal or gastric surgery Patients with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray Patients with endotracheal tube intubation within 2 months before entering study Patients had taken any alginate preparations within 2 days; H2-blocker, prokinetic agent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days before screening Patients with a history of allergy to the study drugs or their related compounds Patients with a history of alcohol or drug abuse, or with any psychiatric disease", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Pharyngitis Healthy, ambulatory, male and female subjects \u2265 18 years of age Presence of sore throat due to upper respiratory tract infection (URTI) Onset of sore throat pain within six days of the screening period Baseline sore throat pain intensity score \u2265 60 mm on the Sore Throat Pain Intensity Scale Have a score \u2265 5 on the Tonsillopharyngitis Assessment Female subjects of childbearing potential who are currently sexually active must be using a medically acceptable form of birth control for at least one month prior to screening (three months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Nuvaring, Depo-Provera, or double-barrier and have a negative pregnancy test at screening/treatment period. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy Understand the pain rating assessments History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs Use of any \"cold medication\" (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product Presence of cough that causes throat discomfort Presence of mouth-breathing or any respiratory condition that, in the Investigator's judgment, could compromise breathing Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies for which aspirin or acetaminophen is contraindicated Relevant concomitant disease such as medically uncontrolled asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than fifty percent obstruction History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory therapy", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Cancer All patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertions Inability to consent for the study Patients less than 18 years old Patients with other benign causes of dysphagia and esophageal obstruction or stenosis Patients with malignant or benign airway esophageal fistulas Patients with cervical esophageal cancer", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-70.0, All Oral Health Oral Cancer Gum Disease Submit to a 24 hour urine cotinine test which will be used to determine smoking status Meet one of the following smoking Non-smoker Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL Does not currently smoke but has quit smoking for more than 10 years and smoked less than 1 pack/day of cigarettes when they were actively smoking and has a urine cotinine (less than 100 ng/mL) Smoker Smokes habitually at least 10 cigarettes/day and a urine cotinine level of >1000 ng/mL. Cigar and pipe smokers who smoke at least 10 grams of tobacco daily are also eligible Agree to consume a standardized vitamin and mineral supplement and avoid other nutritional, dietary, or alternative medications/supplements for the duration of the study No history of malabsorptive, gastrointestinal or other metabolic disorders requiring special diet recommendations Body mass index (BMI) between 20 and 35 kg/m2 Have a known allergy to strawberries, corn, and wheat products or those who have never consumed any of these products Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, ileus, IBS), renal insufficiency, hepatic insufficiency, hyper or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone, insulin) or other endocrine disorders requiring hormone administration Have significant loss of gastrointestinal organs due to surgery, except for appendix Have altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias Heavy alcohol consumers defined as >15 glasses/week (one glass = 1.5 oz. liquor, 5 oz. wine, or 12 oz. beer) Antibiotic use in the last 6 months or on medications that will accelerate or decrease bowel motility Are receiving or in need of dental treatment during the study period Have noticeable open lesions, sores that have not healed for more than 3 months, have had any active oral lesions or maladies within the last month, or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 45.0-999.0, All Lung Cancer Smoking >45 years of age Unable to provide informed consent", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 12.0-999.0, All Upper Respiratory Infections Subject must have one or more symptoms per category (see also screening assessment of cold symptoms, section 6.1) mild to moderate body pain, headache, fever or sore throat nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Baseline sore throat pain of severe intensity, e.g. rated as 3 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe) Baseline dry cough of severe intensity, e.g. rated as 3 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe) Subject has a productive cough History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes Subjects with allergic asthma Use of any inhaler, medicated confectionary, throat lozenges, throat pastilles, sprays, any products with demulcent properties such as chewing gums and boiled sweets or mints, in the 6 hours prior to dosing Use of any medication for sore throat containing a local anaesthetic within the 6 hours prior to dosing Use of paracetamol, any NSAID or any oral nasal decongestant within 6 hours prior to dosing Use of substances of abuse or antihistamines within 24 hours of dosing Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Dysphagia History of dysphagia necessitating a dynamic fluoroscopic swallow study Age > 18 years Ability to complete a comprehensive dynamic fluoroscopic swallow study Ability to provide informed consent for study participation Age < 18 years Pregnant women Prisoner or other institutionalized individual Cognitive disability precluding the ability to provide informed consent or complete a comprehensive swallow study", "label": "2"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-70.0, All Esophageal Squamous Cell Carcinoma Resectable Histological or cytologic diagnosis of Esophageal squamous cell carcinoma ECOG performance status 0-2 Age:18-70 years Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0\uff08AJCC 2009\uff09 Target lesions can be measured according to No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin \u22659 g/dL, WBC\u22653x109/L, Neutrophils (ANC )\u22651.5x109/L, platelet count \u2265100x 109/L, TBIL<1.5 x ULN, ALT and AST \u2266 2.5 x ULN, creatinine \u2266 1.5 x ULN Use of an effective contraceptive for adults to prevent pregnancy Life expectancy of more than 3 months Not suitable to surgery cervical Esophageal Carcinoma(distance of incisor tooth<19cm) early Esophageal Carcinoma(Stage I) complete esophageal obstruction\uff0cEsophageal perforation or hematemesis other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11\u3001 History of serious allergic or castor oil allergy 12\u3001 Patients who are not suitable to participate in the trial according to researchers", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-75.0, All Esophageal Cancer Patients who have histologically confirmed diagnosis of esophageal cancer without prior palliative treatment or an interval of at least 6 months from the last operation, adjuvant radiation therapy and adjuvant chemotherapy. If patients received adjuvant chemotherapy, paclitaxel and cisplatin must be excluded from the regiment or the total dosage of cisplatin must be less than 300mg/m2 Patients must be 18 to 75 years old and both genders are eligible Patients must have measurable or evaluable disease with at least one tumor mass maximum diameter \u226510mm by multi-slice spiral CT or MR scan. If ordinary CT scan is used the tumor mass maximum diameter must \u2265 2cm. Imaging exam must be performed within 15 days from enrollment Patients must have an expected life expectancy of \u2265 3 months Patients must have a performance status of \u2265 80 on the Karnofsky scale Patients must have normal marrow function and the blood tests must be collected within 7 days from enrollment with a hemoglobin (HGB) of \u226590g/L, an white blood cell (WBC) counts of \u22654.0\u00d7109/L\uff0ca neutrophil count of \u22652.0\u00d7109/L, , a platelet count of \u2265100\u00d7109/L, a total bilirubin (TBil) of \u22641.0 upper normal limitation (UNL), a creatinine (Cr) of \u2264 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of \u22642.5 UNL, Alkaline phosphatase (AKP) \u22645.0 UNL. For patients with liver metastasis, the ASAT/ALAT must be \u22645.0 UNL Patients must have normal electrocardiogram results and no history of congestive heart failure Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors Patients who have received prior palliative treatment or less than 6 months from the last operation, adjuvant radiotherapy, adjuvant chemotherapy Previous treatment regiment involve paclitaxel and S-1 Tumor mass >10mm by CT or MR scan. The total area of metastatic tumor lesions in liver is over 50% of whole liver or the total area of metastatic tumor lesions in lung is over 25% of whole lung Patients without measurable or evaluable disease, for example cavity effusion or diffusive metastasis of organs Patients with history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years Patients with serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure Patients with only brain metastasis or bone metastasis Patients with chronic diarrhea Patients with neurological or psychiatric abnormalities including metastasis of the central nervous system that affect cognitive Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 0.0-1.0, All Dysphagia Infants with severe dysphagia on VFFS as defined by dysphagia resulting in aspiration with swallow of at least 2 food textures (e.g. thin and thick liquid) We will children with dysphagia due to a central neurologic deficit. The neurologic diagnosis will be based on the diagnosis from the treating physician Infants with a known or suspected neurodegenerative or peripheral neuromuscular condition or a medical condition that is a contraindication for NMES treatment (tumours in the neck region and neck soft tissue infections) Children with neurodegenerative disorders have been excluded as their natural history of dysphagia would be different from those with a static neurologic disorder", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-65.0, All Overweight and Obesity Males and females 65 years old Body Mass Index (BMI) 27-35kg/m2 Overall healthy Weight Stable (<3 kg change in the past 4 months, before the trial) Medical Heavy smokers (more than 10 cigarettes/day) or heavy alcohol consumers (more than 4 alcohol units/day for male and more than 3 alcohol units/day for female) Obesity of endocrine origin Chronic metabolic conditions: diabetes, hepatic disease, gout, kidney, thyroid or coagulation disease Gastrointestinal disorders: celiac disease, ulcerative colitis, irritable bowel syndrome (IBS), Chron's disease, chronic constipation, diverticulitis, history of gastric bezoar. Suspected strictures, fistulas, or physiological GI obstruction Psychiatric disorder: severe depression, bulimia, anorexia, schizophrenia, bipolar disorder Gastrointestinal procedure or surgery in the past three months Disorders of swallowing, severe dysphagia to food or pills Pregnancy Medication", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 20.0-85.0, All Stroke age between 20-85 years old first-time stroke confirmed by computed tomography or magnetic resonance image dysphagia > 3 weeks, with preservation of the swallowing reflex currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5 or less Mini-Mental State Examination (MMSE)> 21 no obvious mental depression, receptive aphasia or cognitive impairment progressive cerebrovascular disease or other neurologic diseases unstable cardiopulmonary status, serious psychologic disorder or epilepsy tumors, extensive surgery or radiotherapy of the head and neck region cardiac pacemakers swallowing therapy within 2 months before participation", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Oesophageal Adenocarcinoma oesophageal cancer Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery Metastatic disease", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 40.0-72.0, All Esophageal Neoplasm Esophageal Cancer TNM Staging Primary Tumor (T) T2 Esophageal Cancer TNM Staging Primary Tumor (T) T3 Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 Esophageal Cancer TNM Staging Distal Metastasis (M) M0 Stage T2-3N0M0 disease of TESCC patients confirmed by pathology studies who received R0 operations in Cancer Institute & Hospital\uff0cCAMS\uff1b KPS\u226570 before radiotherapy Did not receive neoadjuvant or adjuvant treatment No clear recurrent or metastatic lesions before radiotherapy Intensity modulated radiation therapy(IMRT) is accepted Regular follow-up Exploratory thoracotomy or palliative surgery No clear recurrent or metastatic sites Recurrence or metastasis is not certain death of no definite cause Irregular follow-up", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Small Cell Lung Cancer years or older Patients with histologically proven SCLC (all histological subtypes), treated with concurrent chemo and radiotherapy Ability to understand the protocol and willing to provide written informed consent Concurrent participation in a clinical trial in which the subject is taking or receiving any investigational agent that may affect the frequency, severity or duration of mucositis Pre-existent esophagitis Receiving investigational treatment for the prevention or treatment of mucositis Prior irradiation to the lung or head and neck region", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 25.0-80.0, All Microbiota Lung Cancer Oral Cancer This study will recruit a convenience sample of 50 volunteers (25 current smokers with at least 5 years of smoking history, 25 never smokers). Current smokers are defined as individuals who have smoked more than 100 cigarettes in their lifetime and have smoked 5 or more cigarettes in the last 24 hours. Recent use of other tobacco products (pipe, cigar, snuff, cigarillos, and chewing tobacco) is an overall but use in the remote past (> 6 month ago) is acceptable in smokers. Never smokers are defined as individuals who have never smoked cigarettes nor used any other tobacco products including pipe, cigar, snuff, cigarillos, or chewing tobacco The ethnic mix of the clinic is roughly 50% Caucasians and 50% African Americans with a small number of unspecified or other racial groups. The median age is about 50 and the gender mix consists of an equal number of men and women. We therefore will select smokers and frequency match to non-smokers based on ethnicity (White, African-American), gender (male, female), and age (above or below the median, estimated to be 50) We will pregnant women and other racial groups because they may represent very small numbers and thus be difficult to match. Hormonal changes associated with pregnancy and unique cultural habits associated with specific ethnic groups could be associated with highly unique or variable microbiome patterns, and therefore reduce the power to detect differences associated with smoking which is our primary goal. We will also subjects with antibiotic usage in the last three months and subjects with previous diagnosed major periodontal disease or cancer because they might be potential confounders", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 0.0-0.827, All Dysphagia Infants born prematurely, as defined by birth at less than 37 weeks gestational age, referred for a videofluoroscopic swallow study (VFSS) due to suspected pharyngeal phase dysphagia Infants born prematurely with a corrected gestational age of 43 weeks or greater", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Cigarette Smoking Overweight Obesity Participating Client Not Re-Enrolling USA Resident Wants to quit in the next 30 days Use Cigarettes (other types ok, but must use cigarettes) years or older Speak English Provide Phone Provide Email Address Use 10 cigarettes per day or more Pregnant or Planning Pregnancy within 3 months Diabetic Previous weight loss surgery or planning weight loss surgery in next 12 months", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 30.0-80.0, All Obesity Adults age 30-80 BMI between 30 and 45 prior to starting Weight Watchers Have a documented weight loss of at least 5kg in the past 4-6 months before enrolling Stable health Substance abuse Bulimia nervosa or related behaviors Pregnancy or breast feeding Medical contraindications to counseling about diet, physical activity, or weight reduction Unstable mental illness Screen positive for pathological gambling on the basis of the 10 item DSM-IV (excluded if meets 5 or more criteria) Individuals unable to read consent forms or fill out surveys in English", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 20.0-65.0, All Post Operative Sore Throat ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation preexisting hoarseness or sore throat, upper respiratory tract infection steroid therapy or immunocompromised patients chronic treatment with calcium channel blocker or magnesium allergy to magnesium sulphate Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation fail to tracheal intubation at first trial reduced kidney function Diabetes mellitus", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-25.0, All Smoking U.S. participants 18-25 years of age who are part of the Survey Sampling International (SSI) panel Never smoker (never puffed a cigarette) or former smoker (have at least puffed a cigarette but have not smoked in the past 30 days) Less than 18 or greater than 25 years of age For the main study, they must not have participated in the pilot study in which we will test the how convincing these messages are For both studies, they must not have participated in a previous study in which we originally generated these theme sets Current smokers (people who have smoked in the past 30 days)", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Acute Pharyngitis Sore Throat Primary diagnosis: pharyngitis confirmed by a Tonsillo-Pharyngitis Assessment \u2265 5 Complaint of sore throat with an onset \u2264 4 days prior to randomization Have at least one symptom of upper respiratory tract infection (URTI) on the URTI Questionnaire (e.g., sore throat, runny nose, cough, fever) Have moderate or severe sore throat pain on the Throat Pain Scale Have a baseline Sore Throat Scale (STS) \u2265 6 If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating. She is also willing to take adequate contraceptive precautions through 24 hours after the completion of the study If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy test (UPT) result (indicating \"not pregnant\") obtained on the day of scheduled randomization, prior to the designated time of randomization The patient is willing to remain at the study centre for 3 hours after receiving the dose of study medication During the 3-hour evaluation of the study medication lozenge at the site, the patient is willing to take \"nothing by mouth\" (e.g., no smoking, food, candy, lozenges, chewing gum, liquids) Known allergy and/or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or any other inactive ingredients such as honey, lemon flavor, menthol, or sucrose History of an upper gastrointestinal ulcer within the past 60 days, current clinically significant upper gastrointestinal complaints, or current regular use (\u2265 3 times in the previous week) of any medication for upper gastrointestinal symptoms, including antacids, H2 blockers, proton pump inhibitors or sucralfate History of any hepatic disease or renal dysfunction Other severe acute or chronic medical condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study History of chronic analgesic use (\u2265 3 times per week over the prior 4 weeks) Use of an antibiotic for an acute disease within the previous 24 hours before randomization. (Chronic antibiotic use, such as for acne, is acceptable.) Use of any quinolone antibiotic such as ciprofloxacin or nalidixic acid within the past week or concurrently is specifically prohibited Use of mifepristone in the 12 days prior to the screening visit Use of inhaled therapy (e.g., inhaled steroids or \u03b2-agonists, such as Ventolin) on an acute basis for disease exacerbation in the week prior to the screening visit Use of any immediate release analgesic within 4 hours preceding administration of the study medication Use of any sustained release analgesic within 12 hours preceding administration of the study medication", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 30.0-999.0, All Pancreatic Insufficiency Male or female at least 30 years of age Able to read, understand, and sign informed consent Patients with a negligible smoking history (defined as no smoking for the past 7 years, and a total smoking history \u2264 5 pack-years) OR patients with AT LEAST a 20 pack-year smoking history Patients with a prior diagnosis of pancreatic insufficiency Patients who have a current or remote history of acute or chronic pancreatitis or any other primary pancreatic disease or malignancy Patients who have had pancreatic surgery Patients with a diagnosis of small bowel malabsorption or Celiac disease Patients with any other significant systemic disease that is deemed by the investigator as possibly interfering with the conduct or interpretation of the study", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-60.0, All Personal Satisfaction availability to give written consent age 18-60, men and women (who are not pregnant or nursing) people in good health able to follow protocol must be experiencing a sore throat or cold at least once a year smokers liver and kidney disease inflammatory bowel disease pancreatitis gallbladder or biliary disease neurolgical/psychological disease bleeding disorders platelet abnormatilies gastrointestinal disorders that could interfere with fat absorption serum triglycerides > 500 mg/dL and/or total cholesterol > 300 mg/dL", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 21.0-999.0, All Head and Neck Neoplasms We plan to recruit all patients (controls, precursors, and invasive cancers) at the aforementioned two hospitals. Doctors at these hospitals conduct routine visual and tactile examination as part of Taiwan s national oral cancer screening program. For this screening program, all individuals aged 21 years or older who chew betel-quid or smoke are screened through visual inspection for the presence of precursor lesions or cancer The following individuals will be excluded from the study: subjects younger than 21 years, individuals with a history of cancer, and mentally incompetent individuals", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-35.0, All Fatigue healthy, 18 to 35 year old man or woman smoker pregnancy taking part in other research followed a weight loss diet in the previous 6 months history of gastrointestinal, endocrine, cardiovascular disease or diabetes neurological or psychiatric condition that may cause cognitive dysfunction", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Adenocarcinoma Histologically proven adenocarcinoma of the gastro-oesophageal junction Age 18 years or older International Union Against Cancer (UICC) T2-4 N0-2 M0, potentially resectable disease treated by the CROSS regimen WHO 0-2 Thoracic adenocarcinoma/squamous cell carcinoma Palliative treatment for the oesophageal cancer", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-65.0, All Obesity, Morbid Age more than 18 years and less than 65 years BMI more than 40 kg/m2 or more than 35 kg/m2 with comorbidities likely to improve after weight loss Morbid obesity established at least five years Continued failures to adequately supervised conservative treatments Absence of endocrine disorders that are due to morbid obesity Psychological stability No alcohol or drug abuse Absence of major psychiatric disorders (schizophrenia, psychosis), mental retardation, eating disorders (bulimia nervosa) Ability to understand the mechanisms to lose weight with surgery and understand that not always achieved good results Understand that the goal of surgery is to achieve the ideal weight No acceptance Age less than 18 years or more than 65 years Previous bariatric surgery Previous gastric surgery Inflammatory bowel disease", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-75.0, All Cigarette Smoking Male or female cigarette smokers, 18-75 years Smoked an average of less than 10 cigarettes per day during past month A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Only one subject per household may participate Pregnancy", "label": "2"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Oropharyngeal Dysphagia (OPD) Dysphagia Profound oropharyngeal feeding tube dependent dysphagia of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study Must be receiving 100% of nutritional requirements by enterogastric tube years of age and older, acceptable forms of documentation for verification of age birth certificate, passport, and/or driver's license Diminished upper esophageal sphincter opening defined as less than .55 cm for individuals under 65 years of age and less than .40 cm for individuals over 65 years of age on fluoroscopic swallow study Failure of > 3 months of dysphagia therapy within 3 months of study enrollment No documented history of noncompliance with feeding recommendations Cognition that is within normal limits, as evidenced by an Abbreviated Mental Test Score (AMTS) score greater than 6 Manual dexterity that is within normal limits for age, sex, and hand, as evaluated by a Block and Box Test (BBT) Physical strength to pull the SED forward, as evidenced by the ability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations and a normal Abbreviated Mental Test Score Profound oropharyngeal feeding tube dependent dysphagia < 12 months duration Esophageal phase dysphagia as defined as personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, erosive peptic esophagitis, and/or systemic disease affecting the esophagus Able to safely consume any food or liquid by mouth, as documented by fluoroscopic swallow study Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals under 65 years of age and greater than .40 cm for individuals over 65 years of age on fluoroscopic swallow study Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 60 years of age) years of age and younger, acceptable forms of documentation for verification of age birth certificate, passport, and/or license Success full receipt of dysphagia therapy or < 3 months of dysphagia therapy within 3 months of study enrollment Lack of manual dexterity to operate swallowing expansion device as determined by a Block and Box Test (BBT) score below the normal limits per age, sex, and hand Inability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds Lack of cognitive ability to operate swallowing expansion device or provide informed consent as evidenced by an Abbreviated Mental Test Score (AMTS) score less than 6", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-65.0, All Wound Infection Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer Age > 65 years, < 18 years Thyroid tumor with Grave's disease Thyroid tumor size over 5 cm Second or more than 2 times for thyroid surgery Non-traditional pathway for thyroid surgery ASA > II Pharyngitis Smoking, alcohol drinking history Contraindication or long term use of dexamethasone (allege, ulcer bleeding history, et al)", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 21.0-95.0, All Stroke clinical diagnosis of unilateral ischemic strokes by attending physician (according to the National Institute of Health Stroke Scale (NIHSS)) within 6 months of acute stroke diagnosis a score of 3 or higher on the Penetration-Aspiration scale OR a score of 2 on the Residue scale at any location (oral cavity, valleculae, or pharynx) that is instrumentally documented by a participating SLP during a standardized videofluoroscopic swallowing study between the ages of 21 and 95 ability to perform the strengthening protocol independently or with the assistance of a caregiver physician approval of medical stability to participate decision-making capacity to provide informed consent (confirmed through discussion with the subject's primary physician) phone access ability to return to the clinic for required follow-up appointments degenerative neuromuscular disease prior or current diagnosis of bilateral or hemorrhagic stroke prior surgery to the head and neck region that would affect muscles involved in swallowing history of radiotherapy or chemotherapy to the head and neck patient unable to complete the exercise program taking medications that depress the central nervous system allergy to barium (used in videofluoroscopic swallowing assessment) currently pregnant", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Deglutition Disorders all adult ICU patients post mechanical ventilation (observational analysis) patients prone to die / moribund patients/ or dying patients patients post oesophageal resection / with oesophageal rupture", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 70.0-85.0, All Esophageal Cancer Pathologically confirmed esophageal carcinoma Stage I\uff5eIva By EUS and CT/MRI, without contraindication for radical radiotherapy Aged \u2265 70 and < 85 years, behavioral status evaluation ECOG scores 0-2 In 7 days after being screened, subjects should follow the status: WBC \u2265 3.0 x 10^9/L; ANC \u2265 1.5x 10^9/L; PLT \u2265 80 x 10^9/L; Hb \u2265 90 g/L; serum Cr \u2264 ULN; serum bilirubin \u2264 1.5 ULN; ALT/AST \u2264 1.5 ULN Subjects should sign for the informed consent Subjects should perform good compliance Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy Complete obstruction of the esophagus, or patients who have the potential to develop perforation Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival \u22652 years Patients who have multiple foci esophageal carcinomas Patients who are/were given any other medicine tests currently/in last 4 weeks Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines Patients who have complications as following (1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Sore Throat Post-Operative Sore Throat Men and women ages 18 and older American Society of Anesthesiologists physical status classification system I and II (healthy patient or patient with mild systemic disease) Patient coming for elective surgery (except head and neck) requiring general anesthesia Patients staying for at least 24 hours postoperatively Patients provide informed consent Patients presenting for surgery >1 hour in length and <6 hours History of preoperative sore throat, common colds, upper respiratory infections, immune deficiencies Chronic smokers Patients with Mallampati airway grade of more than 2 Patients requiring more than one attempt for intubation or traumatic intubations Patients requiring laryngeal mask Airway (LMA) placement Patients allergic to zinc Patients requiring quinolones or tetracycline antibiotics pre or intraoperatively Patients undergoing head and neck surgeries Pregnancy", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All HER2 Negative Gastric Cancer Patients \u2265 18 years histologically confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction ECOG (Eastern Cooperative Oncology Group) performance status 0-2 adequate renal, hepatic, and hematologic function measurable or nonmeasurable disease according to the Response Evaluation in Solid Tumors (RECIST). Patients with intraoperatively confirmed intraperitoneal metastases but without detectable disease in radiological studies were also eligible HER2 positive tumors defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+ previous chemotherapy for metastatic or locally advanced disease surgery <3 weeks before the onset of the study treatment congestive heart failure significant dysphagia that would preclude oral administration of capecitabine concurrent malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer) clinical evidence of brain metastases", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-50.0, All Obesity Appetite Ability and willingness to come with their twin to the University of Washington (Seattle) Additional for Aim 1 random sample only: Member of randomly selected MZ pair or Additional for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2 Additional for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant \u2265 5 kg/m^2 History of weight loss surgery or active participation in weight loss program Major medical problem (e.g., diabetes, cancer) Current use of weight loss medications or other medications known to alter appetite Pregnancy or menopause MRI contraindication (i.e., implanted metal, claustrophobia) Lifetime eating disorder Current smoking Current heavy alcohol use (\u22652 drinks per day for females and \u2265 3 drinks per day for males) Self-reported weight >330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not subject from participating in other study procedures BMI < 18.5 or > 45 kg/m^2", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 20.0-80.0, All Postoperative Sore Throat patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation history of gastroesophageal reflux disease (GERD) congenital or acquired abnormalities of the upper airway such as tumour, polyp, trauma, abscess, inflammation, infection, or foreign bodies previous airway surgery; increased risk of aspiration coagulation disorders previous history of difficult intubation or conditions with expected difficult airway including Mallampati classification \u2265 3 or thyromental distance < 6.5 cm planned another type of intubation devices such as lighted stylet or fiberoptic bronchoscopy symptoms of sore throat or upper respiratory tract infection expected to place nasogastric tube during perioperative period requiring nasotracheal intubation", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Smoking Outpatients aged 18 years or above Smoke on at least 1 day in the past 30 days Chinese residents able to communicate in Chinese (Mandarin or Cantonese) Has a telephone Smokers currently receiving smoking cessation interventions Smokers currently enrolled in other smoking cessation trials Smokers who need special care on quitting and are not suitable for AWARD intervention (determined by his/her doctor) Smokers with communication difficulties (physical or cognitive condition)", "label": "0"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Adenocarcinoma (UICC TNM7) Adenocarcinoma of the Esophagogastric Junction Histologically proven adenocarcinoma of the esophagus according to the Union internationale contre le cancer (UICC) TNM7 definition. Both tumors of the esophagus and tumors of which the epicentre is within 5 cm of the esophagogastric junction and also extend into the esophagus are eligible for into the trial in case of adenocarcinomatous histology. Translated to Siewerts Classification of esophagogastric adenocarcinoma all Type AEG 1 are eligible. Type AEG 2 and Type AEG 3 are eligible in case of tumorous esophageal infiltration Pre-treatment stage cT1N+ M0 or cT2-4a N0/N+, M0 (In case of pre-treatment stage cT4a curative resectability has to be explicitly verified by the local surgical investigator prior to randomisation) Age \u2265 18 years No prior abdominal or thoracic radiotherapy ECOG Performance status 0-2 Adequate cardiac function. Patients with a cardiac history should have a cardiology review and should have a left ventricular ejection fraction > 50% (as determined by echocardiography) Adequate respiratory function (pulmonary function tests completed with FEV1 > 1.5L) Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l) Adequate renal function (GFR>60ml/min) and Adequate liver function (Total bilirubin <1.5x Upper level of Normal (ULN); AST <2.5x ULN and ALT <3x ULN Patients with tumors of squamous, adenosquamous or other non-adenocarcinoma histology Patients with advanced inoperable or metastatic esophageal adenocarcinoma Esophageal adenocarcinoma cT1N0 and cT4b Esophageal adenocarcinoma cT4a evaluated as not curatively resectable by the local surgical investigator Gastric carcinoma (according to UICC TNM7) Prior chemotherapy for gastrointestinal cancer Clinically-significant (active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months) Clinically-significant lung disease (FEV1 <1,5l) Peripheral neuropathy Grade >1 Pregnant and lactating women, or patients of reproductive potential who are not using effective birth control methods. If barrier contraceptives are used, they must be continued throughout the study by both sexes", "label": "1"} +{"topic": "A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds.", "doc": "eligible ages (years): 18.0-75.0, All Esophageal pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis with the measureable lesion of the newly diagnosed the esophageal carcinoma age 18-75 years old ECOG\u22642 Expect survival date \u22653 months without serious diseases of important organs signature in the inform consent pregnant or breast-feeding women or using a prohibited contraceptive method with psychiatric diseases with serious diseases or uncontrolled infection with history of other tumors participation other clinical trials within 1 month prior to in the trial not the first antitumor treatment ", "label": "1"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 13.0-999.0, All HIV Infections Patients may be eligible for this study if they Are 13 years of age or older (consent of parent or guardian required if under the age of 18) Are HIV-positive Have either: (1) no previous experience with anti-HIV treatment (defined as no previous protease inhibitor or nonnucleoside reverse transcriptase inhibitor use, 1 week or less of lamivudine use, and 4 weeks or less of cumulative nucleoside reverse transcriptase inhibitor use) or (2) current or previous enrollment in a qualifying CPCRA study ", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Brain and Central Nervous System Tumors Histologically or cytologically confirmed glioblastoma multiforme Some oligodendroglial elements allowed provided they make up < 25% of the tumor Recurrent disease documented by MRI after prior radiotherapy At least 1 bidimensionally measurable target lesion \u2265 2 cm by MRI Undergone prior surgery for recurrent primary brain tumor more than 3 months before study entry Must have a clearly limited target lesion \u2265 2 cm OR evidence of progressive and measurable target lesion OR a second measurable target lesion outside the surgical area Age Over 18 Performance status Karnofsky 70-100% ", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 10.0-999.0, All Anemia, Sickle Cell Each subject must meet all of the following during the screening process in order to participate in the study Patient must have a diagnosis of SCD (known SS, S-Beta-thalassemia or other hemoglobinopathies causing sickle cell disease). Patients with disease due to Hgb SC are not permitted Must present to the ED/EC or other appropriate unit in VOC Greater than or equal to 10 years old Written informed consent/assent has been obtained Subjects meeting any of the following during baseline evaluation will be excluded from entry into the study Exposure to therapeutic nitric oxide within the past 12 hours Patient has received sildenafil or other phosphodiesterase 5 inhibitors, therapeutic L-arginine, nitroprusside or nitroglycerine within the past 12 hours Patient has received previous ED/EC or other appropriate unit treatment for a vaso-occlusive crisis less than 48 hours or hospitalization less than 14 days ago (patients transferred directly from another ED or clinic may be enrolled) Patient has visited the ED/EC or other appropriate unit greater than 10 times in the past year having a vaso-occlusive crisis Patients presenting with clinically diagnosed bacterial infection (e.g., osteomyelitis, pneumonia, sepsis or meningitis) Patients who are currently enrolled in any other investigational drug study except for hydroxyurea studies Pregnant women (urine HCG + )/ nursing mothers Patients who have received an exchange transfusion (not simple transfusion) in the last 30 days or are on a chronic simple or exchange transfusion program Suspected splenic sequestration", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Candidiasis Non-pregnant subjects >/= 18 years of age; admission to the ICU during the preceding 3 days (minimum of 2 days in ICU) and expected to stay in the ICU a minimum of 2 additional days; subjects must have at least 1 of the following: received at least one other dose of any systemic antibiotic on any one of the ICU days before study entry and continue to receive antibiotics at the time of enrollment, and/or presence of a central venous catheter at the time of enrollment and for one additional day during the current ICU stay, and at least 2 of the following: use of total parenteral nutrition on any of Days 1-4 of ICU stay; any type of dialysis on any of Days 1-4 of ICU stay; any in-patient surgery done under general anesthesia or epidural block in the 7 days prior to or on ICU admission*; pancreatitis (documented by computed tomography (CT) scan or lipase >1,000 u/L) in the 7 days prior to or on ICU admission; more than 1 dose of systemic steroids (prednisone equivalent dose >/=20 mg per dose) in the 7 days prior to or on ICU admission; and/or use of more than 1 dose of other systemic immunosuppressive agents (such as azathioprine, tacrolimus, sirolimus, mycophenolate, monoclonal antibodies, and tumor necrosis factor [TNF] immunomodulators) in the 7 days prior to or on ICU admission Excludes placement of vascular catheters Subjects with an allergy or intolerance to caspofungin or other echinocandin analog; absolute neutrophil count <500/mm3 at entry or likely to develop such a count during therapy; diagnosis of HIV, aplastic anemia, or chronic granulomatous disease; moderate or severe hepatic insufficiency as defined by a Child Pugh score of 7 or greater or cirrhosis due to any cause; pregnancy or breastfeeding; subjects unlikely to survive more than 2 days; subjects who have received systemic antifungal therapy within 7 days prior to study entry; subjects with documented active, proven, or probable invasive fungal infection within 7 days prior to study entry; subjects previously enrolled into this trial; subjects currently receiving another investigational agent or who have received an investigational agent within the 7 days prior to study entry; subjects in the ICU 5 or more days prior to enrollment into this study ", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-999.0, All HIV Infections Presently participating, previously participated in, or has given informed consent for participation in a qualifying CPCRA clinical trial Signed informed consent ", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-35.0, All Respiratory Tract Infections Chronic Bronchitis Pneumonia Subjects meeting all of the following will be considered for enrollment into the study Male and female adult outpatient subjects diagnosed with AECB or CAP Female subjects must be either postmenopausal for \u2265 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow \u2264 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the for acceptable birth control Informed consent must be obtained in writing for all subjects upon enrollment Subjects will have a diagnosis of AECB or CAP, as defined below AECB-Specific Subjects greater than or equal to 35 years of age Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70% Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume Subjects producing spontaneous sputum Subjects presenting with any of the following will not be included in the study Subjects with a known history of congenital long-QTc syndrome Subjects who are pregnant or breast-feeding Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax) Subjects who have previously participated in this study Subjects with a previous history of myasthenia gravis Subjects with current acute respiratory failure or subjects who require aggressive airway management Hospitalized subjects and subjects from institutional care facilities", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 1.0-5.0, All Tick-borne Encephalitis Male and female children will be eligible for participation in this study if they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old they are clinically healthy their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent their legal representative agrees to keep a Volunteer Diary Children will be excluded from participation in this study if they have a history of any previous TBE vaccination have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10) have a history of allergic reactions, in particular to one of the components of the vaccine have received antipyretics within 4 hours prior to the first TBE vaccination suffer from a disease that cannot be effectively treated or stabilized suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions suffer from chronic, degenerative and / or inflammatory disease of the central nervous system are known to be HIV positive (a special HIV test is not required for the purpose of the study) suffer from a febrile illness at study entry", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 6.0-15.0, All Tick-borne Encephalitis Male and female children will be eligible for participation in this study if they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday) they are clinically healthy their legal representative and if older than 8 years the volunteer understands the nature of the study, agrees to its provisions and gives written informed consent their legal representative agrees to keep a Volunteer Diary For safety reasons female volunteers capable of bearing children have to fulfill the following at study start negative pregnancy test at study start they agree to employ adequate birth control measures for the duration of the study Children will be excluded from participation in this study if they have a history of any previous TBE vaccination have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10) have a history of allergic reactions, in particular to one of the components of the vaccine have received antipyretics within 4 hours prior to the first TBE vaccination suffer from a disease that cannot be effectively treated or stabilized suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions suffer from chronic, degenerative and / or inflammatory disease of the central nervous system are known to be HIV positive (a special HIV test is not required for the purpose of the study) suffer from a febrile illness at study entry", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 16.0-65.0, All Encephalitis, Tick-borne Male and female volunteers were eligible for participation in this study if they Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old Were clinically healthy Had a negative pregnancy test at the first medical examination, if female and capable of bearing children Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children Provided written informed consent For volunteers under 18 years of age written informed consent of the parents / guardian was available Agreed to keep a volunteer diary History of any previous TBE vaccination History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml) History of allergic reactions, in particular to one of the components of the vaccine Previously received volume substitution with a product containing polygeline (stabilizer in Received antipyretics within 4 hours prior to the first TBE vaccination Suffer from a disease that cannot be effectively treated or stabilized Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics) Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 1.0-15.0, All Tick-borne Encephalitis Male and female children and adolescents will be eligible for participation in this study if they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday) they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial) their parents/legal guardians understand the nature of the study and agree to its provisions written informed consent is available from both parents/legal guardians for Germany/Austria: additional written informed consent is available for children older than 8 years they or their parents/legal guardians agree to keep a volunteer diary For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional negative pregnancy test at study entry Children and adolescents will be excluded from participation in this study if they have a history of any TBE vaccination have a history of TBE infection have a history of allergic reactions to one of the components of the vaccine suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions are known to be HIV positive (a special HIV test is not required for the purpose of the study) have received banked blood or immunoglobulins within one month of study entry have a history of vaccination against yellow fever and/or Japanese B-encephalitis suffer from hemorrhagic diathesis are participating simultaneously in another clinical trial", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 3.0-18.0, All Encephalitis, Tick-Borne Participated in Baxter study 209 and They and/or their parents / legal guardians understand the nature of the study and agree to its provisions Written informed consent is available from the parents / legal guardians according to national law Written informed assent is available from the child/adolescent according to age and capacity of understanding They received the third vaccination with FSME-IMMUN 0.25 ml during the course of Baxter study 209 Blood was drawn after their third vaccination during the course of Baxter study 209 They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >=10 after the third vaccination in Baxter study 209 They or their parents / legal guardians agree to keep a Subject Diary Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml Have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml Received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable) Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies) Subjects will not be eligible for booster vaccination if they Do not meet the / Are not clinically healthy, (i.e. the physician would have reservations vaccinating with a TBE vaccine outside the scope of a clinical trial) Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 17.0-66.0, All Encephalitis, Tick-borne Male and female subjects who received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225 understand the nature of the study, agree to its provisions and provide written informed consent are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the clinical trial) have a negative pregnancy test result at the first medical examination (if female and capable of bearing children) agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children) agree to keep a Subject Diary Subjects who have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225 have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis) have had an allergic reaction to one of the components of the vaccine since participation in Study 225 suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) that can be expected to influence immunological functions have a known or suspected problem with drug or alcohol abuse (>4 liters wine/week or equivalent doses of other alcoholic beverages) have donated blood or plasma within 30 days of study entry have received a blood transfusion or immunoglobulins within 30 days of study entry are known to be HIV positive (an HIV test is not required specifically for this study) are simultaneously participating in another clinical trial including administration of an investigational product", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 7.0-11.0, All Encephalitis, Tick-borne Male and female children who participated in Study 146A if they and/or their parents/legal guardians understand the nature of the study and agree to its provisions written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A Subjects who received any further TBE vaccination since their first TBE booster vaccination Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-999.0, All Relapsing Fever, Tick-Borne Jarisch Herxheimer Reaction suspected exposure to tick-borne relapsing fever after returning from field exercise in a tick-borne relapsing fever infected area having a tick bite or staying in field in close proximity to a subject with tick bite sign known sensitivity to tetracycline or doxycycline febrile illness on recruitment", "label": "1"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 1.0-10.0, All Encephalitis, Tick-Borne Healthy male and female children, 1 to 10 years of age Subjects with documented evidence of TBE Subjects, who have been previously vaccinated against TBE", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 13.0-999.0, All HIV Infections Coenrollment in the SMART study Parent or guardian willing to provide informed consent, if applicable ", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 13.0-999.0, All HIV Infections Coenrollment in the SMART study Parent or guardian willing to provide informed consent, if applicable ", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infections Coenrollment in the SMART study Unable to comply with all study requirements", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.167-4.917, All Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site)", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 16.0-999.0, All Encephalitis, Tick-Borne Male and female subjects will be eligible for participation in this study if they Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age) Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age) Are aged >= 16 years (from the 16th birthday) at screening Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial) Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children) Agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children) Agree to keep a Subject Diary Subjects will be excluded from participation in this study if they Have a history of any previous tick-borne encephalitis (TBE) vaccination Have a history of TBE infection Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) Have a history of allergic reactions, in particular to one of the components of the vaccine Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Have donated blood or plasma within 30 days of study entry Have received a blood transfusion or immunoglobulins within 30 days of study entry Are known to be HIV positive (an HIV test is not required specifically for the purpose of this study)", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-55.0, All Typhoid Fever Healthy Males or Females aged 18 to 55 years, inclusive Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Encephalitis, Tick-Borne Subjects who participated in Study 223 will be eligible for participation in this study if they understand the nature of the study, agree to its provisions and provide written informed consent they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223 blood was drawn after their first booster vaccination in Study 223 Subjects will be excluded from participation in this study if they received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Subjects will not be eligible for booster vaccination if they are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial) suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination) have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.75-3.0, All Cryptosporidiosis Male and female children aged 9-36 months at the time of enrollment Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; >14 days duration for persistent diarrhea) Child's parent/guardian speaks English or Luganda Parent/guardian provides full and free informed consent for child to participate in study Unknown age Known cardiac, CNS, metabolic or endocrine disorders Moribund children Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.5-5.0, All Pneumonia Malaria Age between 6 months and 5 years Present with history of fever or reported fever Present with cough or difficult breathing Age below 6 months and above 5 years Presence of signs and symptoms of severe illness", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-45.0, All Dengue Fever Dengue Hemorrhagic Fever Dengue Virus Healthy, as determined by medical history, clinical examination, and biological safety parameters Aged 18 to 45 years on the day of inclusion Provision of informed consent signed by the subject or another legally acceptable representative For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination Able to attend all scheduled visits and to comply with all trial procedures Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test Breast-feeding woman Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids are allowed Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 35.0-72.0, All Irritable Bowel Syndrome Small Intestinal Bacterial Overgrowth Men and women age 32-75 years Rome III for diarrhea-predominant IBS Symptom onset after an apparent episode of acute gastroenteritis Symptoms of > 3 months duration Normal endoscopic appearance of the colonic mucosa Negative markers for celiac disease and inflammatory bowel disease Normal thyroid function and serum calcium levels Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991) Clinically significant cardiac, pulmonary, hepatic or renal dysfunction History of/or presence of systemic malignancy Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis) Current effects of drug or alcohol abuse Investigator perception of patients inability to comply with study protocol Unstable psychiatric disease Recent change in gastrointestinal medications Subjects with a positive pregnancy test Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-70.0, All Yellow Fever Able to understand and give informed consent Age 18-45 years or greater than or equal to 55 years If possible, participants agree not to take any vaccines within 30 days before or 30 days after yellow fever vaccination Women of child bearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to vaccination Travel to or having lived in a country/area which is endemic for yellow fever History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, Japanese encephalitis vaccination or infection Any history of allergy to eggs, chicken or gelatin or to any previous vaccine A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study History of HIV infection, Hepatitis B or Hepatitis C infection History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal diseases and uncontrolled hypertension). Use of systemic immunosuppressive medications (ex, prednisone) for 2 weeks or more in the past 3 months History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of autoimmune disorder Recipient of a blood products or immune globulin product within 42 days of the vaccination visit Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 1.0-45.0, All Respiratory Sounds Patient and/or parents/guardian signed informed consent Patients with cough or shortness of breath Chest tubes Skin lesions precluding attachment of sensors Respiratory distress Pregnant women", "label": "2"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-45.0, All Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases Healthy as determined by medical history, clinical examination, and biological safety parameters Aged 18 to 45 years on the day of inclusion Informed consent form signed Able to attend all scheduled visits and to comply with all trial procedures For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination History of thymic diseases or thymectomy For a woman of child-bearing potential, known or suspected pregnancy or positive pregnancy test Breast-feeding Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Human Immunodeficiency Virus (HIV), Hepatitis B (HBs Ag) or Hepatitis C (HC) seropositivity in blood sample taken at screening Laboratory abnormalities considered clinically significant upon the Investigator's judgment or above the intensity thresholds (defined in the protocol) in blood sample taken at screening Participation in another clinical trial in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Previous residence in or travel of more than 2 weeks to areas with high dengue infection endemicity", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 1.0-11.0, All Encephalitis, Tick-Borne Male and female children will be eligible for participation in this study if they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening their parents / legal guardians provide written informed consent children provide written assent to the study according to age and capacity of understanding their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits) they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study) provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children) Subjects will be excluded from participation if they have a history of any previous TBE vaccination they have a history of TBE infection they have a history of infection with other flaviviruses they have a history of vaccination against yellow fever and/or Japanese B encephalitis they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines they are suffering from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions they have received any blood product or immunoglobulins within 90 days prior to study entry they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not required specifically for the purpose of this study) they have a functional or surgical asplenia", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.167-4.917, All Acute Respiratory Infections Pneumonia Children aged 2 to 59 months attending the outpatient's clinics of participating sites WHO defined non-severe pneumonia Accessibility for follow-up Written informed consent by a parent or legal guardian WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following Cyanosis Inability to drink Convulsions Abnormally sleepy or difficult to wake Severe malnutrition recognised by weight for age less than third percentile by the NCHS (National Child Health Statistics) growth chart and/or oedema (see chart) All patients with a previous history of 3 or more episodes of wheeze or diagnosed to have asthma Known or clinically recognisable congenital heart disease with cyanosis or, congestive heart failure or cardiomegaly Known or clinically recognisable acute/chronic organ system disorders including jaundice, nephrotic syndrome, severe anaemia manifested as extreme pallor etc Other infectious conditions requiring antibiotic therapy at the day of contact including meningitis, tuberculosis, dysentery, osteomyelitis, septic arthritis etc", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-999.0, All Encephalitis, Tick-Borne Subjects who participated in precursor Study 700401 and meet ALL of the following are eligible for participation in this study Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law) Subject provides written assent to the study according to age and capacity of understanding Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401 Blood was drawn after the first booster vaccination in precursor Study 700401 Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary) Subjects who participated in precursor Study 700401 and meet ANY of the following are not eligible for participation in this study Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401 Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401 Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study) Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable) Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages) Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 1.0-12.0, All Pneumonia Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours) Severely ill patients (hospitalized in intensive care units) Pleural effusion treated with chest drainage Atelectasis detected by x-ray Pneumonia or pleural effusion in the previous six months Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency", "label": "2"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Fever Analgesia Age greater than or equal to 18 years Written informed consent by the patients Medical condition necessitating the administration of antipyretic or analgesic medications \u0391ge lower than 18 years Lack of informed consent History of liver cirrhosis Blood creatinine greater than 3mg/dl Blood AST greater than 3 times the upper normal level according to the lab of the participating hospital History of hypersensitivity to non-steroidal ant-inflammatory drugs History of abuse of analgesics Pregnancy or lactation Fulminant hemorrhage of the upper or lower digestive tract Thrombocytopenia defined as less than 50000 platelets/\u03bcl", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Respiratory Tract Infection Adults, equal to or more than 18 years years of age Patients with respiratory tract infections, including any of the following Acute tracheitis, acute tracheobronchitis Acute sinusitis Chronic sinusitis Acute tonsillopharyngitis Acute bronchitis Mild community-acquired pneumonia Acute exacerbation of chronic bronchitis Known hypersensitivity to or previously intolerant of macrolides Illness severe enough to warrant hospitalization or parenteral therapy Concomitant use of any of the following medications Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir Severe immunodeficiency and chronic disease conditions Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm) Mental condition rendering the subject unable to understand the nature of the study", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 55.0-999.0, All Diarrhoea Clostridium Difficile Male/female patients, above 55 years of age Patient has given written informed consent/Assent to take part in the study Patients are receiving antibiotics as inpatients Patients prescribed therapy with single or multiple antibiotics (oral or IV) will be included Antibiotic therapy must be indicated for a minimum of 72 hours Patients must be able to take medication orally in the study is approved by the admitting consultant and validated by a member of the trial team within 48 hours Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness Subjects with allergy or hypersensitivity to any component of the study product (e.g.: allergy or hypersensitivity to milk proteins) Subjects who had any surgery or intervention in the last 4 weeks Subjects enrolled in another clinical study in the last 4 weeks Subjects who are thought not to comply with the clinical study Subjects presenting with a severe evolving or active pathology or infection of the gastrointestinal tract such as inflammatory bowel disease, Crohn's disease or ulcerative colitis, diverticular disease or liver cirrhosis Any condition affecting the pancreas including acute and chronic pancreatitis Patients who had a surgical operation in their bowels in the preceding 3 months A medical condition such that the life expectancy of the patient is predicted at less than 3 months by the admitting consultant and validated by a member of the trial team Immune-suppressed patients (e.g. HIV) Steroid use of Prednisolone greater than 10mg a day (or equivalent of Dexamethasone) for over 2 weeks prior to entering the trial Patients on Cytotoxic drugs Post-transplant patients Any clinical condition affecting the pancreas including acute and chronic pancreatitis Patients with prosthetic heart valves or a history of endocarditis. Patients who have taken probiotic drinks containing live organisms or over the counter probiotic preparations in the past seven days (see Appendix 10) Foreign travel in the last 7 days", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-999.0, All Increased Drug Resistance Infectious Diseases Clinic practices within Denver Health's Webb Center for Primary Care Clinic practices within the University of Colorado Anschutz Campus: General Internal Medicine Clinic Clinic practices within the High Plains Network, and Clinical practices within the Wilmington Health Associates System The antibiotic prescribing patterns of primary care clinicians in these practices will be monitored over a 2 year period. Practices must be willing to assist in tracking Patient records (pediatric and adult) for conditions related to the International Classification of Diseases (ICD-9) codes associated with common infectious conditions (Upper Respiratory Infection, Acute Bronchitis, Pharyngitis, Acute Sinusitis, Otitis Media, Acute Cystitis, Cellulitis or soft tissue abscess, and Community-acquired Pneumonia) will be assessed for antibiotic prescribing 30-day events (hospitalizations Note: Emergency Department (ED) visits, or grade 3 or grade 4 abnormalities), will also be included in this study Ob/Gyn related clinic visits will not be included in this study as these visits are not typically associated with high volumes of antibiotic prescribing for the infectious conditions of interest", "label": "1"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-45.0, All Gastroenteritis Escherichia Coli Male or female ages 18-45, inclusive Provide written informed consent before initiation of any study procedures Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, and medication history Within 45 days of vaccination, have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), prothrombin time (PT), partial thromboplastin time (PTT), International Normalized Ratio (INR), C-reactive protein (CRP), and fibrinogen as defined in Appendix B Have normal screening laboratories for urine protein and urine glucose Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 70 percent) Capable of understanding, consenting and complying with the entire study protocol including the inpatient period Female subjects must be of non-childbearing potential, (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control (e.g., history of hysterectomy or tubal ligation; use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), cervical sponges, diaphragms, condoms with spermicidal agents, or must have a vasectomized partner) within 2 months of vaccination and must agree to continue such precautions during the study and for 30 days after the Day 28 study visit. Male subjects must agree not to father a child for 90 days after the Day 0 study visit. A woman is eligible if she is monogamous with a vasectomized male Agrees not to participate in another clinical trial during the study period Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test upon admission to inpatient facility Abnormal Vital signs, defined as Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or (heart rate <55 at rest on 2 separate days) Respiratory rate >17 Temperature >/= 38.0 C (100.4 F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of administration of dmLT Active positive Hepatitis B, C, and Human Immunodeficiency Virus (HIV) serologies Have a positive urine drug screen Subjects who are unwilling or unable to cease smoking for the duration of the inpatient stay History of antimicrobial treatment in the 2 weeks before ingestion of dmLT Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholerae challenges; or previous infection with cholera or diarrheagenic E. coli Abnormal bowel habits as defined by fewer than 3 stools per week or more than 2 stools per day in the past 6 months", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.231-999.0, All Rotavirus Gastroenteritis For cases A male or female child born after 6 March 2006 and at least 12 weeks of age Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period Onset of severe gastroenteritis \u2264 14 days prior to admission Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization Written informed consent obtained from the parent or guardian of the subject For controls Admitted for non-gastroenteritis causes at the same clinic/hospital as the case Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians Being born within + For cases Subject has previously participated as case or control in this study Onset of severe gastroenteritis > 48 hours after admission to the hospital (nosocomial infections) For controls For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B Child has participated in the past as a case or control in this study Child living in the same house as the case", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-5.0, All Rotaviral Gastroenteritis A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis Written informed consent obtained from the parent or guardian of the subject The diagnosis for treatment at the study site does not acute gastroenteritis The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-6.0, All Nosocomial Rotavirus Gastroenteritis Viral Gastroenteritis Due to Rotavirus A male or female child aged <6 years at the time of admission in hospital. A child will become ineligible on the day of her/his sixth birthday A subject who is hospitalized with any acute gastroenteritis or rotavirus gastroenteritis during the survey period Participants of any kind of rotavirus vaccine clinical trial", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 21.0-40.0, All Intestinal Permeability Challenge Test Intestinal Health Inflammation Healthy as assessed by the health and lifestyle questionnaire, (P9067 F02; in Dutch) physical examination results of the pre-study laboratory tests Males, Age >= 21 and <= 40 years at Day 01 of the study Body Mass Index (BMI) >= 20 and < 33 kg/m2. Preferably in high and low body fat mass ranges as to be determined by waist circumference Normal Dutch eating habits as assessed by P9067 F02 Voluntary participation Having given written informed consent Willing to comply with the study procedures, including the ETEC challenge Subjects with one or more of the following characteristics will be excluded from participation Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances Having a history of medical or surgical events that may significantly affect the study outcome, including gastrointestinal illness or surgical operations Use of antibiotics, immunosuppressive drugs, antacids, laxatives or anti-diarrhoeal drugs in the last 3 months before the study Alcohol consumption > 28 units/week for males Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening Reported slimming or medically prescribed diet Reported vegan, vegetarian or macrobiotic Not willing to be off working as a food handler, in child care or as a healthcare worker with direct patient contact during the week of ETEC contamination", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-5.0, All Infections, Rotavirus A male or female child aged < 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday A subject, who during the study period Is hospitalised for acute gastroenteritis Or Visits an emergency room for acute gastroenteritis Or Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation ", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.25-13.0, All Kerosene Pneumonitis Ingestion in the preceding 24 hours Presence of respiratory symptoms and/or signs at presentation Informed consent obtained from parent or legal guardian Resident within the Red Cross Hospital drainage area and able to come for two follow-up appointments Asymptomatic and no clinical signs Too ill to be excluded from receiving an antibiotic as judged by Requiring more than 2L/min nasal-prong oxygen Requiring continuous or intermittent positive airway pressure ventilation Fever > 40\u02daC Needing an antibiotic for another reason e.g. otitis media, tonsillitis Current antibiotic use, prior to kerosene ingestion Allergic to amoxicillin", "label": "1"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-999.0, All Diarrhea Accepting to participate and willing to deliver 2 stool samples With diarrhea: the first 10 children and 10 adults presenting each month at the health facility Without diarrhea: In Bissau matched controls drawn from the registration system at Bandim Health Project. In Finland controls selected at the health facilities participating Not willing or able to deliver the stool samples", "label": "1"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.5-6.0, All Fever male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree patients with a bad general heath state patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug moderated or severe dehydration conscience state alteration not capable of ingest oral drugs patients being treated with steroids patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Blastocystis Hominis Infections \u2265 18 years Gastrointestinal symptoms for more than 10 days B. hominis in any quantity in at least one stool specimen out of 3 examined No other pathogenic micro-organism identified Fever > 37.5\u00b0 bloody diarrhoea weight loss > 10% of usual body weight significant decrease of general condition oncological diseases immune deficiencies known chronic intestinal diseases use of anti-protozoan drugs in the last 2 weeks use of anti-coagulant treatment or antabuse pregnant and lactating women", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 4.0-21.0, All Sickle Cell Anemia Acute Chest Syndrome Hemoglobin SS, SC, SB0thal or SBthal Ages \u2265 4-21 years old Patients are admitted to the hematology oncology inpatient service and have been enrolled and consented in the study Meet clinical for ACS an infiltrate on Chest X-ray and one of the following Respiratory symptoms/signs (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline, tachypnea, cough, and increased work of breathing) Fever Chest pain AND Patients' eligible for a simple transfusion based on one of the following Hypoxemia (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline) Hemoglobin < 5 gm/dl Increased work of breathing Patient requires exchange transfusion within first 24 hours of admission Patient requires PCCU transfer within first 24 hours of admission Hemoglobin > 9gm/dl secondary to these patients requiring an exchange transfusion", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Signed and dated written informed consent Male or females \u2265 40 years of age Females must be post-menopausal or using a highly effective method for avoidance of pregnancy Established clinical history of COPD by ATS/ERS definition Post-albuterol spirometry FEV1/FVC ratio \u2264 0.70 and FEV1 \u226530 to \u2264 70% of predicted normal (NHANES III) Former or current smoker \u226510 pack years A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD) Previous stroke Current diagnosis of asthma Subjects with other respiratory disorders including \u03b11-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung volume reduction surgery within previous 12 months Clinically significant abnormalities not due to COPD by chest X-ray or CT scan Hospitalized for poorly controlled COPD within 12 weeks of Screening Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician Lower respiratory infection requiring antibiotics 6 weeks prior to Screening A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 40.0-75.0, All Lung Cancer ages 40-75 years If ages 40-59, then one of the following needs to be met Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR current or ex-smoker with > 25 pack years and COPD OR current or ex-smoker with a > 35 pack year history If ages 60-75, then one of the following additional needs to be met Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR Current or ex-smoker with >25 pack years and COPD OR Current or ex-smoker with a >30 pack year history Subject is able to return to Cleveland Clinic for annual follow-up screening Current health requires oxygen Have had a chest x-ray or CT of the chest within the last 6 months Previous pneumonectomy Lobectomy of the lung within the last 5 years Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer A medical condition that would prevent treatment for lung cancer Within the last 6 weeks, one of the following has occured A new cough or chronic cough that has gotten worse Either new shortness of breath, or any worsening of shortness of breath A cough producing blood", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Clostridium Difficile Infection Men / Women aged 18 and over (We will also those adults who lack mental capacity for whom we have a legal representative) Successful treatment of clinically diagnosed CDAD using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines) Woman of child bearing potential and not willing to use at least one highly effective contraceptive method throughout the study Male with spouse/partner of child bearing potential and not willing to use condoms Pregnant or breast feeding Unable to swallow tablets Life expectancy of <4 weeks Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of its excipients (Tablet core: Sodium starch glycolate type A, glycerol distearate, colloidal anhydrous, silica, talc and microcrystalline cellulose. Tablet coating: hypromellose, titanium dioxide (E171), disodium edentate, propylene glycol and red iron oxide E172) >5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed CDAD", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 1.0-10.0, All Pneumonia children aged 1-10 y presenting to the emergency department must fulfil definition of 'pneumonia', ie any one of fever in the ED a recorded fever at home in the 48h prior to presentation, or WBC > 12 or WBC < 5 in the ED any one of tachypnoea on exam cough on exam or by history increased work of breathing on exam; or or more episodes of emesis in the emergency history of CF, anatomic lung disease, bronchiectasis, congenital heart disease, repeated aspirations, malignancy, immune suppression, recent prolonged admission to hospital, pneumonia diagnosed within the last month, lung abscess within the past six months, > 24 hours of beta-lactam antibiotic therapy prior to presentation, allergy to penicillin, allergy to food colouring evidence of empyaema or necrotizing pneumonia on chest radiograph", "label": "2"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Infectious Keratitis Subjects must be 18 years of age or older Ability to provide written informed consent Likely to complete all study visits Subjects must have one eye that with a diagnosis of infectious keratitis A corneal perforation Descemetocele Pregnancy or breastfeeding Active Herpes corneal disease Patient is unwilling or unable to comply with a medication regimen and follow up appointments", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-45.0, All Gastroenteritis Escherichia Coli Male or female ages 18-45, inclusive Provide written informed consent before initiation of any study procedures General good health, without (a) significant medical illness, (b) clinically significant physical examination findings, including vitals, as determined by the PI, and (c) screening laboratory values outside the site's normal limits Within 46 days of vaccination, have normal screening laboratories, per Appendix B for white blood cells (WBCs), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST) Have normal screening laboratories for urine protein Trace protein is acceptable HgbA1C <6.5% at screening Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 70 percent) Agrees to complete all study visits and procedures Female subjects must be of non-childbearing potential (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential, must be using an effective method of birth control (e.g., use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], cervical sponges, diaphragms, condoms with spermicidal agents must have a vasectomized partner) within 2 months of vaccination, or practice abstinence and must agree to continue such precautions during the study and for 30 days after the Day 29 study visit. Male subjects must agree not to father a child for 30 days after the Day 29 study visit. A woman is eligible if she is monogamous with a vasectomized male Agrees not to participate in another clinical trial during the study period Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test upon admission to inpatient facility Abnormal vital signs, defined as Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or Palpated heart rate <55 or >100 beats/minute at rest on 2 separate days*; or *If heart rate between 45 and 55, subjects may be enrolled with an EKG that demonstrates normal sinus rhythm and does not document conduction disorders Temperature >/= 38.0 degrees C (100.4 degrees F) Symptoms of an acute self-limited illness, including a temperature >/= 38.0 degrees C (100.4 degrees F), such as an upper respiratory infection or gastroenteritis within 7 days of administration of dmLT Positive hepatitis C, or HIV serology or positive hepatitis B serology not consistent with prior hepatitis B immunization Have a positive urine drug screen for opiates Subjects who are unwilling or unable to cease smoking for the duration of the inpatient stay", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Community Acquired Pneumonia age \u2265 18 infiltrate on chest X-ray further cough or production of purulent sputum or pathologic lung auscultation (crackles) or fever hospital inpatient treatment within the last 28 days Immune suppressed patients", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Cough Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English", "label": "2"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.5-10.0, All Community-acquired Pneumonia Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric are met fever (>37.5 C axillary, > 37.7 C oral, or >38 C rectal) recorded in the ED or at home in the 48h prior to presentation any one of tachypnoea on exam (>60 bpm for age <1 y, >50 bpm for 1-2 y of age, >40 bpm for 2-4 y of age, and >30 bpm for >4 y of age) cough on exam or by history increased work of breathing on exam; or auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet criteria.) Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation > 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of > 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin < 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once", "label": "2"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-60.0, All Rheumatic Dermatologic Disorders Informed Consent as documented by signature Indication for yellow fever vaccination according to Swiss FOPH recommendations Individuals under low dose MTX (\u226420mg/week) therapy or healthy individuals Male and Female travelers \u226518 years to <60 years of age Contraindications on ethical grounds Women who are pregnant or breast feeding Contraindication against yellow fever vaccination (e.g. hypersensitivity against vaccine ingredient) Current treatment with other immunosuppressive agent apart from low dose methotrexate Alemtuzumab or rituximab in the last year TNF-blocking therapy in past three months Immunocompromising condition in healthy control Other immunocompromising condition than MTX treatment itself and the underlying disease in patients under MTX Previous yellow fever vaccination No indication for yellow fever vaccination according to Swiss travel vaccination recommendations", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Typhoid Fever Subjects are male or female aged \u2265 18 years at time of dosing Subjects are travelers attending travelers' vaccination clinics Subjects are eligible for typhoid vaccination, according to standard practice Subjects are expected to be able to provide follow-up information Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period) Subjects must sign a written informed consent Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs Subjects with an acute febrile illness Subjects with acute gastrointestinal (GI) illness Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment Subjects with other contraindications as determined by the site investigator", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-999.0, All Diarrhea Enteric Infection Soil-transmitted Helminth Infection Stunting Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years ", "label": "0"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 0.0-999.0, All Fever of Unknown Origin Tick-borne Diseases patients have fever more than one week temperature is higher than 38\u2103 Celsius degree full of physical examination and laboratory examination have been carried out after one week\uff0cbut still cannot make a definite diagnosis fever for non-infectious diseases such as rheumatic autoimmune disease or with tumor we find that the patient selected does not meet the selection within the observation period patients leave with automatic discharge", "label": "1"} +{"topic": "An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates.", "doc": "eligible ages (years): 18.0-999.0, All Travel Medicine Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada Travellers with an expected return date after September 1, 2016 Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 20.0-65.0, All Whiplash Injuries Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks ", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Disorders Criteria:Drivers admitted as result of motor vehicle accidents - Drivers aged < 18 years", "label": "2"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-44.0, All Alcohol Use Screen Positive for a drinking problem in the ED <18years or >44years old", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 30.0-60.0, All Chronic Pain age driving licence driving experience normal vision right-handed fluently Dutch speaking psychological or physical disorder drug or alcohol abuse psychotropic medication use excessive smoking, drinking", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-80.0, All Liver Cirrhosis Liver Disease Deceased donor livers allocated to adult (> 18 years of age) recipients at the research site Deceased donor livers allocated to recipients at centers other than the research site Deceased donor livers allocated to recipients < 18 years of age at the research site Non-heart beating donors Deceased liver and small intestine donors Live liver donors", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 21.0-75.0, All Acute Mountain Sickness age 21 Height greater than 6'2\", BMI greater than 45. Specified acute or chronic medical conditions -", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 15.0-16.0, All Behavioral Intervention Teens between the ages of 15 years 0 months and 16 years 6 months enrolled in a licensed driver education course are eligible to participate Adolescents over the age of 16 years 6 months or those whose parent or legal guardian does not attend the driver education course session to which they are specifically invited will be deemed ineligible for the study", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 7.0-55.0, All Learning Recruitment of teen participants will occur by arrangement with local driving schools in Montgomery County, VA Potential participants aged 16 or 17 who have held their driver's license for one month or less may be eligible Participants may be recruited during their training, and will only be eligible after they have met all requirements for licensure, and after both parental consent and teen assent are obtained If the teen wishes to participate, they must have their parent or legal guardian speak to the VTTI experimenter over the telephone for screening and then accompany the teen at an appointment so that the study can be explained and consent and assent provided Experienced adult drivers will be recruited via one-page recruitment fliers describing the study posted in the Blacksburg, VA area After an appointment is made, a telephone screening will occur using the Telephone Driver Screening and Demographic Questionnaire to assess age, sex, medical and driving history ", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 15.0-45.0, All Post Partum Haemorrhage For maternity units All maternity units belonging to one of the six perinatal networks of the study are eligible For women All women delivering at a gestational age greater than 22 weeks, in one of the participating maternity unit during the study period, will be eligible ", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Visual Acuity Visual Disturbance Intraocular Pressure Male, aged 18 or older Scheduled for Robotic Prostatectomy Surgery ASA Classification of I, II, or III Good comprehension of written and spoken english Allergy to Tetracaine or related anesthetics Glaucoma Asthma History of heart electrical problems", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-60.0, All Vasomotor Rhinitis (cases; n = 14 total; 10 with predominantly \"physical\" and 4 with predominantly \"irritant\"triggers) A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to Changes in temperature and/or humidity predominantly (\"physical triggers\"; n = 10); or Two or more nonspecific irritant triggers predominantly, including: perfumes or colognes,cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, etc. (\"irritant triggers\";n = 4). This history shall be of at least two years' duration (controls; n = 10) A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to one or more nonallergic triggers, including: perfumes or colognes, cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, changes in temperature and/or humidity (all subjects; n = 24) A prior history of allergic disease (allergic rhinitis, asthma, angioedema, anaphylaxis) Significant skin test reactivity to one or more substances in a panel of 24 locally relevant seasonal and perennial aeroallergens Negative wheal response to positive control (histamine) on skin test panel Abnormalities on a screening x-ray (Waters view) of the paranasal sinuses Cigarette smoking (active, within previous 6 months or cumulative history of >20 pack years) Chronic cardiopulmonary diseases (asthma, COPD, coronary artery disease\u2026) Continuous therapy with medications having antihistaminic or autonomic primary or secondary effects (e.g., oral or topical antihistamines, tricyclic antidepressants, ipratropium bromide, albuterol, alpha", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Infection Hospitalized men or women >/=18 years of age Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5 full days but not exceeding 14 days Ability to provide documented and signed written informed consent Confirmed or suspected intra abdominal infection defined as follows For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following Gross peritoneal inflammation with purulent exudates (i.e. peritonitis) Intra abdominal abscess Macroscopic intestinal perforation with localized or diffuse peritonitis Subjects enrolled on the basis of a suspected intra abdominal infection must have Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (e.g. penicillins or cephalosporins), or any of the excipients Women who are pregnant or lactating or in whom pregnancy cannot be excluded History of tendon disease/disorder related to quinolone treatment Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil) Known severe end stage liver disease Creatinine clearance 18 years patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF) patients for whom the above fracture has healed patients willing and able to provide informed consent and able to participate in study procedures patients with known pathological fractures patients with metabolic bone disease patients with humeral head or inter-articular surface fractures, or other upper extremity fractures patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.) patients with neurologic injury to upper extremities", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 50.0-999.0, All Osteoporotic Vertebral Fracture Between T5 and L5 Chronic Arthritis, Longer Than Six Weeks Duration Patient is able to undergo the vertebroplasty or Balloon kyphoplasty procedure Patient has read and sign the informed consent Male or female, 50 years or older One or two non-traumatic vertebral fracture(s) Of osteoporotic origin (low speed trauma such as fall from his own height or less than 80 cm) Fracture(s) older than 6 weeks duration after the onset of pain related to the fracture\u00b7 The fracture(s) exhibit(s) high signal intensity on T2-weighted images and a benign appearance at MRI Persistent pain despite medical treatment according to VAS \u2265 5 or a last resort to morphine treatment The patient will be able to receive the selected protocol treatment within 15 days after treatment randomization The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during vertebroplasty or balloon kyphoplasty Patient with a vertebral fracture of less than 6 week duration after onset of fracture-related symptoms Neurological signs related to the vertebral fracture to treat History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain Patient with more than 2 fractures corresponding to the (old fractures are not taken into account) Known allergy to a contrast media or to one of the cement components used for kyphoplasty More than two recent vertebral fractures Current infection Impossibility to perform the percutaneous approach of the vertebra to treat Known allergy to a contrast media or to one of the cement components used for kyphoplasty Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All One or Two Traumatic Vertebral Fractures Located Between T11 and L5, Balloon Kyphoplasty Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure) Patient must have signed the consent form Male or female patient aged 18 or over One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the classification, and with a regional kyphotic angle > 15\u00b0 and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression Fracture with or without neurological difficulties Non tumoral origin: Confirmed by biopsy at the same time of the Balloon Kyphoplasty procedure Non traumatic, malignant or osteoporotic vertebral fractures History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain Known allergy to a contrast media or to one of the cement components used for kyphoplasty More than two recent vertebral fractures Current infection Impossibility to perform the percutaneous approach of the vertebra to treat Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat Vertebral fracture with loss of 90%or more of the vertebral body height Patient presenting a non correctable spontaneous or therapeutic coagulation disorder", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Post-Traumatic Stress Disorder Primary diagnosis of post-traumatic stress disorder Involved in motor vehicle accident that occurred at least 3 months ago Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression History of psychosis Active suicidality or history of two or more suicide gestures or attempts in the past year Significant cognitive impairment Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 16.0-60.0, All Sprains and Strains Age 16-60 years Onset of ankle sprain at least 2 weeks prior to enrollment Foot and Ankle Ability Measure Activity of Daily Living subscale score less than or equal to 80% Current status of assisted ambulation (eg, use of cane or crutches) Inability to bear weight through the affected extremity immediately after injury combined with tenderness to palpation of the medial and lateral malleolar zones, styloid process of the 5th metatarsal, and navicular Positive anterior drawer or talar tilt dimple test Volume of the affected limb greater than 10% of the unaffected limb Previous history of ligament or bony reconstructive surgery to the ankle and foot Concomitant injury to other lower extremity joints", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Rib Fractures Subjects must be at least >18 years of age Subjects must have one of the following clinical indications >3 rib flail segments with paradoxical chest wall movement Non-repair of defect may result in pulmonary hernia Minimal associated injuries Severely displaced fractures are significantly impeding lung expansion Failure of narcotics or epidural pain catheter to control pain Significant pulmonary contusion Significant brain injury (AIS 4 and/or ICP monitoring) Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization Subjects not expected to survive the 90-day follow-up period Known pregnancy Prisoners", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-80.0, All Whiplash Injuries Patients have had a measurement of the cervical range of motion ", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 21.0-35.0, All Driver Sleepiness He/she is aged between 21 and 35 years old BMI between 21 and 30 85 kg body weight Non smoker Written informed consent Normal static binocular acuity, corrected or uncorrected Normal hearing Possession of a valid driver's license for at least 3 years Regular driver (> 5000 km / year) Be considered as reliable and mentally capable of adhering to the protocol Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test Use of psychoactive medication Pregnancy Positive alcohol breath test Prior enrolment in the same study Physical or mental illness Excessive alcohol use (>21 alcoholic drinks per week) Intake of caffeine-containing beverages under 2 or over 4 glasses per day Regular consumption of Energy Drinks (>1 per month) Shift worker (or no regular sleep pattern)", "label": "2"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Open Abdomen Trauma patients with open abdomen after initial laparotomy Emergency surgery patients with open abdomen after initial laparotomy Able to obtain consent from patient or LAR before any research initiated Seprafilm application at initial laparotomy Patient is a prisoner Inability to obtain informed consent Consentable person does not speak English", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-80.0, All Surgical Complications Relaparotomy Post operative period of abdominal surgery (elective surgery of:colon-rectum, ileum, stomach and, pancreas) Post operative period after Urgent laparotomy for both traumatic and/or non traumatic acute abdomen Patients with signs of sepsis in the post operative period Patients with signs of systemic hypoperfusion in the post operative Liver surgery Drainage of bile, blood and dejection from abdominal drainage Sepsis/ systemic hypoperfusion due to extraabdominal infection site", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 20.0-55.0, All Spinal Cord Injuries Must be able to give voluntary (patients may not be able to write) consent Must be able to understand study information provided to him Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), < 2 weeks in acute category and 2-8 weeks in subacute patients The level of spinal cord injury must be between C4 and T12(neurological level) Spinal cord injury categorized in terms of ASIA Impairment scale Age should be between 20-55 years Mechanical ventilation due to neurological impairment Multiple level trauma Undetermined size and location of Spinal Cord injury Gunshot or other penetrating trauma to the spinal cord Longitudinal dimension of injury by MRI is greater than 3spinal segments Associated severe head injury More than 9cms long bone fracture Women who are pregnant or lactating Serious pre-existing medical conditions Disease or impairment that precludes adequate neurological examination", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Stress Disorders, Post-Traumatic Stress Disorders, Traumatic, Acute Road traffic accident victims hospitalized in surgical department less than 2 weeks Can be called by phone Patient with a coma for more than 15 minutes Patient with a crania traumatism and with loss of consciousness over 15 minutes Homeless", "label": "2"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 0.0-999.0, All Intestinal Disease Feeding Disorder Neonatal Birth gestational age (GA) between 25 and 32 weeks Corrected gestational age less than 34 weeks Enteral feeding tolerated at a minimum of 10 ml/kg/day for a minimum of 48 hours Severe feeding intolerance, defined as a minimum of one or more of the following signs leading to withholding of milk feedings on two evaluations over 12 to 24 hours Significant increased abdominal girth, as evaluated by the treatment team, with abdominal tenderness Visible enlarged bowel loops with abdominal tenderness Recurrent emesis leading to withhold feeds Gastric residuals in excess of one feeding, recurrent or with growing abdominal girth Visible blood in stools without anal etiology Documented informed consent for participation in the study Infants who already reached full enteral feeds for 72 hours, in fact a minimum of 130 ml/kg/day enteral feeds without parenteral supplementation Small for gestational age (SGA) (weight at or less than the 3rd percentile on the Fenton growth chart) NEC (Bell's stage II or higher, radiologic evidence of NEC, pneumatosis intestinalis or free intraperitoneal air)or history of NEC Gastric or intestinal occlusion (no transit, absent bowel sounds, incessant vomiting, bile stained vomiting or air fluid levels) Major congenital malformation Septic infants requiring therapeutic antibiotics or antimycotics (infants only on prophylactic antibiotics or antimycotics should not be excluded) Patients judged as being too ill to enroll in this study, as defined by a requirement for mechanical ventilation with >50% FIO2 Patent Ductus Arteriosus requiring ibuprofen, indomethacin or ligature, until one week after the end of treatment Intraventricular Haemorrhage grade 3 or 4 Hypernatremia \u2265 150 mmol/L", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Adult patients requiring a CT abdomen for clinical purposes will be included Pediatric patients", "label": "2"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 25.0-35.0, All Automobile Driving Male Caucasian ethnicity Age 25-35 years Possession of a driver's licence for at least five years Score \u2265 2 on the modified Apfel-scale to assess risk for motion sickness(*) History of driving under the influence of alcohol and/or illicit substances History or presence of alcohol or illicit drug abuse Former abnormal reaction to any hypnotic drug History of strong averse reactions to blood sampling procedures Regular (daily) intake of any prescribed drug, or intake of grapefruit juice or herbal remedies that can influence the metabolism of zopiclone (e.g. St John's wort) History of severe allergic reactions, or significant mental, cardiovascular, renal or hepatic disorder, or other significant disease as judged by the investigators Detection of any drugs of abuse on pre-session urine drug screening (*)Modified Apfel-criteria for prediction of postoperative nausea/vomiting Smoker? yes 0, no 1", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 6.0-18.0, All PTSD Traumatic Brain Injury Post Concussive Syndrome For the whole sample Children age 6 to 18 Language spoken: Hebrew, Arabic DSM IV R diagnosis: PTSD Car accident event within past 3 years For the m-TBI group Any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain] Diagnosis of MTBI within 3 years as confirmed by CT/MRI/fMRI Glasgow coma scale; GCS<15 Children presenting with psychotic symptoms Children presenting with mental retardation", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 16.0-999.0, All Trauma Teenagers perceived to be students driving near school property Teenagers perceived to be of driving age Teens in 10th, 11th, and 12th grades attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools Any driver driving near school property, which is perceived to be older than of high school age Teenagers perceived as non-attendees of the nearby school Teenagers perceived not to be of driving age Teens not in 10th, 11th, and 12th grades, or not attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools Any driver who does not meet the above criteria", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-60.0, All Intraarticular Fracture and Post-traumatic Osteoarthritis years of age or older Radiographic evidence of tibial plateau fracture Less than 18 years of age Greater than 60 years of age Any history of pre-existing knee osteoarthritis based on previous diagnosis or suggestive history Any history of autoimmune disease Any history of contralateral intra-articular knee injury", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 45.0-74.0, All Postmenopausal Disorder Blood Pressure Over Weight Woman between 45-74 years of age Have not had a menstrual period for at least 12 months Are not regularly physically active (self-reported non-exerciser for previous 6 months) Have a body mass index (BMI) between 25-45 kg/m2 Have high normal blood pressure or (systolic pressure of 130-179 mmHg or a diastolic pressure of 85-99 mmHg) Not limited in your ability to walk Understand these Are willing to provide informed consent Willing to be randomized to either type of walking intervention or a control group being studied, and are willing to follow the protocol for the group to which they have been assigned Have a past history and/or physical examination or laboratory findings of a medical condition including (but not limited to) Have any medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise Have been diagnosed with diabetes Blood pressure is greater than 179 mmHg systolic or 99 mmHg diastolic Participating in another research study which may effect the results of WalkMore", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 0.0-18.0, All Abdominal Injuries Blunt torso trauma resulting from a significant mechanism of injury Motor vehicle collision: greater than 60 mph, ejection, or rollover Automobile versus pedestrian/bicycle: automobile speed > 25 mph Falls greater than 20 feet in height Crush injury to the torso Physical assault involving the abdomen Decreased level of consciousness (Glasgow Coma Scale score < 15 or below age-appropriate behavior) in association with blunt torso trauma Blunt traumatic event with any of the following (regardless of the mechanism) Extremity paralysis Multiple long bone fractures (e.g., tibia and humerus fracture) No concern for inter-abdominal injury or no planned evaluation for possible IAI Prehospital or ED age adjusted Hypotension Prehospital or initial ED GCS score \u2264 8 Presence of an abdominal \"seat belt sign\" continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt Penetrating trauma: stab or gunshot wounds Traumatic injury occurring > 24 hours prior to the time of presentation to the ED Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts", "label": "2"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-70.0, All Type 1 Diabetes Hypoglycemia Have been diagnosed with Type 1 diabetes for at least one year Started taking insulin less than a year after being diagnosed with Type 1 diabetes Measure blood glucose at least twice a day Legal and valid driver's license Drives greater than 5,000 per year Regular access to the Internet, either through family computer or another readily accessible computer Age 18 years English speaker Type 2 diabetes Does not take insulin Does not drive Does not have legal and valid driver's license Does not have routine access to the internet", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-89.0, All Open Abdominal Wounds Abdominal Adhesions Wound Sizes Trauma Population Trauma patients undergoing DC/OA management for traumatic injury Age 18+ Life expectancy longer than 48 hours Prisoners Pregnant patients Younger than 18 years of age", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 0.0-0.615, All Postnatal Growth Disorder Neurodevelopment Gestational age < 32weeks (maternal dates or early fetal ultrasound) Tolerating an enteral intake of \u2265 100 ml/kg/d for \u2265 24h Subject is anticipated to receive the intervention for \u2265 3 consecutive weeks after full enteral feeding (\u2265 150 mL/kg/d) has been achieved; and Written informed consent has been obtained from the infant's legal representative Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities Babies with enterostoma or short gut syndrome Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis Bell Stage 2; air in the biliary tract or free air in the peritoneum Bell Stage 3) Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80 Hepatic dysfunction, defined by jaundice (direct bilirubin >1.0 mg/dl) that is associated with one or more abnormal liver function tests (AST, ALT or GGT) Participation in another clinical trial that may affect outcomes of this study; or Probability of transfer to another NICU or level II nursery outside the McMaster Children's Hospital before the minimum period of three weeks is completed", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Cardiovascular Disease employee of Washington University in St. Louis pregnancy", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 65.0-999.0, All Geriatric Hip Fracture Pain Management Both sex of Age > 65 Traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention Age < 65 Pathological fracture Multiple lower limb fractures Old fracture", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 19.0-65.0, All Diagnostic Colonoscopy Screening Aged 19-65 years American Society of Anesthesiologists physical status (ASA PS) 1-2 Patients scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital Patients who signed on written informed consent The are refusal or inability to provide written informed consent Age < 18 years Pregnancy Previous large bowel surgery Psychiatric disorders History of addiction to opiates and / or sedatives, and previous adverse reaction to any drug used in the study", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 20.0-999.0, All Post ERCP Pancreatitis Consecutive patients were recruited for the study who presented to the Yonsei University Medical Center with variable symptom or cause for ERCP older than 20 years Patients were excluded from study participation if they had a contraindication for diclofenac including patients with recently diagnosed peptic ulcer disease or active/recent gastrointestinal hemorrhage within 4 weeks renal failure (Cr > 1.4) those who had taken an NSAID during the preceding week (ASA 325 mg daily or less acceptable) those who developed acute pancreatitis during the 2 weeks before ERCP those with a history of chronic calcific pancreatitis or allergy to aspirin or NSAID, and those who did not agree intramuscular injection. Additionally, if state of patients was intrauterine pregnancy or breast feeding mother, they were excluded. Finally, patients were excluded for study if they had bleeding tendency and contraindication for intramuscular injection", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Proximal Humeral Fractures traumatic fractures of the proximal humerus surgical treatment over eighteen years of age pathological fractures conservative treatment soft tissue damage delay of surgery more than three days immunological defects multiple trauma", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-80.0, All Pain Female 80 years of age TMJ arthralgia Masticatory myalgia TMJ sounds History of at least 6 weeks use of occlusal appliance therapy Contraindication to sedation including pregnancy or medical history History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy History of steroidal injection into TMJ History of trauma to TMJ TMJ pain longer than 3 years History of narcotic drug use on a scheduled basis Current active infection", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 3.0-60.0, All Blunt Abdominal Trauma 3-60 years of age evaluated for blunt trauma with a GCS of >14 Order of CT abdomen and pelvis imaging Patients requiring intubation or suspected neurological injury (defined above) Pregnant patients Intoxicated patients Patients with age defined hypotension Exploratory laparotomy or transfusion during the ED evaluation Non-verbal patients Positive FAST exam Patients with abdominal trauma or surgery in the last month Victims of sexual assault or non-accidental trauma (NAT) Patients with known or suspected fractures of the femur or pelvis prior to CT imaging", "label": "2"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-98.0, All Trauma to the Abdomen All patients with a post-injury open abdomen Patients to be excluded from analysis deaths within 24 hours, identification of injury > 24 hours, and those transferred from an outside hospital > 24 hours following initial injury", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 13.0-999.0, All Open Abdomen Temporary Abdominal Closure Mechanisms Open Abdomen Patients that die in the first 48 hours after the initial intervention", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Spinal Cord Injury Orthostatic Hypotension inpatients positive diagnosis of OH acute traumatic SCI lesion level above T6 AIS A, B or C fractures of the lower limbs decubitus (NPUAP >2) massive psychiatric dysfunction suicide intention", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 20.0-85.0, All Osteoporosis (1) Patients who are currently taking or plan to take oral glucocorticoid medication for 3 months or longer and thus require treatment as per the 'Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and mineral Research (2004),' and who meet at least one of the conditions below. No restriction is imposed on the underlying disease treated with the oral glucocorticoid medication (i) Have any existing insufficiency fracture (ii) %YAM <80 (iii) Oral glucocorticoid daily dose >= 5 mg prednisolone equivalent (2) Aged between 20 and 85 years (both inclusive) at consent (3) Patients who are able to walk without assistance (4) Provided consent to participate in the study (1) BMD (L1-4 or T-Hip) T score < -3.5 (2) Have 3 or more vertebral fractures between L1 and L4 (3) Have 1 or more SQ grade 3 vertebral fractures, or 3 or more SQ grade 2 vertebral fractures (4) Have received a bisphosphonate preparation for 2 weeks or longer within 6 months before the start of study treatment (5) Have received a bisphosphonate preparation for 2 years or longer within 3 years before the start of study treatment (6) Have received a parathyroid hormone preparation before the start of study treatment (7) Have received one or more doses of an anti-RANKL (receptor activator of nuclear factor-kappa B ligand) antibody (8) Have received one or more doses of an anti-sclerostin antibody or cathepsin K inhibitor (9) Have received any other investigational product (including placebo) within 16 weeks before the start of study treatment in the present study (10) Have received any of the following drugs that can affect bone metabolism within 8 weeks before the start of study treatment, with the exception of calcium preparations: (i) Bisphosphonates (ii) Active vitamin D preparations (including those for topical use) (iii) Selective estrogen receptor modulators (SERMs) (iv) Calcitonin preparations (v) Vitamin K2 preparations (vi) Ipriflavone preparations (vii) Reproductive hormone products (except those for vaginal use such as vaginal tablets and creams) (viii) Other drugs that can affect bone metabolism", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Non-arteritic Anterior Ischemic Optic Neuropathy Decreased Vision Due to Ocular Trauma Multiple Sclerosis You are 18 years or older You have sustained trauma (more than 3 months before this study) OR been diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (more than 6 months before this study) OR been diagnosed with Multiple Sclerosis (MS) and suffered visual loss (more than 3 months before this study) You are willing and able to give written informed consent You are able to commit to enrolling in the study during the full time period of up to 6 months You have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/ six diopters of myopia, retinal detachment, exudative age-related macular degeneration) You have amblyopia (lazy eye) in affected eye, previously diagnosed You are participating in any other interventional clinical trial If you are pregnant OR a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration OR woman unwilling to perform a pregnancy test at study entry/screening You are unable to give signed consent due to memory, medical, communication, language, or mental health problems You are less than 18 years old You are unable or unwilling to complete the evaluation or questionnaire Visual acuity better than 20/40 Inability to detect phosphenes during threshold detection", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 15.0-49.0, All Hypertension, Pregnancy Induced Hydralazine Adverse Reaction Pre-eclampsia Pre-eclampsia Superimposed Pre-existing Hypertension Pregnant or post partum patients with systolic blood pressure \u2265160mm of Hg or diastolic BP \u2265110 mm Hg, on repeat measurement of blood pressure after 15 minutes of rest, meeting following will be included Pregnancy greater than 28 wks(gestational age determined by ultrasound prior to 20 weeks which if unavailable then by uterine size at first prenatal visit or by last menstrual period) with gestational hypertension, severe preeclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, eclampsia and unclassified hypertension Postpartum patients, upto 72 hours after delivery, diagnosed as gestational hypertension, severe preeclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, eclampsia and unclassified hypertension Patients with singleton or multiple pregnancy Patients of all ages and parity Patients with asthma Patients with cardiac failure and heart block Patients with pacing device in place or any type of cardiac arrhythmia. -", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 16.0-999.0, All Hemorrhagic Shock Age \u226516 years of age or estimated weight \u226550kgs if age is unknown Victim of blunt or penetrating trauma Hemorrhagic shock defined as One or more episodes of systolic blood pressure \u226490mmHg at any time prior to enrollment into the study An identified source of blood loss (abdomen, chest, pelvis/retroperitoneum, extremities, external) Admitted to St. Michael's Hospital directly from the scene of injury within 3 hours of the injury Application and completion of RIC within 4 hours of the injury Pregnancy Non-hemorrhagic shock (i.e. tension pneumotorax, cardiac tamponade, spinal shock, etc.) Burns Absence of vital signs prior to admission, ongoing CPR, possibly dead on admission or not expected to survive beyond a few hours Patients requiring immediate transfer to operating room for definitive management will be excluded in order to prevent delay in their treatment", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-65.0, All Injuries, Whiplash victims of motor vehicle accidents signed informed consent pregnancy traumatic brain injury psychiatry disorders active cancerous conditions adrenal diseases medical treatment by estrogens, anti-depressants, melatonin, pain control substance abuse hospitalization due to the trauma contra indication to hydrocortisone treatment over 6 hours from time of injury", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Postoperative Pain Patients >= 18 years old scheduled for internal fixation of an ankle fracture as defined above Ability to read and understand Danish and give informed oral and written consent Multitrauma patients / other simultaneous fractures Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol \"CAVE\" nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason Primary investigator unavailable for PNB administration at scheduled time of operation Infection at PNB injection site Time from fracture to operation > 5 days Existing neuropathy with functional impairment of the fractured extremity Bodyweight < 50 kg Daily use of opioids > 2 weeks preoperatively Pregnancy", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 0.0-0.25, All Transfusion Feeding During Transfusion Transfusion Related Acute Gut Injury Necrotising Enterocolitis <32 weeks of gestational age or <1500 gr, >7 days old premature babies Babies which are fed enterally well at the time of tha planning of transfusion Babies with severe sepsis signs Babies with severe hypoxia and asphyxia Babies with congenital anomaly or complex cardiac anomaly", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Intradialytic Hypotension Must be able to give informed consent for participation in this study Age \u2265 18 years A body weight > 100 lb or a body mass index > 18.5 End-stage renal disease with hemodialysis in-center three times per week Not missing any treatments in the preceding two weeks and in compliance with instructions from the health care provider In the last month had at least two episodes of IDH (defined as having hypotensive symptoms such as dizziness, fainting, headache, nausea, vomiting, cramping, weakness, blurry vision and/or a decrease in systolic blood pressure (SBP) of more than 20 mmHg) Hemoglobin greater than or equal to 9.0 g/dL (hematocrit 27%) to hemoglobin of 15.0 g/dL (hematocrit 45%) \u2022 Pregnancy (self-reported) Allergic to nylon, polyesters and latex Not able to understand the English language Not able to disengage the ACES from compression Having an excessively low systolic blood pressure (SBP which is less than 90 mmHg) Hemoglobin less than 9.0 g/dL or greater than 15 g/dL Excessive intra-abdominal fluid pressure Respiratory distress Bleeding in the chest and abdomen Bleeding dyscrasia causing serious coagulation problem", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 21.0-80.0, All Stroke first-time unilateral cerebral stroke a stroke at least 6 months prior to enrollment gait asymmetry, but able to walk independently no evidence of uncompensated hemianopsia, tested by using Pedretti's method (Pedretti 1985) no evidence of severe (greater than 16 in the Folstein Mini-Mental Status Exam) cognitive impairment (Folstein et al. 1975) or language dysfunction that would interfere with understanding the instructions no evidence of neglect, tested by being asked to copy a simple drawing of a house (Gregory and Aitkin 1971) unable to walk at least 0.3m/s orthopedic or pain conditions history of seizure disorders metal implants (stents, clips, pacemaker) pregnancy any condition that makes balance unstable require a walker to walk uncorrected visual impairments", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Thoracoabdominal Trauma Focused Assessment With Sonography for Trauma (FAST) NanoMaxx Ultrasound System (SonoSite) RP-Xpress (InTouch Technologies) for FAST cohort Patient is 18 years of age or older Patient presenting with blunt or penetrating trauma to the thorax or abdomen Patient transported by MD Ambulance to Royal University Hospital Patient being transported by a paramedic who has received training in the above ultrasound system and who has with them a NanoMaxx Ultrasound System (SonoSite) to be used in connection with the RP-Xpress (InTouch Technologies) Patient will take longer than 10 minutes to transport to hospital Patient's care will not be compromised in completing a FAST exam opinion of paramedic Patient's care will not be compromised in completing a FAST exam opinion of ER physician Patients under the age of 18 Patients whose care would be compromised if other procedures of higher priority (as determined by paramedics and/or remotely-present physicians) were not be able to be executed due to time involved in completing a FAST exam Patients who are not being transported to Royal University Hospital Patients whose expected transport time from scene to hospital is less than 10 minutes", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Trauma Injury Bleeding Haemorrhage Coagulopathy Injured trauma (penetrating or blunt) patients who are at risk of significant bleeding, defined as: i. Systolic blood pressure (SBP) \u2264 100mmHg at any time from the injury scene until 30min after hospital admission AND ii. Red blood cell transfusion has been ordered by the trauma team leader (or delegate) Patients in shock which the etiology is purely not related to bleeding i. Cardiogenic (myocardial or valvular dysfunction); ii. Distributive (septic, anaphylactic, acute adrenal insufficiency and neurogenic) and iii. Obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli) Severe head injury, defined as any of the following i. Glasgow coma scale (GCS) of 3 due to severe traumatic brain injury (TBI); ii. TBI with clear indication of immediate neurosurgical intervention based on clinical findings (mechanism of trauma associated with focal signs such as anisocoria with fixed pupil) or on CT results (bleeding causing mass effect); iii. Unsalvageable head injury such as through-through gunshot wound to the head, open skull fracture with exposure/loss of brain tissue; as per the trauma team or neurosurgery initial clinical assessment or as per initial CT of the head findings Known complete or incomplete spinal cord injury Known hereditary or acquired coagulopathies unrelated to the trauma resuscitation (e.g. known hepatic dysfunction) Use of anticoagulant medications such as warfarin, low-molecular weight heparin, and direct thrombin and factor Xa inhibitors Moribund with evidence of unsalvageable injuries and withdrawal of care, as per the trauma team Received blood products prior to admission Patients with estimated body weight under 50Kg", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-70.0, All Infection Is male or female, 18 to 70 years of age Has provided written informed consent Has experienced abdominal trauma, blunt or penetrating requiring open abdominal laparotomy with primary closure or acute surgical abdomen requiring open abdominal laparotomy with primary closure Undergoes the required surgical procedure within 36 hours of presentation to the healthcare system Known allergy to Chlorhexidine Gluconate (CHG) Abbreviated Injury Scale (AIS) score of six (6) American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater Female volunteers who are pregnant and/or breast feeding Damage control laparotomy Drain is placed within the wound or an intra-abdominal drain exits through the incision Reoperation occurs through the same incision or transgresses the same incision as the index procedure within 30 days Abdomen opened prior to operating room Currently enrolled in a clinical trial", "label": "1"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 14.0-19.0, All Concussion \u2022 Normal healthy volunteer Able to provide written consent Must be 14 years or older and a participant on a competitive and organized sports program Neck circumference of 15 \u00bd \u00bd inches \u2022 Unable to provide written consent History of neurological deficits, previous cerebral infarction, or severe head trauma Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis) Glaucoma (Narrow Angle or Normal Tension) Hydrocephalus Recent penetrating brain trauma (within 6 months) Known carotid hypersensitivity Known increased intracranial pressure Central vein thrombosis Any known airway obstruction", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-90.0, All Pain Fracture Patients at least 18 years old Male or Female All racial and ethnic groups Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand Patients who opt for surgical treatment of their fractures Patients who consent to be randomized Patients who are willing to follow-up for a minimum of 52 weeks Patients younger than 18 years old Patients who are on chronic opioids Patients who abuse opioids Patients who are unwilling to follow-up for a minimum of 52 weeks Neurologic condition that could interfere with pain sensation", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-65.0, All Injuries The basic lower age limit for parents or guardians of children aged 6-11 for this study was 18. Parents or legal guardians could potentially be as old as 65 or older Only English-speaking participants were accepted because the program was developed only for English speakers. All English-speaking parents or guardians living in the U.S., with children aged 6-11 years old, who wished to participate were included. Parents under 18 were excluded from this online study because parental consent cannot be obtained online", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 0.0-999.0, All Injuries Visiting the Pediatric Emergency Department (PED) at Johns Hopkins Hospital or Arkansas Children's Hospital Parent or guardian of child 4-7 years English speaking Have and Android or iPhone smartphone Drive with the child in a car at least once per week in a car that the parent owns, borrows or gets a ride round-trip Resident of Baltimore City, MD or Little Rock, AR and surrounding area PED has flagged case as suspected abuse Another household member is enrolled in the study In Arkansas, less than 18 years without parent present at the PED", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 13.0-18.0, All Health Risk Behaviors Health Care Services Quality of Care Eligible individuals will be 13-18 years old who have an appointment to see a provider at a participating clinic and will be able to read and comprehend English Individuals will be excluded from the study if they do not meet age requirements do not have an appointment at a participating clinic lack the means to complete follow-up interviews (i.e., has neither telephone not internet access) have a sibling who has/is being enrolled in the study and/or are not able to read or comprehend English", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Fasting Diet Biosensing Techniques Awake and alert Not on a regular diet No mild to moderate acute pancreatitis No obstructed bowel not amenable to feeding tube placement beyond the obstruction No massive GI hemorrhage No impending or established toxic megacolon No colonic perforation No severe dysmotility making enteral feeding not possible No high output intestinal fistula Able to access the gut for enteral feeding Not awake and alert On regular diet Mild to moderate acute pancreatitis Obstructed bowel not amenable to feeding tube placement beyond the obstruction Massive GI hemorrhage Impending or established toxic megacolon Bowel perforation Severe dysmotility making enteral feeding impossible High output intestinal fistula Unable to access the gut for enteral feeding", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 16.0-17.0, All Teen Drivers Motor Vehicle Accident High school student (16 or 17 at enrollment) Holds an intermediate driver's license Lives in parent/guardian's home Drives to school Has their own smartphone (iPhone 4S or newer or Android 4.3 or newer) with data plan Parent/guardian is willing to assist with installation Admits to texting while driving at least once in the last month Already uses a smartphone app or hardware device to limit cellphone use while driving", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 0.0-999.0, All Brain Injuries Skull Fractures Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture Died before admitted to hospital", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 12.0-19.0, All Sport-related Concussion Brain Concussion Healthy Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo) History of concussion (suspected or diagnosed) in the previous 6 months History of neck pain or injury in the previous 6 months History of migraine headaches History of personal or parental history of a diagnosed anxiety disorder", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-999.0, All Acute Abdomen Acute Appendicitis Patient presented with the complaint of right lower abdominal pain Suspected acute appendicitis Flank pain Previous appendectomy Pregnancy Unstable vital signs Frank peritonitis US performed before EP's examination", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 2.0-17.0, All Pain Long-bone Fractures children aged 2 through 17 years (17 years included) accompanied by at least one of their parents in the emergency department accompanied by at least one of their parents in the emergency department suspected fracture of a long bone requiring morphine analgesia (VAS \u2265 60/100 or Evendol \u2265 7/15 at the inclusion) within the first 12 hours after the injury at least one signed parental informed consent affiliated to health insurance analgesic treatment within the 6 hours before contraindication to one of the study drug cognitive impairment multiple injuries resuscitation man\u0153uvres open fracture non affiliated to social security parental refusal", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 18.0-35.0, All G.I.T. Motility After General Versus Spinal Anaesthesia Patients set for planned cesarean section under general or spinal anesthesia age from 18 to 37 years Full term(37-41 weeks) Singleton pregnancy Hemoglobin level more than 11 gm/dl Contraindication to regional anesthesia i.e(patient refusal,coagulopathy,significant hypovolemia,systemic or local sepsis,increased intracranial pressure,severe stenotic valvular heart disease,pre existing neurologic conditions and local anesthetic or fentanyl allergy High risk pregnancies as pre eclampsia,eclampsia,any medical disorder(DM,cardiac and thyroid diseases) Previous intestinal surgery,previous C.S. and previous gynecological operations", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 1.0-3.0, All Children With Mobility Disabilities motor delays (sd>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking aged between 12 months to 36 months old able to tolerate sitting with support for 30 minutes able to reach the objects with either one or two hands consent of the parents to agree to the testing procedures and participate in the training program at the hospital children with severe sensory impairments such as blindness, deafness parents/caregivers are not able to make a time commitment for the training phase", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 15.0-999.0, All Wound Infection Complication Scar patients with a clinical diagnosis of acute appendicitis children under 14 are not included", "label": "0"} +{"topic": "A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds.", "doc": "eligible ages (years): 13.0-18.0, All Alcohol Risk Behaviors Health Care Services Quality of Care Eligible individuals will be 13-18 years old who are able to read and comprehend English Participants who indicate alcohol use consistent with moderate to high risk on the Check Yourself App Individuals will be excluded from the study if They do not meet age requirements Do not have a study visit at a participating school-based health clinic Lack the means to complete follow-up interviews (i.e. have neither telephone or internet access) Are not able to read or comprehend English", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-999.0, All Glomerulonephritis, Membranoproliferative Lupus Nephritis Must give written informed consent prior to any testing under this protocol Must be 18 years or older, inclusive, at the time of informed consent Must have a renal biopsy showing active WHO Class III, IV, or mixed membranous and proliferative SLE GN, within the 5 years prior to the first dose of study drug Must have proteinuria of greater than or equal to 1.0 g/day at both the Day-27 and day-13 evaluations Must fulfill any one the following four at each of the two screening visits (i.e., Day-27 and Day-13) Anti-dsDNA antibody greater than 2x the upper limit of normal (ULN) C3 complement less than 80 mg/dL Hematuria greater than 5 rbc/hpf Urinary granular or red blood cell casts Must not have any medical disorder, which in the opinion of the investigator, should the subject from this study ", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Coronary Disease Thrombosis Heart Diseases Lupus Erythematosus, Systemic ", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 1.0-55.0, All Purpura, Schoenlein-Henoch Graft Versus Host Disease Anemia, Hemolytic, Autoimmune Rheumatoid Arthritis Churg-Strauss Syndrome Hypersensitivity Vasculitis Wegener's Granulomatosis Systemic Lupus Erythematosus Giant Cell Arteritis Pure Red Cell Aplasia Juvenile Rheumatoid Arthritis Polyarteritis Nodosa Autoimmune Thrombocytopenic Purpura Takayasu Arteritis Autoimmune thrombocytopenia purpura: platelet count less than 20,000/mm3 Adequate or increased marrow megakaryocytes Presence of detectable platelet associated immunoglobulins not due to alloreactive antibodies or posttransfusion purpura Prior response to immunosuppressive therapy Platelet count chronically less than 20,000/mm3 with petechial bleeding or less than 50,000/mm3 with other bleeding OR Any history of life threatening hemorrhage Refractory to conventional therapy for at least 21 days Splenectomy At least 1 additional immunosuppressive therapy applied after splenectomy OR Controlled on conventional therapy but at price of unacceptable toxicity: Serious steroid related toxicity Absolute neutrophil count less than 500/mm3 25% of time, pure red blood cell transfusion dependent or other toxicities (e.g., hemorrhagic cystitis) that are a consequence of chronic or cytotoxic therapy Unable to wean from chronic daily or intermittent cytotoxic therapy Autoimmune hemolytic anemia or pure red cell aplasia, AIHA: Hemolytic anemia Hemoglobin less than 10.0 g/dL without transfusion Hemolysis as evidenced by both: Sustained reticulocytosis (greater than 125,000/mm3) without evidence of active bleeding or increasing hemoglobin Laboratory evidence of hemolysis Positive direct antiglobulin test or equivalent immune adherence test No evidence for paroxysmal nocturnal hemoglobinuria Negative Ham's test and sucrose hemolysis. For PRCA: Anemia due to selective decrease in marrow erythroid precursors Hemoglobin less than 10.0 g/dL without transfusion Severe reticulocytopenia (less than 20,000/mm3 despite anemia) Severely decreased marrow erythroid precursors Positive marrow coculture with serum or cells or response to immunosuppression No evidence for PNH Negative Ham's test and sucrose hemolysis Severe disease: Chronic (i.e., greater than 1 year) Transfusion dependent or untransfused hemoglobin less than 8.0 g/dL Ferritin greater than 2,000 or evidence of organ dysfunction due to iron overload Refractory to conventional therapy after all 3 of the following: High dose steroids (at least 1 mg/kg) for at least 21 days Splenectomy (except cold reactive antibodies) 1 additional immunosuppressive therapy OR Controlled on conventional therapy but at price of unacceptable toxicity Rheumatoid arthritis: Morning stiffness for at least 6 weeks Arthritis of 3 or more joint areas Arthritis of hand joints Symmetric arthritis Rheumatoid nodules Serum rheumatoid factor Radiographic changes Active rheumatoid disease as evidenced by all of the following: Elevated Westergren erythrocyte sedimentation rate Minimum of 16 swollen or tender joints using the 28 joint count method Must be at high risk for developing deforming joint disease as defined by at least 2 of the following: High titer IgM-IgG rheumatoid factor Radiographic evidence of erosive arthritis developing within the first 24 months of clinical disease Functional class II or III Refractory to conventional therapy after 12 months of: Methotrexate used in combination with cyclosporine, hydroxychloroquine, or sulfasalazine OR Intramuscular gold therapy (total dose greater than 1.0 g and duration at least 6 months) OR Controlled on conventional therapy but at price of unacceptable toxicity Juvenile rheumatoid arthritis: Under 16 years of age at onset Arthritis in 1 or more joints as defined by swelling or effusion, or presence of 2 or more of the following: Limitation of range of motion Tenderness or pain on motion Increased heat Duration of disease 6 weeks or longer Onset type defined by type of disease in first 6 months: Polyarthritis (i.e., 5 or more inflamed joints) Oligoarthritis (i.e., less than 5 inflamed joints) Systemic (i.e., arthritis with characteristic fever) of other forms of juvenile arthritis Active disease evidenced by 1 of the following: Minimum of 2 swollen or tender joints using the 71 joint count method Endocardial or myocardial disease, or serositis Anemia or thrombocytosis of chronic disease High risk for developing deforming joint disease or evidence of potential life threatening involvement for at least 1 internal organ system Radiographic evidence of erosive arthritis developing within first 24 months of clinical disease Functional class II or III Endocardial, myocardial, pericardial, and/or pleural disease Hemoglobin less than 10.0 g/dL or platelet count greater than 600,000/mm3 Refractory to conventional therapy after 12 months of methotrexate used in combination with hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine, or cyclophosphamide OR Controlled on conventional therapy but at price of unacceptable toxicity Systemic lupus erythematosus: Malar rash Discoid rash Photosensitivity Oral ulcers Arthritis Serositis Renal disorder Neurologic disorder Hematologic disorder Immunologic disorder Antinuclear antibody Must have at least 4 of 7 variables on the lupus activity scale measured Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Azathioprine Cyclophosphamide (greater than 500 mg/m2 monthly for 6 months) Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity Vasculitis Definitive diagnosis of 1 of the following forms: Churg-Strauss syndrome Giant cell arteritis Henoch-Schonlein purpura Hypersensitivity vasculitis Polyarteritis nodosa Takayasu arteritis Wegener's granulomatosis Evidence of active disease defined as reversible manifestations of the underlying inflammatory process Must have 1 or more of the following: Elevated Westergren erythrocyte sedimentation rate Elevated C reactive protein Decrease serum complement levels Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy (i.e., failed or relapsed within 6 months) after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Methotrexate Azathioprine Cyclophosphamide Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity Performance status: ECOG 0-1 ECOG 2 allowed provided symptoms directly related to autoimmune disease Hepatic: No history of severe, prior or ongoing chronic liver disease Bilirubin less than 2.0 mg/dL AST less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 2.5 mg/dL OR Creatinine no greater than 2 times normal baseline for age in pediatric patients Cardiovascular: No symptoms of cardiac disease No active ischemic heart disease Ejection fraction greater than 45% by MUGA No uncontrolled hypertension Pulmonary: FEV1/FVC at least 60% OR Resting PO2 at least 80 mm Hg DLCO greater than 50% predicted O2 saturations greater than 94% in children unable to perform PFTs Neurologic: No active or ongoing ischemic or degenerative CNS disease not attributable to underlying disease Other: Not pregnant No poorly controlled diabetes HIV negative ", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 13.0-999.0, All Lupus Erythematosus, Systemic A diagnosis of systemic lupus erythematosus ", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-70.0, All Lupus Erythematosus, Systemic People may be eligible for this study if they Are 18 to 70 years of age Agree to use a reliable method of birth control during treatment and for 6 months after treatment ends Have SLE (by the American College of Rheumatology criteria) Have had SLE for at least 6 months prior to screening Have active SLE disease at the screening visit Have organ disease (lung, stomach, intestinal, blood, kidney, and/or heart) Have failed standard therapy, including at least 1 immunosuppressive agent, or have experienced side effects from an immunosuppressive agent that required discontinuation of treatment Meet blood, liver, and kidney laboratory values set by the protocol Have not taken an immunosuppressive agent for 2 weeks prior to the first treatment People will not be eligible for this study if they Are pregnant or breast-feeding Have heart, lung, nervous system, kidney, liver, stomach, intestinal, or other diseases that may place the patient at risk if participating in the trial Have cranial neuropathy (a condition affecting the head region) Are on blood-thinning agents to prevent blood clotting Have a serious skin disease Have a certain class of heart disease Have had cancer, unless surgically cured basal cell carcinoma or cervical dysplasia Have a long term serious infectious disease such as tuberculosis or a fungal infection that is now active, or active within 2 years of the baseline visit Have had HIV infection or another immunosuppressive state (chemotherapy or radiation therapy)", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 10.0-21.0, All Lupus Erythematosus, Systemic Meets American College of Rheumatology (ACR) revised diagnostic guidelines for SLE Weight of 25 kg (55 lbs) or more Outpatient Ability to complete self-report questionnaires in either English or Spanish Willingness to comply with recommended diet Acceptable methods of contraception Drug-induced lupus Liver disease (ALT or aspartate aminotransferase greater than 2 X normal value) Myositis (CK greater than 3 X normal value) Inability to obtain adequate-quality IMT images Current use of oral or parenteral tacrolimus or cyclosporine Dialysis or serum creatinine reater than 2.5 mg/dL Active nephrotic syndrome (urinary protein greater than 3 g/24 h and serum albumin less than 2.3 g/dl) Total cholesterol greater than 350 mg/dL Xanthoma Familial hypercholesterolemia", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-999.0, All Systemic Lupus Erythematosus Families in which one or more living members have been diagnosed with systemic lupus erythematosus ", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-65.0, All Lupus Erythematosus, Systemic Primary Clinical diagnosis of SLE \"Active\" SLE disease On a stable SLE treatment regimen History of measurable autoantibodies Primary Received a non-FDA approved investigational agent within last 28 days Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan\u2122), or high-dose prednisone (> 100 mg/day) within last 90 days Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days History of renal transplant History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-999.0, All Neonatal Lupus Systemic Lupus Erythematosus Sjogren's Syndrome Congenital Heart Block Mother with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins (RNP) OR Child of mother with such antibodies who has neonatal lupus (congenital heart block, transient skin rash, and/or hepatic or hematologic manifestations) OR Father of neonatal lupus-affected child OR Maternal grandparents of neonatal lupus-affected child OR Maternal aunts and uncles of neonatal lupus-affected OR Unaffected siblings of neonatal lupus-affected child ", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus participants must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit (arthritis) Stable dose of prednisone (<30mg) for at least one month participants experiencing an active lupus flare in the kidney or central nervous systems Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study participants with active viral or bacterial infections participants with any other autoimmune disease as a main diagnosis Prior treatment with rituximab", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Lupus Nephritis Lupus Erythematosus, Systemic Fulfill the revised American College of Rheumatology for SLE Have biopsy-proven membranous nephropathy secondary to SLE Nephrotic syndrome with proteinuria (> 3 g/day) and serum albumin < 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents) Age over 18 with informed consent Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study Patient with abnormal liver function tests Patient with hepatitis B surface antigen or who is hepatitis C antibody positive Patient who is diabetic Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion Patient is allergic or intolerant to macrolide antibiotics or tacrolimus", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis Systemic Lupus Erythematosus SLE, RA, or healthy ", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Clinical diagnosis of SLE Self-reported cognitive impairment Age < 18 years History of non-compliance Pregnancy Liver or renal insufficiency/failure (calculated creatinine clearance < 50 cc/min) Severe SLE flare in the last 6 weeks (defined as > 12 points) Recent (within 4 weeks) change in any medication relevant to cognitive function, including prednisone, anti-depressants, medications for insomnia, narcotic medications, attention deficit disorder medications Current alcohol or illicit drug abuse Current use of Namenda, Aricept, Provigil", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-60.0, All Chronic Fatigue Syndrome Myalgic Encephalomyelitis A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) > 12 months (Appendix D) Age Range: > 18 years old, < 60 years old Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two (2) years or surgically sterile including tubal ligation) or using an effective means of contraception (birth control pills, intrauterine device, diaphragm). Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test within the two (2) weeks prior to the first study medication infusion. Females of child bearing potential agree to use an effective means of contraception from four (4) weeks prior to the baseline pregnancy test until four (4) weeks after the last study medication infusion A reduced quality of life as determined by a documented KPS of 40 to 60 on three (3) occasions, each at least 14 days apart, during the twelve (12) weeks immediately preceding the start of study drug infusions. The KPS must be rounded in increments of ten (10) Ability to walk (minimum of 20 seconds) on the moving treadmill (grade = 0%; belt speed = 1 mph) on a minimum of two (2) occasions during the twelve (12) weeks immediately preceding study entry Laboratory documentation (baseline or historical following onset of CFS/ME) of a negative ANA or a negative anti-ds (double-stranded) DNA, a negative Rheumatoid Factor, and an erythrocyte sedimentation rate (ESR) Laboratory documentation that the patient is euthyroid (patients on thyroid replacement therapy must be on a stable dose during the eight (8) week washout period) based on a thyroid profile (T4, T3, TSH, T3 uptake and Free T4 index) performed during baseline Ability to provide written informed consent indicating awareness of the investigational nature of this study ", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-65.0, All Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Subjects may be included only if they fulfil the following on the pre-treatment days (between Day -14 and Day -2) and on Day 1 (before first application of study medication) Female and male patients aged 18-65 years (females of childbearing potential may be enrolled provided they are routinely using adequate contraception in the assessment of the investigator) Patients with histologically defined dLE or scLE The test sites (lupus erythematosus plaques) must be on the face only, and have a total sign score of 4 or more (sum of erythema, induration and scaling scores) and must be the same within a given patient (ie not differing in the sum for erythema, induration or scaling). Each of the 2 test sites must be at least 3 cm apart The patients must receive a baseline medication with chloroquine Patients must have been informed about the study procedures and medication and must have given their written Informed Consent Patients expected to be available for the duration of the study and able to comply with the study visits Any of the following will disqualify a patient from participating in this study Systemic therapy for lupus erythematosus within one month prior to first application of study medication in this study (steroids, retinoids, herbal medicines, etc) except chloroquine Patients with systemic lupus erythematosus or patients whose chronic discoid lupus erythematosus appears to be spontaneously flaring or improving based on the experience of the investigator Patients who are receiving oral medication, known to precipitate lupus lesions (e.g. procainamide, diuretics, piroxicam, beta blockers, griseofulvin, lithium and other psychotropic drugs) Topical therapy [i.e. corticosteroids, etc.] within 2 weeks prior to first application of study medication Patients with clinically significant medical conditions which could interfere with the conduct of the study. This includes Renal impairment (creatinine > 2.0 mg/dl) Hepatic impairment (liver function test values above notable abnormalities; g-GT, ALAT, ASAT: 2x the upper limit) Haematologic disorders (haemoglobin, platelet, erythrocyte and leukocyte counts above notable abnormalities) Neurologic disorders (significant impairment of sensory and motor function as judged by the investigator)", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-60.0, All Systemic Lupus Erythematosus Male or female subjects between the ages of 18 and 60 years, inclusive Meet at least 4 of 11 American College of Rheumatology (ACR) Revised Classification for SLE Have at least one of the following conditions defining severe steroid refractory disease a) Lupus nephritis Subjects must have severe disease, defined as meeting for BILAG renal category A, and be corticosteroid dependent while receiving at least 6 months of pulse CTX at doses of 500 to 1000 mg/m2 every 4 weeks or MMF at of 2 g/day or greater. If nephritis is to constitute the sole a renal biopsy performed within 11 months of the date of screening must show ISN/RPS 2003 classification of lupus nephritis Class III or IV disease. A renal biopsy must demonstrate the potential of a reversible (non-fibrotic) component. b) Visceral organ involvement other than nephritis Subjects must be without mesenteric vasculitis. The subject must be BILAG cardiovascular/respiratory category A, vasculitis category A, or neurologic category A, and be corticosteroid dependent while receiving at least 3 months of oral (2 to 3 mg/kg/day or greater) or IV CTX (500 mg/m2 or greater every 4 weeks). c) Cytopenias that are immune-mediated Subjects must be BILAG hematologic category A and be corticosteroid dependent while receiving at least one of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months, MMF at 2 g/day or greater for more than 3 months, CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day orally for at least 3 months, cyclosporine at 3 mg/kg/day or greater for at least 3 months, or have had a splenectomy. d) Mucocutaneous disease Subjects must meet BILAG mucocutaneous category A and be corticosteroid dependent while receiving at least 1 of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months; methotrexate at 15 mg/week or greater for at least 3 months; CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day or greater orally for at least 3 months, cyclosporine at 3 mg/kg/day or greater for at least 3 months, or MMF at doses 2 g/day or greater for at least 3 months. e) Arthritis/myositis Subjects must meet BILAG musculoskeletal category A and be corticosteroid dependent while receiving at least one of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months, methotrexate at 15 mg/week or greater for at least 3 months, CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day or greater orally for at least 3 months, MMF at 2 g/day or greater for at least 3 months, or cyclosporine at 3 mg/kg/day or greater for at least 3 months Have the ability and willingness to provide written informed consent. In case of lupus cerebritis, a person designated by the subject may give consent HIV positive status Any active systemic infection Hepatitis B surface antigen positive Hepatitis C PCR positive Use of immunosuppressive agents for other indications other than SLE Any comorbid illness that in the opinion of the investigator would jeopardize the ability of the subject to tolerate therapy For lupus nephritis: renal biopsy, performed within 11 months of the screening date, showing Class I, II, or V disease or Class III or IV disease in conjunction with total sclerosis of 50% or more of the glomeruli Ongoing cancer. Patients with localized basal cell or squamous skin cancer are not excluded Pregnancy, unwillingness to use acceptable means of birth control, or unwilling to accept or comprehend irreversible sterility as a side effect of therapy Psychiatric illness or mental deficiency not due to active lupus cerebritis making compliance with treatment or informed consent impossible", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All SLE Rheumatoid Arthritis SLE, RA ", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 16.0-75.0, All Lupus Nephritis Diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis (LN), with either active or active/chronic disease Proteinuria 75 years of age Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions Lack of peripheral venous access Pregnancy or lactation History of severe allergic or anaphylactic reactions to monoclonal antibodies Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude subject participation Concomitant chronic conditions, excluding SLE (eg, asthma, Crohn's disease) that require oral or systemic corticosteroid use in the 52 weeks prior to screening History of renal transplant Known human immunodeficiency virus (HIV) infection Known active infection of any kind (but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives within 4 weeks of randomization or oral anti-infectives within 2 weeks of randomization", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-60.0, All Systemic Lupus Erythematosus Fulfill ACR Classification for SLE >18 and < 60 years old English-speaking/reading Has a treating rheumatologist at the Hospital for Special Surgery Estimated premorbid verbal I.Q. >80 measured by the North American Adult Reading Test Functional difficulties due to cognitive dysfunction defined as positive endorsement of \u22656 items on the Cognitive Symptoms Inventory (CSI). The CSI is a 21-item, self-report questionnaire designed to assess ability to perform everyday activities in patients with rheumatic disease.47 No physical or mental disabilities that would preclude or confound the results of the neuropsychological testing, e.g., compromised use of hands, severe visual or hearing impairment Able to read normal newsprint and hear a normal speaking voice Normotensive at time of enrollment with or without medication No arrhythmia or left ventricular hypertrophy on ECG Global cognitive impairment as measured by a Modified Mini Mental Status<77 History of arrhythmia; known history of left ventricular hypertrophy, mitral valve prolapse with syndrome, or other significant cardiovascular disease with a reduced ejection fraction Renal insufficiency (creatinine clearance < 30 ml/min) including dialysis patients Known liver disease (e.g., active hepatitis) or any liver function test >2x upper limit of normal (transaminases or GGTP) Significant and serious SLE activity defined as active central nervous system disease, active nephritis, ulcerative skin disease. Other active SLE-associated conditions involving major organ systems may be excluded at the discretion of the investigator Pregnancy, nursing mother, or unwillingness to use barrier contraception Diagnosis of active psychosis, ADHD, ADD Current use of medications contraindicated with the use of modafinil-triazolam, Phenobarbital, cyclosporine A, theophylline, carbamazepine, diazepam, phenytoin, mephenytoin, rifampin, ketoconazole, itraconazole Illegal drug or alcohol abuse (defined as two affirmative responses to the CAGE questionnaire) Prior use of modafinil", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-999.0, All Lupus Nephritis Have renal biopsy proven Lupus Nephritis (with the biopsy-based diagnosis date no earlier than January 1, 1995) Reside within designated counties of eastern North Carolina and South Carolina ", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Rash Non-small-Cell Lung Cancer To be eligible for the study, subjects must fulfill all of the following Be male or female \u226518 years of age (inclusive) Have been prescribed Tarceva as a single agent to treat locally advanced or metastatic NSCLC, after failing at least 1 prior chemotherapy regimen Present with acute signs and symptoms of rash on the face that meet the following Are suspected to be related to Tarceva at least 3 inflammatory lesions, and Are less than CTCAE Grade 3 in severity Have an Eastern Co-operative Oncology Group (ECOG) performance status \u22642 and a life expectancy of at least 4 months Sign an approved informed consent form for the study Be willing to comply with the protocol Subjects meeting any of the following will be excluded from the study A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that, in the study physician's opinion, would confound the evaluation of the rash A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal A diagnosis of anemia, defined as hemoglobin <9.5 g/dL Undergoing any current therapy for NSCLC other than Tarceva Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor Treatment with topical antibiotics, topical steroids, and other topical treatments on the face within 14 days of Day 0 (start of study treatment) Treatment with any systemic antibiotics within 7 days of Day 0 (start of study treatment) Treatment with any systemic medication or therapy known to affect anti-inflammatory responses within 30 days prior to Day 0 (start of study treatment). These medications but are not limited to, oral corticosteroids, cyclosporine, and methotrexate. Short-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) before the study for non-rash related conditions is acceptable, provided that exposure is limited to \u22647 days per course. Chronic low-dose aspirin use is also acceptable Active participation in an experimental therapy study or received experimental therapy within 30 days of Day 0 (start of study treatment)", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 20.0-999.0, All SLE Rheumatoid Arthritis Healthy Subjects SLE, RA, healthy ", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Atherosclerosis Thromboembolism Systemic Lupus Erythematosus Age > 18 years Fulfillment of at least 4 of the American College of Rheumatology (ACR) for SLE Presence of any two of the following risk factors SLE duration of >= 5 years Postmenopausal Age >= 40 years Diabetes mellitus Hypertension (140/90 mmHg) Serum low density lipoprotein (LDL) level >= 2.6 mmol/L or total cholesterol >= 5.5 mmol/L Obesity (body mass index >= 27 kg/m2) Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs Patients with history of arterial or venous thromboembolism Patients receiving aspirin or other anti-platelet agents Patients receiving long-term non-aspirin NSAIDs Patients receiving anticoagulation therapy (e.g., warfarin) Patients with history of intolerance or allergy to the statins Pregnant or lactating women", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-65.0, All Systemic Lupus Erythematosus Eligible women will be those having any two of the following Amenorrhea of 6 months or more Serum follicle-stimulating hormone level of 30 IU/L or more Menopausal symptoms Age 48 years or older Women older than 65 years Severe lupus activity at baseline (SLEDAI score, more than 30) Use of estrogens within 3 months of the screening visit Serum creatinine of 2.0 mg/dL or more Hypertriglyceridemia 500 mg/dL or more Metabolic bone diseases Liver disease Untreated hyperthyroidism Recent thrombosis Malignancy", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Age of 18 and above Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) Classification Criteria Treatment with HCQ for at least 6 months, without modification of HCQ dosage for 2 months Stable dosage of HCQ from one day to another (200 g x 2/day or 400 mg once a day or 200 mg once a day) No increase in the steroids dosage during the 3 previous weeks Steroids dosage lower or equal to 0. 5 mg/kg/day of prednisone equivalent No modifications of a possible immunosuppressor during the 2 previous months < or = 12 Signature of the consent of participation Known retinopathy, present or passed Severe cataract obstructing the ophthalmologic monitoring patients Past history of intolerance with HCQ (in particular gastro-intestinal, or retinal) during the possible former use of a higher dosage Use of nivaquine during the 3 previous months Treatment with biotherapy (for example Rituximab) during the 12 previous months Calculated clearance of creatinin lower than 60 ml/min Chronic alcoholism Liver failure Desire of pregnancy in the next 7 months", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 need not be present at study entry Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification [2003], excluding Class III [C], IV-S [C] and IV-G [C], or the World Health Organization Class III or IV classification [1982], excluding Class IIIc, IVd). If the renal biopsy was performed >3 months but \u226412 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA >upper limit of normal range A stable serum creatinine \u22643 mg/dL Subjects with a rise in serum creatinine of \u22651 mg/dL within 1 month prior to the screening visit Subjects with drug-induced SLE, as opposed to idiopathic SLE Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis [MS]) Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1) Subjects who have received treatment with rituximab < 6 months prior to the screening visit", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus men and women with diagnosis of SLE years and above negative pregnancy test for female subjects of child-bearing age and must accept not to attempt to get pregnant during the period of the study Subject with active disease as defined by SLAM of at least 8 SLICC/ACR damage index of less or equal to 15 Subject must be on stable does of NSAIDs, prednisone, or antimalarial (chloroquine sulfate or hydroxychloroquine) at least 4 weeks preceding the study subjects can be under other medications as long as condition or treatment will not interfere with the experimental medications and assessments must understand either French or English and can give written informed consent previous history of hypersensitivity or intolerance to methotrexate or folic acid total SLAM of less than 8 or total SLICC/ACR score of more than 15 history of medical non-compliance or inability to comply with instructions subject who have received intra-articular or intramuscular corticosteroids in the four weeks prior to study entry clinically significant acute or chronic liver disease with the exception of autoimmune liver disease alcohol use in excess of 2 ounces of 100 proof liquor or its equivalent/week insulin requiring diabetes mellitus with morbid obesity renal impairment such that the serum creatinine is more than or equal to 175 umol/I (SI units) or 2.0 mg/dl interstitial lung disease as defined by an abnormal chest x-ray or decrease diffusion capacity (DLCO < 70% of predicted) without evidence of pulmonary hypertension WBC count ,3,000/ cubic mm. and/or platelet count ,80,000/ cubic mm", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Males or females, aged 18 years and over Patients meeting the diagnostic for SLE (Appendix 2), according to ACR guidelines (including screening for anti-dsDNA (antibody to native DNA in abnormal titer)) > 6 Patients treated with maintenance therapy including azathioprine Patients who are willing and able to participate in the study and from whom written informed consent has been obtained Creatinine clearance of < 20ml/min Patients with any clinically significant infection Patients with known hypersensitivity to myfortic \u00ae or to drugs with similar chemical structures Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin Patients with SLE active CNS manifestations or a past history of SLE CNS complications (e.g. psychosis, grand mal seizures) Patients who have received prior therapy with mycophenolic acids (MPAs) (e.g. MMF) Patients who have received an investigational drug within four weeks prior to study entry Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Cutaneous Lupus Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus Patient of a rheumatologist at Duke University Medical Center Inability to travel to Duke for follow-up visits Inability to speak English Not able to provide informed consent", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Lupus Nephritis age at least 18 years diagnosis of SLE by ACR diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV) currently on prednisolone (5 to 20 mg/day) in partial or complete remission for at least 3 months currently pregnant in end-stage renal failure receiving corticosteroids for an indication other than lupus nephritis", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-21.0, All Lupus Age: Less than 21 years at baseline exam Diagnosis: patients must meet for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS and SLE criteria The five diagnostic categories are SLE with no aPL SLE with aPL, but without manifestations of APS SLE-like APS SLE with APS Primary APS ", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 7.0-22.0, All Lupus Erythematosus, Systemic SlE subjects 4/11 of the American College of Rheumatology for SLE (23), age less than 22 years Neonatal SLE or drug-induced SLE Subjects who are pregnant, and subjects weighing over 300 pounds, as the densitometry techniques are not reliable above this weight Subjects receiving calcium or vitamin D supplementation will not be excluded but this information will be recorded and evaluated further in the dietary/nutritional assessment", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-65.0, All Lupus Erythematosus, Systemic age 18 to 65 years SLE as defined by the ACR classification Stable SLE (treatment not modified during the 2 months preceding the date W0) SLE treated by immunosuppressant only or systemic corticosteroids at a dose \u2265 5 mg/j or systemic corticosteroids at any dose associated with one or more immunosuppressive drugs SLE treated by hydroxychloroquine only months following females must have an effective method of contraception during the first 7 months of the study and with a negative serum or urinary pregnancy test females not wishing to have a child during the 7 months following W0 physical examination signed written and informed consent pregnant females or females wishing to have a child during the 7 months following W0 subjects infected with HIV and/or HBV( Ag HBs+) and or HVC medical history of allergy to any vaccine component receipt of any pneumococcal vaccine less than 5 years receipt of other vaccine within one month prior to enrolment (inclusion visit W0) receipt of immunoglobulin within three months prior to enrolment (inclusion visit W0) splenectomy hematopoietic disorders which give contra-indications to intramuscular and hypodermic route injections active malignancy , cirrhosis intercurrent illness within one month prior to enrolment (inclusion visit W0)", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Eythematosus (SLE) Fulfill the revised ACR for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI) Patients who are pregnant or nursing women, or those with life threatening disease", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Written Informed consent Age >18 yrs SLE meeting ACR {Tan, Cohen, et al. 1982 1482 /id} for at least 6 months.(SLE group) Stable disease activity as evidenced by no change in immunosuppressive therapy in the past 1 month If female of childbearing potential must use an effective method of birth control Renal disease (creatinine >1.5 mg/dL, dialysis, 2+ or more proteinuria) Previous or current history of peptic ulcer disease or gastrointestinal bleed Previous or current thromboembolic or ischemic cardiovascular event (stroke, myocardial infarction, angina) can do aspirin part of study Currently taking an anticoagulant or antiplatelet agent (besides aspirin) Thrombocytopenia (platelet count <135,000) Pregnancy Allergy to aspirin, NSAIDs NSAIDs in the previous week", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-999.0, All Spondylitis, Ankylosing Arthritis, Rheumatoid Psoriasis Arthritis, Psoriatic Participants with ankylosing spondylitis who did not show adequate response to general treatments and with increased serological indices related to severe axial symptoms and inflammation Participants with rheumatoid arthritis who show insufficient response to disease modifying antirheumatic drug (DMARD) including methotrexate Participants with serious, active and progressive disease not previously treated with methotrexate or other DMARD Participant with moderate to serious plaque psoriasis who are unresponsive, contra indicant or intolerable to the systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A (PUVA) Participant with active, progressive, psoriatic arthritis who have shown insufficient response to DMARD treatment ", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus (SLE) For SLE Subjects SLE patients who exhibit ongoing disease activity by greater or equal to 4 SLE patients whose disease activity is controlled by administration of corticosteroids, most commonly, at least 10 mg/day of prednisone years of age or older Updated vaccinations prior to study entry Use of effective contraception for male patients before, during and up to 12 weeks after sirolimus therapy For Healthy Control Subjects years of age or older Must be matched with one of the SLE patients enrolled in the study by age, gender and ethnic origin Must not have any acute or chronic illness For SLE Subjects Patients who are pregnant Patients with allergy or intolerance to sirolimus Patients with life-threatening manifestations of SLE Patients with proteinuria exceeding 500 mg/24 h or urine protein/creatine ratio >0.5 Patients with total cholesterol > 300 mg/dl or triglyceride > 400 mg.dl will be excluded Patients with acute infection requiring antibiotics Patients on sirolimus who develop infections and require intravenous antibiotics and fail to show clinical improvement in 5 days Patients concurrently undergoing B cell-depleting therapy, cyclophosphamide, cyclosporine, and tacrolimus Patients who have received investigational biologic B-cell depleting products within one year of study initiation", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-60.0, All Systemic Lupus Erythematosus High LDL Cholesterol Level SLE patients that on prednisolone more than 30 mg/day Normal liver faction: AST and ALT < 80 mg/dl Normal muscle enzyme : CPK < 100 U/L LDL cholesterol level > 100 mg/dl Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening Statin allergy On statin treatment before screening On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin Pregnancy Abnormal liver function: AST or ALT > 80 mg/dl Abnormal muscle enzyme : CPK > 300 U/L", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 1.0-17.0, All Purpura, Thrombocytopaenic, Idiopathic Subjects between 1 year and <18 years of age at Day 1 Written informed consent from subject's guardian and accompanying informed assent from subject (for children over 6 years old) Confirmed diagnosis of chronic ITP, according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments Day 1 (or within 48 hours prior) platelet count <30 Gi/L Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1 Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease) Concurrent or past malignant disease, including myeloproliferative disorder Subjects who are not suitable for continuation of their current therapy for at least 7 additional additional weeks Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1 History of platelet agglutination abnormality that prevents reliable measurement of platelet counts Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis) Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders) Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1 Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 19.0-60.0, All Posttraumatic Stress Disorders Outpatients between the 19-60 years of age with a diagnosis of PTSD Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study Subjects must be on stable medication (4 weeks minimum) for their PTSD (symptomatic despite current treatment), must be able to provide written informed consent, must be able adequately understand and comply with the study's instructions and protocol Those not meeting the and those not able to give informed consent Women who are currently pregnant or nursing Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness currently abusing alcohol or drugs currently being treated with an investigational medication or medication that is contraindicated with cannabinoids have a known allergy to cannabis-based products", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-80.0, All Metabolic Syndrome Cardiovascular Risk Factors Systemic Lupus Erythematosus Persons aged 18 and above Persons fulfill the diagnostic of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group a history myocardial infarction, angina or stroke", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Age > 18 years at the time of signing the informed consent form Fulfil at least 4 for SLE as defined by the American College of Rheumatology (ACR) Present with active SLE disease with at least one of the following symptoms i) Arthritis > 2 joints with pain and signs of inflammation (i.e. tenderness, swelling, or effusion) ii) Inflammatory-type skin rash iii) Oral ulcers Laboratory values as follows Hemoglobin \u2265 100 g/L Absolute neutrophil count \u2265 1.0 x 109/L Total bilirubin \u2264 1.5 x upper limit of normal (ULN) AST (SGOT) / ALT (SGPT) \u2264 2.5 x ULN Active severe SLE flare with central nervous system (CNS) manifestations, active renal lupus, systemic vasculitis, active pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol Severe renal impairment (estimated or measured GFR <50%) Oral treatment with corticosteroids (>15 mg/day prednisolone or equivalent) or changes in corticosteroid dosing within 30 days prior to the first dose of study medication. This also includes intraarticular steroid injections or topical treatment for SLE symptoms. Inhaled or topical steroids may be given for reasons other than SLE disease activity (such as asthma, contact dermatitis) as clinically indicated Intravenous corticosteroids within 3 months prior to the first dose of study medication Intravenous cyclophosphamide within 6 months prior to the first dose of study medication Treatment with anti-rheumatic/immunosuppressive drugs within 3 months prior to first dose of study medication, other than the following medications at stable doses: methotrexate (\u226425 mg/week), azathioprine (\u22642.5 mg/kg/day), hydroxychloroquine and mycophenolate mofetil (\u22643000 mg/day) B-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-65.0, All Inflammation Systemic Lupus Erythematosus Diagnosis of systemic lupus erythematosus (SLE) Disease duration: 6 months or longer Stable, mild to moderately active systemic lupus erythematosus (SLE) Receiving stable maintenance therapy Significant Lupus Nephritis Active central nervous system (CNS) disease Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start Body weight of 260 lbs/120 kg or more History of alcohol or substance abuse History of cancer Infections Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2) Tuberculosis Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All SLE no administration of drugs that would potentially influence QT duration except hydroxychloroquine no history of ischemic heart disease, congestive heart failure, atrial fibrillation, bundle branch block or abnormal serum electrolytes normal resting ECG and a good-quality ECG recording to measure the QT interval moderate or severe valve disease atrial fibrillation and other ECG abnormalities systolic left ventricular dysfunction (ejection fraction <50% or left ventricular end diastolic dimension >5.5 mm unreliable identification of the end of the T wave in the ECG and known presence of cardiac disease including hypertension, diabetes or coronary artery disease", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 10.0-45.0, All Systemic Lupus Erythematosus Sister Diagnosed with SLE Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40 Proband must have at least one biological sister \u2265 10 years of age and \u2264 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. Both full and half siblings qualify If above are met for the proband, there are no exclusions Sister who does not have SLE Female with a full or half sister who has been documented SLE that meets ACR criteria Sister must be currently between ages \u2265 10 and \u2264 45 at the time of enrollment and not have a diagnosis of SLE Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up Sister should communicate to the recruiter that she is willing to be followed for a period of at least two years by phone and/or internet If Sister meets there will be no exclusions", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-60.0, All Systemic Lupus Erythematosus Atherosclerosis Female SLE patients Age 18-60 years If premenopausal using a reliable method of contraception Clinically stable disease Taking hydroxychloroquine and up to 15mgs of prednisolone daily Smokers Pregnancy or breast feeding Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted) Use of any investigational drug within 1 month prior to screening Acute infections 2 weeks prior to Visit 1 History of ischaemic heart disease or end stage renal disease Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-65.0, All Systemic Lupus Erythematosus age 18-65 Diagnosis of SLE based on ACR presently enrolled in a yoga program osteoporosis (T score \u2265 -2.5) avascular necrosis taking quinolone in the preceding 3 months taking \u2265 30 mg of prednisone daily history of joint replacement or organ transplant Persons with any pre-existing condition that would prevent attendance at the yoga classes", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 10.0-999.0, All Infections, Papillomavirus Subject must be female Subject must be aged 10 and over Subject with obvious fever Subject with obvious severe acute disease Subject with hypersensitivity to any component of Cervarix\u00ae Other than above, subject who is in inappropriate conditions for vaccination", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 2.0-18.0, All Juvenile Idiopathic Arthritis Diagnosis must have been before the patient's 16th birthday Disease duration of at least 6 months before study entry Must have 5 or more joints with active arthritis Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [BSA] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate) May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry Must have qualifying laboratory values at the first visit Have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration Have initiated and/or immunosuppressive therapy within 4 weeks prior to study initiation", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Lupus Erythematosus Diagnosed with cutaneous lupus erythematosus and/or systemic lupus erythematosus by clinical, laboratory, and histopathological findings Ability to speak and read English or Spanish at a 6th grade reading level (a translator will be available with additional consent forms in Spanish) Ability to give written informed consent Less than 18 years of age, since the characteristics of the disease in these subjects could be very different Due to a medication, in which its discontinuation results in the resolution of cutaneous lupus, since the characteristics of the disease in these subjects could be very different Medical conditions who do not warrant a skin biopsy Unable to give written, informed consent or undergo a skin biopsy and/or venipuncture for any other reason", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-45.0, All Systemic Lupus Erythematosus All SLE (Systemic Lupus Erythematosus) pregnant women (aged 18 years) before 14 weeks of gestation, with autoimmune thyroid antibodies SLE (Systemic Lupus Erythematosus) patients already on levothyroxine. Those patients discovered to be hypothyroid who need levothyroxine as part of standard of care", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 5.0-21.0, All Systemic Lupus Erythematosus For SLE subjects: Subjects age 5-21 drawn from rheumatology clinic at Children's Hospital of Philadelphia diagnosed with SLE for at least 1 month. Also subjects with no known vertebral compression fracture of L2 For Control subjects: Subjects age 5-21. Controls will be a 50% male/female For SLE subjects: Subjects with SLE will be excluded if they have conditions or drug exposure unrelated to SLE and known to impact growth or bone health For Control subjects: Chronic disease or syndrome known to affect growth or bone health, prematurity (<37 weeks gestation), or use of any medication known to affect growth", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 20.0-999.0, All Systemic Lupus Erythematosus Subjects who gave consent to this study participation and signed into informed consent form Subjects who are at least 20 years of age at Screening visit Have a clinical diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification with 4 or more of the 11 ACR present, serially or simultaneously during any interval or observation Be on either no SLE medication or a stable SLE treatment regimen of any medication (e.g., low-dose prednisone, NSAIDs; alone or in combination) for a period of at least 2 months prior to the Screening visit Males and females. A female subject is eligible to enter the study if at least one of the following conditions apply Not pregnant or nursing Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to 1 of the following Complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, from 2 weeks prior to administration of the 1st dose of investigational product until 8 weeks after the last dose of investigational product; or Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the investigational product and for 8 weeks after the last dose of investigational product Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan),or high-dose prednisone (>60 mg/day) within 6 months prior to the Screening visit The subject has severe lupus kidney disease (defined by proteinuria > 6 g/day) within 6 months prior to the Screening visit Received IVIG or plasmapheresis within 6 months prior to Screening visit Active CNS lupus [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), motor neuropathy, vasculitis] requiring medical intervention within 6 months prior to Screening visit The subject has hypogammaglobulinemia or IgA deficiency (IgA level < 10 mg/dL) History of renal transplant History or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk History of any other medical disease, laboratory abnormalities, or conditions which would make the subject (in the opinion of the Investigator) unsuitable for the study History of any infection requiring hospitalization or parenteral antibiotics within 4 weeks prior to Screening visit The subject has an abnormality on 12-lead ECG at screening which is clinically significant in the opinion of the investigator", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-70.0, All Systemic Scleroderma Patients with SSc as defined by the American College of Rheumatology with diffuse cutaneous disease (except Group 5) at risk of disease progression Patients must have failed a prior >= 4-month course of either MMF/Myfortic or cyclophosphamide before being eligible for the study (determined at >= 1 week before start of mobilization); \"failure\" is defined as evidence of disease progression or absence of improvement; the response prior to MMF of cyclophosphamide will be assessed by the participating site study rheumatologist Patients must meet in at least 1 of the following 6 groups GROUP 1 Patients must have 1) both a and b below; and 2) either c, or d a) Diffuse cutaneous scleroderma as defined by skin thickening proximal to the elbows and knees and/or involving the torso in addition to distal extremity involvement; a skin score will be obtained but not used to determine b) Duration of systemic sclerosis =< 7 years from the onset of first non-Raynaud's symptom; for those patients with disease activity between 5-7 years from the onset of first non-Raynaud's symptom, recent progression or activity of disease must be documented c) Presence of SSc-related pulmonary disease with forced vital capacity (FVC) < 80% or hemoglobin-adjusted diffusing capacity for carbon monoxide (DLCO) < 70% of predicted AND evidence of alveolitis by high-resolution chest computed tomography (CT) scan and/or by bronchoalveolar lavage (BAL) (if high resolution computed tomography [HRCT] fails to show ground glass, then BAL for diagnosis of alveolitis must be confirmed); alveolitis by BAL cell count will be defined based on a BAL cell differential count (> 3% neutrophils and/or > 2% eosinophils) from any lavaged lobe d) History of SSc-related renal disease that may not be active at the time of screening; stable serum creatinine must be documented for a minimum of 3 months post-renal crisis at the time of the baseline visit; history of scleroderma hypertensive renal crisis is included in this criterion and is defined as follows History of new-onset hypertension based on any of the following (measurements must be repeated and confirmed at least 2 hours apart within 3 days of first event-associated observation, with a change from baseline) Subjects with pulmonary, cardiac, hepatic, or renal impairment that would limit their ability to receive cytoreductive therapy and compromise their survival; this includes, but is not restricted to, subjects with any of the following Pulmonary dysfunction defined as Severe pulmonary dysfunction with (1) a hemoglobin corrected DLCO < 40% of predicted at the Baseline Screening visit, or (3) FVC < 45% of predicted Baseline Screening visit, or Partial pressure (pO2) < 70 mmHg or pCO2 >= 45 mmHg without supplemental oxygen, or O2 saturation < 92% at rest without supplemental oxygen as measured by forehead pulse oximeter Significant pulmonary artery hypertension (PAH) defined as Peak systolic pulmonary artery pressure > 50 mmHg by resting echocardiogram will require right heart catheterization; if pulmonary artery pressure (PAP) is not evaluable on echocardiogram due to lack of a Tricuspid regurgitant jet, then normal anatomy and function as evidenced by normal right atrium and ventricle size, shape and wall thickness and septum shape must be documented to rule-out PAH; otherwise, right heart catheterization is indicated; prior history of PAH but controlled with medications will not patients from the protocol; PAH is considered controlled with medications if peak systolic pulmonary artery pressure is < 45 mmHg or mean pulmonary artery pressure by right heart catheterization is < 30 mmHg at rest Mean pulmonary artery pressure by right heart catheterization exceeding 30 mmHg at rest; if mean PAP is elevated and pulmonary vascular resistance and transpulmonary gradient are normal then the patient is eligible for the protocol New York Heart Association (NYHA)/World Health Organization Class III or IV Cardiac: Uncontrolled clinically significant arrhythmias; clinical evidence of significant congestive heart failure (CHF) (NYHA Class III or IV); left ventricular ejection fraction (LVEF) < 50% by echocardiogram or prior insertion of a pacemaker or cardioverter-defibrillator", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Vitamin D Deficiency Systemic lupus erythematosus Age > 18 years Serum vitamin D levels [25(OH)D] < 30 ng/mL Low to moderate active disease without modification of associated treatments Pregnancy Serum 25(OH)D levels > 30 ng/mL Flare requiring modification of treatments", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Brain Metastases Small Cell Lung Cancer Brain metastases Age \u2265 18 years Signed informed consent Recursive Partitioning Analysis (RPA) class III patients Recursive Partitioning Analysis (RPA) class I-II patients and >3 brain metastases Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT) Previous whole brain radiotherapy", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Male or female of \u226518 years of age Written informed consent Diagnosis of SLE satisfying at least 4 out of the 11 ACR during the course of their illness Disease duration of at least 6 months score \u2265 6 at screening Positive test results for antinuclear antibody (ANA) (HEp-2 ANA \u22651:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (\u226530 IU/mL) at screening Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential Increase in dosing of corticosteroids within 2 weeks prior to screening Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening Change in dosing of immunosuppressants or corticosteroids during the screening period Serum IgG < 6g/L Estimated Glomerular Filtration Rate (GFR) <50 mL/min/1.73m\u00b2 Urinary protein:creatinine ratio >2 mg/mg History of demyelinating disease Breastfeeding or pregnancy Legal or limited legal capacity Additional", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-30.0, All Schistosomiasis Bilharziasis Urinary Schistosomiasis All subjects had to meet the study within 21 days prior to treatment Caucasian volunteers No smoker biological parameters (haematological, biochemical, renal and hepatic) in normal range Health Insurance sign inform consent inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) any immunological deficiency any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) current immunosuppressor treatment any other medication use within 2 weeks before the study any vaccination within the last 6 months no antibodies against Sh28GST protein", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-90.0, All Systemic Lupus Erythematosus Patients with systemic Lupus erythematosus Patients without systemic Lupus erythematosus", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Immune Thrombocytopenia Systemic Lupus Erythematosus Patients older than 18 years old Immune Thrombopenia according to the American Society of Hematology (ASH) guidelines 2011 Positive antinuclear antibodies > 1/160e on Hep2 cells Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative disorders...)", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus Patients diagnosed as cutaneous lupus erythematosus (CLE) Patients receiving corticosteroid more than 15mg/day of the equivalent dose of prednisolone Patients whose CLASI activity scores were less than 4 point at the initiation of Screening (Visit 1) and Day1 (Visit 2) (evaluated by a dermatology specialist) Patients whose fluctuations of CLASI activity scores were \u226520% between Visit 1 and Visit 2 (evaluated by a dermatology specialist). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Have completed the BEL113750 Protocol in Northeast Asia through Week 48 Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in BEL113750 Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Key Black race Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria Active SLE disease Autoantibody-positive On stable SLE treatment regimen which may corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate) Key Pregnant or nursing Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab) at any time Have received treatment with an investigational biological agent in the past year Have received intravenous (IV) cyclophosphamide within the past 90 days Have severe active lupus kidney disease Have severe active central nervous system (CNS) lupus Have required management of acute or chronic infections within the past 60 days Have current drug or alcohol abuse or dependence Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Have a history of severe allergic reaction to contrast agents or biological medicines", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 5.0-17.0, All Systemic Lupus Erythematosus years to 17 years of age at enrollment Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria Have active SLE disease (SELENA score \u2265 6) Have positive anti-nuclear antibody (ANA) test results Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days prior to Day 0 Females of childbearing age are willing to use appropriate contraception Subject age appropriate assent and parent or legal guardian informed consent to participate Pregnant or nursing Have received treatment with belimumab (BENLYSTA\u00ae) at any time. (BENLYSTA\u00ae is a registered trademark of the GSK group of companies.) Treatment with any B cell targeted therapy (for example, rituximab) or an investigational biological agent in the past year Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or plasmapheresis within 90 days of Day 0 Have received high dose prednisone or equivalent (>1.5mg/kg/day) within 60 days of baseline Have received intravenous (IV) cyclophosphamide within 60 days of Day 0 Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent within 60 days of baseline Have severe lupus kidney disease Have active central nervous system (CNS) lupus Have had a major organ transplant", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-64.0, All Inflammation Systemic Lupus Erythematosus Men and women (not pregnant and not nursing) Subjects with SLE meeting the American College of Rheumatology (ACR) with a disease duration of at least 6 months Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA) If taken, background medication must be stable Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 12.0-60.0, All Systemic Lupus Erythematosus The American College of Rheumatology established eleven in 1982,which were revised in 1997 as a classificatory instrument to operationalise the definition of SLE in clinical trials Malar rash (rash on cheeks) Discoid rash (red, scaly patches on skin that cause scarring) Serositis: Pleurisy (inflammation of the membrane around the lungs) or pericarditis (inflammation of the membrane around the heart) Oral ulcers (includes oral or nasopharyngeal ulcers) Arthritis: nonerosive arthritis of two or more peripheral joints, with tenderness, swelling, or effusion Photosensitivity (exposure to ultraviolet light causes rash, or other symptoms of SLE flareups) Blood\u2014hematologic disorder\u2014hemolytic anemia (low red blood cell count) or leukopenia (white blood cell count<4000/\u00b5l), lymphopenia (<1500/\u00b5l) or thrombocytopenia (<100000/\u00b5l) in the absence of offending drug. Hypocomplementemia is also seen, due to either consumption of C3 and C4 by immune complex-induced inflammation or to congenitally complement deficiency, which may predispose to SLE Renal disorder: More than 0.5 g per day protein in urine or cellular casts seen in urine under a microscope Antinuclear antibody test positive Poor compliance With lupus mental damage complication, occurrence of epilepsy or unable to express subjective symptoms during the observation period Taking drugs that affect cytochrome P450 2B6, cytochrome P450 3A4 and cytochrome P450 2C19, except corticosteroids Abnormal liver function", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Key Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria Active SLE disease Autoantibody-positive On stable SLE treatment regimen which may corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate) Key Pregnant or nursing Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days Have received a live vaccine within the past 30 days Have severe active lupus kidney disease Have severe active central nervous system (CNS) lupus Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Key Clinical diagnosis of active SLE Autoantibody-positive Current SLE treatment includes and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics) Key Have received treatment with an investigational agent within the past year Are currently enrolled in a placebo-controlled (belimumab) clinical trial or a continuation trial in which belimumab is used as an investigational agent Have a history of exposure, but are not currently receiving Current SLE treatment includes only an antimalarial (for example, hydroxychloroquine) or only steroids", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-60.0, All Antiphospholipid Syndrome Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or a\u03b22GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations Selected History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis History of Transient Ischemic Attack Confirmed by a Neurologist SLE Diagnosis based on the ACR Classification > 4/11 Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Current Hydroxychloroquine or another antimalarial treatment (-3 months) Current warfarin treatment (-3 months) Current heparin therapy( -3 months) Current pregnancy History of Hydroxychloroquine eye toxicity History of Hydroxychloroquine allergy", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-70.0, All Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid have active DLE or active SCLE confirmed by histological analysis have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of >6 and current or historical positive ANA or anti-dsDNA have an active skin lesion that can be biopsied if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening have an active skin disease other than CLE have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence) have used a topical corticosteroid on active lesion have donated blood (volume >=500 mL) within 56 days prior to screening has been treated with drugs that are associated with CLE induction within 2 months prior to the screening have been treated with >10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-60.0, All Eyebrow Hypotrichosis Thin Eyebrow male or female aged 18-60 years hypotrichosis of eyebrows healthy informed consent obtained underlying diseases alopecia areata or trichotillomania thyroid diseases pregnancy or breast feeding previous eyebrow tattoo, trauma or accident history of eyebrow or hair medications in 6 months history of minoxidil or its ingredient allergy history of eyebrow surgery", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Cetuximab-induced Papulopustular (Acneiform) Rash Who Have Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient Patients must provide written informed consent to participate in the study Anticipated initiation of cetuximab treatment with or without additional chemotherapy Able to self-administer topical interventions or provide for another person to apply the topical interventions Females of childbearing potential who are pregnant or nursing Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion) Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 \u00b1 2 days through day 28 \u00b1 2 days) Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only) Previous therapy with cetuximab within 6 months of consent", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-70.0, All Systemic Lupus Erythematosus SLE Able and willing to give written informed consent and comply with requirements of the study Age 18 years, inclusive, at randomization Diagnosis of SLE, per ACR [32] m-SLEDAI score < 4 at screening visit (SLEDAI score without serologies) Physician Global Assessment (0-3) score of 1 or less at screening visit On a stable dose of MMF (1000-3000 mg/day) for at least 12 weeks prior to randomization Total duration of stable or decreasing MMF therapy must be at least two years for subjects initiating MMF for renal indications (with or without concurrent extra-renal manifestations), or one year for subjects initiating MMF for extra-renal indications A history of life-threatening neuropsychiatric SLE within 1 calendar year prior to randomization Any of the following laboratory abnormalities at the screening visit Proteinuria as defined by a spot protein/creatinine ratio > 1.0 mg/mg Serum creatinine > 2.0 mg/dL Transaminases > 2.5x the upper limit of normal (ULN) Hemoglobin < 9 g/dL, unless the subject has documented hemoglobinopathy White blood count (WBC) < 2000/mm3 (equivalent to < 2 x109/L) Neutrophils < 1000/mm3 (equivalent to < 1 x109/L) Platelet count < 75,000/mm3 (equivalent to < 75 x 109/L) Prednisone > 25 mg/day (or its equivalent) within 24 weeks prior to randomization for lupus activity", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-75.0, All Alopecia Areata Patients between 18 to 75 years of age Patients with a diagnosis of patch type alopecia areata Patients will have >30% and <95% total scalp hair loss at baseline as measured using the SALT score. Two patients with current episodes of alopecia totalis/universalis may be included in this study Duration of hair loss greater than 3 months No evidence of regrowth present at baseline Patients may be na\u00efve to treatment or unresponsive to intralesional (IL) steroids or other treatments for alopecia areata Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis Patients in whom the diagnosis of alopecia areata is in question Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma) that in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration Women who are pregnant or nursing Patients known to be HIV or hepatitis B or C positive Patients with history or evidence of hematopoietic abnormality Patients with <200K platelet count at baseline Patients with history or evidence of renal or hepatic impairment Patients with history of immunosuppression or history of recurrent serious infections", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 0.0-999.0, All Systemic Lupus Erythematosus (SLE) Male or female subject, major or minor of any age with SLE (defined according to the ACR criteria) Onset pediatric (<18 years) OR Syndromic Lupus (associated with growth retardation, neurological deficit not related to lupus, frostbite, lymphoproliferation, the kidney malformations, heart, lung, brain calcifications) OR Lupus in context with familial consanguinity OR Familial cases (2 cases of SLE related first degree relative) OR related topic of the first degree to a lupus patient participant (if family lupus or related parents) A person or beneficiary entitled to a social security scheme or similar Informed consent signed by the person (or parent / holding parental authority for minors) none", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 8.0-18.0, All Systemic Lupus Erythematosus (SLE) Subjects who meet the following will be allowed to participate in the study Complete immunization history must be available at time of enrollment Patients will be aged 8-18 years at time of enrollment Patient will have stable disease activity (no changes in >2 points) during the 3 months preceding enrollment Patients can be enrolled as soon as the seasonal IIV is available and prior to the onset of influenza activity in the community. Generally this will be between September 2013-January2014. If feasible, enrollment will end in December 2013, which is usually before influenza circulates widely in the community Subjects who meet the following will not be allowed to participate in the study Females who are known to be pregnant or breastfeeding Moderate to high SLE disease activity at enrollment (SLEDAI >6) Oral temp \u2265100F (\u226537.8) within 72 hours prior to vaccination History of allergy to egg or egg products or history of allergic reaction to previous influenza vaccination or vaccine constituent History of Guillain-Barr\u00e9 syndrome after previous immunizations Unstable SLE disease activity during 3 months prior to enrollment (change in score >2) Requirement for high-dose IV Solumedrol and/or Cytoxan pulse therapy during 6 months prior to study Any condition that study site investigator deems would put patient at unacceptable risk of injury or render patient unable to meet requirements of the protocol Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-70.0, All Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid Healthy Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE) Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE) Confirmed diagnosis of SLE using American College of Rheumatology and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE) An active skin lesion that can be biopsied (for participants with lupus erythematosus) Known or thought to have a diagnosis of drug-induced lupus An active skin disease that is not a manifestation of lupus erythematosus Has an acute cutaneous lupus erythematosus rash only If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1 Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1 Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Fulfill at least 4 diagnostic for SLE defined by American College of Rheumatology Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA) Active SLE disease as defined by score \u226510 despite on-going stable corticosteroid therapy Subjects with stable nephritis may be enrolled years of age or older Severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes Malignancy within past 5 years Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C Liver disease Anemia, neutropenia, or thrombocytopenia Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections History of active tuberculosis or a history of tuberculosis infection Pregnant or nursing", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-75.0, All Lupus Erythematosus Graft-versus-host Disease Four or more American College of Rheumatology (ACR) for the classification of SLE or 4 or more of the SLICE Involvement of one or more of the following organ systems: renal, neurologic, hematologic, cardiac, pulmonary, gastrointestinal A lack of response to corticosteroids in moderate-to-high doses, and to either an equivalent degree of immunosuppression with azathioprine, methotrexate, cyclosporin, tacrolimus, belimumab, rituximab, mycophenolate mofetil, and/or appropriate other treatment Patients should be eligible for transplantation according to the BMT Policy Manual Age less than 18 years and over 75 years Any risk of pregnancy Patients who are preterminal or moribund", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Systemic Lupus Erythematosus Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study Be 18 years of age at the Day 0 visit Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol Able to provide written informed consent to participate Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0 Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Cutaneous Lupus Any male or female 18 years or older of age with a diagnosis of cutaneous lupus by a dermatologist Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed Able to complete the study and comply with study instructions, including attending all study visits Individuals younger than 18 years of age Known allergy or sensitivity to study medication Inability to complete all study-related visits Introduction of any other prescription medication, topical or systemic, for cutaneous lupus while participating in the study", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Rash Due to Epidermal Growth Factor Receptor Inhibitors Age 18 years and older Subjects with any cancer receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis Scheduled to start Cetuximab or Panitumumab treatment Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or with a negative subunit hCG pregnancy test immediately prior to study entry Able to understand and provide signed informed consent Ability to reliably apply topical FDX104 and vehicle twice a day to the appropriate part of the face Willingness to minimize sun exposure for 5 weeks from randomization ECOG performance status 0-2 Prior allergic reaction or severe intolerance to Doxcycycline and/or other tetracyclines Prior allergic reaction or severe intolerance to soy or coconut oil Cutaneous metastases on the face or might spread to the face The presence of any active skin disease (e.g., eczema), tattoos or other problems at application site, (i.e., located on the face) that, in the investigator's opinion, could confound the evaluation of the rash or make topical application unacceptable Hair on the face (e.g beard) which would interfere with the application of the study drug or its evaluation ANC <1,500/mm3 (or<1.5x109/L), or Platelet count < 100,000/mm3 (or <100x109/L) Abnormal renal functions: Serum creatinine >1.6 mg/dL or 142umol/L (SI units) or calculated estimated creatinine clearance <40 ml/min1.73 m2 based on Cockcroft and Gault formula Abnormal hepatic functions: Serum Aspartate transaminase (AST) or alanine tansaminase (ALT) >5 institutional upper limit of normal (ULN). Or Total billirubin > 2 x institutional ULN or >5 x institutional ULN if documented liver metastasis Any clinically significant safety laboratory results that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study Any clinically significant finding on the physical examination that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Lupus Nephritis Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria Positive antinuclear antibody (ANA) or positive anti-ds DNA test results at visit -1 or any time within 14 days before visit -1 Active proliferative lupus nephritis, as defined by either of the following Kidney biopsy documentation within the last 3 months of ISN/RPS proliferative nephritis: Class III, Class IV, or Class V in combination with Class III or IV Active urinary sediment and kidney biopsy documentation within the last 12 months of ISN/RPS proliferative nephritis: Class III, Class IV, or Class V in combination with Class III or IV. Active urinary sediment is defined as any one of the following >5 RBC/hpf in the absence of menses and infection >5 WBC/hpf in the absence of infection; or Cellular casts limited to RBC or WBC casts UPCR >1 at study entry based on a 24-hour collection Ability to provide informed consent New onset lupus nephritis, defined as lupus nephritis for which the participant has not yet been treated with either mycophenolate mofetil or cyclophosphamide Neutropenia (absolute neutrophil count <1500/mm^3) Thrombocytopenia (platelets <50,000/mm^3) Moderately severe anemia (Hgb < mg/dL) Moderately severe hypogammaglobulinemia (IgG <450 mg/dL) or IgA <10mg/dL Positive QuantiFERON TB Gold test results Pulmonary fibrotic changes on chest radiograph consistent with prior healed tuberculosis Active bacterial, viral, fungal, or opportunistic infections Evidence of infection with human immunodeficiency virus (HIV), hepatitis B (as assessed by HBsAg and anti-HBc) or hepatitis C", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-64.0, All Lupus Erythematosus, Systemic age 18 years American College of Rheumatology (ACR) diagnosis of SLE (1997 revised see appendix 1) Severe SLE flare at screening (see also section 5.2.3.2.), defined as a situation in which 1 or more of the following are met Increase in (SLE Disease Activity Index) with 12 or more points New or worse SLE-related activity of major organs, i.e.: central nervous system (CNS-) SLE (includes NPSLE), vasculitis, nephritis, pericarditis and/or myocarditis, myositis, thrombocytopenia < 60, hemolytic anemia < 4.4mmol/L (=7.0g/dL) Refractory disease, defined as persisting or progressive disease activity (SLEDAI > 6 points) despite conventional immunosuppressive treatment and 1 or more of the following failure of the initial induction treatment at six months, for which a switch to another induction therapy regime has already been carried out intolerance or contraindication for cyclophosphamide and mycophenolate mofetil (MMF) exceeding a cumulative dose of 15 gram of cyclophosphamide a second relapse within two years after start of the initial induction therapy Active pregnancy, as proven by a positive urine beta-HCG (human chorionic gonadotropin) test or a positive serum beta-HCG Significant B-cell depletion (peripheral B-cell counts < 60x10E6) Significant hypogammaglobulinemia (IgG < 8.0 g/L) Immunization with a live vaccine 1 month before screening Active infection at time of screening, as follows Hospitalization for treatment of infection within previous 2 months of day 0 of the study Use of parenteral (intravenous of intramuscular) antibiotics ( including anti-bacterial, anti-viral, anti-fungal or anti-parasitic agents) within previous 2 months of day 0 of the study", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-70.0, All Thrombocytopenia Patients fulfilled the 1997 ACR modified or SLICC classification of SLE\uff1b New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months Thrombocytopenia caused by other reasons, including drugs\uff1b Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection Active HP(Helicopter pylori) infection Severe liver and kidney dysfunction\uff1b Severe neuropsychiatric lupus\uff1b No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment\uff1b Uncontrolled diabetes or hypertension before entry Active GI bleeding 3 months before entry Intolerant to HCQ in the past treatment history\uff1b", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-999.0, All Lupus Erythematosus man and women over 18 YO suffering from SLE (American College of Rheumatology criterias) without SLE flare for 3 months with a signed consent and social security affiliation (required in France) Viral infection within 15 days Other chronic inflammatory disease People with special protection (defined in articles : L1121 \u00a75-8 et articles L3212-\u00a71-3 of French healt care law)", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-35.0, All Systemic Lupus Erythematosus SLE patients Female patients aged 18-35 years Fulfilling the American College of Rheumatology (ACR) for the classification of SLE Having participated in the investigators' original HPV study in 2010 Able to give written informed consent Controls Women aged 18-35 years, matched those of SLE patients recruited No known chronic medical diseases Having participated in our HPV study in 2010 ", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 6.0-999.0, All Systemic Lupus Erythematosus diagnosed with lupus by a qualified physician consents to have 23andMe (via a partner) contact the physician to obtain medical record information willing to submit a saliva sample for DNA testing and complete online surveys related to condition at least 6 years old (minors under 18 require parental consent to enroll) access to the internet resides in the United States ", "label": "2"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-75.0, All Systemic Lupus Erythematosus Eligible male and female subjects, Age \u2265 18 and \u2264 75 years with Body mass index \u2265 18 and \u2264 35 kg/m2 at screening visit Diagnosed SLE (defined by \u2265 4 of the 11 American College of Rheumatology (ACR) classification for SLE) for at least 3 months before screening Moderate to severe SLE disease activity demonstrated by total score \u2265 6, including skin and joint involvement CLASI Activity score \u2265 5 or at least 5 of 66/68 joints with pain and signs of inflammation Positive anti-nuclear antibodies (ANA) test at screening No change in concomitant medication for SLE activity maintenance and symptom control regarding type of medication and dose level for at least 8 weeks prior to baseline (for steroids and NSAIDs/pain medication 2 weeks) Normal electrocardiogram (ECG) Active, severe neuropsychiatric SLE defined as any neuropsychiatric element scoring BILAG level A disease or lupus nephritis Diagnosed psoriasis Presence or history of malignancy within the previous 5 years Systemic antibiotic treatment within 2 weeks before baseline visit A positive diagnosis for viral hepatitis B or hepatitis C or Human immunodeficiency virus (HIV) or tested positive for tuberculosis as assessed or recent infection with Herpes Zoster or Herpes Simplex (Type 1 and Type 2), Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection or reactivation at screening Clinically significant hematologic abnormalities attributed to SLE: Haemoglobin < 8 g/dL; Platelets < 50 E9/L; Leucocytes < 2.0 E9/L Active or history of inflammatory bowel disease (including active or history of colitis) Received the following medications Rituximab within the last 48 weeks before screening Belimumab within the last 12 weeks before screening", "label": "1"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-75.0, All Systemic Lupus Erythematosus Patients with SLE according to the ACR revised criteria Quiescent disease without flare since at least one year (SELENA < or equal to 4, BILAG C, D or E, PGA 0) _ Treatment with 5 milligrams/day of prednisone since at least 1 year failure to sign the informed consent or unable to consent Patient participating to another clinical trial Pregnancy or plan to become pregnant", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-60.0, All Androgenetic Alopecia Men and women, age 18-60 with AGA Completed informed consent form Ludwig stage 1-2 for women Norwood Hamilton Stage 3 to 5 for men Pregnancy or breastfeeding Younger than 18 years Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 3 months of enrolling in the study History of hair transplantation Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2 weeks prior to screening Facial cancer (squamous and basal cell carcinoma, melanoma) Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia) Hemodynamic instability Acute infection Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception: vitiligo and alopecia areata)", "label": "0"} +{"topic": "A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.", "doc": "eligible ages (years): 18.0-65.0, All Systemic Lupus Erythematosus Patients between 18 and 65 years old, male or female, of any race Historical presence of at least 4 of 11 of the ACR Classification 34 Evidence of a positive ANA (\u22651:80 titer) or positive dsDNA antibody test within 6 months of screening Clinically active SLE determined by score \u22656 and the presence of one BILAG A or two BILAG Bs at screening, despite standard of care therapy If BILAG A or two BILAG Bs in the Renal organ system, must have completed at least 6 months of therapy with either mycophenolate mofetil or cyclophosphamide for the current episode of nephritis Able and willing to give written informed consent Active CNS lupus affecting mental status Active lupus nephritis requiring dialysis Laboratory exclusions: eGFR <30, WBC <2.0/mm3, hemoglobin <8 g/dL, platelet count <30,000/mm3, AST or ALT >4 times upper limit normal; Positive testing for HIV, hepatitis B or hepatitis C Pregnant or breast feeding; males or females not willing to use adequate contraception History of renal transplantation Herpes zoster within the past 90 days or any infection requiring hospitalization or intravenous antibiotics within the past 60 days Clinically significant EKG or chest x-ray changes Any other medical condition, related or unrelated to SLE, which in the opinion of the investigator would render the patient inappropriate or too unstable to complete study protocol Use of prednisone >0.5 mg/kg (or equivalent corticosteroid) within 1 month of Baseline visit Change or addition to immunosuppressant regimen within 3 months of Baseline visit (except corticosteroids); Use of other experimental therapeutic agents within 3 months of Baseline visit", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 16.0-999.0, All Appendicitis Criteria:patients with appendicitis, not receiving operation - nil", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-999.0, All Appendicitis Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis Able to take medicine orally after recovering from surgery If female, using birth control History of allergy to any study medication Life expectancy < 72 hours II (health) score > 25 Neutropenic (low white blood cell count) HIV positive with current or past CD4 count < 200/mm^3 Low platelet count (bleeds easily) Malnourished with low albumin Condition requiring use of major tranquilizers", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 15.0-999.0, All Appendicitis Gastroenteritis Patients with acute appendicitis Patients with acute gastroenteritis Patients older than 15 years of age Other acute abdominal diseases", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 12.0-80.0, All Perforated Appendicitis All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent Age less than 12 years older than 80 years perforated appendicitis was not revealed by pathologic investigation diverticulitis being diagnosed during surgery pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation the patient declining to enroll in this study", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 8.0-18.0, All Appendicitis Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 15.0-999.0, All Appendicitis age over 15 years suspected acute appendicitis suitability for laparoscopy patients refusal to participate lack of a laparoscopic surgeon", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-999.0, All Appendicitis Adult patient with acute appendicitis Children", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-60.0, All Acute Appendicitis Age range from 18 to 60 years CT scan diagnosed uncomplicated acute appendicitis Age under 18 years or age over 60 years Pregnancy or breast-feeding Allergy to contrast media or iodine Renal insufficiency metformin medication (DM) Peritonitis (a perforated appendix) Lack of co-operation (unable to give consent) A severe other medical condition CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-999.0, All Acute Appendicitis Patients will be at least 18 years of age Male or female (excluding pregnant females) Patients with ASA \u2266 3 Patients informed about the study, and will have read; understood and signed the patient informed consent. Patients will be willing and able to submit to postoperative follow-up evaluations Patients have previous history of abdominal surgery Patients with ASA > 3 Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation Patients who are incompetent in giving consent", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 8.0-14.0, All Peritoneal Dessication Damage and Inflammation Peri-operative Hypothermia Healthy volunteers aged 8-14 years presenting to Starship Children's Hospital (Auckland, New Zealand) within the study period diagnosed clinically with acute appendicitis requiring diagnostic laparoscopy +/ appendicectomy Consent to participate in study not obtained, partial or total blindness, unable to speak and read sufficient English, presence of any abdominal prostheses, diagnosis of mental retardation, developmental delay, neuromuscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness, immunosuppression, allergy to morphine, and history of previous abdominal surgery", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 2.0-18.0, All Appendicitis All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon Consent to participate Uncertainty about the diagnosis The need for laparotomy for another reason Free intraperitoneal air on imaging Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 14.0-999.0, All Lower Abdominal Pain Right Iliac Fossa Pain Acute Appendicitis Age >14 years Lower / RIF Abdominal Pain Clinical Suspicion of Acute Appendicitis i.e Alvarado Score 5-6 (equivocal for acute appendicitis) Alvarado Score 7-8 (probably appendicitis) Alvarado Score 9-10 (highly likely appendicitis) Informed consent (patient or legal representative) Diffuse peritonitis Antibiotic (Penicillin) documented allergy Ongoing previously started antibiotic therapy Previous appendectomy Positive pregnancy test IBD history or suspicion of IBD recrudescence", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 12.0-65.0, All Gangrenous Appendicitis patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study patients under 12 or older 65 years old Patients with possible immunosuppression such as diabetes, cancer, kidney failure, liver failure Pregnancy Patients who have received antibiotic treatment within seven days before surgery Patients difficult to monitor or follow up", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 3.0-18.0, All Appendicitis Chief complaint of acute appendicitis Patients with symptoms greater than 7 days", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-999.0, All Appendicitis Abdominal Pain Abdominal Sepsis Age >18 years of age (subject to the current ethics approval protocol, may change) Clinical suspicion of appendicitis as the primary or differential diagnoses Patients able to provide informed consent Age <18 years of age (subject to the current ethics approval protocol, may change) Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis Pregnancy Patients with impaired consciousness Patients not able to provide informed consent Patients that will receive an appendicectomy as part of another elective procedure", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 1.0-14.0, All Complicated Appendicitis Children age 1-14 years CA that was defined by one of the followings Demonstration by abdominal ultrasound (US) and/or computed tomography (CT) of appendix perforation and/or peri-appendicular abscess Demonstration by abdominal ultrasound (US) of free fluid, and signs of diffuse peritoneal irritation in the right lower quadrant of the abdomen 3 Documented allergy to any of the study medications, acute or renal insufficiency at admission, and severe septic shock at admission", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 16.0-95.0, All Appendicitis all patients undergoing appendectomy for suspected appendicitis preexisting liver disease", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 15.0-80.0, All Appendicitis Patients with appendicitis Any patient with immunosuppressive or immunodeppressive known pathological conditions Any patient with a pathological report describing a normal appendix", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-999.0, All Appendicitis Age above 18 years Patients undergoing diagnostic laparoscopy for acute appendicitis American Society of Anaesthesiology group 1-3 General Anaesthesia Inability to cooperate Inability to understand and talk danish Allergic to ropivacaine Drug and alcohol abuse Pregnancy or nursing", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 15.0-44.0, All Appendicitis Emergency department visit with suspected symptoms and signs of acute appendicitis Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis Willing to provide telephone or cell phone numbers for follow-up Signed informed consent provided prior to study entry Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs Prior history of surgical removal of the appendix", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 6.0-90.0, All Appendicitis Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age < 6 and > 90y", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-85.0, All Rectum Cancer Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology The rectum cancer is the first malignant neoplasm the patient has got The cancer is solitary, and is 3cm to 20cm to the anus The surgical method is limited to Dixon Being in the acute phase of inflammation before operation and emergency surgery Patients receiving steroid medication or preoperative radiotherapy\u3002 Discovering macrometastasis before or in the operation The rectum cancer that can't be radical resected", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-75.0, All Shoulder Pain English speaking patient Female Age 18-75 must undergo laparoscopic surgery willing to participate in the study Male patients Under 18 or older than 75 Laparoscopic procedures that get converted to laparotomy Intraoperative hemorrhage more than 500 cc Patients with active joint disease History of shoulder surgery Intraoperative laceration to the liver Malignancy Long term daily narcotic use Chronic right upper quadrant/ shoulder pain", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 0.0-999.0, All Appendicitis All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 December 2010 Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure Patients non-resident in Scotland", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 0.0-999.0, All Appendicitis All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 December 2010 Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure Patients non-resident in Scotland", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-999.0, All Appendicitis Patients operated for the clinical suspicion of acute appendicitis that will undergo a diagnostic laparoscopy Age \u2265 18 years Written informed consent Diagnostic laparoscopy and planned appendectomy for an appendectomy a froid Primarily chosen for an open appendectomy Not able to give informed consent (for example language barrier or legally incapable) Refused informed consent", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 2.0-12.0, All Appendicitis All patients aged 2 years old who within the 10 year period of January 2001 December 2010 are entered on the SMR01 database as having a code for appendicectomy Episodes will be extracted with the following codes OPCS (Office of Population Censuses and Surveys), revision 4.5 H01 Emergency excision of appendix We will patients for whom incidental appendicectomy has occurred at the same time as another major abdominal surgical procedure We will patients who are non-resident in Scotland since we will be unable to derive depravity index and urban-rural classification, and may not have access to information on co-morbidities and mortality", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 0.25-16.0, All Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 5.0-18.0, All Suppurative Appendicitis Pediatric patients aged 5-18 Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800 Intraoperative findings of suppurative appendicitis Pregnancy Complex medical history not appropriate for same day discharge", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-999.0, All Appendicitis patients in emergency department with right lower quadrant pain patients under 18 years old pregnant women", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 8.0-17.0, All Appendicitis English and non-English speaking patients Age : 8-17 years US or CT confirmed early appendicitis with US showing hyperemia, \u2264 1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon or CT showing hyperemia, fat stranding, \u2264 1.1 cm in diameter, no abscess, no fecalith, no phlegmon White Blood Cell count > 5,000/\u00b5L and \u2264 18,000/\u00b5L Abdominal pain \u2264 48hours prior to receiving antibiotics History of chronic intermittent abdominal pain Pain > 48 hours prior to first antibiotic dose Diffuse peritonitis Positive urine pregnancy test White Blood Cell \u2264 5,000/\u00b5L or \u2265 18,000/\u00b5L Presence of a fecalith on imaging Evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon Communication difficulties (e.g. severe developmental delay)", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-80.0, All Cholelithiasis age higher than 18 and lower than 80 American Society of Anesthesiologists class (ASA) I-II absence of any previous anesthetic complication accompaniment by a responsible adult during 24 hours symptomatic gallstones candidate to cholecystectomy and a signed informed consent a Body Mass Index (BMI) higher than 35 any laparoscopic contraindication acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy anti-inflammatory allergy psychiatric history that could hinder ambulatory procedure", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-80.0, All Cancer Pancreas Patients of locally advanced pancreatic cancer with Major venous infiltration / thrombosis of the portal vein or superior mesenteric vein extending for several centimeters Tumor encasement (\u2265180\u00b0) of the superior mesentric artery or proximal hepatic artery Tumor abutment (<180\u00b0) of the celiac trunk Tumor invasion of the aorta Presence of metastasis to lymph nodes beyond the field of resection Histopathologically proven ductal adenocarcinoma of the pancreas (biopsy /cytology) Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1 Age: 18 to 80 years At least one of the diameters of the primary tumor or regional lymph node or both should be greater than 4 cm, as confirmed on contrast-enhanced computed tomography (CECT) Histopathology other than ductal adenocarcinoma pancreas Prior radiotherapy to the site of treatment Patients with unequivocal distant metastasis including liver Patients with gross peritoneal carcinomatosis on laparoscopy No prior or concurrent malignancies other than surgically treated squamous cell or basal cell carcinoma of the skin No serious medical illness which would prevent informed consent or limit survival to less than 2 years Active uncontrolled bacterial, viral or fungal infections until these conditions are corrected or controlled Psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements Patients having metal implants, pacemakers or clustered markers Metallic endobiliary stenting would be a contraindication, hence plastic stents may be used if biliary drainage is indicated", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 5.0-999.0, All Acute Uncomplicated Appendicitis Adult or child ages \u22655 years Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and Negative pregnancy test for subjects who are women of childbearing potential instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 18.0-999.0, All Gallstones Patients referred to the radiology department for an abdominal ultrasound Age > 18 years Inability to communicate with the examiner Referral for intervention Metastasis screening Referrals concerning contrast enhanced examinations", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 0.0-18.0, All Appendicitis Potential subjects must be 0-18 years of age, presenting to the pediatric emergency department for evaluation of right lower abdominal pain and suspected appendicitis The clinical diagnostic plan before subject enrollment must abdominal ultrasound and/or abdominal CT Because ultrasound does not involve the use of ionizing radiation or contrast agents, it is not contraindicated in any patients, although image quality may be nondiagnostic in obese patients. The focus of this study is on acquisition of research 3D POC US images to determine feasibility of use in pediatric patients with suspected appendicitis Patients with BMI >30 or mass >70kg, as these patients are anticipated to have nondiagnostic ultrasound images Ultrasound also requires a gel material be applied to the skin surface as an acoustic transmission medium. Allergy to such gel will be an criterion", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 1.0-12.0, All Periodic Fever Aphthous Stomatitis Pharyngitis Cervical Adenitis diagnosis or confirmation of diagnosis of PFAPA from Dr. Bennett based on clinical or laboratory data is or will be undergoing treatment for PFAPA at CCMC agrees to the consent and, if necessary, assent forms is between 1 and 12 years of age is currently taking another probiotic regularly (>=2 times/ week) is allergic to ingredients in the probiotic or placebo may react adversely to the probiotic due to any form of immune deficiency or chronic disease including pulmonary, renal, cardiac disorders including underlying structural heart disease, gastrointestinal disease, or diabetes is not a proficient English speaker does not agree to the consent and/or assent forms patients who use antibiotics or have used them within a month of the study start", "label": "0"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 15.0-999.0, All Wound Infection Complication Scar patients with a clinical diagnosis of acute appendicitis children under 14 are not included", "label": "2"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 7.0-18.0, All Appendicitis Children and adolescents aged 7-18 years old ASA Score I (American Society of Anesthesiologists classification) [Appendix 1]: a normal healthy patient ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease Patients scheduled for laparoscopic appendectomy surgery Uncomplicated appendicitis Hemodynamically stable patient No evidence of appendiceal perforation based on preoperative clinical and imaging assessment Diagnosed to have simple acute appendicitis by intraoperative laparoscopy Patients who have provided a written informed assent Caregivers who have provided a written informed consent ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation Hemodynamically unstable patient Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery Postoperative admission in an intensive care unit with sedation or ventilatory assistance Cognitive impairment or mental retardation Progressive degenerative diseases of the CNS Seizures or chronic therapy with antiepileptic drugs", "label": "1"} +{"topic": "A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen.", "doc": "eligible ages (years): 5.0-19.0, All Appendicitis children and adolescents ages 5-19 years with abdominal pain internal med, family med, or emergency med trained providers at participating EDs select comorbid conditions previous abdominal surgery treated for select comorbid conditions", "label": "2"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Lung Disease Age greater than or equal to 40 years Cigarette smoking greater than or equal to 30 pack years Obstructive Spirometry First degree relative with smoking history willing to participate ", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Methicillin Resistant Staphylococcus Aureus (MRSA) Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding) Subjects with severe neutropenia (<500 cells/mm3) Subjects with hypersensitivity to oxazolidinones or vancomycin", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease, COPD Main Written informed consent Patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the GOLD (Global Initiative on Obstructive Lung Diseases) (2003) Age \u2265 40 years FEV1/FVC ratio (post-bronchodilator) \u2264 70% FEV1 (post-bronchodilator) \u2264 65% of predicted FRC (post-bronchodilator) \u2264 120% of predicted Clinically stable COPD within 4 weeks prior to baseline visit (B0) Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit (B0) or a willingness to have a chest x-ray performed at visit (B0) Main COPD exacerbation indicated by a treatment with systemic glucocorticosteroids not stopped at least 4 weeks prior to the baseline visit (B0) Non smoker, current smoker or ex-smoker (smoking cessation at least one year ago) with a smoking history of < 10 pack years Suffering from any concomitant disease that might interfere with study procedures or evaluation Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit (B0) Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis) Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 2 months preceding the baseline visit (B0) Known alpha-1-antitrypsin deficiency Need for long term oxygen therapy defined as \u2265 15 hours/day Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) Known infection with HIV, active hepatitis and/or liver insufficiency", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 0.167-1.0, All Bronchiolitis Any child 2-12 months old seen in the emergency department A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS) Diagnostic of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions No child will be excluded based on race or gender Patients under the age of 2 months or greater than 12 months Patients with cyanotic heart disease Patients with lobar pneumonia, defined by results of chest radiographs The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not patients Patients with croup Patients with foreign body aspiration Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease Patients with liver or renal disease Patients with sickle cell anemia", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 45.0-999.0, All Chronic Obstructive Pulmonary Disease Acute exacerbation of COPD type I or II according to GOLD Ability to perform lung function tests Ability to take oral medication Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation Progression or new radiographic abnormalities on the chest X-ray Severe exacerbation that required mechanical ventilation History of bronchiectasis Recent or unresolved lung malignancy Other disease likely to require antibiotic therapy Significant gastrointestinal or other conditions that may affect study drug absorption Class III or IV congestive heart failure or stroke", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Asthma Chronic Obstructive Pulmonary Disease Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center Evidence of airflow obstruction on spirometry (FEV1/FVC<70%) Age 18 years or older History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin) Treatment with any macrolide in the 4 weeks prior to study entry Elevated AST or ALT (2 or more times the upper limit of normal) on current admission Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission Elevated total serum bilirubin (more than upper limit of normal) on current admission Previous participation in this study Patients prescribed digoxin (azithromycin may increase digoxin levels) Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin) Patients prescribed pimozide (azithromycin may increase risk of arrhythmias) Patient unable to provide consent (e.g., language difficulty or history of dementia)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Asthma Chronic Obstructive Pulmonary Disease (COPD) Undifferentiated Asthma/COPD Age 18 years and older Admission to the inpatient medical service Physician-diagnosed asthma or asthma/COPD or COPD exacerbation Evidence of airflow obstruction on spirometry More than 24 hours since admission to the inpatient medical service Admission to an intensive care unit Hospital discharge planned within the next 24 hours Other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis) Chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest Chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest Physician declines to provide consent Patient unable (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent Previous participant in this study Corticosteroid therapy (prednisone >0 mg/d equivalent) for >1 week prior to admission", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-70.0, All Chronic Obstructive Lung Disease (COLD) Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included", "label": "2"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All COPD clinical COPD smoking age > 40 years age < 40 years use of antibiotics, corticosteroids or beta-agonists", "label": "2"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-80.0, All COPD Acute Exacerbation COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded", "label": "2"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease Smoker or ex smoker of at least 10 pack years Age 40 or above Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning) FEV1 <80% of predicted, FEV1/FVC ratio <70% Less than 15% change and <200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year Clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease Inability to give informed consent (severe mental illness, mental handicap or brain damage) Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation) Classification as a never smoker Strongly positive skin allergy result (>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 6.0-12.0, All Attention Deficit Disorder With Hyperactivity Tourette Syndrome Diagnosis of ADHD or ADHD plus Tourette syndrome Determined to be dangerous to self or others Scores less than 70 on an IQ test Any seizure disorder, major organic brain dysfunction, major medical illness, major mood disorder, psychosis, pervasive developmental disorder, or peripheral sensory loss Any condition that may make use of methylphenidate unsafe", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 0.167-4.917, All Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site)", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 45.0-70.0, All Quality of Life Exercise Moderate COPD (GOLD classification) , AGE 45-70, both sexes Treated with inhaled steroids and long acting beta agonists Active ischemic heart disease, heart failure, orthopedic problems that preclude ergometric bicycle activity", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-80.0, All Asthma COPD Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects between 18 years Any severity of exacerbation of obstructive airway disease attending the outpatient clinic History of at least two exacerbations in the past 12 months prior to recruitment that required a course of prednisone or antibiotic or long acting bronchodilator or inhaled corticosteroid, in addition to the daily maintenance therapy Signed written informed consent to participate in the protocol and ability to return to the outpatient clinic for repeated clinic visits If the exacerbation is severe enough to warrant hospitalization Active malignancy Significant gastrointestinal, hematological, cardiovascular or cerebrovascular disorder that would affect compliance with follow up visits Recent (within the past 2 months) or planned (within the study period) lung surgery Psychosis, alcoholism, active substance abuse or any personality disorder that would make compliance with the follow up visits problematic Pregnant or nursing females, as this could affect the compliance during the trial Any other medical or social condition, which in the opinion of the investigator could confound the interpretation of the data derived from this study", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Asthma Pulmonary Disease, Chronic Obstructive No change from the MIA and LEUKO trials No change from the MIA and LEUKO trials", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-80.0, All COPD Patients admitted with COPD exacerbation ", "label": "2"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 35.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. age >35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following Current smoking Suffering from COPD according to the GP's diagnosis In command of the Dutch language Too ill Under control of a chest physician Serious physical or psychological comorbidity", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation Phase 1 & 2: COPD & ONE of the following History of hospitalization for COPD exacerbation, OR Currently on supplemental oxygen, OR History of evaluation for lung transplant or LVRS, OR >/= 6 months post-LVRS Phase 1 or 2 Current or former smoker, >/= 20 pack-yr. smoking history FEV1 6 months < 20 pack-yr. smoking history Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass Asthma FEV1 > 70% or FEV1/FVC >70%", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) Current or former smokers with a diagnosis of COPD Having impaired lung function as measured by spirometry History of asthma or nasal symptoms caused by hayfever No telephone Inability to record symptoms in an electronic diary (PDA)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Obstructive Pulmonary Disease Sepsis Antibiotics All patients having a COPD (according to the definition of the American Thoracic Society) and having an acute exacerbation leading to an acute respiratory failure requiring the admission to ICU and mechanical ventilation The acute exacerbation of COPD is defined by increase in the frequency of cough, the volume and the purulence of expectoration and increase of baseline dyspnea. To be included, patients must have respiratory rate >30 cycles/min and one of the following blood gas (with blood gases performed right before the initiation of mechanical ventilation): PaC02 > 6kPa and arterial pH <7.30 Pneumonia documented with chest radiography Antibiotic treatment in the ten previous days of ICU admission Former in the study History of allergy to the quinolones and/or to trimethoprim sulfamethoxazole Pregnancy or breast feeding Severe chronic disease: heart, liver, kidney Known immunodeficiency (malignant hemopathy, AIDS...) Digestive disease which could affect the absorption of the drugs Concomitant infection which requires systemic antibiotic treatment", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-75.0, All Chronic Obstructive Pulmonary Disease Age 18-75 years Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour Physically and mentally able to undergo the total study protocol Written informed consent Participation in another study Alpha-1-antitrypsin deficiency Selected grade 1-3 co-morbidity listed in the ACE-27 Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-50.0, All Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Asthma Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog) for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below) Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable Use of daily theophylline within the past month Pregnancy or nursing a baby Cigarette smoking > 1 pack per month Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to prophylactic use of albuterol prior to exercise)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All COPD FEV1/FVC < 70% FEV1 % predicted > 60% Other major disease Asthma Currently taking inhaled corticosteroids oral corticosteroids in the last 3 month significant cardiovascular disease pregnancy/breast feeding current use of salmeterol or other long acting bronchodilator", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-90.0, All Chronic Obstructive Pulmonary Disease COPD patients All COPD patients who seek medical assistance at the clinic during the study period will be asked about COPD exacerbation related symptoms-medical history and then they will be included in the study if they satisfied all the following COPD diagnosis according to the GOLD Consensus Statement initiation of symptoms diagnostic for COPD exacerbation in the past 72 hours abstention from any new therapeutic intervention absence of any signs suggestive of severe exacerbation requiring hospitalization Control subjects Subjects who seek medical assistance at respiratory clinic for symptoms suggesting acute bronchitis (dyspnea, sputum production, purulence, wheeze, cough) medical history free of COPD, Asthma, pneumonia, other chronic respiratory disease or congestive cardiac failure initiation of symptoms in the past 72 hours Patients with Asthma or other respiratory disease will be excluded from this study", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 45.0-75.0, All COPD stable stage II and III (GOLD) COPD, diagnosed 2 years ago and up Heart failure Malignancy Immune suppressed", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) Smoking Smoking Cessation Chronic Bronchitis Emphysema Group A Healthy nonsmokers Enrolled in the \"Normal\" protocol #0005004439 \"Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy\" Healthy according to the \"Normal\" protocol #0005004439 Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies Male and Female subject \u226518 years of age smoked < 100 cigarettes per lifetime and whose urine nicotine <2 ng/mL and urine cotinine <5 ng/mL, at entry into the study Group B Healthy current smokers Enrolled in the \"Normal\" protocol #0005004439 Groups A Unable to provide proper informed consent Drug and/or alcohol abuse within the past six months Individuals with asthma and with recurrent or recent (within three months) and/or acute pulmonary infection Allergy to lidocaine Significant kidney disease or subjects on dialysis Females who are pregnant or lactating or intending to become pregnant in the next 12 months Major depression or other significant psychiatric disorder HIV+ Subjects that have unstable coronary artery disease as evidenced by unstable angina, >Class II NYHA cardiac status, history of congestive heart failure or MI within the last 12 months", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease Cardiovascular Disease Smoking Bronchodilation COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value) Current cigarette smoking (at the time of performing the study) Willing to provide written informed consent Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test Registered in one of the recruitment institutes COPD gold stage I or IV Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility \u2265 10% of predicted Unable to communicate Physically unable to perform any of the tests Non-COPD respiratory disorders Previous lung-volume reduction surgery and/or lung transplantation Evidence of alcohol, drug or solvent abuse Known \u03b1-1 antitrypsin deficiency", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All COPD Diagnosis of COPD according to GOLD (FEV1/FVC<70%), classification into GOLD I (FEV1 70-100% predicted), GOLD II (FEV1 50-70% predicted), GOLD III (FEV1 30 predicted) or GOLD IV (FEV1 \u2264 30% predicted) Age \u2265 18 years Three or more exacerbations of COPD in one year for which a course of prednisone and/or antibiotic therapy was started Clinically stable during 1 month. Patients have to be free of COPD exacerbation or respiratory tract infection within a month prior to involvement in the study and they should not have received a high dose of systemic glucocorticoids or antibiotics in this period Informed consent Use of antibiotics or high dose of systemic steroids within a month prior to involvement in the study Addition of inhalation steroids to the patient's therapy regimen, shortly before entering the study Pregnant or lactating women Allergy to macrolides Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal) Asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing Presence of a malignancy which is clinically active Bronchiectasis Malignancy of any kind for which the subject is under treatment or is being monitored as part of follow up after treatment Heart failure", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-90.0, All Chronic Obstructive Pulmonary Disease COPD diagnosis according to GOLD guidelines Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease Failure of outpatient treatment Increasing of dyspnea in the last days Comorbidity that causes detriment of respiratory function Life expectancy of less than 6 months Mechanical Ventilation Cardiovascular condition that causes exacerbation Immunosuppression Pulmonary infiltrates that suggest pneumonia Antibiotic treatment in the last month Pregnancy ECG with a large QT segment Hypokalemia Hepatic failure or renal failure", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 50.0-80.0, All Chronic Obstructive Pulmonary Disease Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months Atopy Asthma Concomitant lung diseases (e.g. lung cancer) Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All COPD Exacerbation Bronchitis Sputum C-Reactive Protein Age 40 or over. No upper age limit will be employed Written informed consent obtained according to the GOLD guideline. An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD for hospital admission according to the GOLD: marked increase in symptoms (i.e. resting dyspnoea), severe underlying COPD, onset of new physical signs (cyanosis, edema), failure to respond to initial medical management, significant co morbidities, frequent exacerbations, newly occurring arrhythmias, diagnostic uncertainty Former of current smoker with a minimum smoking history of 10 pack years Patients have to be capable of ingesting oral medication Patients have to be mentally capable of participating in the study (able to complete questionnaires and perform lung function tests) Life expectancy \u2265 30 days Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception Pretreatment with corticosteroids (cumulative dose >210 mg) for the present exacerbation Progression or new radiographic abnormalities on the chest X-ray or CT scan compatible with pneumonia bronchiectasis (HRCT confirmed) Cystic fibrosis Tuberculosis Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs (>30 mg prednisolone/day maintenance dose or equivalent for more than 4 weeks) Recent or unresolved lung malignancy Other disease likely to require antibiotic therapy, such as recurrent sinusitis or urinary tract infection Significant gastrointestinal or other conditions that may affect study drug absorption", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All COPD Signed informed consent Age \u2265 40 years Patients fulfilling for COPD according to the Global initiative for chronic obstructive pulmonary disease (GOLD) stage I or higher Smokers or ex-smokers of at least 10 pack-years Patients suffering an either Admitted to hospital due to (severe exacerbation) or Confirmed at GP (general practitioner) setting (moderate exacerbation) Definition Increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both Patients who have never smoked Patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.) Exacerbation of COPD due to other causes such as pneumothorax and acute decompensated congestive heart failure Difficulties in communication (cognitive deterioration, sensorial disability, language barriers) Severe disease with poor vital prognosis (life length expectancy less than one year)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Cough Male and female subjects, age 18 years and over History of cough for more than 8 weeks Normal chest x ray Chronic idiopathic cough or chronic cough resistant to treatment of specific triggers Smoking status Current smokers Ex smokers with history of smoking > 20 pack years or those who have given up < 6 months ago Prohibited medications Use of medications likely to suppress / affect cough including codeine, morphine, pregabalin, gabapentin, amitriptylline, angiotensin converting enzyme inhibitors (type 1) and baclofen Use of any anti-arrhythmic medication Use of cimetidine, beta blockers, or diuretics Cardiovascular conditions Sinoatrial disease, bradycardia or all types of heart blocks History of ischaemic heart disease or heart failure", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Type of subject: Outpatients Informed consent: Subjects must give their signed and dated written informed consent to participate Gender: Male or Female Age: 40 years of age or older at Visit 1 COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in accordance with the following definition by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC < 0.7 History of exacerbations: At least one COPD exacerbation which required the use of any additional treatment in the last 12 months prior to Visit 1 For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should have at least one COPD exacerbation that required the use of any additional treatment since diagnosis Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 12.0-65.0, All Asthma Male or female patients, age 12 through 65 years at the time of screening Written informed consent obtained from the patient prior to beginning study procedures Documented clinical history of chronic persistent asthma requiring controller therapy Able to complete the study period, including follow-up period, of up to approximately 2 years; and Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator, may compromise the safety of the patient in the study or confound the analysis of the study Lung disease other than asthma (e.g., chronic obstructive pulmonary disease, cystic fibrosis) Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period Current acute illnesses or evidence of significant active infection, such as fever \u2265 38.0\u00b0C (100.5\u00b0F) within 4 weeks of enrollment Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives prior to screening, except omalizumab for asthma Pregnancy at enrollment Breastfeeding or lactating females Elective major surgery planned from screening through study completion History of cancer other than basal cell carcinoma of the skin or cervical carcinoma-in-situ treated with apparent success with curative therapy more than 1 year prior to enrollment History of primary immunodeficiency", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-75.0, All Chronic Obstructive Airway Disease Asthma Chronic Cough General Adult subjects aged 18 years and over Meet for subject groups as outlined below (1) Healthy volunteers Non-smokers No history of respiratory disease (2) Healthy smokers Current smokers with smoking history of \u226510 pack years Spirometry within normal limits i.e. FEV1>80% predicted and FEV1/FVC ratio >75% predicted (3) Asthma Symptoms of upper respiratory tract infection within the last 6 weeks 2) Participation in another clinical trial of an investigational drug within the last 4 weeks 3) Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate, 4) Patients with severe respiratory disease i.e. FEV1 < 1 litre, 5) Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease age 40-80 years old cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment non-smoking controls: no COPD (spirometry based) + < 1 pack year Respiratory disorder other than COPD \u03b11-antitrypsin deficiency Known history of significant inflammatory disease other than COPD COPD exacerbation within 4 weeks prior to study Lung surgery Recent diagnosis of cancer Therapy with oral corticosteroids in the last 6 weeks Significant cardiovascular comorbidity Significant orthopedic/musculoskeletal problems", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Diagnosis of COPD in any field in the pre-index period and 60 days after the index date Diagnosis of depression/anxiety in any field and a medication for treating depression/anxiety in the pre-index period and 60 days after the index date Index date occurs during identification period Patients must be continuously eligible during 1-year pre and 1-year post-index date and be of at least 40 years of age comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, sarcoidosis) during the 1 year pre or post-index periods No other maintenance medications other than the index medication on or 60 days after the index date", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 60.0-999.0, All Lung Cancer Tobacco Use Disorder Patients over 60 seeing a participating General Practitioner Currently smokes 10 or more pack years, meeting at least one of the following New or altered cough of any duration reported to primary care Increased breathlessness or wheezing (with or without purulent sputum) Do not qualify for an urgent referral for a chest x-ray under the National Institute for Health and Clinical Excellence (NICE) guidelines (i.e., hemoptysis or unexplained or persistent [lasting > 3 weeks] signs or symptoms), including having any of the following Cough Chest/shoulder pain Dyspnea Weight loss Chest signs ", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-65.0, All Chronic Obstructive Pulmonary Disease no previously vaccination with PPSV23 a clinical diagnosis of severe COPD which is defined according to the GOLD 2006 guideline (11): FEV1/FVC < 70%, FEV1 reversibility test < 200 ml, and FEV1 < 50% of predicted current or past exposure of smoking no exacerbation in the month prior to enrollment age < 65 years using high daily dose of ICS (budesonide > 800-1600 mcg/day or fluticasone > 500-1000 mcg/day) providing written informed consent Patients are excluded from the study if they are pregnant, or have immunosuppressed status (known current neoplasm, renal insufficiency in dialysis, human immunodeficiency virus (HIV) infection, severe hepatic impairment, hypogammaglobulinemia, anatomical or functional asplenia) Asthma, cystic fibrosis, bronchiectasis, and severe sequelae of pulmonary tuberculosis are also excluded by pulmonary function study and chest imaging before patient's enrollment", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive minimum age 40 years at index continuously enrolled in health plan diagnosis of COPD (ICD-9 codes of 491, 492, 496) at least one moderate exacerbation event as defined previously Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation Receipt of maintenance medication in the pre-period Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 0.083-16.0, All Community-Acquired Infections Respiratory Tract Infections Sepsis Urinary Tract Infections Meningitis Gastroenteritis Children aged 1 month to 16 years Acute illness episode of maximum 5 days recent trauma neurological conditions intoxication psychiatric of behavioural disorders without a somatic cause acute exacerbation of a chronic condition (asthma, known immunodeficiency, diabetes, cystic fibrosis, etc)", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive at least 40 years of age continuously enrolled for medical and pharmacy benefits during their pre and post-period diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx) Patients were excluded if they had MTx in the pre-index period (to ensure of MTx-na\u00efve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation) Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) Inflammatory Disease Endothelial Dysfunction presence of COPD according to standard acute exacerbation of COPD according to recommended international over 40 years of age history of at least 10 py pneumonia history or signs of congestive heart failure acute myocardial infarction thoracotomy incl. resection of lungtissue interstitial lung disease acute or chronic renal failure active malignancy autoimmune disease", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 4.0-21.0, All Sickle Cell Anemia Acute Chest Syndrome Hemoglobin SS, SC, SB0thal or SBthal Ages \u2265 4-21 years old Patients are admitted to the hematology oncology inpatient service and have been enrolled and consented in the study Meet clinical for ACS an infiltrate on Chest X-ray and one of the following Respiratory symptoms/signs (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline, tachypnea, cough, and increased work of breathing) Fever Chest pain AND Patients' eligible for a simple transfusion based on one of the following Hypoxemia (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline) Hemoglobin < 5 gm/dl Increased work of breathing Patient requires exchange transfusion within first 24 hours of admission Patient requires PCCU transfer within first 24 hours of admission Hemoglobin > 9gm/dl secondary to these patients requiring an exchange transfusion", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 19.0-92.0, All COPD Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948) Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years Agrees to volunteers for the study and willing to sign the informed consent form There were negative/normal screening tests for the following Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition \"Normal\" spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69% Impedance oscillometry were within normal limits \"Negative\" physical examination of the chest with absence of wheezing and crackles on auscultation of the chest Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups men of: ages < 18, 31-54 and >92 years old current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years refusal to volunteer for the study and not willing to sign the informed consent form screening test not considered \"normal\" by physician/PI and showing one or more of the following one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.) Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%) \"Positive\" physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest Impulse oscillometry >4 times normal limits Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 8.0-999.0, All Cystic Fibrosis Diagnosis of cystic fibrosis 8 years of age or greater Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Pulmonary exacerbation as defined by Fuchs et al Admission for greater than 48 hours prior to enrollment Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months Current treatment for allergic bronchopulmonary aspergillosis Pregnant or breast feeding History of solid organ transplantation Renal impairment at time of randomization (< 40 mL/min as calculated by the Cockcroft-Gault equation24 \u00acfor adults or the Schwartz equation45 for those < 18 years of age) or receipt of hemodialysis Allergy to study medication", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-85.0, All Chronic Obstructive Pulmonary Disease (COPD) Subjects who the investigator believes can and will comply with the requirements of the protocol Written informed consent obtained from the subject Male or female subjects between, and including, 40 and 85 years of age, at the time of consent Subjects with confirmed diagnosis of COPD (based on postbronchodilator spirometry). [GOLD, 2009] with FEV1 of >80% (mild COPD) or >50% but \u226480% (moderate COPD) of predicted normal and FEV1/FVC<0.7 Subjects have mild or moderate COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging [GOLD, 2009] Subjects have a current or prior history of \u226510 pack years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked Subjects with recent COPD exacerbations, in stable condition, and having stopped antibiotics, can be enrolled one month post exacerbation Subject also has a confirmed diagnosis of asthma (as only cause of obstructive respiratory disorder), cystic fibrosis, pneumonia risk factors (e.g., HIV, Lupus, Parkinson's, Myasthenia Gravis) or other respiratory disorders (e.g., tuberculosis, lung cancer) Subjects having undergone lung surgery Subject has a \u03b11-antitrypsin deficiency as underlying cause of COPD Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids (subjects can be enrolled when their acute or pneumonia has resolved) Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit Subject has other conditions that the principal investigator judges may interfere with the study findings, such as Subject at risk of noncompliance, or unable to comply with the study procedures Evidence of alcohol or drug abuse Others, as per clinical judgement Women who are pregnant or lactating or are planning on becoming pregnant during the study **If subject has any ONE of the above they cannot be enrolled into the study**", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 60.0-999.0, All COPD Exacerbation Presence of purulent sputum documented by colorimetric assay (Allegra et al., Resp Med 2005), plus at least two of the following signs-symptoms Increased cough Increased dyspnea Increase in sputum volume appeared at least 3 days previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin / clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted for at least 3 days with persistence or worsening of symptoms and subsequent use of hospital \u2265 60 years FEV1 <80% and \u2265 30% and ratio FEV 1 / FVC <70% chest x-ray negative for inflammatory infiltrates informed consent asthma pulmonary neoplasms a history of allergy or hypersensitivity to quinolones impracticability in oral antibiotic and / or altered ability to absorption by the gastrointestinal system a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6 months) history of tendinopathy note or severe renal impairment creatinine> than twice the upper limit of the normal range or hepatic impairment (AST and / or ALT> twice the upper limit of the normal range) patients with sepsis, tuberculosis or other infections in other organs or systems cystic fibrosis patients with inherited tolerance to intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate dehydrogenase", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All COPD i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age \u2265 40 years-old iii. Smoking history \u2265 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Chronic Obstructive Pulmonary Disease Diabetic patients with COPD exacerbation Patients treated with steroids during the previous 3 months", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-80.0, All Bronchiectasis Age \u2265 18 years HRCT-diagnosed Bronchiectasis Capable of providing written informed consent Patient judged to have poor compliance Cystic fibrosis bronchiectasis", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 17.0-999.0, All Cystic Fibrosis Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels Chronic infection with Pseudomonas aeruginosa Patients able to produce daily sputum samples Current history of at least two pulmonary infective exacerbations in the past 12 months Able to give written informed consent Unable to provide written informed consent Patients unable to produce daily sputum samples Fewer than two infective pulmonary exacerbations in 12 months", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) Adults, either sex, older or equal than 40 years of age For female patients, the following conditions are to be met has been postmenopausal for at least 1 year, or is surgically incapable of bearing children, or is of childbearing potential, and the following conditions are met has a negative pregnancy test (urine or serum-based) immediately before study entry (i.e., before the start of treatment or any other study procedure that could potentially harm the fetus), and one or more of following must agree to abstinence or use an accepted method of contraception. The subject must agree to continue with the same method throughout the study having only female sexual partners sexual relationship with sterile male partners only Severe exacerbation: defined by need for ventilatory support (indicated by severe dyspnea with failure to respond to emergency treatment and/or persistent hypoxemia (PaO2 <50 mm Hg despite O2 administration and / or respiratory acidosis (pH <7.35 and PaCO2> 45mmHg)) or mental confusion or circulatory insufficiency (need of vasopressors) Fever (>38.5\u00b0C) Known impaired hepatic or renal function Active or suspected tuberculosis infection of the respiratory tract Acute exacerbation of asthma Suspected or known hypersensitivity to, or suspected serious adverse reaction to sultamicillin; suspected or known hypersensitivity to penicillins or cephalosporins Immunosuppression or Immunosuppressive therapy (cytostatic chemotherapy within last 28 days or neutropenia (neutrophils < 1000/\u00b5)l; systemic corticosteroids (\u226520 mg prednisolon equivalent/day > 14 days; HIV-infection; immunosuppression after organ or bone marrow transplant) Patients with metastatic or hematological malignancy, splenectomized patients or patients with known hyposplenia or asplenia Oral/parenteral antibiotic use within 30 days prior to randomization (a singular administration of antibiotics prior to randomization is allowed)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Obstructive Lung Disease 3. and Recruitment Doctors in Pulmonary Medicine Department, Bispebjerg Hospital, which is involved directly in the treatment of patients who are potential candidates can be created as \"investigator\" after proper information and training. Then, these doctors patients. is based on the following in-and and after oral and written participant information The following must all be met for the patient can be First The patient must have confirmed / suspected COPD, and must be hospitalized with COPD exacerbation Second The patient must be an adult (more than 18 years) and age. 3rd There must be a signed informed consent 4th Patients included only on weekdays Exclusions: The following should NOT be satisfied that the patient can be First The patient can not understand or relate to the oral or written information Second The patient has previously been involved in the study", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 0.0-5.0, All Pneumonia Bronchiolitis Asthma All children below 5 exceeding WHO age-dependent tachypnea criteria ", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-85.0, All Chronic Obstructive Pulmonary Disease Endothelial Dysfunction COPD patients in stable condition ( without exacerbation min 1 months ago) Over 40 years History of at least 10 py acute exacerbation of COPD active malignancy autoimmune disease acute myocardial infarction diabetes mellitus with late complications congestive heart failure women of childbearing potential", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All COPD Chronic Obstructive Pulmonary Disease Diagnosis of stable COPD years or older Smoking history of at least 10 pack-years Forced Expiratory Volume in one second (FEV1) \u2264 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70 Dyspnea \u2265 2 on the Medical Research Council (MRC) scale At least 2 exacerbations requiring prednisone treatment in the past 3 years Using a written action plan and having demonstrated adequate use of the self-administered antibiotic & prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response) Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD History of asthma or allergic rhinitis before the age of 40 Regular use of oxygen, oral corticosteroids, antibiotics Unstable or life threatening co-morbid condition Medical conditions or taking medications known to affect tremor and/or heart rate (HR) Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole)) On theophyllines Colonized with pseudomonas aeruginosa", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 50.0-85.0, All Chronic Obstructive Pulmonary Disease Signature of informed consent COPD patients with age raging from 50 to 85 years old Patients with at least a history of COPD of one year COPD patients clinically stable in the last three months COPD subjects with Forced Expiratory Volume at one second (FEV1)<50% of predicted value COPD subjects with Residual Volume (RV) >125% predicted value FEV1/Forced Vital Capacity (FVC) <88% (males) or <89% (females) of Low Levels of Normality (LLN) COPD former or active smokers with at least a smoking history of 20 pack year Acute Bronchial Exacerbation at recruitment Fertile women with age between 18 and 50 years old or with active period Pregnancy Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment FEV1/FVC more than 70% of predicted value in basal conditions FEV1 more than 70% of predicted value in basal conditions Known deficit of alpha 1 antitrypsin Subjects that underwent a Lung Volume Reduction Surgery (LVRS) Subjects with known positivity to Human Immunodeficiency Virus (HIV) Misuse of alcool or drugs", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 58.0-72.0, All Chronic Obstructive Pulmonary Disease ex-smokers (> 10 packets-year) with moderate-severe COPD patients ", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease Age\u2265 40years old The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease Chest radiography shows congestive heart failure Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases Serious cardiac failure, renal insufficiency or hepatic dysfunction", "label": "2"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-75.0, All Chronic Obstructive Pulmonary Disease Post bronchodilator forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio less than 0.7 Stable phase of COPD History of exposure to respirable silica dust, nonsmokers with absence of passive exposure to tobacco smoke or history of exposure to polycyclic aromatic hydrocarbons exhaust, nonsmokers with absence of passive exposure to tobacco smoke or current tobacco smokers without history of occupational exposure COPD risk factor exposure (occupational or tobacco smoke) duration not less than 12 months Male Caucasian Age of 40 years old Control group history of biomass smoke exposure age less than 40 and above 75 years old current COPD exacerbation concomitant asthma tuberculosis and other pulmonary diseases allergic and autoimmune disorders active infections immunodeficiency, including HIV infection parasitological diseases malignancies", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-85.0, All COPD Exacerbation clinical and spirometric diagnosis of COPD for study group: clinical symptoms of exacerbation and infection of low airway Signed informed consent No acceptance of informed consent The STUDY GROUP: treatment with antibiotic more tan 2 days before consultation Another entity known pulmonology other than COPD (non-obstructive disorders, bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension, hypoventilation) Chronic treatment with oral corticosteroids or immunosuppressive drug severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary tuberculosis with important involvement, severe pneumoconiosis Severe alteration of nutritional status Heart disease evolved Limitation for understanding the study (including psychiatric disorder, language problem, social or cultural differences, etc.)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-85.0, All Community Acquired Pneumonia Adults aged 18 to 85, inclusive Has given written, informed consent Has acute illness with onset within previous 7 days Has at least 2 of the following symptoms Difficulty breathing or shortness of breath Cough Production of purulent sputum Pleuritic chest pain Has at least 2 vital sign abnormalities Fever (> 38\u00b0C or < 35\u00b0C) Contra-indication to the administration of any of the study treatments, such as hypersensitivity to any of the glycopeptide agents, beta-lactam agents, linezolid or macrolide antibiotics, or current or recent (within 2 weeks) use of MAO inhibitors or serotonergic antidepressants (within 5 weeks for fluoxetine) (see Section 5.5.1) Has received antibiotic therapy in the 4 days prior to screening, with the following exception: up to 25% of patients may have received a single dose of a short acting (half life < 8 hours) antibiotic Has aspiration pneumonia Has hospital acquired or ventilator associated pneumonia, or healthcare associated pneumonia, or 2 or more days in hospital in the previous 90 days Has cystic fibrosis or known or suspected Pneumocystis pneumonia or known or suspected active tuberculosis Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant Has primary or metastatic lung cancer Has known bronchial obstruction or a history of post-obstructive pneumonia Requires admission to ICU at baseline Has empyema requiring drainage", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 50.0-75.0, All Chronic Obstructive Pulmonary Disease male and female COPD with an FEV1 of under 60% of predicted non-smoker between 50 and 75 years old experiencing an acute exacerbation of COPD (24-48 hours, before treatment) all inflammatory disease (HIV, cancer, renal and cardiac deficiency) hormonal dysregulation inferior limb pathology neuromuscular pathology history of tobacco or alcool abuse oxygen dependent", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-75.0, All Chronic Obstructive Pulmonary Disease Post bronchodilator forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio less than 0.7 Stable phase of COPD History of exposure to respirable silica dust, nonsmokers with no of passive exposure of tobacco smoke or history of exposure to aromatic hydrocarbons, nonsmokers with no of passive exposure of tobacco smoke or current tobacco smokers without history of occupational exposure COPD risk factor exposure (occupational or tobacco smoke) duration not less than 12 months Male Caucasian Age of 40 years old history of biomass smoke exposure age less than 40 and above 75 years old current COPD exacerbation concomitant asthma tuberculosis and other pulmonary diseases allergic and autoimmune disorders active infections immunodeficiency, including HIV infection parasitological diseases malignancies", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive COPD diagnosis and severity: Participants with a clinical history of COPD (established by a physician) in accordance with the following definition by the American Thoracic Society/European Respiratory Society, for at least 6 months prior to enrolment. Participants must have evidence of airflow obstruction, defined as post-bronchodilator FEV1 equal to or less than 80% of predicted normal value calculated using \"Third National Health and Nutrition Examination Survey\" (NHANES III) reference equation at Visit 1 and a FEV1 / FVC ratio <=70% at Screening (Visit 1). Note: Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the participants has self-administered 4 inhalations (i.e., total 400/360 [microgram] mcg) of salbutamol/albuterol via a Metered Dose Inhaler (MDI) (use of spacer will be optional). The study-provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values Exacerbation History: A documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of >=2 COPD exacerbations resulting in prescription for antibiotics and/or oral corticosteroids or hospitalisation or extended observation in a hospital emergency room or outpatient centre. Note: Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD Existing COPD maintenance treatment: Participants must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Notes: Participants receiving only \"pro re nata\" or as needed (PRN) COPD medications are not eligible for in the study. All participants will continue on their current Standard of Care (SoC) COPD medications throughout the entire duration of the study Tobacco use: Participants with a current or prior history of >=10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. One pack year =20 cigarettes smoked per day for 1 year or the equivalent. Number of pack years=(number of cigarettes per day/20) x number of years smoked Sex: Male or female participants aged >=40 years at Screening (Visit 1). A female participant is eligible to participate if she is of non-child bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international unit/milliliter (MIU/mL) and estradiol <40 picogram/milliliter (pg/mL) (<140 [Picomoles per liter] pmol/L) is confirmatory] or if of child-bearing potential is using a highly effective method for avoidance of pregnancy from 30 days before the first dose, for the duration of dosing and until 2 weeks post last-dose Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Corrected ECG QT interval (QTc)<450 milliseconds(msec) or QTc<480 msec for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or manual over-read. For and withdrawal, ideally the same QT correction formula will be used for all participants. However, because this is not always possible, the same QT correction formula will be used for each individual participant to determine for and withdrawal from the study. The QTc will be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period Eosinophils: >2.0% blood eosinophils at Screening (Visit 1) Concomitant medication: COPD Medication: Participants currently on chronic treatment with macrolides or Roflumilast; Long term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen PRN use (i.e. <=12 hours per day) is not exclusionary. Multidrug and toxin extrusion (MATE) transporter 1 (MATE1) inhibitors: cimetidine, pyrimethamine, trimethoprim (short course treatment with trimethoprim is allowed). Other medications: Chronic maintenance therapy with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), phosphodiesterase type 4 (PDE4) inhibitors, or any other immunosuppressive therapy (not including steroids) within 60 days prior to dosing. Any other investigational drug within 30 days or 5 half lives, whichever is longer prior to Screening Visit Other respiratory disorders: Participants with asthma (as primary diagnosis) lung cancer, bronchiectasis, active sarcoidosis, active lung fibrosis, cystic fibrosis, idiopathic pulmonary hypertension, active interstitial lung diseases or other active pulmonary diseases. Participants with alpha-1-antitrypsin deficiency as the underlying cause of COPD Participants with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device Participants who require a non-invasive positive pressure ventilation (NIPPV) device (Note: Use of non invasive ventilation (NIV) in hospital as part of the medical management of an acute exacerbation is permitted.) Lung resection: Participants who have undergone previous lung reduction surgery (e.g. lobectomy, pneumonectomy, or lung volume reduction) COPD stability: Less than 30 days prior to Visit 1 have elapsed from completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation Evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD on chest X-ray (posteroanterior with lateral) or computerised tomography (CT) scan (historic data up to 1 year may be used) Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded Alanine aminotransferase (ALT) >2x Upper limits of normal (ULN) and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-85.0, All COPD, HEAD&NECK CANCER,SCREENING group of adult COPD patients Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine Patients with an acute disease or COPD exacerbation Pregnant patients Patients who were intubated \u22643 months prior to Patients with a medical history of surgical intervention in the upper airway Patients with a medical history of malignant disease in the upper airway Patients who underwent radiotherapy of head and neck", "label": "2"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Adverse Effect of Glucocorticoids and Synthetic Analogues Disease Exacerbation Informed Consent as documented by signature Age \u226540 years History of \u226510 pack-years of smoking (past or present smokers) Airway obstruction, defined as FEV1/FVC\u226470% Current acute exacerbation of COPD by clinical defined by the presence of at least two of the following Change of baseline dyspnea Change of cough Change of sputum quantity or purulence Diagnosis of asthma Initial necessity of hospitalization Women who are pregnant or breast feeding Premenopausal women with insufficient contraception and anamnestic risk for pregnancy Severe coexisting disease with life expectancy <6 months Diagnosis of tuberculosis Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. of the participant Participation in another study involving an investigational drug Previous enrolment into the current study", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-75.0, All COPD Asthma for Healthy Smoking Subjects Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Be between 18 and 75 years of age, inclusive, at informed consent Healthy as determined by a physician, based on medical history and physical examination Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of \u2265 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked) for All COPD Subjects Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening Post-bronchodilator FEV1/FVC ratio of <0.7 for Healthy Smoking Subjects Any potential subject who meets any of the following will be excluded from the participating study Upper or lower respiratory tract infection within 4 weeks of the screening visit Positive test for alcohol at screening Taking prescription medication in the 14 days before screening Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded but are not limited to pipes, cigars and e-cigarettes Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening Urinary cotinine levels at screening < 30 ng/ml Subject is mentally or legally incapacitated Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO Any other reason that the Investigator considers makes the subject unsuitable to participate", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Disease, Chronic Obstructive Patients Male of Female, aged 18 years or above Attended the clinic as a patient Participant is willing and able to give informed consent for participation in the study Patients The patient is unable or unwilling to give consent Health Care Professionals Male or Female, aged 18 or above Attended the clinic as a health care professional Participant is willing and able to give informed consent for participation in the study Health Care Professionals The health care professional is unable or unwilling to give consent", "label": "2"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 0.167-17.0, All Community-acquired Bacterial Pneumonia History of and/or documented fever (rectal, ear, or oral temperature \u226538\u00b0C or axillary temperature \u226537.5\u00b0C) or hypothermia (rectal, ear, or oral temperature <35\u00b0C or axillary temperature <34.5\u00b0C) Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required Presence of at least 2 of the following signs or symptoms Cough Difficulty breathing Production of purulent sputum Chest pain Grunting Hypotension Tachycardia, defined as follows Ventilator-associated or hospital-acquired pneumonia >48 hours of systemic antibacterial therapy confirmed or suspected bacterial meningitis breast-feeding females positive pregnancy test", "label": "0"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Pulmonary Disease, Chronic Obstructive Dental Plaque COPD arm COPD Gold standard 2-4 Peptic ulcer arm H.pylori positive peptic ulcer Physically unable to make it to the dental clinic", "label": "1"} +{"topic": "A 63-year-old man presents with cough and shortness of breath. His past medical history is notable for heavy smoking, spinal stenosis, diabetes, hypothyroidism and mild psoriasis. He also has a family history of early onset dementia. His symptoms began about a week prior to his admission, with productive cough, purulent sputum and difficulty breathing, requiring him to use his home oxygen for the past 24 hours. He denies fever. On examination he is cyanotic, tachypneic, with a barrel shaped chest and diffuse rales over his lungs. A chest x-ray is notable for hyperinflation with no consolidation.", "doc": "eligible ages (years): 18.0-999.0, All Multiple Sclerosis, Relapsing-Remitting Male or Female \u2265 18 years of age Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald (2010 revision) Patient with an acute MS exacerbation as determined by their treating clinician Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation Patient capable of providing informed consent Patients with a diagnosis of Progressive MS Patients that require concomitant corticosteroid therapy Patients receiving experimental drug therapy Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex, or cancer within prior 5 years Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Normal PBPC Donors Eligible to be PBPC donor for allogeneic transplantation as determined by local institution History of splenectomy Previous PBPC mobilization attempts Previous treatment with GCSF or GMCSF", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-85.0, All Pulmonary Embolism age between 18 and 85 symptomatic PE confirmed by: high probability lung scan, or intermediate probability lung scan and objectively confirmed deep vein thrombosis, or spiral CT-scan or pulmonary angiography or TE echocardiography normal blood pressure (SBP >100mmHg) RVD at echocardiography (see criteria) written informed consent absence of RVD at echocardiography shock or hypotension (SBP < 100 mmHg) therapeutic heparin (UFH or LMWH) treatment for more than 48 hours prior to randomization administration of thrombolytic agents within the previous 4 days vena cava filter insertion or pulmonary thrombectomy within the previous 4 days chronic pulmonary hypertension or severe COPD hypertension defined as blood pressure >180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on a single, reliable measurement during current admission at enrolling site prior to randomisation use of GP IIb/IIIa antagonists within the preceding 7 days significant bleeding disorders either at present or within the past 6 months active peptic ulceration", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 16.0-999.0, All Abdominal Injuries Thoracic Injuries Patients with life threatening vital problems: respiratory, circulatory (pulse > 120/min, blood pressure < 100 mmHg, refill > 4 sec, exterior blood loss > 500 ml) or neurologically (Glasgow Coma Score < 14, abnormal pupils) compromised patients Patients with a revised trauma score under 12 Patients with signs of fractures from at least two long bones Patients with clinical signs of flail chest/multiple rib fractures Patients with a clinically evident pelvic rim fracture Patients with signs of unstable vertebral fractures or signs of neural cord compression Patients involved in a high-energy injury mechanism Fall from height (> 3 m) As declared by prehospital emergency medical services Patients suffering from a shock Class IIIB/IV Patients who need immediate neurosurgical intervention Pregnant patients Patients referred from other hospitals Patients who die at the emergency department", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Immune Thrombocytopenia (ITP) ITP with platelet count <30 x 109 /l after 2 weeks of treatment with prednisolon or during prednisolon tapering period i.e. from week three of prednisolon initiation. Patients with platelet count between 30 -50 are eligible if a higher platelet count is considered necessary, because of : concomitant medical illness predisposing to bleeding (hypertension, GI bleeding, bleeding diathesis, previous history of bleeding) concomitant medical condition requiring platelet blocking agents/ anticoagulation, persistent bleeding despite platelets > 30 x 109 /l, prior to surgery, or because of other patient related factors necessitating higher platelet count as occupation, hobby, psychological intolerability Subject is >18 years Subject has signed and dated written informed consent Subject is able to understand and comply with protocol requirements and instructions, and intends to complete the study as planned Females in fertile age should express willingness for use of contraceptive means for 6 months following the administration of the study drugs Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab, or immune-suppressive treatments other than corticosteroids, Dapsone or Danazol Underlying malignancy or previous history of malignancy in the past 5 years (except skin carcinoma) Pregnancy and lactation Not willing to participate in the study Expected survival of < 2 years Known intolerance to murine antibodies Females in child-bearing age not willing to use contraception for 6 months HIV-positive/AIDS-, Hepatitis -B virus positive or Hepatitis -C virus positive Patients with a definite Systemic Lupus Erythematosus (SLE) (> 4 of the American College of Rheumatology Criteria)", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.083-15.0, All Injuries and Wounds All asymptomatic trauma patients from 0 to 15 years old Any pediatric trauma patients with clinical indications for CT scan", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-60.0, All Pain Adult ASA 1-2 Cardiovascular disease Former smoker Pregnant Nursing Asthma", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 35.0-999.0, All Pancreatic Cancer Persons 50 years or older with recently diagnosed diabetes (within 2 years), with at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum CA 19-9, or those undergoing EUS with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening ; OR Persons 35 years old or older with familial pancreatic cancer with 2 or more first degree relatives with pancreatic cancer; OR Persons 35 years old or older with Peutz-Jeghers syndrome; OR Persons 35 years old or older with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks Persons with contraindication to iodinated contrast Allergy to iodinated contrast Renal insufficiency (serum creatinine > 1.5 mg/dl) Patients with contraindication to ionizing radiation Pregnancy Patients with previous pancreatic surgery Contraindication to secretin Allergy to secretin Acute pancreatitis", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-70.0, All Hernia, Ventral Body Image Respiratory Function Tests Quality of Life Laparoscopy Informed consent Age 18 years or older Diagnosis of reducible incisional hernias up to 200 cm\u00b2 Medically fit for general anesthesia Comprehension and use of French language Installed in the geographical region without foreseeable move for two years Incarcerated hernia Ongoing chronic pain syndrome, other than hernia origin Coagulation disorders, prophylactic or therapeutic anticoagulation, unable to stop platelet antiaggregation therapy 10 days before surgery American Society of Anesthesiology Class 4 and 5 patients Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation Mentally ill patients Presence of local or systemic infection Life expectancy < 2 years Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.) Morbid obesity (BMI over 40)", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Peritoneal Cavity Cancer Patients must have histologic proof of peritoneal metastases (includes adenomucinosis) Complete tumor resection possible (may liver metastasis if treatable by resection or radiofrequency ablation) Patients may have received previous chemotherapy (except peritoneal) and/or immunotherapy. If previous chemotherapy, at least 4 weeks must have passed since last dose Patients may have received previous radiation therapy, however radiation to the large bowel, small bowel and/or stomach will make the patient ineligible for this study Patients must have a Karnofsky performance score of \u2265 80% Adequate hematologic, renal and hepatic function within 14 days of registration defined as White blood count (WBC) \u2265 3,000 platelet count \u2265 70,000 serum bilirubin \u2264 2.0 mg/dL serum creatinine \u2264 1.5 mg/dL Metastatic disease is present outside the peritoneal cavity Diagnosis of mesothelioma Grade 2 or higher sensory neuropathy at time of study enrollment History of allergic reaction to platinum compounds Pregnant or lactating women. Pregnancy is a contraindication for receiving therapy, thus where relevant, patients will be required to use effective birth control. The agents used in this study those which are pregnancy category D clear evidence of risk in pregnancy. There is no information on the excretion of agents into breast milk therefore patients must refrain from breastfeeding while receiving study therapy Previous peritoneal chemotherapy Patients with uncontrolled concurrent medical problems (i.e. diabetes mellitus) or history of uncontrolled cardiovascular disease (no history of hospitalization for acute myocardial infarction or congestive heart failure (CHF) within 3 months prior to registration) Patients have psychiatric or addictive disorders that preclude obtaining informed consent", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Intra-Abdominal Infection Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity) Acute appendicitis: Ruptured or perforated with abscess Acute diverticulitis with perforation and/or abscess Acute cholecystitis (including gangrenous) with either rupture or perforation Acute gastric and duodenal ( > 24 hours) perforation Traumatic (> 12 hours) perforation of the intestines Secondary peritonitis due to perforated viscus Intra-abdominal abscess (including of liver and spleen) Traumatic bowel perforation requiring surgery within 12 hours Perforation of gastroduodenal ulcers requiring surgery within 24 hours other intra-abdominal processes in which the primary etiology was unlikely to be infectious Patients lactating or pregnant Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics Patients with rapidly progressive or terminal illness Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2) Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-75.0, All Thrombotic Microangiopathy Thrombotic Thrombocytopenic Purpura Male or female \u226518 to \u226475 years of age Diagnosis of TMA based on presence of Thrombocytopenia, defined as a platelet count <100 x 109 per liter Microangiopathic hemolytic anemia, defined by negative findings on direct antiglobulin test, and evidence of accelerated red blood cell (RBC) production and destruction); AND Absence of a clinically apparent alternative explanation for thrombocytopenia and anemia, e.g., disseminated intravascular coagulation (DIC), eclampsia, HELLP syndrome, Evans syndrome Females: non-pregnant and commit to use of effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment Males: commit to use of a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment Not received an unlicensed investigational agent (drug, device, or blood-derived product) within 30 days prior to randomization, and may not receive such an investigational agent in the 30 days post-randomization (note: investigational use for treatment of TMA of a licensed immunomodulator, e.g., rituximab, is permitted at any time relative to randomization) Capable of understanding and complying with the protocol, and he/she (or a legal representative) must have signed the informed consent document prior to performance of any study-related procedures Females: pregnant or <24 hours post-partum, or breastfeeding History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days Disseminated malignancy or other co-morbid illness limiting life expectancy to \u22643 months independent of the TMA disorder Diagnosis other than TMA which can account for the findings of thrombocytopenia and hemolytic anemia (e.g., DIC, HELLP syndrome, Evans syndrome) Diagnosis of DIC verified by laboratory values for D-dimer, fibrinogen, prothrombin time (PT), and activated partial thromboplastin time (aPTT) Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may not be enrolled in the study if ANY of the following conditions are met The last plasma exchange of the patient's preceding course of treatment occurred less than 7 days prior The patient underwent splenectomy during the preceding course of treatment The new course of plasma exchange has been ongoing for more than 3 days", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-999.0, All Postoperative Pain Splenomegaly 15 cm or longer spleens Patient confirmation to join the study Normal sized spleens Patient denial", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Portal Vein Thrombosis Splenic Vein Thrombosis Scheduled to undergo laparoscopic splenectomy at The University of Alberta or Grey Nun's Community Hospitals Capable of understanding the purpose and risks of the study and willing/able to sign a statement of informed consent Willing to undergo daily subcutaneous injections of Lovenox\u00ae Pregnant or nursing Unable or unwilling to provide informed consent Bleeding diathesis or currently on anticoagulation therapy (i.e. coumadin, heparin, LMWH) Hemorrhagic cerebral vascular accident Severe uncontrolled hypertension Diabetic or hemorrhagic retinopathy Contradictions to anticoagulation (i.e. active GI bleed, gastric or duodenal ulcer, sustained platelet count < 50 x103/uL, splenectomy due to trauma or history of heparin induced thrombocytopenia) Conversion to open splenectomy Allergy to Lovenox\u00ae, heparin, or other low molecular weight heparins Bacterial endocarditis", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.083-6.0, All Cystic Fibrosis Pancreatic Exocrine Insufficiency Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis Current or historical human fecal elastase < 50\u00b5g/gstool Weight greater than 3.75 kg Age 1 month to 6 years Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months Clinically stable condition without evidence of acute respiratory disease or any other acute condition Ileus or acute abdomen History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn\u00b4s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome History of distal ileal obstruction syndrome within 6 months of enrollment Use of an immunosuppressive drug Any type of malignancy involving the digestive tract in the last 5 years Known infection with HIV", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-999.0, All Overwhelming Post-Splenectomy Infection all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years who rejected interview", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Acute Abdomen age > 18 abdominal pain > 2h and < 7 days pregnancy acute abdominal trauma allergy to iodinated contrast media severe renal insufficiency metformin medication combined with elevated plasma creatinin level lack of cooperation (if informed consent is not possible) abdominal pain combined with bleeding shock", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 14.0-999.0, All Laparoscopic Cholecystectomy Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy Elective surgical procedure American Society of Anesthesiologists class I and II Patients refusing randomization Patients already on analgesics Patients with acute cholecystitis Patients requiring preoperative cholangiogram or common bile duct exploration Patients having bile or stone spillage during procedure Patients requiring conversion to open procedure Patients requiring re-exploration for any reason Patients with history of allergy to local anesthetic agents", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-65.0, All Liver Cirrhosis Patients with liver cirrhosis accompanied by portal hypertension and secondary hypersplenism due to hepatitis, alcoholic cirrhosis or schistosomiasis, who undergoing elective azygoportal disconnection and splenectomy Liver function as Child-Pugh C Hemoglobin < 9 g/dL Ascites Abnormal coagulation", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-85.0, All Incisional Hernia Umbilical Hernia Age > 18 Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication Patients with a recurrence of incisional hernia Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible Pregnant women Patients with HIV therapy Patients with cirrhotic ascites or other signs of hepatic insufficiency (bilirubin> 35 micromol / l; TP < 55%) or significant thrombocytopenia (< 60 000 platelets) Patients with a contra indication for laparoscopy Patients with a life expectancy < one year, or whose mobility within two years of treatment will damage proper monitoring Patients unable to understand information about the protocol", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 14.0-74.0, All Peritoneal Carcinomatosis Cytoreductive surgery and intraperitoneal chemotherapy Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment ", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Tendon Injury All patients with traumatic rupture of FDP-tendon in zone II < 18years Fracture crush injury; (partial) amputation CPPD", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Acute Abdomen Signed informed consent form Age > 18 years old Nontraumatic acute abdomen Weight < 120kg Can keep apnoea for 15s Surgeon in charge considers patient fit for participation in study Contraindications of MRI Suspicion of acute vascular disease Severe cardial or pulmonal insufficiency Pregnancy Untreated psychiatric illness", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-999.0, All Ultrasonography Multiple Trauma Kidney Calculi Aortic Aneurysm, Abdominal Pregnancy Catheterization, Venous Activation of the Keller Fire Rescue Emergency Medical Service Meets disease process described earlier Does not meet the disease process", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 16.0-999.0, All Trauma Hospitalized for abdominal trauma diagnosis of splenic contusion confirmed by scanner or during surgery for hemodynamically unstable cases patient has signed a consent form patient is a beneficiary of or affiliated with a social security program Refuses to participate Pregnant or breastfeeding Patient under guardianship", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-65.0, All Head Injuries Subarachnoid Haemorrhage Intra-cerebral Haemorrhage Cerebral Thrombosis Infarction, Middle Cerebral Artery Patients over 18 years of age up to 65 years Patients receiving a decompressive craniectomy for : severe head injuries, Subarachnoid hemorrhage, intra-cerebral hemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke and undergoing to reconstructive cranioplasty Patients informed about the study and giving consent Patients being not assisted by the French NHS Patients allergic to CT contrast products Pregnant and nursing women", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Myelodysplastic Syndrome Males and females aged over 18 years, (no upper age limit) ECOG performance status 0-2 Life expectancy more than 6 months A confirmed diagnosis of MDS WHO type refractory anaemia (RA) hypoplastic RA ineligible for/or failed immunosuppressive therapy (ALG, cyclosporine) refractory anaemia with ring sideroblasts (RARS) refractory cytopenia with multilineage dysplasia myelodysplastic syndrome unclassifiable MDS with bone marrow blasts greater or equal than 5% Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome Chronic myelomonocytic leukaemia (monocytes greater than1.0x109/l) Therapy-related MDS Splenomegaly, with spleen greater or equal than 5 cm from left costal margin Platelets less than 30x109/l Uncorrected haematinic deficiency. Patient deplete to iron, B12 and folate according to local lab ranges Women who are pregnant or lactating Females of childbearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last dose of study medication. Note: Subjects are not considered of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal Females of childbearing potential must have a negative pregnancy test prior to starting the study", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Microcirculation Achilles Tendon Rupture Acute rupture of the achilles tendon (on one or both sides) Older than 18 year of age Firmed letter of approval Patient speaks/understands German Planed surgical treatment No more than 48h after rupture No-traumatic rupture of the achilles tendon More than 48h after rupture No planed surgical treatment History of surgery on the injured leg Condition of diabetes mellitus Condition of peripheral artery occlusive disease", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 1.0-18.0, All Hereditary Spherocytosis Idiopathic Thrombocytopenic Purpura Need for splenectomy Splenomegaly", "label": "2"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Pregnancy Related Trauma Abruptio Placentae Singleton intrauterine pregnancy \u226520 weeks and \u226435 weeks gestational age Chief complaint of minor maternal trauma including motor vehicle accident, patient fall or assault with absence of maternal conditions outlined in Maternal shock Unstable vital signs Altered sensorium Head injury resulting in coma signs or symptoms of intraperitoneal bleeding Emergency laparotomy for fetal or maternal indications Bone fractures History of previous abruptio placenta Known or suspected placenta previa Rupture of membranes", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Cesarean Section Woman having caesarean section for the first time Woman, who have had no previous lower abdominal surgery Woman who speak and understand Danish Woman who can give informed consent Diabetes Mellitus (This does not gestational diabetes) Infection Regular treatment with immunosuppressives Alcohol or drug abuse Age under 18 years old Chronic pain disease eg. fibromyalgia, rheumatoid arthritis BMI over 35", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Distal Bicep Tendon Rupture Complete rupture of the Distal Bicep tendon Acute bicep tendon rupture (< 10 days since rupture) Partial rupture of the Distal Bicep tendon Chronic bicep tendon Ruptures (>10 days since rupture) Under 18 years of age", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Acute Appendicitis Patients who have been admitted and diagnosed as having acute appendicitis Patients under the age of 18 years Pregnancy Uncooperative patients (senile dementia, mentally ill) Not speaking Danish Does not wish to participate", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-999.0, All Splenic Artery Aneurysm Splenic artery aneurysm with diameter greater than 2 cm Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter) Complex aneurysm involving the celiac trunk American Society of Anesthesiologists (ASA) Score > 3", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-80.0, All Tumor of Exocrine Pancreas Patients with solid or cystic neoplasms of the pancreas who are being considered for distal pancreatectomy/splenectomy to be performed in either an open, laparoscopic, of da Vinci assisted fashion No evidence of metastatic disease No evidence of local invasion into surrounding organs ECOG performance status <3 Age 18 years or greater Participants will provide written informed consent to be part of the study Age less than 18 years old Women who are pregnant Known hereditary bleeding disorder with history of post-operative hemorrhage Patients maintained on chronic anticoagulation (eg Coumadin therapy) Known hematogenous disorder Previous gastric fundoplication procedure or any procedure which interrupts the short gastric blood supply to the spleen Known primary or secondary malignancy of the spleen Pancreatic tumors which invade surrounding structures Prisoners Patients with impaired decision-making skills", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Pancreas Tumor Pancreatitis The subject has a surgical indication for distal pancreatectomy In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy At least 18 years of age The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol The subject does not have a surgical indication for distal pancreatectomy In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy Less than 18 years of age The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-75.0, All Urolithiasis men or women = or >18 but <76 years of age presenting with acute renal colic Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones children < 18 years old elderly patients > or = 76 years old pregnancy or planning pregnancy Morbid obesity (>285 pounds in men, >250 pounds in women) patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected) history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-45.0, All Preterm Labor Preterm labor(pregnant between 28th and 37th week) Singleton pregnancy Amnion membranes were intact Past history of preterm labor or premature delivery Urinary tract infections and any other infections Poly or oligohydramnios Fetal distress, fetal or uterine anomaly Membranes rupture and placenta pathology Preeclampsia or intrauterine growth retardation", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-89.0, All Open Abdominal Wounds Abdominal Adhesions Wound Sizes Trauma Population Trauma patients undergoing DC/OA management for traumatic injury Age 18+ Life expectancy longer than 48 hours Prisoners Pregnant patients Younger than 18 years of age", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 16.0-999.0, All Aortic Rupture During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study Non-traumatic aortic rupture Non-traumatic aortic dissection", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Purpura, Thrombocytopenic, Idiopathic and Hepatitis C Subject is \u226518 years old Diagnosed with ITP for at least 12 months prior to screening, and have a platelet count of <30 X109/L on Day 1 (or within 48 hours prior to dosing on Day 1) Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have either not responded to one or more prior therapies (except splenectomy), or who have relapsed prior therapy Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block No history of clotting disorder, other than ITP A complete blood count (CBC), within the reference range, with the following exceptions Platelets <30\u00d7109/L on Day 1 (or within 48hours of Day 1) is required for Hemoglobin: females and males 10.0 g/dl are eligible for Patients with any prior history of arterial or venous thrombosis, AND \u2265 two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, etc) Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study Female subjects who are nursing or pregnant at screening or pre-dose on Day 1 History of alcohol/drug abuse or dependence within 12 months of the study Treatment with thrombopoietin or an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start History of platelet aggregation that prevents reliable measurement of platelet counts An abnormality in bone marrow examination result, other than ITP, identified on the screening examination, which in the opinion of the investigator makes the subject unsuitable for participation in the study (e.g. \u2265MF-2 according to EU consensus scale [Thiele, 2005]) or suggests another primary diagnosis (e.g. Thrombocytopenia is secondary to another disease)", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-999.0, All Trauma Injuries all patients admitted with the trauma team all patients admitted with Injury Severity Score >15 secondary admittance(transfers)>24 post injury", "label": "1"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-999.0, All Myeloproliferative Neoplasms (MPN) Polycythemia Vera (PV) Essential Thrombocythemia (ET) Myelofibrosis (MF) One of the three classical Philadelphia negative myeloproliferative neoplasms (polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)) diagnosed according to WHO or International working group-Myelofibrosis research and treatment (IWG-MRT) Palpable spleen length >5 cms below the costal margin in MF (including primary MF or post-polycythemia vera MF (PPV-MF) post-polycythemia vera ET (PPV-ET)) or palpable spleen of any size in patients with PV or ET Known history of portal vein thrombosis Known history of Budd-chairi syndrome Known history of oesophageal varices Known history of cirrhosis from any cause", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 3.0-60.0, All Blunt Abdominal Trauma 3-60 years of age evaluated for blunt trauma with a GCS of >14 Order of CT abdomen and pelvis imaging Patients requiring intubation or suspected neurological injury (defined above) Pregnant patients Intoxicated patients Patients with age defined hypotension Exploratory laparotomy or transfusion during the ED evaluation Non-verbal patients Positive FAST exam Patients with abdominal trauma or surgery in the last month Victims of sexual assault or non-accidental trauma (NAT) Patients with known or suspected fractures of the femur or pelvis prior to CT imaging", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Blunt Injury Clinical diagnosis of blunt aortic injury (BAI) Clinical diagnosis of penetrating aortic injury", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 15.0-75.0, All Immune Thrombocytopenia adult ITP patients whose platelet counts remain less than 10 x 10^9/L patients whose platelet counts remain less than 30 x 10^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10^9/L after 3 months require continuous glucocorticoid therapy to maintain safe platelet counts Willing and able to sign written informed consent Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit Current HIV infection or hepatitis B virus or hepatitis C virus infections Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are pregnant Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test Patients who are deemed unsuitable for the study by the investigator", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 45.0-75.0, All Laparoscopic Hysteretctomy With Promontofixation Age 45-75 years old Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse Menopaused ASA class I or II Absolute contraindications to laparoscopy Previous history of pelvic surgery, endometriosis and/or infection Pathological peritoneal tissue BMI more than 30 Height less than 150cm", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-75.0, All Antibody-mediated Rejection Humoral Rejection Adult renal transplant recipients, men and women between 18 and 75 years of age Any patient with acute graft dysfunction (elevation of creatinine above post transplant nadir) AND, two out of three, of the following Presence of circulating anti HLA antibody (DSA) Histological findings compatible with Banff Class II or III AMR on transplant biopsy Peritubular capillary c4d positivity on transplant biopsy Patients that have received eculizumab prior to enrolling in the study Patients with ongoing non-acute antibody mediated rejection Patients with predominantly chronic antibody mediated rejection or interstitial fibrosis/tubular atrophy History of severe cardiac disease (e.g., New York Heart Association [NYHA] Functional Class III or IV, myocardial infarction \u2264 6 months of randomization, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases) Prior splenectomy Has a known bleeding disorder Has any active bacterial or other infection which is clinically significant in the opinion of the Investigator and is a contraindication to transplantation Has participated in any other investigational drug study or was exposed to an investigational drug or device within 30 days of screening Has received rituximab (Rituxan\u00ae) \u2264 3 months prior to screening Has received bortezomib (Velcade\u00ae) \u2264 3 months prior to screening", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Acute Abdomen All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion Patients with chronic renal failure already receiving dialysis treatment Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3 Patients judged at the admission not subject to resuscitative measures for severity and comorbidity Patients with massive hemorrhage in operative room or in the immediate perioperative with the need for blood transfusions and abundant blood products > 5 units of Erytrocyte Concentrates (EC) Patients scheduled for Orthotopic Liver Transplantation (OLT) Patients younger than 18 years old", "label": "2"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 30.0-999.0, All Atrial Fibrillation Heart Failure Stroke Myocardial Infarction Patients with a coded diagnosis for atrial fibrillation in their primary or secondary care record Patients in GPRD practices which are deemed \"up to standard\" by GPRD Patients whose records are deemed \"acceptable\" by GPRD and contain at least one year of data Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES A diagnosis of heart failure, stroke, or myocardial infarction occurring before diagnosis of atrial fibrillation", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-80.0, All Wound Infection age \u2265 18 years patients with complicated intra-abdominal infections who needed open abdomen (OA) and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) Eligible patients were properly consented before enrollment. If the patient was incapable, the patient's legal representative was asked to provide consent on the patient's behalf Patients with grade 1b (contaminated OA without adherence between bowel and abdominal wall), 2b (contaminated OA developing adherence) open abdomen, as classified by Bjorck < 18 years pre-existing large ventral hernia Frozen OA with adherent bowel (OA of grade 4) Clean wound (OA of grade 1a or 2a) chronic wound infection critical wound ischemia severe systemic infection end-stage renal disease severe liver disease uncontrolled diabetes mellitus", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-999.0, All Traumatic Subarachnoid Haemorrhage All patients of traumatic subarachnoid haemorrhage Metabolic disorder Altered coagulation profile Cardiac disease morbid illness", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-24.0, All Meconium Ileus premature infants with a birthweight 1500 gram major congenital malformations known gastrointestinal abnormalities", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Postpartum Haemorrhage Pregnancy, gestation age > 24 weeks Age < 18 Adults incapable of giving informed consent Gestational age < 24 weeks", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Thoracoabdominal Trauma Focused Assessment With Sonography for Trauma (FAST) NanoMaxx Ultrasound System (SonoSite) RP-Xpress (InTouch Technologies) for FAST cohort Patient is 18 years of age or older Patient presenting with blunt or penetrating trauma to the thorax or abdomen Patient transported by MD Ambulance to Royal University Hospital Patient being transported by a paramedic who has received training in the above ultrasound system and who has with them a NanoMaxx Ultrasound System (SonoSite) to be used in connection with the RP-Xpress (InTouch Technologies) Patient will take longer than 10 minutes to transport to hospital Patient's care will not be compromised in completing a FAST exam opinion of paramedic Patient's care will not be compromised in completing a FAST exam opinion of ER physician Patients under the age of 18 Patients whose care would be compromised if other procedures of higher priority (as determined by paramedics and/or remotely-present physicians) were not be able to be executed due to time involved in completing a FAST exam Patients who are not being transported to Royal University Hospital Patients whose expected transport time from scene to hospital is less than 10 minutes", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-65.0, All Ovarian Adenocarcinoma Fallopian Tube Adenocarcinoma Primary Peritoneal Carcinoma Stage IIIC unresectable ovarian, tubes or peritoneal primitive adenocarcinoma according to FIGO classification previously treated with 6 cycles of carboplatin-cisplatin neoadjuvant chemotherapy with a response allowing complete surgery after the 6 cycles Time frame between the sixth platin injection and the CRS + HCIP < 10 weeks No disease progression during the neoadjuvant chemotherapy 18 /= 1.5x10^9/L, platelets >/= 150x10^9/L, hemoglobin > 9 g /dl (transfusion allowed) Hepatic function : Bilirubin 60 ml/min (Cockcroft formula) and urinary strip <2 (If urinary strip >/= 2, proteinuria < 1g/24h) Plasmatic albumine > 25 g/l HIV negative status Incomplete cell kill surgery Non-epithelial ovarian cancer Borderline tumors Non in complete remission previous cancer for more than 5 five years before Uncontrolled high blood pressure (blood pressure > 150/100 mm Hg despite antihypertensive treatment) Previous abdominal or pelvic radiotherapy Previous pathology of the central nervous system, except for well controlled pathology like epilepsy Previous stroke, transient ischemic attacks or subarachnoid hemorrhage Previous pulmonary embolism Pregnant or breastfeeding women (Women in age must have a blood negative pregnancy test at least 15 days before going under surgery)", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-90.0, All Intra Abdominal Hypertension Abdominal Compartment Syndrome Adults male or female over 18 year old undergoing emergency laparotomy. Patients that have their abdominal wall closed at the end of surgery by a temporary closure technique Patients that according to the surgeon estimates will not survive 24 hours", "label": "2"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-65.0, All Asplenia Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury Ages less than 18 and greater than 65 Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study", "label": "2"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Hernia, Abdominal Hernia,Ventral Informed Consent Form (ICF) signed by the patient or his/her legal representative primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair recurrence after former abdominal hernia repair WITH MESH recurrence after suture abdominal hernia repair CAN be included no written informed consent patient under 18 years old emergency surgery (incarcerated hernia) patients with expected life time shorter than one year for example due to generalised malignancy BMI exceeding 40.0kg/m\u00b2 contaminated surgical fields patients on immunosuppression, steroid therapy, constant pain therapy", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Malignant Pleural Mesothelioma Patients with histologically confirmed Malignant Pleural Mesothelioma Age of 18 years or more first-line chemotherapy with platinum-Based agents history of prior malignancy pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5* Upper Limit of Normal or Serum bilirubin more than 1.5* Upper Limit of Normal)", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-70.0, All Achilles Tendon Rupture Patient is willing and able to give informed consent for participation in the study Aged 18 years Diagnosed with acute Achilles tendon rupture Presenting within and receiving study treatment within 7 days post injury Patients in whom the decision has been made for non-operative treatment Able (in the Investigators opinion) and willing to comply with all study requirements Able to attend a PATH-2 study hospital site for the 24-week follow-up The patient may not enter the study if ANY of the following apply Previous major tendon or ankle injury or deformity to either lower leg History of diabetes mellitus Known platelet abnormality or haematological disorder Current use of systemic cortisone or an anticoagulant Evidence of lower limb gangrene/ulcers or peripheral vascular disease History of hepatic or renal impairment or dialysis Female patients who are pregnant or breast feeding Is currently receiving or has received radiation or chemotherapy within the last 3 months Has inadequate venous access for drawing blood", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-30.0, All Anterior Cruciate Ligament Injury Sportive, active patient (Tegner score =/>5) Age above 18 untill 30 years at time of Primary rupture of the anterior cruciate ligament, evidence by history (acute trauma, clicking sensation, swelling within a few hours, instability) and physical examination (positive Lachman, anterior drawer test and/or Pivot shift) Primary rupture indicated by MRI No associated ligamentuous disorde of the knee, evidenced by history, physical examination, x-ray or MRI) Time span between anterior cruciate ligament rupture and operation no longer than 21 days Willingness to comply to advised rehabilitation protocol supervised by (NFVS registrated) sports physiotherapist Infection Known hypersensitive response for materials used (Cobalt, chroom, nickel) Serieus pre-existing malaligment of leg indicated for surgery Tendency for excessive scar tisseu formation, such as arthrofibrosis History of previous surgery on leg indicated for surgery History of removal of tendon on leg indicated for surgery Muscular, neurological or vascular disorders negatively affecting healing or rehabilitation Cartilage injury requiring (some kind of) cartilage repair surgery (such as microfracture or cell therapy) Arthrosis more dan ICRS grade 2 evidenced by x-ray Long(er) term use of relevant medication, such as prednisolon or cytostatica", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Malignant Melanoma Head and Neck Cancer Biopsy proven incurable melanoma or incurable HNSCC amenable to have biopsy and/or surgical resection of either the primary and/or locoregional metastatic site, at the University of Colorado Hospital Age \u2265 18 years old Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate bone marrow, hepatic and renal function Absolute neutrophil count \u2265 1,500/\u00b5L Platelets \u2265 100,000/\u00b5L Hemoglobin \u2265 9.0 g/dL Creatinine \u2264 1.5x upper limit of normal (ULN) or calculated creatinine clearance \u2265 60 mL/min Total bilirubin \u2264 1.5x ULN Aspartate Aminotransferase (AST)/Alanine Aminotransferase ( ALT) \u2264 2x ULN Contraindication (absolute or relative) to granulocyte colony-stimulating factor (G-CSF) filgrastim usage known hypersensitivity to E coli-derived proteins' filgrastim, or any other component of the product Sickle cell disorders Clinically significant and active lung hemorrhagic or inflammatory disease, including but not limited to chronic obstructive pulmonary disease (COPD), autoimmune disease, and alveolar hemorrhage; or hypoxemia of any etiology requiring oxygen Clinically significant splenomegaly or splenic metastases; history of splenic rupture, recent splenic trauma or other clinically significant splenic disease that increases the risk of splenic rupture Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer Known hepatitis B or C, or HIV", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-45.0, All Pregnancy American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I Healthy, ASA II mild and controlled systemic disease) Singleton pregnancies 42 weeks gestation Non-labouring Scheduled cesarean delivery English speaking Age 18-45 years Cardiovascular disease Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia) Allergy to phenylephrine, or any other standardized medication Obesity (BMI > 35 kg/m2) Diabetes Mellitus type 1 Smoker Coffee/Caffeine intake within 6 hours of SDF measurement", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 0.0-15.0, All Injuries Trauma Wounds and Injuries Children Child Children 0-15 years inclusive Presenting to either of the study hospitals for assessment or treatment Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0) Due to an incident involving any non-motorized bicycle, tricycle or kick scooter Incidents where the injured child was involved in a motor vehicle collision Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist) Incidents involving a bicycle fitted with 'bull bars' Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion) If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Acute Abdominal Pain Presentation at ED with acute abdominal pain, aged at least 18 years No informed consent, pregnancy, homeless, no social assurance", "label": "2"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Thoracic Injuries, Glasgow Coma Scale (GCS) of 15 stable vital signs admitted within the first 6 hours after injury urgent and urgent triage category", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-65.0, All Biceps Tendon Rupture male subjects between 18 and 65 years of age patient has had a DBTR amenable to surgical repair surgeon must be able to obtain a tension-free repair using an endobutton participants must have been working prior to the injury patient must be expected to return to work post-injury females outside of the specified age range patient with an identified congenital abnormality at the insertion of the distal biceps tendon those who have previously ruptured the tendon or those with tendon ruptures resulting from a multi-trauma patients with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent patients with life expectancy of less than 2 years patients who do not speak/read/understand English patients with no fixed address or contact information patients who are unwilling to complete follow-ups", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Stroke Atrial Fibrillation (AF) Intracerebral Haemorrhage (ICH) Study I: (AF) Adult (\u226518y; no upper limit) patients with a clinical diagnosis of non-valvular AF (verified by ECG) with intention to treat with best practice oral anticoagulants (e.g. warfarin) Previous ischaemic stroke or TIA diagnosed by treating clinician All patients must be able to have GRE MRI before (or within 1 week) of starting best practice oral anticoagulant Any MRI contraindications Previous use of oral anticoagulation Definite contra-indication to oral anticoagulation Serious head injury (resulting to loss of consciousness) Study II: (ICH) \u2022 Adult (>18y) patients treated at participating centres with confirmed ICH (confirmed on CT or MRI scans) with or without a history of anticoagulant use at the time of the ICH Known underlying structural cause for ICH (e.g arteriovenous malformation, tumour, cavernoma, intracranial aneurysm, haemorrhagic transformation of an infarct) Major head trauma (causing loss of consciousness and though to be sufficient to have caused the ICH) in previous 24 hours", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-65.0, All Cardiac Arrest Sudden Death -Eligible patients have the following combination of Adults over 18 years of age and under 65 years of age And Refractory cardiac arrest (defined by the failure of professionals to resuscitate at the 20th minute of cardiac arrest with a minimum of 3 Automatic External Defibrillator (AED) or equivalent analyze And Beginning of external cardiac massage within the first 5 minutes after cardiac arrest (no flow < 5 min.) with shockable rhythm or the presence of signs of life during resuscitation (any rhythm): spontaneous movement, absence of mydriasis and/or pupillary response, respiration And Medical cause of the cardiac arrest And End-Tidal CO2 (ETCO2) above 10 mm Hg at the time of And Absence of major co-morbidity. And Extra-corporeal Membrane Oxygenation (ECMO) team available Children under 18 years of age Adults over 65 years of age Period of more than 5 minutes without cardiac massage after collapsing Known co-morbidity that compromises the prognosis for short or medium-term survival Cardiac arrest during transportation times", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 18.0-999.0, All Primary Myelofibrosis Intermediate-1, intermediate-2, or high-risk PMF, PPV-MF or PET-MF as based on The Dynamic International Prognostic Scoring System (DIPSS) Palpable splenomegaly \u22655 cm below the LCM in midclavicular line by physical examination TSS \u226513 on the MPN-SAF TSS 2.0, not including the inactivity question, based on a single assessment during screening visit Age \u226518 years old at the time of screening (or minimum age of legal consent consistent with local regulations, if minimum is >18 years of age) ECOG performance status 0 to 3 Peripheral blast count <10% Absolute neutrophil count >500/\u03bcL Participants who are platelet or RBC transfusion dependent are eligible Adequate liver and renal function, defined by liver transaminases (AST/serum glutamic oxaloacetic transaminase [SOOT] and alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT]) \u22643 \u00d7 upper limit of normal ([ULN], AST/ALT \u22645 \u00d7 ULN if transaminase elevation is related to MF), direct bilirubin \u22644 \u00d7 ULN, and creatinine \u22642.5 mg/dL At least 6 months from prior splenic irradiation Any GI or metabolic condition that could interfere with absorption of oral medication Life expectancy <6 months Prior treatment with a JAK2 inhibitor Completed ASCT, or are eligible for and willing to complete ASCT History of splenectomy or planning to undergo splenectomy Uncontrolled intercurrent illness, including but not limited to ongoing active infection, or psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements Other malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ confined, or treated non-metastatic prostate cancer with negative prostate specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma Inflammatory or chronic functional bowel disorder, such as Crohn's disease, inflammatory bowel disease, chronic diarrhea, or constipation Clinically symptomatic and uncontrolled cardiovascular disease History of any of the following within 6 months prior to first dose of pacritinib: myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure", "label": "0"} +{"topic": "A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.", "doc": "eligible ages (years): 7.0-18.0, All Appendicitis Children and adolescents aged 7-18 years old ASA Score I (American Society of Anesthesiologists classification) [Appendix 1]: a normal healthy patient ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease Patients scheduled for laparoscopic appendectomy surgery Uncomplicated appendicitis Hemodynamically stable patient No evidence of appendiceal perforation based on preoperative clinical and imaging assessment Diagnosed to have simple acute appendicitis by intraoperative laparoscopy Patients who have provided a written informed assent Caregivers who have provided a written informed consent ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation Hemodynamically unstable patient Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery Postoperative admission in an intensive care unit with sedation or ventilatory assistance Cognitive impairment or mental retardation Progressive degenerative diseases of the CNS Seizures or chronic therapy with antiepileptic drugs", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 6.0-16.0, All Brain Injuries Moderate to severe traumatic brain injury ", "label": "2"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 16.0-45.0, All Brain Injuries Hypothermia FOR EARLY TO 35\u00b0C GCS 3-8 on initial evaluation or deteriorates during transport Mechanism of injury consistent with blunt, non-penetrating trauma to head Systolic blood pressure > 110 mm Hg Diastolic blood pressure> 60 mm Hg Heart rate (pulse) < 120 beats per minute Estimated or known age 16-45 No suspicion of pregnancy Esophageal/rectal probe temperature > 35.5\u00b0C (Pre-hospital cooling only) Injured < 2 hours prior to arrival of pre-hospital providers Following commands upon EMS arrival without deterioration to coma or follows command after an initial period of coma Mechanism of injury GSW or no indication of head injury Systolic blood pressure < 120 mm Hg Diastolic blood pressure < 60 mm Hg Heart rate (pulse) > 120 beats per minute Estimated or know age > 45 or < 16 Suspected pregnancy Forehead scan temp < 35.5\u00b0C (Pre-hospital cooling only) Injured >2 hours prior to arrival of pre-hospital providers Evidence of major chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 9.0-18.0, All Traumatic Brain Injury English speaker Minimum birth weight of 2500 grams (5.5 lbs) and 37 weeks' gestation Additional for Children with Traumatic Brain Injury Head injury resulting in a post-resuscitation Glasgow Coma Scale score of either 13 to 15 or 3 to 8 No evidence of hypoxic injury History of epilepsy, mental retardation, or documented evidence of developmental dysfunction Previous hospitalization for head injury involving loss of consciousness or post-concussional symptoms History of autism, major psychiatric disorder, or pervasive developmental delay History of meningitis or encephalitis History of child abuse History of chronic or uncontrolled serious physical disorders (cancer, uncontrolled diabetes, cystic fibrosis, etc.) Note: siblings of participants with TBI or orthopedically-injured comparison children will not be enrolled to maintain the independence of the groups", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 17.0-70.0, All Traumatic Brain Injury Traumatic Brain Injury with a Glascow Coma Score < 9 (ie: severe head injury) Traumatic Brain Injury with a Glascow Coma Score > 8 with an intracranial pressure monitor in situ and CTscan evidence of one or more of the following: Cerebral oedema (Marshall grades III & IV), midline shift >5 mm cerebral contusion >3cm, evacuated subdural haematoma Enrolled within the first 48 hours after trauma Aged 17 ears Has had a cardiac arrest at or post the trauma scene Pupils are fixed bilaterally and dilated >4mm,GCS=3 Coagulopathy sufficient to contraindicate surgery No chance of survival after consideration of CT and clinical findings Patients with lower limb/pelvic trauma excluded from Innercool monitoring only", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-70.0, All Traumatic Brain Injury severe closed head injury patients or GCS 3-9 patients who receive brain oxygen monitoring ventriculostomy/ICP monitor at least one reactive pupil no known life threatening disease prior to trauma age 18-70 years old consent for microdialysis/brain 02 monitoring legal family representative present that can give informed consent for perfluorocarbon administration no motor response both pupils fixed and dilated no consent available allergy to egg proteins coagulopathy major liver injury major pulmonary injury", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 16.0-45.0, All Traumatic Brain Injury Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5) Estimated or known age > 16 and < 45 years old Time of Injury within 2.5hrs of arrival at hospital GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post randomization GCS = 3 AND bilaterally non-reactive pupils Abbreviated Injury Score (AIS) > 4 for any body area except head Positive abdominal ultrasound or CT scan Persistent hypotension (systolic blood pressure < 110mmHGg) Persistent hypoxia (O2 Saturation < 94%) Positive pregnancy test Injured greater than 2.5 hours from hospital arrival Pre-existing medical conditions, if known", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 0.0-17.0, All Traumatic Brain Injury Patients with a GCS 16/40 sec, INR > 1.7) Hypotensive episode (Systolic Blood Pressure <5th percentile for age>10 min) Documented Hypoxic episode (O2 saturation < 94% for > 30 min) Pregnancy", "label": "2"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 1.0-16.0, All Traumatic Brain Injury have a severe traumatic brain injury as defined by either a GCS \u2264 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score \u2264 3 and normal CT scan are aged between 1 and 16 years are mechanically ventilated are not randomized by 6 hours after injury have penetrating brain injuries have fixed dilated pupils and GCS = 3 have proven cervical spinal cord injury have more than mild neurodevelopmental disability prior to injury have an acute isolated epidural hematoma and are expected to recover rapidly after surgical removal have had a post-traumatic seizure with a normal CT scan have refractory shock, defined as systolic blood pressure more than 2 standard deviations (SD) below the mean for age despite 80ml/kg intravenous fluid resuscitation", "label": "2"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 0.0-999.0, All Minor Head Injury Intracranial Bleeding Traumatic Brain Injury Minor head injury, dizziness, nausea, vomiting no injury to the head", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 2.0-16.0, All Fractures Healthy pediatric emergency patients with isolated extremity injury requiring reduction Active respiratory illness Seizure disorder Craniofacial abnormalities Allergy to soy, ketamine, or propofol Hypertension Significant renal, cardiovascular or neurologic disease", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 0.0-17.0, All Cardiac Arrest Informed consent by parent or legal guardian Age \u2265 38 weeks gestation up to and including 17 years Patient admitted with a diagnosis of a cardiac arrest requiring compressions \u22653 minutes Remain comatose i.e. have Glasgow Coma Score less than or equal to 10 assessed at the tertiary level pediatric hospital at least 1 hour post cardiac arrest Invasive mechanical ventilation Cardiac arrest lasting \u226545 minutes, irregardless of commencement of ECMO Refractory hemorrhagic shock Dysrhythmia leading to cardiac arrest, where cooling would be part of standard therapy Suspected diagnosis of brain death as defined as fixed and dilated pupils, Glasgow Coma Score of 3 and no evidence of brain function on neurological examination Patients who have had a prolonged cardiac arrest at the scene of a trauma Decision to withhold (DNR) or withdraw life sustaining therapies Acute Birth asphyxia Terminal illness, not expected to survive 12 months Cardiac arrest caused by septic shock Severe neurodevelopmental disability or persistent vegetative state prior to cardiac arrest", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 16.0-70.0, All Severe Head Trauma Diagnosis TBI GCS 4-8 Age 16-70 Multiple trauma resulting in shock Bilateral absent pupil response Time from injury > 6 hours Brain tumor or mass effect secondary to hemorrhage or brain surgery Pregnancy Confounding condition or injury Spinal cord injury Sustained high blood pressure or arterial oxygen saturation", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-70.0, All Traumatic Brain Injury Male or female 18 years of age (inclusive) at the time of study entry Weight \u226545 kg Able to begin the infusion of study drug within 12 hours of injury Evidence of severe non-penetrating traumatic brain injury by clinical evaluation, clinical indication for intracranial pressure (ICP) monitoring, Glasgow Coma Scale (GCS) assessment (4-8 prior to randomization, obtained any time prior to dosing and including patients who deteriorate to severe TBI after arrival in the hospital, not including times when the patient is pharmacologically paralyzed for management or treatment) and with definite anatomic signs of injury on head CT scan (e.g., Marshall Grade II-VI or equivalent) At least one reactive pupil at screening. Just prior to study drug administration pupil reactivity must be confirmed again. If the patient is in the peri-postoperative period at that time and reactivity is difficult to assess due to small pupil size, the Investigator will determine if the patient is eligible based on clinical presentation If a patient, due to his or her injuries is unable to provide written informed consent, then written consent may be obtained by an appropriate surrogate decision maker in accordance with preapproved procedures in compliance with local regulations Patients who meet any of the following will not be included in the study Physical Assessment Not expected to survive the next 24 hours Morbidly obese (BMI >40) Absence of a motor response (not including times when the patient is pharmacologically paralyzed for management or treatment) Severe unexpected hyperthermia on admission (e.g. >39\u00b0C) Bilaterally fixed and dilated pupils Penetrating traumatic brain injury Major liver, kidney, or cardiac injury requiring operative intervention Major pulmonary injury, including lung contusion, severe atelectasis, acute respiratory distress syndrome, or acute aspiration pneumonitis", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Hematoma, Subdural, Chronic Patients with chronic subdural hematoma that needs surgical evacuation Age > 18 year Lack of compliance Kidney artery stenosis Stenosis of the aorta Severely decreased kidney function Allergy or intolerance/contraindications toward ACE inhibitors Already in ACE inhibitor treatment Coagulopathies Malignant disorders Fertile women Other neurological disorders", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 3.0-9.0, All Traumatic Brain Injury Moderate to severe TBI that occurred within the last 24 months Overnight hospital stay English-speaking Parent must be willing to provide informed consent Child does not live with parents or guardian Child or parent has history of hospitalization for psychiatric problem Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability", "label": "2"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 8.0-18.0, All Type 1 Diabetes Mellitus 18 years old Have a diagnosis of type 1 diabetes mellitus < 8 years or > 18 years old Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 6.0-18.0, All PTSD Traumatic Brain Injury Post Concussive Syndrome For the whole sample Children age 6 to 18 Language spoken: Hebrew, Arabic DSM IV R diagnosis: PTSD Car accident event within past 3 years For the m-TBI group Any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain] Diagnosis of MTBI within 3 years as confirmed by CT/MRI/fMRI Glasgow coma scale; GCS<15 Children presenting with psychotic symptoms Children presenting with mental retardation", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-89.0, All Subarachnoid Hemorrhage Intracranial Hemorrhage Ischemic Strokes Subdural Hematoma Patients aged between 18 and 89 years old Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage Patients who are expected to stay in the ICU for at least 5 days Hyperglycemia is not an Patients who have received or will be treated with systemic corticosteroids Patients who will be receiving high doses of propofol (>40 cc/hr) Patients with type 1 Diabetes Patients with sepsis or acute trauma Patients with an expected stay in the ICU of less than 4 days Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components Pregnant and lactating patients Patients with prior history of gastroparesis Patients with acute kidney failure (creatinine > 2.5mg/dl) Patients with acute liver failure (bilirubin > 2.0 mg/dl)", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-30.0, All Schistosomiasis Bilharziasis Urinary Schistosomiasis All subjects had to meet the study within 21 days prior to treatment Caucasian volunteers No smoker biological parameters (haematological, biochemical, renal and hepatic) in normal range Health Insurance sign inform consent inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) any immunological deficiency any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) current immunosuppressor treatment any other medication use within 2 weeks before the study any vaccination within the last 6 months no antibodies against Sh28GST protein", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 21.0-28.0, All Physiological Strain healthy civilian volunteers aged 21-28 without known medical illnesses or medication use the existence of or suspicion of existing cardiac or respiratory disease hypertension diabetes any hormonal disease or any other chronic illness that may inhibit participation in the experiment infectious disease 3 days prior to the experiment", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Cerebral Ischemia Subarachnoid Hemorrhage for Admission to one of the participating study centres Age 18 years or over SAH with an aneurysmatic bleeding pattern for Evidence of DCI after the SAH, defined as any decrease in the level of consciousness or the development of new focal neurological deficits after the onset of the SAH that is not due to increasing hydrocephalus, rebleeding of the aneurysm, epileptic seizure, septic or metabolic encephalopathy, unless symptoms of DCI started within 3 hours Co-existing severe head injury Perimesencephalic haemorrhage (perimesencephalic bleeding pattern and no aneurysm on CT-angiography) A history of a ventricular cardiac rhythm disorder, necessitating medical treatment A history of a left ventricular heart failure, necessitating medical treatment Likely transfer to another hospital, not participating in the trial, soon after treatment for the aneurysm Moribund Pregnancy", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 10.0-999.0, All Minor Head Injury Patient with acute MHI was defined as a patient having a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) of 13 to 15 and at least 1 of the following risk factors: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit Patients are excluded from the study if they are younger than 10 years, had GCS score of less than 13 or instable vital signs, came to the ED more than 24 hours after head trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious penetrating skull injury or had contraindications for CT", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 7.0-7.417, All Heart Defects, Congenital Critical Illness Mental Processes Child Seven-year-old children with CHD and healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=<1year) Genetic syndromes (Down, 22q11del), known to result in neurocognitive impairment IQ < 70 Lack of baseline neurocognitive measurements during first follow-up Date of birth before February 2005", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 1.0-17.0, All Trauma Pediatric trauma patients with Injury Severity Score greater than 12 Age 1-17 years Trauma within 8 hours Injury Severity Score less than 12 Pre-existing renal disease On medication that affects serum sodium (i.e diuretic therapy) Blood transfusion within first 24 hours Operation within first 24 hours Oral intake of fluid or solids in first 24 hours", "label": "2"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Traumatic Brain Injury Ages 18 Years or older Males or Females Primary diagnosis of TBI, subarachnoid hemmorhage (SAH), intracranial hemmorhage (ICH), stroke Requires mechanical ventilation Requires or is receiving continuous IV sedation Glascow Coma Score (GCS) of 3 persisting from the scene with bilaterally fixed dilated pupils with no appreciable chance of survival The inability to identify a next of kin or guardian to give consent if patient unable to consent Pregnant Allergy or contraindication to propofol Allergy to contraindication to midalozam Status epilepticus Current neuromuscular blockade Patient with a known hypersensitivity to propofol or midalozam Allergies to eggs, egg products, soybeans or soy products Acute narrow-angle glaucoma", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 10.0-16.0, All Diabetes Diabetic Ketoacidosis To be eligible for the study, all subjects must meet the following Healthy control OR Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines Age 10 years to less than 17 years Parent/guardian understand the study protocol and agrees to comply with it Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English Subjects who meet any of the following are not eligible for the study History of head trauma with any loss of consciousness History of premature birth (less than 30 weeks of gestation) History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age History of neurologic disease independent of diabetes (seizure disorder)", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 0.0-15.0, All Traumatic Brain Injury TBI patients admitted to the pediatric intensive care service (PICU)or pediatric progressive care unit Range in age from birth to 15 years TBI with a Glasgow Coma Scale of 3-15 Acoustic window for adequate transcranial doppler (TCD) ultrasound English or Spanish speaking or understanding parent/legal guardian to consent Access for a buccal swab for genotyping Non-English or Spanish speaking parents/legal guardian Children with a previously diagnosed neurodevelopmental delay", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 60.0-999.0, All Chronic Subdural Hematoma Subdural Drain Patients diagnosed to have symptomatic chronic subdural haematoma confirmed by a computed tomography or magnetic resonance imaging brain scan Ethnic Chinese Age >/= 60 years-old Reasonable expectation of completion of outcome measures at follow-up Written informed consent Unsalvageable patients: fixed and dilated pupils after resuscitation or signs of brainstem herniation that precludes definitive therapy When the operating surgeon judges that drain placement may be hazardous or to be of limited benefit e.g. readily expanded brain in young patients History of previous cranial neurosurgical procedure On concurrent glucocorticoid therapy Suspected intracranial hypotension syndrome Blood dyscrasia Use of antiplatelet medication e.g. aspirin or warfarin without adequate reversal or observation for drug effect to wear off (at least 5-7 days) Thrombocytopenia: platelet level <100 x 109/l Coagulopathy: prothrombin time PT >12sec or, activated partial thromboplastin time (APTT) >37.4 sec End-stage renal/ hepatic failure", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Brain-damaged Patients male or feminine Subjects of 18 or more years old Patients c\u00e9r\u00e9bro hurt presenting disorders(confusions) of the consciousness (Score of Glasgow < 9) and justifying an hourly pupillary surveillance(supervision) in the middle of neurosurgical resuscitation. (Definition of the Score of Glasgow in appendix) acute(sharp) intellectual Aggression bound(connected) to a cranial trauma, a meningeal bleeding by break of an\u00e9vrysme, a cerebral vascular accident, an intra-cranial expansive process, a post-operative neurosurgical complication, an intra-cranial high blood pressure of medical origin (m\u00e9ningo-encephalitis, hypertensive encephalopathy) Admission in resuscitation within first 48 hours of the aggression Subject having a direct eye trauma, as well as any history which can affect(allocate) the relevance of the pupillary examination (anophthalmia, cataract(waterfall) opalescente, surgery irienne, blindness, reached(affected) by III prerequisite, that the character of these affections is bilateral or unilateral) presenting Subject of the signs of irreversible coma in the admission minor Subject, pregnant or breast-feeding woman, subject deprived of freedom, subject not being affiliated to the national insurance scheme", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 30.0-80.0, All Intracranial Arterial Stenosis Intracranial Atherosclerosis Ischemic Stroke Cerebral Angiogenesis TIA or non-severe stroke within 30 days of enrollment attributed to 70% to 99% stenosis* of a major intracranial artery (carotid artery or MCA) *May be diagnosed by TCD, MRA, or CTA to qualify, but must be confirmed by catheter angiography as per usual clinical practice Modified Rankin scale score of \u22643 Target area of stenosis in an intracranial artery that has a normal diameter of 2.00 mm to 4.50 mm Target area of stenosis is \u226414 mm in length Age \u226530 years and \u226480 years * Patients 30 to 49 years of age are required to meet at least 1 additional (i-vi) provided below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in patients 30 to 49 years is atherosclerotic: i. Insulin-dependent diabetes for at least 15 years ii. At least 2 of the following atherosclerotic risk factors: hypertension (BP \u2265 140/90 mm Hg or on antihypertensive therapy); dyslipidemia (LDL \u2265130 mg/dL or HDL \u226440 mg/dL or fasting triglycerides \u2265150 mg/dL or on lipid lowering therapy); smoking; non-insulin-dependent diabetes or insulin-dependent diabetes of <15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, and peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event iii. History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease iv. Any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by noninvasive vascular imaging or catheter angiography and is considered atherosclerotic v. Aortic arch atheroma documented by noninvasive vascular imaging or catheter angiography vi. Any aortic aneurysm documented by noninvasive vascular imaging or catheter angiography that is considered atherosclerotic Negative pregnancy test in a female who has had any menses in the last 18 months Patient is willing and able to return for all follow-up visits required by the protocol Tandem extracranial or intracranial stenosis (70-99%) or occlusion that is proximal or distal to the target intracranial lesion Bilateral intracranial vertebral artery stenosis of 70% to 99% and uncertainty about which artery is symptomatic (e.g., if patient has pontine, midbrain, or temporal occipital symptoms) Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days before the expected enrollment date Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis Presence of intraluminal thrombus proximal to or at the target lesion Any aneurysm proximal to or distal to the stenotic intracranial artery Intracranial tumor (including meningioma) or any intracranial vascular malformation Computed tomographic or angiographic evidence of severe calcification at target lesion Thrombolytic therapy within 24 hours before enrollment", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Subdural Hematoma Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma Chronic subdural hematoma verified on cranial CT or MRI A subdural drainage cannot be placed due to intraoperative circumstances (e.g. brain unfolds) The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy) Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt) no informed consent", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 6.0-17.0, All Traumatic Brain Injury TBI ADHD Between ages of 6-17 Sustained Moderate to Severe TBI TBI occurred at least 6 months prior to beginning the study TBI occurred no earlier than 5 years of age Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale History of developmental disability or mental retardation Current active participation in ADHD-related behavioral intervention History of psychiatric condition requiring an inpatient admission in past 12 months Actively taking medications with a contraindication to Concerta that cannot be discontinued Current use of stimulant medication or ADHD specific medications that cannot be discontinued Non-blunt head injury Family history of arrhythmia Pregnancy", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Head Injury Traumatic Brain Injury (TBI) Photosensitivity Photophobia years old reports a previous head injury that occurred at least 6 months ago score of 2 or 3 (mild TBI) on OSU-TBI ID Survey best-corrected visual acuity of at least 20/30 in both eyes reliable visual field pregnancy significant afferent pupillary defect previous history of neurodegenerative disease intraocular pressure more than 21 mm Hg significant visual field defect active corneal pathology history of retinal or optic nerve disease strabismus (eye turn)", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 15.0-999.0, All Traumatic Brain Injury Blunt or penetrating traumatic mechanism consistent with traumatic brain injury Prehospital Glasgow Coma Score (GCS) score \u2264 12 at any time prior to randomization and administration of sedative and/or paralytic agents Prehospital systolic blood pressure (SBP) \u2265 90 mmHg prior to randomization Prehospital intravenous (IV) or intraosseous (IO) access Estimated Age \u2265 15 (or estimated weight > 50 kg if age is unknown) Emergency Medicine System (EMS) transport to a participating trauma center Prehospital GCS=3 with no reactive pupil Estimated time from injury to hospital arrival > 2 hours Unknown time of injury no known reference times to support estimation Clinical suspicion by EMS of seizure activity or known history of seizures, acute myocardial infarction (MI) or stroke Cardio-pulmonary resuscitation (CPR) by EMS prior to randomization Burns > 20% total body surface area (TBSA) Suspected or known prisoners Suspected or known pregnancy Prehospital TXA given prior to randomization", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-90.0, All Chronic Subdural Hematoma Age \u2265 18 and \uff1c90 years old, male or female CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult) Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)\uff1cGrade 3 Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted Patients have never undergo surgery on the hematoma Patient fully understood the nature of the study, and voluntarily participates and signs informed consent Allergic to the statin or its ingredients Cerebral herniation might occur at any time Hematoma leads to herniation and warrants surgical operation Hematoma caused by tumors, blood and other known comorbidities Abnormal liver function Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study Patients have been on oral Statin treatment for a long time Patients have been on oral Steroids treatment for a long time Participate in clinical trials in the past four weeks Pregnant or breastfeeding", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-85.0, All Intracerebral Hemorrhage Spontaneous intracranial or intraparenchymal hemorrhage 85 years of age Hemorrhage occurred in a supratentorial location Inability to obtain consent within 3 days of hemorrhage onset Known pregnancy Therapeutic anticoagulation with Lovenox, Coumadin or Heparin Prior history of therapeutic radiation to any area Brain tumor Hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation Central nervous system infection Subdural hematoma Subarachnoid hemorrhage Chronic immunosuppression, including steroids or chemotherapy agents", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 22.0-65.0, All Subdural Hematoma, Traumatic Non-penetrating traumatic brain injury GCS motor score \u22645 (not following commands) Estimated or known age 22-65 years Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury Estimated time of injury to time to reach temp of 35\u00b0C<6 hrs Total GCS = 3 and bilateral fixed and dilated pupils Following commands after an initial period of coma (GSC motor score of 6) Known pre-existing neurological deficit (e.g., previous TBI, stroke) Concomitant spinal cord injury Arrival temperature is <35\u00b0C Hemodynamic instability (i.e., MAP<60mmHg for 30 minutes) Active cardiac dysrhythmia resulting in hemodynamic instability Pregnancy Duret hemorrhage Prisoner or Ward of the State", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 5.0-999.0, All Concussion Stress Disorders, Post-Traumatic All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here mild to moderate structural traumatic brain injury (TBI) as evidenced by CT scan demonstrating the presence of hemorrhage (subdural, epidural, subarachnoid or intraparenchymal), brain contusion, or skull fracture non-structural TBI(concussion), meaning no signs of structural injury on imaging; however, they complain of usual brain injury symptoms such as headache, dizziness, cognitive impairments, etc., A subject with a traumatically induced physiological disruption of brain function, manifested by >1 of the following Any period of loss of consciousness (LOC) Any loss of memory for events immediately before or after the accident Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused) Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following Loss of consciousness of approximately 30 minutes or less After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15 Posttraumatic amnesia (PTA) not greater than 24 hours Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2 Pregnant individuals and prisoners will also be excluded from the study", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-89.0, All Chronic Subdural Hematoma Age \u226518 and\uff1c90years old, both gender Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult) The midline shift to less than 1 cm Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted Patients have never undergo surgery on the hematoma Patient fully understood the nature of the study, and voluntarily participates and signs informed consent Allergic to the statin and dexamethasone or its ingredients Hematoma caused by tumors, blood and other known comorbidities Abnormal liver function Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study Patients have been on oral Statin treatment in the past four weeks Patients have been on oral Steroids treatment for a long time Diagnosed Diabetes patients with poorly controlled blood glucose Participate in clinical trials in the past four weeks Pregnant or breastfeeding Failure of completing the trial by poor compliance", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Trauma Injury Bleeding Haemorrhage Coagulopathy Injured trauma (penetrating or blunt) patients who are at risk of significant bleeding, defined as: i. Systolic blood pressure (SBP) \u2264 100mmHg at any time from the injury scene until 30min after hospital admission AND ii. Red blood cell transfusion has been ordered by the trauma team leader (or delegate) Patients in shock which the etiology is purely not related to bleeding i. Cardiogenic (myocardial or valvular dysfunction); ii. Distributive (septic, anaphylactic, acute adrenal insufficiency and neurogenic) and iii. Obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli) Severe head injury, defined as any of the following i. Glasgow coma scale (GCS) of 3 due to severe traumatic brain injury (TBI); ii. TBI with clear indication of immediate neurosurgical intervention based on clinical findings (mechanism of trauma associated with focal signs such as anisocoria with fixed pupil) or on CT results (bleeding causing mass effect); iii. Unsalvageable head injury such as through-through gunshot wound to the head, open skull fracture with exposure/loss of brain tissue; as per the trauma team or neurosurgery initial clinical assessment or as per initial CT of the head findings Known complete or incomplete spinal cord injury Known hereditary or acquired coagulopathies unrelated to the trauma resuscitation (e.g. known hepatic dysfunction) Use of anticoagulant medications such as warfarin, low-molecular weight heparin, and direct thrombin and factor Xa inhibitors Moribund with evidence of unsalvageable injuries and withdrawal of care, as per the trauma team Received blood products prior to admission Patients with estimated body weight under 50Kg", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Subdural Hematoma Healthy Volunteers Patient admitted for surgery of chronic subdural hematoma A CT scan of the patient has been performed, within the latest 96 hours The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5 Patient/healthy volunteer should be \u2265 18 years of age The patient/healthy volunteer has signed a written informed consent Females who are pregnant or breast feeding women Patient/healthy volunteer has a shunt or other foreign object implanted in the brain Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Subarachnoid Hemorrhage Written informed consent of the patient or consent of patient's next of kin Spontaneous SAH Age: \u226518 Glasgow coma scale (GCS) \u2264 12. In intubated patients the GCS assessment will be performed after cessation of sedation or if not possible the last GCS score before intubation will be used SAH due to any other cause or structural abnormality of the brain (trauma, dissection, arterio-venous malformation, dural arterio-venous fistula) Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living abroad)", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 7.0-25.0, All Sarcoma, Soft Tissue Osteosarcoma Tumor Survivors of paediatric bone or soft tissue sarcomas, who were treated from 1992 onwards in the paediatric haematooncology department of UZLeuven according to one of the following treatment protocols *For soft tissue sarcomas: MMT 95, MMT 98, RMS2005 or NRST2005 *For Ewing sarcoma: 92, Euro-Ewing 99 or Euro-Ewing 2008 *For osteosarcoma: EORTC 80931 or Euramos1 protocols There will be variability in treatment regimens, but the patient group will be clustered into four subgroups Cisplatin and anthracyclines Cisplatin, anthracyclines and methotrexate Alkylating agents Alkylating agents and anthracyclines Mental retardation documented before treatment Inability to perform the tests because of motor or sensory deficits Epilepsy Other cognitive disorders Depression Relapse Parameningeal or intracranial sarcomas Syndrome (e.g. Down) Autologous stemcell transplantation Head/neck/spinal radiotherapy or psychopharmaca", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Substance Withdrawal Syndrome intermittent use or continuous infusion opioids for at least 96 hours Patient and/or relatives unable to communicate in French or English Patients unable to communicate (consent form and evaluation) Patient deaf without appropriate hearing aid Patients unable to communicate (consent form and evaluation) Imminent and predictable death according to medical team Severe brain injury, defined as Glasgow Coma Scale (GCS) score of 8 or less at ICU admission Moderate brain injury, defined as GCS between 9 and 12, with elevated intracranial pressure (ICP > 20 mm Hg) who requires ICP monitoring and osmotherapy Major confounding factors for withdrawal syndrome by causing shivering, sympathetic drive and autonomic disorders Underlying active neurological condition (status epilepticus, encephalopathy, hypoxia) Neurological problems are covariates, which would make the assessment of sedation or IWS difficult Patient previously included in the study at any of the two hospitals (readmission to the ICU at a later date during the period of recruitment for the study, limiting to 1 weaning episode per patient)", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Hematoma, Subdural, Chronic years and older evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tomography) scan or MRI (magnetic resonance imaging) classified between 0 and 2 using the Markwalder grading scale contraindications or intolerance to corticosteroid therapy patients already undergoing steroid treatment for any other indication previous neurological surgery up to one year prior to being considered for the study concomitant cerebral pathology of neoplastic or presumed infectious origin anticoagulant therapy that could not be stopped for 6 months refusal to participate in the study", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 0.0-15.0, All Injuries Trauma Wounds and Injuries Children Child Children 0-15 years inclusive Presenting to either of the study hospitals for assessment or treatment Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0) Due to an incident involving any non-motorized bicycle, tricycle or kick scooter Incidents where the injured child was involved in a motor vehicle collision Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist) Incidents involving a bicycle fitted with 'bull bars' Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion) If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted", "label": "2"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 0.0-6.0, All TBI (Traumatic Brain Injury) Children <72 months old in whom a head CT is ordered/obtained with concerns for TBI Present to the Children's Hospital Colorado (CHCO) Emergency Department (ED) or inpatient wards Contraindication to MR (e.g. pacemaker, implanted metallic object incompatible with MR) Prior diagnosis of TBI, structural brain lesion or prior brain surgery including shunted hydrocephalus Prior participation in this study Clinically unstable in the opinion of the patient's attending physician Wards of the State TBI not included in the differential diagnosis of the patient's attending physician (e.g. the indication for imaging is concern for infections, tumor, autoimmune or inflammatory disease) or if imaging has already identified a non-traumatic source for symptoms", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Vestibular Schwannoma Vestibular schwannoma advised to surgical treatment No measurable remaining vestibular function impaired decision making neurofibromatosis signs for central dysfunction remaining vestibular function Patients are advised not to participate in the gentamicin arm if hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70% the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 21.0-80.0, All Pain Head and Neck Disorder Patients with ASA I to II, scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia previous history of either drug or alcohol abuse those who have been using opioids for long term mental disorder with difficult to understand pain scoring system ASA physical status of III and above surgical procedure warranting elective postoperative ventilation", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Brain Injuries Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay Patients admitted less than 24 hour", "label": "1"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 2.0-17.0, All Pain Long-bone Fractures children aged 2 through 17 years (17 years included) accompanied by at least one of their parents in the emergency department accompanied by at least one of their parents in the emergency department suspected fracture of a long bone requiring morphine analgesia (VAS \u2265 60/100 or Evendol \u2265 7/15 at the inclusion) within the first 12 hours after the injury at least one signed parental informed consent affiliated to health insurance analgesic treatment within the 6 hours before contraindication to one of the study drug cognitive impairment multiple injuries resuscitation man\u0153uvres open fracture non affiliated to social security parental refusal", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation (Prevention of Stroke) Age \u226518 years on the day of the first prescription of the study drug (= index date) during study selection window Diagnosis of NVAF on start date of study or anytime during 365 days before this date Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date) Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window Patients with valvular AF Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period Prescriptions of < 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort", "label": "0"} +{"topic": "An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Subdural Hematoma CT scan demonstrating the existence of a subdural hematoma containing a chronic component Diagnosis within the last 14 days Acute subdural hematoma with no chronic component Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency Atrial fibrillation (unless under successful rhythm control therapy) Metallic heart valve Vascular stenting procedure within the last year Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty Ongoing investigation for suspected malignancy Confirmed active malignancy", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-60.0, All Malaria, Falciparum Healthy adult: male or female Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 000 parasites/\u00ce\u00bcL Age 18 years to 60 years Willingness to sign and ability to understand consent form Willingness and ability to return for scheduled follow up visits Mixed malaria infection by Giemsa smear History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin) Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting) Inability to swallow oral medication Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality Any situation which could prevent the patient from returning to follow up visits Pregnancy or breast feeding Any other concurrent illness that may confound the result Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 15.0-49.0, All Malaria in Pregnancy HIV Infections Pregnant women 24 weeks gestation Consent Presenting for ANC at study hospitals/centres Agree to have an HIV test and to be examined for viral load Severe systemic disease AIDS-related disease At-risk pregnancy", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 0.115-4.917, All Malaria Ages 6 weeks to 59 months Residence in the study area Informed consent Known allergy to study drugs Serious underlying illness", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 10.0-999.0, All Malaria Written informed consent Available for 4 x monthly follow ups or more individuals in household Allergy to repellents / plants Malaria positive at baseline", "label": "1"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 1.0-999.0, All Malaria Falciparum Age > 1 year Axillary temperature \u2265 37.5\u00baC and/or history of fever in the previous 48 hours without any other evident cause Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear An informed consent obtained from the patient or his/her guardian (in case of patients \u2264 18 years old) and assent for children (8-18 years old) Willingness to come to the health facility for the following 28 days Signs or symptoms of severe malaria Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition) History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-999.0, All Acute Uncomplicated P. Falciparum Malaria Patients were eligible for if they met all of the following Male or female aged 18 or older (prior to Amendment 1: more than 2 years old) Non-immune patients suffering from acute uncomplicated P. falciparum malaria, or mixed infection including P. falciparum, with parasitemia of less than or equal to 2% asexual P.falciparum parasites, confirmed by microscopy using Giemsa-stained thick film Non-immune patients were regarded as those who had not spent the first five years of their life, nor the last five years in a malaria endemic area, and did not have acute P. falciparum malaria diagnosed during those past five years Non-immune patients who had received prophylaxis with anti-malarials (excluding halofantrine) were included only if clear progression of acute P. falciparum infection was documented Female patients were eligible to participate in the study if they were of non-childbearing potential or had a negative pregnancy test (urine or serum) at screening, and using an acceptable contraceptive method Patients, who had been informed of the study procedures and medication, and had given written informed consent and were willing to comply with the study protocol Patients were to be excluded from participation if they met any of the following Known hypersensitivity to artemether or lumefantrine Signs/symptoms indicative of severe/complicated malaria according to the WHO classification (e.g. cerebral malaria, see Post-text supplement 1) Treatment with artemisinin derivatives within the previous 7 days Concurrent administration of other treatment / prophylaxis for malaria Concurrent administration of medications with potential hemolytic effects Patients taking any drug metabolized by cytochrome isoenzymes CYP3A4 or CYP2D6 Received any other investigational drugs in the last 4 weeks before entry into the study Severe cardiac impairment (i.e. evidence of existing cardiac conduction defect or overt symptoms of cardiac dysfunction or abnormalities of baseline ECG not associated with acute malaria); clinically relevant bradycardia or congestive cardiac failure with reduced left ventricular ejection fraction; pre-existing prolongation of the QT interval; history of symptomatic cardiac arrhythmias Having received halofantrine or any other drug known to influence cardiac function within 4 weeks prior to Screening visit or taking other drugs that are known to prolong the QT interval, including class IA and III antiarrhythmics, neuroleptics, antidepressive agents, certain antibiotics (including some macrolides, fluoroquinolones, imidazole, and triazole antifungal agents), certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 14.0-45.0, All Anaemia Malaria Primigravida Secundigravida Permanent resident Hemoglobin (Hb) > 7 g/dl Hb < 7 g/dl Allergy to sulpha Multiple pregnancy Chronic diseases", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 0.25-4.917, All Malaria For original trial: Children aged 3-59 months present in participating villages For follow-up: Children who were in original trial for at least 1 year For original trial: None For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-50.0, All HIV Infections Permanent residents of the Luanshya district Males and non pregnant adults between 18 and 50 years old Having a CD4 cell count of least 350 per\u00b5L at enrolment HIV sero-status determined at the VCT of the health center No obvious underlying disease at time of enrolment Signed informed consent HIV stage III or IV following the WHO classification (see attached documents regarding policy in Zambia) Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition, TB) Intent to move out of the study catchment area during the study period History of allergy to MQ (or related drugs) or sulfa drugs Chorionic gonadotrophic hormone in urine or obvious pregnancy", "label": "1"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 5.0-60.0, All Malaria Age: 5 years old Fever (axillary temperature equal or higher than 37,5 \u00b0C) or history of fever in the previous 24 hours Monoinfection with P. falciparum, with parasitic density between 1,000 and 200,000 par/\u00b5l Informed consent provided by patient or parent or legal tutor Mixed malaria infection Pregnancy or breastfeeding to child \u2264 6 months of age One or more danger signs or any sign of severe or complicated malaria A concomitant severe disease History of treatment with mefloquine in the last 60 days or chloroquine, primaquine or quinine within the 14 days before the present episode History of neuropsychiatric disease History of hypersensitivity reactions to artemisinins or mefloquine History of splenectomy", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-45.0, All Falciparum Malaria Age > 18 and < 45 years healthy volunteers (males or females) General good health based on history and clinical examination All volunteers have to sign the informed consent form Negative pregnancy test Use of adequate contraception for females Reachable by phone during the whole study period Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the trial History of malaria or residence in malaria endemic areas within the past six months Positive serology for P. falciparum Previously participated in any malaria vaccine study Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers Cardiovascular risk >10% according to European guidelines, taking into account sex, age, cholesterol, weight, smoking habits, blood pressure, diabetes Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests Volunteers should not be enrolled in any other clinical trial during the whole trial period Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period Pregnant or lactating women Volunteers unable to give written informed consent", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 15.0-45.0, All Malaria Parasitaemia Birth Weight Anaemia Pregnant women of all parities Second trimester Severely ill pregnant women Pregnant women in first trimester", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 0.0-0.003, All Malaria Anemia Born in San Francis Designated District Hospital of Ifakara Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus Twins Birth weight < 1,5 kg Clinical signs of cerebral asphyxia Clinical signs of neonatal or congenital infection Mother unreliable (deaf, mentally handicapped)", "label": "1"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-40.0, All Length of Pregnancy Prolongation in Hours All patients admitted with the diagnosis of preterm labor between 24 0/7 and 33 6/7 weeks gestation. Preterm labor will be defined by regular contractions and/or cervical change from last documented exam Cervical exam 4 cm or greater Intact membranes Multiple gestation (>2) Clinical evidence of chorioamnionitis, such as maternal fever, uterine tenderness, fetal tachycardia Lethal fetal anomaly Persistent vaginal bleeding, abruption, or placenta previa Rupture of membranes Maternal illness or fetal indication requiring delivery Inability to give informed consent Serious allergy to study medications. GI discomfort will not be considered a drug allergy", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-85.0, All Orthopedic Disorders Unwillingness to sign informed consent Pregnancy", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 0.0-999.0, All Malaria in Pregnancy Female First or second trimester of pregnancy First or second pregnancy Resident in the study area Refuse to give informed consent", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-999.0, All Malaria in Pregnancy HIV Infections Confirmed HIV seropositivity Permanent residency in the study catchment's area Confirmed pregnancy, gestational age< 28 weeks More than 18 years of age Karnofsky index \u226580 Willingness to deliver at the hospital Written informed consent History of allergy to study drugs : sulpha drugs, mefloquine, quinine History or presence of major illnesses : severe renal disease , severe hepatic disease, severe neuropsychiatric disease Mefloquine or halofantrine received within the 4 weeks prior to enrolment", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-50.0, All Malaria A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening Free of clinically significant health problems Baseline ECG before entering into the study Available to participate for duration of study (approximately 4 months, not including screening period) If the participant is female, not pregnant or lactating and willing to use contraception to prevent pregnancy BMI between 19 and 30 History of malaria or travel to a malarious country within the previous 12 months History of participation in a study in which potential exposure to malaria or vaccination against malaria occurred Planned travel to malarious areas during the study period History of malaria chemoprophylaxis within 60 days prior to time of study entry Chronic use of antibiotics with anti-malarial effects Chronic use (defined as more than 14 days)of immunosuppressants or other immune-modifying drugs within six months of study entry Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination, ECG or laboratory screening tests Significant unexplained anemia History of sickle cell disease or sickle cell trait", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-50.0, All Malaria Subject is willing and able to give informed consent for participation in the study Healthy, non pregnant adult aged 18 years Resident in or near Oxford for the duration of the challenge study Seropositive for CMV and EBV Female subjects of child bearing potential must be willing to ensure that they practice effective contraception during the study Males must be willing to use barrier contraception from day of first vaccination onwards until 3 months after the second vaccination Able (in the Investigator's opinion) and willing to comply with all study requirements Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study Agreement to permanently refrain from blood donation Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis as defined in Appendix B Female patient/subject who is pregnant, lactating or planning pregnancy during the course of the study Healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks Subjects who have previously received an investigational malaria vaccine History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet\u00ae within 2 weeks prior to the challenge Travel to a malaria endemic area within the previous 6 months Planned travel to malarious areas during the study period Any history of malaria Contraindication to both anti-malarial drugs (Riamet\u00ae and chloroquine) concomitant use of other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-65.0, All Influenza Age 18 -65 Have the ability to provide informed consent If a woman of child-bearing potential, willing to use contraception for the period of the trial Acute influenza-like illness at screening History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease Pregnancy or breast feeding Current use of medication with known serious hepatotoxic effects Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin Current severe depression (as indicated by current use of antidepressant medication) Known serious retinal disease Current or recent (within the past 30 days) participation in any other clinical intervention trial Known G6PD deficiency Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-35.0, All Plasmodium Falciparum Malaria Age > 18 and < 35 years healthy volunteers (males or females) Good health based on history and clinical examination Negative pregnancy test Use of adequate contraception for females All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study Volunteer agrees to inform the general practitioner and agrees to sign a request to release medical information concerning contra-indications for participation in the study Willingness to undergo a Pf mosquito challenge For volunteers not living in Leiden: agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till 3 days after treatment) Reachable (24/7) by mobile phone during the whole study period Living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till 3 days after treatment) History of malaria Plans to travel to malaria endemic areas during the study period Plans to travel outside of the Netherlands during the challenge period Previous participation in any malaria vaccine study and/or positive serology for Pf Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) History of arrhythmias or prolonged QT-interval Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old An estimated, ten year risk of fatal cardiovascular disease of \u22655%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system Clinically significant abnormalities in electrocardiogram (ECG) at screening", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-35.0, All Plasmodium Falciparum Malaria Age > 18 and < 35 years healthy volunteers (males or females) Good health based on history and clinical examination Negative pregnancy test Use of adequate contraception for females All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study Volunteer agrees to inform the general practitioner and agrees to sign a request to release medical information concerning contra-indications for participation in the study Willingness to undergo a Pf mosquito or blood stage challenge For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial center during a part of the study (for groups 1 and 3 from challenge day till 3 days after treatment, for groups 2 and 4 from 5 days after challenge till 3 days after treatment) Reachable (24/7) by mobile phone during the whole study period Living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial center during a part of the study (for groups 1 and 3 from challenge day till 3 days after treatment, for groups 2 and 4 from 5 days after challenge till 3 days after treatment) History of malaria Plans to travel to malaria endemic areas during the study period Plans to travel outside of the Netherlands during the challenge period Previous participation in any malaria vaccine study and/or positive serology for Pf Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) History of arrhythmias or prolonged QT-interval Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old An estimated, ten year risk of fatal cardiovascular disease of \u22655%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system Clinically significant abnormalities in electrocardiogram (ECG) at screening", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-35.0, All Malaria Plasmodium Falciparum Age > 18 and < 35 years healthy volunteers (males or females) Good health based on history and clinical examination Negative pregnancy test Use of adequate contraception for females Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study Agreement to inform the general practitioner and to sign a request to release medical information concerning contra-indications for participation in the study Willingness to undergo a Pf controlled infection through mosquito bites Agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till treatment is finished) Reachable (24/7) by mobile phone during the whole study period Available to attend all study visits History of malaria Plans to travel to malaria endemic areas during the study period Plans to travel outside of the Netherlands during the challenge period Previous participation in any malaria vaccine study and/or positive serology for Pf Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) History of arrhythmias or prolonged QT-interval Positive family history in 1st and 2nd degree relatives for cardiac events < 50 years old An estimated, ten year risk of fatal cardiovascular disease of \u22655%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system Clinically significant abnormalities in electrocardiogram (ECG) at screening", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-50.0, All Vivax Malaria Age 18-50 years Gestational age (ultrasound confirmed) > 13.0 weeks Viable fetus as assessed by ultrasound scanning Microscopically confirmed uncomplicated P.vivax malaria Willingness and ability to comply with the study protocol for the duration of the trial Written informed consent provided No signs of labour Known hypersensitivity to chloroquine Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1 Gastrointestinal dysfunction that could alter absorption or motility History or known liver diseases or other chronic diseases (excluding thalassaemia & G6PD deficiency) Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study Splenectomy Hematocrit (HCT) < 20% (based on field reading i.e. capillary sample) Taking contraindicated medications History of narcotic or alcohol abuse", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-999.0, All Immune Reconstitution Inflammatory Syndrome Opportunistic Infections Age > 18 years Informed consent ART naive No informed consent History of ART use Pregnancy", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-35.0, All Malaria Plasmodium Falciparum Healthy volunteers (males or females) of \u2265 18 and \u2264 35 years of age Good health based on history and clinical examination (physical examination and laboratory screening) Negative pregnancy test Use of adequate contraception for females Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study Agreement to inform the general practitioner and to sign a request to release medical information concerning contraindications for participation in the study Willingness to undergo administration of PfSPZ Challenge by needle and syringe and willingness to undergo challenge by mosquito bites For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial centre or living in Nijmegen with a third party that could contact the clinicians in case of alteration of consciousness during a part of the study (day 5 after challenge until treatment is finished) Reachable (24/7) by mobile phone during the whole study period For volunteers living in Nijmegen: living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial centre during a part of the study (day 5 after challenge until treatment is finished) History of malaria Plans to travel to malaria endemic areas during the study period Plans to travel outside of the Netherlands during the challenge period Previous participation in any malaria vaccine study and/or positive serology for Pf Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) History of arrhythmias or prolonged QT-interval Positive family history of 1st and/or 2nd degree relatives who experienced cardiac events when < 50 years old An estimated, ten year risk of fatal cardiovascular disease of \u22655%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system Clinically significant abnormalities in electrocardiogram (ECG) at screening", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolic Disease Deep Vein Thrombosis Pulmonary Embolism Admitted to Scripps Mercy Trauma Service \u226518 Years old Stratified to either Significant or Highest risk of VTE by ACCP guidelines Estimated Injury Severity Score (ISS) \u22649 Likely to be discharged before hospital day 7 Systemic coagulopathy (International Normalized Ratio [INR] of \u22651.2) Body Mass Index (BMI) >40 Likely to Survive for <7 Days Pregnancy Evidence of renal insufficiency (Cr \u22651.3) Delayed transfer to this facility (>24 hrs) Prisoners", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-999.0, All Malaria in Pregnancy HIV Infection age \u2265 18 years HIV positivity gestational age between 16 and 28 weeks CD4+ count > 350 cells/mm3 and no sign of WHO stage 2, 3 or 4 agreement to attend all the antenatal consultations for the study willingness to adhere to all requirements of the study (including HIV-1 voluntary counseling and testing) signed informed consent psychological instability that could interfere with compliance hypersensitivity to sulfamides or dermatological disease(eczema, pemphigoid exanthema) that would increase the risk for severe reactions to the drugs being tested severe anaemia (Hb<7 g/dl)and any other severe disease known hepatic cardiac or renal disease", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-35.0, All Malaria Subject is aged \u2265 18 and \u2264 35 years and in good health Subject has adequate understanding of the procedures of the study and agrees to abide thereby Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre or is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). The subject will remain within the Netherlands during the challenge period, not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period Subject agrees to inform his/her general practitioner (GP) about participation in the study and to sign a request to release by the GP any relevant medical information concerning possible contra-indications for participation Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to Sanquin guidelines For female subjects: agrees to use adequate contraception and not to breastfeed for the duration of study Subject has signed informed consent Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These but are not limited to, any of the following 1 Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening 2 A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of \u22655% at screening, as determined by the Systematic Coronary Risk Evaluation; history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old 3 Functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency 4 History of epilepsy in the period of five years prior to study onset. 1.5 Positive Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) screening tests 6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period 7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, in the past 5 years 8 Any history of treatment for severe psychiatric disease in the past year. 1.9 History of drug or alcohol abuse one year prior to study onset, or positive urine toxicology test for cocaine or amphetamines at screening or prior to infection Females: positive urine pregnancy test at screening or prior to infection Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria study", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 5.0-65.0, All Malaria, Falciparum Age between 5 and 65 years old inclusive Monoinfection of P. falciparum confirmed by microscopy Documented fever (axillary temperature > 37.5\u00b0C) and/or history of fever during the previous 48 hours in the absence of other obvious causes of fever (such as pneumonia, otitis media, etc) Infection with P. falciparum of 1000 and 100,000 asexual parasites per microliter (\u03bcl) to be determined by microscopic examination of a thick or thin smear, and positive confirmation by polymerase chain reaction (PCR); * Presence of sexual form of P. vivax is acceptable; ** PCR confirmation is not an enrollment requirement Informed consent must be obtained from the participant or both parents/guardian (in the case of children), and assent from the child (from 8 to 17 years old) Willingness of the participant to return to the health facility for regular check-ups during the follow-up period of 42 days Willingness of the participant to transfer to the Hospital de Apoyo Iquitos to start treatment Severe malaria signs (as defined by the World Health Organization) Cerebral malaria (irreversible coma) Severe anemia (hematocrit < 15%, or clinic signs) Clinic signs of kidney failure (e.g., serum creatinine > 3 mg/dL) Pulmonary edema Hypoglycemia (glucose in the blood <40mg/dL or clinic signs) Shock (PA systolic < 70 mm Hg in adults; < 50 in children) Spontaneous bleeding/Disseminated intravascular coagulation (CID) Recurrent generalized convulsions Acidemia/acidosis (clinic signs)", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-35.0, All Malaria In order to be eligible to participate in this study, a subject must meet all of the following Subject is aged \u2265 18 and \u2264 35 years and in good health Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre (<10 km) or (if >10km) is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). Furthermore the subject will remain within the Netherlands during the challenge period, not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period Subject agrees to inform his/her general practitioner about participation in the study and to sign a request to release by the General Practitioner (GP) any relevant medical information concerning possible contra-indications for participation in the study Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to current Sanquin guidelines For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study Subject has signed informed consent Subject agrees to refrain from intensive physical exercise (disproportionate to the subjects usual daily activity or exercise routine) for ten days following each immunization and during the malaria challenge period A potential subject who meets any of the following will be excluded from participation in this study Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These but are not limited to, any of the following 1 Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening 2 A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of \u22655% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old 3 A medical history of functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency 4 History of epilepsy in the period of five years prior to study onset, even if no longer on medication 5 Positive Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) screening tests 6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period 7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years 8 Any history of treatment for severe psychiatric disease by a psychiatrist in the past year", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-999.0, All Travelers' Diarrhea Functional Bowel Disorders Reactive Arthritis An Institutional Review Board (IRB) / Ethics Committee (EC)-approved informed consent form is signed and dated Subject is at least 18 years of age Subject's duration of prophylaxis will be least 2 weeks Subject is capable of and willing to comply with all study procedures and available for the end of study visits and sample collection at COO (within 6 months from start of prophylaxis) Women: Non-nursing and negative urine/serum pregnancy test with understanding (through informed consent process) to avoid pregnancy while on study drug. Sole reliance on oral contraceptives (OCPs) for birth control will not be recommended (see section 6.3.2.1.) Should an individual have a documented surgical sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes pregnant during the study, the principal investigator will notify the study research monitor and the IRBs. The pregnancy outcome will be followed per IRB and other regulatory requirements for US and UK personnel (For US Personnel Only). Have consented to participate in TravMil protocol Subject received any systemic or gastrointestinal antibiotic in the 7 days prior to enrollment (except anti-malarial prophylaxis agents) Subject has hypersensitivity or allergy to rifaximin or rifampicin Subject has acute diarrhea within 7 days prior to enrollment Subject has a concomitant disease or condition that could interfere with, or for which treatment could interfere with, the conduct of the study, or could in the opinion of the investigator increase the risk of AEs during the subject's participation in the study Subject is currently taking or plans to take during deployment at least one of the following medications: theophylline or warfarin (Coumadin)", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-50.0, All Malaria All of the following must be fulfilled for a subject to participate in this trial Age greater than or equal to 18 and less than or equal to 50 years In good general health and without clinically significant medical history Malaria comprehension exam completed, passed (a score of greater than or equal to 80% or per investigator s discretion) and reviewed prior to enrollment Reliable access to the clinical trial center and availability to participate for duration of study Females of childbearing potential must be willing to use reliable contraception (as defined below) from 21 days prior to study day -2 to 28 days following last Sanaria Subject to the judgment and discretion of the PI, female participants who meet ANY ONE of the listed immediately below, may not be required to take any additional measures to avoid pregnancy. Such participants will be counseled on risks at the time of consent and at appropriate points (e.g. when pregnancy testing occurs) during the study Females who have had their uterus, and/or BOTH ovaries removed Females who have had BOTH fallopian tubes surgically tied or removed Females who are above the age of 45 and have spontaneously had no menses at any point during the past 12 or more consecutive months (i.e. have reached menopause) A subject will be excluded from participating in this trial if any one of the following is fulfilled Currently is breast-feeding (if female) Pregnancy as determined by a positive urine or serum human choriogonadotropin (beta-hCG) test at any point during the study (if female) Recent travel to a malaria endemic area within 5 years of enrollment Planned travel to a malaria endemic area during the study period History of confirmed malaria diagnosis on peripheral blood smear or by clinical history in the past 10 years Hemoglobin, WBC, platelets, ALT, and creatinine outside of local lab normal range (subjects may be included at the investigator s discretion for not clinically significant values outside of normal range) Abnormal urinalysis as defined by positive urine glucose, protein, and hemoglobin. Subject can be included if investigator determine the abnormality is not clinically significant Anticipated use during the study period, or use within the following periods prior to enrollment Investigational malaria vaccine within the last five years", "label": "0"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 0.833-3.167, All Neurobehavioral Manifestations Enrolled in Makerere University-UCSF II study HIV-uninfected 12 months of age at the time of enrollment Within 30 km of the clinic Serious adverse event to the study drugs requiring cessation of study drug Active illness at enrollment (child can be enrolled once active illness has been treated and they are back to baseline health) Previous history of head trauma or coma in the child Cerebral palsy or other severe neurologic disease Known chronic illness requiring medical care Major medical abnormalities on screening history of past health Known developmental delay", "label": "1"} +{"topic": "A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.", "doc": "eligible ages (years): 18.0-60.0, All Rabies Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Male or female, aged \u2265 18 to \u2264 60 years on day of inclusion In good general health based on medical history and physical exam Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Previous history of receiving the rabies vaccine Previous history of receiving rabies immune globulin Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that are well controlled are not criteria Use of any immunosuppressive drug at the time of the study or 30 days previously. Topical steroids will not be considered an immunosuppressive drug and their use will not be considered an Any immunosuppressive disorder, such as HIV infection, common variable immunodeficiency, active cancers or chemotherapy History of renal insufficiency or requiring dialysis Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-80.0, All Colorectal Cancer Small Intestine Cancer One of the following diagnosis Diagnosis of familial adenomatous polyposis Prior total or subtotal colectomy Attenuated adenomatous polyposis coli May have colon intact 40 duodenal polyps from second portion to 10 cm distal to papilla of Vater Age to 80 Performance status Not specified ", "label": "1"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 0.0-70.0, All Colorectal Cancer Diagnosis of colon cancer or polyps at age 70 or under Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under No history of familial adenomatous polyposis syndrome No hereditary nonpolyposis colon cancer, according to Amsterdam No known I1370K adenomatous polyposis of the colon susceptibility variant Enrolled on 1 of the following clinical trials CLB-9581 CLB-89803 CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible Age ", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-999.0, All Adenomatous Polyposis Coli Males or females at least 18 years of age with familial adenomatous polyposis ", "label": "2"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-75.0, All Colon Adenomas Patients are aged between 18 and 75 years At least 3 adenomas irrespective size or at least one measuring 6mm or more All subjects had a clean colon at the study entry No personal history of colon cancer, no inflammatory bowel disease, no familial adenomatous polyposis, no regular use of aspirin", "label": "1"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-999.0, All Familial Adenomatous Polyposis Patients with Familial adenomatous polyposis who have had ileo-rectal anastomosis and had 20 or less adenomas at previous surveillance examination poor bowel preparation, unable or unwilling to give informed consent, under 18 years of age,those with more than 20 adenoma", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 16.0-999.0, All Adenomatous Polyposis Coli Clinically or genetically proven familial adenomatous polyposis Restorative proctocolectomy with ileal pouch anal anastomosis Chronic or acute renal or hepatic disease History of oesophageal, gastric or duodenal ulcers Known hypersensitivity to sulindac Daily use during the last three months of Aspirin Non-Steroidal Anti-Inflammatory Agents Probiotics", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 20.0-999.0, All Parkinson Disease Parkinson's Disease Subjects eligible for enrollment in the study must meet all of the following criteria. Note that both inpatients and outpatients are eligible Patients with a diagnosis of PD (including juvenile parkinsonism) with Modified Hoehn & Yahr Stages I to IV Patients who have been receiving another dopamine agonist for at least 4 weeks prior to the start of the screening phase and are expected to benefit from conversion to ROP Age: 20 years (at the time of written informed consent) Informed consent: Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own) Gender: Male or female Females of childbearing potential are eligible for enrollment in the study, only if the subject has a negative pregnancy test at the start of the screening phase and agrees to conduct pregnancy testing at the protocol-specified visits during the study and use one of the following acceptable methods of contraceptions properly and accurately Abstinence Oral contraceptive, either combined or progestogen alone Injectable progestogen Subjects meeting any of the following must not be enrolled in the study Patients who present with any serious medical condition other than PD (e.g., cardiac, hepatic or renal disorder or hematopoietic disorder) Serious is defined as Grade 3 as a rule according to the Classification of the Severity of Adverse Experiences Patients with postural hypotension with any subjective symptoms (e.g., dizziness and syncope) Patients who have had any serious psychiatric symptoms (e.g., confusion, hallucination, delusion, abnormal behavior) (including symptoms caused by anti-PD drugs) within 6 months (26 weeks) prior to written informed consent Patients who have initiated any of the following drugs within 4 weeks of the start of the screening phase and have the dosing regimen of the drug changed within 4 weeks of the start of the screening phase L-dopa (+DCI) (NOTE: This does not apply to the monotherapy group.) Anticholinergic agents: trihexyphenidyl hydrochloride, piroheptine hydrochloride, mazaticol hydrochloride, metixene hydrochloride, biperiden, profenamine amantadine hydrochloride droxidopa", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 13.0-24.0, All Familial Adenomatous Polyposis Colorectal Cancer (List All Criteria) 1) Having a confirmed genetic or clinical diagnosis of FAP between the age of 13-24 at the time of recruitment to this study 18-21 year old with a previous cancer diagnosis Able to read and speak English n/a", "label": "2"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 40.0-999.0, All Colorectal Neoplasms Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency Age \u2265 40 -100 years Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160) Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency Less than 1/2 of colorectum remaining Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis) Familial Polyposis Melena, hematochezia", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-85.0, All Familial Adenomatous Polyposis Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total coloctomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. s/p ileostomy Female patients of childbearing age not on effective birth control Pregnant women WBC < 3500/ml Platelet count < 100,000/ml BUN > 25mg% Creatinine > 1.5mg% Patients unable to stop aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial Malignancy other than nonmelanoma skin cancer Active bacterial infection Patients with symptoms of active GERD (symptomatic despite medication or current erosive esophagitis on endoscopy)", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-999.0, All Rectal Cancer Ulcerative Colitis Familial Adenomatous Polyposis Diverticulitis Subjects who will undergo restorative proctectomy or proctocolectomy (<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis diverticulitis, perforation of the bowel/trauma Subjects undergoing Hartmann's reversal with restorative proctectomy (<10 cm from the anal verge) Subjects may or may not have a diverting loop ileostomy as a component of their initial surgery Subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer Subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease Subjects who have significant intraoperative hypotension or cardiac events Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values)", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 10.0-14.0, All Colorectal Cancer Precancerous Condition Diagnosis of familial adenomatous polyposis (FAP) based on genetic predisposition testing Genotype-positive FAP (pathologic Adenomatous polyposis coli (APC) mutation) No attenuated FAP genotype, defined by any of the following Mutation at the 5' end of APC and exon 4 Exon 9-associated phenotypes region mutations Has an intact colon No requirement for colectomy Parent(s) do not desire colectomy (regardless of adenoma burden) Colorectal adenoma burden as assessed by baseline colonoscopy ", "label": "1"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 5.0-18.0, All Vomiting Syndrome Irritable Bowel Syndrome Postural Orthostatic Tachycardia Syndrome Abdominal Pain Chronic Nausea Outpatient services Inpatient services", "label": "2"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-80.0, All Colorectal Cancer Surveillance of patients with a personal history of advanced adenoma or CRC Informed consent obtained Age \u2265 18 and \u2264 80 years old History of advanced adenomatous polyps Or history of non metastatic CRC with curative surgery and without other treatment more than 2 years before enrollment Previous medical examination Screening of patients with a Family history of CRC at high risk Informed consent obtained Age \u2265 18 and \u2264 80 years old First degree family history of colorectal cancer diagnosed <60yrs during the five previous years-Previous medical examination Personal histories Age < 18 or >80 years old history of non adenomatous polyps history of Metastatic CRC familial adenomatous polyposis, Peutz-Jeghers syndrome, hereditary non polyposis colorectal cancer (HNPCC), juvenile polyposis syndrome Familial history of familial adenomatous polyposis Personal history of subtotal colectomy (but not of hemicolectomy, to confer to criteria) Colonoscopy with a polyps resection dated more than 5 years and less than 2 years prior to enrollment Enrollment in another protocol no health insurance affiliation Family histories", "label": "1"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-999.0, All Familial Adenomatous Polyposis Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy Have an endoscopically assessable rectal segment Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration Known allergies or hypersensitivity to berries Diabetes mellitus Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition", "label": "1"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-70.0, All Familial Adenomatous Polyposis Duodenal Neoplasms Duodenal Polyps Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis Spigelman score of duodenal adenoma equal to II or III Incapability of signing informed consent Active gastric or duodenal ulcer, gastrointestinal bleeding Cardiovascular disease or risk Congestive cardiac failure: NYHA class II to IV Proven ischemic heart disease and/or cerebrovascular disease Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (\u22652 first degree family members <55 years) Renal dysfunction: creatinine clearance below 50mL/min Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10 Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study", "label": "1"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 20.0-999.0, All Parkinson Disease Parkinson's Disease at the start of the screening Patients who are diagnosed with advanced Parkinson's disease (PD) with severity of the modified Hoehn & Yahr Stages II-IV Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening phase and demonstrating lack of control with L-dopa therapy in the following circumstances. Wearing-off phenomena. On-off fluctuations. Delayed-on/No on phenomena. Not adequately controlled on L-dopa QTc<450 millisecond (msec) or <480msec for patients with Bundle Branch Block values based on either single ECG values or triplicate electrocardiogram (ECG) averaged QTc values obtained over a brief recording period Age:20 years or older(at the time of informed written consent) Informed consent: Patients who are able to give informed written consent in person. (i.e. patients who are capable of giving informed written consent on one's own) Sex: either sex. Female of child-bearing potential will be eligible for in this study. However they have to have a negative pregnancy test at the screening visit, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the screening visit until the end of the follow-up examination. Abstinence. Injectable progestogen. Implants of levonorgestrel. Estrogenic vaginal ring. Percutaneous contraceptive patches. Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness as stated in the product label. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam /gel / film / cream / suppository) Both inpatient and outpatient status at the start of the non-inferiority verification phase Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers to Grade 3 according to \"the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992) Patients with symptomatic postural hypotension. (e.g. dizziness and syncope) Patients with a current or history of drug abuse or alcoholism Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation) Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug Patients with chronic hepatitis typeB and/or type C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody Patients with a history of drug allergy to ropinirole hydrochloride (HCl) Patients with a current or history of cancer or malignant tumor Others whom the investigator (subinvestigator) considers ineligible for the study", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-999.0, All Colonic Neoplasms Willing to sign informed consent Able to physically tolerate removal of up to 58 ml of blood at one to two different time points Adults at least 18 years old Willing to collect 1-2 stool samples and prepare a FOBT card and five specimen vials from each stool sample Pregnant or nursing women who otherwise meet the may participate Subjects with one of the following Colorectal adenocarcinoma\u2014not treated and in colon at time of stool collection (CRC bin) Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin) Higher Risk Normal Bin Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy Subjects with a personal history of CRC (longer than 3 years ago because of of cancer within last 3 years) with none present at time of qualifying colonoscopy Any family history of CRC (1st degree relative) Normal Control Bin No history or current finding of any colon neoplasia including CRC, adenomas, no personal or family history of HNPCC or FAP Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC or for the higher risk normal bin as noted above Subjects whose screening colonoscopy shows any of these types of polyps may be included in the normal or the higher risk normal bin if they meet the other noted above Hyperplastic polyps Benign mucosal polyps Polypoid granulation tissue Prolapsed mucosal polyps Inflammatory polyp", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 0.0-999.0, All Pancreatic Cancer Biopsy-proven adenocarcinoma of the pancreas or pancreatic mass suspicious for pancreatic cancer Localized disease Scheduled to undergo a resection or exploration of their pancreatic tumor Not specified See Disease Characteristics ", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 20.0-70.0, All Lynch Syndrome proven carrier of a MLH1, MSH2 or MSH6 mutation age between 20 and 70 years written informed consent previous large bowel surgery psychological/physical conditions hampering compliance with the study protocol", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 0.0-999.0, All Ulcerative Colitis Familial Adenomatous Polyposis patients having total proctocolectomy with ileal pouch anal anastomosis hypoalbuminemia prolonged steroid use anemia anastomosis under tension leak with air test bleeding poor vascular supply of anastomosis", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-69.0, All Adenomatous Polyposis Coli Patients who are 18 years or older with a clinical or genetic diagnosis of FAP or attenuated FAP Presence of duodenal polyps with a sum of diameters \u2265 5mm Minimum of two weeks since any major surgery WHO performance status \u22641 Adequate bone marrow function as show by: normal leukocyte count, platelet count \u2265 120 x 109/L, Hgb > 12 g/dL Adequate liver function as shown by: normal serum bilirubin(\u2264 1.5 Upper Limit Normal {ULN}) and serum transaminases (\u2264 2.0 ULN) Patient must discontinue taking any Nonsteroidal anti-inflammatory drugs (NSAIDS) within one month of treatment initiation Patients must be able to provide written informed consent Prior treatment with any investigational drug within the preceding 4 weeks Malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skins Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study as determined by the Principle Investigator such as Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction \u2264 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia Severely impaired lung function Any active (acute or chronic) or uncontrolled infection/ disorders Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis Screening clinical laboratory values that indicate any of the following anemia", "label": "2"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-65.0, All Familial Adenomatous Polyposis Diagnosis of phenotypic Familial Adenomatous Polyposis (FAP) of the colorectum based on meeting the in one of two groups: Group 1-Greater than 100 adenomatous colorectal polyps prior to age 40. Group 2-Greater than 10 adenomatous polyps and age <40 or greater than 25 polyps and age >40; combined with a dominant family history or genotype: More than 100 polyps in a first-degree relative; More than 25 polyps in 2 relatives in 2 generations, including a first-degree family member; Genetic diagnosis in a relative; Genetic diagnosis by in vitro synthesized truncated protein or similar assay No colorectal surgery or prior colon surgery for polyposis at least 1 year prior (total abdominal colectomy with ileal-rectal anastomosis, or total proctocolectomy with ilea pouch-anal reconstruction Baseline endoscopy If no prior colorectal surgery, at least 3 polyps in a cluster each \u2265 2 mm in diameter; or If rectum is in situ and to be assessed, baseline rectal segment endoscopy documenting 3 or more rectal polyps each at least 2 mm in diameter in a defined cluster and/or at least 6 polyps, \u2265 2 mm in diameter, in the distal 10 cm of rectum If ileal pouch neo-rectum is in place, 3 or more pouch polyps in a cluster \u2265 2 mm in diameter, or at least 6 polyps, \u2265 2 mm in diameter, in the distal 10 cm of pouch Clinical/pathological grading of duodenal polyps will utilize the Spigelman Classification Hematopoietic: no significant hematologic dysfunction; WBC \u22653,000/mm3; platelet count \u2265100,000/mm3; hemoglobin \u226510g/dL; no known or prior clinical coagulopathy Hepatic: bilirubin \u2264 1.5 times ULN; AST and ALT \u2264 1.5 times ULN; Alkaline phosphatase \u2264 1.5 times ULN Renal: No significant renal dysfunction; creatinine \u2264 1.5 times ULN High Risk for cardiovascular disease including clinical diabetes mellitus (Type I or II) requiring glycemic medications; Prior personal history of cardiovascular disease or, two or more of the following hypertension or use of anti-hypertensive medications, hyperlipidemia or use of lipid-lowering medications or current smoker Hearing loss that affects everyday life and or for which a hearing aid is required", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 40.0-999.0, All Colonic Adenomas Asymptomatic subjects undergoing screening colonoscopy age > 40 average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial adenomatous polyposis (FAP) or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma no colonoscopy in past 5 years ability to provide a written consent to trial participation Patient age < 50 Patients with prior colorectal surgery Pregnant or lactating women Colonoscopy done within the past 5 years Lack of consent", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-999.0, All Familial Adenomatous Polyposis Diagnosis of phenotypic classical FAP with disease involvement of the duodenum and/or colon/rectum/pouch Genotype: APC mutation (with or without family history) required Classical FAP Phenotype: 100's to 1,000's of colorectal adenomatous polyps, usually appearing in teenage years UGI endoscopy/LGI endoscopy (proctoscopy/colonoscopy) performed within 30 days of randomization Patients with an intact colon/rectum, except for clinical polyposis, and prophylactic surgery is being considered as a stratification site Rectal/pouch polyposis as a stratification site as follows At least three years since colectomy with IRA/proctocolectomy with pouch, and demonstrating polyposis as defined by Stage 1, 2, 3, of the proposed InSiGHT 2011 Staging System (Appendix B) and summarized as follows Stage 1: 10-25 polyps, all < 5 mm Stage 2: 10-25 polyps, at least one > 1 cm Stage 3: >25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of high grade dysplasia, even if completely removed. [Note: For staging purposes only.] For all subjects, any rectal/pouch polyps > 5 mm must be excised at \"baseline\" Duodenal polyposis as a stratification site; one or more of the following Prior pelvic irradiation Patients receiving oral corticosteroids within 30 days of enrollment Treatment with other investigational agents in the prior 4 weeks Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6 weeks Regular use of aspirin in excess of 700 mg per week Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within 12 weeks of study enrollment Hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates; NSAID associated symptoms of gastritis Patients must not have cardiovascular disease risk factors as defined below Uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg Unstable angina", "label": "2"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 8.0-18.0, All Functional Gastrointestinal Disorders abdominal pain related disorder (functional dyspepsia, irritable bowel syndrome or functional abdominal pain (FAPS) diagnosed according to Rome III criteria organic gastrointestinal disease (as established by medical history, complete blood count, urinalysis, stool examination for occult blood, ova and parasites, blood chemistries, abdominal ultrasound, breath hydrogen testing and endoscopy, if needed) other chronic disease growth failure", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 30.0-80.0, All Colon Cancer patients undergoing routine colonoscopy at University Hospitals, Cleveland Ohio Unable to give written consents Unable to fill the questionnaires Aged younger than 30 or older than 80 Unwilling to donate blood samples Diagnosis of colorectal cancer or any cancer Recurrent cases Family history of Familial Adenomatous Polyposis (FAP) or Non-polyposis Colorectal Cancer (HNPCC) History of inflammatory bowel diseases Non-English Speaking", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-999.0, All Colon Polyp Surveillance Any adenoma found on screening/surveillance colonoscopy (ICD9-211.3, Procedure code 45385 or 45380) Greater than 18 years old Less than 18 years old Diagnosis of IBD", "label": "2"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-75.0, All Malignant Pleural Mesothelioma Histologically or cytologically confirmed and documented malignant pleural mesothelioma with pleural effusion Signed Informed Consent after being informed Patients medically and/or functionally at screening not accessible for surgical treatment with planned third cycle of palliative chemotherapy in 21 days Bone marrow function: hemoglobin = 100 g/L; white blood cell count (WBC) = 3.0 x 109/L; absolute neutrophile count (ANC) = 1.5 x 109/L; platelet count = 100 x 109/L Hepatic: aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 times upper limit of normal (ULN)); bilirubin = 1.5 x ULN Renal: creatinine = 2 mg/dL and creatinine clearance = 45 mL/min No concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents The patient has received no major organ allograft HIV-negative HBV and HCV negative Contra-indications to the class of TpP, e.g. known hypersensitivity or allergy to the investigational product Contra-indications on ethical grounds Women who are pregnant or breast feeding Intention to become pregnant during the course of the study Lack of safe contraception: Safe contraception is defined as follows:Female and male subjects of childbearing potential, using and willing to continue using a medically reliable method of double barrier contraception for the entire study duration and the next 2 years, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices in combination with preservatives. Or subjects who are using any other method considered sufficiently reliable by the investigator in individual cases.Subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential Known or suspected non-compliance drug or alcohol abuse Patients with medical history of coronary heart disease (CHD), stroke or peripheral vascular disease (PVD) Patients with medical history of autoimmune disease such as multiple sclerosis, lupus, rheumatoid arthritis, inflammatory bowel disease or small vessel vasculitis Regular intake of immune-modulating drugs", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 20.0-65.0, All Familial Adenomatous Polyposis Patients with familial adenomatous polyposis(FAP) who are 20 to 65 years of age FAP patients who have colonic or duodenal polyp FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization FAP patients with malignant disease, including colorectal cancer FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 6 months of randomization. 4. FAP patients with diabetes mellitus. 5. Pregnant or breast-feeding patients. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test) and significant infectious or respiratory diseases", "label": "2"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 50.0-999.0, All Tubular Adenoma Colon Cancer Hyperplastic Polyp Age \u226550 years Individuals able to provide informed consent Individuals presenting for average-risk colorectal cancer screening by colonoscopy Individuals presenting for surveillance of adenomatous/sessile serrated colon polyps as per the US multi-society taskforce on colorectal cancer Patients who decline to participate Prior partial or complete colectomy Patients with history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) Patients with prior history of colorectal cancer Patients with history of screening colonoscopy within the past 10 years Patients with history of familial polyposis syndromes (Familial Adenomatous Polyposis, Lynch Syndrome)", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 50.0-99.0, All Colonic Adenomas Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation personal history of inflammatory bowel disease, colon adenoma or cancer family history of FAP or Familial nonpolyposis syndrome first degree relatives having diagnosed to have colorectal carcinoma no colonoscopy in past 5 years", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 60.0-74.0, All Colonic Polyps Patients found to have colonic polyps up to 10mm in size Poor bowel preparation Inflammatory bowel disease Polyposis syndrome", "label": "2"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 45.0-75.0, All Colorectal Adenoma Asymptomatic subjects aged 45 years Subjects who will give the written consent Subjects with past history of colorectal cancer Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC) Subjects with familial history of colorectal cancer more than 2 familial member in direct line Subjects with inflammatory bowel disease(IBD) Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification Subjects with past history of colectomy Subjects with history of colonoscopy within 5 years Subjects with history of sigmoidoscopy within 3 years Subjects with history of CT colonoscopy within 10 years Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-85.0, All TTR-mediated Amyloidosis Amyloidosis, Hereditary Amyloid Neuropathies, Familial Familial Amyloid Polyneuropathies Amyloid Neuropathies Amyloidosis, Hereditary, Transthyretin-Related Male or female of 18 to 85 years of age (inclusive) Have a diagnosis of FAP Neuropathy Impairment Score requirement of 5-130 Meet Karnofsky performance status requirements Have adequate complete blood counts and liver function tests Have adequate cardiac function Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV) Had a prior liver transplant or is planned to undergo liver transplant during the study period Has untreated hypo or hyperthyroidism Has known human immunodeficiency virus (HIV) infection Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated Recently received an investigational agent or device Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid", "label": "1"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-74.0, All Colorectal Cancer All increased risk patients (Patients with family history or personal history of colon polyps or colon cancer and FOBT positive) referred for a screening colonoscopy at the Forzani and MacPhail Colon Cancer Screening Centre will be considered for enrollment Average Risk patients Previous colon surgery Hereditary Polyposis Syndromes Suspected polyps or CRC before colonoscopy that have been suggested by another modality (Barium Enema, Virtual Colonoscopy, Flexible Sigmoidoscopy)", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 50.0-69.0, All Colonic Polyps Adenoma The main objective in this study is compare two non-invasive techniques in the study of colorectal cancer. When we calculate the sample size we observed that we need more than 1000 patients per group. In this moment this study is very expensive and it is not feasible. Our proposal is population with a higher prevalence of lesions: individuals with positive FIT (fecal immunochemical test) in which the prevalence of lesions is 60%. In this case, sample size is reduced considerably The eligible population will be men and women, 50-69 years old, with no known risk factors and positive FIT Individuals who have symptoms suggestive of colorectal disease (rectorrhagia, change in bowel movement frequency, constitutional syndrome, anaemia) History of inflammatory bowel disease, colorectal polyposis, colorectal adenoma or CRC, and total or partial colectomy History of familial adenomatous polyposis or other hereditary polyposis syndromes; hereditary colorectal cancer not associated with polyposis (diagnosed by the presence of germinal mutation in the DNA repair genes and/or by fulfilment of the Amsterdam II criteria) Severe co-morbidity that carries a poor short-term prognosis (disease with an average life expectancy of less than 5 years) or a chronic illness that involves significant limitation of physical activity Contraindication to undergoing colon capsule or virtual colonoscopy", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-70.0, All Adenomatous Polyposis Coli Patients with genetically or clinically proven Familial Adenomatous Polyposis. Genetically proven: Adenomatous Polyposis Coli (APC)-mutation identified. Clinically proven: more than 100 colorectal polyps at diagnosis Age 18 to 70 years Written informed consent Adequate potential for follow-up Medical or psychiatric conditions that compromise the patient's ability to give informed consent Proctocolectomy MutYH mutation Concurrent uncontrolled medical conditions Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre-menopausal women with intact reproductive organs and women less than two years after menopause", "label": "1"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 0.0-999.0, All Polyps Cases Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014 Controls Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA) ", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 40.0-70.0, All Colorectal Cancer Colorectal Adenoma First-degree relatives (aged 40 to 70 years) of individuals diagnosed with non-advanced adenoma on screening colonoscopy as Cases FDR of patients with negative findings on colonoscopy identified during the same study period, who are of the same age group as the studied as Cohort A FDR history of CRC A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam Known Familial Adenomatous Polyposis (FAP) syndrome Patients and siblings with known inflammatory bowel disease Undergone colonoscopy examinations in the past 5 years Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination", "label": "0"} +{"topic": "A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas.", "doc": "eligible ages (years): 18.0-80.0, All Adenomatous Polyp of Colon Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes Patients with a prior history of colonic surgeries Patient with Crohns colitis or ulcerative colitis Patient with prior history of colon cancer Patient with poor bowel preparation Pregnant women", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 8.0-13.0, All Osteoporosis Pubertal stage II Calcium intake below a threshold level Caucasian Normal health Medications affecting calcium and bone metabolism Chronic diseases Metabolic bone disease Abnormality in calcium metabolism", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 60.0-999.0, All Osteopenia Osteoporosis Women at least 60 years of age Good general health Willingness to participate in this 3.5 year study Ability to give informed consent Ability to live independently and travel to the research center for visits (we will provide transportation on a limited basis) Spine bone mineral density (BMD) (L1-4) T-score between -1.0 and -2.5, or a hip T-score between -1.0 and -2.5. A T-score of -1.0 is equal to a bone mass of one standard deviation below the mean peak bone mass in healthy young adult women Any history of cancer except the following: (a) superficial basal or squamous cell carcinoma of the skin which has been completely resected or resolved by a topical chemotherapeutic agent, and (b) other malignancies treated curatively at least 10 years previously, without any evidence of recurrence Abnormal transvaginal ultrasound that has not been investigated and cleared by endometrial biopsy History of low-trauma hip or spine fracture previously diagnosed Serious residuals from cerebral vascular disease Diabetes mellitus, except for easily controlled, non-insulin dependent or insulin dependent diabetes mellitus without significant microvascular or neuropathic disease Serum creatinine >1.9 mg/dl Chronic liver disease or alcoholism Treatment with bone active agents such as fluoride or bisphosphonates within the previous 2 years Treatment with calcitonin, estrogen, or a selective estrogen receptor modulator within the previous 6 months Systemic corticosteroid therapy at pharmacologic levels for more than 6 months duration", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 0.0-999.0, All Osteoporosis Chronological age: 6.0 0 years. Study population will be restricted to children greater than 12 years of age until 8 patients have completed 6 months of the study or safety data is available from a comparable study AP Lumbar spine bone mineral density less than or equal to -2 standard deviations for age matched controls (z-score) using Hologic QDR machine Normative data published by Faulkner will be used to calculate Z-scores Patients with Idiopathic Juvenile Osteoporosis, osteoporosis (BMD less than -2 SD compared to age-matched controls) in a child with no identifiable etiology. Children with IJO and delayed puberty will have their z-score calculated on the basis of bone age Inability to swallow pills or comply with administration instructions Upper gastrointestinal tract disease Creatinine clearance greater than or equal to 35 mL per min per 1.73 square meters Prior treatment with bisphosphonates Concurrent therapy with oral aspirin or salicylate containing compounds, excluding delayed-release salicylates which act in the distal gastrointestinal tract (for example, mesalamine, sulfasalazine, etc...) Hypocalcemia Treatment with hGH or calcitonin in the preceding 6 months Inability to undergo dual energy x-ray absorptiometry Positive pregnancy test In females, sexual activity without an effective method of contraception", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-32.0, All Healthy Osteoporosis Premature Ovarian Failure Patients with karyotypically normal spontaneous premature ovarian failure (as defined by screening protocol 91-CH-0127, i.e. women who have at least 4 months of amenorrhea, two FSH levels above 40 mIU/ml, at least one month apart, and a normal 46, XX karotype, diagnosed with premature ovarian failure prior to the age of 40) who are between the age of 18 and 42 years will be candidates General Smokers (more than 2 cigarettes per day) Alcohol users (more than 2 drinks of alcohol per day) Body mass index (BMI, kg/m(2)) greater than or equal to 30 and less than or equal to 19 Previous history of hip fracture or other active hip pathology Abnormalities of the hip precluding the assessment of bone mineral density Major dermatologic disorders, or a history of skin sensitivity to adhesive bandages, tape or transdermal matrix patches Hirsutism score greater than 8 Acne score greater than 1 Hysterectomy", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-72.0, All Osteoporosis Postmenopausal Weight within 90% to 120% of ideal body weight or more months since last menstrual period New York Metro Area resident History of cancer, diabetes, or heart disease Smoker", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 45.0-70.0, All Postmenopause Hot Flashes Osteoporosis, Postmenopausal Resident of the New York Metro Area Postmenopausal Weight within 90% to 120% of ideal body weight ", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-999.0, All Osteoporosis Veterans aged 50 and older drawn from two existing VA cohorts, the Normative Aging Study (NAS) and the Veterans Health Study (VHS) ", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-75.0, All Osteoporosis Healthy caucasian postmenopausal females between 50-75 years of age with low bone mineral density at the lumbar spine or hip as measured using dual energy x-ray absorptiometry or DXA ON estrogen replacement treatment for at least three years Heart, vascular, kidney, liver, lung, hormonal, musculo-skeletal disease (other than osteoporosis), rheumatic, blood diseases are High blood pressure Pregnancy Cancer Alcohol or drug dependence Prior use of a drug treatment for osteoporosis such as PTH, bisphosphonates, raloxifene, or calcitonin within the preceding five years", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 65.0-999.0, All Osteoporosis Osteoporosis, Postmenopausal For Patients PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture Have had an outpatient visit with a participating doctor based on Medicare outpatient claims For Physicians Primary prescribing physicians for PACE beneficiaries ", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-999.0, All Postmenopausal Osteoporosis -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: [BMD > 2.0 standard deviations below young normal mean bone mass for the hip trochanter, PA lumbar spine (L1 to L4), total hip, or femoral neck based on the normative database provided by each individual manufacturer] willing to take study-supplied calcium and vitamin D supplement (or equivalent) and to discontinue any non-study calcium supplements for run-in period and the duration of the study -pregnant or lactating, or of childbearing potential participated in another therapeutic trial with an investigational compound within 30 days of randomization history of hypersensitivity to any component of ibandronate tablets or has hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia unable to stand or sit upright for at least 60 minutes once a month current use of illicit drugs, or history of drug or alcohol abuse within the past five years has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction within six months of entry into the study; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary) history of or evidence of metabolic bone disease (other than postmenopausal bone loss) clinical fracture in the past year is receiving or has received treatment prior to randomization which might influence bone turnover", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-64.0, All Osteoporosis Members of the Harvard Pilgrim Health Plan Individuals who are not members of the Harvard Pilgrim Health Plan", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-50.0, All Opiate Dependence Osteoporosis Erectile Dysfunction Hypogonadism age 18 to 50 methadone maintenance for at least 12 months (for cases) stable dose of methadone for 6 months (for cases) willing to participate in the study competency in English male previous diagnosis of sexual dysfunction previous diagnosis of osteoporosis serum creatinine > 2 mg/dL chronic opiate use (for controls) congestive heart failure illicit drug use", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-999.0, All Osteoporosis fracture caused by osteoporosis fifty years or more of age informed consent Physically or mental state that does not participation", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-999.0, All Osteoporosis Osteopenia Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray) Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture) Significant cognitive impairment (which would preclude them from filling out simple questionnaires) Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene)", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 25.0-44.0, All Osteoporosis women aged between 25 and 44 years of age previous had measurement of bone densitometry thyroid disease renal failure malignancy rheumatoid arthritis history of hysterectomy hormone replacement therapy were pregnant or planning pregnancy within 2 years of study entry lactating", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 0.0-999.0, All Hip Fractures Osteoporosis Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis ", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-65.0, All Osteoporosis Healthy as assessed by the health and lifestyle questionnaire physical examination results of the pre-study laboratory tests Caucasian women Postmenopausal (\u226512 \u226460 months since last menses), determined by interview FSH level \u2265 20 IU/l Body Mass Index (BMI) \u226522 Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of products Osteoporosis, determined by Questionnaire (spontaneous bone fractures, use of medication to treat osteoporosis) DXA scans of the lumbar spine between day -14 and day 1 of the study; threshold is set at -2z score of BMD Severe scoliosis (curvature of the spine) that could interfere with the ability of the subject to go through the DXA scanning procedure and/or with a correct reading of the DXA scans Having a history of medical or surgical events that may significantly affect the study outcome, including surgical menopause (including hysterectomy) antecedents and high familiar incidence of breast and/or endometrial cancer gastrointestinal disease (Crohn's, short bowel syndrome, coeliac disease, gastroenteritis episodes the month before the start of the study)", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 65.0-999.0, All Post Menopausal Osteoporosis women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening patients on HRT within the last 3 months patients on other osteoporosis medication within the last 3 months sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level hypersensitivity to any component of ibandronate contraindication for calcium or vitamin D therapy history of major gastrointestinal upset malignant disease diagnosed within the previous 10 years (except resected basal cell cancer)", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-65.0, All Vitamin D Deficiency Healthy African-American and Caucasian adults aged 18-65 years Subjects who are not either African-American or Caucasian. The investigators plan to examine racial differences in response to oral vitamin D dosing and, therefore, have chosen the most affected (African-American) and the least affected (Caucasian) racial groups. Including other racial/ethnic groups may confound the results unless they are studied as separate groups Any chronic medical illness including diabetes mellitus, history of myocardial infarction or heart failure, malignancy, hypertension (systolic blood pressure [SBP] > 140), obesity (body mass index [BMI] > 35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination Subjects with osteoporosis or taking medications for osteoporosis such as bisphosphonates Pregnancy Use of medication that influences bone metabolism (i.e. anticonvulsant medications, steroids, diuretics) Significant deviation from normal in either history, physical examination, or laboratory tests, as evaluated by the primary investigator Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis Participation in another investigational trial in the past 30 days prior to the screening evaluation Unexplained weight loss of > 15% during the previous year or history of anorexia nervosa Medications that interfere with vitamin D metabolism. Oral contraceptive use will be allowed, but will be appropriately documented", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-999.0, All Osteoporosis Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide Patients with diabetes mellitus current smokers patients with a history of organ transplantation Patients currently of previously on glucocorticoid therapy within the past year Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater) Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis History of radiation therapy Patients pregnant or nursing History of bone metastasis or skeletal malignancies History of hypercalcemia", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 0.0-59.0, All Osteoporosis Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 45.0-80.0, All Healthy 55 or 70-80 years old History of natural menopause defined by the absence of menses for at least 12 months (or history of surgical menopause defined as bilateral oophorectomy) and a FSH level >26 IU/L On no hormonal medication or herbal supplements and/or over the counter menopause therapy for a minimum of 2 months prior to study Normal TSH, PRL, factor V, and CBC Normal BUN and Creatinine (< 2 times the upper limit of normal) BMI \u2264 30 Non-smokers or smoke less than 10 cigarettes/day Absolute contraindications to the use of physiologic replacement doses of estrogen, including a negative screening mammogram within the past 24 months History of coronary artery disease On medications thought to act centrally on the GnRH pulse generator Past history of hypersensitivity or allergy to narcotics, vancomycin, muscle relaxants, aspirin, and/or anaphylactic reaction(s) to other drugs Prior history of breast cancer and/or blood clots", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 65.0-999.0, All Osteoporosis osteoporosis (DXA T-score < -2.5 in hip and/or vertebrae) able to walk at least 15 minutes without an helping device years or older community dwelling at least one fall in the prior year severe cardiac, pulmonary or musculoskeletal disorders pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease) use of psychotropic drugs", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-80.0, All Schizophrenia Alcohol Abuse DSM-IV diagnosis of schizophrenia Onset of illness more than 5 years No severe Medical and endocrinological disorder", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 0.0-999.0, All Post-Menopausal Osteoporosis post-menopausal women >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis inability to stand or sit in an upright position for at least 60 minutes hypersensitivity to bisphosphonates treatment with other drugs affecting bone metabolism abnormalities of the oesophagus, which delay oesophageal emptying", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-999.0, All Osteoporosis Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture Residence in nursing home Fracture sustained in motor bike, push bike or motor vehicle accident Fracture sustained due to high trauma, such as fall from roof or ladder Dementia Inability to participate in group settings Inability to understand spoken English Inability to provide informed consent Pathological fracture Usual place of residence outside South Australia", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-90.0, All Osteoporosis Bone Loss, Age Related Postmenopausal Bone Loss Postmenopausal Osteoporosis Female, post-menopausal women aged 50 to 90 Have a bone mineral density (BMD) evaluation resulting in a T-Score of <-1.0 Have a follow-up appointment with a provider in the areas of Family Medicine (FM), Primary Care Internal Medicine (PCIM), or POM Have no major barriers (i.e., severe hearing impairment, dementia, require interpreter, etc.) to participation in shared decision-making (per provider's assessment) Enrollment is open to females of diverse racial backgrounds Currently taking a bisphosphonate Not available for 6 month follow-up phone call", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-999.0, All Osteoporosis Rheumatoid Arthritis Meet American College of Rheumatology for rheumatoid arthritis Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry Age 18 or older Existing osteoporosis Pregnancy Breast feeding History of breast cancer Physician recommendation to limit calcium intake Class IV rheumatoid arthritis", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 45.0-55.0, All Osteoporosis Female Age 45 (inclusive) to 55 years (inclusive) Race: Caucasian Non-smokers / Smokers up to 10 cigarettes/day Postmenopausal hormone status: 1-3 years since the last spontaneous menstrual bleeding and a follicle-stimulating hormone concentration (FSH) >75 IU/ml and 17-estradiol (E2) of < 20 ng/L Years since menopause between 1-3 years Natural menopause or total hysterectomy with bilateral salpingo-oophorectomy Subjects with E2 results within the range will be assessed on an individual basis if FSH level is less than 75 IU/ml Assessed as age-related healthy, based on a pre-study examination including medical history, physical examination, ECG, vital signs and clinical laboratory. The examination will be performed by a MD at the study site within 1-2 months prior planned study start for the individual subject Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements T-score < -2.5 at total hip and spine (either or both) Suspect lack of compliance BMI > 30 or < 21 Use of HRT within the previous 6 months Use of any drug which might interfere with bone-metabolism (bisphosphate, estrogen receptor modulators, calcitonin) within the previous 12 months Systematic practice of high intensity exercise Vegetarian nutrition or any other extreme dietary habits Use of dietary supplements while on study, except multi vitamin. No \"wash out\" period for supplements must stop before run-in period and refrain until the end of the study Participant in any other study or donation of blood during the last 30 days before start of each dosing phase (T0)", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 55.0-75.0, All Osteoporosis Postmenopausal female, 55-75 years old History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin Body mass index (BMI) of 19-35 Able to move without walkers and without a history of long periods (>3 months) of inactivity Additional for fracture participants Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures will be verified by radiographs Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior Diabetic patients on rosiglitazone or pioglitazone medications high energy trauma, e.g., due to motor vehicle accidents Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs History of fluoride, bisphosphonate, calcitonin or tamoxifen use History of unstable cardiovascular disease or uncontrolled hypertension MRI contraindications", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 45.0-85.0, All Osteoporosis Healthy women aged 45 and above who have been menopausal at least 1 year (absence of menstrual period for a period of 12 months or more) Any chronic medical illness including uncontrolled diabetes mellitus, recent history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, obesity (BMI>35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination Subjects with osteoporosis of the hip (total hip T-score equal or less than -2.5) or taking medications for osteoporosis such as bisphosphonates will be excluded Pregnancy Use of medication that influences bone metabolism (i.e. anticonvulsant medications, chronic use of steroids and high dose diuretics) Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis will also be excluded Participation in another investigational trial in the past 30 days prior to the screening evaluation Unexplained weight loss of >15% during the previous year or history of anorexia nervosa Medications that interfere with vitamin D metabolism Patients with a habitual dietary calcium intake that exceeds 800 mg/day", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-55.0, All Osteoporosis Women between the age of 18-55, pre-menopausal by history (regular spontaneous menstrual bleeding every 21-35 days) or documented FSH <10, no current estrogen therapy, undergoing hysterectomy with (ovx) or without ovariectomy (control group) for benign gynecologic disease (fibroid uterus, endometriosis, dysfunctional uterine bleeding, chronic pelvic pain) or for prophylaxis against ovarian cancer (BRCA positive) History of an active cancer including breast and uterine cancer, treatment with chemotherapy or glucocorticoids History of an immune deficiency syndrome including HIV infection History of severe anemia with hematocrit < 25", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 21.0-70.0, All Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility has diabetes, hypertension, osteoporosis, or infertility 2. Not currently receiving treatment for alcohol or drug problems or substance related medical illness 3. Not currently experiencing physical dependence on alcohol, requiring medically supervised detoxification 4. Not currently abusing or physically dependent on opiates, cocaine, or other illicit drugs 5. Not currently pregnant. Subjects with infertility may become pregnant during the course of the study Not currently nursing. 7. Able to complete study measures Alcohol screen negative or drinks within NIAAA sensible drinking limits for women Does not agree to randomization and study terms", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-60.0, All Osteoporosis All patients meet the Patients with informed consent Breast Cancer inform possible danger Physical and mental health Menopausal transition meet the Age between 40 ~ 55 years old Women with Menopause syndrome or menstrual disorders The second to fourth lumbar spine bone mineral density to normal Early postmenopause meet the Age between 45 ~ 60 years old Tobacco or alcohol abuser History of various malignant diseases Women with Serious chronic diseases, such as liver and kidney dysfunction Women Suffering from endocrine diseases, such as Thyroid disease, Parathyroid disease,Adrenal disease and Osteomalacia Women with Long-term application of drugs, such as Antiepileptic drug, Adrenocorticotropic hormone, Diuretics and Heparin Women had used estrogen or calcitonin in the past 6 months Women has added higher than the physiological requirements VitD Who had taken bisphosphonates or sodium fluoride in the past 1 year Women had been taking Chinese medicines or other unregistered food in past 3 months Women with one of the following medical history or disease: Thrombophlebitis, estrogen-related thrombosis or thromboembolism, Cerebrovascular accident, with known or suspected estrogen-dependent tumor, undiagnosed vaginal bleeding, Cervical Pap smear graded at 3 or more, Serious uterine disorders, Serious breast disorders, Serious gallbladder disease, Severe hypertension and Hypercholesterolemia", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 65.0-999.0, All Type 2 Diabetes Mellitus female >= 65 years old postmenopausal for > 5 years (WHO definition of menopause) currently taking osteoporosis related medication (HRT, SERM, bisphosphonate, PTH, calcitonin, fluoride) had cancer in past 10 years, likely to metastasize to bone (ie: breast, lung) have intrinsic bone disease (ie: Paget's Disease, Cushings syndrome) have untreated malabsorption syndrome (ie: Celiac Disease) renal insufficiency (CrCl <30ml/min) hyperparathyroidism, hypoparathyroidism chronic systemic glucocorticosteroid use > 3mos, dose>2.5mg daily", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 60.0-999.0, All Osteoporosis Proximal Femur Fracture Selection of cases: women with hip fracture woman aged 60 years and more clinical suspicion of osteoporosis based on the following: trivial trauma (fall from the standing position), history of vertebral fracture or visualization of a vertebral fracture by CT availability of radiographs of the proximal femur (anteroposterior view of the pelvis mandatory; anteroposterior and lateral views of the fractured hip optional) signature by the patient of the informed consent document patient under 60 years current bisphosphonate, oestrogen, or SERM treatment started more than 3 months earlier; or past treatment with these medications stopped less than 6 months earlier hip arthroplasty on the other side fracture at the site of a bone lesion psychiatric disorder that might prevent the patient from giving informed consent or from remaining completely still for about 15 minutes during the investigations informed consent document not signed by the patient Selection of controls The controls will be women without hip fracture matched on age to the cases woman aged 60 years and more signature by the patient of the informed consent document", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 55.0-999.0, All Post Menopausal Osteoporosis Adult patients, >/= 55 years of age Postmenopausal osteoporosis Patients who are in the opinion of the physician eligible to participate in this study ", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-60.0, All Hot Flushes Menopause, Premature Obesity Vitamin D Deficiency Women in late menopausal transition or early menopause Age 40-55 BMI >25 kg/m2 Suffer from menopausal symptoms Change in previously regular cycles consisting of at least \u22652 skipped cycles and an interval of amenorrhea (\u226560 days) in the last year Negative pregnancy test Vitamin D insufficiency (<30 ng/ml) Weight stability (+/ ) for 3 months No period for >12 months Hormone use (i.e. menopausal hormone therapy, oral contraceptive, other hormonal medications) in last 3 months History of hysterectomy more than 11 months ago Abnormal screening blood tests (i.e. elevated serum calcium level, elevated creatinine) History of medical conditions where Vitamin D supplementation is not indicated (i.e. chronic renal insufficiency, elevated calcium, sarcoidosis or other granulomatous disease, lymphoma, or tuberculosis History of osteoporosis or osteoporosis on baseline DXA (expect less than 4% of screened population)84 Vitamin D deficiency (<10 ng/ml) as we felt it was unethical to withhold supplementation for 12 months in severe deficiency (according to our KPNW survey, this will <2% of population) Consuming more than 400 IU of Vitamin D supplementation daily (we felt such doses taken outside of the study design could confound results) Current smoker (within the last year) Taking medications that affect body weight", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 45.0-54.0, All Osteoporosis Osteopenia perimenopausal women willingness to participate in the 6-month study, willingness to undergo testing of bone turnover markers before and after the drug therapies and willingness to provide a self-assessment on quality of life and sleep throughout the program Subjects must be willing to take their treatments right before bed and to not to consume alcohol with this medication will women in whom osteopenia is a result of some other known process such as hyperparathyroidism, metastatic bone disease, multiple myeloma or chronic steroid use Those individuals on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs, fluvoxamine or those with severe sleep apnea, severe COPD and those with moderate or severe hepatic impairment will also be excluded Individuals who are lactose intolerant will also be excluded because the placebo and melatonin capsules will contain lactose", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-90.0, All Osteoporosis the risk of osteoporosis the risk of falls ", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-999.0, All Osteoporosis, Postmenopausal Who have been diagnosed with postmenopausal osteoporosis by physician Who have received any oral bisphosphonates (weekly or monthly) at least for 2 months to provide answer of OPSAT-QTM questionnaire Who provide informed consent for study participation Do not understand the contents of the questionnaire", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 55.0-85.0, All Post-Menopausal Osteoporosis in the cross-sectional part of the study which involves assessment of vitamin K status Informed consent to screening stage : assessment of vitamin K status serum vitamin K concentration < 0.15 ug/ml into the randomised controlled trial ambulatory post-menopausal women aged between 55-85 years 2. Post-menopausal osteoporosis ( history of previous fragility fractures or BMD evidence of osteoporosis or osteopenia with at least one clinical risk factors such as low BMI, positive family history of osteoporosis) 3. Treatment with a bisphosphonate and calcium/vitamin D supplements for at least 12 months 4. Informed written consent 5. e GFR >30 ml/min 6. normocalcaemia Age <55 years, or > 85 years Male gender severe renal impairment (CKD stage 4 and 5) poor mobility (inability to walk 100 yards unaided) malabsorption (extensive bowel surgery, short bowel) generalised carcinomatosis glucocorticoid therapy inflammatory disorders (e.g. active rheumatoid arthritis, inflammatory bowel disease requiring oral glucocorticoids) endocrine diseases (e.g. primary hyperparathyroidism, hyperthyroidism) chronic liver disease", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease age 40-80 years old cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment non-smoking controls: no COPD (spirometry based) + < 1 pack year Respiratory disorder other than COPD \u03b11-antitrypsin deficiency Known history of significant inflammatory disease other than COPD COPD exacerbation within 4 weeks prior to study Lung surgery Recent diagnosis of cancer Therapy with oral corticosteroids in the last 6 weeks Significant cardiovascular comorbidity Significant orthopedic/musculoskeletal problems", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-999.0, All Type 2 Diabetes Mellitus Have been diagnosed with type 2 diabetes mellitus Have an HgbA1c value \u2265 7% and \u226417% Are on basal insulin, with or without oral agents Are not on basal bolus insulin therapy Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional Have no known allergy to medical tape or sensors Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day Are willing to not use Acetaminophen while enrolled in the study Are willing not to undergo a MRI procedure while wearing the CGM sensor Are willing and capable of performing self insertions of the device sensor Have been on pump therapy in the 6 months prior to enrollment in the study Are receiving basal bolus insulin therapy Are taking any medication that is not approved to be taken with insulin Are pregnant or have intentions of becoming pregnant during the duration of the study Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc Have a hematocrit \u226430% or \u226555% Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study Are employed by any company that manufactures or is developing a CGM device Are deemed incapable of participating in the study by the Primary Investigator for any reason", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-999.0, All Osteoporosis inherited low-turnover osteoporosis lumbar spine or hip BMD T-score \u2264 -2.5 a written informed consent age less than 18 years generally accepted contraindications for the treatment", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 20.0-45.0, All Adult Idiopathic Generalized Osteoporosis Premenopausal women, aged 20-45, with regular menses and no historical or biochemical secondary cause of osteoporosis Documented adult fractures judged to be low-trauma Must be willing to use effective contraception throughout the period of study drug administration vary slightly based on age category Premenopausal women ages 20-35 years must have at least one major osteoporotic fracture (excluding fractures of fingers, toes and face) AND low Bone Mineral Density(BMD) Premenopausal women above the age of 35 years should have a history of fracture AND/OR low BMD History of any condition that increases the risk of osteosarcoma Early follicular phase serum Disorders of mineral metabolism Suspicion of osteomalacia Vitamin D deficiency Pregnancy or lactation within past 12 months Prolonged amenorrhea (> 6 months) during reproductive years (except pregnancy or lactation) Prior eating disorder Malignancy, except cured basal or squamous cell skin carcinoma Endocrinopathy: new onset untreated hyperthyroidism, hypothyroidism, Cushing's syndrome, prolactinoma", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 65.0-999.0, All Fall Fractures Aged over 65 years with normal renal function Normal transaminase levels Normal calcium blood levels Not homebound (not immobilized) nor in socio-healthcare institutions Need for medical treatment with calcium or vitamin D Hypersensitivity to or contraindication for calcium or vitamin D Medical treatment that includes calcium or vitamin D Physical disability that impedes their collaboration Taking thiazide diuretics Oral anticoagulants Hormone replacement therapy Digitalis drugs Anticonvulsants or barbiturates Having any of the following diseases", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 60.0-999.0, All Osteoporosis Postmenopausal women or men > 60 years DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy Pretreatment with bisphosphonates for at least four years Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009 Signed informed consent Other pharmacological treatment of osteoporosis during the last 48 months Other bone diseases Malabsorption syndromes Renal insufficiency with a calculated creatinine clearance < 35 ml/min Diseases of the esophagus, delayed esophageal clearance UUnability to realise the intake instructions Hypocalcemia", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 18.0-999.0, All Cervical Disc Degeneration Cervical Stenosis virgin spines no emergency operation age above 18 sufficient knowledge of the German language indication for anterior cervical discectomy and fusion absence of concomitant spinal disease prior cervical surgery indications other than ACDF concomitant neoplastic, metabolic, severe general or infectious disease", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 30.0-90.0, All Osteoporosis Females Postmenopausal women Outpatients screened for osteoporosis Women > 45 years Women < 45 years under menopause Women obtained their consent to be measured Premenopausal females Women without any symptom of menopause Women not obtained their consent to be measured", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 65.0-999.0, All Fall and Fracture Prevention. > age 65 Patient of the Centre for Family Medicine Family Health Team (CFFM FHT) Have at least one of the following or more falls in the past 12 months age 75 + high risk of fracture based on the CAROC difficulty with walking or balance as determined by attending physician acute fall history of a fragility fracture after the age of 50 moderate to severe cognitive impairment moderate to severe neurologic impairment not able to communicate in English contraindications to exercise as determined by physician uncontrolled hypertension palliative care, current cancer, on dialysis participation in a similar exercise program including resistance training at least 3 times a week", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-80.0, All Smoking Cessation COPD Active smokers over 40 years and more than 10 pack-years Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern Patients with limitations in performing spirometry Age greater than 80 years Institutionalized patients Patients with a life expectancy less than 1 year Spirometry in the past 2 years", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-999.0, All Type 2 Diabetes Mellitus Osteoporosis inclusion:40-99 years old with type 2 DM patient exclusion:organization people ", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-90.0, All Osteoporosis Postmenopausal women Diagnosis of osteoporosis in the medical record At least one prescription drug to treat osteoporosis in the last 5 years Insured by \"Clalit\" Health Services Hebrew-speaking capability and readiness to answer a questionnaire Premenopausal women No diagnosis of osteoporosis in the medical record No treatment for osteoporosis in the last 5 years Women who do not speak Hebrew or are unable to answer a questionnaire", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-999.0, All Diabetes Mellitus Osteoporosis Osteopenia Type 1 or type 2 diabetes Age \u2265 50 years Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of \u00b1 1 in the same period HbA1c level\u2265 7 % through the previous six months BMI between 19 og 35 Specific for type 2 diabetes Either treatment with metformin, sulfonylureas, dipeptidyl peptidase IV (DPP IV) inhibitors or glucagon-like peptide 1 (GLP-1) analogs Treatment with insulin and insulin in the combination with metformin, sulfonylureas, DPP IV inhibitors or GLP-1 analogs HbA1C > 10% Pregnancy Metal implanted at both ankles and wrists Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives Patients with a bone disease other than osteoporosis Vertebral fracture visible by vertebral fracture assessment (VFA) Patients with renal disease defined by estimated glomerular filtration rate(eGFR) < 50 Other medical disease in unstable phase (fx. cancer, hyperthyroidism) Heart failure; New York Heart Association (NYHA) class IV Patients which the investigator does not believe is fit to participate in the study", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 20.0-75.0, All Healthy Men and non-pregnant women who are at least 20 years and under 75 years of age; and Female subjects cannot be pregnant or breast feeding Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks Recent myocardial infarction (within the prior 12 weeks) Unstable angina pectoris Known or suspected renal insufficiency defined as creatinine>1.5mg/dl Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l) Known hypomotility syndrome: (such as hypothyroidism or scleroderma) Recent major trauma within the prior 12 weeks Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks) Recent hospitalization (within 12 weeks)", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-90.0, All Osteoporosis Adults between the ages of 40 to 90 Adults who been fractures prior to assessment Adults who have ability, well conscious to complete the questionnaires Adults who have treatment currently will not in this study", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 20.0-90.0, All Osteoporosis Postmenopausal women and men referred for bone density examination Patients unable to sign consent for participation", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-89.0, All Osteoporosis Female sex Age 50 to 89 years Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight) Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-79.0, All Osteoporosis Osteoporosis suspicion Age: 50 years (n = 500) and 60-79 years (n = 500) Post-menopausal status At least one of the clinical risk factors for fracture Low body mass index (< 19kg/m2) Previous fragility fracture Parental history of hip fracture Glucocorticoid treatment (\u2265 5mg prednisolone daily or equivalent for 3 months or more) Current smoking Treatment: osteoporosis medication Obesity: body mass index BMI > 30kg/m2 a refusal to participate in the study Healthy Age: 50 years (n = 50) and 60-79 years (n = 50) Post-menopausal status No diseases or treatments which may affect to bone health Treatment: osteoporosis medication a refusal to participate in the study", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-80.0, All Osteoporosis Women between 50 and 80 years Hospitalized In health services, orthopedics, gynecology, surgery Able to respond to an easy questionnaire Able to give their agreement to participate in the study Patients with dementia Patients can not express Patients at end of life Patients previously treated for osteoporosis or recent densitometry (BMD) <3 years Patients could not be seen in time by the nurse during their hospitalization Patients receiving a measure of legal protection", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 35.0-70.0, All Hypertension Diabetes Smoking Cardiovascular Diseases All individuals between the ages of 35 and 70 and residing in the area allotted to the CHW will be offered screening Of the screened individuals, those with at least 1 cardiovascular risk factor (either one of Hypertension (BP>140/90), Diabetes (FBG >126) or current daily smoker (self-reported) will be enrolled in the study Individuals who are bed-bound because of acute illness, or have a chronic condition that makes them bed-bound Individuals who refuse consent Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 20.0-45.0, All Polycystic Ovary Syndrome PCOS diagnosis to three of the Rotterdam pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for >/3 months before the study smokers", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 45.0-70.0, All Osteoporosis Osteopenia Periodontal Disease Women between 45-70 years with Absorptiometry Dual Energy X-ray (DEXA) Control group: post-menopausal women with periodontal disease and normal osseous condition Study group: post-menopausal womens with periodontal disease and osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate or ibandronate 150 mg) for longer than 3 months before the study and another Patients with history of aggressive periodontitis and had received any periodontal treatment when they entered the study Patients with any systemic illness (except osteopenia/osteoporosis) Patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6 months prior to the study", "label": "1"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 35.0-60.0, All Generalized Chronic Periodontitis Osteoporosis Male and Female Patients aged between 35.00 Year(s) to 60.00 Year(s) diagnosed with Osteoporosis and Chronic Periodontitis who are willing to participate in the study Patients who are Systemically compromised and under medications such as steroids Patients who smoke.Pregnant and lactating mothers are excluded from the study", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 40.0-95.0, All Post Menopausal Osteoporosis post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks received their first prescription of Prolia in the last 4 weeks patient has provided informed consent before enrolling in the study patients participating in ongoing or previous Denosumab clinical trials", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-999.0, All Post Menopausal Osteoporosis Postmenopausal women Age 50 years or greater Previously diagnosed osteoporosis, or receiving treatment for osteoporosis", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 35.0-999.0, All Osteoporosis, Postmenopausal Osteoporosis, Steroid Induced Female patients with postmenopausal osteoporosis (T-score \u2264-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of \u2265 low-energy fracture during the last 10 years prior the study Male patients \u2265 50 years old with idiopathic osteoporosis (T-score \u2264-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of \u2265 low-energy fracture during the last 10 years prior the study Male and female patients with steroid-induced osteoporosis (T-score \u2264-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of \u2265 low-energy fracture during the last 10 years prior the study Prior use of teriparatide or PTH(1-84) Hypersensitivity to teriparatide regimen Pregnancy and lactation Hypercalcamia Renal deficiency (eGFR < 30 ml/min) Other bone metabolic diseases (including hyperparathyroidism and Paget's disease) except primary osteoporosis or steroid induced osteoporosis Uninterpretable increases of alkaline phosphatase (ALP) Prior skeletal radiotherapy Skeletal malignancies or bone metastases", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-999.0, All Hypovitaminosis D Spinal Disease Osteoporosis (Part 1, Retrospective Study) 50 years old or older Patients with any form of spinal fusion surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from November 1, 2012 to October 31, 2014 Subjects diagnosed with chronic renal disease Stage IV or V, metastatic spinal disease, bariatric surgery, malabsorption syndrome, seizure medication and chronic steroid use greater than 3 months at time of surgery (Part 2, Observational Study) (Screening period July 1, 2015-June 30, 2016) 50 years old or older Serum Vitamin D level checked prior to or at surgery BMD exam performed anytime within 2 years prior to surgery Patients with any form of spinal fusion cervical, thoracic, lumbar, surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from July 1, 2015 to May 31, 2016 Subjects diagnosed with Chronic Renal Disease with a GFR < 45 at Stage IV Metastatic Spinal Disease", "label": "0"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 50.0-75.0, All Type 2 Diabetes Mellitus Bone Fractures presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes) immobility coexisting metabolic bone disease or comorbidities affecting bone health previous treatment with osteoporosis medication or intake of medications known to affect bone metabolism (e.g. steroids) within 6 months prior to enrolment thiazolidinedione use", "label": "2"} +{"topic": "A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.", "doc": "eligible ages (years): 20.0-90.0, All Osteoporosis age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate severe liver, heart, or kidney impairment, and tumor. Procedures of the study were in accordance with the Declaration of Helsinki and were approved by the local ethics committee", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-999.0, All Cerebellar Disease Dementia Healthy Parkinson's Disease Right handed normal volunteers (18-65 years old) Patients with Parkinson's disease off medication Patients with cerebellar deficits Patients with frontal lobe lesions Patients with frontal lobe dementia Subjects with personal or family history of seizures or other neurological disorders Pregnant women Volunteers or patients with severe coronary artery disease Metal in the cranium except mouth Intracardiac lines Increased intracranial pressure as evaluated by clinical means Cardiac pacemakers Intake of neuroleptics", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-999.0, All Dementia Characterized as having behavioral manifestations using a standardized neuropsychiatric scale and interview FLD patients' frontal cognitive sysfunctions characterized using a short neurobehavioral test battery Patients must be able to be tested and cooperative with the procedures required in this protocol No contraindications to the use of Sertraline No medical conditions that can reasonably be expected to subject the patient to unwarranted risk (e.g., cancer) or require frequent changes in medication. Well-controlled medical conditions such as hypertension and diabetes will not be excluded Patients must not be pregnant or nursing and must be using effective contraception, if still at child-bearing age No history of prior severe traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury Not using any psychotropic medication which cannot be stopped 4 weeks before the study ", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Histologically confirmed stage IIIB with metastatic pleural effusion or metastatic stage IV non-small cell lung cancer Large cell Adenocarcinoma Squamous cell Bronchioalveolar carcinoma Undifferentiated No small cell or carcinoid histologies At least 1 bidimensionally measurable or evaluable indicator lesion Measurable or evaluable indicator lesion(s) must be completely outside the radiation portal or there must be proof of disease progression No current CNS metastases at study entry No meningeal carcinomatosis Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase less than ULN, OR alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT less than ULN Renal: Creatinine clearance at least 50 mL/min Other: No concurrent illness that would effect assessment of this study Not pregnant or nursing Effective contraception required of all fertile patients PRIOR Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for non-small cell lung cancer allowed Radiotherapy for new brain metastases (other than leptomeningeal disease) is allowed during study, but chemotherapy is stopped during and for 2 weeks following radiotherapy Concurrent radiotherapy to other sites allowed if there is no objective for disease progression Surgery: Not specified Other: No other concurrent experimental drug ", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 3.0-16.0, All Brain and Central Nervous System Tumors Histologically proven primitive neuroectodermal tumors of the central nervous system No metastatic disease within or outside the central nervous system Must have survived 1 week following surgery Postoperative CT scan and myelogram required Age: 3 to 16 Performance status: Not specified Life expectancy: Not specified Hematopoietic: No concurrent hematological disorder Hepatic: Not specified Renal: Renal dysfunction allowed Other: No prior history of malignant disease PRIOR Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics ", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-999.0, All Carcinoma, Non-Small-Cell Lung Histologically confirmed locally advanced NSCLC (squamous, large cell undifferentiated or adenocarcinoma) Disease limited to the thorax, adjacent mediastinum and neurovascular structures, and supraclavicular or scalene lymph node area, as defined by the AJCC Staging System. This includes patients with Stage IIIA and IIIB disease Performance status of 0-2 by Southwest Oncology Group criteria Medically inoperable patients (Stage I or II) Locoregional recurrent tumor following surgery will be eligible provided they meet other criteria ", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 40.0-70.0, All Lung Cancer Patients at high risk for the development of lung cancer as defined by the following: At least 40 pack years smoking (may have stopped smoking within past 10 years) at time of study entry FEV-1/FVC ratio less than 70% predicted OR FEV-1 less than 80% predicted obtained from 3 serial performances with less than 5% difference Normal or stable current chest x-ray Age: 40 to 70 Performance status: Not specified Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: See Disease Characteristics Other: No other comorbidity that limits life span to less than 5 years No prior cancer except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified ", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 6.0-90.0, All Intracranial Central Nervous System Disorder Mental Disorder Healthy AND Controls: Healthy normal controls matched to specific patient groups for age, education, gender, and race to be recruited by advertisement from the community or from among friends and relatives of the patient. Individuals with a neurological or psychiatric history or medical condition that would compromise our interpretation of the test results will not be included Patients: Patients will be selected from referrals to the Cognitive Neuroscience Section, the NIH Clinical Center, and from referrals recruited through approved advertisement in appropriate media and medical journals All patients must have a diagnosed CNS disorder with lesions localization (when suspected) verified by CT or MRI scanning available from the referring physician or completed at the NIH Clinical Center. Subjects without neurological, neuropsychological, and imaging evidence compatible with one of the recruited diagnoses will be excluded from the study as will subjects who cannot cooperate with neuropsychological testing (based on family report and the report of the referring healthcare professional) The bulk of the patients recruited for this protocol will have focal or degenerative lesions of the HPFC. We also will recruit patients with non-frontal lesions in order to determine the specificity of the deficit we observe in patients with HPFC lesions. These patients will undergo the same testing but are not expected to have marked cognitive deficits on tests of frontal lobe function Patients with different basal ganglia disorders or limbic system lesions are included because their lesions involve differing subsets of subcortical structures that are thought to play an important role in the automatic activation of stored plans and social behavior. Another prediction from the SEC model is that patients with basal ganglia disorders will have deficits primarily on over-learned components of tasks that require visuomotor interaction (e.g., a visuomotor serial reaction time task) but have spared performance on higher level cognitive planning tasks that don't require simple visuomotor responses The bulk of the patients will be patients with focal penetrating head injuries who will be seen here at the NIH as part of a newly funded study to be conducted primarily, but not solely, at the National Naval Medical Center. Patients with dementing disorders (e.g., frontotemporal dementia) are suitable for assessment of the structure of knowledge, and in particular, the systematic general breakdown of social and non-social SEC knowledge representation. Patients with focal lesions (e.g., dorsolateral frontal) will be studied to assess damage to specific sub-components of the structured event complex model. Occasionally, single cases will be intensively studied due to a unique behavioral presentation (see above for a lengthier description) A durable power of attorney will be appointed if the patient is unable to make decisions about any or all aspects of this protocol. In the past in our protocols, this has almost always been the spouse The age range of the brain-damaged patients will be determined on entrance into the protocol. An equal number of left and right unilateral lesions will be sought for determination of laterality differences. Patients with lesions limited to (rather than simply including) the frontal lobe will also be especially sought Minors (ages 6-17) are included in this protocol in order to examine 3 specific questions: (1) What is the distinction in retrievable SEC knowledge (e.g., plans or social rules) learned prior to adolescence from that subsequent to adolescence?; (2) Does learning and development of all aspects of social cognition require an intact prefrontal cortex?; and (3) Will some effects of early prefrontal cortex lesions only appear after the age of 14? The first question will be addressed by studying healthy normal children before the age of 14 on experimental social cognition and planning tasks slightly modified from those used with adults (see the six studies described above). The second question will be addressed by studying single cases and groups of children with prefrontal cortex lesions on social cognition tasks before and after the age of 14. The third question will be addressed by studying children with prefrontal cortex lesions incurred before the age of 14 both before and after the age of 14 on social cognition, meta-cognition, and planning tasks", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Carcinoma, Non-small-cell Lung Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma Stage IV or Stage IIIB Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen At least 18 years of age Good performance status (ECOG 0 to 1) Adequate liver, renal, and bone marrow function Pregnant or lactating women Treatment with more than one cytotoxic therapy Prior radiation to the whole pelvis Unstable medical conditions such as uncontrolled cardiac arrhythmia Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Squamous Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Patients must have histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete solitary radiological mass or nodule are eligible) Patients must be classified post-operatively as stage IB, II or IIIA on the basis of pathologic At the time of resection a complete mediastinal lymph node resection or at least lymph node sampling should have been attempted; if a complete mediastinal lymph node resection or lymph node sampling was not undertaken, any mediastinal lymph node which measured 1.5 cm or more on the pre-surgical computed tomography (CT)/magnetic resonance imaging (MRI) scan or any area of increased uptake in the mediastinum on a pre-surgical positron emission tomography (PET) scan must have been biopsied; note: a pre-surgical PET scan is not mandatory The nodal tissue must be labelled according to the recommendations of the American Thoracic Society; surgeons are encouraged to dissect or sample all accessible nodal levels; the desirable levels for biopsy are Right upper lobe: 4, 7, 10 Right middle lobe: 4, 7, 10 Right lower lobe: 4, 7, 9, 10 Left upper lobe: 5, 6, 7, 10 Left lower lobe: 7, 9, 10 Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the intraoperative findings; patients who have had only segmentectomies or wedge resections are not eligible for this study; all gross disease must have been removed at the end of surgery; all surgical margins of resection must be negative for tumor Prior or concurrent malignancies; patients who have had a previous diagnosis of cancer, if they remain free of recurrence and metastases five years or more following the end of treatment and, in the opinion of the treating physician do not have a substantial risk of recurrence of the prior malignancy, are eligible for the study; patients who have been adequately treated for non-melanomatous skin cancer or carcinoma in situ of the cervix are eligible irrespective of when that treatment was given A combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumor More than one discrete area of apparent primary cancer (even if within the same lobe, T4, IIIB) Clinically significant or untreated ophthalmologic (e.g. Sjogren's etc.) or gastrointestinal conditions (e.g. Crohn's disease, ulcerative colitis) Any active pathological condition that would render the protocol treatment dangerous such as: uncontrolled congestive heart failure, angina, or arrhythmias, active uncontrolled infection, or others A history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic or that would limit compliance with study requirements Patient, if female, is pregnant or breast-feeding Neoadjuvant chemotherapy or immunotherapy for NSCLC; however, patients may have received pre-operative limited field, low dose (less than 1000 cGy) external beam radiation therapy or endobronchial brachytherapy or laser therapy for short term control of hemoptysis or lobar obstruction; full dose pre-operative radiotherapy of curative intent is a cause for exclusion; patients may have received post-operative adjuvant platinum-based chemotherapy however non-platinum-based chemotherapy is a cause for History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used on this trial; patients with ongoing use of phenytoin, carbamazepine, barbiturates, rifampicin, or St John's Wort are excluded Incomplete healing from previous oncologic or other major surgery", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-999.0, All Healthy Participants will be right-handed volunteers, aged 20 to 70, without history of any disorder of the central nervous system Current serious medical or psychiatric condition of any kind History of any significant trauma or medical condition affecting the brain or skull History of epileptic seizure Current use of neuroactive medications, medications affecting the cerebral circulation, or recreational drugs Presence of metal in the head (other than dental hardware) or body, such as pacemakers, aneurysm clips, metallic prostheses (including heart valves or cochlear implants), patches with metallic foil backing, such as nicotine patches, permanent eyeliner or shrapnel fragments History of welding or metal work Broken skin in the area of the stimulating electrodes Pregnancy/breastfeeding", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Neoplasm Metastasis Brain Neoplasm Single presumed brain metastasis on contrast magnetic resonance imaging (MRI) scan within two weeks before commencement of treatment Systemic cancer diagnosed histologically or cytologically synchronous with, or within 5 years of treatment of the presumed brain metastasis (other than non-melanoma skin cancer and cancer in-situ of the cervix, neither of which would be reasonably attributable as the primary site). Exception melanoma diagnosed > 5 years previously is allowable in view of the extremely variable natural history of melanoma Age >= 18 (no upper age limit) Considered suitable for both S and RS by the neurosurgeon and radiation oncologist (see exclusions) Patient must agree to adjuvant WBRT RTOG RPA Class 1 or 2 (Karnofsky Performance Status [KPS] >= 70 after adequate trial of corticosteroids) RPA Class 3 patients (KPS < 70) eligible if it is considered that the poor performance status is due primarily to the solitary metastasis, aggressive local treatment of which may be expected to restore good performance status. This would ordinarily be associated with minimal systemic disease burden Accessible for treatment and follow-up Patient is infertile or is aware of the risk of becoming pregnant or fathering children and will use adequate contraception Previous history of brain metastasis(es) Surgery indicated to relieve life-threatening raised intracranial pressure or excision required for tissue diagnosis (no extra-cranial site to biopsy ie unknown primary). However, prior diagnostic (non-excisional) biopsy is allowable it is acknowledged that the 50% probability of a repeat surgical procedure on subsequent randomisation would not be acceptable to many patients and clinicians Surgery contraindicated by site (e.g. thalamus, brain stem) or medical co-morbidities Leptomeningeal disease Primary is small cell lung cancer, germ cell tumour, lymphoma, leukaemia or myeloma Prior cranial RT (including RS) Patient is pregnant", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-65.0, All Brain Neoplasms Histopathologically confirmed newly diagnosed base of skull benign tumour Karnofsky Performance Status (KPS) equal to or greater than 70 Brain metastases or recurrent tumour Prior radiotherapy (RT) to head or neck No prior chemotherapy or radiosensitizer", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 20.0-999.0, All Lung Neoplasms patients who have solitary pulmonary nodules in CT patients who don't fit the above", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Asthma Chronic Obstructive Pulmonary Disease Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center Evidence of airflow obstruction on spirometry (FEV1/FVC<70%) Age 18 years or older History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin) Treatment with any macrolide in the 4 weeks prior to study entry Elevated AST or ALT (2 or more times the upper limit of normal) on current admission Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission Elevated total serum bilirubin (more than upper limit of normal) on current admission Previous participation in this study Patients prescribed digoxin (azithromycin may increase digoxin levels) Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin) Patients prescribed pimozide (azithromycin may increase risk of arrhythmias) Patient unable to provide consent (e.g., language difficulty or history of dementia)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Non-small Cell Lung Cancer lung cancer patients undergoing resection with intent to cure age < 18 years", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 16.0-999.0, All Acute Dyspnoea All patients admitted for investigation of acute pulmonary embolus ", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-75.0, All Oral Cancer Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route No history of a prior malignancy in the head and neck region No prior malignancy outside the head and neck region in the preceding 5 years Patient will be reliable for follow-up Age> 18 years and < 75 years No significant co-morbid conditions ASA grade II and I Understands the protocol and is able to give informed consent Prior radiotherapy or surgery for malignancy in the head and neck region Non squamous cell carcinomas of the oral cavity Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease (COPD) diagnosis of mild COPD OR healthy control subjects 80 years old able to perform all study procedures Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects) allergy to atrovent history of asthma, atopy or nasal polyps Oxygen desaturation < 80 % during exercise recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Metastatic Cancer Histologically or cytologically confirmed malignant pulmonary neoplasm New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed Imaging findings compatible with localized treatment failure after prior cryotherapy allowed Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy Metastatic disease must meet all of the following Primary tumors have been resected or have been deemed controlled by other therapies No other widespread metastases evident (e.g., multiple hepatic or brain metastases) Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach No more than 5 targeted masses for study therapy Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter ", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 60.0-999.0, All Depression DSM-IV of major depressive disorder (MDD) Score of greater than 20 on the MADRS (score of greater than 17 for atypical depression) Score of greater than 20 on the Mini Mental State Examination (MMSE) Any condition that may make having an MRI medically inadvisable Any severe or unstable medical conditions Any known primary neurological disorders, including history of stroke Any other simultaneous Axis I disorder History of substance or alcohol abuse disorder within 6 months prior to study entry Currently at risk for suicide History of failed prior adequate trials of two antidepressants for the current depressive episode History of failed prior adequate trial of sertraline Current use of any other psychoactive medications (medication washout will be required)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 12.0-999.0, All Refractory Frontal Lobe Epilepsy Cryptogenic frontal lobe epilepsy Normal cerebral MRI ", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Renal Cell Carcinoma Confirmation of metastatic or recurrent renal cell carcinoma Certain types of previous anti-cancer therapy for Renal Cell Carcinoma Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes Patients with a history of poorly controlled high blood pressure", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.115-0.308, All Pneumonia & AOM Caused by S. Pneumoniae & H. Influenzae A male or female between, and including, 6 and 16 weeks of age at the time of the first vaccination. Pre-term born infants can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age Subjects should be living in the area covered by the surveillance system for community acquired pneumonia (CAP), invasive disease and acute otitis media (AOM) \u2022Written informed consent obtained from the parent or guardian of the subject Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol Use of any investigational or non-registered drug or planned use during the study period Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s) Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or Streptococcus. pneumoniae . Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine .Other locally recommended vaccines are always allowed, even if concomitantly administered with the study vaccines. \u2022Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar is not allowed. If Prevnar immunization needs to be initiated, due to the presence of a high risk disease for pneumococcal infections for which the Prevnar vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific Prevnar immunization program History of allergic disease or reactions likely to be exacerbated by any component of the vaccines History of any neurologic disorders or seizures Acute disease at the time of enrolment For Colombia: infants with low birth weight ( less than (<) 2.500 grams)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 3.0-25.0, All Low Grade Gliomas Craniopharyngioma Ependymomas Meningiomas Patients with primary intracranial tumours such as low-grade glioma, meningioma, craniopharyngiomas, ependymomas and other benign tumours considered for radical focal radiotherapy Tumours measuring upto 7 cms on maximum dimension on the CT/MRI Age 3 to 25 years NPS of 0-3 Informed consent from patients or parents as appropriate Long-term follow up expected Previous radiotherapy Planned adjuvant chemotherapy Expected median survival of less than two years Patient not cooperative for planning and execution of SCRT", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer Subjects with a prior history of lung cancer Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer Altered mental status that would prohibit the giving and understanding of informed consent Dementia Psychiatric illness that would preclude adequate compliance with communication for this protocol Prisoners", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Non Small Cell Have pathologically confirmed non-small cell lung cancer Have measurable primary pulmonary tumors \u2265 1cm Have plans for a clinically indicated non-contrast CT scan of the chest All patients must be \u2265 18 years old Pregnant or lactating women", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Inoperable Stage I/II Non-small Cell Lung Cancer Histologically confirmed non-small cell cancer by biopsy or cytology. Squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging T1, N0, M0 T2 (<=7cm), N0, M0 T3 (<=7cm), N0, M0 Primary tumor must be arising in one of the following central chest locations Within or touching the zone of the proximal bronchial tree (a volume 2cm in all directions around the proximal bronchial tree [carina, R & L main bronchi, R & L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R & L lower lobe bronchi]) Adjacent to (within 5 mm) or invading the mediastinal pleura Adjacent to (within 5 mm) or invading the parietal pericardium To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest MRI will be obtained. If any uncertainty remains, the patient will have four-dimensional CT scans (4DCT) in an effort to determine the degree of tumor motion. A freely mobile tumor during ventilation will be judged to be T3 disease There is no associated with this protocol. Please see the above criteria.-", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Undiagnosed Pulmonary Nodules Lung Nodules Referral to the pulmonary or thoracic surgery service for undiagnosed pulmonary nodules History of smoking exceeding 10 pack-years (pack year defined as number of packs of cigarettes per day multiplied by the number of years smoked) Age >18 Nodule size 5 to 15 mm in diameter Clinical indication for immediate biopsy via bronchoscopy, fine needle aspiration, or video-assisted thoracoscopic Surgery (VATS) Active lung cancer or metastasis to the lung Contraindication to needle biopsy Pneumonectomy Need for supplemental oxygen Radiation pneumonitis Interstitial lung disease", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-21.0, All Pulmonary Nodules Participant has a known or clinically suspected solid malignancy (excluding brain tumor) Nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy Participant has not been off therapy for at least 3 weeks before undergoing PET-CT", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-90.0, All Ulcer Within 24 hours of admission to Neurosurgical ICU after neurosurgery with ventilator support Less than 18 y/o Pregnancy Not suitable for medication from NG route Had GI bleeding at admission to ICU", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Non-small Cell Lung Cancer Patient must be over the age of 18 years Pulmonary nodule with maximum diameter \u2264 5 cm Histological confirmation of primary NSCLC The following stage of NSCLC patients are eligible Stage I: T1 N0 M0 or T2 N0 M0 (Tumor size \u2264 5 cm) Stage II: T3 N0 M0 (Chest wall invasion only, Tumor size \u2264 5 cm) ECOG/Zubrod status of 0, 1 or 2 Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine that the patient is not a surgical candidate In order to be considered medically inoperable, the patient must meet at least one major or a minimum of 2 minor as described below MAJOR Excluding the primary cancer targeted for this treatment, the patient has a prior history of cancer (within the last 5 years) or concurrent cancer other than basal cell or squamous skin cancer Visible endobronchial lesion seen in the trachea, carina, major bronchus, lobar or segmental bronchus on bronchoscopy or microscopic disease detected in the trachea, carina, major bronchus, lobar or segmental bronchus The patient's weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch The patient has received thoracic radiation therapy in the same field as the planned treatment area in the past The patient has completed chemotherapy within less than 30 days of treatment T2: Tumor size > 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and \u2264 5 cm), T4 tumors. Presence of N1, N2 or N3 disease per previously described would be excluded Pancoast tumors would be excluded Current distant metastatic disease (M1) (preferably biopsy proven) The patient is a female with child-bearing potential who refuses to take a pregnancy test prior to treatment The patient is pregnant or a female who is nursing an infant", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 45.0-999.0, All Emphysema Pulmonary Disease, Chronic Obstructive for All Participants Able to read and write English At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years) Able to participate in the informed consent process Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry) for Participants with Emphysema Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR More than minimal emphysema on an acceptable-quality chest CT scan for Participants without Emphysema GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND Pregnant Prisoner Vulnerable populations Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment) Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant Congenital abnormalities of the lung or previous lung surgery Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated) CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Stomach Ulcer those recieved major abdominal surgery (estimated admission to sirgical ICU more than 7 days); give written consent and was randomized within 24 hours of admission age less than 18 y/o; pregnant; allergy to famotidine or pantoprazole; have had GI bleeding", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Histologically confirmed non-small cell lung cancer Stage I or II disease (T1-3, N0, M0) T2 or T3 tumor \u2264 5 cm No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed) Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed \"medically inoperable\" Patients with FDG-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status ECOG performance status 0-2 Not pregnant or nursing Fertile patients must use effective contraception during and for \u2265 6 months after completion of study treatment No history of contrast allergy No psychological issues that would preclude the completion of study treatment No prior radiotherapy or chemotherapy No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan) No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Neoplasms, Unknown Primary Carcinoma Histologic or cytologic proven, non-resectable carcinoma of unknown primary (adenocarcinoma or non-differentiated carcinoma) Measurable tumor lesion(s) according to WHO PS 0 to 1 Paclitaxel/Carboplatin with or without Cetuximab in Adeno and Undifferentiated CUP (PACET-CUP) Signed written informed consent \u2265 18 years of age Effective contraception for both male and female subjects if the risk of conception exists Adequate bone marrow function Neutrophiles blood cell count (NBC) \u2265 1,5x109/L Previous exposure to epidermal growth factor receptor-targeting therapy Previous chemotherapy except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy Investigational agents or participation in clinical trials within 30 days before treatment start in this study Clinically relevant coronary disease or myocardial infarction within 12 months before study entry Possibility of a curative local treatment (surgery and/or radiotherapy) Women with axillary node metastasis as predominant tumor site Women with peritoneal carcinomatosis as predominant tumor site Men < 50 years old with retroperitoneal or mediastinal lymph node +/", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-999.0, All Lung Cancer Diagnosis of suspected lung cancer or lung cancer Inability to undergo therapy", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Neoplasms Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20 cm from the incisors) or gastroesophageal junction are included No distant metastases (M0) Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy Resectable mediastinal nodes are eligible No prior chemotherapy for this malignancy No prior radiotherapy that would overlap the field(s) treated in this study Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon Cancers of the cervical esophagus (< 20 cm are excluded) Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible Patients with biopsy proven metastatic celiac nodes are ineligible", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.5-20.0, All Neuroblastoma Brain Tumors Solid Tumors Histologically or cytologically confirmed neuroblastoma, brain tumor or other solid tumor (at diagnosis) Relapsed or refractory tumors in which correct standard treatment approaches have failed No more than 2 lines of prior chemotherapy Measurable primary and/or metastatic disease on CT/MRI at least one bi-dimensionally measurable lesion For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring Age at 6 months to \u2264 20 years Lansky play score \u2265 70% or ECOG performance status \u2264 1 Life expectancy \u2265 3 months Adequate organ function Adequate haematological function: haemoglobin \u2265 80 g/l, neutrophil count \u2265 1.0 x 109/L, platelet count \u2265 100 x 109/L; in case of bone marrow disease: neutrophils \u2265 0.5 x 109/l and platelets \u2265 75 x 109/l Concurrent administration of any other anti-tumour therapy Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study History of allergic reaction to the compounds or their solvents History of allergic reaction to Dacarbazine (DITC) Galactosemia, Glucose-galactose malabsorption or lactase deficiency Pregnant or breast feeding young women Presence of symptomatic brain metastases in patients with solid non-CNS tumors", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Nodule, Solitary Multiple Pulmonary Nodules Scheduled for chest CT as part of their needed medical care If available, individuals who have had previous imaging to suggest they fulfill the needs of the study years of age, or older In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures Children under 18 years of age Women who are pregnant or who suspect they may be pregnant Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 3.0-18.0, All Pneumonia Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian Boy or girl in the age range of 3-18 years Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever Patient referred by ED physician and presented for CXR Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture) Potentially contagious skin lesion on the back Subject has had lung surgery Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 19.0-999.0, All Lung Cancer Patients will be evaluated for using the following All newly diagnosed patients with small lung nodules < 1cm that require excision with no history of prior ipsilateral thoracotomy The nodules must be located in parts of the lung that are amenable to thoracoscopic wedge excision of the nodules.The external surface of the lesion must be at least 2 cm from the major pulmonary arteries, veins, and main bronchi to allow safe and adequate thoracoscopic excision of the lesion Patients must be mentally competent to give written, informed consent Patients must be capable of independently completing standard English-language QOL instruments Patients will be excluded from the trial if they do not consent to participate in the study, or if the radiologist and surgeon agree that the nodule is located too centrally to be safely excised using thoracoscopic wedge techniques Patients with more than three nodules will be excluded from the study Patients with a positive diagnosis of non-small cell lung cancer obtained from sputum cytology, bronchoscopy, or CT guided needle biopsy will be excluded from the study If the patient is excluded, he/she will receive the current standard treatment, which may needle biopsy, continued observation of the nodule at three to six monthly intervals, or excisional surgery (thoracoscopy or open thoracotomy)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-85.0, All Lung Abscess Adult 18-85 years of age Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter Patients must be fully informed of the investigational nature of the procedure and sign an informed consent Lung nodules or masses greater than 30 mm in the greatest dimention Lung nodules that have solid calification Lung nodules or masses with CT evidence of partial or complete obstruciton of a lobar bronshus, mainstem bronchus or the trachea No prior cancer with the exception of non-melanoma skin cancer Life expectany of < t months Any indifidual who does not give oral and written consent for participation -", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-45.0, All Schizophrenia, Undifferentiated Type For patients Men and women, right handed, 18 to 45 years Having given their written informed consent Presenting a diagnosis of schizophrenia made by DMS IV, hospitalized or followed regularly in a hospital proper, and whose symptoms are stable for at least 6 weeks, at the discretion of the psychiatrist Receiving antipsychotic treatment (risperidone or aripiprazole) monotherapy stable (treatment and dose) for at least than 6 weeks Showing no contra-indication for fMRI Patients whose physical examination is unremarkable clinically significant Patients without serious somatic pathology Affiliated to a social security system For women of childbearing potential, an appropriate contraception is mandatory and an negative pregnancy test For patients Patients in menstruation without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical) Patients who are pregnant or breastfeeding Patients not meeting for schizophrenia according to DSM IV or those with resistant schizophrenia (Kane criteria) Introducing a somatic disease or serious neurological, particularly Parkinson's disease, epilepsy, tardive dyskinesia and disabling cardiovascular disease, liver or kidney disease Presenting a contra-indication to MRI Having a history of alcoholism or drug addiction during the past year Participating in another clinical trial or are in a period of from a previous protocol Patients likely to have behavioral self aggression from the trial investigators During the study", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-80.0, All Lung Cancer Chronic Obstructive Airway Disease age 18-80 competent confirmed lung cancer history of other cancers", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Solitary Pulmonary Nodule Age> 18 years in patients with solitary pulmonary nodule who had percutaneous needle biopsy for diagnosis of lung nodule patients who do not agree the study enrollment", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Patients undergoing elective, open and thoracoscopic thoracic surgery for any indication Age < 18 years old Inability to consent for the study Chest wall anatomy precluding SATS Inability to sit upright", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Melanoma Histologically documented cutaneous malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means Patients must have tumour tissue from their primary and/or metastatic tumour available to assess putative molecular markers of response (paraffin block or 12 unstained slides) Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows Chest X-ray > 20 mm, CT scan (with slice thickness of < 5 mm) >10 mm (longest diameter), Physical exam (using calipers) > 10 mm, Lymph nodes by CT scan > 15 mm measured in short axis All radiology studies must be performed within 21 days prior to randomization (Exception: Within 28 days if negative) Patients must have either maximum tumour lesion size of \u2264 50 mm OR if tumour lesion is > 50 mm, LDH must be \u2264 2.5 x ULN Patients must have a life expectancy of at least 12 weeks Age > 18 years ECOG performance status of 0-1 Previous Therapy Patients with known HIV, Hepatitis B or Hepatitis C infection History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, other interventional cardiac procedure within the past 12 months, autoimmune conditions requiring chronic immunosuppressive therapy, or psychiatric illness/social situations that would limit compliance with study requirements Patients may not have received any other investigational agents within 28 days of study entry, and may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy Patients with known brain metastases or history of CNS metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A head CT or MRI is required on all patients to rule out brain metastases Pregnant or lactating women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rIL-21 or dacarbazine, breastfeeding should be discontinued if the mother is treated with protocol therapy Prohibited Medications: Long Term (> 7 days) Systemic Corticosteroids (e.g. prednisone, dexamethasone, etc.) because these may counteract the stimulatory effects of rIL-21 on lymphocytes. (Note: Topical steroids are allowed)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer All patients with CT identified pulmonary nodules not deemed to be visualizable during VATS who are candidates for VATS resection Inability to consent for the study Patients less than 18 years old Patients with pulmonary nodules easily located during VATS Patients with tumours extending to visceral pleura or chest wall Patients who have chest anatomy precluding VATS resection", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 40.0-80.0, All Yield of Cryo Biopsy in Lung Cancer Solitary Pulmonary Nodule solitary pulmonary nodule < 4 cm no endobronchial lesion indication for bronchoscopy coagulopathy pulmonary hypertension pregnancy", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-18.0, All Craniopharyngioma Obesity Diagnosed with craniopharyngioma for the first time Age at diagnosis 18 years or less of age Agreement from patient's parents or legal guardian as well as the patient for in randomization study Histological diagnosis of craniopharyngioma Age at diagnosis 18 years or less of age Age at primary surgery over 5 years of age Incomplete primary resection Reference radiological confirmation of an incomplete resection Agreement from patient's parents or legal guardian as well as the patient Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Incisional Hernia age \u226518 years asymptomatic/ oligosymptomatic incisional hernia no hernia detectable by physical examination acute incarcerated hernia emergency hernia repair pain or discomfort associated with the hernia during normal activities local or systemic infection ASA score >3 inability to complete or comprehend the preoperative questionnaire repair with biologic prothesis", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 4.0-22.0, All Medulloblastoma Age at diagnosis at least 4 years or 5 years (according to the policy of the National Brain Tumour Group) and less than 22 years Histologically proven medulloblastoma, including the following variants(WHO classification : classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis on MRI supratentorial, arachnoid of the posterior fossa or spine No clinical evidence of extra-CNS metastasis No tumour cells on the cytospin of lumbar CSF. Central Review of CSF cytology is recommended but not mandatory. It will be left to national policy Radiotherapy to start no more than 40 days after surgery Ability to receive twice daily radiotherapy Vital functions within normal range for their age group CTC grades < 2 for liver, renal, haematological and audiological function One of the is lacking Brainstem or supratentorial primitive neuroectodermal tumour Atypical teratoid rhabdoid tumour Medulloepithelioma Ependymoblastoma Large cell m\u00e9dulloblastoma Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF) Patient previously treated for a brain tumour or any type of malignant disease Patients who are pregnant Females who are sexually active and not taking reliable contraception", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-90.0, All Bronchiectasis Bronchiolitis All patients with bronchiectasis or bronchiolitis All patients with severe lung disease other than bronchiectasis Active lung infection Active infection other site except the lung", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Participant is a lung cancer patient Participant is under 18 years old Participant is not a lung cancer patient", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 50.0-999.0, All Solitary Pulmonary Nodules Multiple Pulmonary Nodules Renal Neoplasms Adrenal Gland Neoplasms Aortic Aneurysm, Abdominal Liver Neoplasms Adnexal and Skin Appendage Neoplasms Lymphadenopathy Pancreatic Neoplasms No participant sub-populations will be excluded prior to selection (the E1 population will be matched to the Case Group populations) Data from the 15 participating sites from the ACRIN 6664 trial provide a study data set of 2531 participants, broken down into a total target study data set of 520 participants. Participants will be distributed into one of three cohorts as follows The Case Group will target consenting 141 participants from the cases with indeterminate but potentially significant findings (E3/E4s) other than pulmonary nodules The Pulmonary Nodules Case Group will comprise 119 cases with E3/E4 ECFs characterized as pulmonary nodules The E1 Control Group will be drawn from the 866 E1 ECF cases to create a cohort of 260 E1ECF cases. The Control Group for comparison with the Case Group and the Pulmonary Nodules Case Group will be selected at the Biostatistics and Data Management Center (BDMC). The BDMC will match E1 141 controls to the 141 case-group participants with indeterminate but potentially significant findings (E3/E4s). The BDMC will also match 119 E1 controls to the 119 E3/E4 pulmonary nodules cases. Controls will be matched by site, age caliper (5 years), and sex where possible. Where an appropriate match cannot be obtained, the matching will be relaxed. If potential participants decline study consent, we will then best-match additional cases for the appropriate group to maintain target populations. Any additional cases beyond the initial 520 participants identified for medical record collection will be matched as feasible ", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Small Bowel Obstruction Gastrointestinal Hemorrhage Patients 18 years and older Patient or proxy willing to provide informed consent Patients who require placement of a nasogastric/orogastric tube, in the ED or ICU, as standard of care, AND a member of the study staff is available and present for NG/OG tube placement It is anticipated that the patient will remain in the ED/ICU in order to obtain RightSpot pH Indicator reading and verifying CXR Patients less than 18 years of age Patient or proxy unwilling or unable to provide informed consent Patient with known or suspected pregnancy", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Solitary Pulmonary Nodule Multiple Pulmonary Nodules Subjects who meet all of the following may be enrolled in this Study Subject is male or female, age 18 or older Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging Subject meets one or more of the following conditions indicated for a tissue biopsy of the lung indicated for surgical resection of the lung being followed by CT for nodule growth within a 1-year time frame* subject must receive at least one follow-up CT by their 1-year enrollment anniversary or within 60 days after their 1-year enrollment anniversary to continue in the Study Subject must be able to receive a ProLung Test The following will disqualify a subject from enrollment into this Study Subject has an implanted electronic device in the chest Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis Subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement Subject will have undergone unusually strenuous exercise within 24 hours Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 16.0-999.0, All Hypotension Arterial pressure <100 mm/Hg at presentation At least one of the following symptoms Unresponsive Syncope Impaired mental status Respiratory distress Severe malaise and fatigue Patients undergoing cardiopulmonary resuscitation Trauma patients Electrocardiographic and clinical diagnosis of STEMI or Clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose) Late evolution of shock state in a patient already treated with known diagnostic tests", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 16.0-90.0, All Pneumothorax Radiologic diagnosis of pneumothorax Clinical need to perform a CT scan Ability to perform the lung ultrasound imaging within 20 minutes from the CT study age less than 16 years", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Metastatic Pancreas Cancer Histologically documented metastatic pancreatic adenocarcinoma not previously treated with palliative systemic therapy Metastatic disease based on the presence of clinically and/or radiologically documents Measurable disease base on Adequate tissue (core biopsy) available for IHC testing of hENT1. This may be from primary tumour or metastatic site. Fine needle aspiration biopsies will not be allowed. Histological/cytological confirmation of tissue to ensure sufficient material is available for hENT1 analysis by the Cross Cancer Institute is required prior to starting a patient on study. Biopsies from metastatic sites must be obtained \u2265 3 months after any adjuvant chemotherapy (if applicable). If a patient has had previous surgical resection of their primary tumours, that tissue can be utilized. Tissue sufficient for preparing \u2265 10 unstained slides for central storage and testing is required ECOG performance status of 0 Age \u2265 18 years Life expectancy of at least 3 months based on discretion of treating oncologist Adequate hematologic function defined by the following laboratory parameters Hemoglobin \u2265 100 Platelet count \u2265 100 Absolute granulocyte count \u2265 1.5 Patients who have received prior palliative chemotherapy for their metastatic pancreatic adenocarcinoma Radical pancreatic resections (e.g. Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g. bypass) surgery, or other procedures (e.g. stents) are not allowed < 14 days prior to randomization. In any of the above cases, patients must be adequately recovered and stable prior to randomization Prior treatment with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, prior treatment with irinotecan or oxaliplatin chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy Curative radiation treatment to the pelvis or radiation therapy to \u2265 25% of bone marrow stores Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that may be aggravated by treatment Known dihydropyrimidine dehydrogenase (DPD) deficiency Pre-existing neuropathy \u2265 grade 2 from any cause Patients with unstable metastasis to the central nervous system are excluded. Patients who have treated brain metastasis and are off steroids, anticonvulsants, and have documented stability of lesions for at least 3 months may be eligible. A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Primary Graft Dysfunction All consecutive bilateral lung transplant recipients Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as the investigators would have obtained some ELWI measurements) Contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 20.0-40.0, All Assess the Efficacy of Differentiated and Undifferentiated Stem Cell Therapy in Improving Endometrial Receptivity. ICSI candidates with repeated implantation failure and history of development of good embryos in previous ICSI cycles Advanced maternal age above 38 years Poor endometrial response to ovulation induction drugs Endometrial atrophy Presence of infection in the form of vaginitis, cervicitis or hydrosalpinx Presence of uterine abnormality as uterine septum Presence of any pathology distorting the uterine cavity as submucus polyp or submucus myoma Marked sperm morphology abnormality High FSH > 12 IU", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-999.0, All Pneumonia All patients who present to the ED with respiratory symptoms suspicious for pneumonia In whom the treating physician believes would benefit from diagnostic imaging Patients who arrive at the ED with a previously performed CXR Unstable patients with life-threatening injuries who require ongoing resuscitation", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 40.0-75.0, All Lung Cancer ages 40-75 years If ages 40-59, then one of the following needs to be met Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR current or ex-smoker with > 25 pack years and COPD OR current or ex-smoker with a > 35 pack year history If ages 60-75, then one of the following additional needs to be met Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR Current or ex-smoker with >25 pack years and COPD OR Current or ex-smoker with a >30 pack year history Subject is able to return to Cleveland Clinic for annual follow-up screening Current health requires oxygen Have had a chest x-ray or CT of the chest within the last 6 months Previous pneumonectomy Lobectomy of the lung within the last 5 years Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer A medical condition that would prevent treatment for lung cancer Within the last 6 weeks, one of the following has occured A new cough or chronic cough that has gotten worse Either new shortness of breath, or any worsening of shortness of breath A cough producing blood", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Transitional Cell Carcinoma Written informed consent Age \u2265 18 Life expectancy \u2265 12 weeks Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts Treated patients with incidental prostate cancer (pT2, Gleason \u2264 6) and PSA (Prostate Specific Antigen) \u2264 0.5 ng/mL are eligible Measurable disease as per 1.1 ECOG Performance Status 0-1 Previously received first line platinum based treatment Recurrence within 12 months (by version 1.1) from last cycle of chemotherapy Previous therapy with a taxane Pure non TCC histologies Grade II or more peripheral neuropathy Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) Inadequate organ and bone marrow function as evidenced by Hemoglobin < 9.0 g/dL Absolute neutrophil count < 1.5 x 109/L Platelet count < 100 x 109/L AST/SGOT and/or ALT/SGPT > 2.5 x ULN", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-48.0, All Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery Term healthy parturients Body Mass Index > 35 preeclampsia neurological,cardiovascular, respiratory disease", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 8.0-17.0, All Persons With Frontal Lobe Damage With no Specific Language Disorder frontal lobe damage at least one year after injury native hebrew speaker specific language disorder premorbid learning disability", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 55.0-74.0, All Lung Carcinoma Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or ovary (women only) This includes primary or metastatic PLCO cancers Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only) Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason Individuals who are participating in another cancer screening or cancer primary prevention trial Males who have taken Proscar/Propecia/finasteride in the past 6 months NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 50.0-75.0, All High Risk of Developing Lung Cancer Smokers or former smokers At least 20 pack year history of smoking Ages 50 Had a CT scan of chest within last 24 months History of any cancer within 10 yrs (except skin cancer or cervical cancer) A serious illness that decreases life expectancy to less than 5 years Any current use of Oxygen Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 21.0-999.0, All Lung Cancer All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses Patients with contra-indications to bronchoscopy and CT-TTNA that active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-999.0, All Soft Tissue Sarcoma cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary) ", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Non-small Cell Lung Cancer Metastasis From Other Cancers Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2, N0, M0; or T3, N0, M0 chest wall primary tumors only) patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma\u2026etc) the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size in 4.1.2.1 Patients who have potentially resectable disease should be considered medically inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery is not considered the preferred management option Early stage lung cancer: \u22643 parenchymal lung lesions, Metastatic disease to lungs: \u22645 parenchymal lung lesions Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological evidence of lymph node spread) In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion Adequate lung function to tolerate the planned stereotactic radiation Patients with active systemic, pulmonary or pericardial infection No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma Potential candidate for concurrent chemo-radiation therapy Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer peripheral lung nodules < 3cm in size Surgical candidate Non surgical candidate", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-45.0, All Multiple Sclerosis (MS) Must be between the ages of 18 and 45 years, inclusive Must have a body mass index (BMI) of 19 to 28 kilograms/height (m)2, inclusive, and have a minimum body weight of 50 kilograms (at screening and baseline) Must give written informed consent History of severe allergic or anaphylactic reactions History of hypersensitivity to acetaminophen (paracetamol) or ibuprofen. Subjects in Part III of the study will also be excluded for history of hypersensitivity to human albumin History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease History of asthma, as defined by wheezing, dyspnea, or cough requiring treatment with either inhaled beta-2-agonists, inhaled corticosteroids, inhaled cromolyn sodium, or oral steroids or history of chronic obstructive pulmonary disease (including chronic bronchitis, bronchiectasis, or emphysema) Abnormal screening full pulmonary function tests (PFTs) or baseline spirometry (predicted values are those of the European Coal and Steel Community (Quanjer, 1983)) or abnormal screening or baseline oximetry, as defined by any one of the following <80% predicted Forced expiratory volume (FEV1) <80% predicted forced vital capacity (FVC) <70% FEV1/FVC ratio <80% predicted total lung capacity (TLC) <80% predicted diffusion capacity, corrected for hemoglobin (DLCOcorr)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Metastatic Melanoma At least 18 years of age Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Regional Ethics Board/Independent Ethics Committee (REB/IEC) Histologically documented cutaneous or mucosal malignant melanoma, which is recurrent or metastatic and is not curable by surgical or other means Adequate tumour tissue (greater than 0.5cm3 preferred, 3 X core biopsy acceptable) available and agreement from subjects that this tissue from their primary and/or metastatic tumour be made available for assessment of potential biomarkers Ability and availability to complete all prescribed biomarker studies (Screening and after Cycle 2) Recovered to Grade 1 from reversible toxicities of prior therapy Presence of clinically and/or radiologically documented disease. At least one site of disease (which will not be removed during the course of the study) must be uni-dimensionally measurable as per 1.1 or clinically quantifiable (such as in the case of skin disease) ECOG performance status of 0 Prior treatment with any number of immunotherapies (e.g., IL2, ipilimumab), targeted therapies (e.g., vemurafenib) are permitted but no more than one 1 prior chemotherapy Acceptable liver function Anticancer treatment with radiation therapy, targeted therapies, chemotherapy, immunotherapy, hormones or other antitumour therapies within 28 days prior to first dose of TH-302 Subjects who have received any other investigational drug or agent within 28 days of first dose of TH-302 Current use of drugs with known cardiotoxicity Significant cardiac dysfunction Seizure disorders requiring anticonvulsant therapy Progressing brain metastases (unless previously treated and stable disease for a period of greater than or equal to 3 months on repeat MRI following definitive treatment) History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 2 years Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation less than 90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause hypoxia of normal tissue Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 40.0-999.0, All Emphysema Chronic Obstructive Pulmonary Disease (COPD) Willing and able to provide informed consent and to participate in the study Age > or = 40 years at the time of the screening Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan Minimum of 2 subsegments appropriate for treatment MRCD questionnaire score of 2 or greater at screening Failure of medical therapy to provide relief of symptoms Spirometry 15 minutes after administration of bronchodilator (BOTH) FEV1 < 50 % predicted FEV1/FVC ratio <70 % Lung volumes by plethysmography (BOTH) Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation Requirement for ventilator support (invasive or non-invasive) Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit Pulmonary hypertension, defined as Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg Clinically significant asthma (reversible airway obstruction) or bronchiectasis CT scan: Presence of the following radiologic abnormalities Pulmonary nodule on CT scan greater that 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET) Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Malignant Solid Tumour Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound) Age 18 years or older Life expectancy of at least three months Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation) Eastern Cooperative Oncology Group (ECOG) performance score < 2 Full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing Pregnancy or breastfeeding Active infectious disease Brain metastases requiring therapy Absolute neutrophil count less than 1500 / mm3 Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 \u03bcmol / L, International System of Units (SI unit) equivalent) Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) Serum creatinine greater than 1.5 mg / dl (> 132 \u03bcmol / L, SI unit equivalent) Uncontrolled, severe hypertension", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Malignant Neoplasm of Lung A soft tissue solitary dominant pulmonary nodule of \u2265 8mm and \u226430mm on axial plane Measured on lung window using conventional CT scan No other ancillary evidence strongly indicative of malignancy (e.g. distant metastases or unequivocal local invasion) If clinicians and reporting radiologists believe the patient is being treated as having a single pulmonary nodule and there are other small lesions <4mm that would normally be disregarded, the patient should be included in the trial Nodules already under surveillance can be included provided they have a recent or scheduled FDG-PET/CT18 years of age or over at time of providing consent Able and willing to consent to study Pregnancy History of malignancy within the past 2 years Confirmed aetiology of the nodule at the time of qualifying CT scan As this is a diagnostic study, should the aetiology of the nodule be confirmed by investigation such as FDG-PET/CT or bronchoscopy prior to consent the patient remains eligible as the intention to is made on the analysis of the qualifying CT scan Biopsy of nodule prior to DCE-CT scan Contra-indication to potential radiotherapy or surgery Contra indication to scans (assessed by local procedures)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All PROSTATE CANCER Treatment na\u00efve group Men with no prior diagnosis of prostate cancer undergoing prostate biopsy based on identified lesions on imaging Men with a raised PSA above 15ng/ml Men giving informed consent Treated men Men undergoing tissue biopsy for suspicion of prostate cancer recurrence following previous local or systemic therapy based on identified lesions in multi-parametric MRI, bone-scan, choline PET/CT, or PET/MRI Unable to have MRI scan or CT scan, or in whom artefact would reduce scan quality Unable to have prostate biopsy Unable to undergo biopsy for metastatic evaluation On immunosuppression or predefined immunosuppressed state A coagulopathy predisposing to bleeding Unable to give informed consent", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Solitary Pulmonary Nodule Bronchial Neoplasms age over 18 years Planed thoracoscopic surgery of a pulmonary nodule Informed consent mental incapacity contraindications for this treatment pregnancy", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Squamous Cell Carcinoma of the Anus Histologically or cytologically verified, uni-dimensionally measurable, inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus Age \u226518 years ECOG Performance status \u22642 Measurable disease according to Response Evaluation in Solid Tumours (RECIST) version 1.1 Previous definitive chemoradiotherapy is permitted for early stage squamous cell carcinoma of the anus HIV+ patients will be considered eligible with a CD4 count of \u2265200 Adequate cardiac and respiratory function; absolute neutrophil count (ANC) \u22651.5x10^9/l; white blood cell (WBC) count \u22653x10^9/l; platelets >100x10^9/l; haemoglobin (Hb) \u22659g/dl; creatinine clearance >50ml/minute; serum bilirubin \u22641.5x upper limit of normal (ULN); alanine transaminase (ALT)/aspartate transaminase (AST) \u22642.5x ULN; alkaline phosphatase (ALP) \u22643x ULN Fertile men and women must agree to take adequate contraceptive precautions during, and for at least six months after therapy Life expectancy of at least 3 months Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are excluded Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease Surgery or palliative radiotherapy within 28 days of randomisation Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted) Acute hepatitis C and/or chronic active hepatitis B infection Serious active infection requiring i.v. antibiotics at enrolment", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Acute Respiratory Distress Syndrome (ARDS) intubation and mechanical ventilation in the ICU Ramsay score 6 under sedation and analgesia ICU respirator implemented with pressure-volume curve device age equal to or greater than 18 years ARDS defined from the Berlin absence of pneumothorax on the CXR before the study Absence of pleural effusion greater than 500 ml estimated from ultrasonography no child-bearing woman written inform consent signed by the next of kin Pneumothorax Pleural effusion greater than 500 ml estimated from ultrasonography Thoracic surgery in the last 3 months Contra-indication to CXR contra-indication to PEEP of 15 cm H2O contra-indication to PEEP of 15 or PEEP 15 mandated pressure-volume curve not feasible refusal to participate language barrier of the next of kin child-bearing woman", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Subjects of all races and ethnic origins over 18 years of age will be recruited Patients must have suspicious or known to be malignant solitary pulmonary nodule,5cm or less in size Patients with a contraindication to MRI examinations will be excluded from this study Contraindications to MRI examinations Medically unstable Heart failure Unstable angina Child bearing Lactating Not a surgical candidate Any contraindication per MRI Screening Form (Appendix A attached). This is the same form used in clinical practice at UT Southwestern Titanium implants, pacemakers", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-90.0, All Stroke Upper Extremity Paresis age between 18-90 years old hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 M5 on the paresis scale) as a result of a first stroke sub-acute lesion not more than 6 weeks post ictus insufficient state of consciousness severe aphasia severe cognitive deficits severe pathologies of the upper extremity of traumatic or rheumatic nature severe pain in the affected arm Patients with pacemakers and other active implants", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 21.0-999.0, All Video-assisted Thoracoscopic Surgery (VATS) One-lung Ventilation signed informed consent elective left video-assisted thoracoscopy one lung ventilation Anticipated difficult mask ventilation or intubation tracheal or high bronchial origin of the right upper lobe main bronchus severe COPD or asthma pleural disease previous left thoracic surgery chest radiotherapy chimiotherapy significant systemic co-morbidity active or chronic pulmonary infection fibrosis, other interstitial diseases", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-65.0, All Asthma Bronchial Asthma Males or females age 18 or greater and 65 or less The diagnosis of asthma confirmed by at least one of the following as assessed at least once during the past 5 years before the study Reversibility to \u03b22-agonists \u226512% predicted and \u2265200ml after 400\u03bcg inhaled salbutamol or equivalent Bronchial hyper-responsiveness to methacholine or histamine Peak-flow variability of >20% over a period of 14 days Fall in FEV1 >12% and >200ml when tapering treatment (ICS, oral steroid, LABA and/or LTRA) Subject is taking regular maintenance medication (GINA step 4-5) for past 6 months that includes Inhaled corticosteroid at a dosage \u2265500\u03bcg fluticasone equivalent per day AND Long acting \u00df2-agonist at a dosage of \u2265100\u03bcg per day salmeterol dose aerosol or equivalent) Per protocol bronchial hyper-responsiveness to methacholine (PC20<4 mg/ml) Asthma exacerbation during the prior 4 weeks Subject has 5 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for mechanical or endotracheal intubation for asthma in the previous year Respiratory tract infection within past 4 weeks Subject has a known sensitivity to medications required to perform bronchoscopy Subject is using immunosuppressant therapy other than oral steroid therapy Subject is on anticoagulant medication including anti-platelet agents Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR >1.5) Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis) Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray. Bronchiectasis on HR-CT-of the chest, both centrally or peripherally will be excluded Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke at the discretion of the investigator", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Metastatic Anaplastic/Undifferentiated Thyroid Cancer Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer that demonstrates mutation in the ALK gene as assessed by sequencing of the tumor specimen for Arm A. Other ALK abnormalities as detected by the approved FISH test (Abbott Molecular Inc), using Vysis breakapart probes (defined as 15% or more positive tumor cells); or the Ventana IHC test will also be seen as evidence of ALK abnormality and meeting requirement Patients will not have any other curative therapeutic option, such as radiation or surgery WHO performance status 0-2 Age greater then or equal to 18 years Patients must have recovered from all toxicities related to prior anticancer therapies to \u2264 Grade 2 (CTCAE v 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib. Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment Adequate organ function: the following laboratory have been met Absolute neutrophil count (ANC) greater then or equal to 1.5 x 109/L Hemoglobin (Hgb) \u2265 8 g/dL Platelets greater then or equal to 75 x 109/L Serum total bilirubin \u2264 1.5 x upper limit of normal (ULN), except for patients with Gilbert's syndrome who may be included if total bilirubin \u2264 3.0 x ULN and direct bilirubin \u2264 1.5 x ULN Patients eligible must not meet any of the following Patients with known hypersensitivity to any of the excipients of ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate) Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 1 week prior to study entry to manage CNS symptoms Prior therapy with ceritinib Presence or history of a malignant disease other than thyroid cancer that has been diagnosed and/or required therapy within the past year and is undergoing active anticancer treatment. Exceptions to this the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention) Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as unstable angina within 6 months prior to screening myocardial infarction within 6 months prior to screening history of documented congestive heart failure (New York Heart Association functional classification III-IV)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Melanoma Brain Metastases Cohort 1 and 3 \u226518 years of age Written informed consent AJCC Stage IV (any T, any N, M1c) histologically confirmed melanoma or unknown primary melanoma. Patients must have at least 1 radiological definitive brain metastasis that is \u2265 5mm and \u226440mm measurable per version 1.1 guidelines In patients with prior BRAF inhibitor treatment, intracranial disease progression must be demonstrated (RECIST >20% or new measurable brain metastases) compared with nadir of intracranial response during BRAF inhibitor treatment, and confirmed with a second MRI brain scan after drug washout period (+/\u2010 3 days) No prior localised treatment for brain metastases (eg. surgery or radiotherapy) Neurologically asymptomatic from brain metastases Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\u20102, and life expectancy > 30 days Able to undergo MRI with Gadolinium contrast agent Adequate haematological, hepatic and renal organ function Any melanoma brain metastasis >40mm Ocular melanoma Prior treatment with an anti\u2010PD\u20101 or anti\u2010PD\u2010L1 , anti\u2010PD\u2010L2, anti\u2010CD137, or anti\u2010CTLA\u20104 antibody, or any other antibody or drug specifically targeting T\u2010cell co\u2010stimulation or checkpoint pathways Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll Current systemic treatment with corticosteroids, except prednisone at nonimmunosuppressive doses of \u2264 10 mg/day (or equivalent). Past treatment for non\u2010neurological symptoms allowed, if ceased 2 weeks prior to starting study treatment. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient on a stable dose. Non\u2010absorbed intraarticular steroid injections will be permitted Any investigational drug or other systemic drug therapy for melanoma within 28 days or 5 half\u2010lives from baseline Known to be HIV positive, or a positive test for hepatitis B and C Another malignancy or concurrent malignancy unless disease\u2010free for 3 years Serious or unstable pre\u2010existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance Pregnant or breastfeeding females", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-75.0, All Melanoma Cutaneous melanoma with a tumour thickness of at least 1,00mm Positive sentinel node with micro metastases of max. 2mm in diameter Mucosal or ocular melanoma Cutaneous melanoma located in the head/neck region Evidence of satellite, in transit or local metastases / recurrences Macro metastases of the SN or micro metastases of >2mm in diameter Additional immune-suppressive therapy Pregnant of lactating women", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 0.0-999.0, All Rectal Neoplasms Patients with biopsy-proven confirmed rectal cancer MRI stage: T3/T4 and/or N1/N0 No contraindication to MRI and PET-CT Contraindication to MRI and/or PET-CT Inability to consent Severe claustrophobia Distant metastases Synchronous tumour", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-50.0, All Frontal Lobe Epilepsies (Patients) Age between 18 and 50 Diagnosis of frontal lobe epilepsy Written consent to participate Right-handed Hospital Anxiety and Depression Scale Score under 10 Obsessive Compulsive Inventory Score under 40 Sufficient language skills Social insurance (controls) (Patients) Seizures types other than epileptic (psychogenic etc.) Mental retardation Epilepsies other than FLE Other known neurological diseases Hospital Anxiety and Depression Scale Score over 10 Obsessive Compulsive Inventory Score over 40 Pregnancy non-MRI suitable transplants (cardiac pacemaker etc.), claustrophobia, orthopedic diseases that prevent lying in the scanner During period of other studies", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 40.0-999.0, All Lung Cancer COPD Subjects must meet all of the following Be enrolled in COPDGene\u00ae Phase 1 with or without enrollment in Phase 2 with newly diagnosed, (within the time of enrollment), non-small cell lung cancer (NSCLC) or small-cell lung cancer (SCLC) Documented GOLD stage 1-4 COPD or a history of smoking with no COPD Signed HIPAA Research Authorization and a Release of Protected Health Information form to collect and review medical records regarding lung cancer diagnosis, treatment, and outcome ", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 55.0-74.0, All Lung Carcinoma Solitary Pulmonary Nodule Cigarette Smoker Patients at high risk for lung cancer as defined by the United States Preventive Services Task Force (USPSTF) for lung cancer screening, with a newly discovered indeterminate pulmonary nodules (IPN) (7-30 mm diameter) on CT (newly seen on medical imaging, without prior examinations to demonstrate that the lesion has been stable for two or more years), untreated The patient is aged 55 to 74 years of age, AND Has a 30 or more pack-year history of smoking, AND Currently smokes, or, if the patient has quit smoking, has quit within the last 15 years, or An adult patient with a newly diagnosed, untreated primary lung cancer, with a minimum diameter of 7 mm The patient must be able to give informed consent, which will a layman's explanation of the estimated amount of additional radiation that the patient will receive from the investigational PET/CT scan using 18F-FSPG Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-human chorionic gonadotropin (HCG) pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans Patients with a body weight of 400 pounds or more or a body habitus or disability that will not permit the imaging protocol to be performed The patient's inability to lie still for the entire imaging time (such as due to cough, severe arthritis), as assessed upon pre-enrollment screening, will not be enrolled A recognized active lung infection Previous systemic or radiation treatment for cancer of any type within 2 years Refusal to undergo a clinically indicated biopsy or a 24-month period of follow-up, if needed, to resolve the etiology of their IPN (benign versus cancer) Non-oncologic co-morbidities suggesting a life span of less than two years if not treated, as determined by the potential subjects' treating physician", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Pulmonary nodule on a recent CT non-visible on standard-size bronchoscopy missing informed consent", "label": "1"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 40.0-999.0, All Lung Diseases, Interstitial Lung Cancer equal to above 40 years old ", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Rectal Neoplasms Adenocarcinoma of the rectum classified clinically T2, T3a, T3b (penetration in the mesorectal fat between 1 to 5 mm) by TNM classification (Tumour Node Metastase), < 5 cm largest diameter, < half rectal circumference (by MRI staging), N0-N1 (any node < 8 mm diameter on MRI), M0 Operable patient Tumour accessible to endocavitary contact X-Ray Brachytherapy with a distance from the lower tumour border to the anal verge \u2264 10cm 18 years or above No comorbidity preventing treatment Adequate birth control Patient having read the information note and having signed the informed consent Health care insurance available Follow-up possible Inoperable patient T1, T3cd, T4, T\u2265 5cm, T\u2265 \u00bd circumference Patient N2 at diagnosis or N1 with any node > 8 mm diameter Patient presenting metastasis at diagnosis Previous pelvic irradiation Tumour with extramural vascular invasion Simultaneous progressive cancer Tumour invading external anal sphincter and within 1 mm, and the levator muscle Patient unable to receive CXB or CRT Tumour with poor differentiation (G3)", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 55.0-75.0, All Lung Cancer relatives of the lung cancer patients age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation proved lung cancer either with or without treatment presence of hemoptysis or history of remarkable lung fibrosis any other cancer history or chest CT examination within one year", "label": "2"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 18.0-999.0, All Prostatic Neoplasms Able to provide informed consent ECOG performance status 0-1 Histologic confirmation of prostate adenocarcinoma Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes \u2264 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases) All sites of disease are amenable to stereotactic radiotherapy Castrate resistant prostate cancer Evidence of spinal cord compression Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy) Inability to safely treat all sites of visible disease Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer", "label": "0"} +{"topic": "A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.", "doc": "eligible ages (years): 21.0-999.0, All Solitary Pulmonary Nodule Coin Lesion, Pulmonary Lung Neoplasms Carcinoma, Non-small-cell Lung The target population includes adults with small lung nodules that may represent a new diagnosis of lung cancer, who typically would be managed by CT surveillance in usual clinical practice. Thus, we will enroll all adult patients aged \u226521 years at least one nodule measuring \u226415 mm in widest axial diameter on chest CT Pregnant Women Children Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years Multiple (>10) nodules on chest CT scan", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 45.0-74.0, All Cardiovascular Diseases Heart Diseases Atherosclerosis Asthma Carotid Artery Diseases Coronary Disease Hypercholesterolemia Hypertension Diabetes Mellitus Obesity ", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 0.0-999.0, All Atherosclerosis Coronary Disease Arterial Occlusive Diseases Peripheral Vascular Diseases Cardiovascular Diseases ", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Peripheral Vascular Diseases Atherosclerosis Cerebrovascular Disorders Myocardial Infarction Heart Diseases Hyperhomocysteinemia ", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Mellitus, Type 2 Intermittent Claudication Group I (n=25 PAD patients). This sample will represent the population of veterans with PAD with mild mobility impairment secondary to intermittent claudication in the gastrocsoleus muscles for PAD Subjects diagnosis of PAD (acute or chronic occlusive arterial disease), with or without diabetes mellitus positive Edinburgh Claudication Questionnaire Fontaine stage IIa only (mild claudication, walking distance > 200 feet (one-half block) ambulatory, without assistive devices calf muscle claudication within 10 minutes of treadmill walking and calf muscle exercise Group II (n=25 normal control/reference subjects). This reference sample will represent the population of adults without PAD and related problems. They will undergo the PET-exercise testing for perfusion and glucose metabolism measurements, but will not perform the exercise training intervention for Controls healthy adults, matched by age and sex to PAD subjects for PAD and Control Subjects PAD secondary to Buerger's disease, autoimmune arteritis, fibromuscular dysplasia, chronic and repetitive occupational trauma, venous stasis, hypercoagulability disorder, or arterial embolic disease inability to perform ankle dorsi and plantar flexion exercise cigarette smoking within last 6 months severe claudication, leg rest pain, skin ulceration, necrosis or gangrene (Fontaine stage >= IIa) poorly controlled diabetes mellitus (bA1c >= 9%) poorly controlled hypertension (resting BP > 140/90 mmHg) Raynaud's syndrome changes in prescribed cardiovascular medications within the past 6 months exertional angina, dyspnea, fatigue, or dizziness", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 50.0-75.0, All Hypertension Postmenopausal women Mild to moderate hypertension Statin therapy or LDL\u2264 4.1 mmol/L Severe hypertension LDL > 4.1 mmol/L if not taking anti-hyperlipidemic medication Certain hormonal therapy History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease Diabetes Raynaud's disease or any other significant peripheral vascular disease Allergy to certain medications used to treat high blood pressure Other protocol-defined inclusion/", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-90.0, All Peripheral Vascular Diseases Receive stable peritoneal dialysis patients for more than 3 months Active infection, malignancy and recent hospitalization", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension 18 years of age Patients with stage II systolic hypertension If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg) History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter Laboratory test values considered clinically significant by the investigator Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal Pregnant or lactating females Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-70.0, All Tachycardia Chronic Orthostatic Intolerance Chronic symptoms (> 6 months) with standing upright Obvious cause of hypovolemia or drugs that could worsen tachycardia Chronic severe medical conditions such as cancer or ischemic heart disease", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-80.0, All Venous Insufficiency Diabetes Diabetic ulcer, OR Venous insufficiency ulcer Age range: 18-80 years Wound max. diameter range: 1.5 centimeters Wound San Antonio assessment system: grade 1 and 2, stage A and B Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries Ankle-Brachial Index > 0.7 by Doppler Wound present for at least 6 weeks Wound location: foot or calf, at a location where the device can be attached properly Lack of purulent discharge from the wound Hypoalbuminemia: Albumin < 2gr/dl Right-side congestive heart failure with edema of legs: +2 or higher Renal insufficiency: Cr > 2 mg/dl Abnormal liver function: ALT or AST>300 Skin disorders adjacent to the wound, unrelated to the pathology of the wound Non-cooperative patient", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 21.0-999.0, All Peripheral Artery Disease Severe Intermittent Claudication Males or females equal to or greater than 21 years old Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb persisting for at least 6 months (Rutherford Class 3) Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening Patients with iliac disease amenable to revascularization Patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6 Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 16.0-999.0, All Diabetes Mellitus Hypertension Dyslipidemia Obesity Cardiovascular Disease Coronary Artery Disease Age 16 years or more Informed consent Living in selected community (Health Promotion area of Rajavithi Hospital) ", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Vascular Disease Written informed consent Age > 18 years If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study Patient is willing and able to comply with the specified follow-up evaluation Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss) Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length \u2264 60 mm Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment Acute limb ischaemia Subacute limb ischaemia which requires thrombolysis as first treatment modality Active bleeding or bleeding diathesis Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure Previous implanted stent at the index site Life expectancy of less than 6 months or other factors making clinical follow-up difficult Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease Peripheral Vascular Disease Patient \u2265 18 years old Coronary or peripheral vascular intervention 6 French arterial sheath used Overnight hospitalization following procedure Hematoma or persistent bleeding around the vascular sheath Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery History of bleeding diathesis or coagulopathy Hemoglobin level < 9 g/dl Inability to ambulate at baseline Known allergy to any of the materials used in the SafeSeal Female patients known to be pregnant or lactating Evidence of ongoing systemic or cutaneous infection Uncontrolled blood pressure following PCI (systolic blood pressure > 180 or diastolic blood pressure >110) Current enrolment in another ongoing investigational drug/device trial", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-85.0, All Lower Extremity Chronic Venous Ulcers Patient must have a venous leg ulcer Participants, either men or women are between 18 and 85 years of age Clinical presentation of venous insufficiency demonstrated by Doppler Ankle-Brachial Index > 0.7 by Doppler Good palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries Wound present for at least 6 weeks prior to enrolment Wound length is in the range of: 1.5 centimeters The necrotic tissue area is at least 20% of wound area. (by clinical evaluation, i.e., inspection) Wound San Antonio classification: Grade 1 or 2, Stage A or B Documented sensitivity to Papain, by medical history records Patients in need of surgical debridement Patients with general skin disorders (Psoriasis, Peniculitis ect) that might deteriorate as a result of local trauma Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound Pain sensation is completely absent (wound area is anesthetic) Patients with renal failure. (Cr > 2 mg/dl) Patients with impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit value) Patients having Hypoalbuminemia: (Albumin < 2gr/dl ) Patients with general Immunological disorders that might deteriorate as a result of local trauma Right-side congestive heart failure (CHF) with edema of legs: (NYHA class 2 or higher see 5)", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 50.0-80.0, All Cardiovascular Disease Hypertension Hyperlipidemia Heart Disease All men over 50 to 80 and all women 55 to 80 who are resident in Kalaleh, Golestan, for at least one year Existing cardiovascular disease (stroke, transient ischaemic attack, myocardial infarction or angina) Already taking antihypertensive drugs, aspirin or statins Already have clinical indications for treatment with antihypertensive drugs, aspirin or statins Blood pressure >160/100 mm Hg Total Cholesterol > 240 mg/dL (or LDL >190 mg/dL) Probable diabetes: HbA1c >6.0 Contraindication to a component of the Polypill Contraindications to aspirin Previous history of allergy to aspirin History of peptic ulcer bleeding in whole life or endoscopic evidence of peptic ulcer within the past 3 months", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 19.0-999.0, All Critical Limb Ischemia Severe Leg Ischemia Peripheral Artery Disease Peripheral Vascular Disease Males or females older than 18 years of age Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers Claudication Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia Inability to provide informed consent Previous angiogenic therapy Known sensitivity to gentamycin and/or amphotericin B Use or expected use of antineoplastic drugs Any illness, which might affect the patient's survival after enrollment in the protocol Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results No evidence of acute infection WBC > 15000 WBC < 4000 Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis", "label": "2"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 40.0-999.0, All Intermittent Claudication Aged 40 or older, male or female mo. history of walking limitation or symptoms of intermittent claudication (IC) in at least 1 lower limb, severity of which has not changed in the past 3 mo. and diagnosed by principal investigator as clinically stable Fontaine Stage II peripheral artery disease (PAD) Diagnosis of PAD secondary to atherosclerosis If ankle-brachial index (ABI) is > 1.3 or cannot be measured in either leg, vascular etiology documented by toe-brachial index (TBI) \u2264 0.7 in at least 1 leg Claudication severity, meds. for the treatment of coronary artery disease (CAD), PAD and IC, and exercise habits should be clinically stable for 3 mo. prior to Screening (SCRN) and during study. Pt. is not likely to change smoking and/or exercise habits during study On an exercise treadmill test (ETT), peak walking time (PWT) of at least 1 min., but no more than 12 min. at Baseline Willing and able to discontinue Pletal or Trental for 21 days before SCRN and during study Antihypertensive therapy, cholesterol-lowering therapy, chronic oral nitrates, and diabetic therapy have been stable for 30 days prior to SCRN Willing and able to provide written, signed, informed consent after the nature of the study has been explained and prior to any research-related procedures Willing and able to comply with all study-related procedures Pregnant or lactating Current or history of critical limb ischemia (CLI) Pts. in whom artery insufficiency in the lower extremity is the result of acute limb ischemia (ALI) or an immunological or inflammatory non-atherosclerotic disorder Pts. in whom walking impairment due to pain is the result of other non-atherosclerotic co-morbid conditions A surgical intervention to alleviate symptoms of IC or PAD-specific endovascular intervention or cardiovascular surgery within 3 mo. of SCRN Walking limited by reasons other than claudication Conditions other than IC of significant severity that could confound PWT on the ETT Concurrent severe congestive heart failure (CHF) Life-threatening ventricular arrhythmias, unstable angina, and/or myocardial infarction (MI) within 3 mo. before enrollment (ENRL) Coronary artery bypass grafting or percutaneous coronary intervention within 4 mo. before ENRL", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed Men or women 18 years and older of African American background; self identified Patients with stage 2 hypertension. Patients must have a MSSBP \u2265 160 mmHg and < 200 mmHg at Visit 5 (randomization) Office blood pressure measured by cuff (MSSBP \u2265 200 mmHg and/or MSDBP \u2265 110 mmHg) at any visit Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (CCBs or thiazide diuretics) as the study drugs Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method Adequate barrier methods of contraception diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment History or evidence of a secondary form of hypertension", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 39.0-70.0, All Lower Extremity Ischemia an obliterating lower extremity atherosclerosis IIB a stage (on Fontaine classification) a painless walking distance of 10-50 m pulse absence on \u0430\u0430. dorsalis pedis, tibialis posterior, poplitea absence of a ischemia in a rest and necrotic changes mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously heavy smokers insulin depended diabetes myocardial infarction or a stroke within last year an idiopathic hypertensia III stage anaemia and other diseases of blood decompensation of the chronic diseases which are contraindications to any surgical operation HIV infection a virus hepatitis oncologic diseases chemotherapy in the anamnesis", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-90.0, All Peripheral Arterial Disease Male or female subject 18 to 90 years, of any race Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI \u2264 0.9 in one leg) Subject with stable (>3 month) PAD Fontaine Stage II Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (<30 days) clinical examination Subject has intermittent claudication and claudication pain of the calf Subject has stable intermittent claudication (>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade) Subject willing to participate as evidenced by signing the written informed consent Treatment with Aspirin or Clopidogrel for at least 7 days Willingness to undergo standardized walking exercise Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms Inability to walk Chronic respiratory insufficiency (severe obstructive or restrictive) Coronary artery disease with angina Stroke, myocardial infarction or other acute vascular events in the last 3 months Mild-Severe congestive heart failure Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking Spinal stenosis or disc lesions with lower limb motor sensory defects Leg trauma, limb or skin infection or edema Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 50.0-85.0, All Chronic Limb Ischemia Non-Healing Ulcers Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization Age group between 50-85 Gender Male or Female Race all race and ethnicities Patients with known cardiac disease new MI (within 3 months) Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing Patients on supplemental O2 for chronic obstructive lung disease Bed-ridden subjects either due to chronic disability or neurological problems", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 40.0-999.0, All Peripheral Arterial Disease Subjects with peripheral arterial disease for more than 6 months Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease Over 40 years old Able to comply with protocol requirements Able to provide informed consent Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study Patients with ischemic rest pain in limbs, ulceration, or gangrene At baseline, any condition that prevents walking on a treadmill History of major bleeding Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis) Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures) Moderate to severe renal failure Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study Fish limitations (no more than 2 fish meals per week) Gluten allergy Subjects with allergies to any ingredient in the study product or placebo", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Arterial Disease Claudication Critical Limb Ischemia Has a Rutherford Clinical Category Score of 1 Has evidence of \u2265 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion Each discrete target lesion's length is \u2264 20 cm Reference vessel diameter is \u2265 1.5 mm and \u2264 7 mm Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure Has had a previous peripheral bypass affecting the target limb Has end-stage renal disease defined as undergoing hemodialysis for kidney failure Has presence of severe calcification in target lesion(s) Has in-stent restenosis of the target lesion Has an aneurysmal target vessel Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s)", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 0.0-0.019, All Cerebral Oxygenation Cerebral Blood Flow Prematurity Preterm infant (Gestational Age <37+0) Peripheral arterial catheter (ulnary or radial artery) Complex organ malformation", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 30.0-999.0, All Peripheral Arterial Disease Peripheral arterial disease post surgery > 1 month No discharge of surgical incision Intermittent claudication post invasive treatment Necrosis Above/below knee amputee Other conditions might affect peripheral vascular elasticity", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Essential Hypertension Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg on Day, or has not received antihypertensive treatment within 14 days prior to Screening and has a mean sitting clinic systolic blood pressure greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on Day 1 Females of childbearing potential who are sexually active agree to routinely use adequate contraception, and can neither be pregnant nor lactating from before study participation to Screening to 30 days after the last study drug dose Has clinical laboratory test results within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant Is willing to discontinue current antihypertensive medications up to 3 weeks before enrollment Has a mean clinic diastolic blood pressure (sitting, trough) greater than 119 mm Hg on Day 1 Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome) Has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack Has clinically significant cardiac conduction defects (ie, third-degree atrioventricular block, sick sinus syndrome) Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease Has severe renal dysfunction or disease Has known or suspected unilateral or bilateral renal artery stenosis Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug Has poorly-controlled type 1 or 2 diabetes mellitus at Screening Has hypokalemia or hyperkalemia at Screening", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-75.0, All Painful Diabetic Neuropathy Age \u2265 18 years to 75 years Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of \u2264 10.0%) Diagnosis of painful diabetic peripheral neuropathy in both lower extremities The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is \u2265 3 at Screening Visual analog scale (VAS) score of \u2265 4 cm at Screening (0 cm = no pain cm worst imaginable pain) Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes Lower extremity pain for at least 6 months If female of childbearing potential, negative pregnancy test at screening and using acceptable method of birth control during the study Peripheral neuropathy caused by condition other than diabetes Other pain more severe than neuropathic pain Progressive or degenerative neurological disorder Myopathy Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) Active infection Chronic inflammatory disease (e.g. Crohn's, Rheumatoid Arthritis) Positive HIV or HTLV at Screening Positive Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAB), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV), at Screening or known immunosuppression or on chronic treatment with immunosuppressive drugs, chemotherapy or radiation therapy Stroke or myocardial infarction within last 6 months", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-72.0, All Critical Limb Ischemia Atherosclerotic ischemic peripheral vascular disease or Thromboangiitis Obliterans with Critical Limb Ischemia (Fontaine stages III and IV) Participant must match either a or b Ankle brachial index (ABI) \u2264 0.7 Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure < 30 mmHg A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi segment disease, or extensive infra-popliteal disease not amenable to a vascular graft Age > 18 years old The non-index leg may be treated only in the event and it full fills the same and used in this protocol for the treatment leg Patients must be on maximal tolerated medical therapy for PVD including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to < 7.0 mg/dl, control of hyperlipidemia with statins or other anti-hyperlipidemic drugs as indicated, control of hypertension as indicated C) Antiplatelet therapy with aspirin and / or cilostazol (unless medically contraindicated, e.g. bleeding or allergy) Popliteal vascular entrapment syndrome Lower extremity infection or infected ulcer Hypercoagulable state HIV positive HBsAg positive Uncontrolled arrhythmia, that is, persistence of an arrhythmia despite medical therapy Unstable angina Thrombocytopenia < 50,000/ul", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Arterial Disease patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound) over 18 years old patients had previously undergone revascularization patients were receiving treatment with statins patients with contraindications to statin use patients with coexistence of chronic inflammatory diseases or steroidal medication", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Vascular Diseases Documented acute coronary syndrome (Unstable angina, non-Q-wave myocardial infarction, Q-wave myocardial infarction) or/and documented ischemic stroke/transient ischemic attack (IS/TIA) Previously known symptomatic or asymptomatic PAD confirmed by one of the following diagnostic methods or interventions (documented in the patient's medical record) Non-invasive or invasive vascular diagnostic tools (e.g.: ABI, Toe-brachial index, Duplex ultrasound, Magnetic resonance angiography, Computer tomographic angiography, Contrast angiography) Previous related intervention (such as angioplasty, stenting, atherectomy, peripheral arterial bypass graft, other vascular intervention including amputation) Patients whose ABI cannot be measured accurately Patients already in a clinical trial or a product registry Hospitalized patients", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 20.0-30.0, All Ischemic Preconditioning healthy volunteers aging 20-30 years old no cardiac\uff0chepatic or renal\uff0cperipheral vascular diseases be willing to enter our study and sign an written informed consent younger than 20 years old or older than 30 years old having cardiac\uff0chepatic or renal\uff0cperipheral vascular diseases refuse to enter our study or sign an written informed consent", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 40.0-999.0, All Peripheral Arterial Disease Criteria:Healthy age-matched participants (acute phase of the study) Healthy volunteers, male or female, > 40 years of age Body Mass Index 18-30 Glycated hemoglobin <6.5% Fasting serum total cholesterol <4 mmol/L and triglycerides <2.5 mmol/L Blood pressure <140/90 mm Hg Ankle-brachial index of >0.9 Willing to comply with the protocol requirements Willing to provide informed consent Participants having completed another food-related study are eligible to participate if it has been more than 3 months since their participation healthy age-matched participants (acute phase of the study) Currently smoking, or smoking within the last 6 months (Note: cigar smoking on an occasional basis will be permitted) Presence of a clinically diagnosed disease affecting the heart, liver, kidneys, lungs,gastrointestinal, endocrine or blood/immune systems that requires medical treatment Taking any prescribed medication within the last 3 months with the exception of anti-depressants, birth control and hormone (estrogen) replacement therapy Pregnancy Amputation of upper or lower extremity on both sides Has undergone a surgical procedure requiring local or general anesthetic within the last 3 months History of gastrointestinal reactions or allergies to dietary oils and other ingredients in banana bread such as wheat and eggs Daily consumption of omega-3 supplements Peripheral arterial disease participants (acute and chronic phases of the study)", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 0.0-999.0, All Kidney Diseases Kidney Failure, Chronic Kidney Failure Renal Insufficiency Renal Insufficiency, Chronic Urologic Diseases Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation Living donors Compatible ABO blood type PRA < 20% Re-transplant patients Those with peripheral vascular disease affecting the lower limbs", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Cardiovascular Diseases Cardiovascular Risk Factor African American adults > 18 years old ", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Essential hypertensive patient no less than 18 yeas old Patient who gave informed consent form Patient was diagnosed as secondary hypertension Patient who have white-coat hypertension", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-75.0, All Hyperlipidemia Coronary Artery Disease Written informed consent Men or women, aged 18 -75 Diagnosed with coronary heart disease (CHD) stable angina for more than 1 month and meet the following any one History of myocardial infarction CHD confirmed by coronary angiography Excercise ECG positive for CHD or perfusion defect One or more main branch of coronary artery stenosis \u2265 50% confirmed by CT scanning Hyperlipidemia (lipid-lowering treatment na\u00efve: LDL-C \u2265130mg/dl, or having received lipid-lowering treatment: LDL-C \u2265100mg/dl) The 64 slice CT shows at least one significant coronary artery stenosis \u226520% with the narrowest \u226460% and meeting the following Diameter of coronary artery lesion \u22652mm, length \u22655mm; distance between multiple lesions \uff1e1cm Acute myocardial infarction within 6 months PCI or CABG therapy within 6 months Anticipated PCI or CABG therapy in the following 3 months Tropnin I/Tropnin T higher than ULN Cardiac failure NYHA III or above Coronary artery left main stenosis >50% Emergency coronary angiography(CAG) is needed Serious arrhythmia or tachycardia Secondary hyperlipidemia Familial hypercholestrolemia", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-85.0, All Sepsis Severe Sepsis All adult patients (>18 years) admitted to the intensive care with 1) hemodynamic instability due to severe sepsis, and 2) a mean arterial pressure < 65 mmHg and 3) an arterial lactate concentration > 3.0 mmol/L will be considered for participation moribund severe coagulation disorder (contraindication for central venous catheter placement) severe peripheral vascular disease (interfering with peripheral perfusion measurement)", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 60.0-85.0, All Peripheral Vascular Diseases male or female 85 years femoro-popliteal stenosis TASC B or C category HBA1c <9%, if diabetic creatinine <130\u00b5g/ml blood pressure <160/95mmHg thrombocyte aggregation inhibitors or coumarine derivatives <60 or >85 years stenosis not in femoro-popliteal axis TASC A or D category HBA1c >9%, if diabetic creatinine >130\u00b5g/ml blood pressure >160/95mmHg major trauma malignancy anti-phospholipid syndrome relevant hepatic disease", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Drug Safety The subject is over 18 years old Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period The subject is pregnant or lactating The subject is taking metformin (e.g., Glucophage\u00ae) but is not willing or unable to discontinue at the time of the study procedure The subject manifests thyrotoxicosis or is on dialysis", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-75.0, All Painful Diabetic Neuropathies Age \u2265 18 years to \u2264 75 years Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of \u2264 10.0% at Screening) and currently on oral medication and/or insulin Diagnosis of painful diabetic peripheral neuropathy in both lower extremities Lower extremity pain for at least 6 months Visual analog scale (VAS) score of \u2265 40 mm at Initial Screening (0 mm = no pain mm very severe pain) Symptoms from the Brief Pain Neuropathy Screening (BPNS) is \u2264 5 point difference between legs at Initial Screening The average daily pain intensity score of the Daily Pain and Sleep Interference Diary completed after medication wash-out is \u2265 4 with a standard deviation \u2264 2 The physical examination component of the Michigan Neuropathy Screening Instrument Score (MNSI) is \u2265 3 at Screening Stable treatment of diabetes for at least 3 months with no anticipated changes in medication regimen, and no new symptoms associated with diabetes Peripheral neuropathy caused by condition other than diabetes Other pain more severe than neuropathic pain Progressive or degenerative neurological disorder Myopathy Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) Active infection Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis) Positive HIV or HTLV at Screening Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAB), antibody to Hepatitis B antigen (IgG and IgM; HbsAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at Screening Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Artery Disease Hypertension Men and non-pregnant, non-lactating women 45 years of age or older Able to give informed consent and complete scheduled visits Mild-moderate bilateral lower extremity peripheral arterial disease as defined by an ankle-brachial index (ABI measurement of 0.6-0.9. If a subject has baseline claudication symptoms, the symptoms must be stable for the 3 months preceding enrollment History of hypertension. Blood pressure at the screening visit must be \u2264160/100 mmHg and \u2265100/60 mmHg for all subjects. If a subject is currently prescribed beta-blocker therapy, BP at the screening visit must be \u2264140/90 mmHg. In addition, heart rate must be \u226555 beats per minute if currently prescribed a beta-blocker and \u226460 beats per minute if not currently prescribed a beta-blocker At least moderate risk for CAD Participation in another clinical trial Ongoing ischemic (resting) limb pain, or lower extremity ulceration due to arterial insufficiency, or an ABI indicating <0.6 indicating disease potentially requiring revascularization History of limb or digit amputation due to arterial insufficiency Revascularization of peripheral vessels within the preceding 6 months Uncontrolled hypertension as defined by systolic blood pressure \u2265160 mmHg or diastolic blood pressure \u2265100 mmHg Contraindication or allergy to beta blocker therapy History of myocardial infarction , coronary revascularization, or a cerebrovascular event within the preceding 6 months Class III or IV angina Current or past history of New York Heart Association (NYHA) class III or IV heart failure Inability to walk on a treadmill for any reason", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Lower Limb Ischaemia Aneurysm need for lower limb vascular by-pass surgery allergic to cefuroxime patients refusal to participate", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Blood Lactate Analysis Adult patients 18 years or older Admitted to the Intensive Care Unit (ICU) Determined by their treating clinicians to require both a central venous line and arterial line ", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease Coronary Sinus Circulation, Collateral Ischemia Collateral Flow Index Age > 17 years Stable angina pectoris, patient electively referred for coronary angiography Written informed consent to participate in the study Acute coronary syndrome; unstable cardio-pulmonary conditions Congestive heart failure NYHA III-IV Previous coronary bypass surgery Q-wave myocardial infarction in the area undergoing CFI measurement Anatomical variants not allowing coronary sinus occlusion Severe valvular heart disease Severe hepatic or renal failure (creatinine clearance < 15ml/min) Pregnancy", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Abdominal Aortic Aneurysm Carotid Atherosclerosis Critical Lower Limb Ischaemia Age greater than 18 years patient willing to give full informed consent for participation Patients undergoing elective carotid endarterectomy or Patients undergoing open abdominal aortic aneurysm repair or Patients undergoing endovascular abdominal aneurysm repair or Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) Patients less than 18 years of age Patients who are unable or unwilling to give full informed consent Pregnancy Significant upper limb peripheral arterial disease Patients on glibenclamide or nicorandil (these medications may interfere with remote ischaemic preconditioning) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with a history of myocarditis, pericarditis or amyloidosis Patients undergoing Fenestrated or branched EVAR", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Bypass Complications Disorder of Blood Gas age > 18 years old undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass without informed consent pregnancy", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 17.0-999.0, All Contrast Induced Nephropathy Remote Ischaemic Preconditioning Hospital inpatients undergoing contrast enhanced abdomino-pelvic CT scanning Those with an allergy/hypersensitivity to the contrast solution Those with a Cr of above 150\u03bcmol/dL on admission, as is a contraindication to IV contrast Patients who are not getting IV contrast Any patients with a history of renal transplantation Any patients with a history of previous acute kidney injury necessitating management by a nephrologist Patients taking either a sulphonlurea or nicorandil", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Apnea Register to the social health insurance Referred for a walk test because of claudication Maximal walking ditance < 750m Older than 18 years old Able to understand the protocol of the study Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months Severe reparatory disease already known Parkinson disease, h\u00e9mipl\u00e9gia ou parapl\u00e9gia Does not want to participate to the protocol Pregnant women Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research Being in a period of from another biomedical study", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 50.0-999.0, All Osteoarthritis Cardiovascular Risk Factors Cardiovascular Disease Metabolic Syndrome Patients referred for symptomatic hand or knee osteoarthritis All patients referred in the same period for soft tissue disease > 50 years old Any other rheumatologic condition secondary osteoarthritis", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 0.0-999.0, All Peripheral Arterial Disease a positive history of chronic claudication exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon an ankle/brachial index < 0.90 at rest absence of Peripheral Arterial Disease (PAD) acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma exercise capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 20.0-75.0, All High Risk Cardiovascular Disease Patients high risk hypertension patients a. eGFR > 60 with one of target organ damages b. eGFR <= 60 diabetes mellitus with microalbumin ration (AC ratio >= 30mg/g) anuric ESRD patients on dialysis the relatives of acute myocardial infarction patients under 55 years old (men)/ 65 years old (women) acute myocardial infarction, acute coronary syndrome patients, symptomatic coronary artery disease or history of these diseases symptomatic peripheral artery disease, heart failure and history of these diseases desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis) women with pregnancy or on nursing history of contrast allergy and related side effects", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Arterial Disease Critical Limb Ischemia Intermittent Claudication All adults > 18 years old willing to be randomized Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications Acute thromboembolic disease in the leg Infrainguinal aneurysmal disease Previous participation in the study or in other randomised interventional study of infrainguinal lesions Patients without a Swedish personal identification number", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-65.0, All Hypertension The final selection of the sample of 80 patients diagnosed with stage I arterial hypertension will be based on the ABPM results (24h SBP/DBP \u2265 130/80 mm Hg) Patients who present with normal ABPM values at the end of the 3-month period will be excluded from the study. Subjects diagnosed with white-coat hypertension [increased office BP values (SBP/DBP \u2265 140/90 mm Hg) combined with normal ABPM values (24h SBP/DBP < 130/80 mm Hg)] will also be excluded from the study All subjects with contra-indications for submission of drugs used in the research protocol are going to be excluded from the study. The following categories of patients will not participate in the research: renal failure, hepatic failure, renal artery stenosis, bronchial asthma, vasoconstrictive (Prinzmetal's) angina, hypertrophic cardiomyopathy, aortic valve stenosis, mitral valve stenosis, sinus tachycardia, sinus bradycardia, sick sinus syndrome, Wolff-Parkinson-White syndrome, chronic atrial fibrillation, second and third degree atrioventricular block, right heart failure due to pulmonary hypertension, pheochromocytoma, peripheral artery disease. Pregnant and nursing women will be excluded from the study (history and pregnancy test)", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Abdominal Aortic Aneurysm Carotid Atherosclerosis Critical Lower Limb Ischaemia Age greater than 18 years Patient willing to give full informed consent for participation Patients undergoing elective carotid endarterectomy or Patients undergoing open abdominal aortic aneurysm repair or Patients undergoing endovascular abdominal aneurysm repair or Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) Pregnancy Significant upper limb peripheral arterial disease Previous history of upper limb deep vein thrombosis Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with a known history of myocarditis, pericarditis or amyloidosis Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with severe hepatic disease defined as an international normalised ratio >2 in the absence of systemic anticoagulation Patients with severe respiratory disease (for the trial, defined as patients requiring home oxygen therapy) Patients previously enrolled in the trial representing for a further procedure Patients with previous axillary surgery", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 0.0-999.0, All Peripheral Arterial Disease, Rutherford Stage 4 and 5 With the Possibility to Improve Vascularization. Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention Patients with both legs are affected, but the most severe leg does not exceed stage 5 Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh Patients with limited amputation of the toes can participate Insufficient understanding of the Dutch language No physiotherapy insurance", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-80.0, All ST-Segment Elevation Myocardial Infarction Male or non-pregnant female Age \u2265 18 years old and \uff1c80 years old Consecutive patients who should be hospitalized with documented evidence of ST-Segment Elevation Myocardial Infarction receiving Percutaneous Coronary Intervention All patients havepersistent\u22650.2 Millivolt ST segment elevation in two or more contiguous precordial leads or \u22650.1 Millivolt ST elevation in two or more contiguous limb leads, with one of the following: persistent chest pain or elevatory of biomarkers of myocardial necrosis Time from chest pain onset to receiving Percutaneous Coronary Intervention <12 hours Persistent chest pain <12 hours Provision of informed consent prior to any study specific procedures Involved in other trials In recent one year have P 2 Y 12 receptor antagonist drug treatment history or long-term use of immunosuppressive agents Recurrent myocardial infarction or previous history of Coronary Artery Bypass Graft(CABG) surgery or rescue Percutaneous Coronary Intervention Active bleeding or bleeding history With obvious infection and body temperature (axillary temperature) higher than 38.0 \u2103 Autoimmune diseases Malignancies In recent 6 months have received major surgery Left ventricular ejection fraction is less than 30% Life expectancy less than one year", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-75.0, All Dilated Cardiomyopathy established diagnosis of non-ischemic dilated cardiomyopathy EF < 35% NYHA f.c. II Optimal medical management > 6 months Age < 75 years and > 18 years known hypersensitivity to the medication age > 75 years or < 18 years EF > 35% renal insufficiency (GF < 30) liver dysfunction (liver tests > 3x the upper normal limit)) LQT syndrome drugs that affect CYP3A4 metabolism (azoles, macrolides, calcineurin inhibitors etc.) dementia active hemathological or malignant disease", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-90.0, All Peripheral Arterial Disease General Signed informed consent At least 18 years old Documented symptomatic iliac, femoropopliteal (FP) or below-the knee artery (BTK) atherosclerotic disease (Rutherford/Becker category 2, 3 or \u22654) Undergone clinically indicated uncomplicated endovascular intervention to one or more locations of the iliac, femoropopliteal below-the knee arteries Estimated survival \u22651 year in the judgment of the primary operator Pre-index procedure use of ASA, clopidogrel or both at any dose Angiographic De novo or restenotic lesions in the common and/or external iliac artery, superficial femoral artery (SFA), popliteal artery, tibio-peroneal (TP) trunk, anterior tibial (AT) artery, peroneal artery (PA) or posterior tibial (PT) artery (applies to all target lesions if multiple) Subjects with multiple planned procedures can be enrolled after the completion of the last planned procedure.- General Complicated qualifying procedure (perforation, flow limiting dissection, distal embolization requiring re-intervention, need for repeat endovascular, surgical revascularization, amputation or blood transfusion prior to hospital discharge following an index procedure Extended hospital stay >7 days following the index procedure Allergy to aspirin or clopidogrel MI or percutaneous coronary intervention with drug eluting stents within the past 9 months Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated Intolerance to antiplatelet, anticoagulant, or thrombolytic medications Platelet count <90,000 mm3 or >600,000 mm3 Serum creatinine >2.5 mg/dL", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 0.0-999.0, All Peripheral Arterial Disease (PAD) Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries ", "label": "2"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Arterial Diseases Known moderate PVD New claudication patient with Rutherford stage 2 and Fontaine stage 2a symptoms Known upper limb PVD Severe cardiac condition Risk classification for exercise training: class C and above Severe respiratory condition Previous history of upper limb deep vein thrombosis Patients on glibenclamide or nicorandil May affect RIPC Raynaud's Disease Contra indications for MRA Pregnancy", "label": "2"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Vascular Diseases Patients planned for lower limb Angioplasty Known upper limb PVD Previous history of upper limb deep vein thrombosis Patients on glibenclamide or nicorandil May affect RIPC Raynaud's Disease Intra operative decision to use graft will be documented", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-75.0, All Painful Diabetic Neuropathy Diabetic Neuropathy, Painful Age \u2265 18 years to 75 years Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of \u2264 10.0% at Screening) and currently on oral medication and / or insulin No significant changes anticipated in diabetes medication regimen No new symptoms associated with diabetes within the last 3 months prior to study entry Diagnosis of painful diabetic peripheral neuropathy in both lower extremities Lower extremity pain for at least 6 months Visual analog scale (VAS) score of \u2265 40 mm at Initial Screening (0 mm = no pain mm very severe pain) Symptoms from the Brief Pain Neuropathy Screening (BPNS) is \u2264 5 point difference between legs at Initial Screening The average daily pain intensity score of the Daily Pain and Sleep Interference Diary completed after medication wash-out is \u2265 4 with a standard deviation \u2264 2 Peripheral neuropathy caused by condition other than diabetes Other pain more severe than neuropathic pain that would prevent assessment of DPN Progressive or degenerative neurological disorder Myopathy Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) Active infection Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis) Positive HIV or HTLV at Screening Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAb), antibody to Hepatitis B surface antigen (IgG and IgM; HBsAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at Screening Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 50.0-999.0, All Myocardial Ischemia Surgery written informed consent intermedial and high risk non cardiac surgery general anesthesia ongoing or recently suspended antiplatelet therapy pregnancy planned locoregional anesthesia without general anesthesia unstable or ongoing angina recent (< 1 month) or ongoing acute myocardial infarction in other randomised controlled studies in the previous 30 days peripheral vascular disease affecting the upper limbs cardiac surgery", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Arterial Disease Venous Insufficiency Patient suffering from a PAD (systolic pressure index \u2265 0,60 and \u2264 0,75) and having moderate venous insufficiency or classified as C1s to C4 using the CEAP classification Age over 18 years French health insurance Signed informed consent Hypertension not controlled or hypertensive crisis (risk of non reproducibility of SPI and TBI) Diabetes Mediacalcosis (SPI not computable) Inflammatory arterial diseases of the lower limb Permanent edema, lipedema and lymphedema Wound and fragile skin Phlegmatia coerulea dolens Septic thrombophlebitis Severe coronary artery disease Oozing and infectious skin diseases, skin ulcers", "label": "1"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Congenital Heart Disease Male or Female over 18 years of age Moderate or Complex Congenital Heart Disease Willingness to Consent Pregnancy Surgery within 6 months Unrepaired cyanotic heart disease Patients with Eisenmenger Syndrome physiology", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 18.0-999.0, All Intermittent Claudication Peripheral Vascular Disease All ethnic groups, male or female above the age of 18 years Diagnosis of mild intermittent claudication Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device Blood pressure currently under moderate control (< 160/100mmHg) No current foot ulceration Patients meeting any of the following are to be excluded Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol Has diabetes Ankle Brachial Pressure Index > 0.9 Has any metal implants Pregnant Has a cardiac pacemaker or defibrillator device Has recent lower limb injury or lower back pain Has current foot ulceration or other skin ulcers Has foot deformities", "label": "0"} +{"topic": "A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis.", "doc": "eligible ages (years): 21.0-999.0, All Remote Ischaemic Preconditioning Contrast Induced Nephropathy Elective intra-arterial peripheral angiography/angioplasty Patients >21 years of age Patients with CKD as evidenced by eGFR levels of 30ml/min < eGFR < 60ml/min (moderate risk) or eGFR levels of >= 60ml/min (low risk) Severe renal impairment eGFR <30ml/min Evidence of acute renal failure or patients on dialysis History of previous CIN Contraindication to volume replacement therapy Pregnancy Patients on glibenclamide or nicorandil (these medications may interfere with RIPC)", "label": "1"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 4.0-12.0, All Obsessive-Compulsive Disorder OCD Participants (N = 72) Aged 4-12 years and living within a four-hour commute from NIH Currently meet DSM-IV for OCD Recent onset of symptoms (less than 6 months.) Healthy Controls (N = 60-72) Age and sex matched to ODC participants Must be free of current or past psychopathology OCD Participants Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever Significant or unstable medical illness Full scale IQ less than 80 Healthy Controls Full scale IQ less than 80 Significant or unstable medical illness", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.0-999.0, All Coronary Arteriosclerosis Adults older than 21 years Coronary artery disease established by angiography No myocardial infarction within 1 month Left ventricular ejection fraction greater than 30% No congestive heart failure symptoms within 2 months No medical condition that might prohibit safe participation in cardiac rehabilitation Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography Angina pectoris that is prolonged in duration (greater than 20 minutes), or does not respond to nitroglycerin (2 tablets) Subject physically unable to perform cardiac rehabilitation protocol due to neurologic or orthopedic conditions Hypersensitivity to organic nitrates Women of childbearing age unless recent pregnancy test is negative Lactating women Known hypersensitivity to dipyridamole or to gadolinium if patient eligible for MRI study", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.5-12.0, All Pharyngitis Give informed consent, assent, and documentation of patient authorization for disclosure of study results Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian Age > = 6 months -12 years A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following Tonsillar or pharyngeal exudate Tender cervical lymph nodes Fever or history of fever treated with antipyretics Odynophagia Uvular edema Pharyngeal Erythema of moderate or greater intensity Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology The need for hospitalization or I.V. antimicrobial therapy Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials Patients who are known carriers of S. pyogenes Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also Any rapidly progressive underlying disease with a shortened life expectancy The inability to swallow the study dosage form Unable to understand the requirements of the study Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 4.0-16.0, All Kawasaki Disease Males or females between 4 and 16 Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician Be able to exercise adequately to achieve 85% age predicted maximum heart rate Terminal illness where expected survival is < 6 months", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 5.0-16.0, All Learning Disorders Child Behavior Disorders DSM-IV Axis II diagnosis of mental retardation behavioural and family therapy tried for 6 months but has failed in school, at least part time score of >=8 on hostility scale subject is otherwise healthy Patients with a seizure disorder requiring repeated change of medication extrapyramidal symptoms not well controlled by medication abnormal and clinically significant electrocardiogram (ECG) changes history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs), or neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state) known hypersensitivity to antipsychotic medications, including risperidone", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.0-18.0, All Kawasaki Disease To be eligible for the trial, subjects must meet all of the following All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure Eligible subjects will be infants and children, under 18 years old, with acute KD who remain or become febrile (>/= 38.3\u02da C or 101.0\u02da F) after the end of the 48 h-period after completing their IVIG infusion (2gm/kg) Patients must have persistent or reoccurrence of fever > 48 hours of observation to be eligible for the trial Prior to the initial IVIG treatment, patients must have been febrile for >/= 3 days and have met 4/5 standard clinical (Table 1) patients with fever and 3/5 clinical will be eligible if echocardiogram demonstrates at least one coronary artery segment with a Z score of > 2 Patients must present for their initial diagnosis and IVIG treatment within the first 14 days after fever onset (Illness Day 14) Females of childbearing potential and males must be using adequate contraception (abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the trial All eligible subjects must have a chest radiograph within one week prior to first infusion of study drug with no evidence of malignancy, infection or fibrosis If a subject has any of the following he or she may not be enrolled in the study Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone equivalent daily Have history of TB or TB exposure Have history of histoplasmosis or coccidiomycosis Have received anakinra (Kineret\u00ae), etanercept (Enbrel\u00ae), or adalimumab (Humira\u00ae) within 1 month prior to first study drug administration Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder Have documented history of current active hepatitis B or a history of hepatitis C infection Have documented history of human immunodeficiency virus (HIV) infection Have received a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first study drug administration) Have a known malignancy or history of malignancy within the 5-year period prior to first study drug administration (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence)", "label": "2"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 8.0-25.0, All Kawasaki Disease History of Kawasaki disease more than 12 months before enrollment Present age of 8 years or older Diabetes mellitus Not controlled hypertension Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers Smokers of more than 5 cigarettes per day Total cholesterol higher than 250 mg/dl Triglycerides higher than 300mg/dl Chronic treatment with statins Chronic renal insufficiency (creatinine > 1.5 mg/dl)", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.0-90.0, All Burn Ages 0-90 years Any patient admitted to the hospital with burn injury requiring grafting and a donor site Patient with severe burn injuries expected to die", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 18.0-50.0, All Allergic Rhinitis Ability to understand and provide informed consent Male or Female (non-pregnant), age 18-50 Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using a medically acceptable form of birth control throughout the duration of the study Clinical history of seasonal or perennial allergic rhinitis for at least two years, with or without mild persistent asthma Positive puncture skin test greater than or equal to 5 mm diluent control Positive CAP-RAST to Fel d 1 > 0.35 kU/L Positive intranasal cat allergen challenge as defined by > 5 sneezes or a tripling of measured nasal lavage mediators In vitro assay of basophil responsiveness to cat allergen with greater than 20% histamine release The use of antihistamines, cromolyns, leukotriene modifiers and other non-steroid (astelin and topical decongestants), nasal medications will be allowed, but they will be withheld for 5 days prior to each nasal allergen provocation session. Inhaled corticosteroids for mild asthma will be permissible No known contraindications to therapy with omalizumab Asthma with FEV1 < 80%, moderate to severe asthma classification per NAEP Standards (1997 National Asthma Education and Prevention Program Expert Panel Report II guidelines) Serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment will be excluded Unexplained elevation of ESR, hematocrit < 32%, WBC count 2400/microliter lower limit of normal, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or AST > 100 IU/L Body weight less than 30 kg or greater than 150 kg will be excluded Plans to become pregnant or breastfeed will be excluded from the study A perforated nasal septum, structural nasal defect, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis A life expectancy less than 6 months A terminal illness as determined by the investigator A history of malignancy, anaphylaxis or bleeding disorder are also illnesses Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 2.0-12.0, All Tonsillitis Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae (\"strawberry tongue\"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) and in accordance with local guidelines Patients eligible to anti-TNF therapy Patients na\u00efve to anti-TNFa drugs Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method [Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form Patients with tumors Patients already included in clinical trials", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.167-20.0, All Mucocutaneous Lymph Node Syndrome Kawasaki Disease Male Age 2 months to 20 years of age Female Age 2 months to 11 years of age Provision of Parental Consent Kawasaki Disease Presentation Laboratory Any laboratory toxicity, at the time of the screening visit or at any time during the study that in the opinion of the Investigator would preclude participation in the study or Platelet count < 100,000/mm3 WBC count < 3,000 cells/mm3 Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the Lab Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit Female subjects diagnosed with KD 12 years of age and older Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept Prior or concurrent cyclophosphamide therapy Prior treatment with any TNF alpha antagonist or steroid within 48 hours prior to initiation of IVIG Concurrent sulfasalazine therapy", "label": "2"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.0-999.0, All Hypertension Hypertensive patients who have never taken Micombi Tablets ", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 50.0-999.0, All Hypercholesterolemia Type 2 Diabetes Hypertension Patients meeting the following will be included in the study Patients giving voluntary written consent to participate in the study Male or female patients 50 years of age or older (at informed consent) Hypercholesterolemia patients (Untreated patients: LDL-C level \u2265140 mg/dL; treated patients: LDL-C level \u2265120 mg/dL) Type 2 diabetes patients (HbA1c level \u22656.1% (JDS criteria), with or without history of drug therapy) Hypertension patients (SBP \u2265130 mmHg or DBP \u226580 mmHg, with or without history of drug therapy) Patients with two or more of the following risk factors Male years of age or older Smoker Patients meeting the following will be excluded from the study Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent Patients judged to have familial hypercholesterolemia Patients with a serum triglyceride level of \u2265400 mg/dL Patients with a history of myocardial infarction Patients with a history of coronary revascularization (PCI or CABG) Patients with a history of treatment of unstable angina Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction) Heart failure patients Patients with a history of hypersensitivity to statins", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 18.0-999.0, All Psoriatic Arthritis Males or females, aged \u2265 18 years at time of consent Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of \u2265 6 months duration Meet the Classification for Psoriatic Arthritis (CASPAR) for PsA at time of screening Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs) May not have axial involvement alone Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine Have \u2265 3 swollen AND \u2265 3 tender joints Males & Females must use contraception Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed Have at least one \u22652 cm psoriasis lesion Pregnant or breast feeding History of allergy to any component of the investigational product Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.5-11.0, All Rhinitis Perennial Aged 6 months through 11 years Patients with perennial allergic rhinitis Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4 Patients with vasomotor rhinitis or eosinophilic rhinitis", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 4.0-13.0, All Obsessive-Complusive Disorder Children Anxiety Disorder Autoimmune Disease PANDAS Male and female children 4-13 years of age Presence of (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) DSM-IV TR OCD with or without a tic disorder Moderate or greater severity of symptoms, with a score of greater than or equal to 20 on the Children s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and greater than or equal to 4 on the Clinical Global Impression Severity scale (CGI-S) The acute onset within the previous six months of symptoms in a child previously well, or the first acute recurrence within the previous six months, after a period of relatively complete remission of symptoms. The acuity of symptom onset/exacerbation is key and must be severe, dramatic in onset, and proceed from no/minimal symptoms to maximum severity within 24-48 hours Symptom onset or first exacerbation preceded within four months by a GAS infection, as documented by positive throat culture, exposure to documented GAS infection (in a close contact, such as a sibling sharing a bedroom), and/or documented two-fold rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB, anti-carbohydrate antibodies and others Onset/exacerbation of OCD is accompanied by at least three of the following 7 clinical signs and symptoms. The acuity of the comorbid symptoms must be similar to the OCD symptoms and occur in the same time interval Markedly increased level of anxiety, particularly new onset of separation anxiety Emotional lability, irritability, aggressive behavior and/or personality change Sudden difficulties with concentration or learning Developmental regression (\"baby-talk,\" temper tantrums; behaviors atypical for actual chronological age) History of rheumatic fever, including Sydenham chorea (the neurologic manifestation) Presence of symptoms consistent with autism, schizophrenia, or other psychotic disorder (unless psychotic symptoms have onset coincident with the possible and are attributed to OCD) Presence of a neurological disorder other than a tic disorder IQ < 70. Child subjects need to be able to contribute meaningfully to baseline and follow-up ratings, to report adverse effects, and to assent to participation Presence of serious or unstable medical illness or psychiatric or behavioral symptoms that would make participation unsafe or study procedures too difficult to tolerate IgA deficiency (< 20mg/dL). Intravenous immunoglobulin may contain trace IgA, which may very rarely lead to life-threatening anaphylaxis in IgA-deficient participants with anti-IgA antibodies (Misbah 1993) Hyperviscosity syndromes, which can increase risks associated with IVIG administration Need for live virus vaccine within six months after receiving IVIG (which may be 7.5 months from randomization) since IVIG can interfere with effectiveness of such vaccines. IVIG should not be administered sooner than two weeks after administration of a live virus vaccine, for the same reason Taking nephrotoxic drugs. Every concomitant medication will be subject to scrutiny and possible consultation with pediatric safety monitors before randomization to study drug. See below as well Recent (less than eight weeks) initiation of cognitive-behavior therapy (CBT)", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 18.0-999.0, All Psoriatic Arthritis Subjects must satisfy the following to be enrolled in the study Male or female, aged \u2265 18 years at time of consent Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted Able to adhere to the study visit schedule and other protocol requirements Have a documented diagnosis of Psoriatic Arthritis (PsA, by any criteria) of \u2265 3 months duration Meet the Classification for Psoriatic Arthritis (CASPAR) for PsA at time of screening Have \u2265 3 swollen AND \u2265 3 tender joints Have not been previously treated with disease-modifying antirheumatic drugs (DMARDS) (small molecules or biologics) Be receiving treatment on an outpatient basis If taking oral corticosteroids, must be on a stable dose of prednisone \u2264 10 mg/day or equivalent for at least 1 month prior to screening History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Clinically significant abnormality on 12-lead electrocardiography (ECG) at Screening Pregnant or breast feeding History of allergy to any component of the IP Hepatitis B surface antigen positive at screening Hepatitis C antibody positive at screening AST/SGOT and/or ALT/SGPT > 1.5 x ULN and total bilirubin > ULN or albumin < lower limit of normal (LLN) History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease) Active tuberculosis or a history of incompletely treated tuberculosis", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 20.0-80.0, All Gastric Cancer Age 20~80 Informed consent No other malignancies Proximal gastric cancer met by following conditions Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to proper muscle depth (cT2) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. (cN1) If patients is only suitable to total gastrectomy, he will be excluded", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 18.0-65.0, All Kawasaki Disease History of KD before the age of 18, with or without macroscopic coronary lesions in the childhood phase. (KD group only) years old or older at the time of the study Agree on participating to all explorations of the study Accept genotyping Absence of cardiovascular risk factors Atypical KD (KD group only) Documented or suspected coronary ischemia Refusal to participate to the study or sign the consent Contra-indication to the injection of iodinated contrast agents (allergy, renal failure) Hypersensitivity to dobutamine No effective contraception method for females with child bearing potential Breastfeeding, or pregnant females Treatment modifying endothelial reactivity History of severe intolerance to iodinated contrast agents Subjects who can't hold their breath for at least 20 seconds", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 3.0-999.0, All Strep Throat Male and Female subjects three (3) years of age or older Patients exhibiting at least 3 of the following symptoms fever sore throat swollen lymph nodes in the neck redness of the throat and tonsils white or yellow patches on the tonsils Must be able to collect 2 throat swab samples from patient Patients currently undergoing antibiotic treatment will be excluded from study", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 3.0-999.0, All Group A Streptococcus Strep Throat Presence of sore throat Redness of the posterior pharyngeal wall Tonsillar exudate Tonsillar swelling Tender anterior cervical adenopathy Fever, > 38\u00ba C (100.4\u00baF) at presentation or within past 24 hours Other symptoms that may be present, in addition to above symptoms for GAS Rash, typical of scarlet fever Abnormal tympanic membranes Palatal petechiae Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 1.0-10.0, All Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight) Patients with a fever of 37.5\u00baC or higher axillary temperature at the time of enrollment Patients to whom the study drug can be administered by day 8 of disease Patients who have received vaccination with Bacille Calmette-Gu\u00e9rin (BCG) vaccine within 6 months before the enrollment Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B Patients confirmed to have HIV infection, or patients with a family history of HIV infection Patients who have a history of receiving treatment with infliximab or other biological products Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent", "label": "2"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.083-18.0, All Kawasaki Disease Coronary Aneurysm Treatment arm: Patients aged 1 month to 18 years with confirmed KD will be included in the study if they meet the following Patients with dilation of the right or left anterior descending coronary artery beyond a z-score of +3 during the acute febrile phase of KD Patients with aneurysms of the right or left main coronary arteries during the acute febrile phase of KD Patients with refractory KD after initial treatment with IVIG and dilated coronary arteries on an echocardiogram during the first month of KD Comparison arm: Patients aged 1 month to 18 years with confirmed KD, who do not meet to be included in the treatment group Patients with right or left anterior descending coronary artery measurements below a z-score of +3 during the acute febrile phase of KD The following patients will be excluded from this study Patients with clinically incomplete KD Patients whose parents refuse to administer doxycycline Patients with acute renal failure Patients with chronic liver and kidney disease", "label": "1"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.0-16.0, All Drug Hypersensitivity Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy)", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 19.0-999.0, All Immune Thrombocytopenia Given written informed consent Male or female aged \u2265 19 Primary immune thrombocytopenia (ITP) Platelet <20x10^9 /L Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study Patients who have participate in other interventional study within 30 days Inability in written/verbal communication Engaged with an elective surgery Pregnant or breast-feeding women Women of childbearing potential who do not agree with contraception during this study Patients who had experienced any hypersensitivity or shock with study drug or active ingredient Refractory to immunoglobulin therapy Secondary immune thrombocytopenia HIV-associated ITP Lupus-associated ITP", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 18.0-50.0, All Healthy Volunteers Male or female of any race 50 years old, inclusive Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia) Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening) Meets specific demographic requirements for the monitoring device under study Willing and able to provide written informed consent Able to participate for the duration of the evaluation A room-air baseline % modulation < 1.5% on all four fingers on the test hand Under 18 years or over 50 years of age Pregnant and/or lactating women Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute History of seizures (except childhood febrile seizures) or epilepsy History of unexplained syncope Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of anxiety disorder Recent history of frequent migraine headaches: average of two or more per month over the last year Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.0-18.0, All Kawasaki Disease The 5th revised edition of diagnostic for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002, was adopted. Cases were included in the study if the patients had at least five of the following six clinical manifestations or at least four signs together with coronary abnormalities documented by echocardiography or coronary angiography fever persisting 5 days or longer (inclusive of those cases in whom the fever has subsided before the 5th day in response to therapy) bilateral conjunctival congestion changes of lips and oral cavity, such as reddening of lips, strawberry tongue, diffuse congestion of oral and pharyngeal mucosa polymorphous exanthema changes of peripheral extremities, such as reddening of palms and soles, indurative edema at initial stage, or membranous desquamation from fingertips at convalescent stage acute nonpurulent cervical lymphadenopathy. In addition, the cases of incomplete KD, diagnosed with referring to the guidelines for incomplete KD made by American Academy of Pediatrics (AAP) and American Heart Association (AHA) in 2004, were also included in this investigation The cases were not in accordance with the recruited", "label": "2"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.667-18.0, All Kawasaki Disease Children Patients, male and female, at any age \u2265 8 months (10kg) of life, with KD according to the American Heart Association definition for complete or incomplete KD. fever \u2265 5 days and \u2265 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter. In the presence of less than 4 clinical and 5 days of fever, the diagnosis of disease KD is proposed in case of coronary abnormalities (at least one dilated coronary artery with internal diameter \u2265 2,5 SD from the mean normalized for body surface area (Z score) as determined by echocardiography. For indicative purpose, in case of incomplete KD, other biological supportive for incomplete KD can help to ensure the diagnosis: leucocytosis, elevated CRP, elevated ESR, anaemia, hyponatremia, elevated ASAT, ALAT and gGT, hyperlipidaemia Patients who failed to respond to standard therapy of KD:, e.g. Persistence or recrudescence of fever \u2265 38\u00b0C, 48 hours after the infusion of 2g/kg of IV Ig Weight \u226510Kg Patient, parent or legal guardian's written informed consent is required Patient with health insurance Patient agrees to have effective contraception for the duration of participation in the research Preterm and neonates, pregnancy Patients suspected with another diagnosis Patients with overt concomitant bacterial infection Patients previously treated with another biotherapy Patients with any type of immunodeficiency or cancer Patients with increased risk of TB infection Recent tuberculosis infection or with active TB Close contact with a patient with TB Patients recently arrived less than 3 months from a country with high prevalence of TB A chest radiograph suggestive of TB", "label": "1"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.083-12.0, All Kawasaki Disease Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002 the patients aged from 1 months to 12 years old All included patients required to sign an informed consent form the patients didn't receive treatment before The patients with the application of hormone or other immunosuppressive agents The patients didn't want to signed informed consent", "label": "2"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 18.0-999.0, All Cirrhosis Coagulopathy Patients 18 and older, admitted to the hospital Patients who have clinically documented cirrhosis Patients who are coagulopathic (INR > 1.5 and/or platelets < 50,000) Patients undergoing an endoscopic procedure or neurosurgical procedure Patients must not be pregnant Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis) Patients must not have an active infection (per PI discretion) Patients must not have any known hemostatic disorder", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 35.0-60.0, All Cardiovascular Disease Men and women 35-60 years of age BMI \u2265 25 and \u2264 36 kg/m^2 LDL-C > 116 mg/dL Total Cholesterol below 240 mg/dL Triglycerides below 350 mg/d Non-smokers At least one of the following Systolic blood pressure 120-159 mmHg Diastolic blood pressure 80-99 mmHg History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided) History of diabetes mellitus (and/or a fasting glucose > 126 mg/dL at screening) Stage II hypertension (blood pressure \u2265 160/100 mmHg) Lactation, pregnancy, or desire to become pregnant during the study Unwillingness to discontinue nutritional supplements, herbs, or vitamins, unless approved by investigator Use of medications/supplements for elevated lipids, blood pressure, or glucose Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication Conditions requiring the use of steroids Unwillingness to refrain from blood donation prior to and during the study Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator", "label": "0"} +{"topic": "A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm.", "doc": "eligible ages (years): 0.0-18.0, All Blistering Distal Dactylitis Children 0-18 years Distal blistering dactylitis collected or not collected Positive rapid Group A Streptococcus test Informed consent signed by the parents Subungual or pulp Whitlow Children not affiliated to the social security scheme Refusal by the parents to participate in the study", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-75.0, All Lung Diseases Pulmonary Embolism Men and women suspected of having a pulmonary embolism and who met the to undergo angiography ", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Veno-occlusive Disease Histologically or cytologically proven breast, lung, colorectal, or prostate cancer that has failed prior chemotherapy or hormone therapy No active CNS metastases Hormone receptor status: Not specified Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3500/mm3 Platelet count at least 150,000/mm3 Fibrinogen above lower limits of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Prothrombin time no greater than 1.5 times ULN Active partial thromboplastin time no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No history of heparin associated thrombocytopenia At least 1 year since prior thromboembolic phenomenon such as deep venous thrombosis, pulmonary embolus, or clotted catheter No prior intolerance of unfractionated or low molecular weight heparin PRIOR No concurrent anticoagulation therapy No concurrent enrollment on systemic or radiation therapy study (therapy off study allowed) ", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Lung Diseases Pulmonary Embolism Venous Thromboembolism ", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 35.0-999.0, All Arthroplasty Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side) Patients who have given written informed consent to participate in this study Patients with a contraindication to contrast venography Patients with an increased risk of bleeding Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia Other or to be determined by the physician and study sponsor", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Small Cell Lung Cancer Written informed consent (patient's written understanding of and agreement to participate in this study) Patients with confirmed extensive small cell lung cancer (SCLC) No prior chemotherapy within 5 years of the diagnosis of SCLC Presence of either measurable or non-measurable SCLC by X-ray or physical examination At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient) At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting Laboratory Patients must have adequate bone marrow reserve and adequate kidney and liver function Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids Any active infection Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC Use of an investigational drug within 30 days before the first dose of study medication Women who are pregnant or lactating Patients of child-bearing potential who refuse to practice an adequate form of birth control Patients with clinical evidence of any stomach or intestinal (GI) condition Patients requiring treatment with the drug cyclosporin A", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-85.0, All Pulmonary Hypertension Cancer Lung Disease Cardiothoracic Surgery Ages 18 to 85 years old Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's) PHTN documented by Doppler Echocardiography ( Done with in last 30 days) Must be able to give an informed consent Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90) Active infection or sepsis as defined by fever and need for IV antibiotics Creatinine greater than 3.0 mg/dl Significant valvular disease as a cause for the PHTN Severe Thrombocytopenia (as defined by platelets less than 20,000 or INR > 1.6 Left Ventricle Ejection Fraction (LVEF) <40% (must be done with in the last 30 days prior to signing consent) Hypersensitivity to nesiritide or any of it's components", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-85.0, All Heart Failure Cardiovascular Disease Acute Heart Failure Diastolic Heart Failure Congestive Heart Failure Heart Disease The patient population recruited for this study will patients being admitted for acute congestive heart failure. Eligible patients those who have near normal LV systolic function Age 18 to 85 years old Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR LVEF > or = 40% on recent (< or = 1 month) echo or MUGA NYHA class III or IV on admission Baseline systolic blood pressure > 90 mm Hg Baseline BNP level > 100 pg/ml Able to sign informed consent and return for follow-up assessments Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90 mm Hg) Active infection/sepsis as defined by fever > 101.5 F, currently on IV antibiotics Creatinine greater than 3.0 mg/dl LV ejection fraction < 40% (must be done within the last 30 days prior to signing consent) Significant valvular disease or constrictive cardiomyopathy Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR > 1.6 Hypersensitivity to nesiritide or any of its components Pulmonary capillary wedge pressure (PCWP) <16 mmHg If patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis Adult man or woman, aged \u226518 years, presenting with suspected lower-limb initial or recurrent DVT Moderate or high pre-test probability (PTP) for DVT Onset of symptoms occurred within the last 7 days Women of childbearing potential to have a negative pregnancy test as determined by measuring serum \u03b2-hCG levels at time of study enrolment Receiving anticoagulant therapy at therapeutic doses for >3 days Life expectancy <3 months Patient with a renal transplant Renal dysfunction: serum creatinine >1.5x upper limit of normal range Hepatic dysfunction: serum transaminases >3x upper limit of normal range Current pregnancy or lactation; or conception intended within 90 days of enrolment Of childbearing potential and unwilling to use adequate contraception for 30 days following enrolment Unable to undergo lower limb ascending venography on symptomatic leg(s) Allergy or other contraindication to intravenous contrast dye Prior exposure to murine or humanized antibodies", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Renal Insufficiency Adult patient aged > 18 years Admitted to an ICU with an expected ICU length of stay > 72 hours Severe renal insufficiency, defined by a calculated CrCl < 30 mL/min/1.73m2 ICU admission for > 2 weeks at time of screening ICU admission within 3 months of cardiac surgery or neurosurgery Active bleeding or at high risk for bleeding complications Thrombocytopenia (platelet count < 75 x 10^9/L) at time of screening Coagulopathy (International Normalized Ratio [INR] or activated partial thromboplastin time [aPTT] > 2 times upper limit of normal) at time of screening Patient had an indwelling epidural catheter for epidural analgesia within the last 12 hours Receipt of > 2 doses of LMWH (prophylactic or therapeutic-dose) in the ICU Receiving or requiring therapeutic-dose anticoagulation (eg., deep vein thrombosis [DVT]) at time of screening Receiving dialysis that requires anticoagulation (eg., slow continuous ultrafiltration [SCUF]) at time of screening", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 40.0-999.0, All Heart Failure, Congestive We plan to all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Deep Venous Thrombosis Presenting signs and symptoms sufficiently suspicious for lower extremity DVT to warrant a formal radiology study in the opinion of the treating physician AND 2a. Moderate or high pre-test clinical probability of DVT (Wells Criteria) OR 2b. Low pre-test clinical probability of DVT with a positive D-dimer Documented lower extremity DVT within the past 60 days Anatomic abnormality that, in the judgment of the investigator, would preclude imaging of both femoral and popliteal veins on the affected leg (i.e. above-knee amputation or severe scarring from intravenous drug abuse in the inguinal area) Patient below the age of 18 years", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Critically Ill Deep Venous Thrombosis Admission to ICU Men and women greater than 18 years of age or older Expected to remain in ICU admission greater than 72 hours Contraindications to LMWH or blood products Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times ULN Renal insufficiency as defined by a creatinine clearance <30ml/min A need for oral or intravenous or subcutaneous therapeutic anticoagulation Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT) Receipt of >2 doses of UFH or LMWH in ICU Pregnant or lactating", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Heparin-Induced Thrombocytopenia trauma-surgical patient consent given minimum age 18 expected inpatient period at least 7 days need for thrombosis prophylaxis with heparin intolerance of one of the study drugs malignancy with life expectancy < 3 months pregnancy/lactation drug or alcohol abuse fibrinolytic therapy need for extracorporal circulation (e.g. cardiopulm. bypass, hemodialysis) at study entry participation in another clinical trial within 30 days prior to intended", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Thrombosis Patients admitted to General Medicine Services with a primary or secondary diagnosis related to venous thromboembolism Non-General Medicine Services patients", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Diabetes Mellitus, Type 2 Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months BMI <= 45.0 kg/m2 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 70.0-999.0, All Deep Vein Thrombosis Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (PE)) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hous prior to randomisation) Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention End stage renal disease patients requiring dialysis Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer) Patients with a platelet count < 100 x 10 9/L Patients with a known history of heparin-induced thrombocytopenia Patients with known severe hepatic insufficiency manifested as international normalized ratio (INR) greater than or equal to 1.5", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 16.0-999.0, All Adult Respiratory Distress Syndrome Pulmonary Hypertension After obtaining informed consent the following patients will be included All patients admitted to the ICU with pulmonary hypertension (mean PA > 35 mmHg) All patients in ICU with post operative pulmonary HTN (mean PA > 35 mm Hg) All patients with ARDS (PaO2/FiO2 < 200 arterial hypoxemia, bilateral infiltrates on Chest X-ray infiltrates on CXR and a wedge < 20 mm Hg on swan ganz parameters) or signs of heart failure Patients to be excluded will be those with Pulmonary embolus Cor pulmonale Ejection fraction of < 30%, wedge > 20 mm Hg Non-intubated patients Pediatric patients (< 16 yrs of age)", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Breast Neoplasms Carcinoma, Ductal Adenocarcinoma Patient must be 18 and older Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast Patients must have undergone a segmental mastectomy (SM) or Mastectomy Patients must not have received prior radiation therapy to the breast at any time for any reason Any patient with active local-regional disease prior to registration is not eligible Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines Patients requiring oxygen Sarcoma or Squamous Cell pathology Right-sided breast cancers Metastatic disease to the breast", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Deep Venous Thrombosis Patients who are scheduled for elective Cardiac or Thoracic Surgery Age > 18 years of age Patients with a clinical suspicion or a documented history of DVT/PE Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively) Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively Documented allergy to heparin, desirudin, or lepirudin Patients with a history of coagulation disorder Platelet count< 100 X109 /dl Active bleeding Serum Creatinine \u2265 1.5 mg/dl or CrCl \u2264 30 ml/min Patients with a baseline coagulopathy (INR > 1.5 or aPTT > 45 sec) Patients with liver disease", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease Established clinical history of moderate to severe COPD Post bronchodilator FEV1 of < 50% of predicted normal FEV1 / FVC ratio <70% Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1 Free from exacerbation in the 6 weeks prior to screening Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations Current asthma, eczema, atopic dermatitis and/or allergic rhinitis Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study Has undergone lung transplantation and/or lung volume reduction Female who is a nursing mother Requires regular (daily) long-term oxygen therapy (LTOT) Is receiving beta-blockers (except eye drops) Has a serious, uncontrolled disease likely to interfere with the study Has received any other investigational drugs within the 4 weeks prior to Visit 1 Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis Pulmonary Embolism Deep Vein Thrombosis With Pulmonary Embolism Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate DVT/PE severe enough to require thrombolysis or pulmonary embolectomy DVT/PE in the preceding 3 years Neoplasia diagnosed/treated within previous 3 years Pregnancy Known major thrombophilias Prolonged or continuous immobility or confinement to bed Previous allergy to heparin or warfarin Requirement for long-term anticoagulation Inability to give informed consent", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Phase I Experienced or is scheduled for at least one of the following Hip or knee replacement surgery Hip or acetabular fracture surgery Pelvic fracture Decompression for spinal stenosis surgery Scoliosis corrective surgery Craniotomy surgery for brain tumor Surgery for any of the following cancers: bladder, colon (including caecum and rectum), kidney, ovary, pancreas, or uterus Phase I Currently undergoing treatment for PE or has received treatment for PE in the 4 weeks prior to study entry Hospitalized for fewer than 2 days Anatomic abnormality that would prevent use of a mouthpiece Living situation that makes follow-up difficult (e.g., homeless, incarcerated) Phase II Clinical suspicion of PE with signs or symptom suggestive of PE within 24 hours of presentation and at least one risk factor for PE, as defined under the as outlined in this protocol CTA of pulmonary arteries ordered by clinical care providers years or older or an emancipated 17 year old Written informed consent Phase II", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 0.167-4.917, All Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site)", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 0.0-999.0, All Venous Thromboembolism Pulmonary Embolism Cancer Deep Vein Thrombosis COPD Ultrasound-confirmed DVT patients from 183 institutions ", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-45.0, All Healthy Males 18 to 45 years of age Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke History of important bleeding episodes Previous allergic reaction to immunoglobulin Present or previous history of severe allergy, for example asthma or anaphylactic reactions FVIII:C <50% at screening Clinically significant out of range values for any coagulation test during screening Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 40.0-999.0, All Venous Thromboembolism Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions Congestive heart failure (New York Heart Association [NYHA] class III/IV) Acute respiratory failure (not requiring mechanical ventilation) Acute infection (without septic shock)* Acute rheumatic disorder* Acute episode of inflammatory bowel disease* Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following Age \u2265 75 years Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months) Previous VTE Previous surgery with general anesthesia within 30 days before in the study Patient requiring a curative anticoagulant or thrombolytic treatment Patient at risk of bleeding Stroke Known hypersensitivity to heparin or enoxaparin sodium End stage renal disease or patient on dialysis", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 21.0-999.0, All Respiratory Diseases Pulmonary Diseases Thoracic Diseases Lung Diseases All adult ( \u2265 21 years old ) patients (inpatients and outpatients) under the care of the Department of Respiratory and Critical Care Medicine between 1/07/2008 and 31/05/2009 will be considered eligible Children may have too small body sizes for the current standard sensors and will not be recruited Other will be ability to provide informed consent Conditions that will prevent the placement of sensors oh the patients back such as bony/chest wall deformity and contagious skin conditions The presence of a pacemakers and pregnancy are also considered contraindications because of the yet undefined safety issues associated with these conditions", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Coagulation, Blood Compression Devices, Intermittent Pneumatic Postoperative Complications Thrombelastography Elective major abdominal surgery for neoplasm Planned admission to postsurgical ICU due to the patient's meeting one or more of the following ASA Physical Status Class 4 Surgery of modified Johns-Hopkins class \u2265IV ASA 3 with modified Johns-Hopkins class 3 surgery Expected duration of surgery \u22658 h History of coagulation abnormalities, either congenital or acquired Ongoing treatment with anticoagulants/antiplatelet agents other than LMWH or hormones Massive edema of the legs Severe peripheral arteriopathy or neuropathy Malformations or recent surgery/trauma to the lower extremities", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 0.0-999.0, All Thrombosis Male or female subjects who have a diagnosis of chronic DVT that is at least 2 weeks old and are free from an acute DVT on top of your chronic DVT Male and female patients who have been diagnosed with an acute blood clot by the Diagnostic Vascular Lab and w/symptoms occurring within the previous 2 weeks Patients under the age of 18 who give assent (permission) and whose parents give consent Adult patients who give consent ", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-80.0, All Partial Nephrectomy Patients who have a solitary kidney and present for a partial nephrectomy Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney History of current renal disease beyond the diagnosis of renal malignancy Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Kidney Disease chronic kidney disease stade V treated with hemodiafiltration age >18 year Hematocrit > 30% treatment with vitamin K antagonists treatment with other anti-coagulants or heparin besides the heparin used during dialysis active bleeding, infection or malignancy heparin associated allergy hepatic failure trombocytopenia < 120.000/\u00b5l", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Non-Small Cell Lung Cancer Locally advanced or metastatic NSCLC (stage IIIB or IV) Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy At least one measurable lesion according to Good performance status Adequate haematological, renal and liver function Written informed consent Previous chemotherapy for NSCLC Brain metastasis History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease Concomitant therapy with an anti-angiogenesis agent Contra-indication for LMWH Life expectancy of < 3 months Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-90.0, All Deep Vein Thrombosis Coronary Artery Bypass Surgery Venous Thromboembolism Subject In order to be enrolled in the study, subjects must meet all of the as listed below Consecutive patients undergoing isolated or redo isolated CABG Patients must provide written informed consent Patients must agree to comply with study procedures for the entire length of the study Must be 18 years old or greater Subject Any subject that meets any of the listed below at baseline will be excluded from study participation Patients with medical history that requires chronic anticoagulation with unfractionated heparin or coumadin or LMWH or heparinoids (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement) Patients with contraindications to anticoagulation (coagulopathy e.g, INR>/=1.5, generalized bleeding disorders, peptic ulcer disease, hemorrhagic or ischemic stroke, etc within last 3 months) Patients who are unable to undergo a doppler ultrasound of the lower extremities Renal insufficiency (creatinine clearance < 30 mL/min) Patients who have a body weight < 50 kg Patients receiving continuous (indwelling) epidural Physician diagnosed acute or chronic hepatic failure Pregnancy", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Isolated Distal DVT Proximal DVT Pulmonary Embolism suspected deep vein thrombosis of a leg intermediate/high pre-test clinical probability or high D-dimer levels age < 18 years presence of proximal DVT suspected isolated iliac DVT symptoms/signs lasting from > 30 days presence of symptoms of pulmonary embolism pregnancy or puerperium full dose treatment with heparin or derivatives from > 1 day presence of superficial vein thrombosis limited life expectancy (< 6 months) geographically inaccessible location", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-40.0, All Diaphragm Mobility Breathing Exercises Incentive Spirometry Diaphragmatic Breathing Being 18 to 40 years old Having a normal body mass index Being a non-smoker Not knowing the DB and the IS techniques Reporting the absence of respiratory diseases Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity Inability to understand or perform the procedure", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 0.0-18.0, All Thrombosis Functioning central venous catheter in the upper or lower venous system Cohort A: Asymptomatic patients having placement of a new central venous catheter in the last 40\u00b120 days Cohort B: Subjects who have experienced symptoms for a CVC-related DVT with a CVC in place or subjects who have been incidentally identified by radiographic imaging (imaging modalities to diagnose an incidental CVC-related DVT may but is not exclusive of Echocardiogram, CT scan, MRI, or Ultrasound) performed for other clinical reasons, as having a CVC-related DVT in the veins where the current catheter is placed Males and females from full-term newborns to < 18 years For Cohort A subjects only, present therapeutic dosing of a systematic anticoagulant, systemic thromboprophylaxis or antiplatelet therapy. Local thromboprophylaxis [flushes, low dose infusions of heparin of up to 5 u/kg/hr or locks with heparin, urokinase, t-plasminogen activator] according to standard-of-care at the respective center will be allowed Patients unable to undergo contrast enhanced magnetic resonance imaging Renal function < 50% of normal for age and size", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Neoplasms Patients with cancer and confirmed pulmonary embolism (PE) or deep vein thrombosis (DVT) of the leg who have been treated for minimally 6 and maximally 12 months with therapeutic doses of anticoagulants, i.e. LMWH or VKA or a new anticoagulant in a trial Written informed consent Indication for long-term anticoagulant therapy (e.g. because of metastasized disease, chemotherapy) Legal age limitations (country specific), minimum age at least 18 years Indications for anticoagulant therapy other than DVT or PE Any contraindication listed in the local labeling of LMWH or VKA Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding Life expectancy <3 months", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Pulmonary embolism suspicion ", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Psoriatic Arthritis Males or females, aged \u2265 18 years at time of consent Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of \u2265 6 months duration Meet the Classification for Psoriatic Arthritis (CASPAR) PsA at time of screening Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs) May not have axial involvement alone Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine Have \u2265 3 swollen AND \u2265 3 tender joints Males & Females must use contraception Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed Pregnant or breast feeding History of allergy to any component of the investigational product Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-49.0, All Severe Oligohydramnios Patients above 18 years, who are able to consent Singleton pregnancy Normal structural examination between 16 and 20 weeks of gestation Gestation between 18 and 34 weeks (the pregnancy duration determined by ultrasound verification within the 20th week) At least two US examinations at the presentation for confirmation and for the diagnosis of persistent oligohydramnios Follow up ultrasound examinations weekly in both groups pPROM; 2. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes; 3. Symptoms referring incomplete abortion before 24 weeks of gestation; 4. Maternal contraindications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make the intervention riskful; 5. No active premature labor (shortened cervix <15 mm, <3 cm of cervical dilatation; >6/hour uterine contractions) after 24 weeks of gestation; 6. Cervical cerclage in place; 7. Clear signs of maternal or fetal infection (2 or more of the following: maternal tachycardia >100/min, maternal temperature >38\u00b0C, maternal white blood count cells (WBC) >15,000/ml, maternal C-reactive protein (CRP) >20 mg/l, uterine tenderness, foul-smelling vaginal discharge, fetal tachycardia >160 bpm); 8. Suspicion of placental abruption (uterine tenderness and bleeding episodes); 9. Previous invasive procedure in the pregnancy; 10. Fetal condition mandating immediate delivery; 11. Severe bleeding at present; 12. Maternal HIV and HBV/HCV infection; 13. Multiple gestation", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Ablation of Atrial Fibrillation Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume) Patients must be symptomatic with their AF as noted by their inability to perform their daily activities due to shortness of breath, fatigue, palpitations or other debilitating symptoms Paroxysmal atrial fibrillation is defined as atrial fibrillation that resolves on its own within 7 days of onset Persistent atrial fibrillation is defined as atrial fibrillation that does not resolve on its own and requires medical intervention to medication therapy and/or electric cardioversion Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society All patients with MV +2 mitral regurgitation will be excluded Require other cardiac surgery procedures will be excluded Are unable to take anticoagulation Are unable to take any prescribed anti arrhythmic medication Have a left atrium measuring greater than 6.0 cm (volume) Have had previous catheter ablation for atrial fibrillation Have had previous pace maker implantation Are less than 18 years of age Do not speak English and no translation can be provided", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Perioperative DVTs Age 18+ and consentable Anticoagulation therapy or known DVT", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Psoriatic Arthritis Subjects must satisfy the following to be enrolled in the study Male or female, aged \u2265 18 years at time of consent Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted Able to adhere to the study visit schedule and other protocol requirements Have a documented diagnosis of Psoriatic Arthritis (PsA, by any criteria) of \u2265 3 months duration Meet the Classification for Psoriatic Arthritis (CASPAR) for PsA at time of screening Have \u2265 3 swollen AND \u2265 3 tender joints Have not been previously treated with disease-modifying antirheumatic drugs (DMARDS) (small molecules or biologics) Be receiving treatment on an outpatient basis If taking oral corticosteroids, must be on a stable dose of prednisone \u2264 10 mg/day or equivalent for at least 1 month prior to screening History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Clinically significant abnormality on 12-lead electrocardiography (ECG) at Screening Pregnant or breast feeding History of allergy to any component of the IP Hepatitis B surface antigen positive at screening Hepatitis C antibody positive at screening AST/SGOT and/or ALT/SGPT > 1.5 x ULN and total bilirubin > ULN or albumin < lower limit of normal (LLN) History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease) Active tuberculosis or a history of incompletely treated tuberculosis", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-75.0, All Rupture Venous Thromboembolism Venous Thrombosis Surgical Wound Infection Achilles tendon rupture operated on within 96 hours of diagnose Inability or refusal to give informed consent for participation in the study Ongoing treatment with anticoagulant therapy Inability to comply with the study instructions Known kidney disorder Heart failure with pitting oedema Thrombophlebitis Recent thromboembolic event (during the preceding 3 months) Recent surgery (during the preceding month) Presence of known malignancy Current bleeding disorder", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Chronic Obstructive Pulmonary Disease known or suspected COPD COPD-exacerbation other causes of dyspnea unable to perform CT pulmonary angio (contrast allergy, pregnancy) already included in the study (each patient included only once) use of anticoagulants", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Prophylaxis of Venous Thromboembolic Events Male or female subjects aged \u2265 18 years Written informed consent Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Pregnancy at the time of screening Indication for anticoagulation other than post-operative thromboprophylaxis Active bleeding or high risk of bleeding Anticipated continued use of neuraxial catheter after surgery Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT Uncontrolled hypertension Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency Creatinine clearance <30 mL/min Antiplatelet agents other than low dose aspirin (< 200mg) The use of intermittent pneumatic compression", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-40.0, All Pregnancy pregnant women undergoing planned caesarean section h-40th week of pregnancy age 18-40 years disapproval or non-cooperation of the mother allergy to LMWH coagulation disorders or the risk of anticoagulant therapy in the last 3 months signs of infection history of cancer signs of thrombosis or a history of thrombosis the ongoing non-physiological pregnancy significant obesity, or other severe comorbidity", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Thrombosis, Venous age 18 and older at least one record of a primary inpatient discharge diagnosis of cancer (index hospitalization) a procedure code for a cancer-related surgery during the index hospitalization a code for an anticoagulant treatment (dalteparin, enoxaparin, fondaparinux or unfractionated heparin (UFH)) as thromboprophylaxis therapy during the day prior to or two days after cancer-related surgery during the index hospitalization (this is the INDEX EVENT) a record that the patient received more than one injectable anticoagulant on Day 1 of anticoagulant therapy a record that the patient received anticoagulant therapy prior to index anticoagulant a primary diagnosis code of DVT, PE, or major bleed evidence of an outpatient emergency department or hospital outpatient clinic visit that included a diagnosis code for DVT or PE during the 6 months prior to the index hospitalization patient records for patients transferred from another facility outside Premier system on index hospitalization", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 19.0-999.0, All Air Embolism as A Complication of Medical Care Subject is undergoing ERCP as part of their medical care Subject will be of age 19 or older Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE Subject intolerance of the pressure of the TTE probe Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Deep Venous Thrombosis Pulmonary Embolism Meniscectomy Diagnostic Arthroscopy Removal of corpora libera Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) Pregnancy Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence) Mental of physical disability to fulfill study requirements Insufficient knowledge of the Dutch language Previous participation in the Pot-(K)Cast study", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Deep Venous Thrombosis Pulmonary Embolism All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications Trauma of the lower leg Surgery of the lower leg followed by lower leg immobilization with a plaster cast Non-traumatic indications Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) Pregnancy Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence) Mental of physical disability to fulfill study requirements Insufficient knowledge of the Dutch language Previous participation in the Pot-(K)Cast study", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Thromboembolic Events Post-operative Bleeding primary Uni/bilateral THR/TKR, revision THR/TKR or uni-KR in fast-track setup, Discharged in 3 +-2 days not a danish citizen", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 30.0-90.0, All Deep Vein Thrombosis patients that underwent cemented total knee arthroplasty post-operative infection inadequate follow-up", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Acute Pulmonary Embolism consecutive patients with acute pulmonary embolism age <18 years", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-89.0, All Dyspnea Subjects are included if they are between the ages of 18-89 and present to the Emergency Department with a chief complaint of shortness of breath or dyspnea known history of asthma are 20 or more weeks pregnant, or have had thoraco-abdominal trauma in the past 72 hours", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Pregnancy Deep Vein Thrombosis Pregnant women with clinically suspected DVT Age less than 18 No available informed consent Associated suspicion of pulmonary embolism Ongoing anticoagulant treatment Planned anticoagulant treatment at therapeutic dosage during pregnancy", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 16.0-999.0, All Chest Pain All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich Missing informed consent Cardiopulmonary unstable patients No self reported chest pain Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolic Disease Deep Vein Thrombosis Pulmonary Embolism Admitted to Scripps Mercy Trauma Service \u226518 Years old Stratified to either Significant or Highest risk of VTE by ACCP guidelines Estimated Injury Severity Score (ISS) \u22649 Likely to be discharged before hospital day 7 Systemic coagulopathy (International Normalized Ratio [INR] of \u22651.2) Body Mass Index (BMI) >40 Likely to Survive for <7 Days Pregnancy Evidence of renal insufficiency (Cr \u22651.3) Delayed transfer to this facility (>24 hrs) Prisoners", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 24.0-65.0, All Pulmonary Embolism Diagnostic Uncertainty Clinical Reasoning Evidence Based Medicine Visualization of Uncertainty Medical students, University of Calgary, in clerkship who finished at least 4 weeks of a block of medicine rotation at any hospital site First year subspecialty or Internal Medicine residents Practicing physicians in the subspecialties of Internal Medicine or Emergency Medicine Physicians in the subspecialty of Haematology or Respiratory", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-80.0, All Pain Female 80 years of age TMJ arthralgia Masticatory myalgia TMJ sounds History of at least 6 weeks use of occlusal appliance therapy Contraindication to sedation including pregnancy or medical history History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy History of steroidal injection into TMJ History of trauma to TMJ TMJ pain longer than 3 years History of narcotic drug use on a scheduled basis Current active infection", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-45.0, All Venous Insufficiency Pregnant women 18-45 years of age Fetal gestation between 8-20 weeks Patient is seeking care for the pregnancy at one of the study locations (Johns Hopkins East Baltimore Campus, Johns Hopkins Bayview Medical Center, and Johns Hopkins at White Marsh) Ability to complete informed consent and willingness to comply with protocol (return for all follow-up visits & participate in phone interviews) Inability to wear compression stockings Women who currently have been prescribed to wear compression stockings by a medical professional Chronic dermatological condition (i.e. psoriasis) Chronic deep vein thrombus or chronic phlebitis In women with varicose veins: Presence of primary outcome (superficial thrombophlebitis or DVT) on first visit ultrasound", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-80.0, All Snoring every night snoring no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids) no smoking for the last 6 months no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and written informed consent from each patient duration of snoring less than 60 minutes during sleep study, and central apnoeas more than five percent of total apnoeas", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Arteriovenous Malformations Patients are eligible for in the study if all the following are met Documented presence of new (untreated) pulmonary AVMs requiring embolization Definite clinical diagnosis of HHT or genetic diagnosis of HHT Age \u226518 years Able to provide informed consent Patients will be excluded from the study if, in the opinion or knowledge of the Principal Investigator any of the following criterion is present Participants with multiple AVMs within close proximity where identification of the aneurysm seen on CT cannot be precisely isolated for randomization purposes Contra-indications to embolotherapy Severe chronic renal failure, without availability of dialysis Severe pulmonary hypertension (PA systolic estimated at >60mmHg)", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-80.0, All Treatment of Submassive Pulmonary Embolism Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9 age > 80 Recent thrombolytic therapy (with in 4 days) Active bleeding or know bleeding diathesis Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50 Thrombocytopenia (PLT cound < 100,000) History of any intracranial or intraspinal surgery, trauma or bleed Intracranial neoplasms, AVM, or aneurysm Recent (< 1 month) GI bleed Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy Recent (< 7 days) major surgery, trauma, or obstetrical delivery", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Multiple Pulmonary Emboli Patients referred for CT pulmonary angiogram to pulmonary embolus Class 3 or 4 Congestive Heart Failure Supraventricular tachycardia History of contrast allergy Unable to give informed consent Patients with serum creatinine >1.28 mg/dl without referring physician approval", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Edema Age over 18 years Belongs to one of the following categories A. Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following Dyspnea at rest or with minimal activity Rales on auscultation Evidence of pulmonary congestion or edema on chest X-ray BNP level >400 pg/ml B. Compensated left HF: patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion. The following 3 must be met No dyspnea at rest No rales on auscultation Decompensated left HF subgroup & Non CHF controls Pneumonia currently or in the past 1 month prior to Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) Interstitial lung disease Severe kyphosis, scoliosis or chest wall deformity Pregnant women Compensated left HF subgroup Chronic obstructive pulmonary disease (COPD) Asthma", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 19.0-85.0, All This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment. Adults, age \u2265 18 years Patients who have signed the study informed consent form prior to initiation of any study-related procedure Acute massive PE patients who require thrombolytic treatment Patients who have a contraindication to use of anticoagulation and thrombolysis, such as active bleeding, stroke, cranial trauma, or neurologic surgery within the preceding 6 months, current pregnancy, major surgery, or biopsy within the preceding 7 days, major trauma within the preceding 10 days, gastrointestinal bleeding within the preceding 1 months during their admission Patients who received any anticoagulation medication prior to admission to the hospital", "label": "1"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 50.0-999.0, All Diabetes Diabetes Mellitus, Type 2 Type 2 diabetes Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day One or more oral or injectable antidiabetic agent(s) An acute coronary or cerebrovascular event in the previous 60 days Planned coronary, carotid or peripheral artery revascularisation Chronic heart failure NYHA (New York Heart Association) class IV Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Obesity Adult patient undergoing laparoscopic sleeve gastrectomy The patient undergoes the surgery in the surgical wing of the Tel-Aviv Sourasky Medical Center The patient has received full information regarding the studies nature, has agreed to participate and has given informed consent (documented by a signed informed consent form) Patients with a previous Venous Thromboembolic Event Patients requiring an IVC filter Patients with known thrombophilia due to coagulation factor disorders (i.e factor V leiden) Patients with a bleeding disorder Patients with renal failure", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-70.0, All Obesity Competent patients enrolled in the pre or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA Ability to perform a 6 Minute Walk Test Aged 18 through 70 Willingness to receive dietary recall phone calls and accessibility to a telephone Patients with severe lung disease requiring oxygen therapy Pulmonary embolus or pulmonary infarction Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent) Unstable angina Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise Patients with any health reason that limits walking Patients with a temporary injury that limits walking Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living Patients predetermined to be illiterate or incompetent Patients who are currently pregnant or have been pregnant at any time since bariatric surgery", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis TKA candidacy, osteoarthritis, patients able to understand study intent, and agree to study participation Subjects with personal or family history of DVT, currently taking antiplatelet/anticoagulant drugs, genetic risk factor positive for VTE, pronounced thrombocytopenia, GI bleed within 6 months of surgery, NSAID intolerance, orthopaedic and medical co-morbidities that would prevent postoperative rapid mobilization and compliance with MCD such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity, post-traumatic and inflammatory arthritis, BMI above 40, active knee sepsis, remote sites of active infection, ASA class > lll, cardiac disease failing medical clearance, severe liver disease, peripheral artery disease, seizure disorder, alcohol abuse, smoking abuse", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 0.25-16.0, All Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Concern for PE by attending physician and CTPA ordered If patient is under the age of 18, a prisoner, or a ward of the state CTPA ordered but not performed", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis DVT Age 18 or older Suspect of having DVT Known DVT DVT with in previous 6 months DVT Ultrasound within the last 6 months", "label": "2"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Osteoarthritis with osteoarthritis scheduled for elective primary unilateral THR or TKR provided informed consent can read, write and speak English history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease) pre-operative Hg of <120 g/L Known allergy to Tranexamic Acid Coagulation disorder Acquired disturbances of color vision Hepatic insufficiency, any history of liver disease Renal insufficiency (on dialysis) Preoperative prophylactic use of antiplatelet or anticoagulant therapy such as Clopidogrel, Warfarin, dabigatran or Rivaroxaban. This does not low dose Aspirin (81mg) Patients with a history of subarachnoid hemorrhage [20] Simultaneous bilateral THA or TKA", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-65.0, All Bariatric Surgery Obesity Men or women, 18 to 65 years old with a BMI of 35 kg/m2 or greater who will be undergoing bariatric surgery (VSG and RYGB) Signed written informed consent Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug Women must not be breastfeeding History of documented clotting/coagulation disorder History of cancer (within the last year) Any diagnosis requiring anti-coagulation History of hypersensitivity reaction to apixaban Active clinically significant bleeding Creatinine > 1.5 mg/dL Participants currently receiving any type of anticoagulation or blood thinning medications, including heparin, low molecular weight heparins, Plavix, aspirin Participant who is taking any of the excluded medications Combined P-glycoprotein and strong CYP 3A4 inhibitor Combined P-glycoprotein and moderate CYP 3A4 inhibitor", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 21.0-59.0, All Respiratory Failure Healthy male or female volunteers in the age group Any acute or chronic cardiopulmonary disorder including a simple common cold", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 16.0-999.0, All Pregnancy Suspected Deep Vein Thrombosis Compression Ultrasound D-dimer Unselected pregnant women (preciously documented positive beta hCG on urine or serum pregnancy tests) with Suspected acute symptomatic deep vein thrombosis Defined as new leg swelling or edema with onset in the last month or new leg pain (buttock, groin, thigh or calf) with onset in the last month Prior major VTE (proximal DVT or segmental or greater PE) Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada) Unable or unwilling to provide informed consent Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia) Need or plan for ongoing anticoagulant therapy (>2 weeks), at any dosage (i.e. prophylaxis or treatment dosage), throughout the ante-partum period Need for therapeutic anticoagulant therapy in the post-partum period (i.e. patients that are/will be treated for superficial phlebitis, mechanical valves, atrial fibrillation or other indications)", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 0.0-999.0, All Bronchial Secretion Retention Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following Clinical and radiologic diagnosis of pulmonary infection Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data Stable of hydration status or positive fluid balance at least 2 days before collects the data Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 30 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia Good conscious and well cooperation Pneumothorax (nontreated) Massive hemoptysis Acute myocardial infarction (with angina chest pain) High intracranial pressure (>20 mm Hg) Major arrhythmia", "label": "0"} +{"topic": "A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer.", "doc": "eligible ages (years): 18.0-999.0, All Arthropathy of Hip Arthropathy of Knee Patients undergoing primary unilateral total knee arthroplasty or primary unilateral total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/ New York Presbyterian Hospital Non-English speaking Patient refusal to participate Weight exceeding 100kg Baseline hemoglobin of less than 10 Repeat, revision, or bilateral surgery Known sensitivity or allergy to Tranexamic Acid Active intra-vascular clotting History of coagulopathy or congenital thrombophilia Thromboembolic event in the 12 months prior to enrollment Percutaneous coronary intervention requiring a drug eluting stent in the 12 months prior to enrollment", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 10.0-18.0, All Diabetes Mellitus, Non-Insulin-Dependent Approximately 30 pediatric patients (ages 10-18) believed to have a diagnosis of type 2Y. Each subject must have been diagnosed for at least one year Patients over the age of 18 or under the age of 10 Patients in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 0.0-999.0, All Diabetes Mellitus Foot Ulcer Peripheral Neuropathy History of Diabetes Mellitus Limitation of dorsiflexion ankle range of motion to zero degrees or less Recurrent or nonhealing ulcer (Grade II, Wagner scale) Nonambulatory patients or those that would not benefit from the Achilles lengthening procedure Patients with a history of CVA or other significant neurological problems complicating their rehabilitation Patients with a history of midfoot or hindfoot Charcot fractures Patients with an Ankle-Arm index < 0.45 or absolute toe pressure < 40 mm Hg Patients medically unfit for the anesthesia required for this Achilles lengthening procedure", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcers Diabetic patients with foot ulcers ", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 5.0-999.0, All Insulin Resistance Diabetes Mellitus Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT Family history of type II diabetes Critically ill patients, patients will congestive heart failure, renal or liver insufficiency Inability to give consent History of poor compliance with physician's recommendations", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Foot Ulcer Diabetic Foot Skin Ulcer Diabetic Neuropathies Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12% Minimum of one neuropathic, diabetic ulcer meeting the following stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters No exposed bone at the ulcer site No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Adequate arterial circulation to the foot New ulcers must be meet the following full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Recurrent ulcers must meet the following stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test Hypersensitivity to Gel or one of its components Presence of more than two full-thickness diabetic ulcers on either lower extremity presence of an active systemic or local cancer or tumor of any kind Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation Radiation therapy that included the distal lower extremity, at any time in patient's life Charcot deformity (rocker bottom foot)", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 People with Type I or Type II Diabetes Years or Older ", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 16.0-80.0, All Wounds Patients with a poorly healed wound, in which skin graft is clinically indicated Skin infection Vital signs unstable", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 30.0-999.0, All Foot Ulcer Diabetes Provision of a written informed consent at the enrolment visit Men or women above 30 years of age Fertile women need to take contraceptives or have to be sterilised Diagnosed with any diabetes mellitus type 1 or type 2 Present foot ulcer with an ulcer duration <= 12 months Intolerance to statins at any time in the past Unwillingness to participate A history of alcohol or drug abuse within the last 2 years Foot ulcer with the etiology from vasculitis, pyoderma gangrenosum, angiodermatitis necroticans (hypertensive ulcer), necrobiosis lipoidica, hydrostatic pressure/venous insufficiency or any neoplasms (basalioma, kaposis sarcoma, squamous cell carcinoma etc) History of drug-induced hepatitis or previous liver enzyme elevations (> 3 times the upper limit of normal) while taking statins History of drug-induced creatine phosphokinase (CPK) > 3 times the upper limit of normal Critical limb ischemia that requires re-vascularisation procedures within 2 months Brachial-ankle index < 0.5 Other serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the trial Any clinically significant abnormality identified in the enrolment medical history, physical examination, laboratory test which, in the judgement of the investigator, would preclude safe completion of the study", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Foot Ulcer years of age or older Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted) Diagnosed Type 2 diabetic (i.e. not juvenile onset) Have a DFU on the plantar surface of either foot Have a DFU of >4 wks but <6 months duration Willing and capable of cooperating to the extent and degree required by the study protocol Be < 1cm2 or >10cm2 in area, by planimetry Demonstrate overt signs of infection Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1) Have visible exposed bone or tendon Have an adjacent thermal injury or wound of an etiology other than diabetes Be within 5 cm of any other wound, regardless of etiology Have received enzymatic debriding agents in the past 7 days Have received topical antibiotic therapy in the past 7 days Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement Have exposed bone or tendon, after debridement", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 0.0-999.0, All Pressure Ulcers Bacteremia Patient in the complex nursing department With contaminated pressure ulcers Going to have a debridement procedure Penicillin sensitivity Bacteremia that does not react to the antibiotic treatment", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Diabetic Polyneuropathy Diabetic Foot Ulcer Diabetes Foot Infection diagnosis of diabetes by WHO ability to provide informed consent 80 years of age patients with open ulcers or open amputation sites active Charcot arthropathy severe peripheral vascular disease active foot infection dementia -impaired cognitive function- history of drug or alcohol abuse within one year of the study other conditions based on the PI\u2019s clinical judgment", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Neuropathic Foot Ulceration in Individuals With Diabetes confirmed diabetes neuropathic ulcer grade 1/2 (wagner scale) confirmed sensory neuropathy osteomyelitis patients unable to walk life threatening co-morbidity ankle/brachial index , 0.4", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Diabetes Clinical diagnosis of Type 1 or 2 Diabetes most recent A1C greater than or equal to 7.0% Referred to the Diabetes Improvement Program for diabetes care Age 18-80 English Speaking Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener, or Patients with a diagnosis of significant dementia, psychosis, or blindness", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcer Patient is greater than 18 years of age Patient has Type I or Type II Diabetes Patient must be able to understand English (self or translator) and give written, informed consent Patient has a plantar forefoot ulcer(s) beneath metatarsal head or toe ulcer which has been present for at least 4 weeks, and has received best practice care Evidence of adequate arterial perfusion: Toe plethysmography reading of mmHg or Transcutaneous oxygen measurement of \u2265 30mmHg Patient is appropriately offloaded (contact cast, pneumatic walking cast) Infection and/or osteomyelitis have been ruled out or are being treated Patients must have a platelet count greater than150,000/mm3 Orthopedic assessment has been completed to rule out mechanical source of ulceration TcPO2 <30 mmHg and/or toe plethysmography readings of less then 45 mmHg Limb ischemia requiring re-vascularization or impending amputation Untreated wound infection or osteomyelitis Bleeding disorders, hemophilia, sickle cell disease, thrombocytopenia,and leukemia or blood dyscrasias Anemia with hemoglobin level less than 100 g/L will be included as criteria Patient is taking immunosuppressive agents (e.g. corticosteroids, chemotherapeutic agents, transplant medications) Current treatment for malignancy or neoplastic disease or collagen vascular disease Patient has a highly communicable disease or diseases that may limit follow up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis) Patients taking anticoagulants like heparin or coumadin or others which may hinder in clot (thrombin) formation", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-79.0, All Colitis, Ulcerative Active ulcerative colitis, CAI greater than or equal to 4 Antibiotics in the last 3 months Probiotics Alteration to medications in last 3 months", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 12.0-16.0, All Type 1 Diabetes Mellitus Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months - Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Foot Ulcer, Diabetic Diabetic Angiopathies age over 18 years type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner\u2019s classification ) and existing for at least three months giving their written informed consent hypersensibility to heparin or pig derivatives body weight lower than 35 kg presence of clinical signs of infection that did not resolve in spite of oral antibiotics anticoagulant therapy severe impairment of renal or hepatic function bleeding disorder active peptic ulcer arterial hypertension with poor control pregnancy or lactation terminal illness or a prognosis of survival under three months", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 21.0-999.0, All End Stage Renal Disease Hemodialysis Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula) Temporary catheter dialysis access, inability to be compliant with study medication", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-90.0, All Venous Ulcer Patients of any race and are between 18 and 90 years of age Patients that are able to understand and are willing to give written informed consent Patients that have a non-healing open venous ulcer for at least one month Patients that have greater than 50% of the ulcers surface area covered with non-viable tissue such as fibrin slough, dry crust or a combination of both Patients that have the clinical signs and symptoms of venous ulceration such as varicosities, hyper pigmentation, stasis dermatitis, lipodermatosclerosis, and edema Patients that have a venous ulcer with a surface area of greater than or equal to 1.5 cm2 Patients that have an ankle to brachial index (ABI) > 0.70 Study wound (target ulcer) etiology is other than venous insufficiency Patient has peripheral arterial disease as determined by the following Ankle/Brachial Index < 0.7 (ulcerated leg), evidence of intermittent claudication Patient has the presence of any of the following in the area of the ulcer: cellulitis, osteomyelitis, and ulcer with exposed bone, tendon or fascia Patient has a known hypersensitivity to dressing components Patient is receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy where in the investigator\u2019s opinion could interfere with wound healing Patient is known to have uncontrolled diabetes mellitus (as defined by the investigator) Patient is known to have immunodeficiency disorders that interfere with wound healing Patient has a history of sickle cell anemia, thalassemia, vasculitis, rheumatoid arthritis, lupus erythematosus, polyarteritis nodosa, scleroderma or any connective tissue or collagen vascular disorder Patient has wounds that have been treated with an investigational product within the past thirty days Patient has not signed the informed consent", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-85.0, All Type 2 Diabetes Clinical diagnosis of Type 2 Diabetes most recent A1C >= 7.5% Referred to the Diabetes Care Program for diabetes care Age 18-85; 5. English Speaking Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener Patients with a diagnosis of significant dementia, psychosis, or blindness", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 45.0-69.0, All Diabetic Foot Ulcer A diabetic foot ulcer corresponding to grade 2 No history of deep venous thrombosis and no hemorrhage in ulcer Significant loss of protective sensation Hemorrhage during treatment Vertigo No completion of treatment", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Diabetic Foot diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure ulcer present for at least 2 weeks and measuring 1 cm2 diminished sensesation on target extremity/foot ulcer is not infected Type 1 or 2 diabetes with adequate glycemic control Adequate vascular supply to the target extremity Charcot foot Non-neuropathic ulcers Skin cancer within or adjacent to the target ulcer Osteomyelitis or an infected ulcer Clinically significant medical condition that would impair wound healing Females who are pregnant Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 12.0-999.0, All Keloid Male or females, in good health, and at least 12 years of age Individuals with 2 or more keloids on the trunk, arm, leg, and neck between 0.5 and 2 cm in length Individuals who are willing and able to participate in the requirements of the study, including signing the informed consent In the opinion of the investigator, the 2 keloids can be excised in a similar manner and closed properly with the two techniques and will benefit from the procedure In the opinion of the investigator, the keloid could benefit from surgical procedure Individuals with keloids that do not fit into the criteria Individuals who are planning pregnancy, pregnant, or breast feeding Individuals with a history of medical or dermatologic conditions which, in the opinion of the investigator, would put the subject at heightened risk or would limit complicate the study evaluations required by the protocol Individuals who present with excessive body hair in the designed keloid area Individuals with uncontrolled diabetes Individuals with autoimmune disorders (HIV/AIDs, SLE) Subjects who have received keloid treatment within one month of the first day of the study Individuals who plan to receive keloid treatment(s) during the study Individuals who are currently taking prescription or over the counter medication or interventions on a regular basis that as part of their mechanism of action, have the potential to mask an inflammatory reaction. Examples of such medications but are not limited to, corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), antihistamines, aspirin (81mg or less daily dosage permissible), or other medications that in the opinion of the investigator or designee may expose the subject to heightened risk or complicate the study assessments", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 10.0-16.0, All Type 1 Diabetes a current hemoglobin A1c(HbA1c) of >8.0% an average HbA1c of >8.0% during the past year diagnosed with Type 1 diabetes for at least one year reside in the metro Detroit tri-county area severe mental impairment/thought disorder non-English speaking patient/parent co-morbid major medical condition such as cystic fibrosis", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Varicose Ulcer Pressure Ulcer Patients who are at least 18 years of age Males and females (provided they are not pregnant or, if of reproductive age, are using contraception) Patients with a venous stasis, diabetic foot or decubitus reference ulcer located between the tibia and foot Patients undergoing surgical debridement of their reference ulcer in the operating room (OR) Patients undergoing their first surgical debridement of the reference ulcer Patients suitable for debridement of their reference ulcer with both and conventional debridement techniques Patients who are able to understand the evaluation and are willing and able to provide written consent to participate in the evaluation Patients with clinical signs of infection in the reference ulcer (e.g. purulence and / or odour) Patients with haemophilia Patients who have been treated with topical steroids, systemic immunosuppressants (including corticosteroids), anticoagulants or cytotoxic chemotherapy in the last 30 days, or who are anticipated to require such medications during the course of the study Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be infected with Human Immunodeficiency Virus (HIV) Patients who suffer from acute or chronic bacterial, viral or fungal skin diseases that would interfere with wound healing Patients with a known history of poor compliance with medical treatment Patients who have participated in this evaluation previously or are currently participating in another clinical study", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Mellitus Chronic Ulcers of the Lower Limb Age > 18 years Type 1 or 2 Diabetes Mellitus Wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks Impending urgent amputation due to ongoing or exacerbated infection Exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed Dialysis-dependent renal failure Any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity History of chemotherapy with use of Bleomycin Participation in another investigative drug or device trial currently or within the last 30 days Current candidates for vascular surgery, angioplasty or stenting Major large vessel disease Undergone vascular surgery or angioplasty within the last 3 months Women who are currently pregnant or are breast feeding or women of childbearing potential who are not currently taking adequate birth control", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Type 1 diabetes Type 2 diabetes Candidates of use of a basal insulin as part of their diabetes regimen Unwilling to adhere to therapy or follow up Pregnancy", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months Average HbA1c \u2265 7% OR an average LDL \u2265 100 mg/d Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that both medical and pharmacy coverage Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period Participation in a disease management program", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Corneal Ulcer The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features corneal epithelial defect with stromal infiltration reaction in anterior chamber positive for bacteria or fungus The patients have to receive subconjunctival antibiotic injection twice at least The patients must be informed consent The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection Unable to cooperate with the treatment Pregnant women", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Leg Ulcers \u2022 Patients over 18 who have given written informed consent Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to Patients who are available for monitoring for at least 10 weeks \u2022 Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment Patients who have undergone surgery on the saphenous trunk within the two months prior to Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to Patients who have been taking systemic antibiotics in the two weeks prior to Patients who have been taking systemic corticoids or cytostatics within the three months prior to Patients with unbalanced diabetes at the discretion of the investigator Patients with a known allergy to one of the components in Biatain Argent\u00ae or Biatain Patients who are already taking part in another clinical study Patients who are pregnant or breastfeeding", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Brain Injury Sequelae Stroke Anoxia Trauma Subject has had a brain injury at least 12 months prior to study enrollment Subject is at least 18 years old Etiology of brain injury: Stroke, anoxia, and trauma Must be able to equalize ears, or have tympanostomy tubes Willingness to complete outcome measures and complies with the research protocols Commitment to pay the hospital for hyperbaric oxygen Glasgow Coma Scores less than 13 at the time of hyperbaric oxygen evaluation Poorly controlled seizures(ie:>1 generalized seizure in past 3 months despite appropriate anticonvulsant therapy). Pharmacologically-controlled seizures or focal seizures are not an to participate Inability to participate in outcome assessments (eg: blindness, quadraplegia) Claustrophobia (unwillingness or inability to enter the hyperbaric chamber) Inability to equalize ears. The patient could elect to have bilateral tympanostomy tubes Inability to protect airway, and or requiring frequent suctioning Patients requiring tracheostomy will be ineligible due to limitations in autoinflation of the middle ear space and difficulty to perform airway suctioning in the single-person chamber Pregnancy (beta HCG will be assayed in women who could be pregnant prior to enrollment) Severe psychiatric disorders such as schizophrenia and bi-polar disease. We appreciate that psychiatric problems such as depression and anxiety may follow brain injuries so we would not patients based on brain-injury induced psychiatric disorders, but will patients with severe pre-injury psychiatric disorders Patients taking lithium (due to the possibility of concomitant toxic side effects with hyperbaric oxygen therapy, specifically hyperexcitability)", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcer In-patient or out-patient patients diagnosed with diabetic foot ulcers Gangrene or ulceration occurred more than 3 weeks Over 18 years of age Gender-open The type of diabetes (type 1 or type 2) open Patients receive a written informed consent to participate in the trial Serious complications of heart, liver, lung, kidney damage Malignant tumors Allergy for Chinese medicine used Pregnant women and breast-feeding women", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-70.0, All Trigeminal Neuralgia Pain Age 18-70 Primary TN patient (MRI examination support diagnosis) Suffering from this pain for at least 3 months VAS\ufe6540mm Patient can assess pain intensity correctly Undergone surgery for TN(including nerve injections) within the last year Oral medicine change within the last week With other diseases of nervous system", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 20.0-75.0, All CERVICAL NEOPLASMS Histologically confirmed cervical cancer Clinical stage from 2b to 4a Equal to or younger than 75 Gog performance status 0 Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl Serum creatinine < 2.0 AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl Expected survival equal to or longer than 6 months Who agreed to participate in this study History of chemotherapy or radiation to abdomen or pelvis History of other cancers Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2 History of allergy or hypersensitivity reaction to platinum History of atrial or ventricular arrhythmia, or congestive heart failure Uncontrolled diabetes, hypertension, or ischemic heart disease Myocardial infarction within 6 months Sepsis or severe infection Pregnant women An unapproved therapy within 30 days before enrollment", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All At-risk Drinking Type 2 Diabetes years or older have Type 2 diabetes report at-risk drinking in past month report poor diabetes treatment adherence current alcohol dependence or current psychoactive substance abuse or dependence (excluding nicotine) currently psychotic unable to provide the name and contact information for a significant other to corroborate self-report unable to provide the name and contact information for two people who could serve as locators, do not have access to a telephone", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 40.0-70.0, All Autologous Transplantation Diabetic Foot Age from 40 to 70 years Type 2 diabetic patients bilateral critical limb ischemia(ABI from 0.30 to 0.60) at least with one foot ulcer dry gangrene above the ankle or moist gangrene malignant tumor severe coronary,cerebral and renal vascular disease", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All MARTORELL'S ULCER Hypertensive Leg Ulcer Necrotic Angiodermatitis patients 18 years of age or older, able to give informed consent and to follow the treatment procedure target ulcer area between 1 and 30 cm2 consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive ulcers presence of an arterial hypertension, according to the WHO treated or not; and/or presence of a diabetes treated by oral agent, insulin or diet absence of clinical signs of chronic venous insufficiency: skin hyperpigmentation, lipodermatosclerosis absence of significant peripheral arterial occlusive disease: presence of peripheral pulses or ankle brachial index \u22650.8 absence of clinical sign of arterial insufficiency: intermittent claudication, resting pain superficial spreading necrotic ulcer presence of spontaneous pain presence of a red purpuric margin pregnancy allergy to hydrogel or to becaplermin gel uncontrolled or evolving systemic disease: cardiac or renal failure, hepatic insufficiency, malignant disease, thrombotic disease, vasculitis or other connective tissue disorder presence of a cryoglobulinemia serum creatinine concentration greater than 200\u00b5mol/L or uncontrolled diabetes (fasting blood glucose > 2,5 g/L under treatment) concomitant treatment by bone, joint or tendon (except for achilles tendon) exposition in the wound systemic treatment with corticosteroid agents or cytotoxic drugs in the past 3 months before", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Wounds Subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration Subject must be at least 18 years of age Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator The study ulcer must be from 1 cm2 to 20 cm2 in size The study ulcer must have been present for at least 30 days at study Day -7 The subject's Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day 0 The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form The subject must be available for evaluation on a weekly basis for the twelve (12) weeks of the study. Visits at Week 13 and Week 14 are required for initial wound healing, which is achieved in study Week 11 or 12. The Investigator will evaluate both groups at Week 16. Subjects must be available for evaluation at Week 16 The subject's TCpO2 must be equal to or greater than 25 mm of mercury in the periwound area and ABI greater than 0.7 Subject whose ulcer has healed 30% or greater from the evaluation Study day -7 to the post-debridement Study Day 0 as determined by wound measurements using ARANZ Silhouette A history of alcohol or substance abuse, within the previous year, which could, or in the judgment of the Investigator, would interfere with study compliance or protocol requirements Participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study Subject with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. Anticipated use of the above during the study period will also a subject from entry into the study. Topical and inhaled corticosteroids are not prohibited Subjects with medical comorbidities known to affect wound healing such as end stage renal disease, severe hepatic insufficiency, vasculitis, and HIV will be excluded from this study", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 0.0-999.0, All Diabetes Neuropathic Foot diagnosed as having Type 1 or 2 diabetes mellitus, (recorded within the case notes and confirmed by participant) diagnosed with diabetic peripheral neuropathy palpable or biphasic pulses intact from lower limb vascular or neuropathic ulceration, scoring Grade 0 on the Wagner classification for foot ulcer able to walk a minimum of 10 metres unaided willing to comply with the requirements of the study presented with current or recently healed ulceration less than 6 months prior to study enrolment severe fixed mid-foot or rearfoot deformity e.g. charcot joint, unsuitable for prefabricated insoles and non bespoke footwear history of major bone or joint surgery of the lower limb including major amputation unable to comprehend simple instructions and comply with the study protocols and procedures", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Diabetic Foot The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage The probe-to-bone maneuver was required to be negative Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis Use of steroids or cytostatic drugs Presence of sensory, motor, or visual problems that could impair functional autonomy Active ulcer on the contralateral foot Previous major amputation of the contralateral limb Previous or current deep venous leg thrombosis, OR Mental disorders interfering with patient compliance", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Foot Ulcer, Diabetic Is the subject 18 years of age or older? Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks? Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided? Does the subject show evidence of neuropathy? Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis? Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes? Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)? Is the subject willing to have photos taken of their wound and permit use of the photos in publications? Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information? Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8 Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit? Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year? Does the subject have an infection requiring systemic antibiotic treatment? Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)? Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.) Does the subject have Lupus or Crohn's disease? Does the subject have an oxygen dependency? Has the subject received hyperbaric oxygen therapy within the previous 90 days? Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit? Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 0.0-999.0, All Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Healthy FOR TRIAL PART 1, THE Gender: male Age: 18-55 years BMI (body mass index): 18-28 kg/m2 Study participants considered to be healthy FOR TRIAL PART 2, THE Gender: male or female of no childbearing potential Age: 18-65 years Type 1 diabetes: BMI (body mass index): 18-28 kg/m2 Type 2 diabetes: BMI (body mass index): 22-35 kg/m2 Known or suspected allergy to the trial product or related products Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 21.0-999.0, All Hypercholesterolemia Adults with diabetes LDL greater than or equal to 100 Cholesterol-lowering drug therapy for > 6 months A working telephone At least 2 primary care visits in the past 1.5 years Poor short-term survival (< 1 year) Inability to understand English Recent major surgery (< 3 months) Patients temporarily in the area Inability to provide consent", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 30.0-70.0, All Type 1 Diabetes Type 2 Diabetes Adult with type 1 or 2 diabetes with or without neuropathy Pathology affecting bone metabolism abnormalities of phosphate metabolism proved biologically hepatic chronic alcoholism renal insufficiency (creatinine clearance < 60 ml / min) hyperthyroidism intoxication active smoking occlusive arteritis of lower limbs (IPS > IPS 1.2 or < 0.9) Treatment affecting bone metabolism (corticosteroids or glitazones for over 3 months in the year or bisphosphonates within 6 months) Known HIV positive serology Progressive, inflammatory disease (rheumatoid arthritis, ankylosing spondylitis, bowel inflammatory)", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcer Patient is 18 years of age or older Patient has type I or II diabetes Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care Foot ulcer is on the plantar surface of the forefoot or heel Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization) Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue Patient's Ankle-Arm Index by Doppler is >/=0.7 Patient has adequate circulation to the foot as evidenced by a palpable pulse Female patients of child bearing potential must not be pregnant and must use accepted means of birth control There is clinical evidence of gangrene on any part of the affected foot The study ulcer is over a Charcot deformity The study ulcer is due to a nondiabetic etiology The ulcer has tunnels or sinus tracts that cannot be completely debrided The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm) The ulcer has increased or decreased in size by 50% or more during the screening period Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study Presence of a malignant disease not in remission for 5 years or more Evidence of severe malnutrition, based on a serum albumin level <2.0 Presence of patient having known alcohol or drug abuse", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-90.0, All Pressure Ulcers patient between 18 and 90 years old patients with a non-healing fibrinous wound \u2264 40cm2 (pressure ulcer or venous ulcers pressure ulcers were less than 2cm-deep limb wounds were venous ulcers with an ankle-brachial pressure (ABP)\u2265 0.8 signed informed consent patients pregnant or lactating patients with neuropathy patients perforant ulcer of the foot patients with dementia", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcer of Neuropathic Origin Selection Patients who fulfill all of the following (and none of the described below) are eligible to enter the placebo run-in phase of the study Provide written informed consent to participate Male or female patients age 18 years or older Type 1 or 2 diabetes A single full-thickness DFU that has been present for at least 2 weeks DFU wound surface area below or equal 34 cm2 on the target foot No exposure of bone in the target DFU Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament) No predominant ischemia requiring further exploration or treatment, and confirmed by either ABPI on the target leg ( >0.9;below or equal 1.3) or if ABPI is >1.3 or is not assessable,TBPI on target foot above or equal 0.7, OR", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Cesarean Section Cicatrix Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started Woman who speak and understand Danish Woman who can give informed consent Level I or II caesarean section (ordered less than 30 min. before surgery is started) Diabetics (this does not gestational diabetes) Infection Regular treatment with immunosuppressives Alcohol or drug abuse Age under 18 Chronic pain disease eg fibromyalgia, rheumatoid arthritis BMI over 35 Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time)", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-90.0, All Chronic Skin Ulcers Chronic wound needing debridement >3 cm2 Ulcer history >4mo Adequate arterial blood flow (ABI>0.7) Venous, Inflammatory, Pressure, Diabetic Bleeding disorder ABI<0.7 Uncontrolled diabetes Taking systemic corticosteroids Chemotherapy Participating in another study Treatment with Apligraft, Dermagraft, or Regranex within 90 days", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 49.0-69.0, All Diabetes Mellitus Clinical diagnosis of Diabetes mellitus Must be obese Previous radiotherapy to the foot previous trauma to the foot (fracture, rupture of tendon) rheumatic or vascular diseases malign diseases lymphatic edema", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-50.0, All Vitamin Deficiency Male and female between 18 years old Immigrants with background from Middle East, Africa and South Asia Daily use of vitamin D supplementation and frequently use of artificial UV light exposure Pregnancy Malabsorptive disorders Fracture in the leg /arm within the preceding 6 months. Known osteoporosis Tuberculosis, sarcoidosis, cancer, kidney dysfunction, liver dysfunction and history of kidney stone Regular use of medication that interfere with vitamin D/bone metabolism, such as glucocorticoids, diuretics, lithium, antiepileptics, bisphosphonates Regular use of strong pain killers Medication for diabetes", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-90.0, All Lower Limb Ulcer patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm\u00b2) patients in whom the surgeon has recommended that an Integra\u00ae matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis not eligible for skin flap surgery the patient or patient's representative has agreed to sign the information letter before any investigation required by the research circumferential wound wound infection immunosuppressed patient known allergy to bovine collagen, bovine glycosaminoglycans or silicone patients under legal guardianship pregnant women patients whose health would compromise follow-up for at least 18 months patients whose mental health would compromise completion of the self-evaluation questionnaires wound located in an area not visible by the patient (as no self-assessment would be possible)", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Moderatley to Highly Exuding Venous Leg Ulcers Subject > 18 years Subject is attending weekly office visits at SW Wound Care Center as an out-patient Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex Subject or is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment Subject is willing and able to comply with all specified care and visit requirements Subject has a lesion that does not meet the criteria Subject refuses to participate in the study Subject already participates in the this study with one wound (only one wound per subject is allowed) Subject has known sensitivity to the trial product or any of its compounds Subject is expected to be non-compliant Subject's lesion is a primary skin cancer Subject's lesion is the manifestation of a metastasis Subject is pregnant", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Metabolic Syndrome Impaired Glucose Tolerance Gestational Diabetes Dark Skin Tone (Von Luschan chromatic skin color > 35) Age greater than or equal to 45 years Age 18 to 44 years and a BMI > 25 kg/m\u00b2 with one or more of the following diabetes risk factors Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week) Has a first-degree relative with type 2 diabetes African American, Latino, Native American, Asian American, Pacific Islander Has delivered a baby weighing > 9 lb or previously diagnosed with gestational diabetes Hypertension (\u2265140/\u2265 90 mmHg) or being treated for hypertension HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level \u2265 250 mg/dL or being treated for dyslipidemia with medication Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS) Prior participation under VeraLight protocols: VL-2710, VL-2711 or VL-2712 Under 18 years of age Receiving investigational treatments in the past 14 days Psychosocial issues that interfere with an ability to follow study procedures Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis Diagnosed with any type of diabetes, including type 1 or 2 Taking glucose lowering medications Known to be pregnant Receiving dialysis or having known renal compromise Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Pressure Ulcers ED and ICU admission for critical illness and/or major trauma Over 18 years old Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel pressure ulcer Trauma to sacral and/or heel area", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 40.0-75.0, All Diabetes Mellitus Polyneuropathies Arthropathy, Neurogenic Patients with type 2 diabetes with and without polyneuropathy Patients with type 2 diabetes with a history of Charcot's disease Healthy controls Signed informed consent Peripheral arterial disease: toe pressure < 70 mm Hg and/or transcutaneous oxygen tension < 40 mm Hg and/or claudication Renal insufficiency: MDRD creatinin clearance < 30 ml/min Systemic disease such as vasculitis or rheumatoid arthritis Malignancy (Diabetic) foot ulcer Gout Bacterial infection of an extremity Skin condition of the dorsal aspect of the foot or the medial side of the upper arm Bleeding disorder such as hemophilia Use of medication for asthma", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Venous Ulcer Infection Is 18 years or older; male or female Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux Has a venous ulcer with a wound area between 5 cm2 cm2 Has an ankle brachial index (ABI) >0.8 Has a venous ulcer with duration less than 24 months Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation Is currently using Profore as their standard of care Has not received antibiotics for 6 weeks prior to enrollment Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver) Is currently on antibiotics Has a negative venous duplex Is unable to tolerate 4 layer compression Is unable to continue contact with the investigator for a period of at least two weeks Is unwilling or unable to comply with the study protocol", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Neuropathic Diabetic Ulcer - Foot Subject is \u226518 years of age and has type 1 or 2 diabetes Texas grade 1a or 2a wound located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth \u2264 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts Prior to of an ulcer in the study, each wound will be reviewed for by an independent assessor using a central online review process that includes images of the ulcer For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosen as the study ulcer Ulcer size between 1 cm2 and 12 cm2 (post-debridement) Ulcer duration of \u2265 30 days. Time 0 for ulcer duration of \u2265 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all including lack of ulcer healing until day 0 Study ulcer separated from other ulcers by at least 2 cm Ulcer or affected limb free of clinical signs of infection. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection) Post-debridement, ulcer free of necrotic tissue Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following: (a) Ankle-Brachial Index (ABI) \u2265 0.65 and \u2264 1.2; (b) toe pressure (plethysmography) > 50 mm Hg; (c) TcPO2 > 40 mm Hg; or (d) skin perfusion pressure (SPP) > 30 mm Hg Ulcer not of neuropathic diabetic foot pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, or arterial etiology, or pressure ulcers.) Presence of underlying osteomyelitis Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection History of alcohol or substance abuse, within the previous 2 months Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of randomization visit Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis) Subject has been treated with wound dressings that growth factors, engineered tissues or skin substitutes (e.g., Regranex\u00ae, Dermagraft\u00ae, Apligraf\u00ae, GraftJacket\u00ae, OASIS\u00ae, Primatrix\u00ae, Matristem\u00ae, etc.) within 30 days of randomization or is scheduled to receive during the study Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study Wound on a patient who has a life expectancy of less than 12 months Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Lower Extremity Diabetic Leg Wounds Lower Extremity Venous Leg Wounds Lower Extremity Mixed Aetiology Leg Wounds Patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area <100 cm2 and <10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. Diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease) Wound present for >30 days Patient has wound in location amenable to creation of airtight seal around wound using TNP dressings Patient is able to comply with study protocol requirements Patient is able to understand and provide written consent Patient has evidence of wound infection in the opinion of the physician Patient has a thick eschar that persists after wound debridement Patient has an HbA1C >12% Patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis Patient has untreated osteomyelitis Patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study Patient is allergic to the wound care device or occlusive dressing Patient has exposed blood vessels Patient is pregnant or pregnancy is suspected Patient is actively participating in other clinical trials that may interfere with their participation in this study", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 3.0-999.0, All Mycobacterium Ulcerans Disease Buruli Ulcer Patients with a clinical picture of Buruli ulcer disease in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin, will be included at start of antibiotic treatment All stages of the disease will be included. Only patients with confirmed disease by direct microscopy following acid-fast staining or PCR will be included Patients not on the standard treatment of eight weeks of rifampicin and streptomycin for any reason, will be excluded from this study Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or immune-modulatory drugs including corticosteroids within the previous one month Patients not compliant with the antibiotic therapy will be excluded as well. Non-compliance is defined as the use of < 70 % of the prescribed antibiotics Patients with a contraindication for general anaesthesia are not able to participate Pregnancy Osteomyelitis Lesion close to the eye, with preferred standard treatment to wait for effect antibiotic treatment on extent surgery The BUFLS (Buruli ulcer functional limitation score) cannot be applied to children below three years and therefore will not participate Patients reporting to refuse surgery at any point in the intended treatment, cannot be included Any situation or condition which may compromise ability to comply with the trial procedures", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Varicose Ulcer Patient over 18 years old who has provided his/her written informed consent Patient who can be monitored by the same investigation team throughout the duration of the study Patient who agrees to wear effective venous compression every day, associated with the trial dressing Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2 Ulcer duration between 3 and 36 months Ulcer where the surface area is 70% or more covered by fibrinous tissue Ulcer at least 3 cm away from any other lesion Ulcer moderately or strongly exudative justifying the use of an absorbent dressing Female patient of child-bearing potential who has no effective means of contraception Patient who is pregnant or breastfeeding Patient taking part in another therapeutic trial Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid) Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy Patient with a systemic infection not controlled by suitable antibiotic treatment Patient who, during the 3 months before presented a deep vein thrombosis Ulcer where its surface is totally or partially covered by black necrotic plaque Ulcer which is clinically infected", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-90.0, All Evaluate Surgical, Medical and Pharmacological Factors Influence on Wound Healing Following Primary Arthroplasty Surgery All patients receiving primary hip or knee arthroplasty at Hvidovre Hospital from january 2012 to january 2014 Not willing to participate Drop out at 3 week follow up", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 20.0-62.0, All Ischemic Ulcer Ischemic lower limb based on TASK guide line Rutherford score:2,3 ABI<0.6 Absolute ankle pressure < 60 mmHg Both gender Age:20-62years EF<30% Cr>2 HbA1c>8% Bone marrow disorders:leukemia Cognitive disorders Infections MI with ST elevation during last month Malignancy Immunologic or rheumatologic disorders", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-70.0, All Diabetic Foot Ulcer Adult diabetic foot syndrome subjects over 18 years of age of any sex All stages of diabetic foot syndrome including Wagner stage 5 Mid-foot gangrene only after appropriate surgical treatment Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome Stable metabolic and pharmacological control at recruitment and during the trial period Adequate perfusion of lower limb as measured by HHD and confirmed by APSV Non-diabetic foot ulceration (traumatic, thermal ulceration etc) Diabetic foot syndrome graded 5 on Wagner's scale hind foot gangrene only Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized Presence of slough or sequestrum unless debrided Hemoglobin less than 8 g/dl unless corrected Those receiving NSAIDs, steroids or anti-mitotic drugs Septicemia patients requiring urgent amputation", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 0.0-999.0, All Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy ", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 40.0-75.0, All Foot Ulcer, Diabetic between ages 40 and 75 history of diabetic neuropathic plantar ulcer (test subjects) no history of diabetes (control subjects) no peripheral sensory neuropathy (control subjects) amputation or surgery on right Great Toe", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 0.0-999.0, All Osteoarthritis, Hip Joint Deformities, Acquired Hip Dislocation, Congenital Osteonecrosis Arthritis, Rheumatoid Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year Patients with pre-existing known coagulopathy Patients on chronic Coumadin (Warfarin) therapy Patients receiving erythropoietin therapy for anemia", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-75.0, All Ottawa Score Adenoma patients undergoing colonoscopy disturbance of water and electrolyte history of colorectal surgery severe colonic stricture or obstructing tumor known or suspected bowel obstruction or perforation toxic colitis or megacolon dysphagia compromised swallowing reflex or mental status significant gastroparesis or gastric outlet obstruction or ileus severe chronic renal failure (creatinine clearance \uff1c30 mL/minute) severe congestive heart failure (New York Heart Association class III or IV)", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Mellitus Diabetic Neuropathic Foot Ulcer More of 18 years old man or woman Type 1 or 2 Diabetes mellitus A new plantar ulcer of the fore foot or the toes GRADE 1A or 2 A of the University of Texas Classification Neuropathy assessed by absence of sensation in 10g monofilament test Severe angiopathy (Grade 3 of the PEDIS classification) Osteomyelitis or cellulitis of the foot Transmetatarsal amputation Other study in course Immunosuppressive drugs, antibiotic therapy Hepatic insufficiency No possibility to follow the patients every 14 days No state health insurance Pregnancy", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Ulcer Skin Ulcer Leg Ulcer Diabetic Foot Patient is 18 years old or older Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound Patient's target study ulcer/wound is a lower extremity full thickness ulcer/wound not involving tendon, capsule, or bone Patient's target study ulcer/wound and is \u22651.0 cm2 and \u2264 10.0 cm2 in size at the day of initial consult Study ulcer/wound has been present for greater than 6 weeks prior to initial consult Patients with Charcot foot deformities can be entered so long as the Charcot disease is not active, and the ulcer can be offloaded by an orthotic device The patient has adequate circulation to the lower extremity as evidenced by an ABI (measured by Doppler) of \u2265 0.7. If the patient has non-compressible leg arteries, as documented by an ABI >1.3, then the patient must have a Toe-Brachial Index be > 0.6, or a toe pressure >50 mm Hg Patient must have adequate in-home support to comply with all protocol-mandated visits and procedures, offloading or pressure redistribution as required, and proper application of study products and wound care regimen Patient or his/her legal representative has read and signed the Institutional Review Board-approved Informed Consent form before Screening An ulcer/wound that is \u226510.0 cm2 and \u2264 1.0 cm2 in size at the day of initial consult is not eligible for this study Patient has clinical evidence of gangrene or infection on any part of the affected foot The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits Patient has clinical evidence of active sepsis or invasive infection (e.g., cellulitis, osteomyelitis) Patient has muscle, tendon, or bone exposure in any ulcer bed Patient has known sensitivity or allergy to any component of the study product Olivamine10 Patient has one or more medical condition(s), including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the Investigator would make the patient an inappropriate candidate for this wound healing study Patient has a malignant disease (other than squamous or basal cell carcinoma of the skin) not in remission for five years or more", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Peripheral Artery Disease Without Critical Limb Ischemia Patients need to be at least 18 years old Patients have to be admitted to the university hospitals of Geneva for a non-healing lower limb ulcer Eligible patients are those presenting with non-healing lower limb ulcers for more than 3 months Patients will be hospitalized in the Dermatology inpatient clinic Patients had to benefit from at least one thin skin autograft at the ulcer level in the past or during the index hospitalization Before in the study, patients must undergo complete angiological diagnostic work-up including A baseline ABI, toe pressure and tcPO2 measurements A non-invasive arterial imaging including an angio-CT scan or an angio-MRI The non-invasive arterial work-up must revel mild to moderate PAD, without any or sign of CLI (see flow-chart) Ankle pressure \u2265 50 mmHg Patients who refused to give their written informed consent Patients, in whom the angiological work-up shows the presence of a CLI, mandating a revascularization procedure attempt (i.e. ankle pressure < 50mmHg, toe pressure < 30mmHg, tcPO2 < 20mmHg) (see particular situation n\u00b02) Patients who do not present with peripheral artery disease (i.e., ABI > 0.9 < 1.3, TP > 100mmHg, tcPO2 > 40mmHg) Patients in whom the angiological-dermatological work-up shows the presence of another reversible cause of the non-healing ulcer Special attention will be given to the presence of a treatable venous insufficiency (e.g. compression stocking, varices stripping), an underlying inflammatory/infectious process (treatable with antibiotics or topic-systemic antiinflammatory medications) or other reversible mechanical factors (unadapted shoes, etc.) Patients without any significant lesion of the arterial tree (ilio-femoro-popliteal and infra-popliteal) In case there will be a single BTK vessel disease not perfusing the ulcer area (e.g. pre-tibial ulcer with a significant stenosis of the posterior tibial artery which does not perfuse the ulcer region), the patient will not be included in the study because any significant ulcer improvement would be expected from this non-target vessel revascularization Patients in whom the scheduled revascularization procedure will be judged too risky for the patient's safety Chronic kidney failure (= Creatinin Clearance < 20ml/min) with an increased risk of contrast induced nephropathy", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 5.0-20.0, All Neurogenic Bladder Diagnosis of spina bifida and neurogenic bladder Performing clean intermittent catheterization (CIC) Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder Has not had previous bladder surgery Has had a urodynamic or videourodynamic study done within the last 6 months Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study Urodynamic study (UDS) showing either detrusor leak point pressure >40cm H2O; 30cm below capacity <60% of total bladder capacity, 20 cm capacity <70% of bladder capacity Able and willing to complete CIC Diaries and Quality of Life Questionnaires Consent and assent given to participate in trial History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia Positive urine culture Known allergy to Botox", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 10.0-17.0, All Type 1 Diabetes Mellitus English-speaking patients to 18 years diagnosed with type 1 diabetes for at least 12 months poor diabetes control as defined by having a hemoglobin A1c value > 8% type 2 diabetes developmental delay current participation in another study that may impact glycemic control", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Detrusor Function, Overactive Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement [due to muscle weakness], trembling and sweating), or cerebrovascular accidents (CVAs stroke-sudden loss of blood supply to brain) Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control Overactive bladder symptoms and/or has urge incontinence episodes Must have normal results on urine culture tests and on urinalysis ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3 Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness [myasthenia gravis]; paralysis or inactivity in the intestines that prevents material moving through the gut [intestinal atony or paralytic ileus]; severe inflammation of the bowel [ulcerative colitis] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease [toxic megacolon]; history of major lower urinary tract surgery [transurethral resection will be excluded]) Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose) Pregnant or breast feeding female Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 45.0-65.0, All Fibromyalgia fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure any past hyperbaric oxygen therapy chest x-ray pathology which does not allow the income into the hyperbaric chamber middle ear problems patients, who cannot \"pump\", equals middle ear pressure, effectively patients who suffer from claustrophobia inability or Refusing to sign the Informed Consent Form", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-69.0, All Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results Specific for subject with type 1 diabetes Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive) Specific for subject with type 2 diabetes Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening Treated with insulin for the past 3 months prior to screening Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive) Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator Subject with a history of or presence of cancer Any condition that the Investigator and/or Sponsor feels would interfere with study Specific for subject with type 2 diabetes Therapy with oral antidiabetic drugs within the past 3 months prior to screening", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-92.0, All Bowen's Disease Korean patients aged \u2265 18 years who had biopsy-confirmed BD lesions on the lower extremities porphyria known allergies to the MAL cream or lidocaine pregnancy lactation any active systemic infectious disease immunosuppressive treatment personal history of malignant melanoma tendency towards melasma or keloid formation prior treatment of the lesions within 4 weeks, and any indication of poor compliance", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Chronic and Acute Wounds, Diabetic Foot Ulcers and Venous Leg Ulcers Below the Knee Subjects who meet the following may be included in the clinical investigation, if they present with ALL of the following Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures Age 18 years and older. Subjects may be of either sex and of any race or skin type Subjects fulfilling any one or all of the following chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma diabetic foot ulcer(s) subjects with venous leg ulcers below the knee on the leg or foot with one or more documented failure of maximal medical therapy for their study wound >30 days such as compression bandages (low elasticity, elastic, multilayered, elastic and non elastic compression) Subjects with the following lab results within 30 days of treatment serum albumin level >20g/L Subjects will be excluded from the clinical investigation, if they present with ANY of the following Subjects that have tunneling wounds Subject presents with an active infection in the study wound, as defined by purulence and Fever and leukocytosis OR any TWO of the following Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images) Subjects whose study wound does not require debridement Cardiac pacemaker or other electronic implant(s) Subjects with irradiate, burn or ischaemic wounds or history of keloids", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcer Is aged \u2265 18 Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America (IDSA) Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis Meets certain minimal laboratory criteria Has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol Has received > 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. If a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled Requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Leg Ulcer Diabetic Foot Ulcer Pressure Ulcer Low to highly exuding chronic wound(wound history > 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer Male of female, 18 years and above Signed Informed Consent Form Pregnancy or lactation Wound size not suitable for the wound dressing size Known allergy/hypersensitivity to any of the components in the dressing", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-60.0, All Post-concussion Syndrome Adults, age 18-60, both men and women Able to speak and read English as primary language Able and willing to provide written informed consent for study participation Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure Past history of at least one mild traumatic brain injury with persistent symptoms that meets all of the following 1) Brain injury occurred at least 1 year but no more than 5 years prior to enrollment; 2) Brain injury occurred as an adult (at least 18 years of age); and, 3) Brain injury occurred due to non-penetrating trauma and is graded as mild At least 3 of the following persistent post-concussive symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, or ringing in the ears Diabetes mellitus Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months) Claustrophobia precluding chamber or hood tolerance Implanted devices not cleared for hyperbaric pressurization Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control through the 13-week assessment visit Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease, that raises the risk for pulmonary barotrauma due to air trapping Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygenation Prior military service in theater Alcohol abuse, by self-report, within the last year", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Varicose Ulcer Male or female over the age of 18 years Chronic venous ulceration Defined as wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85 Ulceration present for at least four weeks Colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction Acute infection in the studied lower limb within the last four weeks History of malignancy in the lower limb to be studied History of connective tissue disease Patients on medications that can cause immunosuppression Corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 20.0-999.0, All Pressure Ulcer Wound Necrosis over 20 years of age subject who has untreated wounds subject who has wound size over 3cm x 3cm subject who has wound over stage 2 cellulitis", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Pedal Ulcers Men or women >18 years old One or more foot ulcers without clinical evidence of osteomyelitis Diagnosis of Diabetes Mellitus* University of Texas Grade 1A, 1C, 2A, or 2C ulcer15 ABI >0.7 and Toe pressure >30mmHg Limited life-expectancy Wounds on calf or shin that would be in contact with the TAG Brace Gangrene, active infection Osteomyelitis of the foot with the ulcer Chronically bedridden/Non ambulatory Unable to keep research appointments Wide spread malignancy or systemically immunocompromising disease Ipsilateral revascularization procedure within the last 30 days Unreliable, unwilling or unable to comprehend informed consent", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 14.0-24.0, All Diabetes Mellitus Type 1 diabetes Males and females Age between 14-24 years Any diabetes duration Cared for by the diabetes center for at least 1 year HbA1c \u2265 8% Basal bolus treatment (any insulin) Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recommended Blood Glucose measurements recorded in the glucose meter in the two previous weeks, i.e. <16 Blood Glucose measurements in the last two weeks) Written informed consent obtained from patient or legal representative (for minor) Treatment with other insulin regimen or Continuous Subcutaneous Insulin Infusion Refusal or inability to give informed consent to participate in the study Patients with short life expectancy Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment Requirement for concomitant treatment that could bias primary evaluation Patients with high likelihood of being unavailable for 6 and/or 12 months visits Subject is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study Current addition/abuse of alcohol or drugs Severe visual or dexterity impairment Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-75.0, All Diabetic Foot Ulcer diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2 previous vascular surgery on the side that the ulcer is present uncontrolled diabetes mellitus presence of osteitis, abscess, osteomyelitis, gangrene on the side that the ulcer is present diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 3", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 19.0-999.0, All Type 2 Diabetes Mellitus age >19 years of age type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes A1C \u22658% in past 1 year willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments ability to provide informed consent self identify as South Asian (from India, Pakistan, Sri Lanka, or Bangladesh) regardless of generational status or timing of immigration with ability to speak in English or Punjabi life limiting illness <12 months physical inability to exercise recurrent severe hypoglycemia or hypoglycaemic unawareness family member of, or living in same household as a participant pregnancy or gestational diabetes", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Atopic Dermatitis Eczema Male or female subjects who are not pregnant or lactating 80 years of age Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic for atopic dermatitis Presence of lesional atopic dermatitis skin in both antecubital fossae Positive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/exclusion (one week prior to the screening, treatment and follow-up visits for topical medications and 28 days prior to screening, treatment and follow-up visits and for oral medications) Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier Any subject who is immunocompromised (e.g. provides researchers with a history lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanomatous skin cancer). This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol Active bacterial, viral or fungal skin infections Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Diabetes Mellitus Diabetes Complications Diabetic Neuropathies Wound Infection an adult patient (18-80 years) suffering from infected neuropathic fore or mid-foot ulceration originated from type I or II diabetes (PEDIS-classification \u2265 Grade II) a patient whose life expectancy is less than 6 months an ulceration of ischemic or neuroischemic origin presence of systemic inflammatory response signs heel ulceration presence of osteomyelitis pregnancy known hypersensitivity to any of the ingredient including in the study or control treatment products a patient who is unable to give informed consent a patient who has an advanced malignant disease", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 5.0-18.0, All Ulcerative Colitis (UC) Informed consent Established diagnosis of UC disease Age: 5 years ( inclusive) Mild to moderate active disease, 10 \u2264 PUCAI \u226445 Stable medication (IMM/ 5ASA) use for the past 6 weeks For patients who received antibiotic treatment: age 10-18 (inclusive) Any proven infection such as positive stool culture, parasite or C.difficile Use of Antibiotics Use of steroids in the previous two weeks only Patients that are refractory to full dose steroids ( 1 mg/kg/day) Past acute severe UC Current Extra intestinal manifestation of UC Pregnancy A subset of patients who are on steroids and relapse during steroids treatment \u22640.5 mg/kg with mild to moderate disease activity will act as a second subset for this exploratory study", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcers Men or women Type 1 or 2 diabetes Age \u2265 18 years Wagner 1 or 2 diabetic foot ulcer Diabetic ulcer for more than 8 weeks duration Willing to participate in the study with signed informed consent Ankle/brachial index < 0.4 (critic ischemia) Use topical or systemic antibiotics Inability to attend to the weekly evaluations Inability to do daily ulcer cleansing Autoimmune diseases Active pharmacologic topical or systemic ulcer treatment Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy Pregnancy or lactation", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy Patients between ages 18-90 with Diabetes type I or II and diabetic retinopathy who are scheduled for hyperbaric treatment for other indications than DR Patients who signed an informed consent form and agree to undergo an ophthalmic physical examination, Fundus photography and OCT prior to hyperbaric treatment and oCT exam following every 10 treatments in hyperbaric chamber. Total number of hyperbaric treatments will be conducted according to the main indication for which they have been assigned this treatment Patients with Carotid stenosis of more than 70% Anemia of < 10mg/Dl Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment Patients with claustrophobia or that cannot decompress properly Patients with any malignant disease Patients with inability to sign informed consent Decompression treatment will last 90 minutes in 2 atmospheres pressure with 100% oxygen", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcer Patients receiving care and treatment in OUH Wound Clinic (Odense University Hospital, Denmark) with a diabetic foot ulcer Wagner groups 1 and 2 (Wagner Ulcer Classification System) Patients with an ulcer duration of less than 2 months Ulcer area less than 0,5 x 0,5 cm (or less than 0,25 cm2) Patients who have had vascular surgery performed within the past 2 months Patients who cannot give informed consent Patients who do not read or speak danish Wagner groups 3 and 4 (Wagner Ulcer Classification System)", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 21.0-999.0, All Diabetic Foot Ulcers Bacterial Infection Veterans over 21 years of age with chronic diabetic foot ulcers (wound duration over 8 weeks) who at the clinician's judgment requires wound debridement (25% or more of wound bed covered with non-viable tissue) wound size 1.5 cm (roughly the size of a quarter) or larger in diameter Cognitive impairment that would interfere with patient signing own Informed Consent Veterans on active anticoagulant therapy with most recent (within last week) PT/INR (international normalized ratio of prothrombin time) > 3.0, or other significant bleeding risk Active immune suppression just prior to or during study (on systemic corticosteroids* within 7 days prior, or chemotherapy for cancer or RA treatment within 4 weeks prior to study, or with diagnosis of HIV/AIDS) *Nasal steroid sprays will not be excluded Active systemic antibiotics is an Absent dorsalis pedis pulses and Ankle Brachial Index (ABI) < 0.5 is an (indicates critical limb ischemia) Other possible reasons participants could be removed from this study transfers to other non-VA facilities, participant is unable to tolerate tissue sampling even with local anesthesia, and/or inability to comply with scheduled research visits. Furthermore, if the participant has significant wound healing so that sampling is not possible after the initial sampling, they will be removed from the study", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcer Type 2 Diabetes Male or female, age \u2265 18 Type 2 Diabetes A break in the skin on the foot \u2265 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system Hemoglobin A1c \u2265 5.9% Ability to provide written informed consent Any experimental drugs taken orally or topically within 4 weeks of study entry Malignant disease at/or in proximity to the DFU Target wound of malignant origin Failure to satisfy at least one criterion for one of the two study groups", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-70.0, All Eczema Healthy male or female \u2265 18 and \u2264 70 years of age Body mass index (BMI) \u2265 20 and \u2264 35 kg/m2 Subjects with mild to moderate eczema; determined at screening visit Judged by the Investigator to be in general good health on the basis of medical history Agree to use the Study-supplied cleanser and moisturizer as the only body cosmetic applied to irritated skin Agree to stop all medications and supplements during the entire length of the study Females of child bearing potential must agree to use appropriate birth control methods during the entire study period Agree not to initiate any new exercise or diet programs during the entire study period Agree not to change their current diet or exercise program during the entire study period Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder Known allergy or sensitivity to Herbal products History or presence of cancer in the prior two years, including any skin cancer or suspicious lesions Recent history of alcoholism (within 12 months) or strong potential for alcohol or substance abuse Participation in a clinical study with exposure to any non-registered drug product within 30 days prior Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study Smoking must be nonsmoker for at least 12 weeks prior to screening", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Central Retinal Vein Occlusion Patients age 18-80 years with a documented CRVO who treated by Avastin for more than 12 months Patients who signed an informed consent form Patients with Carotid stenosis of more than 70% Anemia of < 10mg/Dl Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment Patients with claustrophobia or that cannot decompress properly Patients with any malignant disease Patients with inability to sign informed consent", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-85.0, All Foot Ulcer, Diabetic Infection Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria Has at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America guidelines for the \"Diagnosis and Treatment of Diabetic Foot Infections\" (CID 2012; 54:132-173) (IDSA guidelines) has \u2265 2 manifestations of inflammation (local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge (thick, opaque to white or sanguineous secretion) has \u2265 1 of the following characteristics: erythema > 2cm, or involving structures deeper than skin and subcutaneous tissues (e.g. abscess, osteomyelitis, septic arthritis, fasciitis) For patients with multiple infected ulcers, the ulcer with the highest Diabetic Foot Infection Wound score (DFI score) must be on or below the malleolus and all infected ulcers must be completely coverable using no more than 4 sponges (sponges cannot be cut) Has documented adequate arterial perfusion in the affected limb(s) (either palpable dorsalis pedis and posterior tibial pulses, or normal Doppler wave forms, a toe blood pressure \u2265 45 mm Hg or participation is approved by a vascular surgeon) Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis Has received appropriate surgical debridement to remove all gangrenous tissue Has a known history of hypersensitivity to gentamicin (or other aminoglycosides) Has a known or suspected hypersensitivity to bovine collagen Has an ulcer infection which, based upon the patient's known history of hypersensitivity and/or as otherwise in the opinion of the investigator, cannot be adequately treated with at least one of the empiric systemic antibiotic regimens allowed by this protocol Has an ulcer associated with prosthetic material or an implanted device Has received any systemic or topical antibiotic therapy for any reason within 7 days of randomization unless it was administered to specifically treat the infected ulcer(s) and only within 36 hours of randomization Requires or is likely to require treatment with any concomitant topical product or wound therapy before the first follow-up study visit Is severely immunocompromised, or likely to become severely immunocompromised during the study, in the opinion of the investigator Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the investigator Has a history of epilepsy Has a history of alcohol or substance abuse in the past 12 months", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Mellitus, Type 2 Adults 18 years and older (to be confirmed by electronic health record) Individuals who have received a diagnosis for type 2 diabetes mellitus (T2DM) Enrolled as a patient in the Vanderbilt APPC or the Eskind Diabetes Clinic Registered My Health at Vanderbilt user Individuals currently being treated with oral and/or injectable diabetes medication (to be confirmed through electronic health record) Non-English speakers (determined by a trained research assistant) Individuals with a severe hearing or visual impairment (determined subjectively by a trained research assistant) Individuals with delirium or a severe cognitive impairment (determined by a lack of orientation to person, place, and time) Individuals who report a caregiver administers their diabetes medications Individuals who report they do not have a mobile phone or computer with internet access Individuals unwilling and/or unable to provide written informed consent", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Ulcer Wounds A signed and dated informed consent has been obtained from the subject Subject is able and willing to comply with study procedures Subject is able to comply with weekly visits Subject is 18 years of age or older There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2 Subject will not have currently used parenteral or oral antibiotics except for UTI Diabetic subjects: HbA1c < 12.0 % within 90 days preceding enrollment Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory Steroid use >5mg daily Subject is unable to cooperate with offloading and/or compression recommendations ABI = or >0.8 if the wound is located on a lower extremity Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment Subject has medical instability as deemed by the investigator Subject is pregnant Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-80.0, All Foot Ulcer Varicose Ulcer Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Ju\u00e1rez, Quintana Roo Patients of both sexes Patients over 18 years Patients that have basic laboratory at admission (complete blood count with differential) Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc Hemodynamically unstable patients Patients with septic shock from any source Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure Patients with secondary cutaneous ulcer enteral fistula Patients with cutaneous ulcer or cancer tumors Patients with cutaneous ulcer with active bleeding Patients with cutaneous ulcer necrosis Patients with cutaneous ulcer leishmania, insect bite Patients with cutaneous ulcer burns Patients who do not accept their participation in the study through informed consent", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 0.5-85.0, All Xerosis Cutis Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study Child specific written informed consent, if over 7 years of age Subjects with a general good and stable health condition Subjects with clinically stable medical conditions Accept to abstain from sunbathing and solarium during the study Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs TEWL > 12 g/m2/h on the left mid volar forearm Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars Suffering from porphyria Suffering from severe photodermatoses according to the judgment of the investigator Clinically significant, possibly unstable medical conditions such as metastatic tumor Currently having other malignant or benign tumors of the skin in the investigational area Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol Use of (medical) oil-containing bath additives or other oil-containing cleansers Current topical or systemic treatment affecting the skin, e.g. diuretics Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-65.0, All Infection Cohort 1: Diabetic hyperbaric patients with active, chronic infection Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications diabetic lower extremity wounds or refractory osteomyelitis) Diabetes mellitus Current antibiotic use for active infection Prior treatment with hyperbaric oxygen within the last 30 days Consistent vitamin C or vitamin E supplementation in the past year Active tobacco use Pregnancy Cohort 2: Hyperbaric patients without diabetes or active infection Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications crush injury, acute peripheral arterial insufficiency, or radiation necrosis) Prior treatment with hyperbaric oxygen within the last 30 days Consistent vitamin C or vitamin E supplementation in the past year Active tobacco use Pregnancy", "label": "2"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Leg Ulcers Patient over 18 years old who has provided his/her written informed consent Patient who can be monitored by the same investigation team throughout the whole duration of the study Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 Ulcer area > or equal to 5cm2 Ulcer duration > or equal to 6 months Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue Moderately or heavily exudative ulcers Clinical infection on the wound bed", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-100.0, All Diabetes Diabetes Complications Neuropathy Peripheral Neuropathy Diabetic Foot Ulcer Diabetes (according to AAFP diagnostic ) Presence of neuropathy with Loss of Protective Sensation (LOPS), as defined by any loss of sensation as per the assessments included in the Modified Neuropathy Disability Score (MNDS) Active plantar diabetic foot ulcer (Grade 1A, according to the University of Texas Wound Classification System , ) A minimum size ulcer \u22651cm2 and \u2264 12 cm2 post debridement at time of randomization If the subject has more than one ulcer, they should be identified and at least 2 cm apart The duration of the study ulcer is at least 30 days at the time of the screening visit Age >18 At least one palpable foot pulse Ability to understand all of the study requirements Life expectancy greater than the duration of the study Weight > 400 lb (182 kg) Uncorrected visual impairment Active Infection Non-plantar ulcers on the ankle, posterior heel, or other location More than one active plantar ulcer Presence of severe ischemia (any of: absence of foot pulses, Ankle Brachial Index 0.6 > [ABI] > 1.2, capillary refill time > 5 seconds; see Appendix 3) Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study Current smokers Active abuse of alcohol o Subject has a history of any of the following intercurrent illnesses or conditions that would compromise the safety of the subject or the normal healing process", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Lower Limb Ulcers Patient is 18 years of age or older Patient has one of the following difficult-to-treat chronic ulcers in the lower limb 1. Neuropathic lower limb ulcer 2. Venous lower limb ulcer 3. Post traumatic lower limb ulcer 4. Post operative lower limb ulcer In case of Neuropathic foot grade according to University of Texas Classification 1A Wound area measurement ranging between 1-20cm2 Acute ulcer Multiple Ulcers on the lower limb Clinical evidence of infection in the soft tissue, joint and/or bone (osteomyelitis) as presented in the physical examination The wound is penetrating into deep structures and involves bone tendon or joint Wound has necrotic tissue Wound with sinus tracts HbA1c>12 Patients with any other skin disorder unrelated to the ulcer that is", "label": "0"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-60.0, All Diabetic Foot Ulcer Subject is between 18 years and 80 years of age Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit Ulcer located the foot, and ulcer size is between 1 cm2 and 25 cm2 Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2) Ulcer is free of necrotic debris Subjects had adequate circulation to ulcer as documented by either Palpation of pulses around ulcer using Doppler exam Ankle Brachial index (ABI) values ranging between 0.7 and 1.3, or Transcutaneous Oxygen Pressure (TcPO2) > 30 mmHg Subject is able to give written informed consent prior to study start and to comply with the study requirements Ulcer is of non-diabetic pathophysiology The ulcer has increased or decreased in size by 30% or more during one week after the screening visit Subject is Human Immunodeficiency Virus (HIV) positive Subjects with severe hepatic deficiencies Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15% Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue Subjects requiring intravenous (IV) antibiotics to treat the index wound infection Subjects who are currently receiving dialysis Subjects who are pregnant or breast-feeding Subjects who are unwilling to use an \"effective\" method of contraception during the study", "label": "1"} +{"topic": "64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Mellitus Diabetes patients who are users of CVD risk factor medications (antihypertensive therapies, antihyperlipidemics therapies, and oral antihyperglycemic therapies) Diabetes patients considered to be poorly adherent to CVD risk factor medications within the prior 12 months Diabetes patients who have not used the mail order pharmacy to fill any prescribed medications at least once in the prior 12 months ", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Patients must have Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry Required Current treatment with lithium carbonate ", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 8.0-18.0, All Bipolar Disorder Depression Free of manic symptoms for at least 4 weeks. Must be treated with valproate or lithium (mood stabilizers) for at least 4 weeks. Meet for major depression and bipolar disorder (BP-I, BP-II, or BP-NOS). Not pregnant Patients with schizophrenia, autism, schizoaffective disorder, organic mood disorder, obsessive-compulsive disorder, eating disorder, and psychosis. IQ less than 70. Significant chronic medical illness such as diabetes, epilepsy. Pregnancy. Substance abuse in last 3 months. Concurrent psychotherapy. Previous lack of response to adequate treatment with fluoxetine or other SSRI. Current use of psychoactive medication other than lithium or valproate", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Tobacco Use Disorder Smoke at least 10 cigarettes per day Report concern about cessation-related weight gain Motivated to quit smoking Currently pregnant, lactating, or no medically approved method of contraception Major medical problem History of seizure disorder or head injury Current or historical psychosis or bipolar disorder History of alcohol or substance abuse within previous year Current or historical eating disorder Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month Multiple Drug Allergies Current major depressive disorder", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 15.0-999.0, All Bipolar Disorder General current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways) able to give informed consent for data to be harvested meet DSM-IV for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies meet with Clinical Specialist as scheduled able to complete all Study Registry Forms within 3 months of registration General unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations) not competent to give informed consent in the opinion of the investigator (e.g., psychotic) Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-75.0, All Bipolar Disorder ARE NOT BEING FOR THIS STUDY FOR Patients must meet the following in order to participate in the study Male or female inpatients in need of treatment for severe bipolar depression 18-75 years of age Women of childbearing potential must be using an adequate form of contraception as defined by one of the following: 1) a barrier method and 2) oral contraceptives plus a barrier method (women who are on an OCP will be kept on it others must agree to use only a barrier method) DSM-IV diagnosis of bipolar depression I/II, severe, with or without psychotic features A current major depressive episode of at least 6 weeks' duration Score of greater than or equal to 18 on the first 17-item HAM-D at the prestudy visit and at the first baseline phase visit Score of 15 or greater on the HAM-D (17) at the end of the baseline period(s) (i.e., at randomization no more than 20% less than entry enrollment criteria) FOR Patients will be excluded from the study if they meet any of the following Women who are pregnant, intending to become pregnant in the next month or breast-feeding Treatment with any of the following therapies within the specified interval prior to baseline: Fluoxetine weeks; Investigational compounds 4 weeks; MAOIs 1 week; Other antidepressants 1 week Contraindication or history of hypersensitivity to mifepristone as well as cortisol, and CRH Clinically significant organ system disease where mifepristone would be contraindicated or interfere with medical treatment Have evidence of any disorder that represents a contraindication to the use of mifepristone (such as adrenal disease or a condition requiring chronic corticosteroid administration) History of Addison's Disease, Cushing's Disease, insulin dependent diabetes, or other uncompensated endocrine conditions Evidence of infection, severe liver, respiratory, or renal disease", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Schizophrenia Psychotic Disorders Bipolar Disorder You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine You must be able to visit the doctor's office as scheduled for the next 4 months You have a history of an illness that would cause weight loss or gain in the near future You have taken remoxipride within the past 6 months You are allergic to olanzapine or Anti-obesity Agent You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke You have a serious medical illness, such as heart, liver, or kidney disease You are pregnant or breast feeding", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 16.0-999.0, All Bipolar Disorder Bipolar I or II Disorder Meet for rapid cycling, defined as four or more episodes over the past 12 months Meet for a major depressive episode History of intolerability of lithium, divalproex, or lamotrigine", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 15.0-999.0, All Depression Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale Child who is 6 weeks to 30 months old Child who is enrolled in an Early Head Start program Regular use of psychotropic medication Regular use of psychotherapy or drug/alcohol treatment", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 0.0-999.0, All Alzheimer Disease Patient is between the ages of 40 and 90 (inclusive) Patient will have a diagnosis of AD; the study will be confined to patients who are able to provide consent (pass a capacity assessment) The modified Hachinski Ischemia Score must be less than 4 Brain MRI performed within 15 months of enrollment must be compatible with the diagnosis of AD Patient and/or caregiver are willing to adhere to protocol requirements as evidenced by written, informed consent Patients meeting any of the following during screening or during the study will not be enrolled or will be immediately excluded from the study, as appropriate Patient has a history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk Patient has clinically significant laboratory abnormalities that would preclude administration of lithium and divalproex Patient is taking a prohibited concomitant medication. The following medications are forbidden for at least one month prior to the treatment phase (unless otherwise noted) and during the course of the study Any investigational drugs Anti-depressants (eligibility will be considered as long as dosage remains stable throughout the study) Anticonvulsants and other mood stabilizing drugs Treatment that may provoke lithium toxicity due to reduced renal clearance, including metronidazole, spectinomycin, tetracycline Treatment that may substantially increase steady-state plasma lithium levels resulting in lithium toxicity, including angiotensin-converting enzyme inhibitors, diuretics", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-55.0, All Cannabis Dependence Substance Withdrawal Syndrome DSM-IV diagnosis of cannabis dependence with at least a three-month history Seeking treatment for primary cannabis problem Withdrawal identified as barrier to abstinence Other drug dependency (excluding nicotine) Client is breastfeeding or pregnant Client has contraindicated medical or psychiatric conditions Client currently taking other medications that may interact with lithium Known hypersensitivity / side effects with Lithium Currently receiving Lithium from another source Currently prescribed any antidepressant / mood stabilising / antipsychotic medication Currently receiving opioid pharmacotherapy", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 8.0-17.0, All Bipolar Disorder Attention Deficit Hyperactivity Disorder Age: 8-17 BD type I or II comorbid with ADHD Baseline score in the YMRS > or = 20 IQ < 70 Pharmacologic treatment in the last month Pregnancy or absence of a contraceptive method in fertile girls Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency Risk of suicide or homicide Clinical condition that might interfere in the study Known sensibility to aripiprazole", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorders Aged 18-65 Minimum two year history of depressive and hypomanic episodes Mood episodes occuring monthly Meet DSM-IV for Bipolar II Disorder (with exception of minimum 4 day period for hypomanic episodes) Previous treatment with any antidepressant, mood stabilizer or neuroleptic medication History of psychotic symptoms during hypomanic or depressive episodes Current suicidal behaviours Current substantive illicit drug use or alcohol consumption Significant personality disorder Pregnancy or breastfeeding History of heart disease, liver disease, epilepsy or seizures", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 25.0-55.0, All Insomnia Primary Insomnia Psychophysiologic Insomnia Ages 25 a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m Patients with Primary Insomnia will meet diagnostic for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD) complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months Unstable medical or psychiatric illness Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.) symptoms suggestive of sleep disorders other than insomnia polysomnographic data indicating sleep disorders other than insomnia Evidence of active illicit substance use or fitting for alcohol abuse or dependence inadequate language comprehension pregnancy first-degree relatives with bipolar disorder or schizophrenia", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Panic Disorder Generalized Anxiety Disorder Subjects must be 18 years of age or older Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV criteria Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV (except clause \u201cdoes not occur exclusively during a mood disorder\u201d of Criterion F for GAD) Subjects\u2019 bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4 Subjects\u2019 anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4 Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, double barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators\u2019 judgment, require ongoing treatment with that medication Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3) Subjects with clinically significant suicidal or homicidal ideation Subjects with current psychotic symptoms Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder) Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo or hyperthyroidism unless stabilized on thyroid replacement > 3 months", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Depression males or females age 18 to 65 years, DSM-IV episode of Major Depression non-psychotic, \u226514 score on the 17-item HRSD, adequate trial with two antidepressants (see definition above of 'adequate trial'), ability to receive and give informed consent, if patients are of child-bearing potential (male or female), use of an effective contraceptive is required for at least one month prior to the screening Visit and documentation of a negative pregnancy (female) test upon entry into the study bipolar or psychotic depression, overt personality disorder, currently suicidal or a history of suicide attempt in the previous 6 months, current substance abuse or history of substance abuse in the previous 12 months, history of hypersensitivity to aripiprazole, treatment with antipsychotic medications in the previous 3 months, serious or unstable medical disorders which in and amongst themselves may lend to morbidity or mortality during study, any medical illness with relative contraindication for aripiprazole use, starting or terminating psychotherapy during the previous 12 weeks, ECT treatment in the previous 3 months, pregnancy or planning pregnancy, history of severe head injury with sequelae, comorbid anxiety condition which has been focus of clinical attention in previous 6 months (remitted GAD, OCD, Panic, Social Anxiety, PTSD may be allowed)", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 20.0-50.0, All Sleep Disorders Physically healthy Meets DSM-IV for primary insomnia For subjects interested in PET study only: right-handedness Currently taking antidepressants, antianxiety medications or medications for sleep disorders Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease Meets DSM-IV for sleep apnea or periodic limb movement disorder", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 50.0-999.0, All Bipolar Disorder Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI) Must be age 50 or older Must have sub-optimal response to current psychotropic management including at least one of the following Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder Intolerance to current psychotropic medications; and Must live in the Northeast Ohio area An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or Receiving carbamazepine", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 15.0-29.0, All Bipolar Disorder Schizoaffective Disorder Male and female patients aged 15 to 29 Experiencing a first episode psychosis Meet DSM-IV for bipolar either manic or mixed episode, or schizoaffective disorder manic episode Minimum score of 20 on the YMRS Written informed consent to participation Patients at immediate risk of committing harm to self or others Use of neuroleptics or mood-stabilisers in the two months preceding admission to EPPIC Organic mental disease, including mental retardation History of clinically significant illness (liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances) Clinically relevant biochemical or hematological abnormalities Pregnant or lactating woman History of epilepsy History of severe drug allergy or hypersensitivity Non fluency in English", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 19.0-65.0, All Obesity Are men or women, between the ages of 19 and 65, inclusive Have a diagnosis of any type of bipolar disorder or any type of psychotic disorder based on structured diagnostic interview (MINI) Are currently outpatients or inpatients and taking a neuroleptic or mood stabilizer medication (listed below) for the past 6 months, and on a stable dose for the past 2 months Have a body mass index > 25 No substance use disorder in the past 2 months (except for nicotine or caffeine) Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as a barrier method, hormonal contraceptive, or surgical sterilization (females only). All women of childbearing potential must have a negative pregnancy test before beginning study medication Are able to swallow the capsules whole Are willing and able to follow Investigator instructions and study procedures, and report adverse events Not currently actively suicidal or homicidal No use of topiramate within the last 6 months Clinically significant renal or hepatic disease History of acute intermittent porphyria, glucose-6phosphate dehydrogenase deficiency or hemolytic anemia Allergy to zonisamide or sulfonamides Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities Require treatment with any medication (e.g., carbonic anhydrase inhibitors) that might interact adversely with, or obscure, the action of the study drug Are pregnant or lactating (females only) Have a history of nephrolithiasis Refuse to give informed consent Have previously enrolled in this study or previously been treated with zonisamide", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-70.0, All Binge Eating Disorder Associated With Obesity Patients will meet DSM-IV for BED for at least the last 6 months. These are as follows Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: (1) eating, in discrete period of time (eg, within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances and (2) a sense of lack of control over eating during the episode (eg, a feeling that one cannot stop eating or control what or how much one is eating) The binge eating episodes are associated with at least three of the following Eating much more rapidly than normal Eating until uncomfortably full Eating large amounts of food when not feeling physically hungry Eating alone because of being embarrassed by how much one is eating Feeling disgusted with oneself, depressed, or feeling very guilty after overeating Marked distress regarding binge eating The binge eating occurs, on average, at least two days a week for six months Have current body mass index < 30kg/m2 Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.) Subjects who are displaying clinically significant suicidality or homicidality Subjects who are displaying a current clinically unstable depressive disorder (e.g., HAM-D > 21) A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence A lifetime history of a DSM-IV bipolar disorder or dementia History of a personality disorder (eg, schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of binge eating disorder. Patients should be biochemically euthyroid prior to entering the study History of seizures, including febrile seizures in childhood History of clinically significant nephrolithiasis", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 13.0-75.0, All Bipolar Disorder In order to be included in the study patient must meet A, C, D, E, F, G plus any 1 of the 3 listed in section B A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II Patients meeting DSM-IV diagnostic for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or Patients meeting DSM-IV symptomatic for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or Patients meeting DSM-IV for a depressive episode associated with at least three DSM-IV manic/hypomanic symptoms C.MADRS of \u226514 D.YMRS of \u2265 14 E. Age 13years to 75 years F. Male or female G. Outpatient illness precluding the use of LAM Alcohol/drug dependence in the past one month patients with a history of a rash on LAM CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma patients currently taking LAM", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Age above 18 is preceded by an affective episode requiring hospitalisation or outpatient drug treatment (index episode) which can be a manic episode (ICD-10 research criteria), a depressive episode of at least moderate degree (ICD-10 research criteria) or a mixed manic state (manic episode with at least additional three ICD-10 depressive symptoms except for difficulties with concentration or thinking, agitation or dyssomnia). The episode can be with or without psychotic symptoms including Schneiderian first-rank symptoms or bizarre delusions as long as the psychotic symptoms do not occur outside the affective episode No more than 12 months may pass between the onset of the index episode (or admission if that is the case)and date of randomisation (in order to ensure a current risk of relapse as well as reliable psychopathological information) Besides the index episode, at least one previous episode must have occurred within the last five years which meets the mentioned in point number two above. This episode may not necessarily have led to hospitalisation. Two episodes are separated by at least two months without significant symptoms or change in polarity (depression to mania/mixed mania or vice versa) At least one manic episode (or mixed manic episode) within the last 5 years Contraindications to the protocol drugs Severe somatic disease, e.g. epilepsy, which may interfere with study treatment or effect evaluation Pregnancy (or risk of pregnancy) Subject has prior to randomization received prophylactic treatment with lithium or lamotrigine conducted adequately in the sense of sufficient time and dose and ensuring compliance, and experienced a definite lack of prophylactic effect An ICD-10 diagnosis of abuse within the last year with a subsequent risk of protocol violation. Therefore, subjects with a secondary abuse can often be included in the study Anticipated protocol violation for other reasons No written informed consent from the subject can be obtained The subject has previously been randomised in the study", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Obesity Age 18-65 years; BMI 30-50 Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks)", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Binge Eating Disorder Obesity Patients will meet DSM-IV-TR for BED for at least the last 6 months, determined by the Structured Clinical Interview for DSM-IV-TR (SCID) (61) and supported by the Eating Disorder Examination (EDE) (62). These are as follows Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following eating, in discrete period of time (e.g., within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances a sense of lack of control over eating during the episode (e.g., a feeling that one cannot stop eating or control what or how much one is eating) The binge eating episodes are associated with at least three of the following eating much more rapidly than normal eating until uncomfortably full eating large amounts of food when not feeling physically hungry eating alone because of being embarrassed by how much one is eating feeling disgusted with oneself, depressed, or feeling very guilty after overeating Have current body mass index < 30 kg/m2 Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study.) Subjects who are displaying clinically significant suicidality or homicidality Subjects who are displaying a current clinically unstable depressive or bipolar disorder, defined as a Montgomery Asberg Depression Rating Scale (MADRS) (63) > 24 or a Young Mania Rating Scale (YMRS) (64) > 8 A current or recent (within 6 months of the start of study medication) DSM-IV-TR diagnosis of substance abuse or dependence A lifetime history of a DSM-IV-TR psychotic disorder or dementia History of a personality disorder (e.g., schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of binge eating disorder. Patients should be biochemically euthyroid prior to entering the study History of seizures, including febrile seizures in childhood Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication (e.g., stimulants, sympathomimetics, antidepressants, carbonic anhydrase inhibitors, anti-obesity drugs)", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Anxiety Disorder Subjects must be 18 years of age or older Subjects must have lifetime bipolar I, II, or NOS disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV (except clause \"does not occur exclusively during a mood disorder\" of Criterion F for GAD) Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4 Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4 Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be postmenopausal surgically incapable of childbearing Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (text revision) criteria Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3) Subjects with clinically significant suicidal or homicidal ideation Subjects with current psychotic symptoms Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; or a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder) Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo or hyperthyroidism unless stabilized on thyroid replacement > 3 months", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 21.0-64.0, All Insomnia MAJOR Must experience sleep disturbances at least 3 nights/week, based on historical data Must meet the diagnostic requirements for Major Depressive Disorder Must have QIDS-SR16 score between 6 and 15 Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication Age 21-64, inclusive Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit MAJOR Severity of depressive episode had been rated as \"severe\" or \"severe with psychotic features.\" History of a suicide attempt or suicidal ideation History of mania, manic episode or bipolar disease Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag Any abnormal pre-study laboratory values that require clinical intervention Prior failure to respond to escitalopram therapy for depression Current depressive episode requiring inpatient hospitalization Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days History of drug addiction, alcoholism, or drug abuse", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 21.0-64.0, All Insomnia Male or female between the ages of 21and 64 years, inclusive Women must use a medically acceptable form of contraception during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A) Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry History of Post-Traumatic Stress Disorder Concomitant Major Depressive Disorder or Bipolar Disorder Any abnormal pre-study laboratory values that require clinical intervention ", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 6.0-17.0, All Attention Deficit Hyperactivity Disorder Male or female between the ages of 6 and 17 years, inclusive Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria) Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep The sleep disturbance must not be attributable to either the direct physiologic effect of drug abuse or misuse of a prescribed medication Subjects should be stabilized on all long-term therapy, including treatment of ADHD, for at least one month prior to study entry Subjects, if females of childbearing potential (as determined by the initiation of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). Abstinence is an acceptable method of birth control for this study Mental retardation Autistic spectrum disorder A history of sleep apnea A history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview and DSM-IV-TR Current history of substance abuse/dependence Known hypersensitivity to zolpidem or previous adverse experience with zolpidem Pregnant or breast-feeding Current use of hypnotics, antihistamines, melatonin, herbal products, or other sleep aids", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 13.0-17.0, All Bipolar Disorder Between the ages of 13 years, 0 months and 17 years, 11 months Meets The Diagnostic and Statistical Manual of Mental Disorders IV for either of the following conditions: bipolar I or bipolar II disorder with a manic, mixed, or hypomanic episode within 3 months of study entry; or a depressed episode within 3 months of study entry with a prior history of a manic, hypomanic, or mixed episode (if the participant only meets for a current hypomanic episode, there must also be a history of at least one prior depressive, manic, or mixed episode) Has experienced severe depression, hypomania, or mania symptoms for a period of at least 1 week within the 3 months prior to study entry Lives with at least one biological or step-parent who is available and willing to participate in treatment (parents not currently living with the adolescent participant may also participate) Currently in full recovery (experienced minimal symptoms for at least 8 continuous weeks) Meets Diagnostic and Statistical Manual of Mental Disorders, IV for substance abuse disorder or substance dependence disorder within 3 months of study entry (based on the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version ) Meets current for bipolar, not otherwise specified, or substance-induced mood disorder Diagnosis of mental retardation, autism, or organic central nervous system disorder Severe, unremitting psychosis that is unresponsive to neuroleptic medications, and has lasted more than 3 months Requires extended inpatient treatment (although participant can be hospitalized at the time of intake into the study) Current life-threatening eating disorder, neurological condition, or other medical problem that requires immediate treatment Exhibits or expresses serious homicidal tendencies Victim of current sexual or physical abuse by parents or is in an environment marked by domestic violence among the parents or step-parents", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-70.0, All Post-Traumatic Stress Disorder Depression Exposure to an interpersonal traumatic event Diagnosis of depression or PTSD (threshold or subthreshold) Functional literacy Apparent incoherence or disorientation Apparent intoxication at recruitment Hearing impairment", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-75.0, All Generalized Anxiety Disorder Bipolar Disorder Male and female outpatients, aged 18 to 75 years Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II) Current diagnosis of Generalized Anxiety Disorder (GAD) Participants must be on at least one of the following mood stabilizers at steady dose for at least 4 weeks prior to randomization: lithium with blood levels between 0.4-1.4 meq/L, valproic acid/divalproate sodium (with levels between 50-150 ugm/dl) carbamazepine (blood levels between 4-12 mcg/ml), or lamotrigine (dosed 50-400 mg/day) Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months) Patients with current or history of schizophrenia, or patients with current mania, hypomania at study entry. Lifetime psychosis and dementia are exclusionary Patients with current obsessive-compulsive disorder or posttraumatic stress disorder are excluded Patients with a history of alcohol or substance abuse or dependence within the last three months Patients with significant unstable medical illness likely to result in hospitalization or acute medical care. In addition, patients with an established diagnosis of diabetes mellitus are excluded Current cognitive behavioral therapy directed toward the treatment of generalized anxiety disorder History of hypersensitivity to or lack of response to ziprasidone Concomitant treatment with other typical or atypical antipsychotics; patients should be off other typical or atypical antipsychotics for at least one week prior to study baseline Patients with significant suicidal ideation or who have enacted suicidal behaviors within 3 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention Patients who have had a psychiatric hospitalization (including for bipolar disorder) in the past 3 months are excluded", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-64.0, All Insomnia Insomnia as defined by DSM-IV and supported by subject diary Male or female between the ages of 18-64 years Body mass index (BMI) between 18-34 kg/m^2 Females of childbearing potential must use a medically acceptable method of contraception Capable of understanding and willing to comply with study procedures and has provided informed consent Females who are pregnant, breast-feeding or have a positive pregnancy test Any circadian rhythm disorder including planned travel across several time zones during the study period Known hypersensitivity to Zolpidem Has performed regular shift work with the past several months prior to screening An acute clinically significant illness or surgery as determined by the PI within 30 days of screening Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle A history of psychiatric disorder as defined by DSM-IV A history of drug addiction or alcohol abuse Any current significant disease, unless adequately controlled with a protocol allowed medication Known history of HIV or Hepatitis B or C", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-75.0, All Sleep Initiation and Maintenance Disorders Written informed consent is obtained The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age (inclusive) Patient reports insomnia for at least six months, and insomnia causes the patient distress The Investigator determines that the patient meets diagnostic for Chronic Insomnia according to International Classification of Sleep Disorders (ICSD) criteria Sleep diary based screening shows sleep onset latency >30 minutes, and /or wake after sleep onset >30 minutes per night at least 3 nights per week, with combined wake-time-in-bed _> 45 minutes The patient is in good health as determined by a medical and psychiatric history, and physical examination Women must be surgically sterile, 2 years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control, and agree to continued use of this method for the duration of the study The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol Has any clinically significant, uncontrolled medical or psychiatric conditions. (treated or untreated) Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia Used any prescription drugs disallowed by the protocol or clinically significant use of over-the counter(OTC) drugs within 14 days before the screening visit Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V Has a clinically significant deviation from normal in the physical examination Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) Has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery and succinic semialdehyde dehydrogenase deficiency) Has a known clinically significant drug sensitivity to sodium oxybate or sedative hypnotics", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-60.0, All Bipolar Depression A principal diagnosis of bipolar 1 or II disorder Ages 18-60 Physically healthy Outpatient status Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15 BMI 23-30 Able and willing to give written informed consent Prior history of diabetes (types I or II) BMI>30 Non-fasting blood glucose >124 Fasting blood glucose >125 or random blood glucose >200 Presence of dyslipidemia (baseline total cholesterol >240, HDL<50, LDL>160, triglycerides >199) Current or past history of a non-affective psychotic disorder Alcohol or other substance abuse or dependence in the 6 months prior to the evaluation (except for caffeine) Current use of any nicotine products Schizoid, schizotypal, or borderline personality disorder Treatment with olanzapine in the prior 3 months or any history of non", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 12.0-21.0, All Bipolar Disorder Cannabis-Related Disorder Inclusion/ To be included, all subjects must\u2026 have an authorized parent/legal guardian who understands the nature of the study and who provides written informed consent if the study subject is younger than 18 years of age. Additionally, each subject must provide assent to the study be fluent in English be 12 to 21 years of age, inclusive be using a medically accepted means of contraception (i.e., oral contraceptives and barrier methods (diaphragm or condom), medroxyprogesterone acetate injectable suspension, abstinence) if female and of menarche. Oral contraceptives alone are not acceptable means of contraception because concomitant use of topiramate and low estrogen oral contraceptive pills may lead to oral contraceptive failure have a diagnosis of bipolar I disorder in a current manic or mixed episode, in addition to a cannabis use disorder (which includes abuse or dependence) within 28 days prior to screening, as determined by the WASH-U-KSADS have an initial YMRS total score of >16 at screening and baselines use cannabis a minimum of twice per week on average during the 28 days prior to screening Subjects will not be eligible for participation if they\u2026 have a known history of mental retardation", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 10.0-18.0, All Bipolar Disorder Weight Gain Male or female patients, ages 10-18 years Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence) Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000) Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16 Subjects should be fluent in English Female patients who are either pregnant or lactating Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions Any history of current or past diabetes that has been treated with pharmacological intervention Neurological disorders including epilepsy, stroke, or severe head trauma Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR) Mental retardation (IQ <70) History of hypersensitivity to or intolerance of olanzapine or topiramate Prior history of olanzapine or topiramate non-response or allergic reaction DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Mania Diagnosis of Bipolar 1 Disorder Hospitalized or in the process of being hospitalized for a manic or mixed episode History of rapid cycling History of hypersensitivity or adverse reaction to lithium", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-60.0, All Spinal Cord Injuries Subjects of either gender and 18 years of age (preferably 10 males and females each) Subjects with chronic spinal cord injury (defined as 12 months or more post spinal cord injury), as confirmed by a MRI Subjects with neurological status: ASIA A, B or C Subjects must be able to read, understand, and complete the VAS Subjects who have voluntarily signed* and dated* an informed consent form, approved by an IEC/IRB, prior to any study-specific procedures *If a subject consents to participation but is not in a position to personally sign and date the informed consent form because of his or her physical condition, the consent must be confirmed at the time of consent orally, signed on behalf by the subject's relative, and by an impartial witness who is present throughout the whole informed consent process Subjects are excluded if they have a history of hypersensitivity to lithium significant renal, cardiovascular, hepatic and psychiatric diseases significant medical diseases or infection brain injury Addison's disease debilitation or dehydration recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracycline a history of alcohol abuse or drug abuse, or if they are pregnant or lactating women", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 12.0-18.0, All Insomnia patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10 patients whose age at the time of obtaining consent is 12 years or over and 18 years or below patients with schizophrenia or manic-depressive illness patients with insomnia caused by physical diseases patients having a history of hypersensitivity to zolpidem patients with attention-deficit hyperactivity disorder", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-70.0, All Bipolar Disorder Patients with bipolar disorder in major depressive episode according to DSM-IV MADRS score of at least 20 points at screening and baseline 70 years of age Unchanged dose of mood stabilising medication for at least six weeks prior to Voluntary, informed and written consent Non-affective psychotic symptoms at screening Pregnancy or breast-feeding Fertile women without appropriate contraception (the pill, IUD, or contraceptive injection) Substance dependence during the last three months prior to baseline Mental retardation and organic brain disorders Suicide risk that mandates specific measures Novel (within three months) or unstable medical conditions Clinically significant abnormal results on medical examination or blood samples Exposure to escitalopram during the last three months Allergic reactions to citalopram or escitalopram", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-64.0, All Insomnia Adults with history of sleeplessness Allergic to investigational drug Any conditions and medications that may interfere with study drug evaluation", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Brain and Central Nervous System Tumors Cognitive/Functional Effects Neurotoxicity Solid Tumor Histopathologically confirmed extracranial primary malignancy Multiple (i.e., > 3) brain metastases OR < 3 metastases with at least 1 metastasis > 4.0 cm in diameter Not eligible for radiosurgery No requirement for immediate whole-brain radiotherapy No metastases to the midbrain or brainstem Zubrod performance status 0-2 Life expectancy \u2265 8 weeks Platelet count > 100,000/mm^3 ANC > 1,500/mm^3 Hemoglobin \u2265 10 g/dL BUN < 25 mg/dL Creatinine < 1.5 mg/dL Bilirubin < 1.5 mg/dL ALT \u2264 2 times normal Sodium > 136 mg/dL", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Male or female in or out-patients at least 18 years of age Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 & 2 Patients must be considered reliable Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV Documented history of intolerance to olanzapine or Lithium Carbonate Treatment with clozapine within 4 weeks prior to visit 2. Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Insomnia Chronic insomnia and taking greater than or equal to 10 mg zolpidem at least 4 times per week Has been prescribed zolpidem for difficulty in initiating sleep Must report chronic use of zolpidem greater than or equal to10 mg therapy for a minimum of 3 months prior to entry into Period 1 of the study Must have taken zolpidem greater than or equal to 10 mg therapy for at least 4 of 7 days each week of the 4 weeks immediately prior to entry into the double blind phase, Period 2 Expressed a willingness to discontinue zolpidem therapy Habitual bedtime is between 9:00 PM and 1:00 AM based on sleep history Negative test result for hepatitis B surface antigen and hepatitis C virus antibody Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study Known hypersensitivity to ramelteon, zolpidem, or melatonin Participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of run-in study medication Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of run-in study medication History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder History of drug addiction or drug abuse within the past 12 months History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition revised and/or regularly consumes more than 2 alcoholic drinks per day Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of run-in study medication Body mass index of less than 18 or greater than 34 (weight /height2) Any clinically important abnormal finding as documented by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator Positive hepatitis panel", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 2.0-18.0, All Insomnia Sleep Disorder Male or female between the ages of 2 years and 18 years Written consent must be obtained form the parent/legal guardian for all minors. Written assent must be obtained from all minors > 6 years of age Female subjects of child-bearing potential must not be pregnant and if females are fertile and sexually active, must have documented a negative urine HCG and assure use of effective contraception acceptable to the investigator (abstinence accepted) during the study period Subjects must meet the following for a diagnosis of insomnia as determined by the subject's private physician or study investigator and subject's history the complaint is significant difficulty (defined by frequency, severity, and/or chronicity) initiating or maintaining sleep;. The problem is viewed problematic by the child and/or caregiver the sleep disturbance causes clinically significant impairment in school performance, behavior, learning, or development for the child as reported by the child and/or caregiver the sleep disturbance does not occur exclusively in the context of an intrinsic dyssomnia such as narcolepsy, restless legs syndrome, or sleep-related breathing disorders; a circadian rhythm disorder; or a parasomnia the sleep disturbance is not attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication Pregnancy and/or breastfeeding The presence of any untreated (where treatment is available), or unstable, progressive, or evolving clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, neurologic, hematologic, immunologic, cerebrovascular disease or malignancy Elevations in screening blood tests of renal (SCr) and liver (ALT, AST and/or bilirubin) > 2 times the upper limit of normal for age Receiving any medications that may modulate Zolpidem metabolism, primarily drugs that will enhance or reduce the activity of CYP450 3A, 2C9, or 2D6 activity. Note: If patient is receiving a medication that might be considered an inducer or an inhibitor, please discuss with the PI prior to excluding them Receiving any medications with sleep-impairing properties at a dose/dose interval that would be judged by the study investigator as to interfere with the assessment of Zolpidem sleep response Currently using any systemic contraceptive steroids including: oral contraceptives, transdermal patch, vaginal insert, levonorgestrel implant and medroxyprogesterone acetate contraceptive injection", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Neuroendocrine Tumors Must have histologically confirmed metastatic low-grade neuroendocrine neoplasms. Small cell lung cancers, paragangliomas and pheochromocytomas are excluded. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC Must have measurable disease Must have radiographic evidence of disease progression following any prior systemic therapy, chemoembolization, bland embolization, surgery, or observation Must be \u2265 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration Must be \u2265 3 weeks from the completion of radiation therapy to study registration The following laboratory values are to be obtained within 14 days prior to registration: Absolute neutrophils count (ANC) \u2265 1000/mm3; Platelets \u2265 75,000/mm3; Hemoglobin \u2265 8.0 g/dL; Total bilirubin less than or equal 2.0 X the upper limit of normal (ULN); AST less than or equal to 3 X ULN or less than or equal 5 X ULN if liver metastases are present; Creatinine less than or equal ULN; Serum sodium within normal limits PS = 0-2 Capable of understanding the investigational nature, potential risks and benefits fo the study and able to provide valid informed consent Must have available tissue specimens to be analyzed for pathologic confirmation Age \u2265 18 years ", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Hepatitis C, Chronic adult patients, >=18 years of age chronic hepatitis C, genotype 1 insulin resistance other forms of liver disease cirrhosis previous treatment for chronic hepatitis C insulin treatment during prior 2 weeks type 1 diabetes", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Provision of written informed consent before initiation of any study-related procedures Men and women aged 18 to 65 years A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting 296.4x Bipolar I disorder, most recent episode manic, 296.6x Bipolar I disorder, most recent episode mixed, or 296.5x Bipolar I disorder, most recent episode depressed PSQI total score of >=5 MADRS total score of <=12 YMRS total score of <= 12 Female patients of childbearing potential must have a negative urine pregnancy test at enrollment and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study Be able to understand and comply with the requirements of the study, as judged by the investigator Outpatient status at enrollment Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids Patients with a diagnosis of primary insomnia disorders Patients with a diagnosis of severe chronic obstructive pulmonary disease A clinical finding that is untreated (eg, hypertension, poorly controlled diabetes, angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication Patients with active substance abuse diagnoses (except tobacco abuse) Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-75.0, All Bipolar Disorder Current major depressive episode or mixed episode Bipolar disorder History of suicidal behavior Requires detoxification from alcohol or other substances Blood pressure greater than 160/90 mm Hg Active medical problems Requires long-term antipsychotic maintenance Becomes manic on mood stabilizers and antidepressants Contraindication to the use of lithium 1 or valproate (including failure to respond) Failure to respond to adequate trials of paroxetine, bupropion, and venlafaxine in the 2 years prior to study entry Failure to respond to adequate trials of olanzapine, haloperidol, and perphenazine in the 2 years prior to study entry Unable or unwilling to consent to treatment Pregnant or lactating", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 0.0-999.0, All Bipolar Disorder Persons with Bipolar Condition, Depression, Anxiety, Stress and Insomnia Persons with severe mental illness that are confined to mental hospitals etc. as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM) are excluded from this clinical trial", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Panic Disorder Generalized Anxiety Disorder Subjects must be at least 18 years of age and not older than 65 Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV (except clause \"does not occur exclusively during a mood disorder\" of Criterion F for GAD) Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study Subjects who do not have lifetime bipolar disorder by DSM-IV-TR Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP>5) Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S<3) Subjects with clinically significant suicidal or homicidal ideation Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder) Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo-or hyperthyroidism unless stabilized on thyroid replacement > 3 months Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to either of the active study medications", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Medullary Thyroid Cancer Histologically confirmed MTC with signs of residual/persistent disease based on tumor marker levels and/or radiographic imaging. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC Elevated neuroendocrine markers at least 1 month post -op. In MTC, persistently elevated neuroendocrine markers such as calcitonin and CEA are indicative of persistent disease Disease progression is not required for this trial weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration. Subjects will have had standard of care prior to enrollment. Subjects will have had standard of care prior to enrollment (for example it could total thyroidectomy, central lymph node dissection, and when necessary ipsilateral radical neck dissection but is tailored to the patient) weeks from the completion of radiation therapy to study registration The following laboratory values obtained within 14 days prior to registration Absolute neutrophils count (ANC) \u2265 1000/mm3 Platelets \u2265 75,000/mm3 Hemoglobin \u2265 8.0 g/dL Total bilirubin greater than or equal to 2.0 X the upper limit of normal (ULN) Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets) Significant, active cardiac disease Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, and COX2 inhibitors Patients with radiographic evidence of disease will be presented the option to undergo a tumor biopsy although this is not mandatory Patients already taking Lithium for any reason are not allowed on study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Patients with diagnosis of Bipolar Disorder (DSM-IV TR) Patients or their legal representatives have provided informed consent Patients are unable to complete or to understand health questionnaires in Spanish language Patients enrolled in clinical trials or other studies", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 12.0-19.0, All Adolescent - Emotional Problem Smoking 19 years old Major depression Smoke cigarettes Lives with parents No confidentiality issues related to smoking Non English speaking Suicidal ideation Pregnant", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-39.0, All Bipolar Disorder No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Positive test for HIV, Hepatitis B, or Hepatitis C Treatment with known enzyme altering drugs History of allergic or adverse response to lithium, or any comparable or similar product", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 25.0-45.0, All Bipolar Disorder No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Participation in a clinicl trial within 30 days prior to study initiation Positive test for HIV, Hepatitis B, or Hepatitis C Treatment with known enzyme altering drugs", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-38.0, All Bipolar Disorder No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Positive test for HIV, Hepatitis B, or Hepatitis C Treatment with known enzyme altering drugs History of allergic or adverse response to lithium, or any comparable or similar product", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Depression Meets DSM-IV for Axis I bipolar II disorder Meets DSM-IV for Axis I major depressive episode Score of 16 on 17-item HAM-D rating scale Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry Willing to use an effective form of birth control throughout the study History of mania Current primary Axis I diagnosis other than bipolar II disorder Alcohol or drug dependence within 3 months prior to study entry Contraindication to treatment with venlafaxine or lithium Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris) Pregnant or breastfeeding Experiencing suicidal thoughts Requires hospitalization Requires concurrent neuroleptic or MS therapy Requires concurrent AD therapy", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-35.0, All Weight Gain Age 18-35 Body mass index between 23 and 30 Interested in preventing weight gain BMI outside of range specified Age outside of range specified History of or current eating disorder or substance abuse Recent weight loss greater than 5% of weight Currently in another research study that would interfere", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 12.0-35.0, All Depression, Bipolar Depressed bipolar patients (N=100; 15-20 patients/year) Patients will meet DSM-IV for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138 Patient has experienced a maximum of three documented affective episodes Patient has been off medications for one week prior to study enrollment Patient has a Hamilton Depression Rating Scale (HDRS) total score \u226520 Patient is between the ages of 12 and 35 years All subjects will be excluded from participation for the following reasons Any chemical use disorder within 3 months Any history of significant suicidality that would place the patient at risk to participate in this protocol Current score \u22653 on item 3 of the HDRS-17 (Suicide Item) Any medical or neurological disorder that could influence fMRI results A history of mental retardation or an estimated IQ total score <85 An MRI scan is contraindicated in the subject for any reason The patient lives >100 miles from the University of Cincinnati or cannot attend follow-up visits Meets DSM-IV for a bipolar mixed episode", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-64.0, All Sleep Initiation and Maintenance Disorders Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) ", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Depression DSM-IV diagnosis of major depressive disorder (MDD) Drug naive from prior psychotropic medication for more than 6 months before study entry Hamilton-Depression (HAM-D) 17 score greater than or equal to 16 Woman of childbearing age with a negative pregnancy test within 48 hours of scanning DSM-IV Axis I diagnosis other than MDD Use of psychotropic medication within 6 months of study entry History of bipolar disorder Current alcohol or drug abuse/dependence within 6 months of study entry History of sensitivity or intolerance to s-citalopram Medical contraindication to the use of s-citalopram Unstable medical condition (e.g., angina pectoris, untreated hypertension) Pregnant or nursing Woman of childbearing potential not using a medically acceptable form of birth control Actively suicidal or requiring hospitalization", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Healthy Therapeutic Equivalency Sex: Male or Female; similar proportions of each preferred Age: At least 18 years Weight: must be 15% of ideal weight for height and frame Subjects must be in good health and physical condition as determined by medical history Subjects must read and sign the Consent Form history of treatment for alcoholism, substance abuse, or drug abuse within past 24 months history of malignancy, stroke, diabetes, cardiac, renal or liver disease history of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease history of treatment for asthma within the past five (5) years history of mental depression, pulmonary disease, sleep apnea females who are pregnant or lactating history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position inability to read and/or sign the consent form treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 21.0-55.0, All Primary Insomnia Patients with insomnia will meet RDC for psychophysiologic insomnia(99). These are provided in Appendix 2. In addition, the complaint of disturbed sleep will have one or more of the following characteristics > 30 minutes to fall asleep (Initial Insomnia) awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes (Middle Insomnia) An awakening of > 30 minutes prior to the desired \"wake up\" time (Late Insomnia) Any two of the above complaints (Mixed Insomnia) Additionally, total sleep time will not exceed 6 hours (unless the sleep efficiency quotient is < 80%) and the problem frequency must be equal to or greater than 4 nights/ week (severe insomnia) with a problem duration > 6 months (chronic insomnia). This profile must be evident at both intake (based on retrospective reports) and as an average profile from the two weeks of baseline diaries (based on prospective sampling) Unstable medical or psychiatric illness Assessed with the Mini International Neuropsychiatric Interview (MINI) and the The Schedule for Affective Disorders and Schizophrenia-Lifetime Version (SADS-L) To assure that the insomnia is not secondary to these factors Symptoms suggestive of sleep disorders other than insomnia Assessed with the SDS-CL To assure that the insomnia is not secondary to these factors Polysomnographic data indicating sleep disorders other than insomnia Assessed with PSG in collaboration with our sleep medicine consultants To assure that the insomnia is not secondary to these factors History of head injury with a sustained loss of consciousness Assessed by self report during the Intake Interview To help assure that the EEG measures are unconfounded by brain damage Evidence of active illicit substance use or fitting for alcohol abuse or dependence Assessed with a structured psychiatric interview schedule (the MINI) , written versions of clinical interview queries regarding alcohol use, abuse and dependence (the AUDIT and CAGE), the toxicology screen which is part of the clinical chemistries obtained during the screening physical. To assure that the insomnia is not secondary to these factors and to assure that substance use/abuse does not confound treatment Use of CNS active medications, antidepressants, and hypnotics other than zolpidem Assessed by self report and from the toxicology screen which is part of the clinical chemistries obtained during the screening physical. To help assure that the clinical effects observed in this study are due to the study medication and schedule of reinforcement Inadequate language comprehension Informally, assessed by the Clinical Research Coordinator during Intake Interview To assure the quality of self report data as all the measures are in English Pregnancy Assessed by self report and from the clinical chemistries data obtained during the screening physical. Excluded so as to 1) prevent the fetus from exposure to the study medication (although it should be noted that the medication is considered FDA pregnancy category B) and 2) control for the biopsychosocial changes that occur with pregnancy and may alter the response to the study medication and schedule of reinforcement No first-degree relatives with bipolar disorder or schizophrenia Assessed by self report and a structured psychiatric interview schedule (the SADs). Excluded to reduce risk for first onset during the study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Mania Key Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment Key Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder) Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania Thyroid pathology Demonstrated cocaine abuse or dependence within the past 3 months prior to screening History of neuroleptic malignant syndrome from antipsychotic agents Manic symptoms that investigator considers refractory to treatment Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms Significant risk of suicide based on history, mental status exam, or investigator judgment", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-60.0, All Acute Mania in Bipolar Disorder Provision of written informed consent before initiation of any study related procedures. Patients who are deemed incapable of providing informed consent maybe enrolled if written informed consent has been obtained from the patient's Legally Authorized Representative Documented clinical diagnosis meeting the DSM-IV for any of the following 4X Bipolar I Disorder, Most Recent Episode Manic 0X Bipolar I Disorder, Single Manic Episode Have a YMRS score of at least 20 and a score of at least 4 on 2 of the following 4 YMRS items both at enrolment and at randomisation: Irritability, Speech, Content, and Disruptive/Aggressive Behaviour Female patients of childbearing potential must have a negative urine pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e., barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation, during the study Be able to understand and comply with the requirements of the study, as judged by the investigator Manic episode judged to be either the direct physiological consequence of a treatment or medical condition other than Bipolar disorder the direct physiological effect of a substance of abuse; intoxication with hallucinogens, inhalants, opioids, or phencyclidine and related substances the direct physiological effect of psychostimulant or antidepressant medication Evidence of clinically severe or active disease, or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication History of seizure disorder, except febrile convulsions Hospitalization period of 3 weeks or longer immediately prior to randomization for the index manic episode Known history of intolerance or hypersensitivity to quetiapine or lithium, or to any other component in the tablets/capsules Known lack of response to quetiapine or lithium, as judged by the investigator Use of antipsychotic medication or mood stabilizer other than quetiapine and lithium at the day of randomisation (to be tapered to discontinuation between the enrolment visit and randomisation)", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Healthy Sex: Male or Female; similar proportions of each preferred Age: At least 18 years Weight: must be 15% of ideal weight for height and frame Subjects must be in good health and physical condition as determined by medical history Subjects must read and sign the Consent Form History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness History of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease History of treatment for asthma within the past five (5) years History of mental depression History of pulmonary disease History of sleep apnea Females who are pregnant or lactating History of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative Treatment with any other investigational drug during the four weeks prior to the initial dosing of the study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 12.0-39.0, All Schizophrenia Schizoaffective Disorder Schizophreniform; Bipolar I Disorder Bipolar II Bipolar NOS Psychotic Disorder Not Otherwise Specified Autism Children and adolescents ages 12-18 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS Subjects must be on either Olanzapine, Seroquel, Clozapine or Risperdal for less than 6 weeks and have gained at least 2% of the body weight during that time Subjects who have diabetes, hyper or hypothyroidism or other metabolic abnormalities Females who are pregnant or breast-feeding Diagnosis of asthma or peptic ulcer disease Antihypertensive agents, Metformin, lipid-lowering agents, thyroid r replacement therapy", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-55.0, All Methodology Study Age 18-55 BMI 18-30 kg/m2 body weight > 50 kg no history of sleep disorder no concurrent medications no alcohol use no medical issues no smoking", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-45.0, All Bipolar Disorder Medically healthy Meets DSM-IV for bipolar disorder of any subtype No more than 32 weeks gestation, dated by last menstrual period Active suicidality or homicidality Acute psychotic symptoms", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar I Disorder Male and female adult patients with bipolar 1 disorder and acute agitation Agitation caused primarily by acute intoxication History of drug or alcohol dependence Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Age 18-65 male or female DSM -IV for bipolar I affective disorder Ability and willingness to sign informed consent for participation in the study Unwillingness or inability to participate in the study", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-60.0, All Spinal Cord Injury Subjects of either gender and 18-60 years of age Subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer) Subjects with ASIA classification of A, B, or C for at least 6 months unchanged Spinal cord injury vertebral level should be between C4 and T10 Subjects must be able to read, understand, and complete the VAS Subjects who have voluntarily signed and dated an informed consent form, approved by an IRB/IEC, prior to any study specific procedures A history of hypersensitivity or other adverse reaction to lithium Significant renal, cardiovascular, hepatic and psychiatric disease Significant medical diseases or infection Addison's disease Debilitation or dehydration Recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines A history of alcohol abuse or drug abuse Pregnant or lactating women Female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-35.0, All Healthy Healthy Males age 18 to 35 inclusive Body Mass Index 18 to 30 Willing to adhere to prohibitions and restrictions specified in protocol Must give informed consent Clinically significant abnormal lab values for chemistry, hematology or urinalysis at screening Clinically significant abnormal physical exam, vital signs, or 12-lead EKG at screening Significant history of or current significant medical illness Significant history of or current psychiatric or neurological illness or sleep apnea Participation in another research study involving exposure to ionizing radiation within the last 12 months Any clinically significant MR abnormality which may be relevant to the study Metal implants which are relevant for MR or PET procedures or data History of epilepsy or fits or unexplained blackouts Serology positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV antibodies Positive urine screen for drugs of abuse", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 8.0-19.0, All Psychotic Disorders DSM diagnoses that have an FDA indication for atypical antipsychotic use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of Early Onset Schizophrenia Spectrum (EOSS; schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder NOS); Bipolar Spectrum (bipolar I, II and NOS); Major depressive disorder with psychosis; Mood disorder NOS corresponding to Leibenluft and colleagues severely mood dysregulated (SMD) broad spectrum bipolar disorder; Mood disorder NOS corresponding to irritability associated with autism spectrum disorders; or for adult teen participants aged 18-19 years Major depressive disorder. Diagnoses will be determined by clinical interview, Leibenluft's modification of the K-SADS-PL, and the \"Aberrant Behavior Checklist\" (cutoff score of 18, as used by FDA for approval of risperidone and aripiprazole in minors) Clinically stable on current treatment regimen for at least 30 days, as assessed in a three-step process Current SGA treatment with olanzapine, quetiapine, risperidone, ziprasidone aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine for \u2265 8 weeks Stable dose of current SGA and psychotropic co-medications for at least 30 days Body mass index (BMI) at least in the 85th percentile for age and gender Substantial weight gain over the previous 3 years while taking a SGA, as reflected by family and referring physician's judgment. The weight gain did not have to occur on the child's current SGA. Weight needs to have remained stable or increased over past year Agrees to use two effective forms of birth control or to remain abstinent Has a primary caretaker who has known the child well for at least 6 months before study entry Treatment with any medication (other than the currently prescribed psychotropic medications) that would significantly alter glucose, insulin, or lipid levels. Exception: orlistat and amantadine are permitted if the individual has taken the drug for at least one year without weight loss Major neurological or medical illness that affects weight gain or that would prevent participation in physical activities Fasting glucose levels indicating need for prompt treatment Pediatrician or pediatric gastroenterologist recommendation to address abnormal fasting labs by pursuing more active treatment than those in the 2007 American Medical Association guidelines Diagnosis of anorexia nervosa or bulimia nervosa, as based on current or lifetime DSM-IV Diagnosis of substance dependence disorder (other than tobacco dependence) within the past month, as based on DSM-IV Positive urine toxicology indicating ongoing use of illicit substance Current treatment with more than one antipsychotic medication Current treatment with more than 3 total psychotropic medications (i.e., 2 psychotropics plus SGA), with the exception of subjects taking 2 medications for ADHD in which a total of 4 psychotropic medications are allowed Known hypersensitivity to metformin", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 60.0-999.0, All Dementia Alzheimer Disease Dementia, Vascular Sleep Disorders Circadian Dysregulation Age between 60-99 years Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia Subjects who are too agitated to be able to wear the activity monitors Subjects who are actively suicidal or homicidal or for whom the clinical treatment team considers participation in the study to be unsuitable Subjects with untreated primary sleep disorders Subjects who receive any hypnotic medications during their participation in the study; Subjects who received hypnotic medications in normal doses prior to Partners Human Subjects Research Application Form Filename: Protocol Summary Version Date: June 1, 2005 5 enrollment may participate in the study if they agree to stop receiving hypnotic medications (see above) Subjects who are receiving over the counter sleep aids Subjects who can not commit to abstaining from alcohol use while in the study Subjects with any liver disease Subjects with known anaphylactic reaction or angioedema with Zolpidem CR", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 21.0-55.0, All Generalized Anxiety Disease Healthy males and/or females Age from 21 to 55 (inclusive) BMI ranges from 18 to 30 kg/m2 Previous participation in a PD 332334 study Pregnant or nursing females Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Acute Schizophrenia Provision of written informed consent by both patient and legal representative A diagnosis of schizophrenia by Chinese Classification and Diagnostic of Mental Disorder, 3rd version (CCMD-3) Male or female, aged 18 to 65 years MOAS total score \u00b3 10 at both screening and randomization Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment Able to understand and comply with the requirements of the study Pregnancy or lactation Any CCMD-3 not defined in the Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others Known intolerance or lack of response to quetiapine fumarate or haloperidol, as judged by the investigator Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by CCMD-3 Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by CCMD-3 within 4 weeks prior to enrolment Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-55.0, All Weight Gain Subjects must be between the ages of 18 and 55 years old Subjects must have bipolar I disorder, schizophrenia, schizoaffective disorder or MDD as defined by DSM-IV-TR and diagnosed using the Structured Clinical Interview for DSM-IV (SCID) Subjects must have a Young Mania Rating Scale (YMRS) score < 16 and a Montgomery-Asberg Depression Rating Scale (MADRS) score < 24 at screening and baseline visits Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2 Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable method(s) of contraception (e.g., hormonal methods, intrauterine device, abstinence) for at least one month prior to study entry and throughout the study Subjects must be on a stable dose of olanzapine for at least 14 days and must have been on 5-30mg/day for at least 1 month Major Subjects with clinically significant suicidal or homicidal ideation Subjects who have a DSM-IV lifetime diagnosis of a substance dependence disorder within the past 6 months or within the past month have been diagnosed with a substance abuse disorder, (except for nicotine abuse or dependence), as determined by psychiatric history or SCID interview Subjects with a clinically significant or unstable medical disease, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions, that could interfere with diagnosis, assessment, or treatment of bipolar disorder or obesity, as well as subjects with a history of pancreatitis Patients with clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices or clinically abnormal ECG Female patients who are either pregnant or lactating Any female patient whose sexual activity is unknown or in questions Any history of current or past diabetes that has been treated with pharmacological intervention. Subjects who have a diagnosis of diabetes, are currently receiving exenatide, insulin, or an oral anti-hyperglycemic medication, or who have a nonfasting blood glucose \u2265 200 mg/dl or a fasting blood glucose \u2265126 mg/dl on 2 separate tests. Subjects with pre-diabetes will not be excluded Neurological disorders including epilepsy, stroke, or severe head trauma. Mental retardation (IQ <70) Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0 Treatment with concurrent mood stabilizers (except lithium), anticonvulsants, or antipsychotics", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorders Metabolic Complication patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV age between 18 and 65 Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI BP \u2264 3 patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain) diagnosis of eating disorder, substance abuse, and psychotic disorder history of neurological and medical illness pregnant or breast feeding women", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Acute Bipolar Depression Outpatients that meet the diagnostic for bipolar disorder I and bipolar disorder II with the most recent episode depressed The total score of the scale that's used for the evaluation of depression (HAM-D) should be \u226520 The total score of the scale that' used for the evaluation of mania (YMRS) should be \u226412 Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-55.0, All Bipolar Disorder Schizophrenia Concurrently taking Zyprexa\u00ae for a psychiatric indication such as bipolar disorder or schizophrenia Stable body weight (+ 5%) for at least 2 weeks prior to baseline visit No weight loss program participation within past 3 months Treatment with an atypical Anti-psychotic treatment other than olanzapine with the past 6 months BMI > 40 kg/m2 Use of any dietary supplements related to weight gain or weight loss within past 1 month Use of any medication related to weight or plasma lipid concentration (other than hormonal contraceptives). This includes, but not limited to: antihypertensives, benzodiazepines statins, and psychostimulants Uncontrolled hypertension (SBP >140 or DBP > 90 mmHg) Use of a hypertensive medication Known active alcohol or substance abuse or consumption of > three alcoholic beverages/day Active cardiovascular disease", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Endometrial Neoplasms Pain be women at least 18 years old have clinical indications of primary endometrioid adenocarcinoma of the endometrium be scheduled for staging surgery by laparotomy under standardized protocols have the ability to communicate in English sufficient for completion of study materials have no neuromuscular/ movement disorders (for actigraphy purposes) have no uncontrolled medical, sleep, endocrine or psychiatric illness (as determined by their attending physician as part of clinical care) have no ongoing use of medication known to affect sleep or wake function (e.g., hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics, decongestants, sedating antihistamines, beta blockers, corticosteroids) have a history of previous or concomitant cancer have an estimated life expectancy of < 6 months will be admitted to the hospital prior to the day of surgery are unable to complete study measures are unable to provide meaningful informed consent", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-64.0, All Sleep Initiation and Maintenance Disorders Primary Insomnia Diagnosis of primary insomnia based on DSM-IV (307.42) Written informed consent has been obtained Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week) Patients who are pregnant, lactating or intend to become pregnant during the study period Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial Participation in any clinical trial within 1 month prior to randomization", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-76.0, All Cancer Age: 18-76 Current or historical diagnosis of cancer Projected life expectancy of at least one year DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder due to cancer, Adjustment Disorder with anxious features Any stage of cancer diagnosis Epilepsy Renal disease Diabetes Abnormal liver function Severe cardiovascular disease Malignant Hypertension Baseline blood pressure must be less than or equal to 140/90 Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum illness Current substance use disorder Medication contraindications: anti-seizures medications, insulin, oral hypoglycemics, clonidine, aldomet, cardiovascular medications, anti-psychotics (first and second generation), anti-depressants and mood stabilizers", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-60.0, All Bipolar Disorder Patients meeting DSM-IV for either Bipolar I, Bipolar II, Cyclothymic Disorder, or Bipolar Disorder NOS Patients on monotherapy treatment with lithium carbonate at steady state level for a minimum of two weeks prior to study treatment assignment Women are postmenopausal for at least 1 year, or surgically incapable of childbearing, or practicing an acceptable method of birth control (hormonal contraception, intrauterine device, or barrier with spermicide were acceptable) and not pregnant at baseline Patients with a history of an acquired or hereditary neurologic disease, e.g., epilepsy or significant brain trauma Patients on depot medications, including but not limited to haloperidol, decanoate and Depo-Provera Patients who had taken acetazolamide, zonisamide, triamterene, dichlorphenamide, chronic antacids, or calcium supplements, or any medication associated with nephrolithiasis (kidney stone formation) in the month prior to beginning topiramate titration", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Dyssomnias Bipolar disorder patients with sleep disturbance Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Text Revision (DSM-IV-TR; APA, 2000) diagnostic for bipolar disorder type 1 (established with the SCID: Structured Clinical Interview for DSM-IV) Being inter-episode throughout the experiment as defined by cutoffs widely used in previous research. On the basis that a drug-free group would likely be unfeasible and unrepresentative, participants will not be excluded on the basis of medications prescribed for bipolar disorder. Comorbidity will be allowed as long as bipolar disorder is the primary diagnosis. However, it is necessary to assess comorbidity for reporting purposes Participants who have a history of bipolar 1 or suicidal ideation must be under the care of a psychiatrist Experience distress related to significant sleep disturbance Presence of an active and progressive physical illness (e.g., congestive heart failure, cancer, COPD) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) directly related to the onset and course of insomnia Alcohol or drug abuse (except nicotine) within the past year Active posttraumatic stress disorder Evidence of sleep apnea, restless legs syndrome or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome) Patients who pose a current suicidal risk or homicidal risk (assessed by treating psychiatrist) or who have made a suicide attempt within the past 6 months Pharmacotherapy for sleep defined as the benzodiazepine and non-benzodiazepine hypnotics that operate via the GABA A receptor complex and are FDA approved for the treatment of insomnia, selective melatonin agonists, benzodiazepine anxiolytics and over the counter medications with proven efficacy such as melatonin or herbs such as St. Johns wort Use of certain medications known to alter sleep (e.g., steroids, theophylline, propranolol, antihistamines that cause drowsiness)", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-80.0, All Multiple System Atrophy Clinical diagnosis of probable MSA (Gilman, et al. 2008) Age \u226518, <80 Heart failure Liver disease Kidney failure Thyroid disease Sick sinus syndrome and/or significant ECG alterations Hyposodemia Treatment with diuretics Treatment with haloperidol and/or other antipsychotics Treatment with NSAIDs or corticosteroids Treatment with ACE inhibitors", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-80.0, All SPINOCEREBELLAR ATAXIA 2 Molecular diagnosis of SCA2 (\u226534 CAG in the ataxin-2 gene) Age \u226518, <80 SARA score \u22658 SARA score >32 Heart failure Liver disease Kidney failure Thyroid disease Sick sinus syndrome and/or significant ECG alterations Hyposodemia Treatment with diuretics Treatment with haloperidol and/or other antipsychotics Treatment with NSAIDs or corticosteroids", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 20.0-65.0, All Sleep Initiation and Maintenance Disorders Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Patients complaining of insomnia continuously for 4 weeks or longer Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening Patient on most occasions sleeps for a total of \u22653 and <6.5 hours over the 4 week period prior to initial screening Patient's usual wake time after sleep onset in a single night is \u226545 minutes per night for the 4 week period prior to initial screening Patients have a body weight of \u226545 kg and \u226485 kg, a BMI of \u226518.5 and <30 Patients with schizophrenia or manic-depressive psychosis Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic Patients with circadian rhythm sleep disorder Patient works night shifts Patients with alcoholic sleep disorder Patients with alcohol or drug dependence or a history of these Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs Patients with sleep apnea syndrome Patients with restless legs syndrome or periodic limb movement disorder Patients with epileptic insomnia", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 21.0-70.0, All Primary Insomnia age 21-70 yrs non-pregnant females who agree to standard birth control for 12 months and males two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep meet DSM-IV for primary insomnia any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia a history of alcohol or substance abuse within the past two years a prestudy positive urine drug screen consuming >14 standard (1oz) alcoholic drinks per week caffeine consumption >300 mg/day smoking during the night (11pm-7am) medications including: anxiolytics, hypnotics. both prescription and OTC, (except in the chronic zolpidem group), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H1 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented sleep disordered breathing (SDB) defined as >10 apnea-hypopneas events per hour of sleep time or any other primary sleep (e.g., restless legs syndrome) or circadian disorder", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-90.0, All Bipolar Disorder Have a diagnosis of bipolar disorder Be 18 years or older Be a biological parent of a child who is younger than 30 years old Be willing to participate in the survey The participant must be (or must have been) the primary caretaker for his or her child A participant must meet criteria A participant s child cannot have been diagnosed with a mood disorder or other serious psychiatric disorder A participant s child cannot have been adopted The participant s child cannot be 30 years of age or older", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Depression The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) and is currently experiencing a major depressive episode Documentation that the patient has had at least 1 previous manic or mixed episode The patient has had no more than 6 mood episodes in the last year The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid) Written informed consent is obtained The patient is a man or woman 18 through 65 years of age The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry, hematology, and urinalysis Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies The patient has any clinically significant uncontrolled medical condition, treated or untreated The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Schizophrenia Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform Females who participate in this study are unable to have children-OR- are willing to remain abstinent from Day -5 until 90 days after discharge Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge Able and agree to remain off of prior antipsychotic medication for the duration of the study Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone Positive test results within 30 days prior to the start of the study for Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day to follow-up Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 14.0-45.0, All Schizophreniform Disorder Bipolar I Disorder Bipolar II Disorder Major Depressive Disorder With Psychotic Features, Substance-Induced Psychoses Psychosis Not Otherwise Specified Schizophrenia Schizoaffective Disorder Age between 14 and 45 years (inclusive) Male or Female gender DSM-IV-TR diagnosis of Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II), Major Depressive Disorder With Psychotic Features, Substance-Induced Psychoses, Psychosis Not-Otherwise-Specified (NOS) Outpatient status at the time of randomization Duration of antipsychotic treatment of less than 5 years Ability to provide informed consent Female patients of childbearing potential must be using a medically accepted means of contraception Treatment with olanzapine, clozapine, quetiapine,risperidone or paliperidone for less than 8 weeks duration at enrollment BMI between 18.5 and 30 Inability to give informed consent Currently enrolled in a weight management program Currently being treated with a medication to reduce weight Patients with unstable or active cardiovascular illnesses (myocardial infarction, congestive heart failure, etc), active or end-stage renal disease, and unstable thyroid disease, etc Inclusion/ has been intentionally limited in order to maximize the generalizability of the study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Nicotine Dependence Structured Clinical Interview (SCID) derived DSM-IV diagnoses of Bipolar Disorder (Type I or II), and Nicotine Dependence Young Mania Rating Scale Total Score <12 at study entry HAM-D 17-Item Score >5 and <24 at study entry Fagerstrom Test for Nicotine Dependence (FTND) score of 5 or higher Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent \"test\" Smoking at least 10 cigarettes per day (confirmed by an expired breath CO level >10 ppm and a plasma cotinine level >150 ng/ml at baseline) Be motivated to quit smoking within 30 days of initial evaluation, as assessed by a score of 7 or higher on the Contemplation Ladder assessment tool On a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic) Judged by the study psychiatrists and/or trained psychiatric clinicians to be in remission from active manic, hypomanic, major depressive and psychotic symptoms based on a clinical interview and SCID-IV \u22651 month prior to study enrollment Meet for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment Current evidence by SCID-IV and clinical evaluation of suicidality, homicidality or psychosis Meet DSM-IV for current major depression at the time of baseline evaluation A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to varenicline Serious medical conditions (i.e. a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities) EKG abnormalities Prescription of Nicotine Replacement Therapies (NRTs) including patches, gum, lozenges or inhalers Prescription of monoamine oxidase inhibitors (MAO-I's) including selegiline or moclobemide Prescription of varenicline Prescription of bupropion SR", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-40.0, All Weight Gain non-smoking, adults < 16 weeks gestation medical comorbidities", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 19.0-65.0, All Major Depressive Disorder Suicidality 19-65 years of age Diagnosis of major depressive disorder Currently experiencing suicidal thoughts Depressed patients without suicidality Patients with severe psychotic features or with primary diagnoses of bipolar disorder, schizoaffective disorder, schizophrenia, substance abuse/dependence or generalized anxiety Subjects who have taken lithium or an antipsychotic in the last 2 weeks pregnant women", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-50.0, All Sleep Memory to 50 years of age no sleep complaints or problems good sleep quality per questionnaire sufficient time in bed each night any clinically significant unstable medical condition recent psychiatric disorder prior diagnosis or symptoms of a sleep disorder recent history of substance abuse recent use of prescription hypnotic medication or over-the-counter sleep aid recent use of psychotropic medication history of adverse reaction to benzodiazepines body mass index > 36 currently pregnant or nursing currently working rotating or night shift", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 7.0-17.0, All Bipolar Disorder Participants aged 7 years to 17 years, 11 months old at time of first dose Participants must meet DSM-IV diagnostic as assessed by a semi-structured assessment (KSADS-PL) and a separate clinical interview with a child/adolescent psychiatrist for manic or mixed episodes in bipolar I disorder Score of > 20 on the YMRS at screening and baseline The participant and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent Participants with comorbid conditions [attention deficit hyperactivity disorder (ADHD), conduct disorder], except those listed in Criterion 2, may participate If female: is premenarchal, or is incapable of pregnancy because of a hysterectomy, tubal ligation, or spousal/partner sterility. If sexually active and capable of pregnancy, has been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier) for at least one month prior to study entry and agrees to continue to use one of these for the duration of the study. If sexually abstinent and capable of pregnancy, agrees to continued abstinence or to use of an acceptable method of birth control should sexual activity commence Has a negative quantitative serum \u00df-human chorionic gonadotrophin hormone pregnancy test at screening and a negative qualitative urine pregnancy test at baseline, if female Participants with a history of substance abuse may participate if they agree to continue to abstain from drugs during the trial and have a negative drug screen at screening or prior to baseline. Those with an initial positive drug screen during screening may have another screen done 1-3 weeks later while in screening, and a negative result will allow the participant to participate The participant is willing and clinically able to wash out of medications during the screening period. Prior to the administration of lithium, participants will have not used any of the following medications: antipsychotics, monoamine oxidase inhibitors, antidepressants within the preceding 2 weeks; stimulants within the preceding week; or fluoxetine or depot antipsychotics in the past month (no stable participants will be asked to discontinue medications) ECG and bloodwork including CBC, electrolytes, etc. (as per Safety assessment procedures listed in Table 6) showing no clinically significant abnormalities Participant who is clinically stable on current medication regimen for bipolar disorder A current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder (ASQ score > 15), Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder Current DSM-IV diagnosis of Substance Dependence Positive drug screen at screening and on retest 1-3 weeks later Participants with symptoms of mania that may be attributable to a general medical condition, or secondary to use of medications (e.g., corticosteroids) Evidence of any serious, unstable neurological illness for which treatment under the auspices of this study would be contraindicated Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol Current general medical condition including neurological disease, diabetes mellitus, thyroid dysfunction, or renal dysfunction that might be affected adversely by lithium, could influence the efficacy or safety of lithium, or would complicate interpretation of study results Evidence of current serious homicidal/suicidal ideation such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study Evidence of current active hallucinations and delusions such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Panic Disorder Generalized Anxiety Disorder Subjects must at least age of 18 years of age and not older than 65 Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR (26) Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV (except clause \"does not occur exclusively during a mood disorder\" of Criterion F for GAD) Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 (27) Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 (28) Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (26) Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR (26) Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) (27) Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S < 3) (28) Subjects with clinically significant suicidal or homicidal ideation Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder) Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo or hyperthyroidism unless stabilized on thyroid replacement > 3 months Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-64.0, All Sleep Initiation and Maintenance Disorders Primary Insomnia Diagnosis of primary insomnia based on DSM-IV (307.42) Written informed consent has been obtained Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week) Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study Patients who are pregnant, lactating or intend to become pregnant during the study period Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial Participation in any clinical trial within 1 month prior to randomization", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Depression Anxiety Disorders Clinical diagnosis of Major Depressive Disorder or more on MADRS-S Severe depression (more than 35 on MADRS-S or based on interview) Severe psychiatric condition (e.g. psychosis or bipolar disorder) Changed medication during the last three months", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 11.0-17.0, All Eating Disorder Male or female between 11 and 17 (less than 18) at beginning of trial Based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), patient fulfills for diagnosis of Anorexia Nervosa (of which there are two types: restricting or binge-eating/purging) or Eating Disorder Not Otherwise Specified, with a weight of less than or equal to 85% of his or her ideal body weight, as can best be determined at the time of assessment Treated by physician on the eating disorder team at the Children's Hospital of Eastern Ontario (CHEO) Currently receiving treatment with any other antipsychotic medication, mood stabiliser, or stimulant Known diagnosis of: diabetes, impaired glucose tolerance, hyperlipidemia, hepatic dysfunction, substance dependence, narrow angle glaucoma, paralytic ileus, or pancreatitis, or any other medical illness that would be considered to significantly impact treatment or recovery from the eating disorder Any uncontrolled comorbid disease affecting any system including infectious, endocrine, renal, gastroenterologic, respiratory, cardiac, immunologic, or hematologic. Potential participants with controlled comorbidities in these areas may be invited to participate at the discretion of the primary investigator Experienced one or more seizures without clear and resolved etiology Inability to comply with trial requirements including lack of comprehension of English Pregnant or breast-feeding High blood pressure Known allergy or known sensitivity to products in olanzapine Other unspecified reasons that, in the opinion of the investigator, amke the patient unsuitable for enrollment Officially declared incapable of consenting to treatment under the Mental Health Act (Note: If a patient is involuntarily hospitalized, he or she can be invited to participate provided that he or she has not officially been deemed incapable of making treatment decision under the Mental Health Act)", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 30.0-65.0, All Multiple Sclerosis Diagnosis of a progressive subtype of multiple sclerosis by revised 2005 McDonald Criteria EDSS of 3.0-6.5 Ages 30-65 Must be mentally capable of providing informed consent and following study guidelines Relapse or steroid treatment within 1 month of trial entry Any current or previous treatment with mitoxantrone, azathioprine, methotrexate, mycophenolate, cyclophosphamide, or any experimental therapy Women who are pregnant, wishing to become pregnant in the coming 30 months, or are breastfeeding Sexually active women unwilling to use reliable contraception (oral contraceptives, condom, IUD) Patients with known kidney dysfunction or creatinine >1.4; known cardiac arrhythmia or significant conduction abnormality on EKG; uncontrolled thyroid disease or TSH >20% above the upper limit of normal; uncontrolled psoriasis, HIV, or any other severe medical condition Patients with a history of unstable psychiatric illness or active severe depression Patients with a history of seizure Concurrent use of any of the following medications: Antipsychotics, diuretics, digoxin, or iodide salts Use of non-steroidal anti-inflammatory drugs (NSAIDs) 5 or more days a week Patients with a history of substance abuse in the past year", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Medication Adherence Bipolar Disorder Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI) On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant) Have weight gain concerns that individual believes are related to BD medication treatment Sub-optimal adherence as measured by the Tablet Routines Questionnaire (TRQ) and which the patient feels is related to weight gain concerns. TRQ threshold will be defined as missing an average of 20% or more of all prescribed BD treatment in the last week or month or missing 20% or more of the \"offending agent\" in the last week or last month. This is consistent with methodologies in PIs previous BD adherence studies Known resistance or intolerance to ziprasidone Medical contraindication to ziprasidone Individuals on ziprasidone immediately prior to study enrollment Prior or current treatment with clozapine Diagnosis of eating disorder Individuals whose sub-optimal adherence is related to inability to pay for BD medication treatment or inability to arrange transportation to BD treatment clinical visits Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial Current substance dependence High risk of harm to self or others Female who is currently pregnant or breastfeeding", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Depression With Prominent Agitation Male or female Age 18 to 65 Outpatient at enrolment A diagnosis of major depressive disorder Baseline HAMD-17 score > 20 and HAMD Item1 score > 2 both at enrolment and baseline Significant agitation CGI-S score > 4 at screening and baseline Negative serum pregnancy test at enrolment and use of a reliable method of birth control during the study Able to understand and comply with the requirements of the study Able and willing to give meaningful informed written consent Another Axis I diagnosis of primary focus within 6 months of enrolment Axis II disorder causing impact on current diagnosis Current depressive episode <4 weeks, or >12 months Substance or alcohol abuse or dependency as defined by DSM IV within 6 months of enrolment Any pervasive developmental disorder or dementing disorder Treatment with other antipsychotics, mood stabilizer or other psychoactive drugs less than 7 days prior to randomization Treatment with fluoxetine less than 28 days prior to baseline Treatment with MAO inhibitors, anxiolytic drugs in excess of 2 mg lorazepam equivalents/day Insufficient response to more than two antidepressants during the index episode prior to study involvement Known lack of antidepressant response to quetiapine at a dose of at least 50 mg/day x 4 weeks", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-40.0, All Bipolar Affective Disorders Cyclothymic Disorder Schizoaffective Disorder Major Depressive Disorder Dysthymic Disorder Obsessive-Compulsive Disorder Panic Disorder Posttraumatic Stress Disorder Premenstrual Dysphoric Disorder Social Anxiety Disorder 40 year old female women currently taking Lithium or Sertraline currently pregnant or breastfeeding concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera hepatic or renal disease irregular menstrual cycles", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Fathers Parenting High-risk Child Maltreatment Prevention Male Guardian Child enrolled in partnering Head Start site Mental Health issues that prohibit involvement in group-based prevention study (e.g., psychosis)", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Major Depressive Disorder men or women age of 18 years or older meet for major depressive episode, and have a family history of bipolar disorder or completed suicide subjects not able to give informed consent pregnant or breast-feeding women current panic disorder, post traumatic stress disorder or psychosis subjects with a history of mania or hypomania subjects with active substance abuse or dependence in the last 6 months current depressive episode less than 4 weeks or greater than 12 months in duration adequate trial of lithium or paroxetine (lithium level \u2265 0.6mmols/l; paroxetine 20mgs \u2265 5 weeks) for this episode of depression concurrent use of other antidepressants or augmenting agents for the treatment of depression clinically significant medical illness, in particular renal impairment", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 0.0-999.0, All Bipolar Disorder Patients with bipolar disorder Patients treated with lamotrigine tablets for the first time ", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Spinal Cord Injury either gender and 18-65 years old acute or subacute traumatic spinal cord injury (defined as SCI resulting from an exteneral non-penetrating cause that occurred within 4 weeks) neurological status of ASIA A neurological level between C5-T11 MRI shows injury site is within 3 vertebral level and necrotic focus, if exist, is less than 1/3 of the spinal cord diameter professional judgment determinate that subjects need a spinal decompression surgery subjects able to complete neurological examination subjects have voluntarily signed and dated an informed consent form penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic conditions spinal cord lesion exceeds three segments or necrotic focus with diameter larger than 1/3 of the spinal cord severe complications significant medical diseases or infection pregnant or lactating woman, or female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study unavailability of suitable umbilical cord blood cells contraindication of lithium carbonate and/or spinal decompression surgery subject is currently participating in another study or has been taking any investigational drug within the last 4 weeks prior to screening investigator suggests that the subject would not be suitable to participate this study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Schizophrenia Diagnosis (DSM-IV) of schizophrenia or functional psychosis including schizophreniform and acute psychosis with schizophrenia symptoms Receiving olanzapine treatment for no more than 3 months The dose of olanzapine is stable for at least 2 weeks prior to randomisation (Visit 2) and subject is willing to maintain a stable dose of olanzapine for the duration of the study Evidence of weight gain in the last 3 months attributable to olanzapine, prior to screening (Visit 1). Wherever possible, investigator must other possible causes of weight gain, such as change in exercise, diet, or other illnesses Each subject must have further weight gain attributable to olanzapine, in the baseline period (between Visits 1 and 2) no more than 5 months subsequent to commencement of olanzapine treatment Willing to maintain a stable dose of any concomitant medications, and have been on a stable dose for a minimum of 6 weeks (with the exception of olanzapine) No changes in diet or exercise for 6 weeks prior to screening (Visit 1) and subject agrees to maintain stability, for the duration of the study (in the opinion of the investigator) Subject has Axis I (DSM-IV) diagnosis of schizoaffective disorder Subject has drug induced or toxic psychosis (in the opinion of the investigator) Subject presents with a clinical picture and/ or history that is consistent with delirium, dementia, amnesia or other cognitive disorder; bipolar disorder or major depression Subject has a significant history of anxiety, suicidal ideation or self-harm based on history or routine psychiatric status examination (in the opinion of the investigator) Subject has an unstable thyroid pathology (including hypo or hyperthyroidism), within the past six months (in the opinion of the investigator) Subject has a history of neuroleptic malignant syndrome Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2 month period prior to randomisation (Visit 2) Subject has a clinical diagnosis of diabetes Subject is taking insulin (i.e. they are insulin dependent) or have had insulin within 6 months prior to the screening visit (Visit 1) Any known or suspected history of (in the opinion of the investigator)", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Able to provide informed consent before beginning any study-specific procedures Male and female patients at least 18 years of age Meets Diagnostic and Statistical Manual -IV for BPI, BP II, or National Comorbidity Survey-R for sub-threshold BP with or without symptoms, in need of medication adjustment(s) Willing to be randomized to either Lithium or Quetiapine If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation Women with reproductive potential must have a negative urine pregnancy test Unwilling to comply with study requirements Patients who have had severe adverse reaction to Lithium or Quetiapine Patients who require inpatient care Drug/alcohol dependence requiring immediate acute detoxification Pregnancy as determined by serum pregnancy test or breastfeeding History of nonresponse to Lithium at doses >900 mg \u22658 wks or to Quetiapine at doses of at least 300 mg/d \u2265 8 week for depression and at least 400-600 mg/d \u2265 4 wks for mania", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 60.0-999.0, All Sleep Duration on the First Night After Surgery Total hip or knee replacement in fast-track setup Age 60 years or above ASA class 1-3 Anesthesia within the pas 30 days Daily use of alcohol > 21 units / week Use of anxiolytics or hypnotics within the past 30 days Inability to read and understand Danish Marked reduction of sight or hearing Parkinson's disease or other neurological disaese causing function deficits Inability to cooperate to sleep monitoring allergy to the drug tested", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Insomnia Depression Suicidal Ideation Persons 18-65 years of age Persons with confirmed DSM-IV diagnosis of MDE by SCID Persons with Research Diagnostic diagnosis of insomnia Persons free of all psychotropic medications for one week before baseline assessment, except that prior FLX treatment will require 4 weeks of abstinence, and MAOIs will require 2 weeks of abstinence Persons with Scale for Suicidal Ideation (SSI) scores >3 but <15 OR SSI >15 and C-SSRS Suicidal Ideation Score <3 Persons with Hamilton Rating Scale for Depression (HRSD24) score >20 Persons with Mini Mental State Exam (MMSE) score >24 Persons with Insomnia Severity Index (ISI) score > 7 Persons with habitual sleep latency > or = 30 minutes or wake time in the middle of the night of > or = 30 minutes, and sleep efficiency < 85% Non-English speaking, reading, writing persons Persons who pose imminent danger to self or others Persons with severe Severe suicidal ideation (SSI > 15 AND C-SSRS Suicidal Ideation Score >4) Persons with clinical diagnosis of dementia Persons with active or past diagnosis of alcohol or substance abuse, bipolar disorder, schizophrenia per the SCID Persons who screen positive for moderate-severe sleep apnea (AHI >10) or a prior sleep laboratory-confirmed diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder Persons with excessive daytime sleepiness, defined as an Epworth Sleepiness Scale Score >10 Persons with BMI > 50 Persons with a self-reported history of napping > 2 times per week (as these are associated with sleep apnea and periodic limb movement disorder in depressed insomniacs) Persons who might be harmed by exposure to hypnotics, including pregnant women and patients with respiratory conditions", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Bipolar Disorder Insomnia Fulfilling for SCID-1-verified bipolar I or II disorder Euthymic, as defined by Montgomery \u00c5sberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five Fulfilling DSM-IV for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS) Being or having been in a defined affective episode the last month before Hospitalization in the last two months before Working night shifts Sleep apnea Medical conditions incompatible with participation Inability to cooperate in the 3-week initial phase before randomization", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 0.5-85.0, All Influenza For adults and old people Healthy adults aged 18-60 years old, and healthy old people aged >60 years Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years Not participate in any other clinical trials during the study Not receive any immunosuppressive agents during and one month prior to the study Be able to understand and sign the informed consent Woman\uff1a Who breast-feeding or planning to become pregnant during the study Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Autoimmune disease or immunodeficiency Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases Guillain-Barre Syndrome Women subjects with positive urinary pregnancy test Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) Axillary temperature >37.0 centigrade at the time of dosing Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Insomnia Hypersomnia Sleep Problems Men and women age 18-65 DSM-IV diagnosis of bipolar I or II disorder HAM-D-17 score < 17 (i.e. low or no depressive symptoms) YMRS score < 8 (i.e. no or low manic symptoms) Optimized, stable maintenance pharmacotherapy at maximum tolerated dosages in accordance with the revised Texas Implementation of Medication Algorithm DSM-IV insomnia A and B are met (i.e. difficulty initiating or maintaining sleep, for at least 1 month) as operationally defined by Insomnia Severity Index score of > 15 (moderate clinical insomnia) M1 derived average actigraphic total sleep time < 6 hours, and < 40% average total sleep time in high frequency coupling, as measured with the M1 device over 5 days pre-randomization, corresponding to < 1SD below the mean of the M1 normative comparison sample of healthy control participants DSM-IV bipolar I disorder subtype rapid cycling DSM-IV manic or mixed episode in the past 2 months DSM-IV major depressive episode in the past 2 months Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm Pregnancy Medical illness or non-psychiatric medical treatment that is the likely cause of the sleep disturbance or interferes with study participation Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion) Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for > 1 year; past or current substance dependence (including alcohol), schizophrenia, delusional disorder, psychotic disorders not otherwise specified Axis I disorder that needs to be the primary focus of treatment (e.g. current DSM-IV anxiety disorder that disrupts sleep) Sleep apnea, restless leg syndrome, or narcolepsy", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 13.0-21.0, All Adolescent - Emotional Problem age 13 to 21 experience a moderately elevated level of depressive symptoms on the CES-D scale (score 16-34) may or may not have had a past history of depression, anxiety and/or substance abuse currently diagnosed with depression, schizophrenia, or bipolar affective disorder currently taking antidepressants or psychotropic medication CES-D score equal or higher than 35, or a proved serious medical illness that causes significant disability or dysfunction exhibit significant reading impairment, mental retardation, developmental disabilities serious imminent suicidal risk or other conditions that may require immediate psychiatric hospitalization have extreme, current drug / alcohol abuse (greater than or equal to 2 on the", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Age 18-65 written informed consent meets DSM-IV (by SCID-I/P) for bipolar I disorder, current episode depressed MADRS score of at least 20 (i.e., moderate depression) and no greater than 34 (i.e., severe depression) at screen and baseline visit YMRS score < 12 at screen and baseline visit currently treated with a lithium preparation (carbonate or citrate) at stable dose for at least 4 wks with level >0.6 and <1.0; and/or valproate at stable dose for at least 4 wks at level >60 and <110; and/or other atypical antipsychotic at stable dose for at least 4 weeks (at least minimum FDA-labeled dose) Caucasian by self-report please see discussion below Psychotic features in the current episode, as assessed by YMRS item #8 > 6 [where treatment guidelines urge use of antipsychotics that may confound isradipine results] felt by the study clinician to require inpatient hospitalization for adequate management (to serious suicide or homicide risk, as assessed by evaluating clinician) or more failed pharmacologic interventions in the current major depressive episode, excluding lithium/valproate/other atypical antipsychotic [response rates for these subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects] obsessive-compulsive disorder, or any diagnosis of a DSM-IV anxiety disorder where the anxiety disorder and not bipolar disorder is the primary focus of clinical attention current substance use disorder other than nicotine, by SCID-I/P a primary clinical diagnosis of a personality disorder, or comorbid diagnosis of antisocial or borderline personality disorder pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy) women who are breastfeeding other unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests (this will any clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1) history of hypertension or current treatment for hypertension", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 17.0-40.0, All Primary Insomnia Secondary Insomnia primary insomnia secondary insomnia requiring sleep medication (Zolpidem) for a three-week trial active duty military service member stationed at Fort Carson secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication treated for sleep problems using sleep medications which Lunesta, Ambien, Ambien Controlled Release (CR), Seroquel, Trazodone or Remeron major psychopathology (i.e., schizophrenia) severe depression within the past 90 days suicidal ideation within the past 90 days psychiatrically hospitalized within the past 90 days uncontrolled hypertension or diabetes pregnancy previous use of Zolpidem proved to be ineffective or to cause other unwanted side effects actively abusing controlled substances", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Neuropathic Pain Neuralgia Spinal Cord Injuries Age 18 Diagnosis of traumatic spinal cord injury Clinically diagnosed neuropathic pain Pain severity is at least 4 on a 11-point numeric rating scale at screening Pain present regularly for at least 6 weeks before enrollment Able to understand instructions and provide reliable pain assessments Subjects who are voluntarily signed and dated an Ethics Committee approved informed consent form Significant renal, cardiovascular, hepatic, infectious or psychiatric disease Significant brain injury with neurological deficits Debilitation or dehydration Addison's disease Recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines A history of substance or alcohol abuse within past 1 year A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period Current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control Participation in any drug study in the last three months History of oral lithium intake for any reason; or", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 10.0-25.0, All Bipolar Disorder have at least one biological parent diagnosed as bipolar disorder (bipolar I or II) have at least one of the following syndromes i) two or more DSM-IV defined hypomania/mania symptoms, lasting for at least 4 days; ii) two or more DSM defined major depressive symptoms, lasting for 1 week; iii) at least one of the psychotic symptoms, lasting at least 10 min for each manifestation, and 2-7 manifestations a week for at least 3 months, including: ideas of reference; odd ideas, odd belief, unusual perceptual experiences, bizarre thought or speech, Grandiosity, suspicious ideas, paranoid idea, odd mannerisms, hallucination, disorganized/catatonic behavior; iv)two or more of the DSM-IV defined Attention deficit hyperactivity disorder (ADHD)symptoms; and there must be clear evidence of clinically significant impairment in social, academic, or occupational functioning due to ADHD symptoms DSM-IV defined Axis I disorders Serious general medical illness mental retardation was/is treated with antipsychotic drugs unable to complete neuropsychological tests due to physical conditions in pregnancy and lactation was taking thyroxine therapy in the last three months or is taking hormone therapy", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Anxiety Disorders Men and women age 18-65 DSM-IV diagnosis of bipolar I disorder and at least one of three additional anxiety disorders generalized anxiety disorder, panic disorder, or social phobia HAM-D-17 score <16 (i.e. depressive symptoms) YMRS score < 12 (i.e. no or very low manic symptoms) Current, stabilized (> 3 months) pharmacotherapy treatment under the care of a psychiatrist consisting of optimized, stable maintenance pharmacotherapy at maximum tolerated dosages according to Texas Implementation of Medication Algorithm Active suicidality (HAM-D-17 suicide item #3 score > 3) in the past 2 months. Potential participants scoring 3 or higher on the HAM-D-17 suicide item will be immediately evaluated by the PI and Sponsor and referred to a higher level of care if clinically indicated DSM-IV bipolar I disorder subtype rapid cycling DSM-IV manic or mixed episode in the past 2 months DSM-IV major depressive episode in the past 2 months Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm Current Pregnancy Medical illness or non-psychiatric medical treatment that would likely interfere with study participation Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion) Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for > 1 year; current substance dependence (including alcohol), as assessed by the Structured Clinical Interview for DSM-IV-TR, Substance Use Disorders (Section E); schizophrenia, delusional disorder, psychotic disorders not otherwise specified, obsessive compulsive disorder and posttraumatic stress disorder (due to low prevalence of ~6.5% each) Concurrent psychotherapy other than cognitive-behavioral therapy as provided in this study (to rule out other uncontrolled effects of concurrent psychotherapies)", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder with a diagnosis of bipolar I disorder, manic or mixed phase equal or more than 18 scores in Young Mania Rating Scale (YMRS) Serious general medical illness pregnancy and lactation given long-acting antipsychotic drug within the last two month endocrine disease( e.g.Diabetes and thyrotoxicosis) given thyroxine therapy within the last three months or is being given hormone therapy sexually active and not using contraceptives", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 20.0-64.0, All Primary Insomnia Men or women aged between 20 and 64 years Diagnosis of primary insomnia according to defined by DSM-IV Difficulty in maintaining sleep and waking up until 3 am Not having used any psychoactive drug in the last 30 days prior to their in the study Signature of IC Previous history of serious medical illness, neurological or psychiatric disorder Allergy or hypersensitivity to zolpidem Obstructive Sleep Apnea syndrome Polysomnography with apnea and hypopnea index >10/hour or PLM >15/h Other secondary sleep disorders History of substance abuse or dependence History of daily consumption of alcoholic beverages Pregnancy, lactation or refusal to use safe contraceptive methods during the study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 0.0-999.0, All Depressive Disorder Bipolar Disorder Suicide Suicide, Attempted Must be a Veteran of the United States Armed Forces Survived an episode of suicidal self-directed violence (including suicide attempts and interrupted attempts) that occurred within three months of admission to the study, or they were admitted within the past three months to a mental health inpatient unit specifically to prevent suicide Have a diagnosis of an affective disorder meeting DSM-IV-TR (2000) for Bipolar I Disorder, Bipolar II Disorder, or current or recurrent Major Depressive Disorder Are able and willing to identify one or more family members, friends, or other contacts and give permission for both clinical providers and the Research Team to contact them if the patient cannot be reached Are able to provide informed consent There is concurrence from the patient's mental health and primary care providers about inclusion/ and confirmation of the providers' willingness to work with the research team in managing the patient during the course of the study Must be registered at a VA Medical Center Schizophrenia or schizoaffective disorder Cognitive impairment defined as a Brief Orientation Memory and Concentration Test score > 10 Lack of decision-making capacity to evaluate the risks versus the benefits of participation as determined by Jeste's brief instrument for assessing decisional capacity, or adjudication of incompetence and the appointment of a guardian or conservator Six or more previous lifetime suicide attempts as ascertained through SPAN, reports from family, or patient self-report Current or recent (within six months) use of lithium History of significant adverse effects of lithium as ascertained through the medical record or self-report Unstable medical conditions or specific medical comorbidity Congestive heart failure by Framingham", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Major Depressive Episode Suicidal Ideation Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation Moderate to severe suicidal ideation 65 years old Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills Able to provide informed consent Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness Significant ECG abnormality Pregnancy and/or lactation Current psychotic symptoms Contraindication to any study treatment Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal Inadequate understanding of English Prior ineffective trial of or adverse reaction to ketamine or midazolam Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion Diagnosis of sleep apnea", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 7.0-17.0, All Bipolar Disorder Pediatric Bipolar Disorder Childhood-onset Bipolar Disorder 17 years old bipolar disorder type I preferred (at least 1 week of mania) no implanted metal (no braces, no cochlear implants) can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder no active drug/alcohol abuse/dependence", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 12.0-18.0, All Dialectical Behavior Therapy + Pharmacotherapy Standard of Care Psychotherapy + Pharmacotherapy For the proposed study, are as follows: 1) age 12 years, 0 months to 18 years, 11 months; 2) a diagnosis of Bipolar Disorder (BP) I, II or NOS by the K-SADS-PL with an acute manic, mixed or depressive episode in the 3 months preceding study entry; 3) willing to engage in pharmacotherapy treatment at the CABS specialty clinic; 4) at least one parent or guardian with whom the patient lives or interacts on a significant basis (5 hours per week or more) who is willing to participate in DBT skills training; 5) English language fluency and at minimum a 3rd grade literacy level; 6) able and willing to give informed consent/assent to participate For the proposed study are as follows: 1) evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records; 2) a life-threatening medical condition requiring immediate treatment; 3) current victim of sexual or physical abuse", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Suicide Risk Assessment nurses who work in a variety of wards such as Hematology, Oncology, Stroke and Rehabilitation where potential cases with high suicide risk may be identified ", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Suicidal Ideation/Behavior Depression Major depressive episode; inpatient at screening visit; suicidal ideation/behaviour present defined by a clinical rating of 8 on the Sheehan Suicidality Tracking Scale (S-STS) and a rating of \u226520 on the Montgomery Asberg Depression Scale (MADRS) at both screening and baseline visits; both gender, age 18 years Contraindication for and history of lithium treatment within the past 6 months; patient unable to tolerate lithium treatment in the past; comorbid borderline/antisocial personality disorder, currently active substance dependency; patients with acute or unstable severe medical conditions, patients unable to understand the informed consent or involuntary inpatients, positive toxicology screen (illegal drugs), pregnancy and lactation", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 10.0-17.0, All Childhood Anxiety Parents With Bipolar Disorder Children at Risk for Bipolar Disorder 17 years old At least one parent with bipolar disorder Meets clinical for a specific anxiety disorder PARS -5 item scale score > 10 at screening and baseline of initial study phase Fluent in English Provision of written informed consent/assent Agrees to participate in 75% of sessions Have any of the Following Documented diagnosis of mental retardation or IQ <70 Previous participation in mindfulness-based treatment Substance use disorder within last 3 months Judged clinically to be suicide risk Concurrent treatment with psychotropic medication (certain exceptions apply, ask for details) Psychotherapy initiated within 2 months prior to screening or plan to initiate psychotherapy during study participation Any lifetime diagnosis of bipolar disorder, cyclothymia, schizophrenia, or other psychotic disorder Any symptom that requires admission to an inpatient psychiatric unit Anxiety symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 2.0-9.0, All Parental/Caregiver Anxiety Child's Anxiety Pediatric patients ages 2-9 years ASA class I-II inpatient surgeries of at least 2 hours duration requiring postoperative admission of at least 23 hours contraindication to preoperative sedation, known allergy or sensitivity to the study medications those who lack legal representative consent Patients with weights lying below the 5th percentile or above the 95th percentile according to the current published CDC growth chart will also be excluded regardless of existing specific contraindication", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-60.0, All Bipolar Disorder The patient was correctly informed about the study The patient must be insured or beneficiary of a health insurance plan The diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the BEC and confirmed during the preliminary interview at the BEC The patient is euthymic on the day of inclusion. This is supported by a short psychiatric interview conducted at the BEC and the completion of the depression and mania scales (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire) The patient is prescribed a mood stabilizer based on lithium or divalproex The patient is under judicial protection, under tutorship or curatorship The patient formalizes his/her opposition to the studyd It is impossible to correctly inform the patient The patient has mental retardation The patient has practiced substance abuse or dependence within the 6 months prior to study (alcool, cannabis, opiates, psychostimulants) The patient does not meet euthymic (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire) Uninclusion The patients withdraws consent during the study The patient does not understand directions necessary for the neurpsychological tasks The patient is not able to use a computer to complete the neuropsychological tasks", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 13.0-21.0, All Bipolar Disorder Suicidal Ideation Diagnosis of Bipolar Disorder I, Bipolar Disorder II, or Bipolar Disorder Not Otherwise Specified Living with or in close contact with at least one parent who is willing to participate Have had at least 1 week in the prior 3 months of significant suicidal ideation and/or at least one suicidal event in the 3 months prior to study intake Willing to be treated pharmacologically by a psychiatrist in the UCLA Child and Adolescent Mood Disorders (CHAMP) clinic Participants requiring immediate hospitalization Diagnosis of borderline personality disorder, schizophrenia, or schizoaffective disorder Current substance dependence disorder", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-69.0, All Insomnia age between 18 years to 69 years fluent in German language provide written informed consent ability to understand the explanations and instructions given by the study physician and the investigator Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia) Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC; Fachinformation in Germany) assessed by physical examination (including ECG) and medical history allergies to amitriptyline hydrochloride or any of its ingredients allergies to zolpidem or any of its ingredients acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug urinary retention delirium untreated closed-angle glaucoma prostatic hyperplasia pyloric stenosis", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 13.0-19.0, All Insomnia Depression Between 13-19 years of age Are depressed Have insomnia Are not depressed Do not have insomnia Currently using a sleep aid Have bipolar depression Have psychotic disorder Have a sleep disorder other than insomnia", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Prostate Cancer Ability to understand and the willingness to sign a written informed consent form Subjects with histologically confirmed local adenocarcinoma of the prostate who have elected to proceed with radical prostatectomy as primary curative therapy Subjects having no prior administration of lithium or lithium containing medications within 90 days of study enrollment Subjects >/= 18 years of age ECOG (Eastern Cooperative Oncology Group) performance status of /= 50 mL/min Use of adequate contraception ECG (Electrocardiogram) within normal limits Subjects must agree not to take any new vitamin supplements or herbal remedy during the study period Subjects must be able to safety take lithium carbonate for at least 4 weeks before scheduled prostatectomy Subjects who have received any investigational medication within 30 days of first lithium dose Subjects currently receiving, or who have had previous hormonal, chemotherapy or radiotherapy for prostate cancer Subjects with known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to lithium carbonate Uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 21.0-65.0, All Schizophrenia Metabolic Syndrome Vitamin D Deficiency \u2022 Men and women with a DSM-IV clinical diagnosis of Schizophrenia, Schizoaffective or Bipolar disorder to 65 years of age; male and female A willingness and ability to provide signed informed consent The subject should have been on quetiapine 100 mg or more for more than 12 weeks Pregnant women Subjects considered at high suicide risk based on the MINI Suicidality Module (> 17 points) Unstable general medical condition or serious illness (e.g. death or hospitalization is anticipated within one year), poor kidney function or liver function (defined as laboratory values \u2265 three times the upper limit of the normal), and seizure disorders except for childhood seizure disorders Concurrent therapy with certain psychotropics is permitted, provided that the medication and dose have been stable for the past 90 days Patients on concomitant treatment with clozapine and olanzapine are not permitted Patients on immunosuppressant medications or any orexigenic or anorexigenic drug Patients on concomitant treatment with amphetamines and/ or methylphenidate History of hypothyroidism or thyroxine therapy Patients with a known condition or undergoing therapeutic measures that affects weight, including but not limited to: eating disorder, type I diabetes, hyperthyroidism, thyroxine therapy, Topamax therapy, and infectious diseases, such as HIV, hepatitis B, and hepatitis C Active supplementation of vitamin D within the last 3 months", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point) ears to 65years subjects who sign the informed consent document don't have Diabetes and abnormal metabolism of sugar not noticed as bipolar disorder have an organic brain disease pregnant or breastfeeding women don't have heart disease have actively suicidal thought(Suicidal ideation score of MADRS is 6) who are judged by the investigator to should be excluded from the study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Bipolar Disorder Suicidal Ideation Depression Meets DSM-IV for BD I and II current depressive episode Able to give written informed consent Age > to 18 years and < 65 years Currently suicidal as defined by a MADRS suicide item score of > 3 or previous history of serious suicidal ideation that required hospitalization All subjects need to have normal hearing and normal/corrected-to-normal vision Medical illness or non-psychiatric medical treatment that would likely interfere with study participation Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion potentially confounding MRI results) Substance abuse within the past 3 months or current substance dependence (confirmed by MINI) Left-handedness Contraindications to MRI (metallic implants, claustrophobia, etc.) Subjects who need urgent psychiatric care requiring hospitalization (evaluated by clinicians)", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 21.0-50.0, All Healthy Be in good general health as determined by the investigator Have a 3-month history of a normal nightly sleep pattern based on the subject's self report A usual time in bed A regular bedtime between 2200 and 2400 hours No habitual daytime napping Epworth Sleepiness Scale score \u2264 10 Be able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing and able to comply with all study procedures Be able to follow verbal and written instructions provided in English Have a body mass index (BMI) >35 kg/m2 Have symptoms consistent with the diagnosis of any sleep disorder (e.g., insomnia, sleep apnea, narcolepsy, periodic leg movements, or restless leg syndrome) On screening PSG AHI > 10 or PLMAI >10 Have a known or suspected diagnosis of Acquired Immune Deficiency Syndrome (AIDS), or have tested seropositive for human immunodeficiency virus (HIV) antibody or antigen previously Have any clinically significant abnormal finding in physical examination, neurological assessment, vital signs, elevated body temperature, or clinical laboratory tests, as determined by the Investigator Have a known exaggerated pharmacological sensitivity, hypersensitivity, or history of a clinically significant adverse reaction to zolpidem Have a known or exaggerated pharmacological sensitivity, hypersensitivity, or intolerance to doxepin HCl, any tricyclic antidepressant, or antihistamine Currently taking cimetidine or a monoamine oxidase inhibitor (MAOI) Current diagnosis of severe urinary retention Current diagnosis of untreated glaucoma", "label": "1"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-45.0, All Diabetes Weight Gain Weight Loss Cardiovascular Disease Obesity Participants will be men of European (self-report of both parents of white European origin) or South Asian (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin) with BMI <25 kg.m-2, who have been weight stable (\u00b1 2 kg) for >6 months will diabetes (physician diagnosed or HbA1c \u22656.5% on screening), history of cardiovascular disease, regular participation in vigorous physical activity, current smoking, taking drugs or supplements thought to affect carbohydrate or lipid metabolism, or other significant illness that would prevent full participation in the study", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-70.0, All Cirrhosis Age 18 to 70 years Clinical, Biochemical, Radiological ,Histological evidence of cirrhosis of all etiology Child A and B cirrhosis Cirrhosis patients giving h/o persistent sleep disturbances Active alcohol intake or intake within 1 month of enrollment Active substance abuse or intake within 1 month of enrollment Known psychiatric and neurological disorders Patient using antidepressant, anticonvulsants, other hypnotics Pregnancy or lactation Overt hepatic encephalopathy Child C cirrhosis Acute decompensated state of CLD (Chronic Liver Disease) GastroIntestinal bleed, increased jaundice, HE (Hepatic Encepahlopahty) , SBP (Spontaneous Bacterial Peritonitis) HCC (HepatoCellular Carcinoma) with portal vein thrombosis", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-55.0, All Bipolar Disorder Age 18 or older If Pregnant, equal to or less than 26 weeks English-speaking DSM-IV Bipolar Disorder, any subtype, Major Depressive Disorder, or Mood Disorder Not Otherwise Specified Able to provide informed consent Daily dosing of lithium Active substance abuse within last 6 months and/or positive urine drug screen Active suicidality No obstetrical care Use of other drugs that affect metabolism of lithium Medications in FDA categories F or X that are not antimanic drugs Chronic Kidney Disease", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Anxiety Depression Bipolar I Disorder Bipolar II Disorder Age 18 or older Experiencing mood disorders (e.g. depression, anxiety, bipolar) defined as a visit with a specified DSM-V code (295.7 Schizoaffective Disorder (Depressive type), 295.7 Schizoaffective Disorder (Bipolar type), 296.41 Bipolar I Current or most recent episode manic Mild, 296.42 Bipolar I Current or most recent episode manic mod, 296.43 Bipolar I Current or most recent episode manic sev, 296.44 Bipolar I Current or most recent episode manic w psychotic, 296.45 Bipolar I Current or most recent episode manic in partial remission, 296.46 Bipolar I Current or most recent episode manic in full remission, 296.40 Bipolar I Current or most recent episode unspecified, 296.40 Bipolar I Current or most recent episode hypomanic, 296.45 Bipolar I Current or most recent episode hypomanic in partial remission, 296.46 Bipolar I Current or most recent episode hypomanic in full remission, 296.40 Bipolar I Current or most recent episode hypomanic unspecified, 296.51Bipolar 1 Current or most recent episode depressed mild, 296.52 Bipolar 1 Current or most recent episode depressed mod, 296.53 Bipolar 1 Current or most recent episode depressed sev, 296.54 Bipolar 1 Current or most recent episode depressed w psychotic, 296.55 Bipolar 1 Current or most recent episode depressed in partial remission, 296.56 Bipolar 1 Current or most recent episode depressed in full remission, 296.50 Bipolar 1 Current or most recent episode depressed unspecified, 296.7 Bipolar 1 current or most recent episode unspecified, 296.89 Bipolar II, 301.13 Cyclothymic, 296.83 Bipolar due to Medical Condition, 296.89 Other Specified Bipolar, 296.80 Unspecified Bipolar, 296.99 Disruptive Mood Dysregulation disorder, 296.21 Major Depressive Disorder Single Episode Mild, 296.22 Major Depressive Disorder Single Episode mod, 296.23 Major Depressive Disorder Single Episode sev, 296.24 Major Depressive Disorder Single Episode w psychotic, 296.25 Major Depressive Disorder Single Episode in partial remission, 296.26 Major Depressive Disorder Single Episode in full remission, 296.20 Major Depressive Disorder Single Episode unspecified, 296.31 Major Depressive Disorder Recurrent Episode mild, 296.32 Major Depressive Disorder Recurrent Episode moderate, 296.33 Major Depressive Disorder Recurrent Episode severe, 296.34 Major Depressive Disorder Recurrent Episode w psychotic, 296.35 Major Depressive Disorder Recurrent Episode in partial remission, 296.36 Major Depressive Disorder Recurrent Episode in full remission, 296.30 unspecified, 300.4 Persistent Depressive Disorder (Dysthymia), 625.4 Premenstrual Dysphoric Disorder, 293.83 Depressive Disorder due to another medical condition, 311 Other specified depressive disorder, 311 Unspecified Depressive disorder, 309.21 Separation anxiety disorder, 300.29 Specific Phobia, 300.23 Social anxiety do, 300.01 Panic Disorder, 300.22 Agoraphobia, 300.02 GAD, 293.84 Anxiety do due to another med condition, 300.09 other specified anxiety do, 300.00 Uspecified Anxiety do, 309.0 Adjustment do with depressed mood, 309.24 Adjustment do with anxiety, 309.28 Adjustment do with mixed, 309.4 Adjustment do with w disturbance of emotions and conduct, 309.9 Adjustment do unspecified, 300.7 Illness anxiety disorder, 293.83 Mood do NOS, 296.9 Mood do unspecified, 291.89 alcohol inducted mood do, 292.84 amphetamine inducted mood do 292.84 cocaine inducted mood do, unspecified inducted mood do, 296.66 episodic mood dis unspecified, 296.64 Severe mixed bipolar do) Possessing a smartphone with either an Android or iOS platform Able to read and write in English Have a designated primary behavioral health care provider who is either using the app with their patients (intervention) or is issuing the surveys on paper in their clinic (control) ", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Agitation Male and female patients between the ages of 18-65 years, inclusive Patients (or legal representative) willing and able to provide written Informed Consent Form Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders IV, Diagnostic and Statistical Manual of Mental Disorders V or International Code of Disease criteria Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting Previously treated with with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation) Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema) Requirement of family or other caregiver support at study investigator (defined as a patient's relative or caregiver (male or female) \u2264 80 year old, who spend \u2265 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures) Availability of patient's medical records data about the previous treatment with at hospital setting Patient diagnosed with dementia Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis) Patients with a history of allergic reactions to loxapine or amoxapine Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Insomnia Bipolar Disorder Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) for bipolar I disorder (296.70), bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80), with concurrent insomnia related to bipolar disorder (307.42) Currently taking \u2265 1 prescription psychotropic medication (hypnotic agents, anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for management of bipolar disorder Subjective total sleep time (sTST) < 6 hours on \u2265 1 night during the prior week Current hypo/manic symptoms, as evidenced by YMRS total score \u2265 12 Current (past 6 months) alcohol or substance use disorder Current psychosis Patients who are actively suicidal or evaluated as being a high suicide risk Women who are currently pregnant or breastfeeding Clinically significant abnormalities on baseline laboratory tests (comprehensive metabolic panel, fasting lipid panel, CBC with differential, thyroid stimulating hormone) Presence of any unstable and/or potentially confounding neurological and/or medical disorder", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-65.0, All Major Depressive Disorder Bipolar I Disorder Bipolar II Disorder Bipolar Depression Suicidal Ideation Provision of written informed consent [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) Both females and males, aged 18 to 65 years Inpatient status Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active The ability to understand and comply with the requirements of the study and capable of providing informed consent Suffering from suicidal ideation/attempts as evidenced by a score of >0 on either of the SSI or CSSRS or both Current or past psychotic symptoms Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV within 4 weeks prior to enrollment Any pervasive developmental disorder (according to DSM-IV criteria) Diagnosis of dementia (according to DSM-IV criteria) Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator Significant medical condition that would contraindicate the use of ketamine, midazolam or that is untreated and would need urgent attention (as determined by treating physician) Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator", "label": "0"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-64.0, All Depression Alcoholism Drug Abuse African American English speaking Diagnosis of Bipolar Disorder (BD) Able to provide written informed consent Cognitive impairments Acutely psychotic Medically unstable History of schizophrenia spectrum disorder History of mood incongruent psychotic symptoms History of primary substance disorder History of primary organic disease and/or dementia", "label": "2"} +{"topic": "A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem.", "doc": "eligible ages (years): 18.0-999.0, All Healthy Volunteers Male or female study participants, aged above 18 years-old; women cannot be pregnant or breastfeeding Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2 Good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and complementary laboratory tests Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature Known hypersensitivity to the investigational product (Zolpidem) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism Chronic therapy with any drugs, except oral contraceptives History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure Electrocardiographic findings that, at investigator are not recommended for study participation Deviations on screening laboratory results that are considered as clinically relevant by the researcher Smoking Intake of more that 5 cups of coffee or tea per day Unusual food habits, e.g., vegetarians History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/day)", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infections You may be eligible for this study if you Are HIV-positive Are at least 18 years old Have symptoms of AIDS dementia including forgetfulness, loss of concentration, slow mental processing, or a loss of muscle control Have been on stable anti-HIV drug therapy for the past 6 weeks (if you are taking anti-HIV drugs) You will not be eligible for this study if you Have certain serious medical conditions, such as a mental disorder or an opportunistic (AIDS-related) infection", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Spinal Muscular Atrophy Amyotrophic Lateral Sclerosis Spinobulbar Muscular Atrophy ENTRY --Disease Characteristics-- Men aged 18 and over with motor neuron disease, i.e X-linked spinal and bulbar muscular atrophy (Kennedy's disease) Confirmed by androgen receptor, exon-1 mutation genotype Amyotrophic lateral sclerosis Spinal muscular atrophy Significant muscle weakness on manual muscle testing No prisoners No mental disability ", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Dystonia Healthy Healthy volunteers who consented to participate in the study and matched for age, sex, handedness with the group of patients with primary focal hand dystonia Patient with primary focal dystonia from our dystonia patient database who consented to participate in the study. This criterion will be established by the preliminary screening in the Human Motor Control Outpatient Clinic The following subjects will be excluded Healthy volunteers with cognitive complaints, abnormal neurological exam or history of past neurological disease Dystonia patients with the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to primary focal dystonia Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, migraine, past and present history of alcohol abuse, medical conditions that may alter cerebral structure Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs) Subjects with any metallic objects within them just prior to MR imaging (cardiac or neural pacemaker, aneurysm clips [metal clips on the wall of a large artery], metallic prostheses [including heart valves and cochlear implants] or shrapnel fragments. Welders and metal workers are also at risk for injury and may not take part in the study because of possible small metal fragments in the eye of which they may be unaware Subjects not capable of giving an informed consent Women who are pregnant Children", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 21.0-999.0, All Parkinson Disease We will only PD patients with a stable clinical response to L-DOPA and DAergic agents We will only recruit patients with early or mild-to-moderate PD (score on Hoehn & Yahr scale 148 less than 3) To obtain a homogeneous group, the PD cohort will comprise only non-demented, non-depressed, with parkinsonian symptoms and signs primarily akineto-rigid If resting tremor is present, only patients with mild or moderate tremor (UPDRS tremor ratings 1 or 2 in the right upper limb) will be included in the study Our group of healthy volunteers will the following age range: 21-30 years, 31-40 years, 41-50 years, 51-60 years, 61-70 years, and 70 years and over Research subjects may be male or female and they must be right-handed Pregnant women will not participate in the study Research subjects will be asked to refrain from caffeine and nicotine for at least 12 hours and to abstain from alcohol at least 24 hours before the fMRI Subjects belonging to one of the following groups will be excluded from the study Subjects with a familial history of PD Patients with a marked resting tremor (score at the UPDRS scale above 3 in the right upper limb) Patients with a score at Hoehn & Yahr scale equal or above 3 Patients with progressive neurological disorders other than PD Subjects with cognitive impairment (i.e., score on Mattis scale below 123/144) Subjects with significant mood disturbances (i.e., score on BDI scale above 10) Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs) Subjects with a history of significant medical disorders, or requiring chronic treatment with other drugs that cannot be stopped Subjects with prior exposure to neuroleptic agents or drug use", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Pick Disease of the Brain -Six patients referred to the Cognitive Neuroscience Section, NINDS, with a clinical diagnosis of FTD confirmed here, will be selected to participate in the study Greater than 75 years of age Presence of metal in the head other than dental hardware Broken skin in the area of the stimulating electrodes Any behavioral disorder that makes testing impossible Children are excluded, as FTD is not a childhood illness", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 12.0-999.0, All Prion Disease Aged 12 years or more, diagnosed with any type of human prion disease In a coma, or in a pre-terminal phase of disease such that prolongation of the current quality of life would not be supported Known sensitivity to quinacrine Been taking any other putative anti-prion therapy for less than 8 weeks", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 45.0-999.0, All Menopause Postmenopausal Vaginal Atrophy Postmenopausal women whose last menstruation was at least two years previously ", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-80.0, All B Cell Lymphoma \u2022 Patients with one of the following B-cell Lymphoma CD 20 positive : Mantle cell, Marginal zone, lymphocytic, follicular requiring treatment, Histological transformation from low grade to high grade, diffuse large cell without adverse prognostic factors defined by the international prognostic index (IPI) Aged from 18 to 80 years Untreated with chemotherapy except with Chlorambucil or Cyclophosphamide per os alone less than 6 months Previous radiotherapy except if localized Performance status < 3 Signed inform consent Other type of lymphomas: Burkitt, T cell, CD 20 negative Central nervous system or meningeal involvement Contraindication to any drug contained in the chemotherapy regimen HIV disease, active hepatitis B or C Treatment with polychemotherapy before except with Chlorambucil or Cyclophosphamide per os less than 6 months Prior extended radiotherapy Any serious active disease or co-morbid medical condition (according to investigator's decision ) Renal deficiency (clearance < 30 ml/mn), liver deficiency (bilirubin > 30 mmol/l) unless related to lymphoma Neuropathy> grade 2 within 14 days before enrollment Platelets < 30.109/l within 14 days before enrollment", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Dementia Mild Cognitive Impairment Diagnosis of dementia under the DSM-IV or of Mild Cognitive Impairment, using the Peterson Living in the community (home, apartment or collective housing with nursing care available for less than 40 hours per week) Patient able to provide written informed consent, or provision of written informed consent by a legal guardian/proxy Availability of a caregiver willing to provide consent for required components of the study Fluent in English May be participating in a Phase IV or other post-marketing follow up study of an approved product for treatment of dementia No concomitant life-threatening illness (a condition which is likely to interfere with the patient's ability to complete the study) Not unwilling or unable to complete the study Not concurrently participating in a clinical trial of an investigational drug (phase I, II or III) Unwillingness of patient or legal guardian / proxy to provide written informed consent Unwillingness of caregiver to provide written informed consent For patients with diagnosis of mild cognitive impairment: current or previous treatment with any cholinesterase or memantine", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-90.0, All Alzheimer's Disease Mild Cognitive Impairment Healthy for patients with dementia Patients: clinical diagnosis of AD or mild cognitive impairment primary language German for healthy subjects and patients with dementia/MCI Known allergy to levodopa or tetrazine History of medication/drug abuse Acute nicotine withdrawal or > 15 cigarettes per day > 6 cups/glasses of coffee, caffeine drinks or energy drinks per day > 50 grams of alcohol per day Severe hypertonia (systole >160 mm Hg) Severe arteriosclerosis Diabetes, asthma, or glaucoma Severe hearing disability", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All ALS Cases were eligible to participate in the original study if (1) they had received a diagnosis of ALS within 2 years; (2) they lived in New England at least half the year; (3) they spoke English; (4) they were mentally and physically able to participate. The same were used for controls Potential controls were excluded if they had a physician diagnosis of a neurodegenerative disease, polio, post-polio syndrome, or nondiabetic neuropathy Pregnant women were excluded from both case and control groups", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-60.0, All Multiple Sclerosis Diagnosis of relapsing remitting or secondary progressive with superimposed relapses MS Age between 18 and 60, inclusive EDSS between 0 and 6.5 Receiving treatment with Interferon beta (either 1a or 1b) at fully tolerated dose for at least 6 months prior to enrollment and with evidence of clinical efficacy (i.e. reduction or absence of clinical relapses) at the time of the enrollment Clinical relapse at the time of the enrollment or within the previous 3 months Undergoing chronic therapy with any other immunomodulatory or immunosuppressive medication (excluding standard dosages of steroids intravenously/intramuscularly injected and orally taken for the treatment of relapses) besides Interferon within the past 6 months Currently taking medications used for treatment of cognition/fatigue such as Donepezil (Aricept), Modafinil (Provigil), Amantadine, or other drugs that may act as temporary stimulants or depressants for the central nervous system Currently taking other medications used for symptomatic relief that may affect cognition. The study neurologist will make the determination of eligibility Clinically significant medical condition that, in the opinion of the investigator, would compromise patient's safety or affect his/her MRI (e.g., diabetes mellitus, chronic hypertension, severe anemia, kidney disease, heart disease [angina, arrhythmias, congestive heart failure]) Pregnancy or current breastfeeding Previous eye surgery of any kind Inability to provide informed consent. The ability of the patients in understanding all the aspects of the protocol will be judged by the means of a questionnaire Permanent tattooed makeup (eyeliner, lip, etc.) or general tattoos. Subjects with tattoos will be excluded if those are in a dangerous location in the body or made with colors whose content in iron (e.g. dark blue or dark green) cannot be definitely ruled out by the Investigators Any non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (nitro, hormones) that may cause problems if removed, even temporarily, any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunt", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Differentiated Thyroid Carcinoma Hiostologically proved DTC (M0) Preoperative metastasis", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-80.0, All Central Nervous System Disease Cerebrovascular Accident Stroke Patients must be aged 18 or above with subacute (at least 3 months post stroke) thromboembolic or hemorrhagic strokes with impaired motor function in at least one of the limbs but capable of performing the required motor tasks. Assessment of the initial functional state will be taken at the initial visit at the NINDS Stroke Neurorehabilitation Clinic. Patients with additional stroke(s) during the length of the protocol will not be excluded from the study if the conditions stated in the are satisfied Patients with a history of alcohol or drug abuse, poor motivational capacity, or language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less) Patients with medical or technical contraindications to MRI procedures (e.g. metal braces, pacemakers, cochlear devices, surgical clips, and other metal/magnetic implants); claustrophobia; and pregnancy Patients who are unable to comply with the motor testing protocol", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 50.0-999.0, All Parkinson's Disease Idiopathic Parkinson's in accordance to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Born and raised in Denmark >50 years Cerebrovascular disease Dementia not caused by Parkinson's Disease Metabolism anomaly Abuse of drugs, medication or alcohol History of head injuries Severe psychiatric disorder, excluding depression Resident outside the region of Aarhus h) DBS -", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 1.0-18.0, All Leukemia, Lymphocytic, Acute ALL, healthy ", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 65.0-90.0, All Healthy Enrolled in WHIMS At least 65 years old Not diagnosed with dementia Women younger than 65 years of age Have dementia not enrolled in WHIMS", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-90.0, All Amyotrophic Lateral Sclerosis Neurodegenerative Disease Motor Neuron Disease In-patients with probable or definite ALS, ages 18 staying on the neurology floor of Hahnemann Hospital In-patients who do not meet the of the diagnosis of ALS", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-90.0, All Amyotrophic Lateral Sclerosis Neurodegenerative Disease Motor Neuron Disease Medical Subjects Be able to give consent themselves or via a legally authorized representative Diagnosed with a neuromuscular disease and have limited ability to communicate Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones Be able to understand and remember instructions concerning participation Healthy control subjects Be able to consent to give consent themselves or via a legally authorized representative Be able to see visual cues such as targets or letters presented on the screen, and/or ability to hear auditory cues such as tones or words presented through speakers or earphones Be able to understand and remember instructions concerning participation Individuals with cognitive impairments that would impact their ability to follow the instructions", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 55.0-55.0, All Spinal Cord Injury at C5-C7 Level With Incomplete Lesion an incomplete C6 ASIA C (Central Cord) spinal cord injury lower motor function impaired and suffers from significant spasticity (Ashworth scale 4) able to ambulate approximately 10-20 feet with a rolling walker and minimal assistance has sufficient endurance to complete at least two 20-minute therapy sessions per day cognitive abilities are intact psychiatric diagnosis medical contraindications history of bleeding disorders allergy to anesthesia acute or progressive disease active implantable device", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-79.0, All ALS (Amyotrophic Lateral Sclerosis) and Subject will be a veteran with El Escorial \"Lab Supported Probable\" or more definite diagnosis of ALS Subject will have lost the ability to communicate either verbally or in writing (item 1 or item 4 on the ALS Functional Rating Scale-Revised (ALSFRS-R) score of 0, Appendix A) Subject will be an adult (age >18) Subject will be living at home Subject will be living within 100 miles of the participating study site Subject will have corrected visual acuity of at least 20/80 Subject will have the ability to read and understand 6th grade English text on a computer screen Subject will be able to indicate willingness and understanding of the consent form (using their existing method of communication) Subject will be able to identify one significant other Subject will identify one system operator (person that agrees to be trained and set up the BCI). This person can be the significant other", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 16.0-999.0, All Multiple Sclerosis established SPMS according to the McDonald Patients with a history of drug/alcohol abuse, a premorbid (pre MS) psychiatric history, a head injury with loss of consciousness and a concurrent physical disease requiring medical attention (eg. cardiovascular disease etc), MRI contraindication including implants, pacemaker, aneurysm clips and known renal impairment", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 40.0-75.0, All Atrophic Vaginitis Postmenopausal women (no menses for the previous 12 months) Dryness, itching or burning in and around the vagina Discontinued hormone replacement therapy (either local or systemic) at least 3 months Known, suspected, or history of cancer of the breast Known, or suspected estrogen dependent neoplasia (ovarian, endometrial) Known hypersensitivity to any component of the medications or base creams Active deep vein thrombosis, pulmonary embolism, or history of these conditions Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct) Liver dysfunction or disease with elevation of aspartate aminotransferase (AST)>1.5x upper level of normal (ULN); Normal for females is 8-43 U/L Undiagnosed abnormal genital bleeding Known chronic lichen sclerosis Known, untreated vaginal infection Not had a normal screening mammogram within the last 15 months", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Atrophic Rhinitis Symptoms of atrophic rhinitis, with previous clinical treatment without good results Patients with mental illness", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Breast Cancer Estrogen Receptor Her-2 Pgr Diagnosis of breast cancer Node positive OR high-risk node negative disease Tumor > 1.0 cm in diameter No locally advanced, inflammatory, or metastatic breast cancer Previously treated with 4 courses of anthracycline-containing chemotherapy (i.e., doxorubicin and docetaxel OR doxorubicin and cyclophosphamide) Enrolled on clinical trial ECOG-E2197 Adequate tumor material available in ECOG Pathology Coordination Center Previously consented to future cancer-related research Hormone receptor status known Female ", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 30.0-60.0, All General Paresis EEG MR Serological test", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-50.0, All Traumatic Brain Injury Control subjects from 18-50 Patients from 18-50 who have suffered TBI Substance abuse Irremedial sensory deficits (blindness, deafness) Primary psychiatric disorder Neurological disease unrelated to TBI", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-65.0, All Human Immunodeficiency Virus Hepatitis B Hepatitis C Human T-lymphotropic Virus I & II Creutzfeldt-Jakob Syndrome HIV Infections deferred blood donor status, and deferral due to a positive result of a routine blood test for HIV, or hepatitis B, or hepatitis C, or HTLV, or having been identified as at risk of vCJD; and deferral occured in 2008 or 2009 (2007 for the pilot; 2005 for those at risk of vCJD and the control group); and donor registered at one of the NHSBT centres (English Blood Service in England and Wales) not a blood donor; or no record of notification having taken place; or a member of Armed Forces or other profession where contact at the address provided could lead to a breach of confidentiality; or deferred before 2008 (if not in the pilot or notified of increased risk of vCJD) deferred as a result of a non-routine test or syphilis infection only; or donor registered with and notified by the Welsh, Scottish or Northern Irish Blood Services", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Vaginitis Dyspareunia Breast Neoplasms Histologically or cytologically confirmed breast cancer (any stage) Currently be using an aromatase inhibitor (anastrazole, exemestane or letrozole) for primary or adjuvant breast cancer treatment Must have complaints of vaginal itching, vaginal dryness and/or dyspareunia Not undergoing active chemotherapeutic or radiotherapeutic treatment Age >18 years Life expectancy of greater than 2 months CALGB (ZUBROD) performance status <3 Post-menopausal defined by absence of menses for at least 12 months and/or an FSH >25. Not post-menopausal as a function of medications intended to suppress ovarian function, such as gonadotropin releasing hormone agonists. Surgically post-menopausal subject eligible The effects of topical testosterone cream on the developing human fetus at the recommended therapeutic dose are unknown. For this study only post-menopausal women are included and all women of child-bearing potential are excluded. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Patients who have not recovered from adverse events due to chemotherapeutic agents administered more than 4 weeks earlier History of allergic reactions attributed to compounds of similar chemical or biologic composition to testosterone or the emollient delivery cream used in the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women and women who are breast-feeding are excluded from this study because it is limited to post-menopausal women", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Shock, Septic patient (or representative) received the information notice patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension body temperature > 38.3\u00b0C or < 36\u00b0C heart rate > 90 bpm Tachypnea > 20 C/min or PaCO2 < 32 mmHg or mechanical ventilation leukocytes > 12000 \u00b5L-1 ou < 4000 \u00b5L-1 ou > 10% immature forms oliguria < 0.5 ml/kg/h for at least 2 hours abrupt alteration (24 h) of conscienceness thrombocytopenia < 100 000 G/L or disseminated intravascular coagulation mottled skin and / or capillary refill time> 3 sec patient is dying or limitation or cessation of active treatment patient is already included in another trial patient or family refusal patient not affiliated with a social security system", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 50.0-80.0, All Parkinson's Disease Medical clearance to perform an exercise tolerance test and training program A diagnosis of PD at stage 2 on the Hoehn and Yahr scale A neurological condition other than PD/ Anyone who is currently taking any vitamin supplementation Smokers Anyone currently engaged in weight training", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Alzheimer's Disease Gait Apraxia Impaired Cognition All elderly patients from the University Memory Center of Angers University Hospital Able to walk without any walking aid on 15 meters Mini-Mental Status Examination score > 10 Being affiliated to a social security regime Mini-Mental Status Examination score \u2264 10 Subject suffering from pre-existing impellent disturbances History of cerebrovascular accident or other cerebro-spinal pathology Poor workmanship of the written or oral French language Use of walking aid such as walking frame with wheels or tricycle Acute medical or surgical disease in the past 3 months Refusal to participate (or trustworthy person) Near visual acuity < 2/10", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 30.0-80.0, All Stroke for patients wth stroke Age 40-80 years sustained a single stroke between 3-24 months prio t study leading to upper limb paresis have at least Stage 3/7 arm control (mild to moderate motor deficits) on the Chedoke-McMaster Scale <81 yrs old to minimize confounding effects of age-related changes in sensorimotor functions for patients wth stroke other neurological or orthopaedic problems that may interfere with interpretation of results significant deficits in attention, constructional skills, neglect and apraxia shoulder subluxation, arm pain lack of endurance as judged by a physician undergoing other therapy, surgery or medical procedures within the study period for healthy control subjects Age 40-80 years for control subjects any neurological or orthopaedic problems that may interfere with interpretation of results", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Mumps Subjects with upper or lower limb spasticity Subjects must use botulinum injection for the first time ", "label": "2"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 55.0-95.0, All Dementia, Alzheimer Type Non-institutionalized patients with a diagnosis of Alzheimer's disease as defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) with symptoms of delusions or hallucinations, which have been present, at least intermittently for one month or longer Mini Mental State Examination (MMSE) score of 6 to 24 points Patients capable of self locomotion or locomotion with the aid of an assistive device Patients with an identified caregiver or proxy For Extension Phase Eligible patients were males and females who had completed the 10-week Acute Phase in either treatment group; had a Week 10 Total Score of \u2265 6 on the NPI; and were, in the judgment of the investigator, deemed suitable for participation in the long-term trial Treatment beyond 140 weeks All subjects who completed the extension phase of CN138-006 in any French Investigational Site may be considered eligible for entry until they are no longer receiving clinical benefit, per the investigator's judgment Patients with an Axis I (DSM IV) diagnosis of delirium amnestic disorders bipolar disorder schizophrenia or schizoaffective disorder mood disorder with psychotic features Patients with reversible causes of dementia Patients with psychotic symptoms continuously present since prior to the onset of the symptoms of dementia Patients with psychotic symptoms that are better accounted for by another general medical condition or by direct physiological effects of a substance Patients with a current major depressive episode with psychotic symptoms of hallucinations or delusions", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-35.0, All Graft Versus Host Disease (GVHD) Acute Myocardial Infarction (AMI) Age 18 to 35 years Willingness to provide written informed consent Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum Presence of communicable disease risk associated with xenotransplantation Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device History of malignancy Pregnancy In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Menopause Postmenopausal Vaginal Atrophy Atrophic vaginitis due to estrogen deficiency Post-menopausal ", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 40.0-85.0, All Parkinson's Disease Mild Cognitive Impairment Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable) Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel Active suicide ideation Weighing less than 100 lbs (45 kgs) History of Deep Brain Stimulation surgery Diagnosis of Dementia Taking certain types of medications may be an this will be reviewed with all potential participants Females that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of childbearing potential will need to verify that they are not pregnant by a negative urine pregnancy test", "label": "2"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 50.0-999.0, All Alzheimer's Disease for AD cases Diagnosis of probable AD, defined according to the criteria51 Light to moderate severity of the disease, defined by a MMSE score >10 (global evaluation of cognition) Patient aged 50 years or more Patient benefiting from social insurance for controls Absence of suspicion of dementia, based on normal performance according to age and educational level at neuropsychological testing defined as Free recall \u226517 and total recall \u226540 for the Free and Cued Selective Reminding Test (Grober and Buschke test 52) MMSE \u2265 norm for age and educational level (defined by mean SD) Isaac's set test \u2265 norm for age and educational level (defined by mean for all patients History of Parkinson's disease or other neurodegenerative disorder History of Horton's disease History of inflammatory neuropathies (in particular Devic's disease, multiple sclerosis) History of vascular ischemic neuropathies and chronic intracranial hypertension History of pituitary tumors Presence of diseases (systemic and/or ocular diseases) or behavioural or cognitive symptoms incompatible with eye examination Known diabetes Person under tutorship or curatorship, person unable to express consent Additional", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Differentiated Thyroid Cancer Age over 18 years Patient has thyroid cancer Patient is judged as being capable of understanding the information sheet and of giving informed consent (Mental Capacity Act 2005) Responsible clinician is approached and is happy for the patient to be included in the study Age of less than 18 years Patient has additional risk infections (HIV, Hep B/C) Patient is involved in other medicinal or treatment based clinical trial at the time of recruitment or in the previous 4 months", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Breast Cancer newly diagnosed breast cancer no metastasis detected operation for breast cancer female patient unilateral breast cancer informed consent given age min. 18 yrs metastasis of breast cancer bilateral breast cancer other cancer within the last 5yrs", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-55.0, All Multiple Sclerosis, Relapsing-remitting Enrolled into the 2-year, double-blind, placebo-controlled ASA study and entered 3 year extension study MRI was performed on all patients using a 1.5 T magnet MRI images unable to be processed All 5 MRI time points not collected", "label": "2"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 40.0-70.0, All Arthrosis of the Knee The participants of the study are patients that have been scheduled for a primary TKA using the usual indications for TKA at the Department of Planned Elective Surgery Z, Gentofte Hospital Severe osteoarthrosis of the knee with indication for a TKA Age between 40 and 70 years Diseases affecting the bone metabolism (osteoporosis, Pagets disease, hyperparathyreoidism etc.) Patients estimated not to be able to understand the \"Information to patients\" papers or do not want to participate in the study", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-80.0, All Knee Arthritis patients waiting for knee replacement neurologic disease", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 8.0-21.0, All Brain Structural Connectivity Cognitive Function Ages 8-21 without current and past history of any psychiatric disorder and autistic symptoms Current symptoms or lifetime history of DSM-IV-TR diagnosis of attention-deficit/hyperactivity disorder, pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, bipolar disorder, depression, severe anxiety disorders or substance use With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy With major systemic disease Full-scale IQ < 80", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 65.0-89.0, All Mild Cognitive Impairment Dementia Memory Disorders Age between 65 and 89 Successful completion of primary school MCI, as Mini Mental State Examination score between 20 and 27 and confirmation through neuropsychological examination by a specialist, according to current guidelines Moderate/severe dementia Clinical signs of depressive disorder or other primary psychiatric disorders Neoplastic diseases Neurologic or musculoskeletal deficits barring neuropsychological examination or physical or cognitive training Severe heart disease End stage renal disease (eGFR<35 ml/min(1.73 m2) Severe chronic obstructive pulmonary disease (COPD) and/or respiratory failure Complicated or decompensated diabetes Overt peripheral artery disease Any inability to successfully complete a brain magnetic resonance scan", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-90.0, All Ischemic Stroke Involving Corticospinal Tract. Patients of 18 to 90 years old Subcortical stroke Achievement of the internal capsule, according to MRI Ability to perform MRI within 10 days after the onset of symptoms NIHSS over or equal 2 and < 20 Rankin Score over or equal 1 and \u2264 5 Written informed consent after information about the protocol, from patients or reliable person if patient is in incapacity to sign Affiliation to a social security scheme Pregnant or nursing women Other cerebral lesion, concomitant or preexisting Concomitant disease causing unfavorable prognosis within 3 months after pre-existing psychiatric illness Alcoholism or other chronic intoxication Cortical localization of the infarction Patient in a coma, who cannot be examined and evaluated Patient intubated, ventilated, sedated Cerebral hemorrhage, intra-parenchymal and / or subarachnoid Persons protected by law (guardianship, curators and judicial protection)", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 40.0-79.0, All Lower Limb Spasticity After Stroke patients with lower limb spasticity after stroke duration more than 6 months Modified Ashworth Scale of ankle joint more than 2 patients with previous botulinum toxin injections to lower limbs patients with serious hepatic, renal or cardiac dysfunction patients with respiratory failure patients who cannot understand the instructions", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Breast Neoplasms Newly diagnosis of breast cancer for which surgical intervention is planned patients received neoadjuvant chemotherapy before breast surgery", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 30.0-999.0, All Atrial Fibrillation Heart Failure Stroke Myocardial Infarction Patients with a coded diagnosis for atrial fibrillation in their primary or secondary care record Patients in GPRD practices which are deemed \"up to standard\" by GPRD Patients whose records are deemed \"acceptable\" by GPRD and contain at least one year of data Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES A diagnosis of heart failure, stroke, or myocardial infarction occurring before diagnosis of atrial fibrillation", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 65.0-85.0, All Disturbance; Balance, Labyrinth Parkinson\u00b4s Disease Elderly The patient is able to provide informed consent Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist Hoehn and Yahr Stage 1-3 Able to ambulate without an assistive device On stable doses of Parkinson's medications prior to study onset Mini Mental Status Exam (MMSE) < 24 Change in Parkinson's medications in the duration of study Uncontrolled orthostasis Symptomatic coronary artery disease Fracture of lower limb prior to study onset Other neurologic diagnosis Physical therapy before and during to study duration Significant camptocormia Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 50.0-999.0, All Sleep Disordered Breathing Alzheimer's Disease Male and female subjects with normal cognition and >50 years of age will be enrolled. Younger subjects are not included as the risk for cognitive impairment is too low. Moreover, by selecting this age-range we minimize the possibility of including early-onset genetic forms of neurodegenerative diseases such as Alzheimer's disease and Frontotemporal Dementia Normal subjects will be within normal limits on neurological and psychiatric examinations. All subjects enrolled will have both a Clinical Dementia Rating = 0 and Global Deterioration Scale < 3 All subjects will have had a minimum of 12 years education.The education restriction reduces performance variance on cognitive test measures and improves the sensitivity for detecting pathology and disease progression using the robust norms available at NYU School of Medicine All subjects will have an informed family member or life partner interviewed to confirm the reliability of the subject interview. All subjects will agree to the MRI imaging, the lumbar puncture, apolipoprotein E (ApoE) genotyping and DNA banking Diagnosis of any brain disease or MRI evidence of brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts are excluded. Subcortical infarcts and white matter lesions are not exclusions History of brain tumor Any radiation or chemotherapy anywhere in the body in the past 3-years Significant history of alcoholism or drug abuse History of psychiatric illness (e.g., schizophrenia, mania, PTSD, or life long history of major depression) Hamilton Depression Scale >16 only with history of life long depressive episodes. Otherwise not excluded Evidence of clinically relevant and uncontrolled cardiac, pulmonary, or hypothyroid or hematological conditions. Insulin dependent diabetes and/or history or treated hypertension are not an exclusion. Normal subjects with current levels of HbA1c >5.9% or diabetics >7.0% (American Diabetes Association, 2010) and/or current blood pressure levels >140/90 mm Hg (JNC on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, 2003) will be advised to seek referral Physical impairment of such severity as to adversely affect the validity of psychological testing Hostility or refusal to cooperate Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 2.0-17.0, All Cerebral Palsy Spasticity Female or male subject of 2 to 17 years of age (inclusive) Uni or bilateral Cerebral Palsy (CP) with clinical need for injections with NT 201 for the treatment of upper limb (UL) spasticity at least unilaterally Ashworth Scale (AS) score in the main clinical target patterns in this study Flexed elbow: AS\u22652 in elbow flexors (at least unilaterally). and/or Flexed Wrist: AS\u22652 in wrist flexors (at least unilaterally) Clinical need according to the judgment of the investigator in one out of five treatment combinations (A-E, as shown below). AS score must be \u22652 for each target pattern chosen for injection at the Baseline Injection Visit V2 A. UL(s) treatment only (GMFCS I-V) A1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW) Pre-treated (non-na\u00efve) subjects must not have received BoNT treatment within the last 16 weeks prior to study treatment at V2 in any indication", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Lower Limb Spasticity Men or women age 18 years and above Post-stroke lower-limb spasticity Prior agreement with the patient to inject BoNT-A If previously treated with BoNT-A, (at least 3 months interval between last injection and inclusion) Therapeutic goals agreed jointly with the patient Functional Ambulation Classification (FAC) score 2-5 Capacity to comply with the protocol Written informed consent Documented positive antigenicity to botulinum toxin Neuromuscular disease Use of medications that interfere with neuromuscular transmission Severe muscle atrophy in any muscle to be injected Any other indication that might interfere with rehabilitation or the evaluation of results Any non-stroke spasticity diagnosis Pregnancy or nursing mothers Previous participation in any study using Goal Attainment Scale (GAS)", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 65.0-999.0, All Postoperative Cognitive Dysfunction Delirium Dementia Age \u2265 65 years Elective major surgery Planned general anesthesia Cardiac surgery Neurosurgery including carotid endarterectomy Preoperative Mini Mental State (MMS) Examination Score < 24 Previous pathological neuroimaging (if available) History of cerebral or cerebrovascular pathology Chronic use of psychiatric medication Alcohol or substance abuse A history of chronic pain unrelated to the planned surgery Any contraindication for MRI (e.g. pacemakers and other MR-incompatible metal implants) Claustrophobia", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Induced Pluripotent Stem Cells OR THIRD PARTY (ALLOGENEIC CELLS, AND Subjects who meet ALL of the following will be considered for enrollment into this study Be greater than or equal to 18 years of age, as of the date of enrollment. There is no upper age limit for donor enrollment Able to provide informed consent Meets the donation requirements established by AABB and FDA for allogeneic or autologous use with the exception of hemoglobin/hematocrit Subjects who meet ANY of the following will be excluded from participation in this study as a third party donor or research volunteer Medical history that includes any of the following, as per AABB or FDA requirements for allogeneic use Thrombocytopenia or other blood dyscrasias Bleeding diathesis Antibiotic use within the prior 48 hours History of cancer History of exposure to transfusion transmitted diseases including HIV and hepatitis B and C as defined by the Standards for Blood Banking and Transfusion Services, AABB Travel to an area where malaria is endemic as defined by the CDC (www.cdc.gov/travel) At risk for the possible transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) as described in the FDA Guidance for Industry, January 9, 2002, Revised Preventive Measures to Reduce the Possible Risk of Transfusion of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products Febr le (temperature > 38 (Infinite)C)", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Gaucher Disease Type 1 Age: >18 Gaucher disease type 1 Able to undergo a DEXA test Minors", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Amyotrophic Lateral Sclerosis (ALS) Patients \u226518 years of age, diagnosed with ALS (<2 months before inclusion) according to Airlie House : definite, probable, or probable laboratory supported Time between first symptoms and diagnosis less than 18 months Sporadic or familial cases Patient agreement to be followed in a given ALS centre during the duration of the study Patients with a loss of at least 1 point in 3 items of the rating scale or with a loss of at least 2 points in 2 items of the rating scale Patients who signed the informed consent form Associated dementia or inability to understand the requirements of the protocol No helper ONS already begun Artificial nutrition: enteral or parenteral nutrition Known hypersensitivity to components of ONS Absence of treatment with Riluzole (RILUTEK\u00ae) Patient under guardianship or curatorship Participation in another research protocol", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 30.0-75.0, All Stroke Paresis Motor deficits of the upper limb after a first ever stroke A minimum punctuation of 11 in the subtest from the Motricity Index and Trunk Control Test which evaluates grip and pinch Less than 6 months from stroke Age between 30 and 75 years Right-handed Inability to speak and understand the Spanish or Catalan language Major cognitive impairment affecting comprehension Neurological or psychiatric co-morbidity Substance abuse Formal musical education (i.e. professional musicians) Metallic implants incompatible with neuroimaging assessment Withdrawal from the study Voluntary withdrawal of consent A new episode of stroke during the participation in the study", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 0.0-999.0, All Dementia Paratonia Severe cognitive impairment (complete dependency in all activities of daily living (ADLs) Diagnosis of Alzheimer's disease, vascular dementia,or frontotemporal dementia Score> 3 on the paratonic assessment instrument, with paratonic rigidity in an arm(s) interfering in the provision of care Alternate etiologies for increased tone Botulinum toxin 6 months preceding the study", "label": "1"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-80.0, All Spasticity Men and women \u2265 18-80 years Poststroke limb spasticity Patients who have suffered a stroke in the previous 6 months Treatment goal has been previously agreed with the patient or their legal representative Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation No previous treatment with BoNT-A Patient is able to follow the protocol Written informed consent Neuromuscular disease Use of drugs that interfere with neuromuscular transmission Any other condition that could interfere with rehabilitation or evaluation of the results Diagnosis of spasticity not associated with stroke Pregnant or nursing mothers Prior participation in any other study in the 6 months before study entry", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 65.0-999.0, All Major Depressive Disorder Current DSM-IV diagnosis of MDD, unipolar type, without psychotic features and 6 weeks minimum duration of current depressive episode Moderate severity of depression using the Hamilton Depression Rating Scale (HDRS > 20) English speaking, male or female 65 years of age or older Good general health Able to give informed consent Antidepressant use or psychotherapy within the past 6 weeks or electroconvulsive therapy within the past 6 months Recent history (<6 months) of substance or alcohol abuse or dependence (DSM-IV criteria) Use of cognitive enhancing medications Current diagnosis of Post-Traumatic Stress Disorder or other Axis 1 psychiatric disorder Neurological diseases (e.g., Parkinson's disease, epilepsy, cortical stroke, Alzheimer's disease, traumatic brain injury) or dementia History of surgical procedures affecting study outcomes Contraindications for MR exam, i.e., no claustrophobia, no paramagnetic metal implants, able to fit in the MRI machine comfortably (BMI \u2264 38) Acute or uncontrolled medical illness or medication use impacting cognitive function", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Parkinson's Disease Idiopathic Parkinson's Disease with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry Despite optimal pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonia or bradykinesia A life expectancy of at least two years Age below 18 years Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy) Previous CLI (through a PEG-tube or Nasal Jejuna| tube) Hoehn and Yahr stage 5 at the best moment during the day Other severely disabling disease Dementia or signs of severe cognitive impairment Psychosis Current depression Contraindications for DBS surgery, such as a physical disorder making surgery hazardous Contraindications for PEG surgery such as interposed organs, ascites and oesophagogastric varices, or for Duodopa", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Leukoencephalopathy diagnosis of glioma (stage 3 to 4) both genders age > 18 years treatment by radiotherapy and chemotherapy clinical monitoring post radiotherapy in Neurology Department, Piti\u00e9-Salp\u00eatri\u00e8re University Hospital and in the radiotherapy department of the Paul Strauss Institute other neurological tumors and brain metastases psychiatric severe illness, including severe depression", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 35.0-999.0, All HIV - Human Immunodeficiency Virus Cognitive Impairment age 35 years or older HIV infection for at least 1 year able to communicate in English or French capable of providing informed consent easy access to the internet EEG and MRI compatible presence of dementia life expectancy < 3 y other neurological disorder including active opportunistic CNS infection psychotic disorder current substance dependence or abuse; and Hepatitis C requiring interferon therapy during the study period", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-999.0, All Cancer Rectal Cancer High-risk patients with biopsy proven rectal adenocarcinoma who will undergo long-course chemoradiotherapy (CRT) and who are potentially eligible for curative surgery Patients who have persistently (i.e. in baseline and post-treatment MRI) mrEMVI positive (with superior rectal vein invasion) or mrEMVI negative tumours Patients aged over 18 years Negative (on CT) for metastatic disease Under 18 years of age Patients with any metastatic disease Patients with a synchronous second malignancy", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-55.0, All Multiple Sclerosis 55 inclusive years of age at the time of informed consent Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald Currently taking Tysabri Systemic steroid users comorbidities that could confound MRI outcomes", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 35.0-75.0, All Parkinson Disease Dementia Age at the time of enrollment: 35 years Diagnosis of idiopathic PD with probable Parkinson's disease dementia (PDD) as defined by the MDS consensus guidelines (Emre et al., 2007) Mild to moderately severe dementia as defined by a Mini-Mental State Examination (MMSE) score of 10 to 24 Duration of bilateral idiopathic PD: \u22655 years of motor symptoms Severity of bilateral idiopathic PD in the meds off state: modified Hoehn and Yahr stage \u22652 UPDRS subset III score of \u226530 in the meds off, stim off state Levodopa must improve PD symptoms by \u226530% in a levodopa challenge test, as measured by UPDRS subset III score PDD with a symptom onset at least 2 years after first symptoms of PD Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary) if mentally competent or, if incompetent, their legally authorized representatives Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression Any current drug or alcohol abuse Any history of recurrent or unprovoked seizures Any prior movement disorder treatments that involved intracranial surgery or device implantation A history of neurostimulation intolerance in any area of the body Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators Pregnancy, breast-feeding, or lack of reliable contraception", "label": "0"} +{"topic": "A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration.", "doc": "eligible ages (years): 18.0-80.0, All Hereditary Spastic Paraplegia Age between 18 and 80 years Clinical diagnosis of Hereditary Spastic Paraplegia Ability to walk at least 10 meters: Assistive devices are permitted Wheelchair bound patients Additional neurological symptoms that may significantly impact gait such as ataxia, polyneuropathy or dementia Fixed tendon contractures Antecedents of allergy or adverse reaction to botulinum toxin Pregnancy or breastfeeding condition Mental retardation Dementia", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 45.0-80.0, All Colon Cancer Polyps Patients who are 45 to 80 years old for routine screening colonoscopy Patients with inflammatory bowel disease Patients with polyposis syndromes Pregnant women Patients over 350 pounds Patients with bright red blood per rectum Patients who have a contraindication to undergo outpatient colonoscopy, including patients on blood thinners, prior myocardial infarction (MI) in the last six months, history of congestive heart failure (CHF), history of arrhythmia, patients too weak to transfer themselves from a bed to a chair, or patients with severe constipation who would require a two day bowel preparation All subjects will undergo informed consent by the St. Luke\u2019s institutional review board (IRB). Referred subjects will be asked if they are interested in the study and those responding affirmatively will be transferred to a recruiter to learn about the study and begin the consent process if interested", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Polyps Patients: over 18 years of age, with clinical indication for colonoscopy who are considered by the endoscopist to be fit for the procedure Endoscopists who have started colonoscopy training on a recognised training rotation. Consultants who perform colonoscopy regularly patients under 18 years, patients with previous colorectal surgery or known familial polyposis, patients unable to give informed consent, pregnant patients, patients for whom coloscope insertion was difficult or uncomfortable, patients whose colon is not sufficiently cleared of stool, those unwilling to participate", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Colorectal Neoplasms Metastatic colorectal cancer Histologically or cytologically proven colorectal cancer Measurable disease on CT scan with at least one lesion >/= 2cm diameter (to allow adequate scout infusion imaging) Expected survival of at least 4 months ECOG performance status 0-2 Vital laboratory parameters should be within normal range including Neutrophils >/= 1.5 x 10^9/L Platelets >/= 150 x 10^9/L Serum bilirubin 50 ml/min Previous treatment with capecitabine Untreated active metastatic disease to the central nervous system (new or enlarging lesions on CT or MRI), or within 3 months of treatment (ie surgery or radiotherapy) for brain metastases Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders Liver involvement with metastatic disease > 50% liver volume Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas) Previous external beam irradiation except if: (i) it was for standard adjuvant pelvic radiation for rectal cancer; (ii) it was for localised irradiation for skin cancer; or (iii) the sum total of all previous external beam irradiation port areas is not greater than 25% of the total red marrow Previous treatment with a monoclonal antibody or antibody fragment AND a positive huA33 HAHA titre Concomitant treatment with systemic corticosteroids. Topical or inhalational corticosteroids are permitted Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study Lack of availability of the patient for clinical and laboratory follow-up assessment", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Skin Cancer Male or Female and over 18 years of age Patients undergoing an examination of their skin Patients with a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions Patients whose lesion also warrants a biopsy Signed informed consent document Patients with absence of skin lesion(s) in one of the five categories Patients whose identified lesion did not need a biopsy Patients who did not sign the informed consent and agree to participate", "label": "2"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 0.0-999.0, All Skin Rash receiving bone marrow transplant - not receiving other growth factors", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 45.0-999.0, All Venous Insufficiency Aged 45 years and older CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers) Ankle brachial index (ABI) 0.9 3mm Hg 0 absence of peripheral arterial disease Intact skin sensation measured with 10 gram monofilament Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces Agreement to wear compression garments such as wraps or stockings during waking hours Phone, e-mail, or mail accessible Working freezer ABI < 0.8 mm Hg or > 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature) Active systemic or localized infections such as cellulitis (raises skin temperature) Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon Body temperature > 37.6 degrees C (febrile state raises skin temperature) CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing) Known peroneal nerve injury Impaired skin sensation Unable to detect light touch measured with a 10 gram monofilament at lower leg skin surfaces Unable to detect not/cold sensation measured with thermal sensory tester at lower leg skin surfaces Not wearing compression or not agreeing to wear compression wraps or stockings", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 5.0-10.0, All Molluscum Contagiosum, Skin Disease Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum Anyone with immunosuppression including HIV or previous organ transplantation Anyone taking immunosuppressive medications Anyone who has previously received treatment with cantharidin Any female who has had her first menstrual period", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Carcinoma, Advanced Metastatic Histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion and not a candidate for curative surgery or radiation therapy) Completed \u22651 conventional therapy Clinically indicated surgery or procedure to collect available tumor in sufficient quantity (\"golf ball size,\" pleural or ascites fluid may also be collected) for vaccine processing Subjects that have completed all acceptable therapies that are the current standard of care for their respective diseases Recovered from all toxicities related to prior therapies Subjects with brain metastases treated at least \u22652 months prior to enrollment, without related clinical symptoms and must have a stable neurological exam on the screening evaluation \u22651 measurable or evaluable lesion Age \u226518 years ECOG performance status (PS) 0-1 Normal organ and marrow function Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to entering the study Patient must not have received any other investigational agents within 30 days prior to study entry Patients with known brain metastases unless treated and stable for \u22652 months Patients with mucinous adenocarcinoma Short term (<30 days) concurrent systemic steroids \u2264 0.125 mg/kg prednisone per day (maximum 10 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded Prior splenectomy Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for \u22652 years Kaposi's Sarcoma Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients who are pregnant or nursing", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Effects of Chemotherapy patients receiving docetaxel as mono or combination therapy patients with no nail disorders at the start of treatment life expectancy of at least 3 months patients previously treated with taxane chemotherapy Raynaud's phenomenon distal metastases ungual pathology arteriopathy cold intolerance peripheral neuropathy of grade 2 or higher patients currently enrolled in clinical trials", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Melanoma Patients or volunteers with or without a history of melanoma One or more palpable skin or subcutaneous lesions for which at least one of the following is true A tissue diagnosis has been made for the lesion(s) in question, by prior cytologic or histologic evaluation (Category A1) A tissue diagnosis will be obtained for the lesion(s) in question by cytologic or histologic evaluation (Category A2) A tissue diagnosis is not available, but a clinical diagnosis of melanoma or benign lesion is available with a high degree of confidence. Examples are hemangiomas, skin tags, seborrheic keratoses, dermatofibromas, lipomas, or growing pigmented skin lesions that are comparable to other cutaneous metastases of melanoma in the same patient (Category B) All patients must have the ability and willingness to give informed consent and must be age 18 years or older at the time of study entry Known or suspected allergy to the adhesive skin markers or water-soluble ink used for the labeling of lesions Very fragile skin that may be susceptible to injury from adhesive markers Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator", "label": "1"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Skin Cancer Men and women over the age of 18 Skin lesion suspected to either BCC or SCC etc Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician Pregnant women Children", "label": "1"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-75.0, All Basal Cell Carcinoma Study subjects must have had diagnosed at least one benign or malignant skin lesion Subject is from 18-75 years of age, inclusive Subject must sign and date all informed consent statements Subject is exhibiting signs of a bacterial or viral infection, including fever Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis", "label": "2"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All RECTAL NEOPLASMS Diagnosed with a large non-pedunculated rectal adenoma (sessile or flat) with a largest diameter of \u22652 cm (estimated by an opened resection snare of 20 or 30 mm) The lower and upper borders of the adenoma are located at \u22652 cm and \u226415 cm from the anal verge, respectively Biopsies of the lesion did not show malignant neoplastic tissue on histopathological evaluation; only lesions with low or high grade dysplasia are suitable for inclusion During flexible video endoscopy there are no signs of endoscopic suspicion for submucosal invasive cancer (Kudo pit pattern type V; excavated/depressed type morphology; fold convergence; or large smooth nodule >1 cm in a flat lesion) (33). In case of doubt, patients will undergo EUS as described at (2) In case doubt remains after flexible video endoscopy, endoscopic ultrasonography (EUS) of the rectal adenoma should invasion into the submucosal layer and pathological lymphadenopathy (lymph nodes >1 cm). When pathological lymph nodes are present, fine needle aspiration will be performed to lymph node metastasis (N+ disease) If not performed already, total colonoscopy will be done to detect and remove all synchronous colonic adenomas or cancers first. Cecal intubation must be confirmed by identification of the appendiceal orifice and ileocecal valve The general health condition of the patient permits general anesthesia (ASA classification I-III) Absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 \u00d7 109/l) Patient age of 18 years or older Preoperative histologically detected malignancy Previous anorectal surgery Contraindications to general anaesthesia", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 0.0-2.0, All Hemangioma Patients with ages up to 2 years Clinically diagnosed hemangioma, in proliferative or involutive phase, with relative indication for clinical treatment, as itemized lesion causing alteration of regional anatomy with no systemic or functional damage and with a diameter greater than 1 centimeter, or lesion causing aesthetic deformity, or lesion causing local repetitive complications such as ulceration, bleeding or local infection, or lesion causing partial damage of orifices, or lesion causing psychological compromise Absence of cardiopathy (normal physical examination, anamnesis, echocardiography, electrocardiography and thoracic radiography) Informed consent signed by responsible parties Hemangioma with absolute indication for treatment, presenting a risk to function or life Patients with previous treatment for infantile hemangiomas Cardiac disease Pulmonary disease (asthma, bronchiolitis,bronchopulmonary dysplasias) Raynaud syndrome Pheochromocytoma Altered echocardiography, even if asymptomatic", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 11.0-999.0, All Acanthosis Nigricans Hyperinsulinemia Spectroscopic Analysis Subjects must have an elevated fasting insulin level, suggesting they are in an insulin resistant state Subjects must carry a diagnosis of acanthosis nigricans, which will be verified by a Dermatologist before entry into the study. If necessary, a small 4mm punch biopsy may be taken to document dermatopathology consistent with acanthosis nigricans Subjects must be willing and able to undergo treatment with Metformin, including initial referral and follow up Agree to abide by the investigator's guidelines Be able to understand the requirements of the study, the risks involved and are able to sign the informed consent form Agree to follow and undergo all study-related procedures Subjects with Type 1 Diabetes are excluded because of their naturally insulin-deficient, rather than hyper-insulinemic, states Women who are lactating, pregnant, or planning to become pregnant Any reason the investigator feels the patient should not participate in the study", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Benign and Malignant Skin Neoplasms Patients with skin lesions undergoing biopsy for diagnosis Patients with skin lesions which do not require biopsy for diagnosis", "label": "2"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 20.0-85.0, All Lymphadenopathy Malignancy Patients with malignant cervical lymphadenopathie With US-FNA or US-CNB evaluation before No ultrasound exam", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-45.0, All Infant and Young Child Feeding Mothers with healthy children between 6 and 24 mo ", "label": "1"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 0.0-999.0, All Colonic Polyp Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included bleeding tendency poor preparation sessile polyp", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Actinic Keratosis Male or female, age 18 years or older being seen in a dermatology clinic Informed consent of participation must be given by subject Inability to complete all study questionnaires Subjects who are unable to read and write English", "label": "2"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 20.0-35.0, All Acne Vulgaris Have Acne vulgaris, presenting at least inflammatory lesion on the face Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman) Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic Electrocardiogram (ECG) consistent with normal cardiac conduction and function Non-smoker Adequate contraception method for both men and women. If a woman, must have a negative pregnancy test Signed an informed consent document History of or current clinically significant medical illness that the investigator considers should the participant or that could interfere with the interpretation of the study results Clinically significant abnormal values for hematology, biochemistry or urinalysis Clinically significant abnormal physical examination, vital signs or ECG Use of any prescription or nonprescription medication within 14 days before the study treatment History of drug or alcohol abuse within the past 5 years Drug allergy or drug hypersensitivity Blood donation, depending on the volume of blood collection Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis Dermatological disease at application site Photosensitivity", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 21.0-999.0, All Venous Disease Venous Vascular Diseases and Syndromes Venous Insufficiency Venous Ulcers aged 21 years or older CEAP Classification: Stage C4 (skin damage) and 5 (healed VLU) leg ulcer healed within past month with intact epithelium history of healed VLU within past 2 years ankle brachial index (ABI) 0.80 3 mmHG, absence of peripheral arterial disease intact skin sensation intact thermal sensation agreement to ear compression during waking hours phone, email or mail accessible diagnosed arterial disease or ABI <0.80 or >1.3 mm Hg (blood flow to the skin is reduced in arterial disease and cooling could cause tissue ischemia) surgical procedures on leg in past 1 year (can affect venous circulation/cause edema) open leg/foot ulcers recent leg infection within past month (increased inflammation) impaired cognitive status (cannot perform procedures) chronic inflammatory and vascular conditions where blood flow of the skin may be impacted such as Lupus erythematosus, lymphedema, Raynaud's, rheumatoid arthritis, scleroderma, end stage renal disease, chronic obstructive pulmonary disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, or patients on chemotherapy", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Actinic Keratosis Subjects must be competent to understand the nature of the trial and provide informed consent Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp Subject at least 18 years of age Female subjects must be of either Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy Female subjects of childbearing potential must be willing to use effective contraception Location of the selected treatment area on any location other than the face or scalp within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or SCC Prior treatment with PEP005 Gel on face or scalp Selected treatment area lesions that have atypical clinical appearance and/or recalcitrant disease History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy", "label": "1"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Postpolypectomy Bleeding Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure) Patients younger than 18 years of age Patients with a platelet count of less than 50000, INR larger than 1.5 Patients who refused to give their informed consent", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-50.0, All Non-palpable Breast Lesions Have had stereotactic or ultrasound-guided biopsy with marker placement Have a lesion or biopsy marker that is visible under ultrasound Have surgical target < 6 cm from the skin when lying supine Have a discreet surgical target Have a lesion in which the center/focal area is defined Be at least 18 years of age or older Have a palpable lesion that does not require localization Require more than one localization needle for localization of the surgical target Have undergone previous open surgical biopsy or lumpectomy in the operative breast Have an implant in the operative breast Have a cardiac pacemaker or defibrillator device", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 60.0-999.0, All Basal Cell Carcinoma (BCC) Patients over 60 years old BCC was determined with tissue diagnosis in the lower extremity One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use Patient unable to read, understand and sign the consent form", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Wide-neck, Saccular Intracranial Aneurysms At least 18 years old A wide-neck intracranial saccular aneurysm with a neck \u2265 4mm or a dome to neck ratio <2 in the ICA from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) Life expectancy > 12 months Signed Informed Consent Females who are pregnant or intend to become pregnant during the study. (Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment) Extradural aneurysms Known multiple untreated cerebral aneurysms at study entry Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0 Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast Contraindication to CT and/or MRI scans Known allergy to the metal component of the Penumbra Liberty Stent System Evidence of active infection (WBC >10x109 /L) Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases)", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Non-melanocytic Skin Tumors Melanocytic Skin Tumors seborrhoeic warts nevi dermatofibroma basal cell carcinoma actinic keratosis squamous cell carcinoma Bowen's disease Merkel cell carcinoma malignant melanoma employers of the Medical University of Vienna patients during compulsory military service patients with an appointed guardian", "label": "2"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 0.0-999.0, All Clinically Atypical Pigmented Skin Lesion Cutaneous lesions examined with MelaFind must satisfy all of the following The lesion is pigmented (i.e., melanin, keratin, blood) The diameter of the pigmented area is not < 2 mm, and not > 22 mm The lesion is accessible to the MelaFind The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form Cutaneous lesions that meet any of the following will not be accepted The patient has a known allergy to isopropyl alcohol The lesion has been previously biopsied, excised, or traumatized The skin is not intact (e.g., open sores, ulcers, bleeding) The lesion is within 1 cm of the eye The lesion is on mucosal surfaces (e.g., lips, genitals) The lesion is on palmar hands The lesion is on plantar feet The lesion is on or under nails The lesion is located on or in an area of visible scarring", "label": "1"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-80.0, All Colorectal Polyp pedunculated colorectal polyps larger than 2cm in diameter long-term antiplatelet therapy presence of intraepithelial", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-79.0, All Body Temperature Changes belong to ethnic groups requested suffering any change in skin sensitivity, illness of an infectious nature or previously diagnosed diseases that respond negatively to the use of cold", "label": "1"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 10.0-999.0, All Keloid Cicatrix, Hypertrophic Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr) A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks Patients with all Fitzpatrick17 skin types Patients older than 10 years of age pregnancy diabetes mellitus", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-45.0, All Postprandial Glycemia Age 18-45 Male No regular medication No participation in a drug trial or blood donation within 2 months Non-smoker Signs informed consent Body mass index 18.5-27 kg/m2 Fasting plasma cholesterol < 5.5 mmol/l Fasting plasma triacylglycerols < 2.6 mmol/l Fasting plasma glucose 4-6 mmol/l Regular smoking Alcohol abuse Regular medication", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Foreign Object Accidentally Left in Body During Surgical and Medical Care Healthy men and women Ages 18 or older - Under 18 years of age Pregnant female or if female has not had a negative pregnancy test prior to the research scans", "label": "2"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 10.0-999.0, All Keloid Cicatrix Hypertrophic Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr) A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks Patients with all Fitzpatrick17 skin types Patients older than 10 years of age pregnancy diabetes mellitus", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 35.0-70.0, All Skin Aging female gender age > 35 years old good general state of health woman who had already undergone Hyaluronic acid injections woman who have not applied any retinoid product in the last 3 months woman who are not in a recovery period after laser/peeling/acne treatment accepting to return to the centre for the planned visits accepting to follow the investigator's instructions during the entire study period agreeing to present at each study visit without make-up accepting to not change their habits regarding: food, physical activity, face cleansing and make-up use Pregnancy (only for subjects not in menopause) lactation (only for subjects not in menopause) subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study subjects not in menopause who do not accept to perform the pregnancy test during the basal visit (T0), 6 and 12 weeks after the intradermal implant execution subjects participating to a similar test less than 3 months ago sensitivity to the test products or theirs ingredients subjects whose insufficient adhesion to the study protocol is foreseeable dermatitis presence of cutaneous disease on the tested area as lesions, scars, malformations clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.)", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All External Genital Warts Adults at least 18 years old with at least two visible EGWs Subject must be in good general health as confirmed by the medical history Subject must be able to read, sign, and understand the informed consent Subject must be willing to forego any other treatments for his/her EGW lesions Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study Subject with any evidence of herpes genitalis or any other current and/or recurrent genital or uncontrolled infection, including Human Immunodeficiency Virus, Hepatitis B or Hepatitis C Subject with an unstable medical condition as deemed by the clinical investigator Subject with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of EGW lesions Subject who has previously been treated in an EGW clinical trial, had treatment of anogenital warts or had systemic intake of virostatics or immunosuppressive medication within 30 days prior to Baseline Visit Women who are pregnant, lactating, or planning to become pregnant during the study period Subject who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc) Subject who have active chemical dependency or alcoholism as assessed by the investigator Subject who have known allergies to any component of the study ointment Subject who have organ allograft, skin conditions that may interfere with study ointment, or having internal (vaginal or rectal) warts that have required treatment Subject who has received any of the following within 90 days prior to study treatment initiation", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-80.0, All Bleeding Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included bleeding tendency, poor preparation, sessile polyp", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Seborrheic Keratosis Subject is at least 18 years of age Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis Subject has 4 appropriate seborrheic keratosis target lesions, as defined below (Section 5.4), on the trunk/extremities Have a clinically typical appearance Be treatment na\u00efve Have a PLA of \u22652 (Section 6.1.2) Have a longest axis that is \u22657mm and \u226415mm (Section 6.1.3) Have a longest dimension perpendicular to the longest axis that is \u22657mm and \u226415mm (Section 6.1.3) Have a thickness that is \u22643mm Be a discrete lesion Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser-Trelat) Subject has a current systemic malignancy Subject has a history of keloid formation or hypertrophic scarring Subject has used any of the following systemic therapies within the specified period prior to Visit 1 Retinoids; 180 days Glucocorticosteroids; 28 days Anti-metabolites (e.g., methotrexate); 28 days Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, that in the investigator's opinion, interferes with the application of the study medication or the study assessments LASER, light (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]) or other energy based therapy; 180 days", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 0.0-999.0, All Melanoma All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for in the study. There are no age limits but patients under the age of 18 years will also have their subject to parental/guardian consent There is no exclsion", "label": "1"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Brain Micrometastases Adult patients with brain metastasis from any primary tumour receiving GKR All intracranial micro-metastases including lesions located in the cerebral hemispheres, thalamus, basal ganglia and cerebellum and excluding lesions located in the brain stem below the level of the superior colliculi Target volume < 0.14 cc3 and maximum diameter < 7 mm The subject consents to participate in the study Inability to consent Younger than 18 years of age Lesions in the brainstem (below the level of the superior colliculi) are better treated with the 4 mm collimator and they will be excluded from the study Patients with more than 25 brain lesions suitable for randomisation will be excluded from the study Co-morbidity or previous treatment such as surgery, chemotherapy or WBRT is not to be considered as Pregnancy in the context of brain metastases is not a contraindication for GKR, and therefore it will not be considered as for this trial", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-75.0, All Seborrheic Keratosis Subject is at least 18 years of age Subject has a Fitzpatrick skin type of 1-4 Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face Have a clinically typical appearance Be treatment na\u00efve Have a PLA of \u22652 (Section 6.1.2) Have a longest axis that is \u22657mm and \u226415mm (Section 5.4) Have a longest dimension perpendicular to the longest axis that is \u22657mm and \u226415mm (Section 5.4) Have a thickness that is \u22642mm Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser-Trelat) Subject has a current systemic malignancy Subject has a history of keloid formation or hypertrophic scarring Subject has used any of the following systemic therapies within the specified period prior to Visit 1 Retinoids; 180 days Glucocortico-steroids; 28 days Anti-metabolites (e.g., methotrexate); 28 days Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments LASER, light (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]) or other energy based therapy; 180 days", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-65.0, All Keratosis, Seborrheic Subjects are Caucasian or Asian Subjects who are between 18-65 year olds Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy Subjects have Fitzpatrick skin type I-III Subjects are in good health Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator History of keloids or hypertrophic scars Pregnant or lactating or intends to become pregnant in the next 3 months Active skin disease or skin infection in the treatment area Previous history of lidocaine allergy History of methemoglobinemia Unable to understand the protocol or to give informed consent Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-999.0, All Breast Neoplasm Have had stereotactic or ultrasound-guided biopsy with marker placement Have a lesion or biopsy marker that is visible under ultrasound Have a surgical target =< 6 cm from the skin when lying supine Have a discreet surgical target Have a lesion in which the center/focal area is defined Have the ability to understand and the willingness to sign a written informed consent document Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an criterion Ability to understand and the willingness to sign a written informed consent document Require more than one localization needle for localization of the surgical target (bracket localization) Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast Have a prosthesis/implant in the operative breast Have a cardiac pacemaker or defibrillator device Be contraindicated for surgery Be pregnant", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 20.0-999.0, All Colonic Polyp All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm) (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 12.0-999.0, All Acne Vulgaris Male or female at least 12 years of age and older Written and verbal informed consent must be obtained Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits Subjects must be willing to comply with study instructions and return to the clinic for required visits Any dermatological conditions on the face that could interfere with clinical evaluations Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive Subjects with a facial beard or mustache that could interfere with the study assessments Subjects who are unable to communicate or cooperate with the Investigator Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 9.0-999.0, All Acne Vulgaris Male or female at least 9 years of age and older Written and verbal informed consent must be obtained Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits Subjects must be willing to comply with study instructions and return to the clinic for required visits Any dermatological conditions on the face that could interfere with clinical evaluations Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive Subjects with a facial beard or mustache that could interfere with the study assessments Subjects who are unable to communicate or cooperate with the Investigator Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study", "label": "0"} +{"topic": "A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented.", "doc": "eligible ages (years): 18.0-60.0, All Dermatitis Healthy Subjects with Fitzpatrick Skin Types I, II or III Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infections for Step 1 HIV infected Triple-class antiretroviral treatment, as determined by the site investigator and as defined by all of the following: a) exposure to 2 or more nucleotide reverse transcriptase inhibitors (NRTIs) for at least 3 months each; b) exposure to 2 or more non-boosted protease inhibitors (PIs) for at least 3 months each, or exposure to a dual PI regimen for at least 3 months; and c) exposure to at least 1 non-nucleotide reverse transcriptase inhibitor (NNRTI) for at least 3 months CD4 cell count of at least 50 cells/mm3 within 45 days prior to study entry Viral load of 2000 copies/ml or more within 45 days prior to study entry On current antiretroviral treatment regimen for at least 30 days prior to study entry. If current treatment includes abacavir, abacavir must be discontinued at least 30 days prior to study entry Willing to use acceptable methods of contraception for Step 1 Pregnant or breastfeeding Allergy or sensitivity to the study drugs and their formulations Diabetes mellitus Cataracts or any measurable loss of vision due to lens opacity Best-corrected visual acuity worse than 20/200 Certain drugs or vaccines within 30 days prior to study entry History of any of the following: kidney disease; serious illness within 14 days prior to study entry; end organ cytomegalovirus infection; Kaposi's sarcoma; cataracts; active herpetic infection or peptic ulcer disease within 12 months; or malabsorption, severe chronic diarrhea, or inability to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/mouth and throat discomfort Current alcohol or drug abuse that would interfere with adherence to study requirements", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Hemorrhage Patients must be men or non-pregnant women at least 18 years of age Patients who present with a gastric or duodenal ulcer Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation Patients presenting with active bleeding and/or NBVV at 2 or more separate sites Patients with any severe concomitant diseases, eg, end stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 0.0-6.0, All Asphyxia Neonatorum Hypoxia Encephalopathy Seizures The infant will be assessed sequentially by A, B and C listed below A. Infants =>36 completed weeks gestation admitted to the NICU with at least one of the following Apgar score of =<5 at 10 minutes after birth Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord, arterial or capillary pH <7.00) Base Deficit =>16 mmol/L in umbilical cord or any blood sample (arterial, venous or capillary) within 60 minutes of birth Infants that meet A will be assessed for whether they meet the neurological abnormality entry (B) by trained personnel B. Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following hypotonia abnormal reflexes including oculomotor or pupillary abnormalities Infants expected to be > 6 hours of age at the time of randomisation Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that brain dysgenesis", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...) Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days Deficient haemostasis (platelets < 40 x 109/l, international normalised ratio of the prothrombin time > 1.5 (or prothrombin time < 70%), or activated partial thromboplastin time > 40 seconds (or according to the normal ranges validated, from local lab)) Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins) Terminal stage illness in which endoscopy is contraindicated", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer Age > 18 years old Informed consent Concommitant use of high dose steroid or warfarin New start on non-steroidal anti-inflammatory drugs or aspirin or COX2 inhibitors Renal failure (serum creatinine > 200umol/l) Previous gastric surgery Oesophagitis, esophageal varices Terminal illness or malignancy", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Hemorrhage Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following SBP \u2264 90mmHg; P of \u2265110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or A documented HCT drop of at lest 6% from baseline Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer Pt can either have primary or secondary acute UGI haemorrhage Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer there is more than one type of significant bleeding lesion Documented hx of cirrhosis / portal HT ESRF requiring any form of dialysis Expected or persistent (>24hrs) coagulopathy with INR> 1.5 Platelet count is under 50000/mm3 Aspirin User / Plavix [Clopidogrel] User If the ulcer is neoplastic Cannot obtained consent Age < 18 or is pregnant", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-90.0, All Peptic Ulcer Hemorrhage all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb age 15 years Written consent available ulcer bleeding not controlled in first endoscopy Bleeding from malignant ulcer or tumor Bleeding from Dieulafoy lesion/ angiodysplasia Bleeding from injection sclerotherapy ulcer Patient with ASA category 5", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 16.0-999.0, All Peptic Ulcer Hemorrhage Age >16 , can obtain written consent Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b Moribund patients with terminal malignancy Pregnancy Intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Cardiac Arrest Male or female patients \u2265 18 years Witnessed out-of-hospital cardiac arrest of presumed cardiac origin in which the initial rhythm is ventricular fibrillation, ventricular tachycardia, pulseless electrical activity (PEA) or asystole First attempt at resuscitation (ACLS or CPR) by emergency medical personnel initiated within 15 minutes of collapse Restoration of spontaneous circulation (ROSC) within 60 minutes of collapse Time from restoration of spontaneous circulation to initiation of cooling is \u2264 6 hours Informed consent provided by authorized representative/family member Temperature of less than 35\uf0b0C on admission Comatose or vegetative state prior to cardiac arrest Positive pregnancy test Purposeful response to verbal commands after ROSC and prior to initiation of hypothermia Evidence of hypotension (MAP<60) for more than 30 minutes after ROSC and prior to initiation of hypothermia Evidence of hypoxia (oxygen saturation<85% despite supplemental oxygen) for more than 15 minutes after ROSC and prior to initiation of hypothermia Terminal illness that preceded the arrest (life expenctancy < 1 year) Patients experiencing cardiogenic shock Patients continuing to experience refractory ventricular arrhythmias at the time of enrollment Patients receiving 2 or more high dose vasopressors", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Shock Mean arterial pressure less than 70 mmHg or systolic pressure less than 100 mmHg persisting despite adequate fluid loading (in example with at least 1000 mL crystalloid or 500 ml colloid) unless central venous pressure (CVP) or pulmonary artery occluded pressure (PAOP) are elevated (e.g. CVP> 12 mmHg or PAOP > 14 mmHg) Serious arrhythmia such as rapid atrial fibrillation (> 160/min) or ventricular tachycardia Brain death Open label administration of dopamine, norepinephrine, epinephrine or phenylephrine for more than 4hours", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 15.0-999.0, All Shock, Traumatic Blunt or penetrating trauma Prehospital Systolic Blood Pressure (SBP) <= 70;OR Prehospital SBP 71-90 AND Hear Rate (HR) \u2265108 years of age or older, or 50kg or more if age unknown Known or suspected pregnancy Age younger than 15 or less than 50kg if age unknown Ongoing prehospital cardiopulmonary resuscitation (CPR) Administration of more than 2000cc crystalloid or any colloid or blood products Severe hypothermia (suspected Temperature less than 28 degrees celsius) Drowning or asphyxia due to hanging Burns Total Body Surface Area (TBSA) more than 20% Isolated penetrating injury to the head Inability to obtain prehospital intravenous access Time of call received at dispatch to study intervention greater than four hours", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-90.0, All Peptic Ulcers Upper Gastrointestinal Bleeding Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy Variceal esophageal bleeding Concurrent PPI use Moribund patients", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-79.0, All Hypothermia Heart Arrest Age between 18 and 79 years old Out-of-hospital cardiac arrest (OH-CA) due to a presumed cardiac etiology Delay between OH-CA and return of spontaneous circulation (ROSC) < 60 minutes Delay between ROSC and starting cooling < 240 minutes Patient not obeying verbal command after ROSC and prior to starting cooling Availability of the \"CoolGard\" device (ALSIUS product) Do not reanimate order or terminal disease before Known pregnancy Clinical hemorrhagic syndrome or known coagulopathy Contra-indication to device usage (such as femoral venous access impossible) Hypothermia at admission < 30\u00b0C Etiology of OH-CA thought to be extra-cardiac (trauma, bleeding or anoxia) In hospital cardiac arrest Refractory shock (need for extra-corporeal life support)", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-40.0, All Nausea Vomiting Cesarean Section Must be pregnant with a single baby Must be at term in their pregnancy (estimated gestational age of at least 38 weeks) Must be scheduled for an elective Cesarean section Must be between 60-70\" tall Must be free of severe systemic disease (ASA class I or II) Contraindication to spinal anesthesia Any allergy to any of the medications included in the study History of pregnancy-induced hypertension or preeclampsia History of preexisting hypertension Diabetes mellitus Hyperemesis gravidum Previous perioperative nausea and vomiting History of motion sickness Women carrying a fetus with a known abnormality will also be excluded from the study", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Gastric Ulcer Duodenal Ulcer Daily intake of low-dose Aspirin (ASA) The subject must fulfill at least one of the following (a-e) Aged \u226565 years Aged \u226518 years and with a documented history of uncomplicated peptic ulcer(s) Aged \u226560 years and na\u00efve to low-dose ASA (ie, treatment started within 1 month prior to randomization) Aged \u226560 years and with stable coronary artery disease Aged \u226560 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of \u22655 gastric and/or duodenal erosions at the baseline endoscopy Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD) Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline History of peptic ulcer complications such as clinically significant bleeding and/or perforation", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-75.0, All Healthy Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age No clinically important abnormal physical, laboratory, ECG findings Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR) Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke Any autoimmune disease Previous allergic reaction to immunoglobulin Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration Abnormal platelet function or clinically significant out of range values for any coagulation tests History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage Screening FVIII:C < 50%", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Perforation Patients surgically treated for benign peptic ulcer perforation Age < 18 years Pregnant and breastfeeding women Malign ulcer perforation", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Hemorrhage Patients older than 18 Informed Consent signed Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer Life expectancy longer than 6 months Able to attend further clinical controls Absence of the following Previous eradication treatment Use of antibiotics 2 weeks prior to inclusion Need for Antisecretor treatment that cannot be stopped to perform the breath test Pregnancy or breastfeeding", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 0.0-21.0, All Vomiting Syndrome Migraines Subjects age 0-21 years old with CVS (different phenotypes). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent Subjects age > 22 years old Vomiting is not due to CVS or other related condition", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-80.0, All Peptic Ulcer Hemorrhage Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission If patients were pregnant Did not obtain initial hemostasis with endoscopic injection of epinephrine Did not give written informed consent Had bleeding tendency (platelet count < 50\u00d7109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-85.0, All Fever Brain Hemorrhage Two or more days with core temperature \u2265 100.4F Approval of the patient's primary attending physician Need for core temperature measurement independent of the study Admission to the Neuro-ICU [intensive care unit] for an underlying condition Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central nervous system] infection or urinary tract infection Expected death from any cause Known sensitivity to the device History of pre-admission hypothalamic dysfunction or known temperature dysregulation Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely Hemodynamic instability", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 12.0-65.0, All Scorpion Envenomation (All of the following) Patients of both sexes, in the age range of 12-65 years reporting to the PHC/ hospital within 48 hours of scorpion sting and associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the below:) Grade Symptoms Sweating 0 Limited to the extremity of the sting site Minimal sweating all over the body, slight nasal secretions Generalized sweating with rigors and cold extremities Gen.profuse sweating,wetting of clothes and cold clammy skin Pulse rate 0 70 (Any of the following) Composite score less than 5 and greater than 21 Grade of 5 in any of the criterion Severe Pulmonary edema with oxygen saturation below 80% Severe scorpion envenomation with reporting time more than 2 days Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc Severe anaphylactic reaction to any of the study drugs Patient (or relative in case of child) not willing to participate", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Non-Small Cell Lung Cancer Locally advanced or metastatic NSCLC (stage IIIB or IV) Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy At least one measurable lesion according to Good performance status Adequate haematological, renal and liver function Written informed consent Previous chemotherapy for NSCLC Brain metastasis History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease Concomitant therapy with an anti-angiogenesis agent Contra-indication for LMWH Life expectancy of < 3 months Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Non-variceal Upper Gastrointestinal Bleeding Gastrointestinal Ulcer Gastrointestinal Hemorrhage Patients admitted to the hospital or inpatients with an overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia, as well as other clinical/laboratory evidences of acute blood loss from the upper GI tract Evidence that an upper GI endoscopy was performed The complete medical record is available for study related hospitalization ", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-65.0, All Pain Male or female, more than 18 and less than 65 years of age Women using a method of contraception and with a negative pregnancy test before entering the study, or women who have been menopausal for at least 1 year Patients meeting one of the following Closed benign trauma of the motor system occurring within the last 24 hours Contusion of the motor system occurring within the last 24 hours Acute rheumatologic conditions (acute lower back pain, lumbar sciatica, cervicobrachial neuralgia) Abarticular rheumatism Requiring treatment with Bi-Profenid for 5 days With resting pain intensity measured on a numeric scale at baseline >or= 3 (before administration of any treatment) Receiving a prior medical examination suited to the study Need for surgery Need for hospitalization Need for an analgesic other than step I at the baseline visit Need for treatment with another selective or non-selective NSAID (per os and/or topical), including aspirin, selective cyclo-oxygenase 2 inhibitors, corticosteroids or muscle relaxants at baseline and throughout the study Serious trauma: knee luxation, any fracture, ruptures such as Achilles tendon rupture Sprain treated with a cast Bursitis Local and/or general severe infection Pregnant or nursing women Hypersensitivity to ketoprofen or to any of the excipients of the product", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 16.0-999.0, All Peptic Ulcer Hemorrhage Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy Patients who refuse endoscopic procedure Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation) Pregnancy Patients with serious concurrent diseases such as malignant tumors or end-stage diseases History of previous gastrectomy or vagotomy Known hypersensitivity to proton pump inhibitors Elderly patients Epilepsy", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer/Erosions upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks years old or older concurrent erosive or ulcerative esophagitis pyloric stenosis previous gastric or duodenal surgery other than oversewing of a perforation thrombocytopenia renal failure with estimated creatinine clearance less than 10 ml / min active cancer known allergic to aspirin, famotidine or pantoprazole pregnancy, lactation, child-bearing potential in the absence of contraception psychosomatic disorder planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 40.0-90.0, All Peptic Ulcer Ulcer Complications Patients are eligible if they have received PCI for their stenotic coronary arteries and taken both aspirin and clopidogrel Patients who had a past history of PUD without complication, who have taken aspirin or clopidogrel before enrolling for their CV disease will be allowed to enroll Patients are excluded if they have New York Heart Association class IV heart failure, if they had contraindications to antithrombotic or antiplatelet therapy, if they have clinical severe thrombocytopenia (platelet count< 80000/mm3), if they have previous disabling, or hemorrhagic stroke or intracranial hemorrhage, if they have severe and unstable conditions in hepatic, renal, and pulmonary disease, if they have unstable and progressive malignancy, if they have epigastralgia or have a positive occult blood in stool, if they have current or recent PUD and take PPI or histamine receptor-2 antagonist without proving healed ulcer by scopy, if they have received a surgical intervention due to PUD complication (bleeding, perforation, obstruction) in the past, if they have received a GP IIb/IIIa inhibitor fewer than 3 days before randomization", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer aged more than 18 years undergo emergent endoscopy within 24 hours of presentation have peptic ulcers in the gastroesophageal junction, stomach, or duodenum high-risk stigmata of peptic ulcers: Forrest classification IA~IIB endoscopic hemostasis by thermocoagulation or clip placement pregnant or lactating written informed consent not obtained initial endoscopic hemostasis fail bleeding tendency (platelet count < 50\u00d7109/L, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants) PPI use within 14 days of enrollment comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dL, serum creatinine more than 5 mg/dL, or under dialysis) bleeding gastric cancers", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-75.0, All Advanced Esophageal Informed consent form signed before performing any of the study's specific procedures ECOG performance status 0-2 Age > 18 and < 75 Measurable disease by Response Evaluation in Solid Tumors (RECIST) greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique Histologically confirmed diagnosis of locally advanced esophageal Life expectancy of more than 3 months Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency Neutrophils \u22653\u00d7109/L, platelet count\u2265100\u00d7109/L and haemoglobin\u22659g/dL ,Creatinine \u2264 1.5 x NUL Previous radiotherapy or chemotherapy Pregnant or breast-feeding women Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection Evidence of distant metastasis Participation in other clinical trials Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis Uncontrolled psychiatric disease or seizure Patients not fit for the clinical trial judged by the investigators", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-65.0, All Bleeding Marginal Ulcer patients status post laparoscopic RYGB surgery with active gastrointestinal hemorrhage secondary to marginal ulcer bleeding marginal ulcers after other bariatric procedures staple-line bleeding after RYGB iron-deficiency anemia (chronic) secondary to non-actively bleeding marginal ulcer after RYGB other sources of GI bleeding different from marginal ulcer such as from staple-lines, complicated PUD, and other surgical and medical causes of GI hemorrhage missing records and/or unreachable patients with scant information for analysis", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-65.0, All Ulcer Disease After Gastric Bypass Marginal Ulcer Perforated Marginal Ulcer Acutely Perforated Marginal Ulcer Laparoscopic repair of perforated marginal ulcer after RYGB Perforated marginal ulcers after other bariatric procedures Repair by open approach Missing records and/or unreachable patients with scant information for analysis", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention Surgical candidate for endoscopic, laparoscopic, or open procedure Age > 21 Informed written consent Prior gastric or duodenal surgery Prior total abdominal colectomy or transverse colectomy Prior omentectomy or omental flaps Known perforation site other than stomach or duodenum Patients with contra-indications for laparoscopy Patients with contraindications for endoscopy Upper gastrointestinal anatomy that would preclude endoscopic therapy Coagulopathy or thrombocytopenia Pregnant patients Patients <21 years of age", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-65.0, All Postoperative Nausea and Vomiting ASA I or II female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital age <18 or >65 severe hypertension,diabetes mellitus, significant hepatic or renal disease excessive blood loss sustained (>10 min)>20% from baseline drop in BP after treatment inability to follow protocol refusal to sign consent", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 0.0-999.0, All Peptic Ulcer We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months serious disease 2.refuse informed consent", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Bleeding Peptic Ulcer Arterial Embolization Actively bleeding peptic ulcers (Forrest I), NBVV or Forrest IIa ulcer Successful endoscopic hemostasis by combination treatment of injected epinephrine followed by either 3.2mm heat probe 30J (4 continuous pulses) or hemo-clipping (at least 2 clips) And one of the followings Spurting hemorrhage during endoscopy Ulcer >= 2 cm is determined by an opened biopsy forceps Hb on admission of < 9 g/dl; or Hypotension prior to endoscopy defined by SBP of <90 mmHg AND HR of >110 bmp ", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Bleeding Age \u2265 18 Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb Endoscopic hemostasis achieved Informed consent obtained No consent Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding) Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated Moribund patients in whom active treatment of any form is not considered Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation Upper GI malignancy or disseminated malignant disease Esophageal varices A Mallory-Weiss lesion Phenytoin or theophylline treatment Uses of PPI or H2RAs within 3 days of admission, including uses at Emergency Department N.B. Usage of aspirin or NSAID is not an", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Upper Gastrointestinal Bleeding Established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract Written informed consent provided prior the start of participation in the study Subjects who are unwilling or unable to provide informed consent", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 1.0-14.0, All Gastroenteritis All acute gastroenteritis patient between 1-14 years presenting to PEC Al Saad with diarrhea, persistent vomiting , fail oral rehydration and admitted to the observation unit for intravenous hydration will be eligible for the study Previous abdominal surgery Suspicion of surgical abdominal Bile stained vomitus History of hepatic and renal illnesses In-born error of metabolism Children with shock or impending shock Sever dehydration Previous hypersensitivity or abnormal reaction to metoclopramide or ondansetron Antiemetic treatment within 48 hours prior to presentation Seizure disorder", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer A history of H. pylori-negative idiopathic peptic ulcers, defined as No exposure to aspirin, NSAIDs or drugs of unknown nature including traditional Chinese medicine within the 4 weeks before hospitalization Biopsies taken during endoscopy must be negative for both the urease test and histology for H. pylori in the absence of acid suppressive therapy; and No other causes of ulceration identified Endoscopically confirmed ulcer healing Age >18 years old Informed consent Concomitant steroid or anticoagulant Concomitant use of NSAIDs, aspirin or COX2 inhibitors Previous gastric surgery Requirement of maintenance PPI (e.g. reflux oesophagitis) Advanced comorbidity (defined as ASA 4 or above) or active malignancy Subjects who are pregnant or lactating, or is intending to become pregnant before, during, or within 1 month after participating in this study Subjects who have known hypersensitivity or allergies to any component of lansoprazole or famotidine Subject who has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcers Age \u2265 18 Confirmed ulcer bleeding with Forrest Ia, Ib, IIa Endoscopic hemostasis achieved by combined endoscopic hemostasis Informed consent obtained No consent Unsuccessful endoscopic treatment Upper GI malignancy History of subtotal gastrectomy Bleeding tendency, platelet count < 80x109/L, prothrombin time INR >1.5 Myocardial infarction or cerebrovascular accident within one week Ulcer bleeding because of mechanical factors (such as, induction of NG tube) Malignancy or other advanced disease with a life expectancy of < 6 months IV PPI > 40mg within 24hrs before enrollment Decompensated liver cirrhosis", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Re-bleeding in NVUGIB Adult patients (>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia Evidence that an upper GI endoscopy was performed GI bleeding not from", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer aspirin users who have a peptic ulcer confirmed by endoscopy serious medical illness (including cardiovascular events within 6 months before endoscopy) acute gastrointestinal bleeding a history of gastric or duodenal surgery allergic to the study drugs require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents pregnancy", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Melena Hematemesis Peptic Ulcer Hemorrhage Variceal Hemorrhage Patients greater than 18 Patients presenting with actual or reported hematemesis or coffee ground emesis or melena Refusal to participate Patient is hemodynamically unstable People with dysphagia or another swallowing disorder Pacemaker Known or suspected gastrointestinal obstruction, stricture or fistula Prisoners Patient lacks the ability to give informed consent High suspicion of pregnancy", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Peptic Ulcer Bleeding A history of documented peptic ulcer bleeding (self-reported history without confirmation by the clinician is not acceptable) Negative tests for H. pylori or successful eradication of H. pylori based on urease test and histology Expected regular use of ASA for the duration of the trial Age \u2265 18 Written informed consent obtained A history of gastric or duodenal surgery other than patch repair Severe erosive esophagitis (LA grade C or D) Gastric outlet obstruction Terminal illness Active malignancies", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 15.0-999.0, All Blunt Trauma Penetrating Wound Hemorrhagic Shock Included will be those with Blunt or penetrating injury Age \u226515yrs or weight \u226550kg if age is unknown Prehospital SBP \u2264 90 mmHg Excluded will be those with Ground level falls Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) \u2264 8 Bilateral paralysis secondary to suspected spinal cord injury Fluid greater than 250ml was given prior to randomization Cardiopulmonary resuscitation (CPR) by Emergency Medicine Service (EMS) prior to randomization Known prisoners Known or suspected pregnancy Drowning or asphyxia due to hanging Burns over a Total Body Surface Area (TBSA) > 20%", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-85.0, All Postoperative Nausea and Vomiting (PONV) Nausea Adult patients to 85 years of age Scheduled for neurosurgery requiring opening of the cranium and dura at Ohio State University Medical Center and who consent in writing to participate in this study are eligible Patients will be excluded from this study if they are prisoners pregnant women mentally ill under the age of 18 or over the age of 85 American Society of Anesthesiologist (ASA) classification V alcohol or drug abusers have a cerebral perfusion pressure (CPP) greater than 150 mmHg or less than 50 mmHg", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 20.0-80.0, All Esophageal Cancer cytologically or histologically confirmed esophageal carcinoma age of 20 -80 Karnofsky performance status \u2265 70 no treatments prior to enrollment at least one measurable lesion on CT, MRI or esophageal barium exam normal functions of heart, lung, liver, kidney and bone marrow blood exams qualified for chemotherapy, which included hemoglobulin \u22659 g/dl, neutrophil \u22651.5\u00d7109/L and platelet (PLT) \u2265100\u00d7109/L, creatinine \u22641.5 UNL informed consent signed prior treatments of chemotherapy or irradiation poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis participating in other clinical trials pregnancy, breast feeding, or not adopting birth control drug or alcohol addiction, uncontrolled epileptic seizure, or psychotic with no ability of self control coexisted morbidities that investigators believed not suitable for chemoradiation", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 16.0-60.0, All Blood, Injection, Injury Type Phobia Gastrointestinal Ulcer Haemorrhage Adverse Reaction to Epinephrine all adult patients with gastroduodenal ulcer Patients with non ulcer bleeding Patients with malignancy Patients with bleeding disorders or under coagulation therapy Patients with known allergy to epinephrine", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 39.0-83.0, All Peptic Ulcer Bleeding Hypoalbuminemia Clinical presentations of melena, hematochezia, or hematemesis Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage A Rockall score \u2265 6 Gastric or esophageal, or duodenal tumor bleeding Ulcer due to mechanical factors Warfarin use Failure to establish hemostasis under gastroscopy Hypersensitivity to omeprazole, esomeprazole, albumin or any component of the formulation", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Trauma Hemorrhagic Shock Age>=18 years Acutely injured SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute Visibly or verbally reported pregnant women known prisoners unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization) known objection to blood products the patient has an opt-out bracelet or, necklace or wallet card a family member present at the scene objects to the patient's enrollment in research", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 0.0-999.0, All Bleeding Peptic Ulcer General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months ", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 40.0-84.0, All Peptic Ulcer [Iowa Type (107680.0010)] Patients aged 40-84 years in 1997-2005 ( see study population description) Patients aged below age 40 and 85 years and above ( see study population description)", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Acute Abdomen All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion Patients with chronic renal failure already receiving dialysis treatment Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3 Patients judged at the admission not subject to resuscitative measures for severity and comorbidity Patients with massive hemorrhage in operative room or in the immediate perioperative with the need for blood transfusions and abundant blood products > 5 units of Erytrocyte Concentrates (EC) Patients scheduled for Orthotopic Liver Transplantation (OLT) Patients younger than 18 years old", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-80.0, All Gastric Varices Portal Hypertension Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis The age of the patients range from 18 to 80 years old Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy Patients who have abnormal portosystemic shunt according to the imaging results Patients who have no previous upper gastrointestinal bleeding history Patients who have multiple endoscopic treatments for esophagogastric varices before", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 20.0-75.0, All Gastric or Duodenal Ulcer Patients with peptic ulcer disease Age: 20-75 years old Patients who submitted informed consent Peptic ulcer disease with spurting and oozing Shock, hypotension, pregnancy Gastrointestinal malignancy", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 19.0-85.0, All This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment. Adults, age \u2265 18 years Patients who have signed the study informed consent form prior to initiation of any study-related procedure Acute massive PE patients who require thrombolytic treatment Patients who have a contraindication to use of anticoagulation and thrombolysis, such as active bleeding, stroke, cranial trauma, or neurologic surgery within the preceding 6 months, current pregnancy, major surgery, or biopsy within the preceding 7 days, major trauma within the preceding 10 days, gastrointestinal bleeding within the preceding 1 months during their admission Patients who received any anticoagulation medication prior to admission to the hospital", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Chemotherapy-induced Nausea and Vomiting Minimum age of 18 years Histologically proven solid organ cancer Eastern Cooperative Oncology Group Performance status 0-2 More than 3 months for life expectancy Patients scheduled to receive the first line, first cycle (5-FU, Oxaliplatin, Leucovorin) or (5-FU, Irinotecan, Leucovorin) chemotherapy Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Patients who have nausea and vomiting caused by other reasons such as CNS metastases or gastrointestinal obstruction Patients who were exposed previously to any chemotherapy except adjuvant FL (5-FU and leucovorin) Patients who take anti-emetic drugs or dopamine antagonist within 72 hours prior to administration of chemotherapy Patients who take other drugs that may affect serum level of biomarkers (ex. steroid, megesterol, hormone replacement therapy, parenteral nutrition)", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-80.0, All Upper Gastrointestinal Bleeding Adult patients (18-80) who are admitted to the ICU for hematemesis, or coffee ground emesis Patients younger than 18 yrs old or older than 80 yrs Patients who refuse to consent to be in our study Pregnant patients Prior use of prokinetics in the last 48 hours History of cardiac arrhythmia Allergy to erythromycin or metoclopromide Patients with QT prolongation (query 7)", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-50.0, All Nausea Vomiting undergoing elective orthognathic surgery age 18-50 year olds signed informed consent pregnant women past history of oesophageal surgery, oesophageal varices or stricture patients who have received antiemetic medication in the 24 hours before surgery emergency surgery prior history of motion sickness and/or PONV, vertigo or migraine headaches", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 21.0-999.0, All Bleeding Peptic Ulcers Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB) Patients younger than 21 years of age Refusal to participate in study Contraindicated for endoscopy Pregnant or lactating patients Bleeding secondary to non-peptic ulcer source Patients requiring mechanical ventilation Patients with acute coronary syndrome", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Gastrointestinal Hemorrhage Adults aged 18 or over years presenting with AUGIB, defined by haematemesis or melaena Patients with whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Hb result due to severity of bleeding Existing hospital in-patients who develop AUGIB", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Gastrointestinal Hemorrhage Patients presenting with fresh blood hematemesis, coffee ground emesis, or melena Patients with hematochezia and hypotension (systolic blood pressure < 90 mm Hg) or tachycardia (heart rate > 110 beats per minute) Identification of a bleeding source within the first 5 minutes of the upper endoscopy or no blood seen in the upper GI tract as these patients do not require additional suctioning Age < 18 No endoscopy was performed Endoscopy previously performed for current episode of UGIB Patients unable to consent and who do not have a substitute decision maker", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-70.0, All Gastric Ulcer Induced by Anti-platelet Agent Duodenal Ulcer Induced by Anti-platelet Agent Age 18-70 year-old Had cardiovascular disease which needed clopidogrel and aspirin Stable enough for gastroscopy Gastroscopy revealed peptic ulcer Had contraindication for gastroscopy Not allowed for gastroscopy by cardiologist", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 20.0-95.0, All Peptic Ulcer Hemorrhage Bleeding peptic ulcers with major stigmata of recent hemorrhage All of these major SRH are treated by local injection of diluted epinephrine 1:10000 with or without combined therapy with a heater probe, argon plasma coagulation, band ligation, or hemoclip therapy Bleeding due to tumor or cancer Bleeding due to the presence of a Dieulafoy lesion Ulcer bleeding due to mechanical factors (i.e., gastrostomy tube induction) Proton pump inhibitors use within one week before enrollment Failure to establish hemostasis under gastroscopy Hypersensitivity to esomeprazole, pantoprazole, or any component of the formulation Previously participated in the study", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 20.0-999.0, All Bleeding Ulcers (i) over 20 years of age and (ii) patients with high-risk peptic ulcer bleeding (i) the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis); (ii) coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen); (iii) treatment with an anticoagulant (eg, warfarin); (iv) pregnancy; (v) the presence of operated stomach or; (vi) refusal to participate in the study", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Bleeding Peptic Ulcer Patients presented with bleeding peptic ulcers Age > 18 year old Informed consent for the study and OGD Unable or refuse to give consent Onset more than 7 days Pregnancy", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 0.0-999.0, All Stress Ulcers Stress-related Mucosal Disease (SRMD) The subject population that will be included in the NIS are the consecutive discharged patients \u226518 years old who were hospitalized to Neurosurgical departments. Those whose Glasgow Coma Scale (GCS) \u226410[4] within 24 hours of lesion/admission will be defined as critically ill patients. Three kinds of cases will be included: brain trauma critically ill patients, cerebral haemorrhage critically ill patients or postoperative brain tumour critically ill patients If participating in any clinical trial, the subject cannot take part in this study. Subjects are ineligible if they have below conditions Those who were likely to swallow blood (for example, those with severe facial trauma or epistaxis Patients with previous total gastrectomy Known upper GI lesions that might bleed (e.g., varices, polyps, tumours, etc) Evidence of active GI bleeding including oesophageal and gastric variceal bleeding, Peptic Ulcer Disease (PUD)", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 19.0-999.0, All Peptic Ulcer Male or female over 19 years of age Accompanied by hypertension, diabetes, ischemic heart disease, arrhythmia, dyslipidemia patients who are required to continuous administration of low-dose aspirin(100mg) Patients who get Modified Lanza Score (MLS) 0 in screening period according to endoscopic findings Patients who have stomach or duodenal ulcer scar in screening period according to endoscopic findings. But, the cases that scars caused by other disorders or endoscopic treatment are excluded Patients who have no digestive symptoms(except for mild physconia, abdominal pain, diarrhea and vomit, nausea-vomiting) in screening period Signature of the written informed consent Within 4 weeks prior to screening period, patients who continuously take aspirin or NSAIDs Patient who has hypersensitivity to PMK-S005 and aspirin components or is banned to use them Patients who had a abdominal surgery that affect gastrointestinal motility (Except appendectomy and hysterectomy), But, patients who had enterectomy is excluded regardless of the time period Patients who are judged by investigator that they have other upper gastroesophageal disease, active/healing-stage peptic ulcer, digestive malignant tumor or Barrett's esophagus Patients with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's disease, Zolinger-Ellison syndrome History of esophagus, liver, pancreas, stomach, colorectal cancer or malignant tumors within 5 years History of malabsorption within 3 months prior to screening period Patients who have been taken drug that affect the validity within 2 weeks before beginning of the clinical test Patient who is needed continuously to take antithrombotic agents , anti coagulant , anti", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Ulcer Bleeding Age >=18 Informed consent obtained Successful endosopic hemostasis Risk Score >= 5 Age < 18 Pregnancy Incomplete endoscopic haemostasis -", "label": "2"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Pain, Postoperative Postoperative Nausea and Vomiting Postoperative Hemorrhage Body Weight Changes years and older Surgical indications: Chronic tonsillitis, Snoring, Sleep apnea Surgical procedure: Tonsillectomy with monopolar cautery, hemostasis with monopolar cautery and/or suction cautery. The surgical procedure can also Adenoidectomy with suction cautery Additional surgical procedures (i.e. UPPP (uvulopalatopharyngoplasty), septoplasty, inferior turbinate reduction) during same surgery Pregnant females Indications: Suspected malignancy History of chronic pain or daily pain medication used for another medical problem History of liver disease Contraindications to preoperative Decadron Contraindications to pain regimen medications (Tylenol, Norco, Percocet, Dilaudid)", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-65.0, All Oral Glucose Tolerance Body mass index (BMI) of 18.0-30.0 kg/m2 and with no known diseases systemic infections, psychiatric or metabolic disorders, known food allergies or intolerances related to the products used in the study (e.g. dairy or gluten), ongoing or former drug abuse, high intake of alcohol (defined as a weekly intake of >7 units for women and > 14 units for men), pregnancy or ongoing planning of pregnancy, vegetarianism or veganism, participation in other scientific studies during the study period, and blood donation during or in the month leading up to the study period", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-999.0, All Overt Upper Gastrointestinal Bleeding Individual aged \u2265 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent endoscopy UGIB with fresh hematemesis requiring urgent endoscopy dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery presence of an electromedical device (pacemaker or internal cardiac defibrillator) altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation medications, allergy to Maxolon, unwillingness to swallow the capsule, patient expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting the capsule, patient on medications that may coat the upper GI tract such as antacids or sucralfate, or inability to provide written informed consent Allergy to Maxolon Patients with known Esophageal Varices or Gastric Varices with or without prior bleeding episodes Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or hepatocellular carcinoma or pancreatic cancer", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 20.0-95.0, All Peptic Ulcer Hemorrhage Eligible participants included patients \u226520 years who had undergone gastroscopy for melena, haematochezia, or haematemesis due to bleeding peptic ulcers with major stigmata of recent hemorrhage. The major stigmata of recent haemorrhage were classified as Forrest class Ia, Ib, IIa, and IIb. All of the stigmata are given one or a combination of endoscopic therapies, including local injection of diluted epinephrine 1:10000, bipolar heated probe, argon plasma coagulation, band ligation, or hemoclip therapy. Patients will undergo a follow-up endoscopy about 12 to 16 weeks later to confirm that the ulcer has healed to be less than 0.5 cm; otherwise, patients are not enrolled Patients are excluded if they had tumor bleeding or ulcer bleeding due to the presence of a Dieulafoy lesion or mechanical factors (e.g, gastrostomy tube induction), comorbid with reflux esophagitis grade C or D, Barrett's esophagus, or marginal ulcer bleeding, hypersensitivity to esomeprazole or any component of the formulation, or had previously participated in the study. Because of concern for patient safety with certain drug-drug interactions, patients who receive anti-platelet therapy, e.g., aspirin, clopidogrel, or others for prophylaxis of established cardiovascular or cerebrovascular diseases will be excluded", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 19.0-85.0, All Hemorrhage, Surgical Hip Replacement, Total Thrombocytopathy patient scheduled for elective hip replacement surgery age between 19-85 years signed informed consent informed consent not signed traumatic hip fracture anemia (hemoglobin level < 100 g/l) allergy to study drug and/or multiple allergies chronic heart failure with LVEF < 30% shock states coagulopathy thrombocytopenia thrombocytopathy chronic kidney disease with oliguria", "label": "1"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-45.0, All Anesthesia; Adverse Effect, Spinal and Epidural Hypotension Complications; Cesarean Section The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2 Pregnant women with singleton pregnancy Gestational age greater than 36 weeks Cesarean delivery under spinal anesthesia Use of cardiac medication or medication for blood pressure control Cardiovascular disease Multiple gestation Gestation diabetes requiring insulin Refusal to be in study History of chronic opioid use (chronic pain syndrome) Emergent caesarean delivery for maternal and/or fetal distress Preeclampsia Eclampsia Progressive neurologic disease", "label": "0"} +{"topic": "A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a \"coffee ground\" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care.", "doc": "eligible ages (years): 18.0-65.0, All Shock, Hemorrhagic Fractures, Bone Multiple Trauma multitrauma defined as Injury Severity Score (ISS) > 17 dislocated pelvic fracture type B or C according to Tile[10] on emergency department pelvic radiograph hemodynamic instability defined as systolic blood pressure (SBP) <90 mmHg after administration of 4 units of packed red blood cells (PRBC) monotrauma, or ISS \u2264 17 age > 65 years age < 18 years", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-50.0, All PMDD PMS Depression The subjects of this study will be women who meet the for MRMD as described in Protocol No. 81-M-0126, 'The Phenomenology and Biophysiology of Menstrually-related Mood and Behavioral Disorders.' In brief, these history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity--i.e., disturbances that are distinct in appearance and associated with a notable degree of subjective distress symptoms should have a sudden onset and offset age 18-50 not pregnant and in good medical health medication free All patients participating in this protocol will have already participated in Protocol No. 81-M-0126 and will have a prospectively confirmed and predictable relationship between their mood disorder and the premenstrual phase of the menstrual cycle, i.e., a 30% change in severity of symptom self rating scales, relative to the range of the scale employed, during the seven days premenstrually compared with the seven days post-menstrually in two out of three months of study The Schedule for Affective Disorders and Schizophrenia will be administered to all patients prior to study entry. Any patient with a current axis I psychiatric diagnosis will be excluded from participating in this protocol Prior to treatment, a complete physical and neurological examination will have been performed and the following routine laboratory data obtained A. Blood The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol current Axis I psychiatric diagnosis history consistent with endometriosis diagnosis of ill-defined, obscure pelvic lesions, particularly, undiagnosed ovarian enlargement hepatic disease as manifested by abnormal liver function tests history of mammary carcinoma history of pulmonary embolism or phlebothrombosis undiagnosed vaginal bleeding porphyria diabetes mellitus", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-55.0, All Porphyria ENTRY --Disease Characteristics- Acute porphyria, i.e.: Acute intermittent porphyria Hereditary coproporphyria Variegate porphyria Definite cyclic attacks with severe abdominal pain and other porphyria symptoms during luteal phase of menstrual cycle only Attacks resolve completely within 5 days of onset of menses, i.e., no symptoms between attacks At least 4 to 6 attacks during the 6 months prior to entry More than half of these attacks must meet the following Readily distinguishable from menstrual cramps and premenstrual syndrome Required hospitalization for narcotic analgesics, phenothiazines, hematin, intravenous fluids, or other treatment Luteal attacks not requiring hospitalization must be similar in symptoms and differ only in severity No life-threatening porphyria attacks No cyclic abdominal pain unless caused by porphyria --Prior/Concurrent Therapy- At least 6 months since ovulation suppression --Patient Characteristics- Reproductive: Menstrual cycle 25-35 days for at least 6 months prior to entry Pelvic exam normal within 60 days prior to entry Pap smear normal, i.e., no dysplasia No amenorrhea No other menstrual abnormality No other gynecologic abnormality Negative pregnancy test Medically approved contraception required for 2 months prior to entry and throughout study OR at least 1 menstrual cycle following tubal ligation Other: No allergy to gonadotropin-releasing hormone analogues No clinically significant abnormal laboratory test results No medical contraindication to protocol treatment ", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-999.0, All Amphetamine-Related Disorders years of age. Treatment seeking for meth dependence Please contact site director for more details", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-40.0, All Endometrial Bleeding Periodontal Disease Regular menstrual periods for the last 2 cycles Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry Currently not using tetracycline-class antibiotics Normal Pap smear Pregnancy or breastfeeding within 2 months of study entry Chronic migraine headaches Uncontrolled high blood pressure Untreated sexually transmitted diseases Alcoholism or drug abuse within 12 months of study entry Insulin dependent diabetes Liver, kidney, or gallbladder disease Participation in another clinical trial within 30 days of study entry History of cancer History of blood clots, strokes, or heart disease", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-45.0, All Endometriosis Female patients with endometriosis-associated pelvic pain Pregnant or lactating women history or suspicion of hormone dependent tumor therapy resistant endometriosis need for primary surgical treatment any other conditions which forbid the participation", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 21.0-40.0, All Infertility Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict or >5 million total motile sperm on IUI prep Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube Patients with surgically corrected stages I and II endometriosis will be included Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study) Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for prior to any gonadotropin therapy Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin Female body mass index \u2264 38 Previous tubal reconstructive surgery in which the pelvis was not restored to functional Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET) Female body mass index > 38", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 25.0-50.0, All Leiomyoma Female gender-to evaluate effects in the target population for clinical trials History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the American College of Obstetrics and Gynecology (ACOG) practice bulletin Excessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection Uterine leiomyoma(ta) of at least 2 cm size In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the-counter drugs is acceptable but must be recorded Menstrual cycles of 24 days Hemoglobin greater than 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts Willing and able to comply with study requirements Significant abnormalities in the history, physical or laboratory examination Pregnancy Lactation Use of oral, injectable or inhaled glucocorticoids or megestrol within the last year Unexplained vaginal bleeding History of malignancy within the past 5 years Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations Use of agents known to induce hepatic P450 enzymes; use of imidazoles Current use of Gonadotropin-releasing hormone (GnRH) analogs or other compounds that affect menstrual cyclicity Follicle stimulating hormone (FSH) greater than 20 IU/mL", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 40.0-999.0, All Menopause Insomnia Women 40+ years old Subject must have any of the following perimenopausal or postmenopausal signs and symptoms as defined by the Stages of Reproductive Aging Workshop (STRAW) Early Menopausal Transition (Stage -2): Variable cycle length >7 days different from normal Late Menopausal Transition (Stage -1) : > 2 skipped cycles and an interval of amenorrhea > 60 days Post Menopause (Stage +1): Amenorrhea for at least 12 months Surgical Post Menopause Hysterectomized women with one or both ovaries preserved will be eligible if FSH levels > 20 IU/L If on hormonal therapy, history of menstrual-cycle abnormalities consistent with any of 2a-2e above indicating peri-/postmenopausal status prior to initiation of hormonal therapy One or both the following insomnia symptoms for \u00b3 3 nights per week for at least one month prior to study enrollment Difficulty initiating sleep (\u00b3 30 minutes) According to M.I.N.I (Mini International Neuropsychiatric Interview), subject meets current or past for past 3 months Major Depression Dysthymia Panic disorder PTSD (Post-Traumatic Stress Disorder) According to M.I.N.I, subject has no evidence of current suicidal ideation, homicidal ideation, or psychotic symptoms at screening visit Suicide attempt in the past 5 years According to M.I.N.I, subject meets for substance use disorder diagnosis within the past 5 years Subject has current or recent use (in the past month and used > 25% of time) of hypnotic agents Subject is on an antidepressant or hormone therapy in past 2 months. (Unless they are taking currently and have had a stable dose for \u2265 2 months)", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 20.0-999.0, All Dysmenorrhea Patients aged 20 years or older at obtaining informed consent Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment Patients with ovarian chocolate cysts Patients with fibroid needed to be treated Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer Patients with undiagnosed abnormal vaginal bleeding Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases Patients aged 35 years or older who smoke at least 15 cigarettes per day Patients with migraine accompanied by prodromata Patients with pulmonary hypertension or valvular heart disease Patients who are regularly taking nutritional products that contain St. John's Wort Patients who underwent surgical treatment for endometriosis within 2 months prior to screening", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-45.0, All Bipolar Disorder Ages 18-45 Bipolar Disorder (BD) I or II (DSM-IV criteria) must agrees to communication between PI and Psychiatrist Healthy Control without Past or Current Major Depression, Psychotic Disorder, premenstrual syndrome or Premenstrual Dysphoric Disorder 31day menstrual cycles Minimum 6 menstrual cycles per year Current DSM-IV Alcohol or Substance Abuse/Dependence Pregnancy Chronic Anovulation (<4 menstrual cycles/yr) Menopause (< 1menses in 1yr) Active thyroid disease Hormonal Contraception", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 20.0-45.0, All Breast Pain Premenstrual mastalgia Age 20-45 years Reliable non-hormonal contraception Pregnancy Breast cancer or uterine corpus cancer Unexplained menstrual disorders Serious health problems Hormonal contraception, including hormonal IUD trade name Mirena Oestrogen and/or progestin treatment Hysterectomy and/or oophorectomy or radiation therapy Artificial cardiac pacemaker/metallic prostheses", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 6.0-18.0, All ADHD Trichotillomania DSM-IV Diagnosis of trichotillomania DSM-IV diagnosis of ADHD Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to entering the study History of moderate or severe adverse event, related to MPH History of any psychotic disorder Current drug abuse, acute psychotic or affective disorder", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-999.0, All Metrorrhagia Women age 18 or older who are initiating Depo-Provera for contraception English or Spanish-speaking Have a negative urine pregnancy test Contraindications to either Depo-Provera or Femring (estrogen vaginal ring) Have used Depo-Provera or Mirena in the prior 6 months Have had an induced abortion, spontaneous abortion, or birth in prior 8 weeks", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-48.0, All Premenstrual Syndrome Meets DSM-IV for PMDD by history Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry Willing to use barrier methods of birth control during the study if sexually active If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry Suicide attempt or severe suicidal ideation within the 2 years prior to study entry History of any psychotic disorder or bipolar disorder Substance abuse, except nicotine, within the 6 months prior to study entry Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry Use of sleeping pills more than once per week Consumption of more than 50 ounces of alcohol per week Pregnant or breastfeeding Hepatic, renal, autoimmune, or chronic inflammatory disease", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-45.0, All Premenstrual Syndrome Depression Women who are non-smokers between the ages of 18-45 years (smokers 18-34 years) Regular menstrual cycles (26-34 days in length, predictable within 7 days) for the past 6 months Determination that the antidepressant medication was initiated for the treatment of unipolar major depression, minor depression (depression, not otherwise specified), or dysthymia. Major depression and dysthymia will be evaluated through administration of the Mini-International Neuropsychiatric Interview (MINI). Minor depression will be evaluated by administration of the Structured Clinical Interview for Diagnosis-IV(SCID)10 section J.3 Use of an antidepressant for at least 3 months for treatment of a depressive disorder, with stable dose for at least 2 months. It is acceptable to be on more than one psychiatric medication as long as one of them is an antidepressant Expected continued use of the same antidepressant at the same dose for the duration of the study 30% increase of the mid-follicular phase Montgomery-\u00c5sberg Depression Rating Scale (MADRS) score to the late-luteal phase MADRS will be required for during the tracking phase of the study and will be assessed prospectively over 1 menstrual cycle Normal pelvic exam and PAP smear in the past 12 months Normal TSH at screen if on thyroid medication, must be on a stable dose for 2 months or greater, and have a normal TSH at screen Negative serum HCG at baseline, and negative urine HCG at visits 3 and 5 Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5) Current cigarette smoking in women who are older than 34 years Presence of any of the following psychiatric and substance use disorders, based on administration of the MINI at the baseline study visit Any history of mania or hypomania suggesting bipolar disorder Any lifetime history of a psychotic disorder Depression deemed by the physician investigator to be too severe to be treated in the study Use of benzodiazepines or antipsychotic to target premenstrual symptoms Luteal-phase dose adjustment of the antidepressant. Use of a hormone releasing IUD (intrauterine device) Use of an OCP or other systemic hormonal therapies (oral, transdermal or injection preparations of androgens, estrogens, or progestins) in the past 2 months Any contraindication or previous adverse event to any OCP therapy", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-50.0, All Contraception Signed and dated informed consent Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1 Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction) Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment) Body mass index (BMI) >32 kg/m2 Hypersensitivity to any of the study drug ingredients Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules Safety relevant laboratory values, provided by the central laboratory, outside range before start of treatment Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise) Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Any disease or condition that may worsen under hormonal treatment Undiagnosed abnormal genital bleeding Abuse of alcohol, drugs, or medicines (eg, laxatives)", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-45.0, All Contraception Bleeding Must be of reproductive age from 18 to 45 years Must be choosing LNG-IUC for contraception Must be English-speaking Be willing to avoid additional use of exogenous hormones, such as oral contraceptives, for the duration of the study Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as ibuprofen or aspirin for the duration of the study Be willing to comply with the study protocol, keep the bleeding diary and comply with follow-up visits and telephone interviews as scheduled Be willing and able to provide informed consent Known or suspected pregnancy Contraindication to estrogen use, such as presence or history of venous thromboembolism Arterial thrombosis Thrombophilia disorders, or known family history of Hypertension Migraine headaches with aura or focal neurologic involvement, or any migraine over age 35 years Recent or planned future major surgery which will result in prolonged immobilization during the study period Presence or history of severe hepatic disease or liver tumors Known or suspected estrogen-dependent neoplasm", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-45.0, All Endometriosis Infertility Chronic Pelvic Pain Tubal Ligation A patient who meets all of the following is eligible for the study Premenopausal female 18 to 45 years of age Attending for her first diagnostic laparoscopy or for laparoscopy for tubal sterilisation Has no previous history of endometriosis diagnosis through surgery A patient who meets any of the following is ineligible for the study Already has a surgically-confirmed diagnosis of endometriosis Aged less than18 or greater than 45 Aged 18-45 but post-menopausal", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 0.0-999.0, All Achalasia Alacrima early age onset primary achalasia patient less than 35 years old secondary achalasia patients", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 20.0-45.0, All Premenstrual Syndrome Person is over the age of 20 but not older than age 45 Person is willing to participate as evidenced by signing the written informed consent form Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity) Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities At least one of the PMS symptoms interfere with relationships with others i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms Pregnant or lactating woman Oral contraceptives during last three months, including hormonal IUD (trade name mirena) Serious health problems Unexplained menstrual disorders Treated by hormones (estrogen and progesterone) For healthy: Irregular or abnormal test results", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-40.0, All Contraception Healthy female subjects in need for contraception will be selected to participate in the trial Each subject must be >=18 to <=40 years of age at screening and in need for contraception Each subject must have given birth to at least one child (gestational age >=28 weeks) Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri A subject must not be pregnant or suspected to be pregnant A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis A subject must not have a history or presence of any malignancy A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism) A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of >=3 times the upper normal limit A subject must not have congenital or acquired malformations or distortions of the uterus or cervix A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator A subject must not have vaginal bleeding of undiagnosed etiology A subject must not have dysmenorrhea interfering with daily activities or menorrhagia", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension age 18 years or older stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg ability to provide written informed consent severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8% known severe or malignant retinopathy hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5 acute or chronic inflammatory status need to treatment need to additional antihypertensive drugs during the study need to concomitant medications known to affect blood pressure during the study", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 40.0-60.0, All Hot Flushes Menopause, Premature Obesity Vitamin D Deficiency Women in late menopausal transition or early menopause Age 40-55 BMI >25 kg/m2 Suffer from menopausal symptoms Change in previously regular cycles consisting of at least \u22652 skipped cycles and an interval of amenorrhea (\u226560 days) in the last year Negative pregnancy test Vitamin D insufficiency (<30 ng/ml) Weight stability (+/ ) for 3 months No period for >12 months Hormone use (i.e. menopausal hormone therapy, oral contraceptive, other hormonal medications) in last 3 months History of hysterectomy more than 11 months ago Abnormal screening blood tests (i.e. elevated serum calcium level, elevated creatinine) History of medical conditions where Vitamin D supplementation is not indicated (i.e. chronic renal insufficiency, elevated calcium, sarcoidosis or other granulomatous disease, lymphoma, or tuberculosis History of osteoporosis or osteoporosis on baseline DXA (expect less than 4% of screened population)84 Vitamin D deficiency (<10 ng/ml) as we felt it was unethical to withhold supplementation for 12 months in severe deficiency (according to our KPNW survey, this will <2% of population) Consuming more than 400 IU of Vitamin D supplementation daily (we felt such doses taken outside of the study design could confound results) Current smoker (within the last year) Taking medications that affect body weight", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-45.0, All Uterine Hemorrhage Signed and dated informed consent Healthy female subjects requesting contraception Age: 18 years inclusive Successful interval insertion of History of regular cyclic menstrual periods Normal or clinically insignificant cervical smear not requiring further follow up Pregnancy or lactation Climacteric symptoms prior to the screening visit Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study Undiagnosed abnormal genital bleeding Current or history of thrombembolic disease, or established risk factors for venous thromboembolism Current migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, or exceptionally severe headaches Hypersensitivity to any ingredient of the investigational medicinal products or the non-investigational medicinal product Daily or frequent use of a nonsteroidal anti-inflammatory drug (NSAIDs) for any condition Not willing to use nonsteroidal anti-inflammatory drug (NSAIDs) medication as pain medication during the double blind treatment period", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-40.0, All Healthy Middle-aged Subjects Age Range Was 18 to 31 Years Caucasian Whites Males and Females healthy middle-aged subjects volunteers with systemic or ocular diseases", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-45.0, All Cyclic Mastodynia Premenstrual Syndrome Females aged 18 to 45 who have signed an Informed Consent Form (ICF) at screening visit S-2 (screening visit -2) at the latest Subject has a history of cyclic mastodynia and premenstrual syndrome Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2 At screening visit S-2 subject is reporting at least one physical premenstrual syndrome symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list At screening visit S-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list In both run-in cycles Visual analog scale greater or equal 50 mm at least on one of the days of the late luteal phase Cyclic course of the mastodynia, i.e. visual analog scale in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the visual analog scale in the late luteal phase (maximum value of 5 daily recordings) Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1) At least one physical premenstrual syndrome symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present Pre Menstrual Dysphoric Disorder Intake of any of the following medications before treatment start (visit S-2 up to visit V0) and within 6 months prior to visit S-2 Any treatment for mastodynia or premenstrual complaints Sexual hormones, combinations and inhibitors Pituitary hormones and their inhibitors Hypothalamic hormones Neuroleptics, antidepressants Serotonin-re-uptake-inhibitors Prolactin-inhibitors or prolactin stimulating preparations", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-44.0, All Infertility infertile females with preserved gonadal function ages 18 years old included first oocyte donation cycle BMI: > 28 recurrent miscarriages (3 or more) recurrent of implantation failure severe male factor important miomas > 44 years old Problems with the drugs used in the study", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 45.0-55.0, All Perimenopausal Depression Females who are currently physically well and between 45 and 55 years of age Current DSM-IV diagnosis of depression disorder Able to give informed consent Perimenopausal as determined by symptom profile on the Stages of Reproductive Aging Workshop and gonadal hormonal profile Known abnormalities in the hypothalamic-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal Pap smear results in the previous 2 years Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; or the presence of illness causing immobilisation Patients receiving treatment for depression including antidepressant medications, electroconvulsive therapy (ECT) / Transcranial Magnetic Stimulation (TMS), formal psychotherapy or counselling, within the past 6 months Patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment Patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet Pregnancy / Lactation Smoking cigarettes and other nicotine products illicit drug use and more than 3 standard drinks per day", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-999.0, All Uterine Fibroids Age>18 years Premenopausal Symptomatic fibroids Fibroids accessible for focused ultrasound treatment Desires future fertility Current pregnancy Hematocrit <30% Emergency room visit in last 3 months for fibroid symptoms History of venous thromboembolism Fibroids that are: >10cm, non-enhancing with contrast Adenomyosis Contraindications to undergoing MRI Unexplained menstrual irregularity", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 20.0-40.0, All Endometriosis for patients with endometriosis Female patients with ovarian endometriosis, peritoneal and recto-vaginal Aged between 20 and 40 Signing of informed consent for collection and storage of biological samples Contraindications for endometrial biopsy Failure to sign informed consent for collection and storage of biological samples", "label": "2"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 0.0-21.0, All Menorrhagia Menstruating females with menorrhagia or menometrorrhagia referred to hematology or gynecology clinics at Texas Childrens Hospital. Menorrhagia is defined as regular periods with heavy menstrual bleeding with a PBAC score greater than 100; menometrorrhagia is heavy vaginal bleeding occurring at irregular intervals PBAC Score greater than 100 for 2 consecutive cycles Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12 months prior to study participation Normal external genitalia examination within 6 months prior to study participation Normal thyroid stimulating hormone (TSH) in the last 6 months prior to study participation Negative urine or serum pregnancy test within 4 weeks prior to study participation Presence of intra uterine device Presence of a diagnosed bleeding disorder based on the standard work-up including complete blood count (CBC), prothrombin time, partial thromboplastin time, fibrinogen, von Willebrand panel and platelet function analysis (PFA-100) or platelet aggregation Intake of medications with increased risk of bleeding Taking herbal products Sexually active status Body weight less than 40 kg", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-35.0, All Copper Intrauterine Device Induced Bleeding Regularly menstruating women before CIUD insertion Age between 18 and 35 years Hormonal treatment has not been taken at least two months before the study Non steroidal anti-inflammatory drugs has not been taken 24 hours before the examination Pregnancy The presence of pelvic pathology as ovarian cysts, pelvic endometriosis, endometrial polyps or fibrosis Present or past history of pelvic inflammatory disease Patients on hormonal treatment in the last two months before the study Patients on non steroidal anti-inflammatory drugs last 24 hours before the examination", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-55.0, All Uterine Fibroids Women, age between 18 and 55 years Weight < 140 kg Pre or peri-menopausal Uterine size < 24 weeks Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue Fibroids selected for treatment meeting the following Total planned ablation volume of all fibroids should not exceed 250 ml, and No more than 5 fibroids should be planned for ablation, and Dominant fibroid (diameter) is greater than or equal to 3 cm, and Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis) Desire for future pregnancy Significant systemic disease, even if controlled Positive pregnancy test Hematocrit < 25% Extensive scarring along anterior lower abdominal wall (> 50% of area) Surgical clips in the direct path of the HIFU beam MRI contraindicated MRI contrast agent contraindicated Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 20.0-45.0, All Adenomyosis Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis Planning for birth spacing for at least 2 years Patient aged between 20-45 years old Ultrasonographic and Doppler examination suggestive of adenomyosis Living in a nearby area to make follow-up reasonably possible Pregnancy Evidence of defective coagulation History or evidence of malignancy Hyperplasia in the endometrial biopsy Incidental adnexal abnormality on ultrasound Contraindications to COCs Absolute contraindication of LNG-IUS insertion Previous endometrial ablation or resection Uninvestigated postcoital bleeding Untreated abnormal cervical cytology", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 21.0-999.0, All Uterine Fibroids Premenopausal (at least 1 menstrual period in last 3 months) Age >21years Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia Desires surgical management of fibroids Uterus \u226416 weeks in size All fibroids \u2264 10cm in maximum diameter by ultrasound or MRI assessment within the last year Total number of fibroids \u22646 by ultrasound or MRI assessment within the last year. (For this study \"Fibroids\" will be leiomyomas > 2cm) Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding) Able to tolerate laparoscopic surgery Planned treatment for infertility Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid) Intracavitary (FIGO Type 0) fibroid Symptomatic fibroids are only FIGO Type 1 (submucosal with \u2265 50% intracavitary) Planned concomitant surgical procedure in addition to treatment of uterine fibroids Use of Essure or any other metallic, implantable device within pelvis Pregnancy Pelvic infection with the last 3 months History of pelvic malignancy and/or pelvic radiation Known or high suspicion for dense pelvic adhesions", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-60.0, All Low Back Pain Symptom of low back pain during last 4 weeks Low back pain history for more than 3 months Have lower limbs radiating pain beyond knee joints Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases Spinal surgical history Severe heart, lung, liver, kidney disease or high blood pressure With cardiac pacemaker Coagulopathy or thrombosis Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months Mental illnesses or none cooperation Pregnancy", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-999.0, All Uterine Leiomyomas Fibroids Uterine Fibroids Myomas Able and willing to give consent Age 18 or older Presence of known uterine leiomyoma Suspected malignancy", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-35.0, All Endometriosis Age 18-35 years of age. Written and signed informed consent by the patient to participate in the study. Patients with regular menses, both ovaries, serum TSH within normal range, body mass index (BMI) <30 kg/m2 with normal sperm analysis of the husband Patients with previous endocrine disorders. Cases in which the cause for infertility was other than endometriosis (except for patients with tubal obstruction, in the control group) Patient with previous surgery for endometriosis", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-38.0, All Endometriosis aged18-38 years clinically diagnosed with endometriosis (Stage I-IV) patient is seeking pain relief from symptoms of endometriosis/ pelvic pain/ dyspareunia/ dysmenorrhea pregnancy or current breastfeeding use of hormonal suppression for symptom control (OCP, progestins, GnRHa) within past 3 months surgical treatment for endometriosis within last 3 months history of renal disease, liver dysfunction, myopathies in the past baseline AST, ALT or creatinine levels that are more than 1.5 times the normal limits current use of medications that may interact with statins (erythromycin, gemfibrosil, antifungals, antiretroviral, other cholesterol lowering drug etc)", "label": "2"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 20.0-45.0, All Adenomyosis Infertility Dysmenorrhea Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms Postmenopausal women Pregnant women Gynaecological cancer GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy Endometriosis Uterine fibroids", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 25.0-50.0, All Adenomyosis Premenopausal women aged 30 years old scheduled for vaginal, abdominal or laparoscopic total hysterectomy one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia junction zone definable postmenopausal women pregnancy gynecological cancer GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy junctional zone not identifiable", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 38.0-52.0, All Adenomyosis females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic pain, menorrhagia, metrorrhagia refusal of the patient to get enrolled in the study", "label": "2"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-37.0, All Deep Endometriosis Stage III Deep Endometriosis Stage IV female patient between 18 and 38 years endometriosis stage III or IV in the AFSr classification laparoscopy included deep endometriosis procedures (adhesiolysis, ureterolysis, cystectomy, resection of bowel, urinary or deep peritoneal endometriosis) written informed consent previous adnexectomy or adnexectomy during surgery", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-90.0, All Constipation diagnosis of constipation according to Roma III complete bowel movements per week <3 total bowel movements per week <6 written informed consent report of loose (mushy) or watery stool in the absence of laxative use ongoing artificial nutrition lactose intolerance chronic inflammatory bowel disease previous abdominal surgery use of anti-cholinergics use of antibiotics in the 6 weeks before baseline visit Radio chemotherapy Cognitive decline (Mini Mental State Examination <27)", "label": "0"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 21.0-999.0, All Leiomyoma Uterine Fibroids \u226521 years old Premenopausal (at least one menses in last 3 months) Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia) Fibroids that are \u22644 in total number or Fibroids that are \u22647 in total number if all fibroids are less than 4cm (40 mm) each Fibroids that are \u22647cm in maximum diameter, on screening imaging, if \u22644 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid >2cm) Up to date in Pap smear screening and surveillance Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy Has primary care provider or gynecologist Agrees not to start new medications/treatments for fibroids during the study Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months Any submucosal fibroid \u22652cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months) Pregnant, lactating, or planning to become pregnant in the next 6 months Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo) History of osteopenia or osteoporosis History of hyperlipidemia Current liver or kidney disease Unable or unwilling to attend 4 study visits Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-38.0, All Endometriosis Patients over 18 years Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014 Patients under 18 years", "label": "1"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-999.0, All Endometriosis Quality of Life Pain Sexuality Anxiety Depression Infertility female >18 years fluent German Cases: diagnosis of endometriosis Control 1: no endometriosis, no chronic pain Control 2: no endometriosis, chronic abdominal/pelvic pain male <18years not fluent in German", "label": "2"} +{"topic": "A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26.", "doc": "eligible ages (years): 18.0-100.0, All Uterine Fibroid Able to give informed consent A type 3 uterine fibroid Sufficient physical condition to undergo deep sedation Waist circumference that allows positioning on the HIFU table top inside the MR bore Contra-indication for MRI scanning according to the hospital guidelines Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR <30 mL/min/1.73 m2) Surgical clips or considerable scar tissue in the HIFU beam path A total of more than ten fibroids Post or peri-menopausal status Fibroid size >10 cm in diameter Patient has an active pelvic infection Patient has an undiagnosed pelvic mass outside the uterus Patient who is not able to tolerate the required stationary prone position during treatment", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.0-17.0, All Guillain-Barre Syndrome ENTRY --Disease Characteristics-- Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure sensory neuropathy; No prior history of GBS Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable to walk 5 meters without assistance); Must not have improvement of one or more disability grades prior to randomization in this study No paresthesias, numbness, or weakness that began more than 14 days before randomization in this study No CNS involvement --Prior/Concurrent Therapy-- Biologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg) Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma) Radiotherapy: Not specified ", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-45.0, All Bacterial Infections Group B Streptococcus This information currently is not available ", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Hypothyroidism Male or female subjects >18 years of age Primary hypothyroidism \u22656 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment Thyroxine dose \u2265100 mcg/day No change in thyroxine dose in past 2 months Serum TSH of 0.1-4.8 mU/L Adequate contraceptive measures for women of childbearing age Major systemic illness affecting quality of life or likely to affect participation in the study Treatment with T3 currently or in past 2 months History of thyroid cancer requiring suppression of TSH secretion by thyroxine Ischaemic heart disease \u2013 previous myocardial infarction, angina or coronary artery revascularisation Renal failure: serum creatinine >135 micromol/L Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range Bony fracture in past 3 months or Paget\u2019s disease of bone Secondary (central) hypothyroidism or hypopituitarism", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 5.0-17.0, All Influenza Healthy children enrolled in the target schools Written informed consent obtained from the child's parent(s) if they agree to participate History of severe hypersensitivity (anaphylactic response) to egg products or previous FluMist FluMist is licensed exclusively for use in healthy individuals age 5-49 years. Therefore children for whom annual receipt of inactivated influenza vaccine for specific medical condition(s) is recommended will not be eligible. These conditions Asthma, other chronic pulmonary diseases, kidney disease, metabolic disease, heart disease, or hemoglobinopathy Immunosuppression of child Severe immunosuppression of a household member Pregnancy Past history of Guillian-Barre Syndrome Aspirin therapy within 1 month prior to FluMist or the anticipated use of aspirin containing products for one month after FluMist administration Administration of any inactivated vaccine within 2 weeks or any live vaccine within 4 weeks prior to receipt of FluMist Received anti-influenza medication in the past 48 hours", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 8.0-17.0, All Hypothyroidism Patients should have clinical and biochemical evidence of hypothyroidism, T4 less than 5.0 ng /dl , fT4 less than 1.0 mcg/dl and TSH of more than 10. Patients with prolonged hypothyroidism should have growth failure and delayed bone age of at least 2 SD from the mean. Patients with short term hypothyroidism should have normal growth velocity and bone age Females 8 to 16 years old Males 9 to 17 years old Patients without any chronic medical conditions Availability of a parent or guardian to attend study visits with the patient and to be actively involved in the patient treatment plan Give written informed consent prior to any study specific screening procedure with the understanding that the patient has the right to withdraw from the study at any time without penalty Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic steroids) Experiencing other health problems/conditions that affect their growth rate such as growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases Patients with any condition that is a contraindication for GH therapy would conditions such as an active tumor, impaired glucose tolerance, neurofibromatosis (worsening of neurofibromatosis), and hypertrophy of tonsils and adenoids with sleep apnea. Contraindications for patients for GNRHa therapy would a severe systemic reaction to GNRHa which is rare, osteopenia, and osteoporosis, because delaying puberty will worsen the condition Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist Patient is not willing to continue with the study. -", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.0-0.192, All Congenital Chylothorax Infants with congenital chylothorax requiring thorax drain ", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.0-999.0, All Hypothyroidism Defined group of women who tested positive for post partum thyroiditis in 1985 Control group randomly picked from those who tested negative ", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-64.0, All Influenza Healthy Adults Previous vaccination with an influenza Vaccine containing the H5N1 strain History of clinically significant medical conditions History of Guillian-Barre Syndrome or active Neurological disease", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Advanced Cancer Patient with drowsiness/sedation caused by opiate for > 3 days and its intensity more or equal to 3/10 (0 to 10 scale; 0 = no sedation, 10=worst possible sedation) Patient receiving a regular dose of a strong opioid for the treatment of cancer pain, and no dose changes or dose change within 50% for at least 48 hours.Regular administration, defined as short acting opioids oral or parenteral every 4 hours around clock, slow release oral opioids every 12 hs or 24 hs, or transdermal opioids every 72 hours. Strong opioids morphine, hydromorphone, methadone, fentanyl, and oxycodone Patient with relatively intact cognition defined by the Mini Mental State Examination according to age and educational level. A score of 24 or above is usually considered normal Patient willing to engage in follow up visit with a nurse by phone on day 2-7 (each day), 11 and 15 of the study and to return for follow up visit on day 8 of treatment. If patient is unable to come to clinic, assessment will be performed through telephone Sexually active females at risk of being pregnant with a negative urine pregnancy test Written consent form signed Patients are 18 years or older Concurrent radiation treatment (defined as 10 or less fractions for a palliative indication) is allowed Concurrent chemotherapy is allowed, if the first two cycles have been well tolerated (defined as no grade 3 or 4 non-hematological toxicity) Major contraindication to donepezil i.e. hypersensitivity to donepezil or piperidine derivatives Patients in whom a major change in opiate dose, analgesia requirements, anesthetic procedures or general anesthetic is expected over the next seven days Treatment with anti-cholinergic agents (i.e., glycopyrrolate) Patients taking Methylphenidate Patients with tube feeding (due to difficulty of accurate assessing some of the symptoms such as appetite and anorexia) History of ongoing arrhythmia causing a rhythm other than a sinus rhythm", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-90.0, All Dry Eye Syndromes Signed and dated informed consent Male or female aged from 18 to 90 years old Known treated bilateral dry eye Dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine green staining, BUT and Schirmer, performed within the last 12 months before Visit, for both eyes Bilateral symptomatology suggestive of dry eye defined by: at least one of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and Questioning on patient\u2019s feeling (score >=3) Fulfilling the following of dry eye syndrome in both eyes defined by: Keratoconjunctivitis defined by a lissamine green score \u2265 4 (Van Bijsterveld score) and Schirmer test <= 10 mm in 5 min or BUT < 10 s severe dry eye symptom eyelid dysfunction severe progressive rosacea any relevant ocular anomaly interfering with ocular surface best corrected far visual acuity <= 1/10 history of ocular allergy traumatism, infection, inflammation within last 3 months ocular surgery and laser within the last 3 months lasik, laser, PKR within the last 12 months contact lenses", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-75.0, All Secondary Hypothyroidism Hypopituitarism Hyperlipidemias hypopituitarism of at least 3 axes (TSH plus gonadotropin, somatotropin, corticotropin or ADH deficiency) termination of surgical or radiation treatment of pituitary tumors at least six month before study entry BMI of 20 9 kg/m2 non-smoking status history of cardiovascular or pulmonary diseases current thyroxin dosage > 1.6 \u00b5g/kg bw pregnancy epilepsy cerebrovascular diseases nodular goiter", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 20.0-999.0, All Neoplasms, Gastrointestinal Tract Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject is provided in the Investigator's Brochure (IB) Pilot Part Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following Signed informed consent Male or female; \u2265 20 years (at the time of giving consent) Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of \u226550% required if normal range of LVEF is not provided by institution) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Able to swallow and retain oral medication Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study Subjects meeting any of the following must not be enrolled in the study Pregnant or lactating female at anytime during the study Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2) Peripheral neuropathy of Grade 2 or greater Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety Life threatening infection Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.0-999.0, All Congenital Hypothyroidism Patients with congenital hypothyroidism due to thyroglobulin defective synthesis Patients with another disease", "label": "1"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Hypothyroidism Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis Healthy controls matched regarding sex, age and body mass index Pregnancy, breastfeeding", "label": "1"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 23.0-73.0, All Iron Deficiency Anemia Subclinical Hypothyroidism Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism Must be able to swallow tablets Multifactorial anemia or anemia due to other reasons Iron deficiency anemia requiring urgent intervention cardiac ischemia, severe anemia, GI or GU losses due to malignancy and or acute/subacute big loses by respiratory, G\u0130, GU, etc. system Prior thyroid disorder and/or treatment history Presence of any other co-morbid disease like renal insufficiency/ failure, coronary heart disease, hypertension, diabetes mellitus, any endocrine system disease other than subclinical hypothyroidism", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 20.0-90.0, All Thyroid Nodule age between 20 to 90 years old Benign nodular goiter diagnosed with thyroid echo and fine-needle aspiration cytology Age younger than 20 or older than 90 years old Pregnancy Allergy to eltroxin Taking other drugs which will have drug interaction with eltroxin patients with cardiovascular disease, hypertension, gastrointestinal disease", "label": "1"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.0-0.077, All Hypothyroxinemia Birth weight: less than 1500g Gestation: 22 weeks 0 day \u2264 Serum free thyroxine level lower than 0.8 ng/dl Serum thyrotropin lower than 10 \u03bcU/ml Age of between 2 and 4 weeks after birth Informed consent any known thyroid disease in mother", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 2.0-6.0, All Gram Positive Infection Concurrent Antibiotic Treatment Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care Male or female between the ages of 2 and 6 years old, inclusive Able to comply with the protocol for the duration of the study Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy A calculated creatinine clearance rate (CLcr) \u2265 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1 Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry Known allergy/ hypersensitivity to daptomycin History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency Pneumonia as sole Gram-positive infection being treated with standard antibiotics Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator Administration of rifampin within 7 days of study drug administration Body mass index (BMI) that is outside of the 5th to 95th percentile Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator) History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-48.0, All Hypothyroidism Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones Peri and postmenopause Pregnancy Major comorbidity Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 17.0-44.0, All Hypothyroidism TSH value >98th centile in early pregnancy Women with known hypothyroidism", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-80.0, All Schizophrenia Schizoaffective Disorder Weight Gain non-diabetic schizophrenic or schizoaffective currently prescribed olanzapine or ziprasidone 80 y.o <18 or >80 years of age diabetic not schizophrenic or schizoaffective not currently prescribed olanzapine or ziprasidone", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-80.0, All Depression Age 18 Written informed consent Current MDD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) Recently started to receive or about to start receiving treatment for MDD Quick Inventory of Depressive Symptomatology Clinician-Rated (QIDS-C) and QIDS-IVR scores equal or greater than 10 at baseline visit Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months History or current diagnosis of dementia Diagnosis or history of hypothyroidism", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-70.0, All Arthroplasty, Replacement, Knee Scheduled for total knee replacement or revision of total knee replacement Agree to have a regional technique including neuraxial analgesia for post-operative analgesia Be 18 to 70 years old Classified as ASA score I-III Allergic to morphine Allergic to local anesthetics Been on opioids for more than 4 weeks Not willing to be randomized On anticoagulation medications that prevent placement of epidural Sensitive to effects of neuraxial opioids BMI>35 Severe COPD Obstructive sleep apnea (OSA, see below). Each patient will be asked the questions below to determine their risk for OSA (STOP questionnaire). Patients who answer yes to 3 or more of the major of the STOP questionnaire and have one of the minor will be excluded from the study STOP Questionnaire for OSA", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 4.0-18.0, All Chronic Constipation Less than 2 per week defecation Fecal incontinence Retentive behavior Pain at defecation and Hard stools Medication use (calcium, antacid, diuretic and hematinic) Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental delay neuropsychomotor, kidney disease and metabolic diseases)", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 60.0-95.0, All Subclinical Hypothyroidism TSH between 4 and 10 mUI/L inclusive Known and treatment of thyroideal disease Arrythmia Anticoagulant treatment Dementia Disease leading to dementia (acv, LIVER....)", "label": "1"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-65.0, All Fibromyalgia Female volunteers who have been diagnosed with fibromyalgia by a rheumatologist Overall body pain average score \u2265 4 Age range: 18 to 65 years old You must be on stable doses of anyone of these fibromyalgia-related medications for at least 4 weeks: cyclobenzaprine, tramadol, gabapentin, pregabalin, amitriptyline, nortriptyline, trazodone, sertraline, fluoxetine, paxil, remeron, venlafaxine and duloxetine Willingness to restrict any change (add or switch or change in the dose) of any fibromyalgia-related medication for 12 weeks Volunteers who have long-standing history of diabetes (> 2 years), or have been diagnosed with any type of peripheral neuropathy Have a prior history of myocardial infarction (heart attack) or unstable angina or other heart arrhythmias Have been diagnosed with multiple sclerosis or any other demyelinating disorder Have planned to undergo an elective surgery over the next 12 weeks Have other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease) Are currently pregnant or actively trying to become pregnant", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 12.0-65.0, All Vitiligo Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo Body surface area (BSA) involvement \u2265 3% Unable to consent Any topical, systemic or phototherapy for Vitiligo in the previous 2 months Pregnancy, breast feeding Liver or kidney disease Epilepsy Bleeding disorder or anticoagulant treatment", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Anemia years or older Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome karyotype except del 5q[31] Anemia that requires red blood cell transfusions Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level > 500 mU/mL Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \u2264 2 Must agree to follow pregnancy precautions as required by the protocol Must agree to receive counseling related to teratogenic and other risks of lenalidomide Must agree not to donate blood or semen Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or deoxyribonucleic acid (DNA) modulation agents Allergic reaction to thalidomide Renal insufficiency creatinine clearance (CrC1)<40 mL/min by Cockcroft-Gault method) Prior history of cancer, other than MDS, unless the subject has been free of the disease for \u2265 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed) Absolute neutrophil count (ANC) < 500/uL Platelets < 50,000/uL Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3X upper limit of normal Uncontrolled hyperthyroidism or hypothyroidism Significant neuropathy Prior stem cell transplantation", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Neuropathy Men and women, ages of 18 or greater Documented evidence of HIV-1 infection Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain Pain starts in the feet Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9 Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 21.0-85.0, All Cerebral Stroke Ischemic or hemorrhagic stroke greater than 3 months prior Residual hemiparetic gait with observable asymmetry in the gait pattern Women or men aged 21 to 85 years Completed all conventional physical therapy Adequate language and neurocognitive function to participate in training, testing, and to give informed consent Minimal ankle flexion in either direction (dorsi or plantar-) MMSE score < 23 (9th grade education or more) or MMSE score < 17 (8th grade education or less) CES-D score > 16 Clinical history of orthopedic, chronic pain or severe neuromuscular disorders restricting participation in a short term ankle movement training paradigm Severe or global receptive aphasia which confounds reliable testing and training Women of child-bearing potential, if there is any self-reported chance that they may be pregnant", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 65.0-999.0, All Acute Myeloid Leukemia Diagnosis of one of the following Newly diagnosed de novo acute myeloid leukemia (AML) AML secondary to myelodysplastic syndromes (MDS) AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years Bone marrow blasts >30% Age \u2265 65 years Easter Cooperative Oncology Group (ECOG) 0-2 Previous cytotoxic or biologic treatment for AML (except hydroxyurea) Previous treatment with azacitidine, decitabine or cytarabine Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors) AML French American British subtype (FAB M3) AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes Prior bone marrow or stem cell transplantation Candidate for allogeneic bone marrow or stem cell transplant Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, \"in-situ\" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure) Malignant hepatic tumors Uncontrolled systemic infection", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 40.0-80.0, All Macular Degeneration for subjects will be a clear diagnosis of Age-related Macular Degeneration (AMD) for controls will be less than five small (< 63 um) hard drusen At least a 20/40 view of the fundus The ability to provide a blood sample, and the absence of listed We will individuals with ocular diseases that might simulate Age-related Macular Dengeration (AMD) or preclude its diagnosis Those might prior laser photocoagulation, cryopexy, media opacity, and inflammatory diseases It is important for potential control subjects not to exhibit media opacity (e.g., cataract), which will prevent visualization of the macula Also, subjects will be excluded if they exhibit diseases that phenotypically overlap with Age-related Macular Degeneration (AMD) such as drusen or pigmentary disturbance of the retinal pigment epithelium (RPE), or that provided insufficient evidence to diagnose Age-related Macular Degeneration (AMD) In addition, subjects with pattern dystrophies, toxoplasmosis, histoplasmosis, degenerative myopia, central serous chorioretinopathy, or any disease or treatment that would diminish the ability to recognize drusen such as laser photocoagulation, prior retinal detachment surgery, posterior uveitis, and trauma will be excluded", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 35.0-60.0, All Hypothyroidism Recently diagnosed hypothyroid subject (either during the period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor Subject, who has given his/her oral consent for participation Subject included in clinical trial or having participated in a clinical trial during the last 3 months Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) All contraindications to L\u00e9vothyrox", "label": "2"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.538-0.712, All Nursing Care Preterm Infant were included according with the Official Mexican Norm -007-SSA2-1993 (1995) Preterm Infant were not included in case of malformations that involved lost of the cutaneous integrity or in case of severe cardiac congenital disease", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-49.0, All Phase 1 Safety Study of GelVac\u2122 Nasal Powder H5N1 Influenza Vaccine. able to read and sign Informed Consent Form (ICF) male or female > 18 and < 49 years of age at the time the ICF is signed generally healthy, as determined by medical history and clinical assessment able to attend all scheduled visits and to comply with all trial procedures if female of child-bearing potential, use of an acceptable method of contraception or abstinence for at least 4 weeks prior to the first vaccination through at least four weeks after the second vaccination. Acceptable methods are hormonal birth control or a barrier method with spermicide if female, post menopausal (no menstrual period within the last 12 months), surgically sterile (hysterectomy or tubal ligation), or have a negative urine pregnancy test within 24 hours prior to the time of vaccination has a known allergy to fruits (e.g., apples, oranges) or pectin and/or pectin by-products (including jams or jellies) has a known allergy to dairy/milk products/lactose is breast-feeding or pregnant or planning on becoming pregnant within 1 month of vaccination has a history of a chronic viral infection (i.e.; Shingles, Herpes Zoster, HIV) has a history of severe allergic reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances has a history of demyelinating disease (esp. Guillian-Barre Syndrome) history of Bell's Palsy immunosuppression as a result of underlying illness or treatment use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 \u00b5g/day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination use of other immunosuppressive or cytotoxic drugs or radiation therapy within six months prior to vaccination", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.0-5.0, All Hypothyroxinemia Gestational age < 32 WG FT4 (5, 6 or 7 days of life) \u2264 0.8 ng/dL TSH (5, 6 or 7 days of life) < 20 mIU/L Written consent from the parents Maternal thyroid disease FT4 (5, 6 or 7 days of life) > 0.8 ng/dL TSH (5, 6 or 7 days of life) > 20 mIU/L Grade III or IV intracerebral hemorrhage", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-80.0, All Dyslipidemia Patients >18 years old With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c >9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter State of pregnancy, Breast feeding or allergy to levothyroxine", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 3.0-17.0, All Pediatric Solid Organ Transplant Patients Pediatric SOT patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral) Must be at least 6 months after transplant 17 years of age, inclusive Available for duration of study Parent or guardian able to be reached by phone History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein History of Guillian-Barre syndrome Receipt of rituximab within the past one year Rejection treatment with intravenous steroid bolus within 30 days Rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. Alemtuzumab, Muromonab-CD3, etc.) within 90 days Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol Have any condition that the investigator believes may interfere with successful completion of the study History of received 2011-2012 influenza vaccine Pregnant female History of proven influenza disease after September 1, 2011", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.0-999.0, All Hypopituitarism All patients with pituitary hypopituitarism Unavailability of data", "label": "1"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.5-1.5, All Down Syndrome patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21 patient having undergone a cardiac ultrasound not demonstrating any severe heart disease patient aged 6 to 18 months at congenital hypothyroidism hypothyroidism demonstrated by laboratory tests presenting or having presented hyperthyroidism presenting or having presented leukaemia presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis) presenting severe heart disease on cardiac ultrasound, with haemodynamic effects presenting non-controlled cardiac arrhythmia Apgar < 7 to 5 min at birth Gestational age < 245 days (35 weeks)", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-45.0, All Group B Streptococcal Infection pregnant women with positive GBS screening culture at 35-37 weeks of gestation singleton gestation subjects with agreement to abstain from the use of any systemic or intravaginal antibiotic, anti-fungal agents, or any other intravaginal product (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc) throughout the trial period multiple gestations subjects with impaired immunity , diabetes or other significant disease or acute illness that in the investigator's assessment could complicate the evaluation vaginal or systemic antibiotics or antifungal therapy within 2 weeks of the screening visit", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 80.0-999.0, All Hypothyroidism Males and Females aged 80 years or older Diagnosed with hypothyroidism and treated with Levothyroxine for at least 6 months Living independently in the community All TSH results within the range 0.4 U/L in the 3 months before commencing the study Participant has provided written informed consent for participation in the study, prior to any study-specific procedures Established dementia and therefore deemed incapable of providing informed consent Other medical conditions which, inthe opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound) Nursing Homes or Residential Care Home residents Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH Individuals on 25 mcg dailty of LT4: dose reduction will mean that they stop thyroid replacement treatment Non english speaking individuals Participation in any other investigational trials within the last 3 months Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil) Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP)", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-65.0, All Acute Mountain Sickness Healthy adults History of serious illness Current smoker or Hemoglobin >15.5gm/dL Uncontrolled hypertension", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Neoplasms Patients must have biopsy-confirmed non-hematological malignancy Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy Patients must be of age >=18 years Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to influenza vaccination Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document Patients who have already received the influenza vaccine during the season in which they are considered for will be excluded History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless used as part of a chemotherapy regimen Patients must not be on any other agents that can suppress the immune system Planned concurrent therapy with radiation Uncontrolled illness at time of enrollment or influenza vaccination including, but not limited to, ongoing or active febrile illness Psychiatric illness/social situations that would limit compliance with study requirements Known immunosuppression eg. history of organ transplantation or known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because they may not be able to mount an appropriate immune response History of influenza-like illness, defined as a temperature > 37.8 degree C with cough or sore throat starting October 1, 2011 throughout the duration of the study", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-40.0, All Sprain of Lateral Ligament of Ankle Joint age equal or less than 40 years-old, military subject, acute ankle injury, To have completed and signed the informed consent contraindications to cryotherapy ( cold allergy, cryoglobulinemia, Raynaud's phenomenon, cutaneous sensory abnormalities, and diabetes mellitus), paracetamol allergy, 4th grade sprains according to the Trevino Classification (with bone wrenching), to take analgesic or anti-inflammatory treatment other than paracetamol", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Women at Risk of Neonatal Infections Colonize With GBS (Group B Streptococci). Patient having a positive vaginal swab for GBS at the end of pregnancy (PCR +) Patient aged over 18 years Patient who received information and agreeing to sign informed consent Patient affiliated or beneficiary of an insurance Patient does not speak and does not understand French", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-65.0, All Primary Hypothyroidism. Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old Patients scheduled for deployment will be excluded", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 8.0-20.0, All Down Syndrome Subclinical Hypothyroidism Males and females, ages 8 years Diagnosis of Down syndrome Subclinical hypothyroidism: TSH level between 5 mIU/L, normal T4 Parental/guardian permission (informed consent) and if appropriate, child assent Females who are at least 11 years of age or who are menarchal must have a negative urine/serum pregnancy test Committed to adherence to levothyroxine treatment and study completion Pregnancy Type 1/Type 2 diabetes Chronic medical conditions or medication use that can affect growth, nutrition, blood glucose, insulin secretion, or thyroid function (such as lithium or certain seizure medications) Current use of levothyroxine or anti-thyroid hormone Cyanotic congenital heart disease, or pulmonary hypertension (as described by last echo report in subjects with CHD), or congenital heart disease considered medically unstable by the study cardiologists", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Thyroid Cancer Differentiated thyroid cancer treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago TSH < 4 imU/L Pregnancy Known metastasis", "label": "1"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 40.0-75.0, All Hypothyroidism Thyroid Diseases Endocrine System Diseases 75 years old Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months Pregnant or lactating women Severe hepatic or renal dysfunction Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism Obviously poor compliance", "label": "1"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 65.0-999.0, All Subclinical Hypothyroidism Depression Community-dwelling patients aged >= 65 years with subclinical hypothyroidism Written informed consent Subjects currently on Levothyroxine or antithyroid drugs, amiodarone or lithium Recent thyroid surgery or radio-iodine (within 12 months) Grade IV NYHA heart failure Prior clinical diagnosis of dementia Recent hospitalisation for major illness or elective surgery (within 4 weeks) Terminal illness Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Subjects who are participating in ongoing RCTs of therapeutic interventions (including CTIMPs) Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period)", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Celiac Disease Hypothyroidism Celiac Sprue Malabsorption Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease", "label": "2"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 5.0-6.0, All Dental Caries attending kindergarten in one of the participating schools must have parental permission children with severe stomach illness (ex. Crohn's disease, ulcerative colitis, Celiac disease, irritable bowel syndrome, etc.) children with strict dietary restriction (ex. Diabetes)", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 0.0-999.0, All Congenital Hypothyroidism Patient: newborn (0-27 days) or infant (28 days 23 months), or child or adult with congenital hypothyroidism (that is to say with a TSH > 15 mU / ml at screening on filter paper and / or plasma TSH> 10 mU / ml) diagnosed in the first months of life, whatever their age, sex, weight and size Subjects with blood levels of free thyroid hormones (FT3 and FT4) in the standards will be described as having subclinical hypothyroidism If treatment with L-thyroxine could be stopped without relapse (that is to say, always with a TSH <5 mU / ml with different controls), hypothyroidism is said to be transient, whatever the age of discontinuation of treatment No pre or neonatal goitre by palpation or ultrasound thyroid negative perchlorate test (ie decreased rate of iodine captation <10% at 2h injection of perchlorate) when the thyroid gland in place No self-immunity known to thyroid in children with and / or his mother (defined by a antithyroperoxidase antibodies and / or antithyroglobulin) Signature of free and informed consent by the patient or his legal representative Affiliation or enjoying a social security system Presence of markers antithyroid autoimmunity in children and / or mother (antithyroperoxidase antibodies and / or antithyroglobulin) Pre or neonatal goiter on palpation or ultrasound thyroid Test positive perchlorate (ie salting rate of iodine> 10% at 2 injection perchlorate) Patients of foreign origin returned to their country will be excluded from the study", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Gullian Barre Syndrome Patients aged >18 years diagnosed with GBS according to NINDS diagnostic Onset of weakness due to GBS is less than 2 weeks ago Patients who are unable to walk unaided for >10 metres (grade >3 on GBS disability scale) Patients who are being considered for or already on IVIg treatment First dose of eculizumab must be started within 2 weeks from onset of weakness and any time during the IVIg treatment period Signed informed consent Age <18 years Patients who are being considered for, or already on, plasma exchange Pregnancy or lactation Patients show clear clinical evidence of a polyneuropahty caused by e.g. diabetes mellitus (except mild sensory), alcoholism, severe vitamin deficiency, and porphyria Patients received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil, tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month Patients known to have severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS, severe COPD, TB Inability to comply with study related procedures or appointments during 6 months Any condition that in the opinion of the investigator could increase the patient's risk by participating in the study or confound the outcome of the study Related to the administration of eculizumab Unresoled Neisseria meningitidisinfection of history of meningococcal infection Unsuitable for antibiotic prophylaxis (e.g due to allergy) Known hypersensitivity to eculizumab, murine proteins or to any of the excipients Known or suspected hereditary complement deficiencies Women of child-bearing potential who are unwilling to use effective contraception during treatment and for 5 months after treatment is completed", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-80.0, All Constipation To be considered eligible for enrolment into the study, subjects must Be able to give written informed consent Be between 18 and 80 years of age Subject has chronic functional constipation according to the Rome III Diagnostic where (f) is mandatory i. Must two or more of the following Straining during at least 25% of def\u00e6cations Lumpy or hard stools in at least 25% of def\u00e6cations Sensation of incomplete evacuation for at least 25% of def\u00e6cations Sensation of anorectal obstruction / blockage for at least 25% of defaecations Manual man\u0153uvers to facilitate at least 25% of def\u00e6cations (e.g., digital evacuation, support of the pelvic floor) Subjects will be excluded from the study if they meet any of the below criteria Are less than 18 and greater than 80 years of age Females are pregnant, lactating or wish to become pregnant during the study Are hypersensitive to any of the components of the test product Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study Subject has an obstructive or metabolic aetiology for constipation Subject has a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative) Subject has used a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit Subject has a history of drug and/or alcohol abuse at the time of enrolment Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-40.0, All Muscle Injury for control subjects [primary target being Reserve Officer Training Corps (ROTC) personnel]: 1) healthy individuals ages 18-40 years; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion for control subjects (primary target being ROTC personnel): 1) previous history of trauma and/or surgery to the lower extremities that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) diabetes; 4) previous traumatic head injury or post-traumatic stress disorder; 5) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia; and 6) currently performing an exercise program that specifically targets the dorsiflexor muscles for subjects with muscle atrophy: 1) individuals ages 18-40 years with an injury to the lower leg requiring immobilization but no surgical intervention; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion for subjects with muscle atrophy: 1) previous history of trauma and/or surgery to the lower extremities, other than the injury for being immobilized, that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) orthopedic conditions affecting the contralateral, uninvolved lower extremity that may limit function; 4) diabetes; 5) previous traumatic head injury or post-traumatic stress disorder; and 6) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-60.0, All Asthma years of age or older Known Asthma The exacerbation is defined as moderate or severe Not currently enrolled as an active participant in another clinical trial of a medical therapy or device The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy years of age or older Known thyroid disorders Subject where thyrotoxicosis is suspected Known heart disease Heart rate > 140", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 60.0-75.0, All Aging Age 18 to 35 years, or 60 to 75 years Body mass index \u2264 27 kg\u2022m2 Ability to sign informed consent Score of \u226526 for Mini-Mental State Exam Diabetics (plasma glucose concentration >200 mg/dl at 2 hr after oral intake of 75 g glucose) Fasting plasma triacylglycerol concentration above 500 mg/dl Kidney disease Liver disease Bleeding disorders Anaemia (Hb < 13 g/dl in males or < 12 g/dl in females) Endocrine disease (with the exception of well-regulated hypothyroidism) Positive hepatitis or HIV screens Alcohol (CAGE questionnaire; abnormal liver enzyme values) or drug abuse (amphetamines, cocaine, opioids, marijuana) Lipid altering agents", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 60.0-90.0, All Disorder of Aging Aged 60 years; diagnosis of failure / vitamin D, preserved cognitive status, disability accepting participate and are not included in any of the excluded from the study in the elderly using vitamin D supplements; anticonvulsant drugs or for the treatment of HIV / AIDS; diagnosis of type I diabetes mellitus, nephrotic syndrome, acute or chronic renal failure, liver disease, hypothyroidism, hyperthyroidism, history of cerebrovascular accident (CVA) or acute myocardial infarction (AMI) Vascular past 6 months and chronic consumptive diseases, alcoholic or smoker chronic", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-60.0, All Multiple Sclerosis, Secondary Progressive written informed consent obtained with Multiple Sclerosis, and with secondary progressive disease course screening Expanded Disability Status Scale (EDSS) score between 4.0 and 6.5 inclusive screening timed 25 foot walk (average of two trials) lof 9 seconds or more Long QT interval, defined as corrected QT interval of more than 470 msec in men and more than 450 msec in women on baseline ECG Patients with known long-QT syndrome Patients with known ventricular arrhythmia Patients with a known electrolyte disturbance Patients undergoing treatment with drugs that increase the QTc interval Patients undergoing treatment with drugs that inhibit CYP3A4, in particular: Ketoconazole, Fluconazole, Erythromycin, Clarithromycin, Ritonavir Patients with a history of breast cancer or carcinoma in situ Patients with known renal insufficiency Patients with known allergy or other intolerability to domperidone Patients currently using Fampridine or 4-aminopyridine", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 70.0-999.0, All Subclinical Hypothyroidism men and women aged 70 and older TSH between 4.5 and 19.9 mU/L as an outpatient ability to provide informed consent Laboratory Tests TSH <4.5 mU/L or >20 mU/L on repeat testing at least four weeks later or free T4 level outside the reference range thyroid peroxidase (TPO) antibody positive abnormal liver function tests (LFTs >3 x upper limit of normal) hemoglobin <11 g/dL Surgeries or Procedures thyroid surgery pituitary surgery bariatric surgery bowel resection", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-65.0, All Latent Hypothyroidism latent hypothyroidism Factors that Alter Thyroxine and Triiodothyronine Binding in Serum Increased thyroxin-binding globulin Decreased thyroxin-binding globulin Binding inhibitors Inherited Salicylates Pregnancy Androgens Furosemide Neonatal state Anabolic steroids", "label": "1"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-100.0, All Pancreatic Cancer Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas Stage I or II disease Surgically resectable disease (R0 or R1) by spiral CT scan No distant metastases ECOG Performance Status of 0 to 1 Adequate organ function as defined by study-specified laboratory tests Must use acceptable form of birth control Signed informed consent form Willing and able to comply with study procedures Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, psychological or other medical conditions Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), CNS or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis) Patients who have been diagnosed with another cancer in the past 5 years (except for superficial bladder cancer, non-melanoma skin cancers, or a low grade prostate cancer not requiring therapy) Patients who have received therapy for pancreatic cancer Using systemically active steroid use Patients who have known history of infection with HIV, hepatitis B, or hepatitis C Patients on home oxygen Patients with oxygen saturation of <92% on room air by pulse oximetry Pregnant or lactating Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Prostate Cancer Have metastatic castration-resistant prostate cancer Life expectancy of greater than 3 months ECOG performance status 0 or 2 Age \u226518 years Have measurable disease Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator) Ability to take oral medication Patients must have adequate organ and marrow function defined by study-specified laboratory tests Must use acceptable form of birth control while on study Ability to understand and willingness to sign a written informed consent document Known history or evidence of brain metastases Prior chemotherapy for metastatic disease in castration-resistant prostate cancer Had surgery within 4 weeks prior to the first dose of study drug Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug Systemic steroids within 1 weeks prior to the first dose of study drug Had prior enzalutamide, ARN-509, or galeterone therapy Have moderate or severe cardiovascular disease Have a history of a seizure Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-65.0, All Diabetes Mellitus Healthy or treatment naive type 2 diabetes euthyroid subjects, with a micronodular texture of the thyroid gland Recreationally active With stable body weight and diet during the last two months Any systemic disease(besides glucose abnormalities) Any medication therapy Diabetic complications", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-999.0, All Group B Streptococcus Age \u2265 18 years Pregnant women presenting for unplanned obstetrical care at a participating clinical study site Gestational age between 21 6/7 and 36 6/7 weeks Subject has not participated in the study before Subject agrees to complete all aspects of the study and provide informed consent in accordance with applicable regulations Signs and/or symptoms suggestive of preterm labor, whereby the managing clinician suspects preterm labor Uterine contractions (with or without pain) Intermittent lower abdominal pain, dull backache, pelvic pressure Vaginal bleeding during the second and third trimester Menstrual-like intestinal cramping (with or without diarrhea) Exposure to antibiotics within 1 week prior to enrollment (15) Known GBS bacteriuria at the time of enrollment Prior history of neonatal GBS sepsis", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 35.0-79.0, All Osteoarthritis, Knee Planned unilateral TKA done at Verdun Hospital Capacity to communicate in French or English Complications during or after the surgery Inability to perform the tests due to other diseases Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 18.0-40.0, All Streptococcus B Carrier State Complicating Pregnancy Age: 18 to 40 Origin: Arab Gestational age: 34 to 40 Rupture of membranes Women in active labor who has had one or more vaginal examinations", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 50.0-64.0, All Chronic Obstructive Pulmonary Disease for patients with COPD will be Signed informed consent prior to initiation of study-mandated vaccination Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD Patients meeting GOLD Classification of Stage C or Stage D COPD Patients 50 years old years old for Healthy participants will be Signed informed consent prior to initiation of study-mandated vaccination No active symptoms of lung disease FEV1/FVC in the normal range > 70% age predicted value Severe allergy to eggs Severe reaction to past doses of influenza vaccine Guillian-Barre syndrome Currently recieving dialysis Current, active, treatment for cancer History of transplant (allograft) Dementia or Alzheimer's disease diagnosis Prior diagnosis of HIV or AIDS Moderate to severe pulmonary hypertension Serum AST/ALT > 3x the upper limit of normal", "label": "0"} +{"topic": "A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly.", "doc": "eligible ages (years): 17.0-70.0, All Cough chronic cough group cough lasting \u2265 8 weeks,characterized by irritating dry cough sensitive to fumes\uff0cdust,the odorous and cold air with normal chest x-rays. 4.17-70 years old without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result chronic cough group and healty controls group with respiratory tract infection within 8 weeks with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week women during pregnancy or lactation patients with malignant tumours", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-50.0, All HIV Infections Co-existing Condition Patients with the following are excluded Neuropsychological (NP) impairments more severe than described in the Criteria Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections Lymphoma or other tumor requiring cytotoxic chemotherapy Concurrent Medication Excluded Other antiretroviral agents Patients with the following are excluded AIDS or advanced ARC", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All West Nile Virus In order to participate in this clinical trial, all subjects (or legal representative) must provide written informed consent. Only patients meeting entry will be enrolled. Eligible subjects must fall into one of two categories A. Hospitalized patients greater than or equal to 18 years of age with encephalitis and/or myelitis as defined below New neurologic abnormality Asymmetric extremity weakness without sensory abnormality; or Other neurologic abnormality (including altered level of consciousness, dysarthria and dysphagia) plus fever (subjective or objective) within the previous 4 days AND CSF examination within the previous 96 hours showing Absence of organism on gram or fungal stain White blood cell count greater than or equal to 4 per mm(3) corrected for significant red blood cell contamination Ratio of CSF: plasma glucose of greater than or equal to 40% (CSF glucose/plasma glucose greater than or equal to 0.4) Unable to obtain valid informed consent History of intolerance (including anaphylaxis) to IVIg or related compounds Known history of IgA deficiency Known history of hypersensitivity to maltose History of (or at time of study entry) hyperviscosity syndrome including but not limited to Waldenstrom's macroglobulinemia Multiple myeloma Total white blood cell count greater than 80,000/mm(3) Hematocrit greater than 55% Platelet count greater than 700,000/mm(3)", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-50.0, All HIV Infections HIV uninfected At low risk for HIV infection Willing to receive HIV test results Good general health Acceptable methods of contraception for females of reproductive potential Hepatitis B surface antigen negative Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive Meets educational requirements of the study HIV vaccines or placebos in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first study vaccine administration Blood products within 120 days prior to first study vaccine administration Immunoglobulin within 60 days prior to first study vaccine administration Live attenuated vaccines within 30 days prior to first study vaccine administration Investigational research agents within 30 days prior to first study vaccine administration Subunit or killed vaccines within 14 days prior to first study vaccine administration Allergy treatment with antigen injections within 30 days prior to first vaccine administration Current tuberculosis prophylaxis or therapy Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 17.0-65.0, All Spinal Cord Injuries Injured subjects Complete or incomplete acute SCI between C0 and T11 Admitted within 48 hours of injury Undergoing spinal decompressive surgery Undergoing lumbar puncture for spinal anesthetic or myelography Neurologically intact Pre-existing neurodegenerative disorder Associated head or spine injury", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Pneumococcal Meningitis Adults (> 18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit Allergy to one of the antibiotics used in the study", "label": "2"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infections Lymphoma, AIDS-Related Adult (18 years old or older) HIV-infected patient HIV infected by OraQuick rapid test using saliva, venipuncture whole blood, or fingerstick whole blood; or by reactive ELISA and Western Blot as determined by an outside CLIA-approved laboratory facility or by NIH Clinical Pathology Laboratory or SAIC-Frederick Inc Monitoring Laboratory. HIV infection as determined by an outside CLIA-approved laboratory facility will be verified by a standard HIV-1 ELISA with Western Blot confirmation prior to brain biopsy Evidence of contrast-enhancing focal brain lesion(s) as seen on MRI or CT Willingness to give informed consent and provided by Durable Power of Attorney. In the event that no Durable Power of Attorney has been designated and the patient is unable to do so, the NIH Ethics Committee will be consulted. All patients must designate a Durable Power of Attorney in order to participate in the study Willingness to undergo the procedures involved in the diagnostic evaluation: lumbar puncture, FDG-PET scan, 201Tl-SPECT scan, and brain biopsy Permit the storage of blood, CSF, and tissue samples for future research use Willingness to undergo HLA testing Previous PCNSL History of prior malignancy other than PCNSL unless in remission for 1 year or longer; non-melanoma skin cancer and Kaposi's sarcoma excepted History of previous diagnosis of toxoplasmic encephalitis or other CNS infection causing focal contrast-enhancing brain lesions Pregnancy or currently breast feeding Have any other condition that the research team considers a contraindication to participating in the study, e.g. severe cardiac, renal, or pulmonary dysfunction Weight greater than 400 lb for PET and 500 lb for SPECT (limit of the gantry)", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-14.0, All Pneumococcal Meningitis All children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study ", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-64.0, All Back Pain Need a lumbar or cervical myelogram as part of routine care Not needing a myelogram in the cervical or lumbar spine", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 8.0-18.0, All Migrainous Headache Males or Females age 8-18 years Girls 11 years or older must have a negative urine/serum pregnancy test Diagnosis of pediatric migrainous headache. The for pediatric migraine headache based on the most recent ICHD are listed below. The requirement of 5 attacks (A) will not be required for this study, this making the diagnosis migrainous headache. As described elsewhere in the protocol, this change is required to make the study applicable to ED patients who require treatment before five attacks have occurred Evidence that headache is due to a secondary underlying disorder based on history or physical examination Pregnant or lactating females Any investigational drug use within 30 days Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity If patients re-present to the ED, they can not be re-enrolled", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-999.0, All Minor Head Injury Traumatic Brain Injury head injury, nausea, vomiting no head injury", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Cardiac Arrest Arrhythmia Cardiac Arrest Patients 18 years and older with cardiac arrest in the hospital and successfully resuscitated, or with cardiac arrest out of the hospital and successfully resuscitated ICD patients Patients 18 years and older Who are undergoing elective procedure in the electrophysiology laboratory for placement of a cardiac defibrillator and who will most likely undergo induction of ventricular arrhythmia as part of the procedure Cardiac Arrest Cardiac arrest and a known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery CNS infection Skull defects and scalp diseases that are not amenable to standard EEG testing ICD patients Known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery CNS infection Skull defects and scalp diseases that are not amenable to standard EEG testing", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 20.0-65.0, All Post-Traumatic Stress Disorder Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. [2003]) will be used for diagnosis Pathologic condition: Patients who experienced a motor vehicle accident (MVA) with severe or potential severe physical injury more than 3 months ago but less than 12 months ago Patients aged 20 and <65 at the time of signing the Informed consent Male and female patients Inpatient/outpatient status: Both are permitted Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own) Patients whose combined score of the CAPS-SX standard B, C, and D is over 50 Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia [simple phobia], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase) Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD Patients receiving disability payments due to PTSD or other psychiatric diseases Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders Patients who meet the DSM-IV-TR for substance abuse or dependence (alcohol or drugs) within 6 months of Week -4 (start of baseline phase) Patients with history of a suicide attempt within 6 months before Week -4 (start of baseline phase), or have, in the opinion of the investigator, \"C. high risk of suicide\" according to the MINI at Week -4 Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant Patients receiving electro-convulsive therapy (ECT) prior to Week -4 (start of baseline phase) Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase) Patients with a history or complication of manic psychosis", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Chiari Malformation Type I Age >18 years Clinical Diagnosis of Chiari Type I Malformation Radiogrpahic evidence of downward tonsillar herniation (displacement of the lower part of the cerebellum below the level of the skull) Signed Written Informed Consent Presence of Hydrocephalus or previous CSF diversion procedure, such as shunt Prior operation on the posterior cranial fossa Inability to understand the informed consent or unwillingness to participate in the study Inability to return for follow-up evaluation 3 months after the surgery Evidence of spinal dysraphism Allergy or history of allergic reaction to Duragen, Duraguard, or their components Pregnancy as documented by a urine or blood test", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-75.0, All Spinal Procedure Requiring Dura Incision Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria) Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds Active spinal and/or systemic infection Patient requires additional spinal surgery within the study time period Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure Patient has a pre-existing external lumbar CSF drain or internal CSF shunt Patient is participating in a clinical trial of another investigational device or drug Patient with creatinine > 2.0 mg/dL Patient with total bilirubin > 2.5 mg/dL Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation Patient has been treated with chronic steroid therapy (>4 weeks) unless discontinued more than 6 weeks prior to surgery Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or at the time of surgery", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.167-15.0, All Bacterial Meningitis All children aged \u2265 2 months, admitted to Queen Elizabeth Hospital, Blantyre, Malawi, with possible or confirmed acute bacterial meningitis Age less than two months Trauma Relevant underlying illness such as intracranial shunt, previous neurological disease (cerebral palsy, Down's syndrome) Previous permanent hearing loss (not conductive hearing loss) if known Immunosuppression except HIV infection", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-45.0, All Familial Mediterranean Fever Fulfilling the Tel Hashomer for the diagnosis of FMF [5] Suffering from episodes of exertional leg pain and or exertional ankle edema 18-45 years old On a stable (\u2265 2 weeks) dose of oral colchicine therapy Non-smokers with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) Suffering from muscular or neurological diseases not related to FMF With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 3.0-999.0, All Pathological Processes in the Posterior Fossa Dura Defects Preoperative Subjects undergoing elective craniotomy / craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformations, and Chiari 1 malformations) that result in dura defects requiring dura substitution for closure and who are able and willing to comply with the procedures required by the protocol Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures Age >= 3 years, either gender Intraoperative Surgical Wound Classification Class I and Risk Index Category (RIC) <= 2. Penetration of mastoid air cells during partial mastoidectomy is permitted and will be recorded A patch of autologous fascia or pericranium or suturable collagen-based dura substitute was cut to size and then sutured into the dura defect The hem of native dura exposed along and under the craniotomy edge is wide enough to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product Preoperative Female subjects who are breastfeeding, pregnant, or intend to become pregnant during the clinical study period Subjects with a dura lesion from a recent surgery that still has the potential for cerebrospinal fluid (CSF) leakage unless it can be expected that the lesion will be excised completely, including all old suture holes Chemotherapy scheduled within 7 days following surgery Radiation therapy to the head scheduled within 7 days following surgery Subjects with severely altered renal (serum creatinine > 2 mg/dL) and/or hepatic function [ALT, AST > 5 x upper limit of norm (ULN)] Evidence of an infection indicated by any one of the following: fever > 101\u00b0F, white blood cell (WBC) count < 3500/\u03bcL or > 13000/\u03bcL, positive blood culture, positive chest X-ray. A positive urine culture (> 10^5 colony-forming units (CFU)/mL) leads to unless acute cystitis is the sole cause. Evidence of infection along the planned surgical path. A WBC count of < 20000/\u03bcL is permitted if the patient is being treated with steroids in the absence of all the other infection parameters Conditions compromising the immune system; existence of autoimmune disease Known hypersensitivity to aprotinin or other components of the investigational product Non-compliant or insufficient treatment of diabetes mellitus [glycosylated hemoglobin (HbA1c) > 7.5%]", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-75.0, All Elective Cranial Procedures With Dural Incision Patient is between 18 and 75 years of age Patient is scheduled for an elective cranial procedure that entails a dural incision Evidence of intraoperative non-watertight closure ", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 6.0-14.0, All Status Epilepticus Seizures Children presenting convulsing to the pediatric emergency or developing seizure while in casualty Age 6-14 years Known hypersensitivity to any benzodiazepine Child has received any parenteral anti-convulsant within 1 hr prior to enrollment Presence of severe cardio-respiratory compromise or cardiac arrhythmias Presence of upper respiratory tract infection Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Acute Renal Failure SIRS Sepsis Critically Ill Multiple Organ Dysfunction Syndrome Critically ill, postoperative/posttraumatic patients with threatening acute renal failure Life expectancy < 24 hours Participation in other trials Known or suspected pregnancy", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Posttraumatic Stress Disorder Diagnosis of Posttraumatic Stress Disorder Diagnosis of psychosis, drug or alcohol dependency/abuse Unable to fill in questionnaires in Dutch Color blindness (Stroop test)", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-65.0, All Posttraumatic Stress Disorder willingness to participate in a naturalistic treatment study using paliperidone and in two fear conditioning tests, one at baseline and one at the end of the 6 weeks treatment study We will PTSD subjects on medications (possible medications antidepressants, benzodiazepines) who have no or only partial treatment response. Paliperidone will be added to the existing treatment regime which will remain unchanged during the study period. PTSD subjects will have a minimum score of 50 on the Clinician-Administered PTSD Scale (CAPS; Blake et al, 1995) a comorbid diagnosis of bipolar illness, schizophrenia or other psychotic disorders, acute or chronic suicidality, acute or chronic unstable medical conditions (including severely impaired hepatic function as indicated with abnormal PT and PTT, abnormal CBC, and liver enzymes more than 50% above the upper normal range, not well controlled blood pressure) current diagnosis of substance abuse or dependence unsuccessful treatment history with paliperidone known hypersensitivity to paliperidone or any of its inactive ingredients administration of any investigational drug up to 90 days before entry into the study intake of Class 1A (e.g., quinidine, procainamid) or Class III (e.g., amiodaronme, sotalol) antiarrhythmic medications, antipsychotics, antibiotics (e.g., gatifloxacin, moxifloxacin) (up to 90 days before entry into the study or during the study) subjects with a positive screen for drugs of abuse no startle or skin conductance response, or excessively high startle response to the startle probe (100 dB acoustic stimuli) during the pretest", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 16.0-999.0, All Rhinitis, Allergic, Perennial Patients of mongoloid race residing in Japan who satisfy all of the following Patients having symptoms of perennial allergic rhinitis of moderate or severe degree, according to the classification of severity in the guidelines for the treatment of nasal allergy (partial revision) as well as a score of at least 4 in the score of 4 nasal symptoms, at the time of obtaining informed consent and during the pretreatment observation period Patients with a positive skin reaction test or specific IgE antibody quantitation, and with a positive cytological examination of nasal discharge (eosinophils) or nasal challenge test Outpatients who are at least 16 years of age at the time of informed consent obtained Male or female Patients who have the ability to give written informed consent (informed consent of the guardian must also be obtained for patients younger than 20 years) Patients who can keep nasal allergy diary without fail Patients with coexisting tuberculous disease or lower respiratory tract infection, or patients who, at the time of registration, have acute upper respiratory tract infection, acute pharyngitis, acute amygdalitis etc Patients with coexisting infections or systemic mycosis for which there are no effective antibiotics Patients with unhealed nasal septum ulcers, nasal surgery scar, or nasal trauma Patients with a history of hypersensitivity to steroids or mometasone furoate Patients who are pregnant or nursing or who may be pregnant and patients or patients' partners who desire to become pregnant during the study period Patients with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension or other serious coexisting diseases and whose general condition is poor Patients also allergic to pollen and the pollen release season occurs during the study period Patients with vasomotor rhinitis or eosinophilic rhinitis Patients with a nasal condition which may interfere with efficacy evaluation of the investigational product Patients who develop disease affecting nasal symptoms during the pretreatment observation period, i.e., during the 7 days before actual registration", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 16.0-999.0, All Perennial Allergic Rhinitis Patients with perennial allergic rhinitis meeting all of the followings Patients with symptoms of perennial allergic rhinitis, the severity of which is moderate or severer according to the severity grading provided in the \"Guidelines for the Management of Allergic Rhinitis in Japan\" (partly modified) with the 4-nasal symptom score of 4 or over at informed consent and during the pre-treatment observation period Patients with positive reaction to the eosinophil count in nasal discharge or nasal challenge test in addition to the skin test or specific IgE antibody test Outpatients aged 16 years or over at informed consent Patients in either sex Patients (or their legal representatives in case of patients aged under 20 years) capable of giving written informed consent Patients capable of recording nasal allergy diary every day Patients with a complication of tuberculous diseases or lower respiratory tract infections, and those with a complication of otorhinolaryngeal infections(acute upper respiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.) requiring treatments judged by the investigator (subinvestigator) at the time of enrollment to randomization Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available Patients with a complication of recurrent epistaxis Patients with uncured nasal septal ulcer, operated nose or nasal trauma Patients with a history of hypersensitivity to steroids and any ingredients of the study drugs Pregnant, lactating or possibly pregnant patients or the patients who themselves or whose partners wish to become pregnant during the study Patients with severe hepatic or renal disorder, heart or blood disease, diabetes mellitus, hypertension, or other serious complication, suffering from problems with systemic condition Patients who have pollens as multiple allergens and the period from 7 days before enrollment to randomization to completion of the treatment period coincides with the period of scattering of relevant pollens Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis Patients with a complication of a nasal disease (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which may interfere with efficacy evaluation of the study drugs", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All West Nile Neuroinvasive Disease West Nile Virus Infection Encephalitis Meningitis Acute Flaccid Paralysis West Nile Fever Provide written informed consent Be >=18 years of age at the time of enrollment Have West Nile Fever defined as temperature >38\u00b0C, headache, AND positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum or cerebrospinal fluid (CSF) OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as \u2022 West Nile encephalitis (must meet a and b below) Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours) CSF pleocytosis >=5 cells/mm^3 AND/OR ", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Brain and Central Nervous System Tumors Breast Cancer Metastatic Cancer Meets 1 of the following Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis Other type of cancer with evidence suggestive of carcinomatous meningitis Meningeal syndrome without context of cancer No other prior cancers Not pregnant or nursing No prior intrathecal treatment At least 4 weeks since prior interferon No concurrent participation in another clinical trial ", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 12.0-999.0, All Vasomotor Rhinitis Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis Negative skin tests to a panel of allergens and positive histamine test within last 2 years History of symptoms related to defined VMR triggers Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit Chronic use of drugs that can cause rhinitis", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 5.0-15.0, All Rhinitis, Allergic, Perennial Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen) Male or female outpatients aged 5 to 15 years at the time of providing informed consent Subjects for whom any of the main below is applicable will not be registered in this study Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics Subjects with repeated epistaxis Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-999.0, All Brain Injuries, Traumatic Injuries, Acute Brain TBI (Traumatic Brain Injury) Adults and children with physical trauma who: 1) are transported directly to or are transferred to a level I TC by participating EMS agencies, 2) have hospital diagnosis(es) consistent with TBI (either isolated or multisystem trauma that includes TBI), and 3) meet at least one of the following definitions for severe TBI: a) last prehospital GCS or first hospital/trauma center GCS <9; b) AIS-head of \u22653, c) CDC Barell Matrix-Type 1, d) undergo prehospital ETI, nasal intubation, or cricothyrotomy Patients with brain injury from: 1) non-mechanical mechanisms (e.g., drowning); 2) choking, primary asphyxiation, or strangulation; 3) environmental injury (e.g., hyperthermia); 4) poisoning (e.g., drug overdose, carbon monoxide, insecticides); 5) intracranial hemorrhage of non-traumatic origin; 6) other non-traumatic, acute neurological emergencies (e.g., bacterial meningitis)", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Cerebrospinal Fluid Leaks Main (Positive response) \u2022 Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid Approach to the middle fossa: Subtemporal (+/ petrous apex drilling), pterional approach (any fronto temporal approach +/ orbitozygomatic deposition) Approach to the anterior fossa: Subfrontal (uni or bilateral) Approach to the midline posterior fossa (Negative response) Has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months? Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7\u00b11 week? Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28\u00b12 weeks? The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial transfacial approaches with wide defect in the skull base? I.e. any of the following Trans basal approach Total petrosectomy Trans facial approach Trans sphenoidal approach", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-50.0, All Perennial Rhinitis Seasonal Rhinitis All patients have to sign the informed consent or give verbal confirmation prior to their in the study Outpatient (external) male or female over 18 years and under 50 years Patients with active rhinitis (anterior or posterior rhinorrhea, sneezing, nasal congestion and itching) persistent (\u2265 4 days a week for 4 consecutive weeks) or intermittent (< 4 days a week for \u2264 4 consecutive weeks) Patient with medical history of rhinitis 2 years prior to their participation in this study and whose nasal symptoms have been severe enough to require continuous or intermittent treatment (it requires a patient's symptoms need treatment at least for a 4 weeks period) Patient with the ability to understand the risks and benefits requirement while participating in the study and is able to accomplish the study treatment and with filling questionnaires and patient's diaries Patient with other nasal disease including: nasal polyps or nasal trauma recent Patient with intranasal malformations (cysts and fistulas of the nose dorsum, prenasal space malformation, midline dystrophy, arrhinea, abnormalities of the tear ducts), or other conditions such as; recent nasal biopsy, drug rhinitis Non-controlled asthma or who were under systemic corticosteroid treatment Patient with Chronic Obstructive Pulmonary Disease Medical history of respiratory infection or other disease including bronchitis, pneumonia, common cold, acute or chronic sinusitis, influenza, etc. within 30 days prior to its in the study Patient receiving antibiotic therapy for any acute illness during the past 14 days Patient vaccinated against pneumococcus, H1N1 & seasonal influenza (past 30 days) Patient required initiation or dose escalation immunotherapy. Immunotherapy is permitted if started 90 days ago and the patient received a stable dose during the last 30 days Patient has participated in another research study within 30 days preceding this visit Patient with medical history of hypersensitivity to steroids or any excipients of this class of drugs", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 7.0-15.0, All Perennial Allergic Rhinitis Patients aged between 7 and 15 years Patients with a weight of at least 20 kg Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period Patients with vasomotor rhinitis or eosinophilic rhinitis Patients who have concurrent nasal disease that may affect the efficacy of TAU-284 Patients with a history of any of the nasal surgical procedures Patients who have a positive result for pollen antigens which are dispersed during the study period Patients who have a positive result for dog dander or cat dander antigen Patients with current or previous history of drug allergy Patients who concurrently have renal function abnormalities that may cause safety problems", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-18.0, All Head Trauma Children who had a radiography for head trauma ", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 50.0-999.0, All Seizures Pneumococcal Meningitis Adult patients > or = 50 years old Diagnosed of pneumococcal meningitis due to clinical characteristics plus a positive CSF Gram stain and/or a detection of pneumococcal antigen or PCR Suspected pneumococcal meningitis since it is an episode related to otitis, pneumonia, sinusitis or pericranial fistula or in patients with known risk factors such as myeloma or splenectomy To have seizures prior to arrive to the hospital or the in the study Pregnancy or breastfeeding To have conduction abnormalities in ECG History of allergy or intolerance to phenytoin Patients with meningitis as a complication of neurosurgical procedures Epileptic patients taking usually anticonvulsivants Refusal by the patient or family to participate and/or to sign the informed consent", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Post-lumbar Puncture Headache Backache All adult patients (>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture Contraindication to get a lumbar puncture", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-50.0, All Meningococcal Meningitis Meningococcal Infections Willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explain For the purpose of this study, a healthy volunteer is defined as healthy male or female, with no significant chronic conditions Age 18 to 50 years old Either gender. Abstinence or use of contraception during the eight weeks after vaccination will be required for non menopausal (< two years post-menopause) or non surgically sterile women Persons with antibody titer(s) of <2 \u00b5g/mL to serogroup(s) A, C, Y, or W-135 polysaccharides as measured by ELISA Age less than 18 years or over 50 years History of Guillain-Barr\u00e9 syndrome (GBS) Pregnancy or lactation History of meningococcal meningitis History of invasive (clinical or laboratory diagnosis) meningococcal disease History of meningococcal meningitis vaccination Screening laboratory abnormalities (in the opinion of the Investigator) that would raise safety concerns for participation in the study Use of immunosuppressive drugs within 30 days prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents History of anaphylactic shock, asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination History of severe allergic disorders or autoimmune connective tissue disorders, including rheumatoid arthritis. A high sensitivity C-Reactive Protein (CRP) test at screening will be used as part of the assessment of autoimmune disorders by the Principal Investigator", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-50.0, All Post Dural Puncture Headache 50 years old Undergoing diagnostic LP for any indication for the first time COPD Any known chronic pulmonary disease Acute febrile illness Persistent headaches Known sensitivity to Benzodiazepines Current or prior substance abuse disorder Cognitive decline", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-30.0, All Schistosomiasis Bilharziasis Urinary Schistosomiasis All subjects had to meet the study within 21 days prior to treatment Caucasian volunteers No smoker biological parameters (haematological, biochemical, renal and hepatic) in normal range Health Insurance sign inform consent inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) any immunological deficiency any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) current immunosuppressor treatment any other medication use within 2 weeks before the study any vaccination within the last 6 months no antibodies against Sh28GST protein", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.25-16.0, All Meningitis Age > 3 months and < 16 years Bacterial meningitis Written parental (or appropriate legal representative) informed consent prior to study Gram-negative bacteria in the CSF Creatinine clearance < 80ml/min/1.73m2 Creatinine phosphokinase level > 2x upper age related norm Known allergy or hypersensitivity to daptomycin Known clinical significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrine, hematologic, autoimmune disease, or primary immunodeficiency Height and weight below 3rd or above 95th percentile History of, or current muscular disease Underlying neurological disease with disruption of blood brain barrier Epilepsy Muscular weakness, history of peripheral neuropathy, or Guillain-Barr\u00e9 syndrome", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.167-15.0, All Bacterial Meningitis The study entry is assessed for all children at age 2 months years who present at these centers with the symptoms and signs suggestive of BM, and to whom lumbar puncture is performed All patients whose cerebrospinal fluid (CSF) turns out to be cloudy, positive by Gram staining or latex agglutination, or shows at least 50 leukocytes per mm3, will be enrolled in the study Participants Trauma, or relevant underlying illness such as intracranial shunt, previous neurological abnormality (cerebral palsy, Down's syndrome, meningitis) Previous hearing impairment (if known) Immunosuppression, except HIV infection More than one parenteral dose of a pretreatment antimicrobial. Children with oral antimicrobials are included, this information being marked in the sheet Active tuberculosis (if tuberculotic meningitis is diagnosed during trial, it will be included in intention-to-treat (ITT) analysis) Known hepatic disease", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-0.247, All Meningitis Informed consent form signed by the parents/carers Chronological age below 90 days inclusive The presence of clinical signs consistent with BM (hyperthermia or hypothermia or temperature instability PLUS 1 or more neurological findings among coma, seizures, neck stiffness, apnoea, bulging fontanelle) OR CSF pleocytosis (\u2265 20 cells/mm3) OR a positive Gram stain of CSF Presence of a CSF device Proven viral or fungal meningitis Severe congenital malformations if the infant is not to expect to survive for more than 3 months Other situations where the treating physician considers a different empiric antibiotic regimen necessary Known intolerance or contraindication to the study medication Participation in any other clinical study of an investigational medicinal product Renal failure and requirement of haemofiltration or peritoneal dialysis Meningitis with an organism known to be resistant to meropenem", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-65.0, All Acute Migraine Willing and able to provide written informed consent prior to participation in the clinical investigation Male or female aged between 18 and 65 years Diagnosed as suffering from migraine with or without aura according to IHS classification (ICHD-II) Reported history of 2 to 6 migraine episodes per month during previous 3 months, confirmed during a prospective baseline period of one month Reported history of no less than 50% of migraine episodes involving moderate or severe pain intensity, confirmed during a prospective baseline period of one month Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during a prospective baseline period of one month Reported history of the majority of untreated migraine attack durations lasting 8 hours or more Onset of migraine headache occured before age 50 Reported history of migraine for more than one year Able and willing to maintain current preventive headache medication regimen(s) (no change in type, frequency or dose) from baseline screening visit to 2 weeks post-treatment Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during a prospective baseline period of one month Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during a prospective baseline period of one month Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visit Previously treated with an implantable stimulator or any implantable devices in the head and/or neck Diagnosed as having a pronounced anterior septal deviation History of sinus surgery, transphenoidal surgery for pituitary or other lesions or CSF rhinorrhea Fitted with a pacemaker /defibrillator Previously treated with radiation to the face Ongoing bacterial infection in the nasal cavity", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-999.0, All Streptococcus Pneumoniae Neisseria Meningitidis Haemophilus Influenzae Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol Written informed consent obtained from the subject/from the parent(s)/LAR of the subject A male or female subject who visits the hospital with suspected bacterial meningitis CSF sample taken as part of routine practice Child in care", "label": "2"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Meningitis, Bacterial Positive CSF culture and/or positive soluble antigens in CSF with or without a cell reaction Positive PCR in CSF Purpura fulminant (with or without positive CSF culture) Positive PCR in blood and/or positive blood culture AND CSF cell reaction Age less than 18 years old Refusal to participate", "label": "2"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-999.0, All Pneumonia, Bacterial Pneumonia, Viral Meningitis, Bacterial Pneumonia surveillance resident of T\u00f4ne sanitary district requiring hospitalisation for at least one night for clinical pneumonia syndrome hospitalised in a study site during the study period absence of informed consent by patient or legal tutor Meningitis surveillance resident of T\u00f4ne sanitary district presenting clinical signs of acute bacterial meningitis hospitalised in a study site during the study period absence of informed consent by patient or legal tutor", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Stress Disorders, Post-Traumatic Myocardial Infarction Age over 18 years STEMI (ST-elevated myocardial infarction) or non-STEMI Stable circulatory condition Numeric Rating Scale (NRS) (0-10): a score of at least 5 for \"pain (during MI)\" plus a score of at least 5 for \"fear of dying (until admission to the CCU)\" and/or \"making sorrows and feeling helpless (when being told about having MI)\" Written informed consent Participating in any other randomized-controlled trial run by the Cardiology Department of the University Hospital of Bern Emergency coronary artery bypass graft surgery Comorbid serious disease likely to cause death within 1 year Current clinically severe depression Not fully oriented to the situation, person, and place Cognitive impairment according to an adapted short version of the Mini-Mental State Examination Insufficient knowledge of German language in reading and understanding Affirmation of suicidal ideation in the last two weeks", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 30.0-70.0, All Posttraumatic Stress Disorder PTSD as determined by the Structural Clinical Interview for DSMIV (SCID) interview of PTSD and the Clinical Administered PTSD Scale (CAPS) Veteran with history of active duty service and currently discharged from active duty service Free of psychotropic medication for four weeks before the study History of shrapnel or other foreign bodies which would preclude MRI scanning Meningitis Traumatic brain injury Neurological disorder or organic mental disorder History of loss of consciousness Current or lifetime history of alcohol abuse or substance abuse or dependence base on the SCID Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia based on the SCID History of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness Evidence of a major or neurological illness on physical examination or as a result of laboratory studies positive urine toxicology screen", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-65.0, All Tuberculous Meningitis Age 18 years or older Probable/possible tuberculosis meningitis using uniform case definition Agree to participate in the study Patient with antituberculosis treatment within last 2 weeks Increase liver function >5x upper limit of normal Pregnancy", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 8.0-17.0, All Traumatic Brain Injury Brain Concussion Children aged between 8 and 17 years old. This will be limited to this small spectrum of age to insure better homogeneity in the evaluation of the participants and streamlining of outcome measures. Also, this is the age group for which our measurement tool has been validated Occurrence of a mTBI as defined by the presence of a head trauma, a Glasgow coma scale of 13 to 15 and at least one of the three following criteria4 Any period of loss of consciousness Any loss of memory for events immediately before or after the accident Any alteration in mental state at the time of the accident (eg, feeling dazed, disoriented) And the absence of the following Post-traumatic amnesia greater than 24 hours Glasgow Coma Scale < 13, 30 minutes post accident The trauma occurred in the preceding 24 hours Inability to obtain a proper written informed consent (language barrier, absence of a parental authority, developmental delay, intoxication, patient too confuse to consent according to the treating physician) Known allergic reaction or intolerance to ondansetron. 3. Known rhythm or cardiac problem, or history of sudden death in the proximal family 4. Patients who are taking a medication which could increase the QT interval. 5. Patients who received ondansetron in the previous 24 hours 6. Any abnormality on radiological studies, including any bleeding in the brain or skull fracture Multi-system injuries with treatment requiring admission to hospital or procedural sedation in the ED", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 7.0-15.0, All Perennial Allergic Rhinitis Patients aged between 7 and 15 years Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc Patients with vasomotor rhinitis or eosinophilic rhinitis Patients who have concurrent nasal disease that may affect the efficacy of TAU-284 Patients with a history of any of the nasal surgical procedures Patients who have a positive result for pollen antigens which are dispersed during the study period Patients who have a positive result for dog dander or cat dander antigen and have a chance to touch dogs or cats Patients with current or previous history of drug allergy Patients who concurrently have renal function abnormalities that may cause safety problems etc", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-55.0, All Meningococcal Meningitis Meningococcal Infections (IC) Participant is willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explained Male or female, aged 18 to 55 years old In general good health with no significant chronic or acute conditions that would interfere with immune response or expected Adverse Event (AE) evaluation in the opinion of the investigator as determined by Medical history and/or History-directed physical examination Abstinence or use of effective contraception by the participants or their partners during the trial and continuing for four weeks after vaccination will be required for males or female participants of child bearing potential Able (in the opinion of the investigator) to comply with all study requirements (EC) Unwilling or unable to understand study requirements and give written informed consent for the study Prisoners History of Guillain-Barr\u00e9 syndrome (GBS) Pregnancy (confirmed by positive pregnancy test) or lactation Previous diagnosis of laboratory confirmed meningococcal disease Previous meningococcal meningitis vaccination in the last five years Laboratory abnormalities that are considered Grade 2 or higher (based on AE, ranges as described in the protocol appendix) that in the opinion of the Investigator would raise safety concerns for participation in the study or interfere with evaluation of study objectives, or abnormalities >2 times the Upper Limit of Normal range (ULN) Known or suspected autoimmune or connective tissue disorders, including rheumatoid arthritis and congenital or acquired immunodeficiency. Does not mild to moderate seasonal/perennial allergies treated with over the counter antihistamines Use of systemic immunosuppressive drugs or therapy within 6 months prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents. Includes anti-cancer chemotherapy, radiation, and long term systemic corticosteroid therapy. History of anaphylactic shock, severe asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination or known hypersensitivity to any vaccine component", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 50.0-999.0, All Low Trauma Non Vertebral Fracture Patients of more than 50 years old Low trauma non vertebral fracture Ambulatory patient Direct access to mobile phone (or access with the help of a close person) and ability to communicate via SMS Patient who doesn't oppose to his participation in the study Affiliation to the social security Patients hospitalized for the fracture in the orthopaedics department because these more severe patients have a systematic screening and management of osteoporosis Fractures whose location is not suggestive of osteoporotic fracture (cervical spine, skull, hands, fingers, toes) Pathological fractures (cancer or myeloma) Traumatic fractures Severe alterations of cognitive functions Resident subjects except Paris and the surrounding area", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 12.0-999.0, All Perennial Allergic Rhinitis Diagnosed with perennial allergic rhinitis Outpatient Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) Coexisting infections or systemic mycosis for which there are no effective antibiotics Asthma complication under treatment Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed Vasomotor rhinitis or eosinophilic rhinitis Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug History of hypersensitivity to antihistamines or study drug Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Nasal Septum Deviation Headache All patients older than 18 years whom underwent sinuses or facial tomography Patients with clinical history of trauma", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-85.0, All Primary Headache 85 years old Benign headache Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic Unable to provide informed consent Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection Known renal impairment Known hepatic impairment A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease Perforated ear drum Pregnant", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-999.0, All Inner Ear Malformations Must have an inner ear malformation Must meet the for cochlear implantation Prior cochlear implantation surgery", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Traumatic Brain Injury Severe or moderate brain trauma subjects with need of ICU care Glasgow Coma Score (GCS) \u2264 8 after the primary stabilization has been performed in the field (= patient not hypoxic or hypotensive) and at least 30 min interval from the moment of injury GCS 9 and the patient is deteriorating The patient has GCS \u2264 13 and has other injuries, which require interventions for hemodynamic or ventilatory incidents The patient is in urgent need of neurosurgery (craniotomy, impression skull fracture, severe haemorrhagic contusion, or ICP measurement) Moderate or mild brain trauma not in need of ICU care All other patients who fulfil the diagnostic for an acute TBI but without any defined below Age < 18 years at study entry Blast-induced TBI Perforating or penetrating mechanism of TBI Unable to live independently because of a brain disease (= e.g. people with moderate dementia, Down's syndrome, cerebral palsy etc.) or other medical cause before the injury TBIs or suspected TBIs not needing cranial CT imaging (excludes the mildest TBIs with negligible risk for incomplete recovery) for control subjects Age \u2265 18 years at study entry Acute orthopaedic non-trivial trauma that needs either surgery or conservative measures and clinical follow-up (including mere superficial soft tissue injuries) for control subjects", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-18.0, All Head Injury Parents and their child, seeking care for a child who Is < 18 years of age Had blunt trauma above the eyebrows (not isolated to face or eyes) Is positive for at least 1 of the clinical prediction rule predictors described below Predictors for children < 2 years of age Severe mechanism (PECARN definition)* Loss of consciousness > 5 seconds Acting abnormally per parent Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture predictors for children 2-18 years of age Severe mechanism (PECARN definition)* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)** Any sign of basilar skull fracture Clinicians attending physicians and fellows or midlevel providers caring for children with head trauma Parents of children with GCS scores < 15 Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination Brain tumors Ventricular shunts Bleeding disorder Pre-existing neurological disorders complicating assessment Neuroimaging at an outside hospital before transfer Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication) Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 5.0-999.0, All Concussion Stress Disorders, Post-Traumatic All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here mild to moderate structural traumatic brain injury (TBI) as evidenced by CT scan demonstrating the presence of hemorrhage (subdural, epidural, subarachnoid or intraparenchymal), brain contusion, or skull fracture non-structural TBI(concussion), meaning no signs of structural injury on imaging; however, they complain of usual brain injury symptoms such as headache, dizziness, cognitive impairments, etc., A subject with a traumatically induced physiological disruption of brain function, manifested by >1 of the following Any period of loss of consciousness (LOC) Any loss of memory for events immediately before or after the accident Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused) Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following Loss of consciousness of approximately 30 minutes or less After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15 Posttraumatic amnesia (PTA) not greater than 24 hours Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2 Pregnant individuals and prisoners will also be excluded from the study", "label": "2"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-55.0, All Cephalalgia Complain about cephalalgia Age 28 to 55 years Fever > 38,0 \u00b0C History of breath disease, long term use of oxygen therapy, chronic obstructive pulmonary disease, dyspn\u00e9a History of cranial traumatism, heart attack, cerebrovascular accident <3 month Inability to read or understand french Pregnancy", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 2.0-5.0, All Cold for patients with common cold Male or female at least 2 but not older than 5 years of age at screening Have a diagnosis of a common cold defined as presence of acute onset of rhinorrhea (within 48 hours of screening visit) and at least 1 of the following Presence of swollen nasal membranes characteristic of a common cold on examination at screening Presence of fever up to 102\u00b0F (oral or equivalent) within 48 hours of visit (may be taken at home/away from the clinic) or at time of screening Capability of parent/legal guardian to read and understand the informed consent, record trial diary information, administer trial drug and read and understand trial assessment questionnaire for patients with allergies Male or female at least 2 but not older than 5 year of age Have a diagnosis of seasonal or perennial allergic rhinitis defined as having both of the following Positive skin or Radioallergosorbent test (RAST) test to a relevant allergen within 12 months of screening or at the screening visit. For the purpose of this trial a positive skin test is defined as wheal diameter that is at least 3 mm greater than the negative control for both common cold and allergy Significant cardiovascular, renal, hepatic, endocrine, metabolic, neurologic or other systemic disease. A significant disease was defined as one which, in the opinion of the Investigator, either put the patient at risk because of participation in the trial or influenced the results of the trial or the patient's ability to participate in the trial Presence of rales or rhonchi suggestive of a lower respiratory tract infection An oral (or equivalent) temperature higher than 102\u00b0F Presence of otitis media Be initiating or advancing immunotherapy regimen during the course of this trial. Patients receiving a maintenance dose of immunotherapy are eligible Known intolerance to anticholinergics of hypersensitivity to benzalkonium chloride Excluded medications prior to Visit 1 and during the trial included 24 hours before Over-the-counter decongestants or nasal/ocular cromolyn", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-50.0, All Healthy Volunteers Male or female of any race 50 years old, inclusive Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia) Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening) Meets specific demographic requirements for the monitoring device under study Willing and able to provide written informed consent Able to participate for the duration of the evaluation A room-air baseline % modulation < 1.5% on all four fingers on the test hand Under 18 years or over 50 years of age Pregnant and/or lactating women Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute History of seizures (except childhood febrile seizures) or epilepsy History of unexplained syncope Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of anxiety disorder Recent history of frequent migraine headaches: average of two or more per month over the last year Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Spontaneous Intracranial Hypotension years or more No contraindication for BPE Severe or moderate headache within 15 min standing, mild or no headache after 15 min bed rest Headache from 5 to 28 days Normal or evidence of low CSF on MRI Signed informed consent Known dural leak in the previous 2 months Abnormal MRI First BPE for SIH The patient has participated in another clinical trial than can interact with the evaluation Contraindication of Trendelenburg position", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 55.0-85.0, All Probable Alzheimer Disease (AD) Parkinson Disease (PK) Neurological Disease Without Cognitive Degradation Brain Trauma Acute Hydrocephaly Reports written consent, informed and signed by the patient and a trusted person Subject member or beneficiary of a social security system Specific for group 1 and 2B Age between 55 and 85 years old for patients Subject with AD or other neurodegenerative disease (frontotemporal dementia, dementia with Lewy bodies, Parkinson disease) Subjects with chronic adult hydrocephalus (HCA) requiring depletion lumbar puncture (PL) Specific for group 2A Adult patient requiring neurosurgery with CSF shunt (subject with brain trauma, acute hydrocephaly) and favorable evolution that allows removal of the shunt Patient deprived of liberty by judicial or administrative decision Major protected by law Pregnancy, women of childbearing age with risk of pregnancy, or breast-feeding Presence of a transmissible viral disease (HlV, hepatitis B and C) Patient included in a clinical trial lnadequate cardiac, hepatic or severe renal disfunction Disease amino acid metabolism (Leucinose..) Information clinical and para-clinical insufficient or unavailable Patient deprived of liberty by judicial or administrative decision Major protected by law", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-80.0, All Pituitary Adenoma Patients with suspected nonfunctioning pituitary macroadenomas (\u2265 1 cm) with planned transsphenoidal surgery Adults (age 18-80 years) Medically stable for surgery Reasonable expectation that patient will complete study and be available for follow-up assessments Prisoners Pregnant women Patients with suspected functioning pituitary adenoma Unable to obtain MRI of the pituitary (e.g., pacemaker, anaphylaxis to gadolinium, low GFR) Pituitary apoplexy", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-999.0, All Brain Injuries Skull Fractures Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture Died before admitted to hospital", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Cerebrospinal Fluid Leak Subjects \u226518 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent Surgical wound classification Class I The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon's judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product Presence of intra-operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage Chemotherapy scheduled within 7 days following surgery Radiation therapy to the head scheduled within 7 days following surgery A previous craniotomy/craniectomy within 6 months prior to the study surgery Known hypersensitivity to the components of the investigational product Subjects with a known allergy to FD&C Blue #1 dye Subjects with an infection present at the surgical site Subjects with an infection indicated by any one of the following: clinical diagnosis of infection, fever, positive urine culture, positive blood culture, positive chest X-ray Female subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period Female subjects who are nursing", "label": "2"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.083-18.0, All Bacterial Meningitis Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 \u00b0C rectal or 38.0 \u00b0C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following A. turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl) Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis Congenital immunodeficiency patients HIV patients Patients with corticosteroid treatment for long time Patients with disorders in adrenal gland and pituitary gland and hypothalamus Patients with tuberculosis", "label": "2"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Brain Injuries Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay Patients admitted less than 24 hour", "label": "2"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 0.0-0.083, All Neonatal Sepsis Neonatal Infection Neonatal Meningitis This study aims to all neonates presenting here and at the high and medium care facilities with clinical signs of infection, sepsis or meningitis (age: 0-1 month) that require infection work up (i.e., laboratory testing and culturing) Baseline controls: uncomplicated jaunice, no other signs of infection Clinical signs of infection: tachypnea, dyspnea, apnea, grunting, tachycardia, bradycardia, hypotension, poor perfusion, vomitus, abdominal distension, constipation, poor feeding, lethargy, irritability, convulsions, temperature instability, pale, yellow, bleak, petechiae, bruising, bleeding Extreme prematurity: gestational below 32 weeks of gestational age Extreme dysmaturity: birthweight below 1500 grams Maternal HIV or malignancy", "label": "0"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-75.0, All Acute Traumatic Spinal Cord Injury Aged 18-75 years inclusive Diagnosis of acute SCI Injury is less than 24 hours old Impairment Scale Grade \"A,\" \"B\" or \"C\" based upon first evaluation after arrival to the hospital Neurological level of injury between C4-C8 based upon first evaluation after arrival to the hospital Women of childbearing potential must have a negative serum \u03b2-hCG pregnancy test or a negative urine pregnancy test Patient is willing to participate in the study Informed consent document signed by patient or witnessed informed consent document No contraindications for study treatment(s) Able to cooperate in the completion of a standardized neurological examination by standards (includes patients who are on a ventilator) Injury arising from penetrating mechanism Significant concomitant head injury defined by a Glasgow Coma Scale (GCS) score < 14 with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator) Pre-existing neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia) Prior history of SCI Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator Is a prisoner Participation in another clinical trial within the past 30 days Acquired immune deficiency syndrome (AIDS) or AIDS-related complex Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study", "label": "1"} +{"topic": "A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination.", "doc": "eligible ages (years): 18.0-999.0, All Meningitis Meningococcal Meningitis Meningococcal Infections Aged \u2265 18 years on the day of Received booster dose of Menactra vaccine in trial MTA77 Informed consent form has been signed and dated Able to attend the scheduled visit and to comply with all trial procedures Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77 Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture at the discretion of the Investigator Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily Current alcohol abuse or drug addiction Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.)", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.0-999.0, All Deglutition Disorder Motor Neuron Disease Any Clinical Center inpatients and outpatients with known or suspected dysphagia on any other NIH institute protocol can be included for study as well as patients who are admitted specifically for this protocol Those patients at risk for oropharyngeal dysfunction will be screened initially by completing a self-assessment swallowing questionnaire, and by an interview with staff and/or family members. Patients who demonstrate appropriate signs and symptoms of dysphagia and oral motor impairment on the screening assessment will be considered for the protocol Difficulty swallowing food or pills Changed swallowing ability Coughing or choking when eating Shortness of breath during swallowing Food backing up into the mouth or nasal passage Fever or voice changes after swallowing Pain when swallowing Unexplained loss of weight Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions Patients who are non-ambulatory will be excluded if they can not be braced or supported within the fluoroscopy unit Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment Infants and children under age 3 will be excluded due to radiation risk on the developing visual system", "label": "2"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 20.0-80.0, All Phonation Disorder Spastic Dysphonia Voice Disorder Normal Volunteers Normal volunteers between the ages of 20 and 80 years of age will be selected after a screening examination Subjects will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by an otolaryngologist None of the subjects included for study will have a reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm Normal Volunteers Any patient with a history of airway obstruction will be excluded from the study No smokers or tobacco users will be included in the study Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not a person from participation Any individual with: 1) an implant or surgical clip implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular implant, aneurysm clip, artificial heart valve, insulin pump, orthopedic pins or prosthesis: 2) a foreign body metal shavings, shrapnel, orthodontic braces, tattoos or permanent eye liner; and/or, 3) any other implanted device or foreign body not listed above that is possibly ferromagnetic will also be excluded from study seven because of contraindications for magnetic resonance imaging Patients with Spasmodic Dysphonia Symptoms present during speech and not apparent at rest Symptoms less evident during whisper, singing or falsetto", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 20.0-70.0, All Voice Disorders The for normal volunteers are normal vocal function and average health as determined by the staff otolaryngologist. Normal vocal function refers to normal voice quality, a negative history for voice or laryngeal disorders. Persons with significant pulmonary, neurological and psychiatric function will not be recruited. The primary for the voice disordered groups are a current diagnosis of spasmodic dysphonia (abductor or adductor type), muscular tension dysphonia or voice tremor. These persons will not have pulmonary, neurological or psychiatric disorders or criteria for Patients with Spasmodic Dysphonia Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch are present during vowels, liquids (r & l) and semi-vowels (w & y), during speech for adductor SD or prolonged voiceless consonants producing breathy breaks for abductor SD Less prominent symptoms during whisper, singing or falsetto Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry A diagnosis of adductor or adductor spasmodic dysphonia based on voice testing and fiberoptic nasolaryngoscopy by a board certified otolaryngologist and Speech-Language Pathologist during the initial interview of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist for Patients with Muscular Tension Dysphonia Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles on palpation A consistent hypertonic laryngeal posture for phonation, such as either an anterior-posterior squeeze (pin-hole posture) or ventricular hyper adduction and an absence of SD or vocal tremor as determined by a Speech-Language Pathologist and the staff otolaryngologist Any individual with a history of one or more of the following contraindications will be excluded from the study Airway obstruction, smoking or tobacco use Pulmonary, or neurological disease Pregnancy as reported by the volunteer or a positive pregnancy result from a urine sample obtained on the day of testing Psychiatric disorder, under psychiatric care, or on medication for psychiatric disorders. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, major depression, schizophrenia or a bipolar disorder. A history of a previous episode of minor reactive depression would not a person from participation Speech or hearing problems as determined by medical history and examination by the otolaryngologist. A 30 dB HL hearing screening between 500 and 3000 Hz will be conducted if subjects report difficulty following spoken instructions or significant noise exposure A reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm as determined by videolaryngoscopic examination by the staff otolaryngologist Complete aphonia, a history of airway obstruction or structural abnormalities affect the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, chronic laryngitis as determined by videolaryngoscopic examination by the staff otolaryngologist Individuals having any condition that would present unnecessary risk to them, e.g., claustrophobia Specific contraindications for magnetic resonance imaging i) Any implant or surgical clip", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.0-999.0, All Auditory Perception Males and females of any race or ethnicity will be eligible to participate in this study Volunteers must be between the ages of 18 and 45 with normal hearing and voice function. Participants will be further selected for having a steady heart rate. A history of voice training is not required, but participants must be able to produce grossly independent voice F0 and amplitude changes Contraindications to participation pregnancy, cardiac pacemaker or auto defibrillator, artificial heart valve, neural pacemaker, surgical metal clips in the brain, eye, or on blood vessels, cochlear implants, ocular implants or foreign bodies such as metal shavings or splinters, insulin pump, implanted drug infusion device, shrapnel, bullet or shot wound, and tattooed makeup. Participants will be screened with the NMR Center Safety Screening Questionnaire which also includes items such as intraventricular shunts, transdermal medication patches, wire sutures, bone/joint pins, screws, nails, or plates, and body piercings. Given that surgical staples, orthopedic pins, orthodontic braces and dental implants are no longer considered absolute contraindications in MRI, Dr. Saxon or Dr. Kearney will approve or disapprove participation in the study based on their judgment of the MR compatibility of these items, using published guides including those referenced above Volunteers will be also excluded if they are found to be pregnant, report any tendency toward claustrophobia or are unable for any reason to lie still within an MR scanner", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.0-999.0, All Healthy The Healthy volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech, swallowing and hearing problems as determined by medical history and examination by a physician History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to any study to volunteers who might be at risk for endocarditis. Subjects will have an EKG as part of the screening for participation in the study Pregnancy will women from participation because the study involves radiation exposure None of the Healthy volunteers will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint abnormality or neoplasm Healthy Volunteers who have a cardiac demand pacemaker, dementia, exhibit non-stop vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be included for VitalStim, as these are contraindications to use of the device", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 6.0-21.0, All Cerebral Palsy Drooling diagnosis of cerebral palsy severe drooling aged 6-21 yrs subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form age below 6 yrs or above 21 yrs known allergy or sensitivity to the study medication or its component diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function subjects who have prior surgery of the submandibular gland subjects who are receiving medication that affect drooling such as anticholinergic drug inability to give informed consent", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.5-13.0, All Tonsillitis Pharyngitis Age 6 months to less than 13 years of age (<13) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs Tonsil and/or pharyngeal erythema and/or exudate Cervical adenopathy Uvular edema Fever Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Females of childbearing potential (ie, have reached menarche) Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm) Myasthenia gravis Known impaired renal function, as shown by creatinine clearance \u226425 mL/min The subject", "label": "1"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 13.0-999.0, All Tonsillitis Pharyngitis Age equal to or over 13 years For female subjects, the following conditions are to be met Subject is premenarchal or surgically incapable of bearing children Subject is of childbearing potential and all of the following conditions are met Have normal menstrual flow within 1 month before study entry Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and Must agree to use an accepted method of contraception throughout the study (if sexually active) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm) Known impaired renal function, as shown by creatinine clearance \u226425 mL/min Myasthenia gravis History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins Previous enrollment in this study or previous treatment with telithromycin", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.115-0.231, All Pneumococcal Infections Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol Written informed consent obtained from the parent or guardian of the subject Free of obvious health problems as established by medical history and clinical examination before entering into the study Born after a gestation period between 36 and 42 weeks Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3 Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases History of allergic disease or reactions likely to be exacerbated by any component of the vaccines History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease Acute disease at the time of enrolment Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical A family history of congenital or hereditary immunodeficiency", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 1.0-18.0, All Sleep Apnea, Obstructive Respiration Disorders year old to 18 years of age, clinical signs or symptoms of obstructive sleep apnea (snoring, witnessed apneas, daytime somnolence, restless sleeping, or cyanosis), abnormal polysomnogram (mild, moderate, or severe OSA) including CO2 measures, failed or refused trial of CPAP, or not recommended by their pulmonologist or primary care doctor prior laser supraglottoplasty, prior adenoidectomy prior tonsillectomy, stridor with cyanosis or apnea, severe respiratory distress, recurrent pneumonia (x3), Laryngeal cyst, vocal cord (VC) Paralysis, airway vascular malformation, neoplasm, subglottic hemangioma, paradoxical vocal cord (VC) motion, posterior glottic stenosis, glottic webs, discoordinate pharyngolaryngomalacia, or refusal to participate", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.167-4.917, All Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site)", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 3.0-18.0, All Cerebral Palsy Neurological Conditions Mental Retardation Sialorrhea To be included in this study, patients must meet the following Male or female, weighing at least 13 kilograms (27 pounds), aged 3 through 18 years Diagnosis of cerebral palsy and/or mental retardation or any other neurologic impairment or condition (cognitively capable and cognitively impaired patients may be enrolled) Chronic drooling in the absence of treatment to the extent that the chin or clothing becomes wet on most days by confirming the Modified Teacher's Drooling Scale score \u2265 5 Must be living in a situation where reliable parents/caregivers are willing and capable of administering medications, as determined by the investigator Written informed consent signed by the parent or legally acceptable representative Written assent signed by the age-appropriate patient if mentally capable, as determined by the investigator, and required by the site's Institutional Review Board If female of childbearing potential, the patient must have a negative pregnancy test at screening and Visit 2 If female of childbearing potential and sexually active, she must use a medically acceptable form of contraception Patients are excluded from this study if they meet any of the following Patients who used glycopyrrolate within approximately 24 hours prior to the start of the baseline period, which began on Day -2 Patients who used prohibited medications within 5 plasma half-lives of the medication prior to the start of the baseline period Patients injected with intrasalivary gland botulinum toxin within 10 months prior to the start of the baseline period Patients using intraoral devices or prosthetics for the treatment of drooling within 1 week prior to the start of the baseline period Patients receiving acupuncture for the treatment of drooling or who have received acupuncture for the treatment of drooling within 3 months prior to the start of the baseline period Patients who have medical conditions contraindicating anticholinergic therapy including gastrointestinal reflux, narrow-angle glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract (i.e., delayed gastric emptying, pyloroduodenal stenosis, etc.), paralytic ileus, intestinal atony, vesicoureteral reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant electrocardiogram abnormalities, as determined by the investigator Patients who have a known contraindication to the study medication, including allergy to the study medication or any of its components Patients who have poorly controlled seizures defined as daily seizures Patients who have a history of obstructive disease of the gastrointestinal tract (i.e., intestinal obstruction)", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-85.0, All Drooling Parkinsons' Disease patients with Sialorrhea for at least 3 months Patients with non-idiopathic PD parkinsonism Patients previously exposed to botulinum toxins Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia Patients with prior salivary gland surgery", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 2.0-4.917, All Healthy Healthy Age: born within the same calendar quarter as the reference FluMist vaccinee Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-85.0, All Intrathoracic Malignancies Unilateral Vocal Cord Paralysis Patients with UVCP undergoing type I thyroplasty or vocal fold augmentation for rehabilitation of speech and swallowing for the healthy subjects From age 18-85 for the UVCP patients includes the following History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia) History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease History of previous moderate to severe traumatic brain injury History of significant cardiovascular, gastrointestinal or renal disease (e.g. myocardial infarction within the previous 12 months, significant vaso-occlusive disease, severe or advanced asthma, or renal compromise) History of achalasia History of dysphagia, odynophagia, or aphasia unrelated to present illness History of significant claustrophobic reactions Standard contraindications to MR examinations (e.g. implanted stimulators, pregnancy) for the healthy subjects includes the following", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-80.0, All Paralysis American Society of Anesthesiology physical status grade I-II Age 18-80 yr Elective gynecological surgery Supine position Known or predicted difficult airway Body mass index >35 kg m-2 Risk of aspiration", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.231-999.0, All Rotavirus Severe Gastroenteritis for enrolled subjects and cases A male or female child born after 1 March 2006 (which corresponds to the date of introduction of Rotarix\u2122 in the EPI) and at least 12 weeks of age Subject admitted to the study hospital for SGE (refer to the glossary) during the study period Onset of SGE <= 14 days prior to admission Laboratory confirmed (i.e. by ELISA at the hospital laboratory) RV positive stool sample at hospital admission or during the first 48 hours of hospitalisation. Note: This criterion is applicable only for cases Written informed consent obtained from the parent or guardian of the subject for controls Admitted for non-GE causes at the same hospital as the case. Note: This criterion is applicable to hospital controls only Living in the same neighbourhood as the case for at least three consecutive months. Note: This criterion is applicable to neighbourhood controls only At least 12 weeks of age and being born within \u00b1 2 weeks from the date of birth of the case. If the list of children born within \u00b1 2 weeks is exhausted, then the range would be extended to \u00b1 4 weeks for enrolled subjects and cases Subject has previously participated as case or control in this study Hospitalisation is unrelated to GE Onset of SGE > 48 hours after admission to the hospital (nosocomial infections) for controls For hospital controls: Child who has symptoms of GE during current hospitalisation or on the day of interview of his/her parent or guardian For neighbourhood controls: Child who has symptoms of GE on the day of interview of his/her parent or guardian children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus Influenzae Type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B Child has participated in the past as a case or control in this study Child living in the same house as the case. Note: This criterion is applicable to neighbourhood controls only", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 1.0-999.0, All Varicella (Chickenpox) Chickenpox Vaccines Male or female child at least one year of age, born on or after July 1 2003 Residence in Germany At least one previous well-child visit to the practice Written informed consent obtained from parents/guardians of the subject as per local requirements Specific criterion for cases Suspected primary varicella disease (i.e. chickenpox) at the time of study entry Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are History of hypersensitivity to any of the components of the vaccines Congenital or acquired immunodeficiency Treatment with immunosuppressive therapy HIV-infected patients, when CD4 < 25% of total lymphocytes Previous history of chickenpox by physician record or parental report Lack of documented vaccination history (written or computerised practice records or child's vaccination card/booklet)", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 21.0-80.0, All Spasmodic Dysphonia Focal Dystonia Healthy research volunteers and adult patients with ADSD and WC will be eligible for the study Adult patients with ADSD will have clinically documented ADSD established by voice and speech testing and fiberoptic nasolaryngoscopy Patients will be required to have Intermittent uncontrolled voice breaks in vowels, liquids (r & l), semivowels (w & y) during speech in ADSD (at least 3 voice breaks), or Less prominent symptoms during whisper, singing, falsetto, or shout Normal voice and vocal fold movement during protective laryngeal functions and emotional phonation, such as cough, laughter, cry Adult patients with WC will have clinically documented WC established by history and neurological examination Controls will be healthy subjects with a negative history of laryngeal, neurological, or psychiatric problems All participants will be from 21 to 80 years old and right hand dominant All participants should be able to perform a sequential finger-tapping task for 40 seconds consecutively Subjects who are incapable of giving an informed consent Pregnant or breastfeeding women until a time when they are no longer pregnant or breastfeeding Subjects with past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than SD and WC in the patient group), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence; (b) psychiatric problems, such as schizophrenia, major and/or bipolar depression, obsessive-compulsive disorder; (c) laryngeal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis. (d) ventricular arrhythmias, renal and hepatic insufficiency, vascular headache, or carcinoid syndrome Patients who are currently taking medications known to affect GABA and dopamine receptor binding. Occasionally, patients report receiving such medication, although dopaminergic and GABA agonist/antagonists are not typically prescribed in these patients Patients who received treatment with botulinum toxin injections into the laryngeal muscles within the past 3 months Patients with vocal and hand tremor or muscle tension dysphonia Subjects who have tattoos with contraindications to MRI, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that cannot be removed for the purpose of study participation Subjects who received previous radiation exposure greater than 5.0 rem per year WC patients who experience focal hand dystonia at rest WC patients who have focal hand dystonia associated with trauma or a known neuroanatomic lesion or disease", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.167-1.667, All Haemophilus Influenzae Type b Infants of either sex, aged 16 months / 2 months in good health as determined by: medical history physical examination clinical judgment of the investigator available for all visits scheduled in the study and able to comply with all study regulations written informed consent obtained, from at least one parent or legal guardian parent or legal guardian is unwilling or unable to give written informed consent to participate in study infants who presented a previous disease potentially related to Haemophilus influenzae type b infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease infants who have received any other Haemophilus influenzae type b immunization dose before (for 16-20 months old children who have received a booster vaccination already) premature (before 37th week of gestation) or birth weight less than 2500 g history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component fever \u226538.0 \u00b0C (axillary body temperature) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-54.0, All Haemophilus Influenzae (NTHI) for Inoculated Volunteers Healthy 18-54 years old (male or female) with no chronic medical conditions with the exception of well-controlled hypertension Availability for study visits over the next 1 month Normal hemoglobin, white blood cell count, creatinine, alanine aminotransferase (ALT), platelet count Signed informed consent form In good health as determined by medical history and physical exam on the screening evaluation [including heart rate 55-100 beats per minute (bpm); blood pressure: systolic 90-140 mm Hg and diastolic 50-90 mm Hg]. If the subject is a well trained athlete by the judgment of the Principal Investigator (PI), heart rate of 40-100 bpm is acceptable Negative urine pregnancy test for women of childbearing potential If the subject is female and of childbearing potential, she agrees to use acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes abstinence, implants, injectables, combined oral contraceptives, effective intrauterine devices, or a vasectomized partner) Negative human immunodeficiency virus (HIV) enzyme linked immunosorbent assay (ELISA) for HIV 1 and 2 or indeterminate Western blot or other assay confirming that the serostatus does not reflect HIV infection, negative hepatitis C and hepatitis B serology or other assay confirming that the serostatus does not reflect active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection Negative urine protein and glucose by dipstick for Inoculated Volunteers Acute illness within the week prior to inoculation Acute febrile illness (oral temperature greater than or equal to 100.4 degrees Fahrenheit) on the day of inoculation Allergic rhinitis requiring therapy in the past year Treatment for sinusitis, otitis, chronic bronchitis, pneumonia, bronchospasm or asthma in the past 5 years Abnormal gag reflex Active drug or alcohol abuse Smoking tobacco within the past year Average ingestion of more than one alcoholic beverage per day for women or two alcoholic beverages per day for men Splenectomy or disease that results in functional asplenism such as sickle cell diseases", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.5-17.0, All Intubation months of age to 17 years of age (not yet 18) Male or female English or Spanish speaking Normal airway (Mallampati Classification ) American Society of Anesthesiology Physical Status Classification I or II Elective surgical procedure expected to last at least 45 minutes in length Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable) < 6 months of age, > 17 years of age Difficult airway (Mallampati Classification) History of previous difficult intubation, suspected abnormal airway: *micrognathia facial trauma airway tumor epiglottitis retropharyngeal abscess foreign body, etc Scheduled for non-elective, emergent OR procedure Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.5-3.0, All Croup Written informed consent obtained by parents/legal representative prior to any study-related procedures Male or female subject aged between 6 months and 3 years referring to ER with acute onset barky cough, stridor, hoarseness, and respiratory distress Children with a diagnosis of moderate croup (Westley score 3-8) Symptoms or signs of any other cause of stridor Previous acute angioneurotic oedema Children with diagnosis of severe croup (Wesley score >8) History of congenital or acquired stridor, diagnosis of epiglottitis, chronic pulmonary disease, asthma, severe systemic disease, exposure to chickenpox virus within the previous 21 days, or known immune dysfunction Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study Treatment with oral or parenteral corticosteroids within the previous 2 weeks; Treatment with epinephrine for respiratory distress before enrollment Previous visit to an emergency room department due to croup during this episode of the disease Inability of the parent to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments Enrollment in another clinical trial in the previous 4 weeks or subject already admitted in this study Lack of a telephone at home", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.0-999.0, All Abscess, Peritonsillar clinical existence of a PLA (phlegmon), validated by a senior ENT, usually (but not necessarily) following a request by an emergency. The visible appearance to the merits throat must justify puncture. Cases will be included whether or not they had consulted for a \"sore throat\" in the 10 days preceding the date of diagnosis Neoplastic disease of the throat, scalable Hematologic with tonsillar localization History of tonsillectomy", "label": "1"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 19.0-999.0, All Dysphagia Dysphonia Patients undergoing revision anterior cervical spine surgery Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-999.0, All Angioedema Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study Must currently be on an ACE inhibitor Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF All females of childbearing age must have a negative pregnancy test prior to administration of the study drug Participation in another investigational study within 30 days prior to enrollment Patients who improve on conventional (standard of care) therapy Patients previously treated with ecallantide Hypersensitivity to ecallantide Pregnancy or breast feeding Other definable causes of angioedema (i.e., hereditary or acquired angioedema) Patients receiving C-1 inhibitor as prophylaxis Treatment requiring tranexamic acid, and epsilon-aminocaproic acid Receiving fresh frozen plasma within 3 days prior to enrollment", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.5-1.0, All Haemophilus Influenzae Type b (Hib) Infection Infants 6-12 months of age Prior Hib vaccine administration History of serious reaction(s) following vaccination Any vaccination within 14 days of study vaccination Known or suspected immune impairment For additional entry please refer to the protocol", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-60.0, All Thyroidectomy Distress Surgery (a) a minimally invasive follicular thyroid carcinoma \u22644 cm in diameter, or (b) a papillary thyroid carcinoma \u22642 cm in diameter (a) previous neck operations (b) age <21 or >65 years (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 1.083-4.917, All Haemophilus Influenzae Type b (Hib) Infection Infants 13-59 months of age Prior Hib vaccine administration History of serious reaction(s) following vaccination Any vaccination within 7 days of study vaccination Known or suspected immune impairment Premature (before 37th week of gestation) or birth weight less than 2500g For additional entry please refer to the protocol", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-999.0, All Abscess Patients presenting to the Civic Campus emergency department of The Ottawa Hospital with an abscess less than 5 cm diameter, as judged by the attending emergency physician (measurement with tape measure for diameter) between the hours of 7 am and 10 pm will be approached for possible enrollment. Ultrasound will be used to assess the appropriate Patients under the age of 18 years Patients with a Glasgow coma scale score of <15 (i.e. not completely alert and oriented) Patients suspected of having necrotising fascitis Patients with hemodynamic instability (defined as SBP <90, and/or HR >110) Patients admitted to hospital Patients who are neither French nor English speaking Patients who are not available for telephone follow-up (i.e. homeless) Ultrasound image demonstrates that the abscess is not compressible (generally indicates that the contents of the cyst includes solids, which would not be amenable to aspiration) Ultrasound demonstrates that there is no abscess to manage Patients with perianal abscesses who have either Crohn's disease or ulcerative colitis or known perirectal fistula", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 8.0-21.0, All Cystic Fibrosis With Mild to Moderate Lung Disease CMRI of Lung Perfusion Lung Perfusion Lung Vascularization Research subjects must meet the following Age 8 years to age 21 years Weight > 20kg Diagnosis of cystic fibrosis confirmed by a prior sweat chloride evaluation of > 60 mmol/liter or by two identified CFTR mutations on genetic analysis Able to perform acceptable and repeatable spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) joint consensus criteria Have valid spirometry data for at least 3 years Must have mild to moderate lung disease (Mild lung disease will be defined as an FEV1%p of 80-99% predicted. Moderate lung disease will be defined as an FEV1%p of 60-79% predicted.) If under the age of 18, the subject must assent to participation in the study, and the subject's parent or guardian must be able to give written informed consent and comply with the requirements of the study protocol If 18 years of age or older, the subject must be able to give written parental permission and comply with the requirements of the study protocol For female subjects: negative serum pregnancy test and must be willing to use contraception during study participation Research subjects will be excluded from the study based on History of CF-related liver disease with portal hypertension Currently smoking cigarettes or other tobacco products Use of daytime oxygen supplementation Previous organ transplantation Unstable or uncontrolled hypertension Ongoing use of oral corticosteroids For female subjects: pregnancy or lactation and unwillingness to use contraception during study participation Any hemodynamically significant congenital or acquired cardiac disease or significant cardiomyopathy, hematologic disease (i.e. hemoglobinopathies), or pulmonary disease associated with an increased risk of pulmonary perfusion defects or pulmonary hypertension other than as an outcome of CF History of renal and/or hepatic insufficiency, defined as cystatin-C level that exceeds normal range and a previous diagnosis of liver cirrhosis", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 3.0-12.0, All Tonsillectomy children age 3-12 years ASAI,II contraindication for usage of Ketamine, dexamethasone upper respiratory tract infection increase intracranial pressure( ICP) history of allergy ,seizure,psychiatric illness, , bleeding disorders chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery history of peritonsillar abscess, , tonsillitis within two weeks, -", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 1.0-1.559, All Haemophilus Influenzae Type b (Hib) Infection Infants 365-569 days of age Subjects who already received a booster dose of Hib vaccine History of serious reaction(s) following vaccination Any vaccination within 7 days of study vaccination Known or suspected immune impairment", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-65.0, All Peritonsillar Abscess Criteria:patients with PTA in ages 18-65, who agreed to join the research - cave to dypiron and/or tramadol, pregnant women, mental illness,soldiers", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 20.0-70.0, All Dysphagia The Stroke Center inpatients and outpatients with known or suspected dysphagia can be included for study as well as patients who are admitted specifically for this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or choking when eating, shortness of breath during swallowing, food backing up into the mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained loss of weight Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. Non-ambulatory patients will be excluded if they cannot be braced or supported within the fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 2.0-5.0, All Crossbite Openbite Drooling healthy children aged 3-4 years that use a pacifier children suffering from a chronic or developmental disease that can affect the orofacial region finger sucking children children suffering from low muscle tonus, abnormal drooling", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-999.0, All Peritonsillar Abscess referring doctor suspects peritonsillar abscess patient is voluntary patient has daily access to his/her e-mail patient speaks and understands Finnish of Swedish female patients have adequate birth-control method patient has peritonsillar abscess allergy to penicillin allergy to metronidazole use of metronidazole in preceding one month pregnancy breast-feeding renal insufficiency liver insufficiency alcoholism (drunk at least once a week) participant in another clinical trial at the moment treatment of peritonsillar abscess requires in-patient care", "label": "2"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 6.0-10.0, All Vocal Fold Nodules is contingent on the presence of apparent vocal fold nodules, which are defined as bilateral, localized, benign, superficial growths with protrusion on the medial surface of the true vocal folds at the junction of their anterior and middle thirds. This examination is based on video-stroboscopic examination, or, in rare cases, on operative microsuspension laryngoscopy. In addition, strict are applied toward excluding masses that are not nodules. Defining characteristics for these are based upon the evaluations of three senior otolaryngologists of each participant's exam. Children evaluated by the senior otolaryngologist at each institution suspected to have vocal fold nodules are candidates for to this study. Patient de-identified images of the stroboscopy are reviewed by each of the other two laryngologists; only those children with confirmed vocal fold nodules by the all three senior otolaryngologists will be considered for entry into this study Children 6 to10 years of age will be enrolled. The rationale for this age range was previously noted. In brief, children in this age range (a) have similar educational and social exposures; (b) will likely not yet encounter pubertal changes affecting the larynx; and (c) are relatively cognitively homogeneous. Moreover, children in this age range have the ability to cooperate with voice therapy and have also been shown to be tolerant of stroboscopic examination. Finally, the voice therapy regimen in this protocol has been shown to be clinically effective for many children in this age range Voice-related quality of life must be affected to the extent that baseline scores are <87.5 (on a scale of the worst, 0, to the best, 100) at the time of entry into the trial. Based on previously published data, this subset of scores will be clearly distinct from scores in children with normal voices. In addition, scores <87.5 represent worse than average scores among children diagnosed with vocal fold nodules Dysphonia duration prior to randomization must be at least 12 weeks, in order to ensure that vocal dysfunction is chronic in nature Hearing in better ear of 35 dB or better Agreement by informed consent from the parents and informed assent from the child participant with anticipated commitment to compliance throughout the follow up period of 3 months is necessary for enrollment which includes time commitment of up to 3 hours per week to therapy sessions and homework Vocal fold nodules are a pathology that predominantly affects males. A number of studies and the databases utilized to track this pathology at the clinical sites indicate that the male: female ratio is approximately 7:3. Given this background, the enrollment plan for the current investigation will seek to have a 30% female representation of the patients enrolled in this study to ensure appropriate gender representation. Additionally, patients with a diagnosis of pediatric vocal fold nodules predominantly are found in Caucasian populations. However, in accordance with the National Institute of Health Revitalization Act of 1993 the of minorities in this proposal will be targeted to the representation of minorities in the greater Boston, Philadelphia and Milwaukee metropolitan regions Children with non-standard nodules or masses that are not unequivocally nodules are excluded, including those with irregular epithelium, concern for malignancy requiring biopsy, rapid growth pattern, airway obstruction requiring urgent or operative intervention, and prior laryngeal surgery. Furthermore, since there are several lesions that can present as bilateral true vocal fold masses (such as unilateral cysts or polyps with contralateral fibrovascular reaction, contact granulomas, and Reinke's edema), masses with the following characteristics will be excluded: a) yellow or blue color suggestive of a mucous or fluid-filled component, b) pink friable lesions at the posterior aspect of the true vocal folds, c) watery edematous expansion without a distinct protrusive mass. Defining characteristics for these are determined and corroborated by the evaluations of three senior otolaryngologists of each participant's videostroboscopic exam. This examination is based on video-stroboscopy, or, in rare cases, on operative microsuspension laryngoscopy. The video images will be placed on a password-protected server to which all three senior investigators will have access; these video images will not contain any patient identifying information but rather a study number that will be assigned to each participant. In addition, strict are applied toward excluding masses that are not nodules Children who have previously received any form of speech therapy targeting voice and/or resonance with the exception of articulation or speech therapy Children for whom voice therapy protocols will be problematic are excluded: developmental delay, cognitive disorder, behavioral disorder, neurologic disorder, articulation disorder, phonological disorder, language disorder, expressive and/or receptive language delay, specific language impairment, central auditory processing disorder, fluency disorder, prior knowledge of voice therapy principles through previous interventions (with the exception of articulation or speech therapy), and inability to commit to at least 12 weeks of therapy as determined and evaluated by the treating speech language pathologist and confirmed by consensus of all three PIs Children whose caregivers cannot complete the primary endpoint are excluded: non-English speaking as the instrument is administered in English, and those unable to commit to the 3-month treatment and follow-up schedule Children whose caregivers are not willing to commit up to 3 hours per week to vocal therapy including therapy sessions and homework for up to 12 weeks Children who cannot tolerate a conscious video-stroboscopic examination and whose parents feel that the diagnostic information gained by a planned examination under anesthesia is not valuable for the severity of presenting symptoms are excluded Children with significant confounders of voice-related quality of life are excluded: vocal fold paralysis, neurologic disorder of the larynx (dystonias, tics, tremors, etc), ongoing acute upper respiratory tract infection (defined by at least 2 of the following: sneezing, coughing, nasal congestion, runny nose, or temperature greater than 100.4\u00b0 F (38.0\u00b0 C), and untreated or unsuccessfully treated allergic rhinitis/post nasal drip", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.5-6.0, All Infections, Respiratory Tract Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol A male or female child between, and including, six to 72 months of age at the time of enrolment Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject No antibiotic therapy within four weeks prior to the visit No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome No documented evidence or suspicion of gastroesophageal reflux disease No evidence of an upper viral respiratory infection four weeks prior to the visit In addition, all subjects regarded as 'cases' must satisfy all the following at study entry Persistent cough greater than eight weeks No response to five-day prednisolone treatment Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Child in care", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.5-3.0, All Seasonal Influenza; Influenza; Influenza Due to Unspecified Influenza Virus Human Influenza Male and female previously unvaccinated healthy children aged 6 to <36 months Any known or suspected impairment of the immune system, any serious disease Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.164-0.329, All Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Influenzae Infections Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems Have a normal gestational age (\u2265 37 weeks); birth weight > 2.5 kg There is no congenital disease detected through interview and clinical examination Already had or not yet received Hepatitis B vaccination at birth Do not have dermatological diseases such as eczema, allergies Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures Already vaccinated with DTP vaccine Have an acute infection at the time of study vaccination Contraindications to Quinvaxem Receiving treatment with systemic corticosteroids Currently participating in another clinical trial In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth Parents intend to move to another location during the study (the next 12 months)", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.167-5.0, All Haemophilus Influenzae Type B Infection Male and female children 2 months to 5 years of age scheduled to receive vaccination Contraindications to Vaxem\u2122Hib Korean Prescribing information", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.5-5.0, All Healthy Healthy subjects aged from 6 months to 5years old of normal intelligence The subjects'guardians are able to understand and sign the informed consent Subjects established as healthy after medical history questioning,physical examination and clinical decision and in accordance with vaccination requirements of the experimental vaccine Subjects who can comply with the requirements of the clinical trial program according to the researcher's views Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine Subjects with temperature \uff1c37\u00b0C on axillary setting for the first dose Subject who has a medical history of Meningitis Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on Subject who is allergic with tetanus toxoid components Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection Subject who has a history of allergic reactions Any known immunological dysfunction Had received gamma globulin or immune globulin, in the past two weeks Subject suffering from congenital malformations, dysgenopathy or serious chronic disease Any acute infections", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.5-5.0, All Group A, C Polysaccharide Meningitis Type b Haemophilus Influenza For the children (aged from 2 to 5 years old) Healthy subjects aged from 2 to 5 years old of normal intelligence The subjects' guardians are able to understand and sign the informed consent Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine Subjects who can comply with the requirements of the clinical trial program according to the researcher's views Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine Subjects with temperature \uff1c37\u00b0C on axillary setting Subject who has a medical history of Meningitis Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on Subject who is allergic with tetanus toxoid components Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection Subject who has a history of allergic reactions Any known immunological dysfunction Had received gamma globulin or immune globulin, in the past two weeks Subject suffering from congenital malformations, dysgenopathy or serious chronic disease Any acute infections Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 50.0-55.0, All Herpes Esophagitis Vocal Fold Palsy Patient of Herpes esophagitis with vocal palsy presentation Patient of Herpes esophagitis without vocal palsy presentation", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.25-0.417, All Meningitis Influenza Healthy subjects aged 3 to 5 months, normal intelligence The subjects' guardians are able to understand and sign the informed consent Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine Subjects who can comply with the requirements of the clinical trial program according to the researcher's views Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine Subjects with temperature\uff1c=37\u00b0C on axillary setting for the first vaccination Subject who has a medical history of Meningitis Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on Subject who is allergic with tetanus toxoid components Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection Subject who has a history of allergic reactions Any known immunological dysfunction Had received gamma globulin or immune globulin, in the past two weeks Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws Any acute infections in last 7 days", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-999.0, All Abrasion of Soft Palate Intubation Complication Informed patient consent ASA I III Age > 18 years Elective surgery, other than head and/or neck surgery Pre-operative Mallampati I III BMI < 35 kg/m2 Fasted (\u22656 hours) No informed patient consent ASA \u2265 IV Age < 18 year Emergency surgery, surgery of head and/of neck Locoregional anaesthesia Pre-operative Mallampati IV BMI > 35 kg/m2 Fasted < 6 hours Pre-operative expected difficult airway (restrict neck movement, thyromental distance < 65mm, retrognathia) Bad, fragile dentition", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.0-5.0, All Infections, Rotavirus Continuously enrolled from birth. (Note: Due to the absence of birth dates in insurance claims data, this criterion will be met if a child's year of first enrollment and year of birth are the same. If so, then the date of first enrollment will be used as proxy for date of birth.) Received both medical and pharmacy benefits Enrolled in capitation-based health plans For MarketScan Commercial, residence in states with universal vaccination programs that the RV vaccine or where RV vaccine cannot be ascertained (i.e., Alaska, Idaho, Massachusetts, Maine, North Dakota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming) Lost to follow-up or had RV prior to 6 weeks of age", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-999.0, All Peritonsillar Abscess Older than 18 years of age Diagnosed with a peritonsillar abscess that has been drained and purulence has been obtained Pregnant Under the age of 18 Bilateral peritonsillar abscesses Recently drained peritonsillar abscess Immunocomprimised", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.0-999.0, All Streptococcus Pneumoniae Neisseria Meningitidis Haemophilus Influenzae Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol Written informed consent obtained from the subject/from the parent(s)/LAR of the subject A male or female subject who visits the hospital with suspected bacterial meningitis CSF sample taken as part of routine practice Child in care", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-70.0, All Airway Morbidity ASA (American Society of Anesthesiologists patient fitness category) I, II, III Age 18-70 General anesthetic for where LMA placement is not contraindicated will be included Small mouth opening Preoperative sore throat/dysphagia/dysphonia Patients at increased risk for aspiration Morbid obesity BMI > 40 Untreated chronic GERD Pregnancy Suspected supraglottic abnormalities N2O use Need for oral-pharyngeal suctioning Undergoing oral and nasal surgery", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-999.0, All Recurrent Tonsillitis Recurrent Peritonsillar Abscess Obstructive Sleep Apnea Any adult patient who meets and is scheduled for tonsillectomy Any patient with prior use of acupuncture Individuals under age 18 Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy Patients with a known personal or family history of a bleeding disorder will be excluded Patients with a history of kidney or liver problems will also be excluded Patients found to be pregnant will be excluded from participation Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-70.0, All Sleep Apnea, Obstructive for OSA Patients OSA (elevated AHI) Age range 18-70 years Any known cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease Susceptible to stomach ulcers Pregnant women History of hypersensitivity to Afrin, Lidocaine, trazodone and/or donepezil History of bleeding diathesis and/or gastrointestinal bleeding Use of any medications that may affect sleep or breathing A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day Desaturations to below 70% lasting greater than 10 seconds in duration per event on polysomnography", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 60.0-85.0, All Pulmonary Aspiration Age 60-85 years' old Both male and female patients ASA I-II Body mass index (BMI) \u2264 30 kg/m2 Elective surgery under general anaesthesia with the use of laryngeal mask airway (LMA) / LMA Proseal / LMA Supreme Type of surgery: Urogynecological, General Surgery, Orthopedics, Eye, Vascular, Plastic Surgery/anaesthesia lasting for 0.5-3 hours Patients with difficulty in swallowing, preexisting neuromuscular or central nervous system disorder Patients undergoing intra abdominal, thoracic, face, nasal or throat surgery Known condition interfering with gastric emptying Patients with cognitive or hearing impairment and inability to provide informed consent ASA III-IV patients Use of muscle relaxant during the course of general anesthesia Contraindication or previous adverse response to any of the study drugs", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-999.0, All Esophageal Cancer age \u2265 18 years dysphagia due to unresectable esophageal cancer participant resides within 50 km of Tenwek Hospital tumor is \u2264 9 cm in length and > 2 cm distal to the upper esophageal sphincter (UES) no esophago-respiratory fistula (ERF) or suspected perforation is present unable to provide written informed consent", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 3.0-9.0, All Nasopharyngeal Carriage of Streptococcus Pneumoniae for FinIP-vaccinated children age 3 to 5 years enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1) at least one parent with fluent Finnish informed consent from one parent for FinIP-vaccinated children PCV vaccination administered, other than the randomized study vaccine history of antimicrobial treatment within 4 weeks (the child can be enrolled later) for unvaccinated siblings age 5 to 9 years younger sibling living in the same household having participated in the FinIP trial (regardless of the vaccination schedule) at least one parent with fluent Finnish informed consent from one parent for unvaccinated siblings PCV vaccination administered", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 3.0-9.0, All Pain Postoperative, Intraoperative Hemorrhage children aged 3-9 years American Society of Anesthesiologists 1-2 status, scheduled for adenotonsillectomy Children with systemic disease, metabolic and endocrin disorders, growth developmental and motor-mental retardation, those who had a history of allergy to any of the study drugs, peritonsillar abscess, hypertension, psychiatric and epileptic disorders, chronic pain syndrome, and those who received analgesics within 24 h prior to surgery were excluded from study", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 20.0-60.0, All Voice Disorders Age between 20-60 No occurence of speech therapy simultaneously to the intervention Professional voice use in another activity Frequent use of alcohol and tobacco Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 4.0-11.0, All Vocal Fold Nodules Diagnosis of vocal fold nodules Age 4-11 yr Informed Consent English comprehension and production sufficient to participate in the protocol and in voice therapy Considered behaviorally and cognitively appropriate by the ear, nose, and throat physician and speech-language pathologist for voice therapy Parent and child willingness to participate in all aspects of the protocol and voice therapy Co-morbid medical conditions or medications that would mask or amplify the outcome of voice therapy, including (a) developmental or other neuromuscular conditions, (b) major illness, chronic or acute, with the exception of laryngopharyngeal reflux disease (LPR) or allergies and their treatments, which are common in both children and adults with voice disorders, thus their would severely restrict the participant pool and, moreover, threaten external validity Hearing loss: > 20 dB hearing loss at 1000, 2000, 4000 Hz in at least one ear", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-70.0, All Obstructive Sleep Apnea Ages 18-70 years sleep study (with apnea hypopnea index>5) Diagnosis of obstructive sleep apnea Any known unstable cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease Susceptible to stomach ulcers Pregnant women or Nursing mothers Using positive airway pressure (PAP) therapy over one week or longer Body weight <55kg History of hypersensitivity to Afrin, Lidocaine and/or Donepezil History of bleeding diathesis and/or gastrointestinal bleeding Use of any medications that may affect sleep or breathing A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 0.083-65.0, All Abscess Soft tissue abscess suspected by patient history and physical exam and confirmed by bedside ultrasound Able to provide written consent/ assent Incision and drainage to be performed by ED physician Peritonsillar abscess Pilonidal cyst, genital or perirectal abscess Post-surgical wound infections Pregnant Prisoners Previous incision and drainage for current abscess", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 2.5-4.0, All Premature Birth Child was born between 26 and 37 weeks gestational age Infant is a singleton (matched between groups) Mother is 18 years of age or older Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent) Child demonstrates developmental deficit (language, cognition, motor, emotion) The child has severe congenital anomalies including chromosomal anomalies The child has severe motor or physical disability Mother currently presents with psychosis or is currently taking antipsychotic medication Status of enrolled subject changes and subject no longer falls in Mother and/or infant has a medical condition that precludes intervention components Mother and/or infant has a contagion that endangers other participants in the study", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-60.0, All Sleep Apnea, Obstructive Healthy control subjects Cardiovascular disease other than well controlled hypertension Depression", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-60.0, All Sleep Apnea, Obstructive Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr) Cardiovascular disease other than well controlled hypertension Depression", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 2.0-3.917, All Autism Spectrum Disorder Diagnosis of autism Currently do not emit vocalizations or minimally verbal Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks Children with significant problem behavior that interferes with structured intervention", "label": "0"} +{"topic": "A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled \"hot potato\" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines.", "doc": "eligible ages (years): 18.0-85.0, All Sialorrhea Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications Able to read and provide written informed consent before enrollment into the study, or the subject's caregiver (Legally Authorized Representative) can provide written informed consent Male or female, 18 to 85 years of age (inclusive) Minimum unstimulated salivary flow rate of 0.2 g/min at screening Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at screening Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis A moderate to high risk of aspiration will participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate Respiratory forced vital capacity (FVC) of <20% of predicted Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening Subjects should be excluded if, in the Investigator's opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subject's participation is complete) Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function Prior salivary gland surgery Current treatment or treatment at any time during the study with Coumadin\u00ae (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary Evidence of any clinically significant neurologic disease Pregnancy or lactation Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not the subject from continued study participation", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 0.0-999.0, All Anemia, Hemolytic, Autoimmune Felty Syndrome Purpura, Thrombocytopenic Autoimmune Diseases ENTRY --Disease Characteristics-- Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants) Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3 --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Age: Not specified Performance status: Not specified ", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 0.5-10.0, All Malaria presentation at health centre with febrile illness monoinfection with P falciparum parasitaemia >=500/microlitre fever or history of fever signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul) severe malnutrition clinically evident concomitant disease PCV <20% history of allergy to the study medications residence outside the study area and hence difficult to follow up", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 0.0-999.0, All Myelodysplastic Syndromes diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line + dysplasia in 2 cell lines (and no other cause (especially deficiencies)) and a pathologic anatomic diagnosis after bone marrow punction refractory anaemia (RA): blood: \u2264 1% blasts, \u2264 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts \u2264 15% of the erythroid cells refractory anaemia with ringed sideroblasts (RARS): blood: \u2264 1% blasts, \u2264 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts > 15% of the erythroid cells refractory anaemia with excess blasts (RAEB): blood: < 5% blasts, \u2264 1 x 109 monocytes; bone marrow: blasts \u2265 5 -\u2264 20% chronic myelomonocytic leukaemia (CMML): blood: >1 x 109/l monocytes, <5% blasts; bone marrow: blasts < 20%, increase of the monocytic component erythrocyte transfusion need working knowledge of the national language written consent for participating this study (informed consent) candidate for bone marrow or organ transplantation medication: growth factors (GM-CSF), or EPO patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks refractory anaemia with excess blasts in transformation (RAEB-t): blood: \u2265 5% blasts or Auer rods; bone marrow: or blasts > 20 < 30% or Auer rods pregnancy at the moment of patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia patients with AIDS or a severe congenital or acquired (e.g. iatrogenic) immunological disorder severe active infections at the moment of", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 9.0-15.0, All Schistosomiasis Helminthiases Anaemia Criteria:all schoolchildren, in grade 2 and 3, at four selected schools - ", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 0.0-999.0, All Rh Isoimmunization Pregnant women with red cell alloimmunization associated with a risk of fetal anemia (D, E, c or Duffy (Fya )antibodies, alone or in combination with other antibodies) Gestational age between 12 and 34 weeks at study entry, viable fetus and accurate dating Maternal serum test-result, above the threshold at which the fetus is considered to be at risk of developing hemolytic anemia and thus a potential candidate for invasive testing Presence of Kell-antibodies Presence of fetal hydrops at first ultrasonographic examination Major fetal congenital or chromosomal anomalies", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Schistosomiasis For screening Female, age 18 or over Present to a study midwife with suspected pregnancy Live in a study village For the main study Infected with S. japonicum Pregnancy as determined by urine pregnancy test Age 18 or older Participant is otherwise healthy as determined by history, physical exam, ultrasound and laboratory assessment Pregnancy between 12-16 weeks gestation Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound and laboratory assessment. In particular History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g. active hepatitis, tuberculosis, heart disease Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), Creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Grade 2 or higher abnormality of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will warrant exclusion. For hemoglobin, women with severe anemia defined as hemoglobin less than 7.0 g/dl will be excluded Women with myoma on ultrasound that are sub-mucosal or women with myoma that is in any location and greater than 5 cm in size Women with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of prematurity such as duplicate uterus, uterine septum For less clear cases, the researchers will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. In the case of acute medical conditions such as urinary tract infection, pneumonia, febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness) or the illness self resolves if this occurs before 16 weeks gestation Presence of cysts in the eye suggestive of neurocysticercosis Regular use of a medication for a chronic medical condition History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration Fetus has congenital anomaly determined by 12-16 week ultrasound or is determined to be nonviable (e.g. blighted ovum)", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 0.5-18.0, All Leukemia All children greater than 6 months of age and less than 18 years of age with newly-diagnosed previously untreated or previously diagnosed JMML, which has reoccurred after treatment with chemotherapy, stem cell transplantation, and/or cis-retinoic acid A diagnosis of JMML is confirmed only if the following for JMML are met: a) ALL of the following: Absence of t(9;22) or BCR-ABL by PCR or FISH; Absolute monocyte count >1000 (1 X 109/\u00b5L); <20% bone marrow blasts; b) At least 2 of the following: Elevated Hb F hemoglobin; Myeloid precursors in peripheral blood; WBC >10,000 (10 X 109/\u00b5L); GM-CSF hypersensitivity in methylcellulose culture of bone marrow progenitors cells Adequate hepatic function (bilirubin equal or less than 2.0 mg/dl; ALT equal or less than 3x normal) Adequate renal function (serum creatinine equal or less than 2 x normal) Performance Status: Have a Karnofsky score >50 Written, informed consent according to institution guidelines Pregnant or lactating Receiving any other chemotherapy. Patients must have been off chemotherapy for at least 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment Febrile neutropenia at study entry", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Iron Deficiency Anemia > 18 years of age and signed written informed consent Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery) g/dl < Hb < 13.0 g/dl for men and 10 g/dl < Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery) Ferritin < 100 \u03bcg/l or 100-300 with TSat < 20% Suspicion of iron overload (Ferritin >300 \u03bcg/l or/and TSAT>50%) Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy Folate-and/or Vitamin B12 deficiency (according to local lab reference range) Known history of hepatitis B/C or HIV-positive Liver values 3 times higher than normal Immunosuppressive or myelosuppressive therapy A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients Pregnancy or lactation Transfusion within 1 month prior to study EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the in the trail Participation in any other therapeutic trial within the previous month", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-45.0, All Iron Deficiency Folic Acid Deficiency Healthy pregnant women between 18 and 45 years of age in the second or third trimester of pregnancy (24-32 weeks of gestational age) Normal Hb (Hb\u2265110g/L and Hb\u2264144g/L) Chronic illness (clinically significant neurological, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic diseases) A history or presence of hemosiderosis, hemochromatosis, peptic ulcer, regional enteritis, ulcerative colitis A history of or current use of IV iron therapy or erythropoietin therapy A history or presence of any clinically significant gastrointestinal pathology (eg. chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved gastrointestinal symptoms (eg. diarrhea or vomiting), steatorrhea, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of iron or folic acid Abnormal hemoglobin electrophoresis ie. sickle cell anemia, thalassemia, etc Current acute illness and/or taking antibiotics Known or suspected allergies to Materna\u00ae, or any ingredient present in Materna or SuppleFem Sprinkles or any of the foods to be consumed during the trial Mildly to severely anemic women (Hb<110 g/L) or elevated hemoglobin (above 144g/L) Complications in pregnancy (including pregnancy induced hypertension, preeclampsia, a history of severe antepartum hemorrhage) Blood transfusion within last 3 months", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-55.0, All Anemia Every patient followed at the HME at the beginnig of the pregnancy pregnency women who don't speak french pregnancy women affected by b\u00e9ta thalassemia pregnancy woman having had a p\u00e9riconceptionnel treatment against the anaemia", "label": "1"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 5.0-999.0, All Sickle Cell Disease Hemolytic Anemia Established Diagnosis of Hemolysis Sickle Cell Disease (e.g., HbSS, HbS/\u03b2-thalassemia, HbSC) Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH) Age SCD participants: 5 years of age up to 19th birthday All other participants: 5 years of age and up (no age limit) Previous cardiac surgery Known left ventricle dysfunction (i.e. shortening fraction < 28%) Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-65.0, All Chronic Hepatitis C Male and female patients aged 18-65 years Elevated liver enzymes levels Compensated liver disease Available liver histology confirming F2 fibrosis Written consent to participation Age <18, >65 Prior ribavirin treatment Intolerance towards ribavirin, PegIFN or erythropoetin Pregnancy or breast feeding Relevant cardiovascular or pulmonary disease Kidney insufficiency (creatinine clearance <50ml/min) Coinfection with HIV or hepatitis B virus Hepatic comorbidities (hemochromatosis, Wilson's disease, autoimmune disorders) Alcohol consumption > 40g/day Psychiatric disorders", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Iron Overload Oxidative Stress Iron-deficiency Anemia Women less than 4 weeks postpartum years of age or older Took prenatal vitamins for at least 3 months during pregnancy Successfully initiated breastfeeding Anemic (Hgb < 110 g/L)", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-40.0, All Anemia Caucasian Primiparous Singleton pregnancy (wk 20 to wk 30) Non smokers Pre pregnancy BMI between 19.8 and 26 Healthy, free from iron metabolism disorders (pregnancy induced hypertension Not taking medicines known to influence iron status Not taking iron supplements (multivitamins will be accounted for) Free from gastrointestinal disorders No allergies Pregnancy haemoglobin concentrations are not within the normal range (below 70g/l or over 160g/l)", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 16.0-85.0, All End-Stage Renal Failure Functional Iron Deficiency Two groups of random routine anonamised blood samples (for use in determinimg a local normal range for the Reticulated Haemoglobin Content [RetHe])will be included in the study Normal red blood cell (RBC) Indices (Hb , Haematocrit, Mean Cell Volume ande Mean Cell Haemoglobin Content) ; an attempt will be made to select an equal mixture of men / women and an appropriate age spread to provide a valid control range for the group of test subjects (renal patients) The student Investigator will ask Haematology staff to record minimum details of iron deficient patients and \"normal\" test results noted at routine validation [positive identification number (barcode)/ age / sex] these samples will be coded and additionally analysed for RetHe test All renal patient who have had surgery and / or a Blood Transfusion OR bleeding episodes within the last month prior to the study are excluded as this would interfere with red cell parameters All patients < 16 years and >85 years are excluded from the study", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Anaemia Pregnant women aged \u226518, gestational week \u226520, \u226433 at baseline visit with normal antenatal screening test results Iron deficiency anaemia defined as Hb concentration \u22658 g/dl and \u226410.4 g/dL and serum ferritin \u226420 mcg/L at screening Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein >10 mg/dl or outside reference range), any acute infection at screening Pre-eclampsia Multiple pregnancy Evidence on any significant abnormalities on anomaly ultrasound Haemochromatosis or other iron storage disorders Folate deficiency (S-folate <4.5 nmol/L) at screening Vitamin B12 deficiency (S-cobalamin <145 pmol/L) at screening Serious medical condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Warm Autoimmune Hemolytic Anemia Age > 18 years AIHA defined at time of diagnosis by a Hgb level \u00a3 10 g/dL, with a reticulocytes count > 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern) Disease duration equal or less than 6 weeks at time of --> removed by amendment n\u00b04 and substituted by :First episode of AIHA to \"hot\" antibody previously untreated or treated corticosteroids for less than 6 weeks Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be eligible for the study if the platelet count is over 30 x 109/L at inclusion Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion Absence of detectable lymph nodes on a total body CT-scan (to be performed before if not performed at diagnosis) Effective means of contraception during treatment and for six months after completion of treatment for all women of child bearing age Negative serum pregnancy test within 14 days prior to study entry Written informed consent Previous treatment with rituximab AIHA diagnosed and treated more than 6 weeks prior to removed by amendment n\u00b04 and substituted by AIHA relapsed or newly diagnosed but treated with corticosteroids for more than 6 weeks Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment administered within 2 weeks prior to the beginning of the study treatment Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years Autoimmune disorder such as SLE with at least one extra-hematological manifestation requiring a treatment with steroids and/or immunosuppressive drugs Any other associated cause congenital or acquired hemolytic anemia (except thalassemia trait or heterozygous sickle cell anemia) Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of a monoclonal IgM with cold agglutinin properties Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen (HbsAg) Neutrophils count < 1,000/mm 3 at inclusion", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 20.0-45.0, All Pregnancy Iron Deficiency Iron Deficiency Anemia pregnant women with one of genetic thrombophilia markers as factor V Leiden, prothrombin 20210A mutation, antiphospholipid antibodies, hyperhomocysteinemia and deficiencies of antithrombin, protein C, or protein S pregnant women affected by HT and suffering of iron deficiency (ID) and iron deficiency anemia (IDA) different trimester of pregnancy previous miscarriage/s previous preterm delivery/ies iron disorders as iron deficiency and iron deficiency anemia are defined by the number of red blood cells <4.000.000/mL, the hemoglobin concentration \u2264 11 g/dL, the total serum iron \u2264 30 mg/dL and serum ferritin \u226412 ng/mL absence of iron deficiency and iron deficiency anemia non-pregnant women uncomplicated pregnancies no informed consent other treatments of iron supplementation recent blood transfusion other concomitant diseases ascertained allergy to milk proteins or to iron products", "label": "1"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 15.0-45.0, All Malaria Women aged 15-45 years resident in the predefined study area Pregnant, with gestational age <23 weeks Failure to provide a blood sample Initial haemoglobin concentration <90 g/L Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes Obstetric history suggestive of eclampsia or pre-eclampsia Obvious mental retardation or metabolic disorder No written consent Carrying multiples Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter Woman planning to deliver outside the research clinic", "label": "2"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Autoimmune Hemolytic Disease (Cold Type) (Warm Type) Newly diagnosed \"warm\" or \"cold\" AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria) Idiopathic \"warm\" or \"cold\" AIHA relapsed after first line treatment with oral prednisone Aged >18 years ECOG performance status grade 0, 1 or 2 No psychiatric illness that precludes understanding concepts of the trial or signing informed consent Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice Cell or humoral immunologic deficit (congenital or acquired) Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients History of malignancies within 3 years prior to study entry Concomitant immunosuppressive or cytotoxic treatment Positive pregnancy test. Lactation The presence of associated organ-specific autoimmune diseases do not constitute Previous splenectomy does not constitute", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 1.0-3.333, All Non-anemic Iron Deficiency Age between 18 and 36 months attending any well child visit Informed parental consent Previously diagnosed: developmental disorder, genetic, chromosomal or syndromic condition, chronic medical condition, (with the exception of asthma and allergies), including chronic anemia, iron deficiency or recent oral iron supplementation or treatment Prematurity with a gestational age less than 35 weeks; low birth weight less than 2500 grams Attending the office for an acute illness, such as a viral illness, or other health concern other than well-child assessment Any contraindications to receiving elemental iron (i.e. NHP [natural health product], comparator or placebo) The use of any Natural Health Product containing the same medicinal ingredient(s) as the investigational product English not spoken to the child in the home or in a child care setting", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Sickle Cell Disease Sickle Cell Anemia Anemia, Sickle Cell All volunteer subjects must be at least 18 years of age and have provided informed, written consent for participation in this study. in the study is determined prior to enrollment on the basis of the following and Laboratory values obtained within the preceding 60 days are sufficient for screening purposes for SCD Cohort Males or females 18 years of age or older Diagnosis of sickle cell disease (any form; electrophoretic or HPLC documentation is required) for SCD Cohort Chronic scheduled transfusions Current known pregnancy or lactation Hemoglobin < 5.0 g/dL; however, subjects may return for repeat evaluation at a later date Currently smoking and unable to refrain from smoking for 24 hours Subjects previously known to have conditions that may independently affect hemolytic rate", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 15.0-35.0, All Iron Deficiency Singleton pregnancy Non-smoker No pre-existing medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) Complicated pregnancy (including gestational diabetes, pregnancy-induced hypertension, or preeclampsia) Individuals been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study", "label": "2"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 0.75-2.0, All Iron Deficiency Iron Deficiency Anemia Between 9-24 months of age Weighed 5.5 lbs or more at birth Born at 34 week gestation or more Consumed infant formula within the past 3 months Inflammatory bowel disease, cystic fibrosis, liver or kidney disease, cancer, HIV, primary immune deficiencies, anemia unrelated to iron status, chronic blood loss in stool, inherited disorders or iron status, or bleeding or coagulation disorders) Previous diagnosis of iron deficiency or iron deficiency anemia Previous treatment of iron deficiency or iron deficiency anemia", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 0.5-49.0, All Malnutrition Gestational age \u2264 20 weeks Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area) Pregnancy identified and registered in the CHDP program before the beginning of the enrollment", "label": "1"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-45.0, All Iron Deficiency Anemia Women 18-45 years old with iron deficiency anaemia haemoglobin level between 85 g/L and 105 g/L serum ferritin level < 15 \u00b5g/L D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation Standard diet Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure Haemochromatosis or iron overload of secondary origin (blood transfusion) Long term treatment known to modify iron absorption Gastro duodenal ulcer Inflammatory bowel disease or any digestive disease which could modify iron absorption Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders) Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Lung Hypoxia Pulmonary Arterial Hypertension Iron Deficiency Willing and able to give informed consent for participation in the study Men and women aged 18 years or older and generally in good health Detectable tricuspid regurgitation on echocardiography during both normoxia and hypoxia enabling measurement of pulmonary arterial pressure For iron-deficient volunteers: ferritin \u226415microg/L and transferrin saturation <16% For iron-replete volunteers: ferritin \u226520microg/L and transferrin saturation \u226520% Haemoglobin <8.0g/dl Haemoglobinopathy Iron overload defined as ferritin >300microg/L Hypoxia at rest or on walking (SaO2 <94%) or significant comorbidity that may affect haematinics, pulmonary vascular or ventilatory responses, e.g. current infection, a chronic inflammatory condition, known cardiovalvular lesion or pulmonary hypertension, uncontrolled asthma or chronic obstructive pulmonary disease Exposure to high altitude (>2,500m) within the previous six weeks or air travel >4 hours within the previous week Iron supplementation or blood transfusion within the previous 6 weeks Pregnancy or breast feeding", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 9.0-25.0, All Autoimmune Diseases in Subjects Receiving Cervarix\u00ae Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses for the exposed female cohort Female aged from 9 to 25 years at the reference date (01 September 2008 through 31 August 2010) Recorded in the CPRD GOLD for at least 12 months before the reference date The first dose of Cervarix received between 01 September 2008 through 31 August 2010, Full date (day/month/year) of Cervarix vaccination(s) available Subject defined as acceptable in CPRD GOLD for the unexposed historical female cohort Female aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007) Recorded in the CPRD GOLD for at least 12 months before the reference date Subject defined as acceptable in CPRD GOLD for all cohorts Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date Subjects who received at least one dose of unspecified HPV vaccine or Gardasil at any time before the reference date Subjects who have been included in the other cohort for the non-exposed cohorts \u2022 Subjects who received any dose of Cervarix at any time before the reference date", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 13.0-80.0, All Ulcerative Colitis Crohn's Disease Patients with proven iron deficiency anaemia on World Health Organisation (WHO)criteria Patients aged 13 will be considered adolescents, and aged >18 as adults Anaemia caused by B12 or folate deficiency, or secondary to drugs used to treat IBD; haemoglobinopathies or myelodysplasia; severe cardiopulmonary, hepatic or renal disease; severe cardiopulmonary, hepatic or renal disease; pregnancy and breast feeding females", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-49.0, All Iron Deficiency Anemia 49 years Regular menstruation in the last three months Hemoglobin <12 mg/dl Serum Ferittin<20mcg/L BMI 18.5Kg/m^2 to 29.9 kg/m^2 history of gastrointestinal or hematological disorders taking medications that could interfere with hematopoiesis or dietary iron absorption pregnant (based on pregnancy test)", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-75.0, All Amyotrophic Lateral Sclerosis The patient has been correctly informed The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is at least 18 years old and less than 75 years old Probable, or laboratory-supported probable or definite ALS as defined by El Escorial Revised ALS diagnostic (according to Airlie House Conference 1988) Stable on riluzole treatment for more than 3 months with liver function test results < 2ULN Disease duration \u2264 5 years Vital capacity \u2265 70% of normal Ability to swallow without the requirement for nasogastric or PEG feeding Agreement for patient to use an adequate method of contraception throughout the study and for 2 weeks after post study visit The patient is participating in another interventional study Within the past three months, the patient has participated in another interventional The patient is in an period determined by a previous study The patient is under judicial protection The patient is an adult under guardianship The patient refuses to sign the consent It is impossible to correctly inform the patient Other life threatening disease Presence of contra-indicated concomitant treatments or with potential neuroprotective benefit (see section 11.2 of the protocol) Presence of tracheostomy or non-invasive ventilation", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 20.0-35.0, All Treatment of Iron Deficiency Anemia in Pregnancy Maternal age 20-35 years old Singleton pregnancy between 16 weeks Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study Extremes of reproductive age (less than 20 years old or more than 35 years old) Patients with multiple pregnancies Anemia not linked to iron deficiency Allergy to iron derivatives Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer Those who had received parenteral iron treatment earlier within 3 months before the start of the study Any obstetric complicating factors like pregnancy induced hypertension Patients with history of chronic blood loss", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 16.0-999.0, All Autoimmune Hemolytic Anemia Patients diagnosed with primary warm Autoimmune Hemolytic Anemia Secondary Autoimmune Hemolytic Anemia (infections, hemopathy, systemic diseases) Naive to any treatment for hemolytic anemia or in relapse Older than 16 years of age Able to understand written and spoken French who have provided written informed consent \u2022 for Persons without an auto-immune disease, or cancer or an active infection Older than 16 years of age Able to understand written and spoken French Cold agglutinin disease Pregnant women Persons not covered by national health insurance Non-Inclusion controls Persons treated with corticoids or immunosuppressants Pregnant women Persons not covered by national health insurance", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-45.0, All Iron Deficiency Anemia Iron Deficiency Anemia Female, 18 to 45 years old Serum ferritin levels <20 \u00b5g/L Normal body Mass Index (18.5-25 kg/m2) Body weight <65 kg Signed informed consent Anaemia (Hb < 11.7 g/dL) Elevated c-reactive protein or alpha1-glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) Continuous/long-term use of medication during the whole studies (except for contraceptives) Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months Earlier participation in a study using stable iron isotopes Known hypersensitivity or allergy to iron supplements Women who are pregnant or breast feeding Intention to become pregnant during the course of the studies", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-45.0, All Iron Deficiency Anemia Iron Deficiency Anemia Female, 18 to 45 years old Serum Ferritin levels <20 \u00b5g/L Normal body Mass Index (18.5-25 kg/m2) Body weight <65 kg Signed informed consent Anaemia (Hb < 11.7 g/dL) Elevated c-reactive protein or alpha1 glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) Continuous/long-term use of medication during the whole studies (except for contraceptives) Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months Earlier participation in a study using stable iron isotopes Known hypersensitivity or allergy to iron supplements Women who are pregnant or breast feeding Intention to become pregnant during the course of the studies", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-45.0, All Anemia mildly anemic (on the basis of screening) volunteer males and non-pregnant and non-lactating females, giving written informed consent normolipidemic, normotensive no history of: i. diabetes, hyperlipidemia, obesity, asthma, cancer, respiratory, cardiovascular, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, sexually-transmitted disease, during the last 5 years ii. severe acute or chronic blood loss during last 6 months. iii. bleeding or clotting abnormality during last 1 year. iv. regular cigarette smoking, tobacco chewing v. consumption of vitamin E, vitamin B12, folate, iron or antioxidant during the last 6 months prior to enrollment pregnant and lactating females cigarette smoking, tobacco chewing, alcohol consumers blood transfusions during the last 1 year history of diabetes mellitus, hypertension, dyslipidemia , obesity asthma, cancer, respiratory, renal, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, cardiovascular disorder/disease during the last five years severe acute blood loss during last 6 months bleeding or clotting abnormalities during the last 1 year consumed vitamin E, B12, folate, iron or antioxidants supplements during the last 6 months", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Iron Deficiency Iron Deficiency Anemia uncomplicated singleton pregnancy, first enrollment visit \u2264 20 weeks gestation - < 18 years of age did not live in the county did not anticipate delivery at participating hospital were not mentally competent had a chronic health problem or hemoglobin < 100 g/L at the initial visit were taking iron at the time", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-50.0, All Pregnancy Morning Sickness Nausea Vomiting Hyperemesis Gravidarum Any woman who discontinued her standard vitamins due to gastrointestinal symptoms or due to the tablet size, with one ofthe following conditions Morning sickness Gastrointestinal disorders: Crohn's disease, ulcerative colitis, peptic or duodenal ulcer, irritable colon, celiac disease Iron deficiency anemia Hypothyroidism Depression Women who do not agree to consent to this protocol Women with a known hypersensitivity to any of the ingredients of Pregvit\u00ae, or Orifer\u00ae F", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-50.0, All Iron-deficiency Anemia Pregnant women of any age in their first trimester of pregnancy with anemia defined as a Hemoglobin less than 11 and/or a hematocrit less than 33 Willingness and ability to cook in provided cast iron pot at least 3x/week Singleton gestations Any secondary cause of anemia including inherited and acquired hemolytic anemias (sickle cell disease, thalessemia, malaria, etc) Inability or unwillingness to try to use cast iron pot approximately 3x/week Women with severe chronic illness and high likelihood of preterm birth and/or expected long-term hospitalizations during pregnancy. Multifetal gestations", "label": "2"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Pregnancy Singleton pregnancy Iron deficiency anemia Intolerance or low compliance for oral iron Known allergy for iron supplements Anemia not due to iron deficiency Acute infection Liver failure or viral hepatitis Thalassemia or hemoglobinopathies Asthma Multiple pregnancy", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 2.0-17.0, All Sickle Cell Anemia Pediatric participants with a severe form of sickle cell anemia (HbSS, HbS\u03b20 thalassemia, HbSD, HbSOArab) Age: \u2265 2 and \u2264 17 years of age, at the time of enrollment Time-averaged maximum velocity (TAMV) TCD Velocity in the conditional (170 cm/sec) or abnormal (\u2265200 cm/sec) range by Transcranial Doppler ultrasonography examination within 6 months of enrollment, abnormal or conditional TCD velocity and currently on commercial hydroxyurea for primary stroke prevention, or previously enrolled in SCATE, a previous stroke with abnormal or conditional TCD prior to stroke event Parent or guardian willing and able to provide informed consent and child gives assent Ability to comply with study related treatments, evaluations, and follow up visits Inability to take or tolerate daily oral hydroxyurea, including Known allergy to hydroxyurea therapy Known positive serology to HIV infection Known malignancy Current lactation Abnormal historical laboratory values (most recent pre-enrollment values unless previously enrolled in SCATE) Hemoglobin concentration < 6.0 gm/dL Absolute reticulocyte count < 100 x 109/L with a hemoglobin concentration < 8.0 gm/dL White Blood Cell (WBC) count < 3.0 x 109/L Absolute neutrophil count (ANC) < 1.0 x 109/L", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-999.0, All Warm Antibody Autoimmune Hemolytic Anemia Subject must have had a diagnosis of primary or secondary warm antibody AIHA Must have previously received at least 1 prior treatment regimen for AIHA and have evidence of relapse Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria Subject with a platelet count of < 100,000/\u03bcL Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure \u2265 140 mmHg, or diastolic blood pressure \u2265 90 mmHg", "label": "0"} +{"topic": "A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine.", "doc": "eligible ages (years): 18.0-65.0, All Anemia, Iron-Deficiency Hemoglobin (Hb) < 120 g/L in men and Hb < 110 g/L in women; Mean Corpuscular Volume(MCV) < 80 fl, Mean Corpuscular Hemoglobin(MCH) < 27 pg, and Mean Corpuscular Hemoglobin Concentration(MCHC) < 0.32; the blood biochemical examination: serum ferritin < 12 g/L, serum iron < 8.95 mol/L, transferrin saturation <15%, and total iron binding capacity>64.44 mol/L; with a history of Menorrhagia, monophagia or eating disorders; Willing to sign a Informed consent form Pregnant women; drug allergy; the patients with serious gastrorrhagia, other peptic ulcers, active bleeding, hepatic insufficiency, heart disease or renal insufficiency; those patients can't tolerate the medicine orally, or participate in other clinical study, or refuse to sign a Informed consent Form", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 60.0-999.0, All Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases Men and women, aged 60 or over. Isolated systolic hypertension. Normal diastolic pressure of less than 90 mm Hg ", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 65.0-999.0, All Arrhythmia Atrial Fibrillation Cardiovascular Diseases Heart Diseases Elderly men and women with atrial fibrillation and other risk factors for stroke ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Carotid Atherosclerosis Cerebrovascular Accident Diabetes Mellitus Hypercholesterolemia Hypertension Male or female greater than 18 years of age Patient must have documented hypertension (diastolic BP greater than 90 mmHg or systolic BP greater than 140 mmHg) for greater than 1 year OR hypercholesterolemia (LDL greater than 160 or total Chol greater than 240 with a total cholesterol/HDL-Chol ratio more than 1.6 for greater that 1 year OR Diabetes (blood glucose greater than 150 mg/dl requiring oral antihyperglycemics or insulin dependent) for greater than 1 year OR any combination Subgroup for risk factors with cerebral ischemic events must meet #2 plus documented stroke by physical exam and CT and/or MRI consistent with ischemic infarction or TIA witnessed and recorded by medical personnel Patient will be excluded if enrollment time is within 30 days of a stroke, myocardial infarction, or surgery. Patient may be enrolled after 30 days of the above events No patients on immunosuppressive therapy No patients who are unable to follow up for 1 year from the time of enrollment No stroke patients with an identifiable cardiac source (including atrial fibrillation, mural thrombus, valvular disease with vegetation) ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Cardiomyopathy, Hypertrophic Heart Hypertrophy Patients of either gender, aged 18-75 years, with HCM caused by sarcomeric gene mutations determined by existing protocols LV wall thickness of greater than or equal to 20 mm measured in any LV segment by MRI Severe symptoms refractory to medical treatment (New York Heart Association functional class III or IV) No LV outflow tract obstruction at rest greater than 30 mm Hg as determined by cardiac catheterization No coronary artery disease (greater than 50% arterial luminal narrowing of a major epicardial vessel) No chronic atrial fibrillation No bleeding disorder (PTT greater than 35 sec, pro time greater than 14 sec, platelet count less than 154 k/mm(3) No anemia (Hb less than 12.7 g/dl in males and less than 11.0 g/dl in females) No renal impairment (serum creatinine greater than 1.3 mg/dl) No hepatitis B or C; nor unexplained abnormal LFTs ", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Coronary Disease Cerebrovascular Accident Heart Diseases Heart Failure, Congestive Myocardial Infarction Asthma Emphysema Lung Diseases, Obstructive Aortic Aneurysm, Abdominal Bronchitis Dementia Hypertension Chronic Obstructive Pulmonary Disease Heart Failure ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 65.0-999.0, All Cardiovascular Diseases Coronary Disease Heart Diseases Cerebrovascular Accident Diabetes Mellitus Hypertension Heart Failure, Congestive ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Heart Diseases Hypertension Carotid Artery Diseases Atherosclerosis ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Cerebrovascular Accident Patients may be enrolled in the study only if they meet all of the following Diagnosis of acute ischemic stroke with onset between 3 and 24 hours prior to planned start of study drugs. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia, and not otherwise attributable to ICH or another disease process. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 24 hours are not eligible if their first symptoms started more than 24 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be intact. A careful history is important to determine when the patient was last without the presenting deficits Disabling neurological deficit attributable to the acute stroke at the start of study drugs NIHSS less than or equal to 16 Evidence on PWI MRI of a perfusion defect corresponding to the acute stroke syndrome of at least 2cm in diameter in both long and short axis in any slice. The PWI will be assessed by relative mean transit time (MTT) images. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion defect is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal DWI are eligible Age 18 years, inclusive Patients will be excluded from the study for any of the following reasons General Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial Time interval since stroke onset of less than 24 hours impossible to determine with high degree of confidence Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage Evidence of acute myocardial infarction defined as having at least two of the following three features: 1.) Chest pain suggestive of cardiac ischemia; 2.) EKG findings of ST elevation of greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3.) Elevated troponin I Contraindication to MRI scan Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test Patients who would refuse blood transfusions if medically indicated Stroke Related", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Cardiomyopathy, Hypertrophic HCM Patients HCM defined as maximal LV wall thickness by echocardiography greater than 13mm in the absence of other causes of LVH or greater than 15mm asymmetrical LV wall thickness if there is a history of mild hypertension (defined as systolic less than 160mmHg and diastolic less than 100mHg) controlled for greater than 6 months Non-obstructive HCM Age greater than or equal to 21 years Patients with LV obstruction treated by LV myotomy and myectomy or percutaneous septal alcohol ablation that meet are eligible for this study HCM Patients LV outflow obstruction noted during Doppler echocardiography at rest or with Valsalva maneuver defined as instantaneous peak gradient greater than 30 mmHg Hemodynamically significant valvular disorders, history of significant coronary obstruction (greater than 50% in any single artery), angina symptoms, myocardial ischemia on an imaging stress test or evidence of prior myocardial infarction. Patients older than 40 years of age with effort induced anginal symptoms typical of coronary insufficiency and a coronary distribution of myocardial ischemia on an imaging stress test will be considered for the study if coronary angiography rules out significant obstructive coronary disease Chronic atrial fibrillation Cardiac pacemaker or other metallic implant unsafe for MRI Uncontrolled hypertension Dependence on a beta blocker that cannot be withdrawn Dependence on a calcium blocker that cannot be withdrawn Current use of digoxin History of digitalis intolerance", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Acute Ischemic Stroke Acute ischemic stroke, any territory, with an appropriate neuroradiologic study (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke Onset of symptoms of qualifying stroke within 48 hours prior to randomization. In patients receiving thrombolytic therapy for the acute stroke, such as tissue-type plasminogen activator (tPA), administration of study drug may not start until at least 24 hours after completion of thrombolytic therapy Significant motor impairment of the leg, as indicated by a NIHSS score \u22652 on item 6 Inability to walk without assistance Females who are pregnant, breast-feeding, or of childbearing potential and not using medically acceptable and effective contraception Clinical evidence of VTE at screening Any evidence of active bleeding on the basis of clinical judgment Prior history of intracranial hemorrhage (including that at screening) Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours Thrombolytic therapy (e.g., tPA) or intra-arterial thrombolytic therapy within the preceding 24 hours.Thrombolytic therapy is permitted for treatment of the acute stroke but must have been completed 24 hours prior to randomization Comatose at screening (NIHSS score \u22652 on item 1a) Known or suspected cerebral aneurysm or arteriovenous malformation Confirmed malignancy that may pose an increased risk for bleeding or otherwise compromise follow-up or outcome assessment (e.g., lung cancer) Impaired hemostasis, i.e., known or suspected coagulopathy (acquired or inherited); baseline platelet count <100,000/mm3; aPTT 1.5 X the laboratory upper limit of normal; or international normalized ratio(INR) >1.5", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension, Pulmonary Pilot: The pilot study will enroll two groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), and 2) age, gender, and race matched control subjects for each patient Main: The main study will enroll three groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), 2) patients with PH ascribed to a nonvascular injury process, and 3) age, gender, and race matched control subjects for each PAH patient. Subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. There is no based on race or gender FOR The for this study are as follows Patients diagnosed with IPAH Patients diagnosed with secondary pulmonary hypertension known to have histopathology similar to the primary form or PAH. Clinical conditions causing pulmonary hypertension with histopathology similar to the primary form are listed below i. Eisenmenger Syndrome ii. Collagen vascular disease iii Liver disease with portal hypertension iv. Toxin induced injury (anorexic agents, rapeseed oil) FOR WITH Pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test) Age less than 18 years Inability to provide informed written consent for participation in the study Mean PA less than or equal to 25mmHg or PVR less than 3 wood units PCW greater than 16 mmHg unless increase accounted for by increased transpulmonary gradient greater than or equal to 10 mmHg Patients receiving more than 1 year of oral therapy or more than 6 months of IV therapy FOR WITH The are as follows Patients diagnosed with pulmonary hypertension not known to have histopathology similar to the primary form. Etiologies are listed below", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 80.0-999.0, All Hypertension Aged 80 or older Sitting systolic BP 160-199 mmHg AND sitting diastolic BP < 110 mmHg Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema) Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only Renal failure (serum creatinine of more than 150 \u00b5mol/l) Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not although the patient must be neurologically and cardiologically stable.) Condition expected to severely limit survival, e.g. terminal illness Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause) Gout Clinical diagnosis of dementia Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable) Unable to stand up or walk", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-65.0, All Migraine With Typical Aura Patients must have a current history of migraine with typical aura where the aura is usually followed by headache according to the International Headache Society (IHS) criteria Patients are male or female. N.B. When female patients are treated for migraine attacks with triptans then the required precautions and safety measures should be taken in order to prevent pregnancy Patients with an age between 18 and 65 years Patients must have experienced 1-4 moderate (grade 2) or severe (grade 3) migraine attacks per month for at least two months prior to entry into the study Patients must be willing to keep their prophylactic drug treatment for migraine unchanged Patients must be able to distinguish migraine headaches from other headache types (e.g. tension-type headaches) at the onset of a migraine attack Patients must be able to understand and complete the diary card Patients must be willing and able to give written informed consent prior to entry into the study Patients must be willing and able to carry the Migraid and, if necessary, apply it in a public place Migraine patients with a typical aura but without any migraine headache thereafter Patients with a history suggestive of ischaemic heart disease (IHD) or any present evidence of ischaemic heart disease (like angina pectoris, previous myocardial infarction, documented silent ischaemia, Prinzmetal's angina), or symptoms consistent with IHD Patients suffering from coronary vasospasm or any atherosclerotic disease (cerebrovascular disease [CVD], peripheral vascular disease [PVD] or Raynaud\u2019s disease) which places them at increased risk of coronary ischaemia Patients with a history of cerebrovascular accident (CVA) or transient ischaemic attacks (TIA) Patients with a supine diastolic blood pressure of > 95 mm Hg and/or systolic blood pressure > 160 mm Hg (treated or untreated) at Visit 1 Patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold Patients with tension-type headaches > 15 days/month in either of the two months prior to the study Current abuse of opioid analgesics or other psychotropic drugs. History (within the past year) or current abuse of ergotamine (abuse as defined as > 10 mg/week). Current abuse of alcohol (according to local recommendations) or other drugs Patients suffering from any severe concurrent medical condition which may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in a clinical study Patients with a history of ophthalmoplegic, basilar or hemiplegic migraine", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 65.0-999.0, All Brain Infarction Hypertension Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs) Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging Secondary hypertension Atrial fibrillation History or signs of cerebral disorders other than cerebrovascular disease Malignant tumor Chronic renal failure Severe congestive heart failure Hyperkalemia Stenosis of bilateral renal artery", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 21.0-85.0, All Albuminuria Mild to moderate hypertension Type 2 diabetes mellitus Presence of protein in the urine (albuminuria) Kidney disease not caused by diabetes or hypertension Renal artery stenosis Myocardial infarction or stroke within the last 6 months Type 1 diabetes mellitus Pregnant or lactating females Cancer within the last 5 years", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 70.0-85.0, All Aged Systolic Hypertension Outpatients aged over 70 years and less than 85 years, regardless of sex Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks Previously untreated patients or patients who are on other therapy that can be converted to valsartan Patients with secondary hypertension or malignant hypertension Patients with seated systolic blood pressure of over 200 mmHg Patients with seated diastolic blood pressure of over 90 mmHg Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry Patients with severe heart failure (NYHA functional classification III and IV) Patients with severe aortic stenosis or valvular disease Patients with atrial fibrillation, atrial flutter, or serious arrhythmia Patients with renal dysfunction with serum creatinine level of over 2 mg/dL Patients with serious liver dysfunction", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 40.0-80.0, All Hypertension type 2 diabetes elevated blood pressure and pulse pressure albuminuria Severe hypertension History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney (not caused by diabetes), or pancreas disease Type 1 diabetes or uncontrolled type 2 diabetes Allergy to certain medications used to treat high blood pressure Other protocol-defined inclusion/", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 40.0-70.0, All Hyperlipidemia TC:220\uff5e270mg/dl Male: 40-70 years old/ female: postmenopausal-70 years old <40kg in weight History of CHD(angina, MI, post-PTCA/CABG, etc.) History of CVA(stroke, TIA, etc.) Underlying malignant tumor", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Atrial Fibrillation Radiofrequency Catheter Ablation Patients requiring MV surgery with at least 6 month history of atrial fibrillation Patients with sick sinus syndrome Hyperthyroidism Permanent pacemaker Previous cardiac surgery", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 75.0-999.0, All Acute Myocardial Infarction Subjects of 75 or more years of age Diagnosis of AMI: chest pain or any symptom of myocardial ischemia of, at least, 20 minutes of duration, not responding to nitrate therapy, an evolution period of less than 6 hours after symptom onset until randomization process, and, at least, one of the following alterations ST-elevation >=2 mm in 2 or more precordial leads ST-elevation >=1 mm in 2 or more anterior leads Complete de novo (or probably de novo) left bundle branch block (LBBB) Subject should be able to give informed consent prior to randomization process and should agree to fulfill all procedures described in the protocol, including follow-up after hospital discharge. A written consent signed by a close relative with witness is also acceptable Documented contraindication to the use of fibrinolytics. 1.1. Internal active bleeding or known history of hemorrhagic diathesis 1.2. History of previous CVA of any kind or at any time 1.3. Intracranial tumor, arteriovenous malformation, aneurysm or cerebral aneurysm repair 1.4. Major surgery, parenchymal biopsy, ocular surgery or severe traumatism in the 6 weeks prior to randomization 1.5. Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to randomization 1.6. Confirmed arterial hypertension with a reliable measurement of systolic AP >180 mmHg or diastolic AP >110 mmHg 1.7. Known thrombocytopenia < 100.000 platelets/mL 1.8. Prolonged (>20 minutes) or traumatic cardiopulmonar resuscitation (CPR) in the 2 weeks prior to randomization 1.9. History or signs suggesting aortic dissection Cardiogenic shock Estimated door-to-needle time >120 minutes Administration of fibrinolysis in the 14 days prior to randomization Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hours prior to randomization Administration of any Low Molecular Weight Heparin (LMWH) in the 8 hours prior to randomization Actual oral anticoagulant treatment Suspected AMI secondary to occlusion of one lesion treated previously with a percutaneous coronary intervention (within the previous 30 days for angioplasty or conventional stent and within the previous 12 months for coated stents) Dementia or acute confusional state at the time of randomization Subject incapacity or unwillingness to give informed consent -at least, verbally", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 65.0-999.0, All Atrophy Community living Caucasian woman \u2265 65 years; live expectation > 2 years secondary osteoporosis CVD-events including stroke Participation in other studies Medication with impact on bone during the last 2 years bisphosphonates parathormone strontium HRT, anabolic steroids calcitonin natriumflourides", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Males or females, 18 years of age or older Acute ischemic cerebral stroke (IS) with uncontrollable hypertension that may need to be controlled for the purpose of considering thrombolytic therapy or anticoagulation therapy Intracerebral hemorrhagic (ICH) stroke patients, including subarachnoid hemorrhage (SAH) (surgically treated or not), any territory with an appropriate study (head CT scan or MRI scan) providing results consistent with this diagnosis, who may require the control of hypertension or control of blood pressure Allergy to Nicardipine or known hypersensitivity to Nicardipine Chronic renal failure or Creatinine blood sample levels> 2.0 Impaired hepatic function defined as a two times value of liver enzymes Severe left ventricular dysfunction defined as ventricular ejection fraction < 30% Patients or authorized representative who refused be enrolled into this study Advanced aortic stenosis Pregnant or nursing women will not be enrolled in this study No patient will be allowed to be enrolled in this study more than once Patients may not be enrolled into other clinical studies during their involvement with this study", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 The following patients will be eligible for study participation Patients with either type 1 or type 2 diabetes. Diabetes will be defined as those patients presently taking either oral hypoglycemic agents or insulin therapy (oral hypoglycemic agents to all drugs in the drug classes of: alpha-glucosidase inhibitors, biguanides, meglitinides, sulfonylureas, thiazolidinediones and adjunctive therapy) taken for >6 months to rule-out steroid-induced diabetes and gestational diabetes Patients will be excluded from the study if they Do not provide or are unable to provide written informed consent Refuse or are unlikely to attend follow-up visits for BP measurements Are institutionalized Are <18 years of age Do not understand English Enrolled in other diabetes or hypertension trials Subjects will be recruited whether or not they are receiving antihypertensive therapy", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-85.0, All Acute Ischemic Stroke Patients must meet all of the criteria Diagnosis of acute ischemic stroke with onset less than 4.5 hours prior to the planned start of intravenous alteplase. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 4.5 hours are not eligible if their first symptoms started more than 4.5 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be at baseline Disabling neurological deficit attributable to acute ischemic stroke in the middle cerebral artery territory NIHSS less than or equal to 18 for left hemisphere strokes, NIHSS less than or equal to 16 for others Evidence of MCA occlusion (stem or branch) prior to drug administration by TCD, CTA or MRA Age 18-85 years, inclusive Able to sign informed consent For MRI Arm only Screening MRI diagnostic of focal cerebral ischemia corresponding to the clinical deficits. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion deficit is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal appearing DWI are eligible Evidence on PWI MRI or a perfusion defect corresponding to the acute stroke syndrome. The PWI will be assessed by relative mean transit time (MTT) images obtained prior to the start of rt-TPA therapy Patients will be excluded from study participation for any of the following reasons Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 30) assessment in this trial Absence of acoustic window to insonate the MCA on the involved side Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage Evidence of acute myocardial infarction defined as having at least two of the following three features: 1) Chest pain suggestive of cardiac ischemia; 2) EKG findings of ST elevation of more greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3) Elevated troponin I Acute Pericarditis Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2) High clinical suspicion of septic embolus", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-65.0, All Lung Cancer Heart Disease COPD Healthy sedentary smokers (> 4 per day for at least one year) Ages 18 to 65 years Must be able to give informed consent Must live in the area for the next 3 months Willing to use the nicotine patch to attempt smoking cessation Must receive consent to participate from primary care physician Cannot read or write fluently in the English language Pregnancy or plans to attempt pregnancy minutes or more per week of moderate or vigorous physical activity Smokes cigars, pipes, or uses smokeless tobacco at least once per week Currently in a quit smoking program Currently using NRT of any kind or using any other quit smoking method or treatment Never had an adverse reaction to the nicotine patch resulting in discontinuation of use Poor willingness or inability to comply with protocol requirements An employee of the Centers for Behavioral and Preventive Medicine Previous participant in Commit to Quit or Fit to Quit smoking cessation studies", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 65.0-999.0, All Type 2 Diabetes type 2 diabetes managed by diet or metformin only A1c < 8.5% treated with insulin or oral agents other than metformin in the past 6 months evidence of diabetic complications including coronary artery disease, stroke, transient ischemic attacks, peripheral vascular disease, nephropathy, retinopathy, or neuropathy type 1 diabetes or a history suggestive of a secondary causes of diabetes A1c \u2265 8.5% participated in another clinical trial within the past 30 days", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 65.0-999.0, All Type 2 Diabetes Type 2 diabetes > 3 months duration Male or female Over 65 years of age Diet controlled only HgbA1C < 8.5% Treatment with oral hypoglycemic agents or insulin or the likelihood of requiring treatment with these during the study Anemia hgb below 130 g/L (males) and below 120 g/L (females) Taking medications that known to interfere with glucose metabolism eg systemic corticosteriods, non-selective beta blockers Known or suspected allergy to glyburide, sulfa drugs or GlucoNorm impaired liver function, as shown by but not limited to AST and/or ALT > 2x the upper limit of normal Impaired renal function, as shown by but not limited to serum creatinine > 133 \u00b5mol/L (males) or 124 \u00b5mol/L (females) Participated in another clinical trial within the past 30 days", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Contrast Induced Nephropathy Subjects age 18 and over and of either gender Scheduled to receive CT scan with intravenous contrast dye Non diabetics or subjects with type 1 or 2 diabetes mellitus Written informed consent Subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded Subjects who have received n-acetylcysteine or sodium bicarbonate pre CT scan will not be excluded Pregnant or lactating women End-stage renal disease (on hemodialysis or peritoneal dialysis) A known history of acute renal failure Subjects receiving glucophage/metformin or glucovance Subjects who cannot give written informed consent Subjects receiving peritoneal dialysis or hemodialysis Subjects enrolled in another investigational drug study \u2264 30 days of enrollment into the present study Subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine Subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin Age < 18 years", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Seasonal Influenza Vaccine Subjects eligible for enrollment into this study are male and female adults who were \u2265 18 years of age, mentally competent, willing and able to give informed consent prior to study entry available for all the visits scheduled in the study and able to comply with all study requirements in good health as determined by medical history physical examination clinical judgment of the investigator Written informed consent had to be obtained from all the subjects before enrollment in the study after the nature of the study had been explained Subjects were not to be enrolled into the study if at least one of the following was fulfilled Any serious chronic or acute disease such as Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy Congestive heart failure Advanced arteriosclerotic disease Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below) Insulin dependent diabetes mellitus Acute or progressive hepatic disease Acute or progressive renal disease", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-70.0, All Atrial Fibrillation History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance Age between 18 and 70 years Failure of at least one Class I or III rhythm control drug Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study Structural heart disease of clinical significance including Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair) Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing Left atrial diameter >55 mm Moderate to severe mitral or aortic valvular heart disease Stable/unstable angina or ongoing myocardial ischemia Myocardial infarction (MI) within 3 months of enrollment Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-65.0, All Schizophrenia Schizoaffective Disorder Bipolar Disorder Patients must be male or female, age 18-65 Patients must have a definitive diagnosis by DSM-IV of schizophrenia, bipolar or schizoaffective disorder Patients can be receiving inpatient or outpatient treatment at time of enrollment Patients must have been treated with (Mellaril) thioridazine, (Risperdal) risperidone or (Seroquel) quetiapine at least three months at time of enrollment Patients must be able to provide written informed consent Patients with a primary diagnosis other than schizophrenia, schizoaffective or bipolar disorder Patients who are currently taking other medications that have been shown to prolong the QTC, including tricyclic antidepressants, fluoroquinolones or antiarrythmics Patients unable to provide written informed consent", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Stroke Cerebrovascular Accident Sudden focal neurological deficit attributable to a stroke Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset Age between 18 and 80 years Disability preceding stroke consistent with a modified Rankin scale score of 2-4 (see glossary for Rankin scale) Coma at onset Severe stroke as assessed clinically (e.g. NIHSS>25) Rapidly improving neurological deficit or minor symptoms Seizure at onset of stroke Clinical presentation suggestive of a subarachnoid hemorrhage (even of CT scan is normal) or condition after subarachnoid hemorrhage from aneurysm Previous history of or suspected intracranial hemorrhage Previous history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) Septic embolism, bacterial endocarditis, pericarditis Acute pancreatitis", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 16.0-999.0, All Hypertrophic Cardiomyopathy Any patient that is hemodynamically stable and is identified to have hypertrophic cardiomyopathy based on prior symptoms, 2D ECHO findings, genetic testing, and/or ECG voltage criteria Patients that have signed informed consent after understanding the risks and benefits of participation. Individual age 16-17 with the consent and approval of a parent and /or legal guardian Patients with prior history of myocardial infarction, CAD demonstrated by stress test or angiogram, and/or CABG will be excluded from this study Any patient that has undergone invasive treatment at the time of enrollment including procedures such as myomectomy and/or septal ablation. However, already enrolled subjects who have these procedures post-enrollment into the study will be eligible for future scans Patients encountering any significant symptoms, chest pain, or who are hemodynamically unstable Any patient with an ICD or pacemaker Patients who are underage and do not have the consent of a parent and/or legal guardian", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Patent Foramen Ovale Stroke Patent foramen ovale-(PFO) recurrent stroke failed antiplatelet/anticoagulant therapy International normalized ration (INR) outside of 2-3 intracardiac thrombus (subjects may be enrolled after resolution of thrombus)", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation for Atrial Fibrillation group Male or female at least 18 years old Subjects with a history of or current Atrial Fibrillation Subjects able to give informed consent for Controls Male or female at least 18 years old Subjects with no history of Atrial Fibrillation Subjects able to give informed consent ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Stroke, Acute Subject For in the study, subjects must fulfill all of the following Written Informed Consent Eighteen years of age or older Symptoms consistent with acute stroke (ischemic or hemorrhagic) Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours) Subject The following is the sole criterion for from the study Unlikely to complete study through 90-day follow-up", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-85.0, All Cardiovascular Diseases Hypertension Hyperlipidemia Hyperglycemia Adults 18-85 years Signed consent ", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 65.0-999.0, All Type 2 Diabetes Clinical diagnosis of type 2 diabetes Impaired renal or liver function Cardiac disease Subjects with metal implants Hypertension Diabetes complications Exogenous insulin therapy", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 30.0-85.0, All Ischemic Stroke Patent Foramen Ovale Age 30-85 Ischemic stroke within 30 days Glasgow outcome scale \u2265 3 No contraindications to warfarin/aspirin Basal INR > 1.4 Post-procedural stroke Severe carotid atherosclerosis Cardioembolic stroke Contraindications to transesophageal echocardiography", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication Secondary hypertension patients Patients not receiving hypertension medication", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Stroke Age between 18 and 80 years Onset of symptoms until call at least 30 min prior to the end of the approved time window for thrombolysis (and not after awakening) Clinical signs of ischemic stroke with suddenly occurring, measurable neurological deficits defined as impairment of language, motor function, facial palsy or asymmetry Patient is willing to participate voluntarily and to sign a written informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relative Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make undoubtfully clear that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet Age younger than 18 or older than 80 years Non-acute onset of symptoms No focal stroke-like symptoms Pregnant patients", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 70.0-999.0, All Orthostatic Hypotension Diabetes Mellitus Type 2 diabetes mellitus age (70 years and older) Known autonomic dysfunction Neurodegenerative diseases Current malignancy Living in a nursing-home Irregular pulse", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-75.0, All Prostate Cancer Age of patients: up to 75 years Men scheduled for radical prostatectomy due to prostate cancer Patients who are able and willing to give consent and able to attend all study visits Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) Severely abnormal coagulation (INR>1.5) Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP > 100 on medication), and patients with cardiac pacemakers Severe cerebrovascular disease (multiple CVA or CVA within 6 months) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.) Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc\u2026) Any spinal pathology that prohibits maintaining supine position for more then an hour Any previous radiation to the pelvis", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Stroke Female or male inpatients Age: 18-80 years If female, patient must not be pregnant Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage Onset of symptoms within 3 hours prior to initiation of rt-PA administration Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure or migraine disorder Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtful that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. A written consent has to be obtained as soon as possible Willingness and ability to comply with the protocol Evidence of intracranial haemorrhage (ICH) on the CT-scan Violation of not approved by clinical study director or study safety officer Failure to perform or to evaluate screening or baseline examinations Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period Participation in another therapeutic clinical trial 3 months before baseline Patients with any history of prior stroke and concomitant diabetes Prior stroke within the last 3 months Platelet count of below 100x103/mm3 Blood glucose <50 or >400 mg/dl (<2.77 or >22.15 mmol/L) Known haemorrhagic diathesis", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Cryptogenic Stroke Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours Negative brain image for hemorrhagic stroke In sinus rhythm at time of enrollment Know history of atrial fibrillation Previous implanted cardiac device (ppM or ICD) Serious illness making it unlikely to survive one year Known secondary cause of stroke", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Stroke Age > 18 years Seen at UCSF Medical Center for cryptogenic stroke or high-risk TIA Onset of stroke or TIA symptoms within the previous 60 days Definite small-vessel etiology by history or imaging Source found on vascular imaging of possible culprit vessels Source found by echocardiography (TEE not required) History of atrial fibrillation Atrial fibrillation on admission ECG Atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required) Obvious culpable systemic illness such as endocarditis Patient unable to provide written, informed consent", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 2.0-90.0, All Aged elderly subjects over the age 65 years who had not received pneumococcal vaccination adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination) children subjects over the age of 2 years with no previous history of pneumococcal vaccination immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 70.0-999.0, All Hypertension Age >= 70 years Systolic office blood pressure >= 160 mmHg Systolic home blood pressure >= 155 mmHg Diabetes Mellitus Atrial fibrillation Dementia Renal failure requiring dialysis Life expectancy of less than 1 year Disabling stroke Contraindication for MRI or anti-hypertensive medication Systolic blood pressure > 220 mmHg", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-70.0, All Hypertension Type 2 Diabetes Mellitus Regardless of whether they are currently receiving antihypertensive therapy, systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg Whether or not use oral hypoglycemic agents or insulin injections, the fasting plasma is higher than 7.0 mmol/L, or postprandial blood glucose higher than 11.1 mmol/L With life-threatening disease With the various effects of metabolic diseases such as hyperthyroidism, hypothyroidism, etc Stroke, myocardial infarction and other serious cardiovascular and cerebrovascular diseases occurred within 3 months Serum creatinine level higher than 176.8 mmol/L Dementia or severe cognitive decline Unable to do a long-term follow-up or do not agree to participate in this trial", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 19.0-999.0, All Stroke Patients presenting to the emergency Signs and symptoms of acute ischemic stroke: impairment of language, motor function, cognition and/or gaze, vision or neglect Patients with an NIH Stroke Scale score > 4 Age less than 19 Patient symptomatic for greater than five hours. Intravenous thrombolytic therapy must be instituted within three hours of symptom onset in order to minimize the risk of Intracerebral or symptomatic hemorrhage; other interventions such as intra-arterial thrombolytic therapy and clot retrieval allow for a six-hour window. One hour is an achievable time for arrival to institution of therapy, therefore a five-hour limit on enrollment allows the greatest number of patients the possibility of therapy Inability to verify a clear onset of symptoms. As noted, time elapsed since the patient's last known baseline state is correlated to Intracerebral and symptomatic hemorrhage, and therapy is approved only for patients with a clear time of onset", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 40.0-75.0, All Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease) Able to provide a written informed consent <75 years of age, but >40 years of age Able to hold breath for at least 10 seconds Sinus rhythm New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) Greater than 6 hours since presentation to ED BMI >40 kg/m2 Impaired renal function as defined by serum creatinine >1.5 mg/dL* Elevated troponin-T (> 0.09 ng/ml) Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) Known allergy to iodinated contrast agent Currently symptomatic asthma Documented or self-reported cocaine use within the past 48 hours (acute)", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-90.0, All Stroke Foramen Ovale, Patent years old patients signed informed consent all consecutive patients undergoing a successful percutaneous closure of a PFO secondary to a cryptogenic stroke all patients with an alternative aetiology of the initial stroke all patients in whom the percutaneous closure of the PFO is contraindicated all patients with a known allergy to aspirin and or clopidogrel", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Palpitations Age 18 years or older Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness) Terminates before presentation to hospital Episodes occur at a frequency of less than once every two weeks Never previously caught on ECG or ambulatory monitoring Normal resting ECG Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc Palpitations suggestive of extrasystoles (single missed or dropped beats) Known or suspected severe valvular or myocardial heart disease An audible heart murmur Any abnormality on the surface ECG Thyrotoxicosis Patients who refuse an ILR when offered will not be included in either limb of the study", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 30.0-75.0, All Acute Myocardial Infarction Male or female patients aged 30 to < 75 years inclusive Patients presenting within 12 hours with symptoms presumed secondary to an acute myocardial infarction lasting at least 20 minutes and accompanied by ECG evidence of > 1mm of ST elevation in 2 or more limb leads or > 2mm in 2 or more contiguous precordial leads or suspected new left bundle branch block will be eligible Patients must be in the hospital or the emergency department and able to receive the study medication within 12 hours of onset of symptoms Females of child-bearing age, not using a generally accepted method of contraception must have a negative urine pregnancy test Written informed consent should be sought from the patient prior to in the study. If unable to do so, informed verbal consent will be obtained. If neither is possible, a legally acceptable representative (relative) should provide written consent NB Verbal or written consent should be followed by written informed consent from the patient at the earliest subsequent opportunity Previous administration of staphylokinase Active bleeding or known hemorrhagic diathesis Any history of stroke, transient ischemic attack, dementia, or structural CNS damage e.g. neoplasm, aneurysm, AV malformation Major surgery or trauma within the past 3 months Significant hypertension i.e. SBP 180 mm Hg and/or DBP 110 mm Hg at any time from admission to randomization Current treatment with vitamin K antagonists resulting with an INR > 1.5 Anticipated difficulty with vascular access Prolonged (>10 min) cardiopulmonary resuscitation or cardiogenic shock Patients who have participated in an investigational drug study within the past 30 days Pregnancy or lactation, parturition within the previous 30 days", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-75.0, All Chagas Cardiomyopathy Cardiac Arrhythmia Stroke Left Ventricular Function Systolic Dysfunction Cardiac Death Clinically stable outpatients with at least 10 years of regular outpatients follow-up and positive epidemiological history and serological confirmation of Chagas disease with ate least two immunological tests Any degree of atrioventricular block or non-sinus rhythm Previous documented acute coronary events (due to documented obstructive epicardial coronary vessels) Chronic obstructive pulmonary disease Rheumatic valvular heart disease Alcohol addiction Thyroid dysfunction Abnormal serum electrolytes and biochemical abnormalities", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 35.0-70.0, All Erectile Dysfunction Due to Arterial Insufficiency Subject must be undergoing coronary or peripheral angiography for suspected or known coronary or peripheral atherosclerotic disease Subject must be male \u2265 35 and \u2264 70 years old Subject must provide written informed consent before any study-related procedures are performed Subject must agree to comply with study procedures and follow-up for the entire length of the study Subject is unable to safely attempt sexual intercourse secondary to severe cardiac disease or other health condition Subject has a life expectancy of < 12 months Subject's serum creatinine is > 2.5 mg/dl Subject has known aorto-iliac occlusive disease, previous AAA endograft procedure or open surgical procedure Subject has history of prostatic carcinoma requiring surgery (i.e., prostatectomy), pelvic radiation, or hormonal/chemotherapy Subject has a history of myocardial infarction, stroke, life-threatening arrhythmia, or unstable angina requiring hospitalization within 3 months (90 days) prior to enrollment Subject has had exposure to PDE5 inhibitor (per subject's concomitant medication list) within the 72 hours prior to the scheduled baseline angiography Subject has a history of renal transplantation Subject has a penile implant Subject has become unstable or has received a maximum radiation dose, increased procedure time, and/or maximum contrast dose (in the Investigator's opinion) from the primary angiographic procedure that would compromise the safety of the subject by proceeding with enrollment into the study", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 20.0-95.0, All Osteonecrosis Osteoarthritis Osteoarthritis of hip joint requiring total hip arthroplasty Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism Multi-systemic inflammatory arthritis which debilitates patients other than hip joint", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease The patient is male or female \u2265 18 years of age The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain) The patient is scheduled for coronary angiography, with possible angioplasty The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI) The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent The patient does not present with any form of illness or condition that in the investigator's opinion would impair the results of the study Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment Patients in cardiogenic shock Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI Known history of heparin-induced thrombocytopenia Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study Pregnant women or nursing mothers", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 1.5-999.0, All Stroke Computerized Tomography (CT) or Magnetic resonance imaging (MRI) verified cryptogenic stroke or TIA > 18 years of age the ability to provide a written consent prior or known AFIB AF found during work up including 24 hour telemetric monitoring", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Contrast Induced Acute Kidney Injury For specific aim 1 Subjects with reduced kidney function Adult (>18 years of age) men and women All races and ethnicities Chronic kidney disease stage 3 with an estimated GFR by MDRD formula between 30 ml/min/1.73 m2 Being scheduled for a coronary angiography study as part of their clinical care For specific aim 2 Subjects with normal kidney function Adult (>18 years of age) men and women ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Patent Foramen Ovale Subjects who have had a cryptogenic stroke within the previous 3 months, radiologically verified Subjects who have been diagnosed with a high-risk* Patent Foramen Ovale (PFO), echocardiographically verified (*PFO size \u2265 2 mm or atrial septal aneurysm or hypermobility by TEE) Subjects willing to participate in follow-up visits Absence of other potential causes of stroke Any identifiable cause of thromboembolic cause other than PFO Subjects with intracardiac thrombus or tumor, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis Subjects with significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis and coagulopathy Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina Subjects who have a non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI) History of intracranial bleeding, confirmed arterio-venous malformation,aneurysm or uncontrolled coagulopathy Pre-existing neurological disorders or intracranial disease, e.g. multiple sclerosis Subjects with left ventricular aneurysm or akinesis Subjects with atrial fibrillation/atrial flutter (chronic or intermittent) Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Stroke Adult patients (age greater or equal to 18 years) Hypertensive patients, with a sitting Systolic Blood Pressure above 140 mmHg or 130 mmHg in diabetics and high/very high risk patients, according to ESC/ESH Guidelines Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice Patients with at least one of the following conditions Newly diagnosed hypertension Inability to tolerate other antihypertensive medications, or Lack of response to current antihypertensive medication(s) Any contraindication to eprosartan or the excipients (according to the local label)", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Hemodialysis Hyperphosphatemia hemodialysis patients with hyperphosphatemia who require phosphate binders hemodialysis for more than 3 months patients who have at least one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus) intact-PTH > or = 240pg/mL life expectancy > 1 year with written informed consent contraindications to lanthanum carbonate and calcium carbonate swallowing disorders severe GI disorders history of obstructed bowels history of IHD/stroke within 6 months before randomization NYHA classification \u2162-\u2163 severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution require treatment of arrhythmia severe malnutrition malignancy of any type within the last five years", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation atrial fibrillation scheduled for catheter ablation contraindication to magnetic resonance imaging pregnancy life expectancy of less than six months participation in another trial that would conflict with this trial", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 35.0-999.0, All Acute Coronary Syndrome Coronary Artery Disease Cardiac Death Myocardial Infarction Patient is in Sinus Rhythm Typical or atypical chest pain lasting more than 5 min in the last 24 hs Estimated pre-test probability of significant coronary artery disease more than 15% Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation >1 mm or T Wave inversion > 4 mm in at least two contiguous leads) Negative initial troponins I at admission (<0.05 ng/ml) Known allergy to iodinated contrast Known renal insufficiency or Creatinine >1.5 mg/dl at admission History of known coronary artery disease or prior myocardial revascularization Any of the following:hemodynamic instability, persistent chest pain despite treatment, Systolic blood pressure <100 mm Hg Cardiac arrhythmia with rapid or irregular ventricular response Inability to perform an exercise test Patient is incapable of providing informed consent", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 35.0-85.0, All Hypertension Stroke aged 35 to 85 years hypertensive patients who had an ischemic stroke patients aged below 35 years or above 86 years patients who had a hemorrhagic stroke patients whose systolic BP (SBP) was over 220 mmHg or whose diastolic BP (DBP) was above 120 mmHg during an acute phase, or whose SBP was over 180 mmHg or whose DBP was over 110 mmHg one week after their hospital visit patients with secondary hypertension related to renovascular, endocrinologic, or pregnant conditions patients who went to bed in the middle of the day or very late at night; (6) patients who were using intravenous antico-agulants or thrombolytics (7) patients with a severe stroke (NIH stroke scale > 20); (8) patients who could not give their consent to investigators; (9) patients with severely impaired liver function (AST or ALT \u2265 100); (10) patients with severely impaired renal function (serum creatinine \u2265 2.0 mg/dL); (11) patients with cancer; (12) patients who were pregnant or lactating; (13) patients with other grave diseases such as hypertensive encephalopathy, aortic dissection, acute myocardial infarction, or severe congestive heart failure; and (14) patients who were allergic to the test or control drugs", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation Atrial Flutter Patient meets the approved FDA indication to receive the ICM Patient is suspected, based on demographics, to be at high risk of having AF, as determined by the clinical investigator Patient has a CHA2DS2-VASc score \u2265 2 [Note: stroke/TIA criterion as part of the CHA2DS2-VASc score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.] Patient is 18 years of age or older Patient has a life expectancy of 18 months or more Patient has a documented history of AF or atrial flutter Patient has a symptom complex consistent with an arrhythmia (where an ICM may have an alternate indication for use) Patient had an ischemic stroke or TIA within past year prior to enrollment Patient has a history of a hemorrhagic stroke Patient is currently implanted with a permanent pacemaker, insertable loop recorder, implantable defibrillator, cardiac resynchronization therapy device (pacemaker or defibrillator) NYHA Class IV Heart Failure patient Patient had heart surgery within previous 90 days prior to enrollment Patient had an MI within the previous 90 days prior to enrollment Patient is taking chronic immunosuppressant therapy Patient is taking an anti-arrhythmic drug", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-65.0, All Paroxysmal Atrial Fibrillation paroxysmal atrial fibrillation, symptomatic atrial fibrillation other than PAF, asymptomatic, previous AF ablation", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation Age >= 18 years CHADS2 score >=2 Sinus rhythm Cardiac Implantable Electronic Device Atrial fibrillation Severe heart valve disease Anticoagulation therapy Pregnancy", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Ischemic Stroke Atrial Fibrillation Transient Ischemic Attacks Transient Cerebrovascular Events Patients >18 years of age Signs and symptoms suggestive of acute ischemic stroke or TIA Arrival to the emergency department or hospital within 8 hrs of symptom onset or last known normal time Head CT or MRI ruling out other pathology such as vascular malformation, hemorrhage, tumor or abscess which would likely be responsible for presenting neurologic symptoms Consent must be obtained Any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days Any form of head trauma, stroke or intracranial hemorrhage in the past 30 days Known primary or metastatic cancer involving the brain Active Cancer defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer Autoimmune diseases: such as lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis Active infectious diseases (eg. HIV/AIDS, hepatitis C) Any underlying medical condition which in the opinion of the investigator would prohibit the patient from providing informed consent Major surgery within three months prior to the index event", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope Any patient regardless of the age of gender Any non-correctable secondary cause of increase or decrease in blood pressure or a pathology that alters the prognosis before the entrance of the patient into this registry nephropathy prior to the admission familial dyslipidemia previous gastric bypass pre-existing heart failure chemotherapy-induced cardiotoxicity arrhythmogenic right ventricular dysplasia long QT syndrome hypertrophic cardiomyopathy", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Patients with massive PE aged 18 years or older with confirmed PE and able to give informed consent will be included in the study. PE is defined according to current guidelines as adult patients presenting with signs and symptoms suggestive of PE plus imaging documentation on computed tomography angiography. Massive PE was defined as acute PE with sustained hypotension (systolic blood pressure<90 mm Hg for at least 15 minutes or requiring inotropic support, not due to a cause other than PE, such as arrhythmia, hypovolemia, sepsis, or left ventricular [LV] dysfunction), pulselessness, or persistent profound bradycardia (heart rate<40 bpm with signs or symptoms of shock) Patients with prior intracranial hemorrhage, known structural intracranial cerebrovascular disease (eg, arteriovenous malformation), known malignant intracranial neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent surgery encroaching on the spinal canal or brain, and recent significant closed-head or facial trauma with radiographic evidence of bony fracture or brain injury were excluded from the study", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 70.0-90.0, All Atrial Fibrillation Stroke Hypertension Diabetes To be eligible for the study subjects must fulfil the following at Living address in Region Zealand, Region of Southern Denmark or the Capital Region of Denmark (study subjects from other regions of Denmark who actively contact the study for participation can be included if they wish to participate) 90 years of age at the time of screening and in addition the study subject should be clinically evaluated to be biologically a potential candidate for anti-coagulation therapy and additionally have at least one of the diseases mentioned below Known diabetes mellitus (type 1 or type 2, with or without medical therapy) History with hypertension with or without a therapy that may reduce blood pressure (i.e., an increased blood pressure at randomization is not required) Heart failure: New York Heart Association (NYHA) class II-IV or a reduced left ventricular ejection fraction (< 0.50) Previous diagnosed stroke (preferably diagnosed in hospital and verified by imaging; previous (TIA, transitory ischemic attack, is not considered an criterion; a specific time interval from previous stroke to time is not required) Concerning the four qualifying diseases the study subject is considered qualified for study if he has a history of one of the diseases (for example subject is now normotensive on life-style correction or medical therapy and similarly if blood glucose has been normalised upon life-style corrections or medical therapy) Uncorrected, congenital heart disease or severe valvular stenosis, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis Recipient of any major organ transplant (e.g. lung, liver, heart or kidney) Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months before randomization or clinical evidence of current malignancy with the following exceptions: Basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable, localized disease with a life expectancy of > 2.5 years in the opinion of the investigator) Known to be human immunodeficiency virus (HIV) positive with an expected survival of less than 5 years due to HIV infection Renal failure treated with permanent dialysis Recent (within 3 months) history of alcohol or drug abuse based on self-reporting Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study Known atrial fibrillation irrespective of its type (paroxysmal, persistent, long-lasting persistent or permanent) Ongoing therapy with OAC or newer OAC (whereas therapy with platelet inhibitors such as acetyl-salicylic acid, clopidogrel, persantine is not considered as an exclusion) Patients who have a pacemaker (including cardiac resynchronization therapy-pacemaker, CRT-P) or implantable cardioverter defibrillator (ICD), including a Cardiac Resynchronization Therapy defibrillator (CRT-D)", "label": "1"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Permanent Atrial Fibrillation To be eligible, each patient must be in the following condition Permanent atrial fibrillation (>6 months) which has been considered unsuitable for ablation or failed ablation Narrow QRS \u2264 110 ms Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below) New York Heart Association (NYHA) class IV and systolic blood pressure <80 mmHg despite optimized therapy severe concomitant non-cardiac disease need for surgical intervention myocardial infarction within the previous 3 months previous implanted devices (PM/ICD/CRT)", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 60.0-999.0, All Transient Arthropathy of Hip y/o/ and more Both sexes Schedule for total hip replacement Patient with previous bedsore Patients under 60 y.0 Previous CVA", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Acute Ischaemic Stroke or less years old patients with acute stroke produced by a main artery occlusion NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment) Patients receiving EVT or IVT within 4.5 hours after onset EVT or IVT contraindication Previous neurological impairment, severe concomitant disease or poor prognosis Pregnancy or breastfeeding Known hypersensitivity to any study drugs Severe organic disease for which there is not risk compensation", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Stroke Atrial Fibrillation Premature Atrial Complexes admitted with ischemic stroke at a single center time from diagnose to maximum 7 days written informed consent or surrogate informed consent eligible age > 18 years hemorrhagic stroke terminal illness and expected lifespan of less than 6 months any physical or mental condition which make the patients unsuitable for participation in the study known with a pacemaker anticoagulation treatment of other reasons than atrial fibrillation", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Cryptogenic Embolic Stroke Active Cancer Subjects with acute ischemic stroke who presented within 7 days from symptom onset Subjects with unknown cause of stroke despite of initial evaluation including electrocardiogram and brain imaging upon admission Subjects who performed brain magnetic resonance image (MRI) and MR angiography (MRA), cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal echocardiography with injection of agitated saline (or agitated saline transcranial Doppler monitoring), and 24-hour Holter and/or telemonitoring) Subjects with informed consent Subjects with single subcortical infarction Subjects with primary brain tumor", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Stroke Female or male in-patient Age 18 years Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition, gaze, vision and/or neglect. Ischemic stroke is defined as an event characterized by sudden onset of acute focal neurological deficit, presumed to be caused by cerebral ischemia, after CT scan of hemorrhage Onset of symptoms within 3 hours prior to initiation of thrombolysis treatment Stroke symptoms present for at least 30 minutes that had not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder Patients are willing to receive thrombolysis treatment and to give informed consent with regard to retrieval of data and follow up procedures, according to the regulations in participating countries Willingness and ability to comply with the study protocol Evidence of intracranial hemorrhage (ICH) on the CT-scan Symptoms of ischemic attack began more than 3 hours prior to infusion start or when time of symptom onset is unknown Minor neurological deficit or symptoms rapidly improving before start of infusion Severe stroke as assessed clinically and/or by appropriate imaging techniques Seizure at onset of stroke Symptoms suggestive of subarachnoid hemorrhage, even if the CT-scan is normal Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory Patients with any history of prior stroke and concomitant diabetes Prior stroke within the last 3 months Platelet count of below 100,000/mm\u00b3", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 41.0-999.0, All Ischemic Stroke Patients with a recent ischemic stroke or transient ischemic attack (TIA) with brain infarction on brain imaging No history of atrial fibrillation or finding of atrial fibrillation on standard inpatient monitoring (electrocardiogram, telemetry, 24-hour Holter monitor) Have a presumed stroke etiology: Lacunar or small vessel thrombosis, extra-cranial or intracranial atherosclerotic stenosis or dissection, arteriopathy or vasculitis, hypercoagulable state, aortic arch plaque with or without mobile elements, or evidence of a low-risk cardiac source (e.g., patent foramen ovale with or without atrial septal aneurysm and with or without evidence of venous thromboembolic source) Have virtual CHADS2 score \u22653 or Have 2 or more of the following co-morbidities: obstructive sleep apnea, coronary artery disease, (Chronic Pulmonary Obstructive Disease (COPD), hyperthyroidism, Body Mass Index> 30, prior myocardial infarction, prolonged PR interval (>175 ms) or renal impairment (GFR 30-60) Patient or legally authorized representative who is willing to sign written consent form Patient is \u226540 years old (patients younger than 40 years old have a very low likelihood of having atrial fibrillation and are therefore excluded from the study) Patient can have the device implanted within 7 days of the incident ischemic event Documented history of AF or atrial flutter Evidence of a high-risk cardiac source of embolism (Left Ventricular or Left Atrial thrombus or \"smoke,\" emboligenic valvular lesion or tumor) Untreated hyperthyroidism Myocardial infarction or coronary bypass grafting within 1 month prior to the stroke/TIA Valvular disease requiring immediate surgical intervention Permanent indication for anticoagulation at enrollment Permanent oral anticoagulation contraindication Already included in another clinical trial that will affect the objectives of this study Life expectancy is less than 1 year Pregnancy. Urine or serum pregnancy test is required for women of child bearing potential to pregnancy", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Myocardial Infarction Ischemic cardiac pain of >= 20 minutes and <= 6 hours Age 18 years Ability to give informed consent (witnessed verbal or written) Ability to follow protocol and comply with follow -up requirements Current participation in another clinical trial Patient will be ineligible for pre hospital administration of actilyse if any of the following apply Acute myocardial infarction (AMI) treated with a thrombolytic agent within the preceding 4 days BP (blood pressure) > 180/100 mmHg (on one measurement) Significant bleeding disorder within the past 6 months Major surgery, biopsy of a parenchymal organ, or significant trauma (including any trauma associated with the current AMI) within 3 months History of stroke, transient ischaemic attack, or central nervous system structural damage (e.g. neoplasm, aneurysm, intracranial surgery) Oral anticoagulation Recent (within 10 days) non compressible vascular puncture", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Death Stroke Myocardial Infarction previously cardiac operation, CABG or AVR Previous Atrial fibrillation", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 70.0-999.0, All Sarcopenia Diabetes Mellitus Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the of the American Diabetes Association Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the of the European Working Group on Sarcopenia in Older People (EWGSOP) Healthy volunteers: no diabetes, no sarcopenia and none of the (overall population) acute diseases chronic obstructive pulmonary disease (COPD) conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer) obesity (body mass index \u226530 kg/m2) moderate-severe hepatic disease chronic kidney disease (estimated glomerular filtration rate <30 ml/min per 1.73m2) metal prostheses recent or ongoing infection inability or unwillingness to provide informed consent", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Stroke Atrial Fibrillation Arrhythmias, Cardiac Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA occurring within the previous 90 days. The event must be either an arterial ischemic stroke confirmed by neuroimaging; or transient ischemic attack with diffusion weighted positive lesion on MRI At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter The patient is being actively investigated for the etiology of the stroke/TIA event and additional cardiac monitoring is desired to screen further for the possibility of occult paroxysmal atrial fibrillation/flutter Age 18 years or older Informed consent from the patient The patient is expected to survive at least 6 months Any previously documented atrial fibrillation or atrial flutter, i.e. a past history of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter, or telemetry following the index stroke/TIA event (a remote history of transient perioperative atrial fibrillation is not exclusionary) Planned carotid endarterectomy or carotid artery stenting within 90 days Any condition for which there is already an indication for long term anticoagulation Pacemaker or implantable cardioverter defibrillator device Work-up for stroke that has already included extended (>48 hour) external ECG (excluding telemetry) Stroke and/or comorbid illness will prevent completion of planned follow-up assessments", "label": "2"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 20.0-80.0, All Type 2 Diabetes 80 years of age Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months) in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day HbA1c between 7.0% and 10.0% ability to understand and use smartphone application type 1 diabetes or patients using insulin pump severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary & peripheral artery within recent 6 months) uncontrolled hypertension pregnant woman, fertile woman who will not use contraception unable to use application during treatment taking medication which can affect on glucose level alcohol abuse or dependency over 2.5 times from the upper limit of liver enzyme level DKA(diabetic ketoacidosis) or HHS(Hyperglycemic hyperosmolar syndrome) history during recent 6 months", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-80.0, All Atrial Fibrillation Stroke Systemic Embolism 80 years Have documented AF episodes The occurrence of ischemic stroke, TIA or systemic thromboembolism in the previous 1-6 months Having at least one of the following major risk factors of stroke: HT, DM, or HF, or having two of the following minor factors of stroke: \u226565 y, vascular disease, or female Capable of understanding and signing the CRF Reversible AF Modified Rankin score \u22654 Having a history of rheumatic, severe valvular heart disease or heart valve replacement Having symptomatic carotid artery disease Having another disease which requires lifelong warfarin therapy Medical conditions limiting expected survival to <1 year Women of childbearing potential (unless post-menopausal or surgically sterile) Participation in any other clinical mortality trial Unable to give informed consent", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 0.0-999.0, All Atrial Fibrillation Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-999.0, All Stroke Prevention and Control Atrial Fibrillation Patients \u226518 years of age diagnosed with non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent) Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care Patients who have given their informed consent in writing Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires Patients who started anticoagulant therapy for non-valvular atrial fibrillation with a direct oral anticoagulant ", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 60.0-999.0, All Hypertension Atrial Fibrillation Female and male outpatients aged 60 years and older Patients having being diagnosed with arterial hypertension For patients without a history of AF diagnosis, the decision to perform electrocardiography testing, either standard 12-lead ECG or ambulatory ECG, at the study visit has been made as per the investigator's routine practice Patients with available medical records Written signed and dated informed consent Presence of any condition/circumstance which in the opinion of the investigator would make the patient unfit to participate in the study or would compromise the quality of the study data (e.g., non-native speaker or patient who does not understand the local language unless reliable interpreter services are available; failure to cooperate due to major psychiatric disturbances, dementia, or substance use disorder) Patients currently participating in any investigational program with interventions outside of routine clinical practice or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment", "label": "0"} +{"topic": "Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own.", "doc": "eligible ages (years): 18.0-90.0, All Atrial Fibrillation Primary and secondary diagnosis with AF The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included Patients younger than 18 and older than 90 years of age", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-75.0, All Asthma Lung Diseases Patients with asthma; specific vary for each study ", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.0-999.0, All Chest Pain Sickle Cell Anemia Males or females 18 to 65 years of age Diagnosis of sickle cell disease (electrophoretic documentation of SS homozygosity is required) or identification as a normal volunteer Hematocrit greater than 18% (with an absolute reticulocyte count greater than 100,000/ml) Hematocrit 18-21% (with an absolute reticulocyte count greater than 100,000/ml): Only 100 ml of blood may be drawn. The study subject may be re-entered in the study after four weeks (with repeat full screening labs) Clinically unstable sickle cell anemia defined by the following Having greater than two acute pain crises in the last two months; on hydroxyurea or butyrate therapy any time in the last 12 months; or blood transfusion within last three months, or % hemoglobin A greater than 20% Age less than 18 years or greater than 65 years Current pregnancy or lactation Inability to exercise the anterior tibialis muscle Active cigarette smoker-defined as the inhalation of smoke from any tobacco product in the last one month Medical conditions: diabetes mellitus; coronary artery disease; peripheral vascular disease; migraine headaches in the last 12 months; history of previous CVA or stroke; or creatinine greater than 1.0 mg/dL MRI Exclusions: cardiac pacemaker or implantable defibrillator; aneurysm clip; neural stimulator (e.g. TENS-Unit); any type of ear implant; or metal in the eye (e.g. from machining); any implanted device (e.g. insulin pump, drug infusion device); or any metallic foreign body, shrapnel, or bullet Hematocrit less than or equal to 18 percent: will not be eligible for the study; may return for evaluation at a later date No aspirin or non-steroidal anti-inflammatory drugs (no and caffeine the day of the study.) Patients on opiates and acetaminophen will not be excluded", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.0-999.0, All Healthy Hypercapnia Any normal volunteer above the age of 18 years old who is capable of giving informed consent Subjects will be excluded if they have contraindications to MR scanning, such as the following: aneurism clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, chochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump. Also, subjects will be excluded if they have panic disorder or migrane (because of possible complications with CO2 inhilation), or if they have cirrhosis, are on high dose aspirin therapy, or have an allergy to acetazolamide injection). Subjects will be excluded if they have allergies to sulfonamide drugs or if they have a chronic respiratory illness", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.0-999.0, All Healthy Hypercapnia Any healthy normal volunteer above the age of 18 who is capable of giving informed consent Subjects will be excluded for the following reasons They have contraindications to MR scanning, such as the following: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump They have panic disorder or migraine (because of possible complications with CO2 inhalation) They have cirrhosis, any renal dysfunction, or a chronic respiratory illness (such as asthma) They have allergies to sulfonamide drugs or cyclo-oxygenase inhibitors (NSAIDS)", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 21.0-55.0, All Asthma Mild to moderate persistent asthma (NAEPP 1997 revised guidelines) Current use of inhaled beta-2 agonists or steroid inhaler therapy only (No use of prednisone in past 3 months) No use of products (i.e. antacids, laxatives, supplements) containing more than 50 mg Mg daily in the last 3 months No current use of theophylline, leukotriene antagonists, or other systemic immunomodulating compounds Nonsmoker No concurrent pulmonary disease (pulmonary hypertension, cystic fibrosis, sarcoidosis, bronchiectasis, hypersensitivity pneumonitis, restrictive lung disease, abnormal DLCOva) No concurrent medical diagnoses (alcoholism, coronary artery disease, diabetes, HIV infection, chronic hepatitis, uncontrolled hypertension, chronic renal failure or a psychiatric disorder that is judged to make full participation difficult) Not pregnant or lactating ", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 15.0-85.0, All Rhinitis, Allergic, Seasonal Asthma, Bronchial Non-smoker A 2-year documented history of seasonal allergic rhinitis A 1-year documented history of chronic asthma Positive allergy testing Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 8.0-17.0, All Asthma Allergy Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97) Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6 Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2) Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16) Positive house dust mite skin prick test, with a more than 3 mm infiltrate Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial Active smoking Dogs or cats in the home Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 2.0-10.0, All Asthma All patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation Male or female patients 2 to 10 years of age Parents or legal guardians of patients must sign an Informed Consent Form prior to participation in the trial Patients with known or suspected hypersensitivity to study drugs Patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications Patients with first wheezing episode only Prior intubation for asthma for more than 24 hours Patients who used ipratropium within six hours prior to consultation Patients with concurrent stridor or possible presence of intra-thoracic foreign body Patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease) Patients requiring immediate resuscitation or airway intervention With psychiatric disease or psychosocial problems Patients on other investigational drugs or have used any other investigational drugs within the past month", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-50.0, All Asthma Allergy Normal lung function, defined as (Knudson 1976/1984 predicted set) FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > 80 % of predicted values Evidence of allergy to house dust mite Oxygen saturation of > 94 % Normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) Symptom Score (defined in section \"f\") no greater than 20 (out of a possible 60) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3 IgE within the following ranges and body weights for omalizumab dosing: IgE \u226530-700 int. units/mL, and weight 30-90 kg A history of significant chronic illnesses (to diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma, hypertension) Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose, polyethylene glycol) Positive pregnancy test at time of initial screening Medications which may impact the results of the ozone challenge, interfere with any other medications potentially used in the study (to steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics) Mega doses of vitamins and supplements, homeopathic/naturopathic medicines Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks. Documentation of normal lung function (as defined in \"Specific Criteria\") must be met Unspecified illnesses, which in the judgment of the investigator increase the risk associated with ozone inhalation challenge, will be a basis for exclusion Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable", "label": "1"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 1.0-5.0, All Asthma Children ages 1 years, enrolled in one of the designated SPARK child care centers Children under the age of 1 year Children whose parents do not want to participate Children whose child care centers do not want to participate", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 1.0-2.5, All Asthma Allergic Sensitization Diagnosed with eczema (atopic dermatitis) Family history of eczema, allergic rhinitis, or asthma Allergy to one or more of the following: egg white, cow's milk, peanut, or soybean Weigh at least 9.5 kg (20.9 lbs) Parent or guardian willing to provide informed consent Allergy to house dust mite, cat, or timothy grass Born prematurely (before 36th week's gestation) Previous diagnosis of asthma OR have had 3 or more distinct episodes of wheeze during the first year of life Chronic pulmonary disease Chronic disease requiring therapy Past or current treatment with systemic immunomodulator medication Past or current treatment with allergen-specific immunotherapy Received 10 or more days of systemic steroids in the 3 months prior to study entry Orofacial abnormalities that are likely to interfere with the subject's ability to take study treatment Participated in another clinical study within the 3 months prior to study entry", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 2.0-10.0, All Asthma Asthma Receives asthma care at a clinic in Western Washington Has access to the internet at home Does not speak or read English", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 4.0-12.0, All Asthma Allergies A child will be included in the HEAL intervention study if he or she Is a male or female child four to twelve years old, inclusive, at the time of recruitment, living in Orleans Parish or surrounding areas impacted by flooding Has previously been given a diagnosis of asthma by a healthcare provider and who has symptoms as described below (Criteria 3) for more than one year Is currently receiving long-term asthma control therapy, as reported at baseline, and either has symptoms consistent with persistent asthma (criterion 3a, see below) or has evidence of uncontrolled disease (criterion 3b); or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma (criterion 3a) and also has evidence of uncontrolled disease (criterion 3b) . Evidence of persistent asthma as defined by the National Asthma Education and Prevention Program (NAEPP) of the National Heart Lung and Blood Institute Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma (1997), which includes: asthma symptoms 3 or more days per week during the last two weeks, sleep disturbed due to asthma at least 3 times in the past month, or albuterol use (Metered Dose Inhaler or nebulizer) for quick relief at least 8 times in the past two weeks, not including use as a preventive for exercise . Evidence of uncontrolled disease as defined by at least one of the following additional i. One asthma-related unscheduled visit to an emergency department (ED), urgent care (UC), or clinic in the previous 12 months ii. One asthma-related overnight hospitalization in the previous 12 months iii. One or more bursts of oral corticosteroids or equivalent in the previous 12 months Has a parent or legal guardian willing to sign the written informed consent prior to initiation into the study A child will be excluded from the HEAL intervention study if she or he Is defined as having mild intermittent asthma at baseline evaluation Has had a life-threatening asthma exacerbation in the last 5 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure Has significant medical illnesses other than asthma such as: any hematologic, endocrine, respiratory (other than asthma) or cardiac condition requiring daily medications; significant neurological disorder requiring daily medications; any clotting disorder; any obvious severe mental retardation that prohibits the child or the child s caregiver from answering questions or following instructions; any autoimmune disease; any immune deficiency; or any other serious medical condition including Juvenile diabetes mellitus, hypo or hyper thyroidism, hemophilia, Von Willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis Has not had a home evaluation completed within 4-6 weeks of the Screening Visit (may be re-screened) Lives with a foster parent Has caregiver (typically the parent or guardian) who does not have access to a phone Plans to move out of the recruitment area over the next year", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 1.0-999.0, All Influenza Participants should be informed and assent to participate in this study. For children, informed consent should be provided by their parents or legal guardians. Children aged from 10 years old to 18 years old will be asked to assent Adults or children older than 1 year old Satisfying above definition of cases and controls Infants younger than 12 months For any cases or controls who need proxy, they should be excluded under below situations Proxy can not provide sufficient information for this study, or Proxy refuses to participate in this study, or No suitable proxy can be found", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 6.0-14.0, All Asthma, Bronchial Patient is male or female, 6-14 years of age with mild persistent asthma Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc Patient has asthma diagnosed by a doctor Patient is hospitalized Patient has had major surgery or participated in another clinical trial in the last 4 weeks Patient has been on a breathing tube for asthma", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 12.0-999.0, All Rhinitis, Allergic, Seasonal male or female subjects \u2265 12 years year history of seasonal allergic rhinitis documented hypersensitivity to local seasonal allergens (grass pollen) documented pollen-induced asthma without acute ongoing exacerbation of asthma or allergic rhinitis no continuous ongoing treatment for rhinitis or asthma non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity symptomatic rhinitis or asthma due to tree pollens currently treated by specific grass pollen immunotherapy suffering from non-allergic asthma chronic use of inhaled steroids and/or long acting \u03b22 agonists; and/or corticosteroid dependent asthma atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids contraindication for salbutamol use", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-50.0, All Pulmonary Disease, Chronic Obstructive Healthy adult male or female aged between 18 and 50 years Body mass index within the range 19-29.9 kilograms/metre2 Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7 The subject has an increase in sGAW of >% over pre-dose baseline within 2 h of administration of 400 ug salbutamol by MDI inhaler at screening or in the 3 months before screening Subject has an increase in sGaw of 25% over pre-dose baseline within 2 h following 40 ug ipratropium bromide at screening or in the 3 months before screening Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years A past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject History of respiratory disease Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec Supine mean heart rate outside the range 45-90 beats per minute (bpm) at screening Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort) Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 1 month Infected with the Hepatitis B, Hepatitis C, or HIV virus Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 6.0-17.0, All Allergic Rhinitis Patients Patients between 6 and 17 years old Patients with allergic rhinitis Witness Patients between 6 and 17 years old Patients without allergic rhinitis and asthma Rhino-bronchitis infection dated from less than 15 days Patients younger than 6 or older than 17 years", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 5.0-12.0, All Asthma Physician diagnosis of asthma for at least a year At least one acute exacerbation of asthma in past 12 months that required a visit to the emergency department, hospitalization or an unscheduled office visit for acute care and/or a course of oral steroids Taking daily controller medications or symptoms consistent with persistent asthma No phone Unable to speak English Child has another disease that requires regular monitoring by pediatrician A sibling is already enrolled in the study Child's primary asthma provider is an asthma specialist", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 12.0-999.0, All Allergic Asthma Allergic Rhinitis Allergic asthma or allergic rhinitis age 12+ smokers", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 1.0-45.0, All Respiratory Sounds Patient and/or parents/guardian signed informed consent Patients with cough or shortness of breath Chest tubes Skin lesions precluding attachment of sensors Respiratory distress Pregnant women", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.25-2.0, All Asthma age 3-23 months be delivered at >=37 weeks first wheezing episode written informed consent from guardian chronic illness other than atopy previous systemic or inhaled corticosteroid treatment participation to another study varicella contact if previously intact need for intensive care unit treatment, or poor understanding of Finnish", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.5-16.0, All Aspirated Foreign Body of Lower Respiratory Tract age between 6 months and 16 years suspicion of a foreign body aspiration health care assurance information of parents emergency situation certainly of foreign body presence delay for CT Scan realization longer than 24 hours no speaking French parents parents refusal", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 6.0-12.0, All Rhinitis, Allergic, Seasonal Asthma Children must be >= 6 to < 12 years of age of either sex and any race Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal symptoms (eye symptoms) as itching, burning, tearing and redness, during the previous pollen season Ascertained skin prick positivity (or RAST positivity) to one of the following: grasses, parietaria, birch, hazelnut (the skin test has to be performed within the last year) Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and the non-nasal symptoms severity score must be >= 2 Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be evaluated at visit 1 (day 1) and graded only for child with concomitant asthma Children who have not observed the designated washout periods for any of the prohibited medications Children with persistent asthma (mild, moderate or severe) or perennial allergic rhinitis (PAR) Children with rhinitis medicamentosa Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1) Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids Children with a history of hypersensitivity to desloratadine or any of its excipients Children who have any current clinically significant metabolic, cardiovascular, hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety A known lack of response to H1-antihistamines", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-50.0, All Asthma Hypersensitivity for healthy controls Normal lung function, defined as (Knudson 1976/1984 predicted set) FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > .75 Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score Negative methacholine inhalation challenge as performed in the screening protocol. (Less than a 20% decrease in FEV1 at a maximum methacholine concentration of 10 mg/ml) --Negative pregnancy test for females Negative allergy skin test (AST) for allergic asthmatics also Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) except for use of cromolyn exclusively prior to exercise Use of daily theophylline within the past month Use of tricyclics and MAO inhibitors Pregnancy or nursing a baby Cigarette smoking > 1 pack per month Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma", "label": "1"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 3.0-10.0, All Asthma All 6 must be met Physician-diagnosed asthma (based on caregiver report with validation from the child's physician) > 2 ED visits or > 1 hospitalization for asthma within past 12 months Mild persistent to severe persistent asthma based on NHLBI guidelines (7-9) having any 1 of the following An average of > 2 days per week of asthma symptoms > 2 days per week with rescue medication use (albuterol, xopenex) OR > 2 days per month of nighttime symptoms Age > 3 and < 10 years Reside in Baltimore Metropolitan area Not currently participating in another asthma study or sibling enrolled in PAAL study Inability to speak and understand English No access to a working phone or alternate phone for follow-up surveys Co-morbid respiratory condition including cystic fibrosis, chronic lung disease (BPD), lung cancer, tracheostomy that could interfere with the assessment of asthma-related outcome measures Children residing in foster care or where consent cannot be obtained from a legal guardian", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-39.0, All Asthma Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema, allergic rhinitis in the biological father of the child Gestational age between 10 and 18 weeks at the time of randomization Maternal age between 18 and 39 years Not a current smoker English or Spanish speaking Intent to participate for the full 4 years (through Pregnancy and then until the 3rd birthday of the child) Not meeting Gestational age greater than 18 weeks Presence of chronic medical conditions Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3 Multiple gestation pregnancy (twins, triplets) Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF)", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 6.0-9.0, All Bronchial Asthma Clinical diagnosis of bronchial asthma Must be able to swallow tablets Steroid inhalation or ingestion", "label": "1"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All Avian Influenza Virus Diseases Be at least 18 years old Be willing to participate by signing a consent form, completing the study questionnaire, and providing a blood sample Less than 18 years old Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample) Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 6.0-14.0, All Asthma Allergic Rhinitis children with intermittent asthma and allergic rhinitis children with acute respiratory symptoms in the last 4 weeks children with nasal polyposis or bronchial or respiratory tract infections children with a severe exacerbation of asthma resulting in hospitalization during the last month", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 3.0-10.0, All Asthma (all 4 must be met) Physician-diagnosed asthma (based on parent report) Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following An average of >2 days per week with asthma symptoms >2 days per week with rescue medication use >2 days per month with nighttime symptoms \u22652 episodes of asthma during the past year that have required systemic corticosteroids Age \u22653 and \u226410 years Attending school in participating Rochester City School District preschools or elementary schools Inability to speak and understand English. (*Parents unable to read will be eligible, and all instruments will be given verbally.) No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number) Family planning to leave the school district within fewer than 6 months The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures Children in foster care or other situations in which consent cannot be obtained from a guardian", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All Allergic Asthma Allergic Rhinitis Subjects over 18 years old with allergic asthma and/or allergic rhinitis who are beginning allergen desensitization Smokers Subjects of dimished capacity", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-65.0, All Asthma male or female to 65 years of age non smoker beta agonist naive for at least 14 days baseline FEV1 at least 70% predicted no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1 poorly controlled asthma pregnant or lactating women", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-60.0, All Asthma Male or female subjects with history of mild atopic asthma between 18 and 60 years-of-age Body mass index (BMI) between 18 and 35 kg/m2 Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes history of mild atopic asthma Used only inhaled short-acting \u03b22-agonists infrequently to treat asthma No current exposure to allergens to which subject experiences asthmatic responses No other lung disease, exacerbations of asthma or lower respiratory tract infections for at least 6 weeks prior to screening Positive skin prick test to common aeroallergens at screening Additional apply History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion History or current medical conditions that are contraindicated for methacholine challenge, such as myocardial infarction or stroke within previous 3 months, known cardiac disease, uncontrolled hypertension and aortic or cerebral aneurysm Evidence of active or suspected bacterial, viral, fungal or parasitic infections within past 6 weeks Subject has know type I/II diabetes History of residential exposure to tuberculosis or has a positive PPD or QuantiFERON test within 4 weeks before randomization Subject who has history of malignancy of any type within 5 years prior to enrollment Subjects tested positive for drugs/alcohol or nicotine use at screening Subjects tested positive for HIV, Hep B or Hep C Additional apply", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 6.0-11.0, All Asthma Subjects will females (6 to 9 years of age) and males (6 to 11 years of age) All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study Subjects must be willing to comply with study requirements Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days Subjects will be excluded if they had more than one burst of systemic steroids within the past year Subjects will be excluded if their baseline FEV1 is < 80% predicted Subjects will be excluded if they have any other serious systemic disease other than asthma Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles Subjects will be excluded if they have any history of tuberculosis of the respiratory tract Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All Asthma Subjects eligible for enrolment in the study must meet all of the following Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS with or without LABA (either a fixed combination or via separate inhalers), and for at least 4 weeks prior to Visit 2 Other background asthma medication such as anti-leukotrienes are permitted All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than twice per week, use of short-acting beta2-agonist bronchodilator more than twice per week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms are based on subject's recall and are consistent with the GINA and in principal with the BTS/SIGN guidelines) Subject questionnaires: Subjects must be able to complete the electronic subject questionnaires as well as those questionnaires that are completed by phone or provide a proxy e.g. a partner/relative/a friend who can do so on their behalf Gender and Age: Male or female subjects aged \u226518 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<147 pmol/L) is confirmatory OR Child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to one of the highly effective and acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study Subjects meeting any of the following must not be enrolled in the study Recent history of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the GP/ Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta2-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the GP/ Investigator, contraindicates the subject's participation will also be excluded Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 2 or within five half-lives (t\u00bd) of the prior investigational study (whichever is longer of the two), (if unsure discuss with the medical monitor prior to screening) Chronic user of systemic corticosteroids: A subject who, in the opinion of the GP/Investigator, is considered to be a chronic user of systemic corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening) Subjects who are using LABA without an ICS as asthma maintenance therapy Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 12.0-65.0, All Asthma Written informed consent Adolescents aged 12-17 years & adults aged 18-65 years (both inclusive) Documented clinical history of severe asthma requiring prednisone/prednisolone therapy, high-intensity treatment ICS, OCS, LABA Stable OCS dose for \u22657 days before Screening Visit & during Screening Period At least 80% compliant w/regular asthma medication per investigator at end of Screening Period Documented asthma reversibility within 5 yrs prior to/during Screening Period, or diagnosis of asthma that is incontrovertible per investigator Ability to use nDPI correctly, per investigator's review of completed inhaler operation checklist Ability to use eDiary correctly, assessed by investigator at end of Screening Period Ability to comply w/study procedures, including blood sampling Ability to perform technically satisfactory pulmonary function tests ", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All CHRONIC OBSTRUCTIVE PULMONARY DISEASE ASTHMA HEALTHY SUBJECTS COPD patients, either male or female, over the age of 40 with a clinical diagnosis of COPD with airflow obstruction(FEV1/FVC<0.7) and post-bronchodilator FEV1>50% predicted, gas trapping (on lung volume testing), and decreased carbon monoxide transfer factor Healthy subjects will be nonsmokers(or exsmokers stopped 5 years ago), will have no respiratory disease, normal spirometry and be age-matched to the COPD patients Asthmatic subjects, either male or female, over the age of 18 with a clinical diagnosis of Asthma with airflow obstruction (FEV1/FVC<0.7) All patients should be capable of giving informed consent Oral corticosteroids taken within last month Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products Previous adverse reaction to short or long acting \u03b22 agonist Any subject with a contraindication to taking inhaled beta2-adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit) Pregnant or breastfeeding women Subjects unable to give Informed Consent", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.5-15.0, All Croup Pediatric population: 6 months to 15 years of age or more episodes of croup in 12 month period croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress Grade 3 or 4 subglottic stenosis Subglottic hemangioma Posterior laryngeal cleft Recurrent respiratory papillomatosis External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc) Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease Other medical conditions necessitating chronic steroid utilization", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 5.75-6.5, All Focus of Study: Association of Blood DHA and Lutein With Cognition in Children full-term single birth (no multiple births) no major illness or surgery requiring hospitalization likely to impact the outcomes no metabolic, congenital or allergic disease that impact food intakes parents have sufficient command of English language to complete the informed consent and study documents The specific enrollment for Group 1: children consuming <25 mg/day DHA and < 400 \u03bcg/day lutein, n=24; Group 2: children consuming >150 mg/day DHA and >1,200 \u03bcg/day lutein, n=24; Group 3: children consuming >150 mg/day DHA and <400 \u03bcg/day lutein, n=10 children of mothers enrolled in studies by our group that involved randomization to supplemental DHA during pregnancy children for whom blood, diet records or developmental tests at 5 years and 9 months of age are incomplete children consuming 25-150 mg/day DHA or 400-1200 \u03bcg/day lutein children of mothers who do not sign the informed consent any children having a cardiac pacemaker, aneurysm clip, cochlear implant of possible metallic foreign bodies in the eyes or other contraindication as detailed in the C&W MRI Patient Screening Form will be excluded from this study", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 50.0-90.0, All Pulmonary Disease COPD patients (Global Initiative of Chronic Lung Disease (GOLD) definition COPD stage II, III, IV Patients who are followed in Outpatients' Unit Patients >50 years of age Patients who accept PIF to be measured using the In-Check Inhaler Patients who have signed the Informed Consent Patients who will comply with study demands and procedures COPD stage I patients Patients who are hospitalized Patients <50 years of age Patients who do not accept PIF to be measured using the In-Check Inhaler Patients who have not signed the Informed Consent Patients who face problems in order to comply with study demands and procedures", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.167-4.917, All Bacterial Pneumonia Viral Pneumonia Acute Asthma children aged 2 to 59 months with cough and or difficult breathing Presence of a serious concurrent illness such as meningitis, Children with congenital or acquired heart disease Severe anaemia Measles pneumonia Foreign body inhalation A confirmed diagnosis of pulmonary tuberculosis", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 1.0-17.0, All Asthma Child presented to study institution emergency department during study period Child was 1 years-old Child has physician-diagnosed asthma by parent report Attending physician for child believed emergency department visit was due to asthma Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study Child has major pulmonary or cardiac co-morbid illness Family of child was non-English speaking Child was triaged to the med-trauma bay for severe respiratory distress", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-40.0, All Memory Functions Healthy, male and female, aged between 18 and 40, BMI be-tween 19 and 27 kg/m2, normotensive (BP between 90/60 mmHg and 140/90 mmHg), native or fluent German-speaking, caucasian (European ancestry), able and willing to give written informed consent and comply with the requirements of the study protocol, willing to donate saliva sample for DNA-analysis - Acute or chronic psychiatric or somatic disorder, tachycardia at rest (> 100 bpm), known hypersensitivity to salbutamol, pathological ECG, pregnancy, breast-feeding, long-term medication within last 3 months (oral contraceptives are disregarded) smoking (>3 cigarettes per day), concurrent participation in another study, participation in one of our previous studies using the same memory tests, inability to read and understand the participant's information. -", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.0-72.0, All Asthma Parent(s) must speak English Moms age 14 and older (will sign Informed Consent Statement (ICS), not an assent) Mother of child enrolled must have a physician diagnosis of asthma or being treated for asthma Must live within a reasonable distance to the Indianapolis area Child must be between 0-72 hours of age Signed informed consent from parent or legal guardian Must consent to all procedures Child has a history of wheezing or underlying lung disease Prior use of antibiotics Respiratory complications at birth (airway support higher then nasal cannula) Not be able to comply with research procedures or be available for long term follow up as determined by the site investigator Born earlier then 37 weeks gestation Congenital heart defects (not including Patent Ductus Arteriosus (PDA), hemodynamically insignificant Ventricular Septal Defect (VSD) or Atrial Septal Defect (ASD) Underlying neuromuscular disease Severe upper airway obstruction, sleep apnea, tracheomalacia, or laryngomalacia Hydrocephalus History of seizures", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-65.0, All Asthma Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent Body weight >=50 kg and body mass index within the range 19.0 0 kilogram per square meter (inclusive) A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, \"documented\" refers to the outcome of the investigator's/designee's review of the subject's medical history for study as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli-international units per milliliter (MlU/mL) and estradiol < 40 picograms per milliliter (pg/mL) (<147 picomole per liter) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in listed in protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at screening or urine hCG prior to dosing AND; Agrees to use one of the contraception methods listed in protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until follow-up; OR has only same-sex partners, when this is her preferred and usual lifestyle Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the or outside the reference range for the population being studied may be included only if the Investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Alanine transaminase, alkaline phosphatase and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Based on single or averaged corrected QT interval (QTc) values of triplicate ECGs obtained over a brief recording period: QTcF <450 milliseconds Current non-smokers who have not used any tobacco containing products within 3 months of screening and with a total pack year history of <=10 pack years [number of pack years = (number of cigarettes per day / 20) x number of years smoked] Able to use all medical device products included in the study adequately after training Part B Able to tolerate the charcoal block at screening Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) History of sensitivity to any of the study medications, or components thereof (including milk protein allergy) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Hypertension All cases referred to the clinic for assessment for possible pulmonary hypertension patients with a cardiac pacemaker or retained temporary pacing wire patients with aneurysm clip non MRI compatible heart valve prosthesis intra orbital metalic foreign body pregnancy metal prosthesis/spinal rods retained shrapnel cochlear implants/bladder stimulator", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-50.0, All Mild, Allergic Asthma Age 18-50 of both genders Negative pregnancy test for females who are not s/p hysterectomy with oopherectomy History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine) by the method used in a separate screening protocol FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours or long acting beta agonists for 24 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response Symptom Score (this will be submitted as an attachment) no greater than 16 (out of a possible 24) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3 subjects must be willing to avoid caffeine for 12 hours prior to all visits Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Moderate or Severe asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to prophylactic use of albuterol prior to exercise) Viral upper respiratory tract infection within 2 weeks of challenge Any acute infection requiring antibiotics within 2 weeks of exposure or fever of unknown origin within 2 weeks of challenge Severe asthma Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements Medications which may impact the results of the CCRE exposure, interfere with any other medications potentially used in the study (to steroids, beta antagonists, non-steroidal anti-inflammatory agents)", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.5-4.0, All Asthma The written informed consent must be obtained from his/her parent or legally acceptable representative. If the investigator can get the oral consent from the patient, the investigator should record so in the informed consent which is signed by his/her parent or legally acceptable representative Ethnic origin is Japanese Aged >=6 months and <=4 years at Visit 1 Male and pre-menarchial female. Pre-menarchial females are defined as any female who has yet to begin menses Patient: outpatient Diagnosis as a pediatric asthma has been made by reference to JPGL 2012 and the document which is of help as evidence should be kept as source document. As for <2 years old, children are going to be diagnosed according to an instruction as follows in JPGL2012 as a reference. There are 3 or more episodes of marked expiratory wheezing, regardless of the presence of respiratory tract infection. It is also needed to confirm that there is asymptomatic period for about a week between each episode. In addition to this finding, if there is at least one of following findings, it is more helpful to diagnose infantile asthma: At least one of parents is diagnosed with bronchial asthma by a physician (including past history); Specific immunoglobulin E (IgE) antibody for inhalation antigen is detected in at least one of parents; Diseased child is diagnosed with atopic dermatitis by a physician (including past history); Specific IgE antibody for inhalation antigen is detected in diseased child; High serum IgE level in diseased child or his/her family (serum IgE level should be determined by considering age); Eosinophils and creola bodies found in sputum (examine nasal discharge eosinophilia and peripheral blood eosinophilia); Expiratory wheezing occurs when there is no airway infection; Expiratory wheezing and labored respiration or oxygen saturation are improved after beta-2 stimulant inhalation A patient who needs to be treated with Inhaled corticosteroid (ICS)/ Long-acting beta 2 agonist (LABA) and fulfill following all conditions: At least one documented exacerbation in that the patient treated with systemic glucocorticosteroids, aminophylline dose intravenous(d.i.v) or continuous isoproterenol inhalation in the 12 months prior to Visit 1. Or a well-documented regular treatment with ICS (FP 200-400 mcg daily or equivalent) continuous use in the 12 months prior to Visit 1; The patient has not received systemic glucocorticosteroids, aminophylline d.i.v., ICS (FP>200 mcg daily or equivalent) or continuous isoproterenol inhalation within 4 weeks prior to Visit 1 A patient who has suffered from upper and lower respiratory tract infection and then received medication within 2 weeks prior to Visit 1 A patient who is diagnosed upper and lower respiratory tract infection at Visit 1. Or a patient who has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available. Or a patient who is suspected to have respiratory syncytial (RS) virus infection and cannot be identified to be negative for RS virus antigen A patient who has respiratory disorder other than bronchial asthma, and the investigator judges the respiratory disorder affect the assessment of efficacy in this study A patient who has unstable liver disease or chronic stable hepatitis B receiving significant immunosuppressive agents due to risk of hepatitis B reactivation A patient who has malformation/foreign particle lodged in an airway. Or subjects who have known, pre-existing, clinically significant gastroesophageal reflux disease , endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment A patient who has or is suspected to have hypersensitivity to study medications, the rescue medication or any ingredients of them A patient who has been treated with another investigational product within 1 months prior to Visit 1 or within five half-lives (t-half) of the prior investigational study (whichever is the longer of the two) As for the patients who has evaluable ECG data at Visit 1, QT interval corrected (Fridericia) for heart rate (QTc[F])>=450 milliseconds (msec). The QT interval corrected for heart rate (QTc) should be based on averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. As for the patients who don't has evaluable ECG data at Visit 1, if the patient has known prolonged QTc>=450 msec (any correction is valid), the patient will be excluded A patient who is child in care (including foster parent system), or whom the investigator judges inappropriate for the study Randomization Criterion ", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All Asthma Male or female patients aged >=18 years Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5 Pre-bronchodilator FEV1 \u226540% and <80% of their predicted normal value Pregnant or lactating women Diagnosis of COPD Patients treated for asthma exacerbations in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 7.0-12.0, All Asthma Male or female patients with a diagnosis of asthma according to the American Thoracic Society Patients aged 7 to 12 years inclusive Patients able to perform spirometry Patients with FEV1 (forced expiratory volume in the first second) \u2265 80% of predicted normal value after saline Patients with PD20 (provocative dose that reduces FEV1 by 20 %) metacholine lower than 8 mg/ml Patients or responsible relatives willing and able to sign an informed consent form Patients on treatment for or suspected as having glaucoma Patients with known allergy of contra-indications to either salbutamol, ipratropium or their excipients Patients suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum Patients with a history of chest surgery Patients with other respiratory conditions if diagnosed. These pulmonary fibrosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary tuberculosis, pulmonary complications of AIDS Patients requiring drugs for the treatment of the acute asthma attack other than the study drugs or oxygen Patients who have been previously recruited into this study Patients with myocardiopathy, pulmonary edema or other life threatening diseases, which in the judgement of the pediatrician precludes their entry into the study Patients with obvious or previously diagnosed serious hepatic or renal disease Patients who have been under the following drugs within the specified periods of time prior to determination of Baseline FEV1 or metacholine challenge", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Male and female patients with moderate to severe stable COPD Patients with a diagnosis of chronic bronchitis and/or emphysema FEV1 <65% of predicted value without regard to prior treatment Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial Patient aged \u226540 years Patients with a smoking history of \u226515 pack-years Patients must have given informed consent to participate in the trial Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans Patients with any of the following untreated angle closure glaucoma hypertrophic obstructive cardiomyopathy tachyarrhythmia recent myocardial infarction (within six months of screening visit) severe organic cardiac or vascular disorder untreated hyperthyroidism diabetes mellitus (after approval of Protocol Amendment 1, the of well controlled diabetic patients was allowed) Patients who are pregnant, or who are planning a pregnancy, and nursing mothers", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 3.0-6.0, All Asthma Boys or girls between 3 and 6 years old Presenting to emergency departments with an acute asthmatic attack Requiring nebulised bronchodilator therapy Rint increased by 200 % compared to theoretical Rint Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH) Ipratropium bromide received within four hours before admission First acute asthmatic attack Hospital admission to intensive care with asthma within six months before Hospital admission for asthma during the month prior to Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy Concomitant cardiac disease Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients Renal or hepatic insufficiency Poorly controlled diabetes", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.25-1.0, All Behavior infants less than 12 month are permanent residents in the area have no plan to move away during the intervention period are willing to adopt the agriculture activities; and have adequate place and time to adopt developed gardens & backyard poultry production infants with severe acute malnutrition warranting referral to nutrition rehabilitation program with Ready-To-Use Therapeutic foods severely ill infants with clinical complications warranting hospital referral; and infants with obvious congenital or chronic abnormalities that impair feeding or physical growth measurements", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 3.0-17.0, All Asthma caretaker is age 18 or older and child is age 3-17 have not controlled as thma residence in King County spoken language is English or Spanish Child is enrolled in a Medicaid managed care health plan offered by Community Health Plan of Washington (CHPW) or Molina Health Plan of Washington, Inc (Molina) Parent/guardian plans to move out of King County within the next year or lacks permanent housing Parent/guardian has a mental or physical disability making it impossible to participate in the protocols The household appears to be unsafe for visitation by the CHW The child has other serious chronic medical conditions (e.g. poorly controlled sickle cell disease, cystic fibrosis) that cause sufficient limitation in functional status so that that asthma control is not a priority The family is enrolled in another asthma research study within the past three years. This is to avoid the potential confounding effect from other studies The child is in foster care or group care settings", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All Cough Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-75.0, All Asthma History of asthma \u2265 5 years and diagnosed before 40 years old Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) \u22651.5 Pre-bronchodilator FEV1 \u226540% and <90% of their predicted normal value Positive reversibility test Pregnant or lactating women Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Patients treated for asthma exacerbation in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 12.0-999.0, All Asthma Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities Subjects must be outpatients >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects >=18 years of age only) Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly Subjects must have a FEV1 of >=80% of the predicted normal value Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1 All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use, as needed, for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits If in the opinion of the investigator the subject's asthma is well controlled History of Life-Threatening Asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or in the opinion of the Investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1 A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t\u00bd) of the prior investigational study, whichever is longer of the two Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of inhaler, inhaler or FP 250 History of severe milk protein allergy Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug A subject must not be using or require the use of immunosuppressive medications during the study", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 6.0-15.0, All Rhinitis Asthma Inflammation Hypersensitivity Clinical diagnosis of allergic rhinitis and/or asthma Sensitized to more than 1 common aeroallergens Respiratory infection 2 weeks prior to initial visit Children with nasal polyposis History of immunotherapy Unable to complete the test or had limited understanding Use of systemic corticosteroids 4 weeks prior to initial visit Nasal and inhaled corticosteroids 2 weeks prior to initial visit Leukotriene receptor antagonists 2 weeks prior to initial visit", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 14.0-17.0, All Allergic Rhinitis Asthma Clinical cases n\u00b0: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age Controls n\u00b0: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All Allergic Rhinitis persistent allergic rhinitis the presence of asthma or nasal polyps acute and chronic upper respiratory infections administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 40.0-70.0, All Chronic Obstructive Pulmonary Disease Provide informed consent Males not donating sperm and using adequate contraception or females who are surgically sterile or postmenopausal lead ECG showing:Heart rate 45 to 90 bpm, QTcF\u2264450 msec, QRS \u2264120 msec, PR interval \u2264220 msec, no clinically significant abnormality Capable of complying with all study restrictions and procedures including ability to use the study nebuliser correctly BMI 18 to 33 kg/m2 with a minimum weight of 45 kg COPD diagnosis for at least 1 year and clinically stable COPD in previous 4 weeks Demonstrates reversibility to bronchodilator (two puffs of salbutamol followed by two puffs of ipratropium) via spirometry Post-bronchodilator FEV1/forced vital capacity (FVC) ratio of \u22640.70 Post-bronchodilator FEV1 \u226540 % and \u226480% of predicted normal \u2265150 mL increase from pre-bronchodilator FEV1 History of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation COPD exacerbation requiring oral steroids in the previous 3 months History of one or more hospitalisations for COPD in the previous 12 months Respiratory tract infection (both upper and lower) treated with antibiotics in previous 12 weeks Evidence of cor pulmonale or clinically significant pulmonary hypertension Other respiratory disorders Previous lung resection or lung reduction surgery Oral therapies for COPD in the previous 3 months and throughout the study Drug or alcohol abuse in the past 3 years Received an experimental drug within 3 months or five half lives, whichever is longer", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 0.5-999.0, All Healthy Volunteers Only All children between the ages of 6 months to 12 years of age who are typically developing and born of a full term pregnancy if under 24 months of age, healthy, and English speaking are eligible for in the study. Typically developing children would not have any diagnosed congenital conditions, developmental delay or disability, dyslexia, PDD, ADD, ADHD, or ASD. In addition, we will only enroll subjects if they are from a racial and ethnic group that is still needed to ensure the diversity and representative nature of our sample as set forth in the Planned Enrollment Form. These are the initial screening that will be used Children outside of the 6 month-12 year age range: These years cover early life and are the ages of interest for children s play and are of central significance to the Consumer Product Safety Commission s goals Families not fluent in English: Fluency in English is essential for parents to be able to fill out surveys. Families also need to be fluent in English so that they can comprehend verbal directions given by the experimenter during the testing session. If we included people who were not fluent in English, we would need many additional staff members who speak the multitude of languages of the diverse population of the Washington, D.C metro area to work with participants during the testing session and code the videos after the testing session is complete Children who are sick, not typically developing, born premature (if they are under 24 months of age), blind, or deaf: We must recruit a healthy sample of typically developing children born in a full term pregnancy (if they are under 24 months of age) who are not blind or deaf for this project to remove any potential confounds that atypical conditions may have on children s play. Typically developing children would not have any diagnosed congenital conditions, developmental delay or disability, dyslexia, PDD, ADD, ADHD, or ASD. Including other populations such as deaf or blind children would require a different experimental set up, stimulus toys, and resources (i.e., someone who could convert our surveys to American Sign Language or Braille and could code the videos for the parent child behaviors during those sessions) Children who are not adding to the ethnic and racial diversity of the sample: The goal of our study is to recruit a sample of subjects who are racially and ethnically diverse. By making this diverse sample a priority, we hope that our results will be applicable to the diverse populations residing within the United States. To keep with this goal of a diverse and representative sample of children, we may have to some families if we have already reached the quota of families from that particular racial or ethnic group", "label": "2"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 12.0-999.0, All Allergic Rhinitis Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen A previous specific immunotherapy finished at least five years ago had to be successful Contraindications according to the patient information leaflet", "label": "0"} +{"topic": "A 4 year old boy presents to the emergency room with wheezing. He has had a history of allergic rhinitis, but no history of wheezing. His mother reports that 5 hours ago patient was playing in the backyard sandbox when she heard him suddenly start coughing. The coughing lasted only moments, but he has been audibly wheezing since. Mother was concerned, because his breathing has not returned to normal, so she brought him to the ED. On exam, the child is playful and well appearing. Wheezing is heard in the mid-right chest area. O2 sats are 100% on room air.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Hepatitis C \u226518 years of age 2 consecutive positive HCV RNA tests at least 6 months after estimated date of infection HCV genotype 1 HCV RNA <6 million copies by Roche TaqMan Assay No evidence of hepatic cirrhosis (as determined by two indices: Fib4<3.25\u2014an accurate test for detecting cirrhosis based on age, AST, ALT and platelets [sensitivity/specificity 76-100/82-91%], confirmed by the fibrosis-cirrhosis index (FCI)<1.25 based on ALT, bilirubin, albumin and platelets [sensitivity/specificity 86/100%]) Drug injection in past 30 days by self-report and physical exam evidence of injection drug use (e.g. track marks) injected with others in past 12 months by self-report Lab values within acceptable range (platelets>50,000, creatinine clearance by Cockroft-Gault>30mL/min, hemoglobin >10g/dL, INR<1.5 x upper limit of normal (ULN) unless stable on anticoagulant regimen or known hemophilia, AST/ALT<10 x ULN) Able to speak English No plans to leave San Francisco area for at least 9 months and either lives or works in San Francisco, or travels to San Francisco at least weekly HIV+ by rapid test or pooled viral load HBV surface antigen + Non-definitive HCV genotype results Previously received treatment for HCV (interferon, ribavirin, or DAA) Taking medications that affect pharmacokinetics of LDV-SOF (proton-pump inhibitors, anticonvulsants [phenobarbital, phenytoin, carbamazepine, oxcarbazepine], rifamycins, rosuvastatin, herbs [St. John's wort, silymarin, echinacea]) History of any of the following Current gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug History of hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage) History of solid organ or bone marrow transplantation Current treatment for cancer", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 16.0-23.0, All Cervical Cancer Genital Warts Female with an intact uterus with lifetime history of 0-4 sexual partners Prior Human Papillomavirus (HPV) vaccination Prior abnormal paps History of genital warts", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-70.0, All Cervix Neoplasms Women with ONLY the following results on a routine Pap smear Low grade epithelial abnormality Minor changes in squamous cell Minor changes in squamous cells with appearances consistent with Papillomavirus Women aged between 18-70 years Women who are pregnant or planning to become pregnant in the next 12 months Women with previous Pap smear abnormality for 2 years", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 20.0-30.0, All Papillomavirus Infection Participated in study 580299/001 and received all three doses of vaccine/placebo Written informed consent obtained from the subject prior to enrollment Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 15.0-25.0, All Infections, Papillomavirus A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) A woman between, and including, 15 and 25 years of age at the time of the first vaccination Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent) Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study Subject must have a negative urine pregnancy test Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements Subject must have intact cervix Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8) Previous administration of components of the investigational vaccine Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Previous vaccination against human papillomavirus (HPV) History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 26.0-999.0, All Infections, Papillomavirus A woman who the investigator believes that she can and will comply with the requirements of the protocol A women of at least 26 years of age at the time of the first vaccination Written informed consent obtained from the subject prior to enrolment Free of obvious health problems as established by medical history and clinical examination before entering into the study Subject must have intact cervix Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study) A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 84) Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0 the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Previous administration of components of the investigational vaccine Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 20.0-25.0, All Human Papillomavirus (HPV) Infection Papillomavirus Vaccines Cervical Neoplasia Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination Written informed consent obtained from the subject prior to enrolment Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study Subjects must have a negative urine pregnancy test Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series Subject must have an intact cervix Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/control within 30 days preceding the first dose of study vaccine/control, or planned use during the study period Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose previous administration of components of the investigational vaccine Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine Previous vaccination against HPV History of vaccination against hepatitis A or a known clinical history of hepatitis A disease Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-999.0, All Papillomavirus Infections HIV Infections HIV-infected men who have sex with men ", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 21.0-100.0, All Cervical Neoplasia Women in KPNC aged 25 years or older who tested positive for HPV Will also a random sample of women who tested negative for HPV Male Children under 18", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 26.0-65.0, All Cervical Intraepithelial Neoplasia Five-hundred women attending colposcopy and 500 women receiving cytology screening, including 250 unscreened women, will be recruited for the study. Non-pregnant, non-hysterectomized women aged 26-65 will be recruited Women under 26 or over 65 years of age Pregnant women or women having given birth to a child in the past 8 weeks. To insure women included in the study are not pregnant, we will ask women during the consenting process if they are pregnant. Women who answer yes for either query will be excluded. Participants will also receive a reminder call for their 2-week self-collection. At that time, women again will be asked if they are pregnant. If any woman answers yes, she will be instructed to not self-collect Women who have had a total hysterectomy Women who have an overt cancerous lesion visible upon exam by the clinician Other reasons to women the inability to speak English, the appearance of mental incompetence, or refusal to participate or sign the informed consent form", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-999.0, All Cervical Cancer Precancerous Condition Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following CIN grade 2-3 or higher Repeated CIN1 (times 6) Abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS] or worse) HIV seropositive Negative cytology but positive for high-risk human papillomavirus (HPV) Negative cytology and negative HPV HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73) >= 18 years of age < 18 years of age Pregnant at screening Cervix not intact not able to provide informed consent", "label": "2"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 25.0-65.0, All Cervical Cancer Screening Women from 25 to 65 years of age, registered with the Medical Services Plain in BC attending a collaborating healthcare provider for routine cervical screening in Metro Vancouver or Greater Victoria pregnant history of invasive cervical cancer no cervix HIV positive or on immunosuppressive treatments unable or unwilling to give informed consent Treatment of moderate or greater dysplasia within last 5 years", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-26.0, All Papillomavirus Infections Women between 18 and 26 years of age Women able to consent for themselves Referring Pap smear was ASCUS, + HPV or LGSIL Women who decide they wish to get the Gardasil vaccination series Women who have had previous cryotherapy of the cervix, LEEP or cervical conization Women who had their first Gardasil injection prior to their referring Pap smear Women under the age of 18 Women unable to consent for themselves Women who are pregnant currently trying to conceive Women in an immunocompromised state (diabetes, HIV, on chronic immunosuppressants or steroids, etc) Women who do not want the Gardasil vaccination series", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 15.0-25.0, All Infections, Papillomavirus Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study Subjects who participated in study 580299-007 Written informed consent obtained from the subject prior to enrollment Use or planned use of any investigational or non-registered product other than the study vaccine Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-45.0, All Papanicolaou Smear female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives has other concurrent/active STD's has a history of known prior vaccination with an HPV vaccine has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 25.0-55.0, All Patient With Invasive Cervical Carcinoma Patient With CIN Lesion Patient With HPV Infected Patients Without Histopathologic Lesion Normal Populations. Healthy volunteers People infected with HPV type 16 but without CIN lesions Patients with CIN lesions Patients with cervical cancer from National Taiwan University Hospital Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards ", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-24.0, All Cervical Cancer Precancerous Condition Currently enrolled in a college, university, or community college in the Greater Cleveland metropolitan area Currently single and never married Not specified Not specified ", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-999.0, All Cervical Cancer years and older Ability to speak and clearly understand English Female patients No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.) Women who have had Pap smears within the previous 10 months Women under the age of 18 Women who are pregnant Inability to give informed consent in English", "label": "2"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 25.0-80.0, All Cervical Cancer Healthy volunteers People infected with HPV type 16 but without CIN lesions Patients with CIN lesions Patients with cervical cancer from National Taiwan University Hospital Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards ", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-26.0, All Human Papillomavirus Infection Between the age of 18 and 26 years Registered female sex worker living in Lima Healthy with no known immune deficiency Willing to participate in a study of HPV vaccine including a Pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months Willing to provide informed consent Currently pregnant or planning to get pregnant in the next six months Known immune deficiency disorder Current receipt of immunosuppressive drugs Allergy to yeast or known contraindication to HPV vaccine Women who have had their cervix removed Previous HPV vaccination Current fever over 100 degrees Fahrenheit", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 9.0-26.0, All Inflammatory Bowel Disease Uterine Cervical Dysplasia Women 9-26 years of age Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis) Pregnancy Taking corticosteroids Allergy to yeast aluminum component of the HPV vaccine Positive for all HPV types in the Gardasil vaccine\u20146, 11, 16, 18", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 21.0-30.0, All Cervical Neoplasia HPV Infections To be eligible to receive crossover vaccination, participants must fulfill all of the following Participation Status: Women previously randomized into the HPV-16/18 vaccine trial 04-C-N191, also known as the Costa Rica Vaccine Trial Planned Residence: Residents of Guanacaste or Puntarenas Province or willingness to visit one of the study clinics for participation Consent: Written informed consent obtained prior to enrollment into the crossover protocol The following will be checked for all potential participants at the time of enrollment. If any apply, the participant will not be included in the study History of (a) allergic reaction (e.g., difficulty breathing) after receipt of any vaccine, (b) hypersensitivity to latex History of vaccine related adverse events during the vaccination phase that, at the discretion of the investigators, preclude vaccination during the crossover phase Are receiving vaccination with Cervarix , are sexually experienced and of childbearing potential (i.e., not surgically sterilized), and are unwilling to use an effective method of birth control for 30 days before vaccination until 60 days after the last Cervarix vaccination (approximately 9 months). Acceptable forms of birth control abstinence, surgical sterilization, hormonal contraceptives (e.g., oral, injectable, implant, and patch), intrauterine devices, and diaphragm or condom History of chronic condition that per attending doctor opinion precludes her from receiving vaccination (e.g., no proper treatment available or participant is unwilling to stay under proper treatment) The participant has a diagnosed autoimmune illness (per the specific requirement of the IRB) The vaccine or vaccines the participant is interested in receiving are contraindicated in her case", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-65.0, All HPV-related Cytological Abnormalities on PAP Smear (LSIL) women with a new LSIL diagnosis an HPV positivity on PAP smear women over 65 immunocompromised patients (because of disease or drugs)", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-999.0, All Cervical Intraepithelial Neoplasia Cervical Smears HPV DNA Probes Diagnosis of ASCUS or LSIL years or older Able to give informed consent with reasonable likelihood of follow-up Previous Hysterectomy History of excisional or ablative treatment of cervix, such as laser treatment, radiation therapy, cauterization (burning), freezing or surgery such as cone biopsy or LEEP Already known to be pregnant Already known to be HIV positive (HIV may negatively affect the clinical history of HPV, making triage less appropriate", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-999.0, All Human Papillomavirus Infection Women >= 18 years of age attending a clinic for gynaecological examination Women who agree to provide a cervical sample for human papillomavirus testing Written informed consent obtained from the subject Referral for abnormal cervical sample at the current visit Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed History of hysterectomy Known diagnosis of immunosuppression, or patient on immunosuppressives Pregnant women Having received one or more doses of HPV vaccine prior to participating in the study", "label": "2"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 0.0-999.0, All Genital Warts Human Papilloma Virus All female patients with genital warts Patients who are pregnant, too frail or ill for gynaeoclogical examination and refusal to participate", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 21.0-999.0, All Infections, Papillomavirus Cervical Cancer A female aged 21 years or more, presenting with a lesion macroscopically suggestive of invasive cervical cancer Scheduled for cervical biopsy as per routine procedure at the participating institution on the day of the visit or on a later date Written or oral-witnessed informed consent obtained from the subject prior to any study procedure No prior chemo or radiotherapy for cervical cancer ", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 15.0-999.0, All Infections, Papillomavirus Cervical Cancer Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study Women >=15 years of age attending a clinic for routine cervical screening Written informed consent obtained from the subject and/or subject's parent/guardian Referral for abnormal cervical sample at the current visit Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed No cervical sample provided History of hysterectomy Known diagnosis of immunosuppression, or patient on immunosuppressives Pregnant female >=25 years of age", "label": "2"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 25.0-65.0, All DNA Probes E6 Protein Uterine Cervical Neoplasms HPV have not been previously diagnosed with cervical cancer have a cervix are not pregnant are physically able to undergo routine cervical cancer screening 5) are able to provide informed consent We will not women if they have had previous cervical cancer screening because we assume that even if a few women have been screened for cervical cancer, the quality of cytology screening was very poor are not married AND report never having had sexual intercourse 2) have had a total hysterectomy have a history of cervical cancer are physically or mentally unable to undergo routine cervical cancer screening or unable to provide informed consent are pregnant or have been pregnant in the last month -Women who are currently menstruating at the time of enrollment will be deferred from participating, and will become eligible to participate 7-14 days after menstruation has ended. The menstruating women will be advised to return for the screening 7 to 14 days after their menstrual period has concluded", "label": "2"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-999.0, All Human Papillomavirus Infection \u2022 the subject attended a colposcopy visit, and the referral Pap sample had a valid HPV Assay result, and the sample had an HPV Assay positive result, or the sample had an HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 [CIN2] or more severe (eg, CIN2, CIN grade 3 [CIN3], or cervical cancer; \"CIN2+\"), or the sample had an HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 ( or equal to 350 cells/mm3 For subjects receiving HAART Good compliance to therapy At least two suppressed viral loads HIV-RNA (<37copies/ml9 during 6 months prior to enrollment For female subjects (both HIV-infected and healthy) Pregnancy or breastfeeding Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded For both females and males (HIV-infected and healthy) Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator Acute infection requiring therapy or fever at time of enrollment Chronic autoimmune or oncologic disease receiving chemotherapy Concomitant therapies (other than HAART)", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 0.0-999.0, All Cervical Cancer Squamous Cell Human Papilloma Virus Infection Human Papilloma Virus-Related Carcinoma Prevention Any women who come to do the Papanicolaou test at the Barretos Cancer Hospital and in the mobile units on the remote Brazilian areas ", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 21.0-999.0, All Atypical Squamous Cells of Undetermined Significance Cervical Cancer Cervical Intraepithelial Neoplasia Grade 1 Cervical Intraepithelial Neoplasia Grade 2 Cervical Intraepithelial Neoplasia Grade 3 Health Status Unknown Human Papilloma Virus Infection Stage 0 Cervical Cancer Able to provide informed consent in English Have had hysterectomy Currently pregnant Received treatment of cervical dysplasia with loop electrosurgical excision procedure (LEEP), cone biopsy, laser procedure or cryotherapy within THREE years Received colposcopy of cervix within TWO years Received Pap test within ONE year Immunocompromised (positive human immunodeficiency virus [HIV] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs) Decisionally impaired adults requiring a legally authorized representative", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-90.0, All Anal Intraepithelial Neoplasia MSM with HIV negative MSM with HIV positive ", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 0.0-999.0, All Uterine Cervical Neoplasms Referred to follow up due to one or more abnormal Pap or an HPV infection Subjects who have provided informed consent Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines Known to be pregnant With prior complete or partial hysterectomy involving removal of cervix Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry this includes acetic acid, iodine, spermicide, douche, anti-fungal meds Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed", "label": "2"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-40.0, All Human Papillomavirus Infection Couple must have been in a new relationship that started no more than six months prior to study entry Both partners plan on remaining in Montreal for at least 1 year Plan on having continued sexual contact with partner Be willing to comply with study procedures Volunteers must not have been vaccinated against HPV (both partners) Any history of cervical, penile, oral or anal cancers Being pregnant or plan on immediately becoming pregnant", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 30.0-65.0, All HPV Infection Age 30 to 65 years of age the sex life of female patients , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive) kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68 (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 20.0-49.0, All Cervical Intraepithelial Neoplasia Fertile women between age of 20 and 49 Patients with cervical intraepithelial neoplasia 1(CIN1) HPV(Human Papilloma Virus) positive(+) White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10^6/L AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray Be informed of the nature of the study and will give written informed consent Malignant tumor in any organ other than cervical intraepithelial neoplasia Active liver disease, immune disorder and severe renal failure Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded) Diagnosed diabetes Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc) Pregnancy and breastfeeding Registered in other clinical trials Patients whom the investigator considers inappropriate to participate in the study", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 30.0-64.0, All CIN3 CIN2 Cervical Cancer Aged 30-64 years Mentally competent to be able to understand the consent form Able to communicate with study staff Physically able to have a pelvic exam Reporting no previous sexual activity History of cervical cancer Previous treatment for cervical pre-cancer in the last six months Hysterectomy Plans to move out of the study area in the next 12 months Screened for cervical cancer in the last 12 months (depending on local regulations)", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 40.0-999.0, All High Grade Cervical Dysplasia Cervical Cancer Women \u2265 40 years old Previous or current high grade cervical dysplasia or cervical cancer Women \u2265 40 years old because the median time between the diagnosis of anal cancer and previous cervical cancer is approximately 20 years chemotherapy or radiation therapy within the last 6 months", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 18.0-999.0, All Cervical Abnormality Female years or older Able to give informed consent Intact cervix No prior history of invasive cervical cancer English speaking Willing to have biological specimens stored for future studies Resident of Appalachian Ohio Pregnant Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 25.0-69.0, All Cancer of the Cervix Cervical Intraepithelial Neoplasia Australian female residents aged 25-69 years who are attending for routine cervical screening Participants may have been previously enrolled in the Compass Pilot but must have been discharged to routine screening. Women may also be in follow-up management for a previous abnormality or unsatisfactory cytology Previous total hysterectomy (uterus and cervix) The presence of symptoms or signs for which cervical cancer must be excluded Currently undergoing treatment for cervical cancer Currently enrolled in the Compass Pilot Study", "label": "1"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 25.0-59.0, All Compliance Cervical Cancer Women between 25-59 years-old Not pregnant Had held their last Pap smear for over a year Could read Women with previous hysterectomy History of cervical cancer or its precursors Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases) Those who underwent self-collection of their specimen during menstrual period", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 30.0-999.0, All Patient Adherence Women 30 years and older living in a household visited by Community Health Workers (CHWs) Women with a previous HPV test Women with precancerous lesion or cervical cancer Current pregnancy Women with Mental disability", "label": "0"} +{"topic": "A 32 year old female with no previous medical history presents to clinic to discuss lab results from her most recent pap smear. She reports no complaints and is in general good health. The results of her PAP were cytology negative, HPV positive.", "doc": "eligible ages (years): 30.0-60.0, All Human Papilloma Virus Infection Women aged 30 years Women attending gynaecological practices for routine screening Women who gave informed consent to participation in the study Women with hysterectomy or known destructive therapy to the cervix Women who are pregnant Women with an abnormal cytology result during the previous 6 months Women with known HIV infection or history of transplants Women vaccinated against HPV Women participating in another research protocol", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Cardiovascular Diseases Heart Diseases Heart Failure, Congestive Heart Failure Men and women, ages 18 and over. Patients had compensated congestive heart failure due to idiopathic dilated cardiomyopathy or coronary disease with ejection fraction less than or equal to 0.35, were in the New York Heart Association functional class III or IV, and were taking an angiotensin-converting enzyme inhibitor, digitalis, and if needed, a diuretic. Patients with a specific indication for, or contraindication to, beta-blockade were excluded ", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Atherosclerosis Heart Failure, Congestive Hypertension Myocardial Infarction Patients over 18 years with endothelial dysfunction requiring diagnostic cardiac catheterization Normal volunteers or patients undergoing catheterization who have normal coronary arteries without risk factors for atherosclerosis will be used as controls No unstable angina No significant left main disease (greater than 50% stenosis) No recent myocardial infarction (less than 1 month) No pregnancy, lactation No allergy to losartan No renal failure (creatinine greater than 2.5 mg/dl) Ability to withdraw ACE inhibitors ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Atherosclerosis Heart Failure, Congestive Hypertension Myocardial Infarction Patient must be over 18 years of age requiring diagnostic cardiac catheterization will participate Women on chronic estrogen therapy are eligible for the study Patients investigated for chest pain syndrome with normal coronary arteries with and without risk factors for atherosclerosis, patients with coronary artery disease, and patients with heart failure No patients with unstable angina; significant left main disease (greater than 50% stenosis); Recent myocardial infarction (less than 1 month); Pregnancy, lactation; Allergy to losartan; Renal failure (creatinine greater than 2.5 mg/dl); Inability to withdraw ACE inhibitors ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 35.0-84.0, All Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Disease Hypertension Cerebrovascular Disorders African American ", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Heart Diseases Heart Failure, Congestive Heart Failure ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Heart Failure CHF diagnosis, NY stage 2 or 3 ", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Heart Failure EF <40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English ", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Heart Diseases Heart Failure Coronary Disease Diabetes Mellitus Hypertension Obesity ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Metastatic Cancer Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan Resectable disease Histological evidence of metastatic carcinoma by intraoperative pathology No primary lymphoma, germ cell carcinoma, or small cell lung cancer Age and over Performance status Karnofsky 70-100% Life expectancy At least 3 months ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 65.0-999.0, All Brain Infarction Hypertension Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs) Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging Secondary hypertension Atrial fibrillation History or signs of cerebral disorders other than cerebrovascular disease Malignant tumor Chronic renal failure Severe congestive heart failure Hyperkalemia Stenosis of bilateral renal artery", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 20.0-79.0, All Hypertension Ischemic Heart Disease Congestive Heart Failure Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure Pregnancy Severe renal damage Severe liver damage Acute myocardial infarction", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 20.0-79.0, All Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke Clinical diagnosis of hypertension Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH) Patients who have already been administered ARB Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG) Severe/malignant/secondary hypertensive patients Pregnant women and women of childbearing potential History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block Severe renal impairment (Serum creatinine >3.0 mg/dl) Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Congestive Heart Failure, Atrial Fibrillation Patient is willing and able to comply with the protocol Patient is willing to sign written informed consent Patient is expected to remain available for Follow-up visits Patient age is 18 years and older patient is on a stable medication regimen (including beta blockers) for at least 4 weeks prior to enrollment Baseline patients should meet all of the following to be determined at the baseline assessment procedure within 4 weeks prior to device implantation New York Heart Association functional classification III or IV QRS duration > 130 ms Left ventricular ejection fraction < 35% measured by echocardiography left ventricular end diastolic dimension > 55 mm measured by echocardiography Patients with unstable angina or who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 3 months prior to enrollment or who are candidates for CABG or PTCA Patients who have experienced CVA or TIA with permanent disability within 3 months prior to enrollment Patient on, or anticipated to require, intravenous inotropic drug therapy Patients with severe primary pulmonary disease (such as cor pulmonale) Post heart transplant patients and patients on an urgency list for cardiac transplantation Supine systolic blood pressure greater than 170 mm Patient who are not expected to survive for 8 months of study participation due to other medical conditions Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control Serum creatinine greater than 250 mol/l Untreated hyperthyroidism", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure, Congestive Renal Insufficiency Stable congestive heart failure Impaired renal function Taking oral loop diuretic Acutely decompensated (unstable) and end stage heart failure Diuretics other than loop diuretics Pregnant or nursing Inability to follow instructions Participation in another clinical trial within past 30 days", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure, Congestive Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema Left ventricular ejection fraction less than 40% Indication of intravenous positive inotropic treatment Indication to withdraw beta-blocker treatment", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 65.0-999.0, All Heart Failure, Congestive All new residents to participating long-term care facilities Age 65 or over Residing in any long-term care facility for more than 8 weeks Inability or refusal to obtain informed consent Palliative diagnosis and not expected to survive 6 weeks Residents admitted for respite care and expected to be returned to the community", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-18.0, All Dilated Cardiomyopathy Pediatric Diagnosed with dilated cardiomyopathy normal heart anatomy or those with repaired congenital defects that have a 4 chambered heart referred for a Biventricular pacemaker implantation or upgrade with the diagnosis of dilated cardiomyopathy or for an echocardiogram due to the diagnosis of dilated cardiomyopathy without pacemaker signed informed consent cannot travel back to Children's Healthcare of Atlanta for follow-up Patients with a transplanted heart no informed consent", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-80.0, All Heart Failure, Congestive Congestive heart failure patients due to any cause Patients with normal cortical function Congestive heart failure patients who are on diuretic therapy Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention Patient refusal Signs of infection", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Symptomatic Decompensated Congestive Heart Failure Congestive Heart Failure in Acute Coronary Syndrome Patients with dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal activity such as talking, eating, or bathing having evidence of heart disease, rather than pulmonary disease, as the primary cause for the dyspnea (by demonstrating at least two of the following: jugular venous distension, paroxysmal nocturnal dyspnea or 2-pillow orthopnea within 72 hours before the start of study drug, abdominal discomfort due to hepatosplanchnic congestion, chest x-ray with findings indicative of heart failure) having elevated cardiac filling pressures either by clinical estimate in non-catheterized patients, or a measured pulmonary capillary wedge pressure (PCWP) >= 20 mm Hg in catheterized patients requiring hospitalization and intravenous therapy for at least 24 hours for the treatment of acutely decompensated heart failure NPatients having systolic blood pressure consistently less than 90 mm Hg having cardiogenic shock (a sudden decrease in blood pressure that results in decreased perfusion of body tissues and organs), volume depletion, or any other clinical condition that would contraindicate the administration of an intravenous agent with potent vasodilating properties having their most recent pulmonary capillary wedge pressure (PCWP) < 20 mm Hg within 24 hours before randomization having a clinical status so acutely unstable that the potential subject could not tolerate placement of a right heart catheter or the 3-hour placebo period unable to have intravenous nitroglycerin withheld (e.g., intravenous nitroglycerin for management of an acute coronary syndrome)", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 16.0-999.0, All Leukemia Diagnosis of acute myeloid leukemia Previously untreated disease Previous hydroxyurea and/or corticosteroids are acceptable No preexisting history of a hematologic disorder Myelodysplastic features allowed No acute leukemia secondary to previous therapy No leukemic meningitis Bilirubin < 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia) Creatinine < 2.0 mg/dL Pregnant or lactating patients are ineligible ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure Symptomatic heart failure and indication for cardiac resynchronization therapy (CRT), Hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (<25% of optimal dosage) chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; Severe aortic stenosis or other primary valve disease causing cardiomyopathy", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Lung Cancer Patients must be enrolled in the trial: \"A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer,\" Principal Investigator: T. Mekhail, M.D Patient must be in maintenance therapy phase of the study and have received erlotinib for \u2265 1 week No known CNS primary or metastatic cancer at any time prior to time of enrollment No MRI evidence of pathological enhancement at the time of study entry Patients must use adequate birth control measures while in the study No significant side effects to erlotinib that require dose reduction or interruption None of the following medical issues which could make a lumbar puncture unsafe Platelets < 100,000/mm\u00b3 INR > 1.1 Known bleeding dyscrasia ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 30.0-999.0, All Congestive Heart Failure (CHF) Physician diagnosed CHF Member of Kaiser Permanente Georgia ", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-90.0, All Congestive Heart Failure Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are Older than 18 Not pregnant Have heart failure with worsening hypervolemia despite oral diuretics Have at least two of the following signs or symptoms of hypervolemia: JVD, edema >1+, rales pulmonary edema on chest x-ray, orthopnea or PND Not more than 10 kg above their usual baseline weight Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal Systolic blood pressure < 90 mmHg Serum creatinine > 3.0 mg/dL Hematocrit >45 % Uncontrolled arrhythmias Need for hospitalization Require renal replacement therapy Contraindication to anticoagulation with heparin Poor venous access", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Heart Failure Hospitalized for episode of worsening heart failure as primary cause of admission or significant heart failure symptoms that develop during the hospitalization when the initial reason for admission was not heart failure Systolic dysfunction (LVEF < 40%) or heart failure symptoms in the setting of preserved systolic function (diastolic dysfunction) This study has no", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 20.0-999.0, All Congestive Heart Failure Clinical diagnosis of heart failure based on a slight modification of the Framingham as previously described within 6 months before the entry Current status of heart failure is NYHA II or III Currently, loop diuretic(s) is (are) administered No change in baseline therapy and symptoms of heart failure within a month Current symptomatic hypotension Hypertension that has not been controlled to the satisfaction of the investigator Hemodynamically significant (in the investigators opinion) LV outflow tract obstruction (due to either aortic stenosis or ventricular hypertrophy) Acute coronary syndrome Primary pulmonary hypertension or pulmonary hypertension not due to LV dysfunction Serious cerebrovascular disease Acute myocardial infarction within the last 3 months Patients who require intravenous inotropes Cerebrovascular accident within the last 3 months Percutaneous coronary intervention or open heart surgery within the last 3 months", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-80.0, All Hypertension African-American males and females current diagnosis of type 2 diabetes documented by medical history mean sitting diastolic blood pressure of \u2265 90 and \u2264 110 mm Hg HbA1C \u2264 9.5% having unilateral or bilateral renal artery stenosis having clinically significant cardiac dysrhythmias having a significant history of coronary artery disease within the past 6 months having a history or diagnosis of congestive heart failure (CHF) having any clinically relevant cardiac valvular disease", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Heart Failure, Congestive primary hospitalization with heart failure and LVEF < 40% patient informed consent has been obtained absence of pulmonary congestion age > 18 years End-stage renal or hepatic disease Acute myocardial infarction as primary diagnosis during index hospitalization Life-expectancy < 6-months Contraindication to beta blocker use Current beta-blocker therapy Planned bypass or valve surgery during index hospitalization", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 45.0-999.0, All Congestive Heart Failure Age over 45 years old CHF class II or III with LVEF<40% Hospitalized at least once for CHF deterioration over previous 12 month period Able and willing to cooperate with this trial for at least a 3 month period Home close to participating center Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation Asthma or COPD", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Prostate Cancer Histologically confirmed adenocarcinoma of the prostate meeting any of the following for high-risk disease Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen [PSA]) Gleason score 7 (4+3 only) or \u2265 8 (any stage or PSA) Serum PSA \u2265 10 ng/dL (any grade or stage) Any stage, PSA, or Gleason score with \u2265 35% chance of biochemical failure at 5 years based on Kattan's nomogram No clinical evidence of CNS metastases No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry Appropriate medical candidate for radical prostatectomy ECOG performance status 0-1 Creatinine \u2264 2.0 mg/dL ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-99.0, All Congestive Heart Failure NYHA III-IV QRS > 120 msec On medical therapy, but beta blocker dose not @ target (carvedilol 25 bid, metoprolol succinate 200 qd) QRS < 120 msec On target beta blocker dose", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Diseases Advanced HF (Stage D or advanced Stage C HF) with symptoms of dyspnea at rest or with minimal exertion systolic dysfunction or preserved systolic function (\"diastolic heart failure\") Outpatient care setting (office, clinic or home hospice) Patient already receiving optimal medical therapy per ACC/AHA guidelines (ACEI or ARB + \u03b2-blocker +aldosterone antagonist) for at least 1 month or explanation of intolerance of specific medication. We will those not on optimized medications with no notation of intolerance; however, we will keep a tally to quantify patients who are considered \"advanced Heart Failure\" but are not on recommended medications Can be awaiting LVAD, transplantation or other procedure Age > 18 years and able to sign informed consent to participate Cognitive or other impairment which prevents accurate assessment of symptoms or ability to provide informed consent Heart failure due to recent onset of acute viral myocarditis, peripartum myocarditis Patient on hemodialysis or receiving mechanical ventilation Patients receiving investigational agents or devices Patients who have received heart transplant or a destination Left Ventricular Assist Device", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 20.0-999.0, All Obstructive Sleep Apnea Syndrome Obstructive sleep apnea syndrome based on symptoms and a sleep study Sleep disorders other than obstructive sleep apnea syndrome Other than mild, stable cardiovascular disease Other than mild lung disease Chronic rhinitis, previous uvulopalatopharyngoplasty Treatment with drugs that affect respiratory center drive Internal, neurologic or psychiatric disease that interferes with sleep quality Previous intolerance to moderate or low altitude < 2600m", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Mellitus Females of childbearing potential must be using appropriate birth during the entire duration of the study or must be surgically sterile Subjects with a clear diagnosis of type 2 diabetes mellitus using diagnostic of the American Diabetes Association who have been taking a sulfonylurea and/or insulin for at least 30 days prior to Visit 1 or who have been withdrawn from metformin therapy, during the 30 days prior to Visit 1, due to congestive heart failure Subjects with a clinical diagnosis of congestive heart failure, New York Heart Association Class II or early Class III. Subjects should not previously have been in Class IV heart failure Diagnosis of left ventricular congestive heart failure as evidenced by a left ventricular ejection fraction less than 40% at screening based on an echocardiogram Subjects who have demonstrated the need for oral hypoglycemic agents and have participated in dietary counseling Glycosylated hemoglobin greater than 7.0% at screening Subjects on optimal therapy for congestive heart failure. Medication doses should be stable for at least two weeks prior to randomization Na\u00efve to antidiabetic therapy Within the past three months were treated with rosiglitazone, pioglitazone HCl, or troglitazone or those previously treated with rosiglitazone, pioglitazone HCl, or troglitazone but discontinued from therapy due to lack of efficacy or clinical or laboratory signs of intolerance Type 1 (insulin-dependent) diabetes mellitus or a history of ketoacidosis Has taken any other investigational drug during the 30 days prior to Visit 1 or who will receive such a drug during the timeframe of this study History of chronic alcoholism or drug abuse during the six months prior to the study Has had any of the following within three months prior to Visit 1: myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, or documented cerebrovascular accident that in the investigator's opinion would warrant from the study Abdominal, thoracic, or vascular surgery during the three months prior to Visit 1 that in the investigator's opinion would warrant from the study Subjects with a planned surgical or catheterization intervention within the six months following Visit 1 Subjects awaiting cardiac transplantation Intercurrent illness severe enough to require hospitalization during the three weeks prior to Visit 1", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-90.0, All Heart Failure HF by Framingham At least one admission to hospital for HF within the last 180 days New York Heart Association Class II thru IV Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction >45% Creatinine clearance <40 mls/min/1.73m2 Potassium >5.0 mmol/L Recent acute coronary syndrome in the prior 4 weeks Planned revascularization, defibrillator or pacemaker in next 4 months Known previous intolerance to aldosterone antagonist", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure, Congestive Received or is eligible to receive a principal hospital discharge diagnosis of HF or decompensated HF is present as determined clinically by the patient care team Heart Failure is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Congestive Heart Failure age18 or older primary diagnosis of CHF in the Emergency Department admission to the hospital or transfer to the Observation Unit minors, prisoners,pregnant women,unable to provide consent unstable angina or acute myocardial infarction in the ED dialysis dependent patients use of nesiritide as a therapy in the ED", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-80.0, All Rheumatoid Arthritis Interstitial Pneumonia Diagnosis of RA according to the revised 1987 American Rheumatism Association Absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than UIP or NSIP, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors Diagnosis of progressive interstitial pneumonia of UIP or NSIP subtype, based on the following Clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening Worsening as demonstrated by any one of the following within the past year > 10% decrease in Forced Vital Capacity (FVC) increasing infiltrates on chest X-ray or High Resolution Computed Tomography (HRCT), or worsening dyspnea at rest or on exertion Diagnosis of UIP or NSIP by either of the following Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP or NSIP HRCT scan showing definite or probable UIP or NSIP AND abnormal pulmonary function tests (reduced FVC or decreased diffusing capacity of carbon monoxide (DLco) or impaired gas exchange at rest or with exercise) AND insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation History of clinically significant environmental or drug exposure known to cause pulmonary fibrosis Forced expiratory volume in one second (FEV1) FEV1/FVC ratio < 0.6 at screening (pre or post-bronchodilator) Residual volume > 120% predicted at Screening Evidence of active infection Any pulmonary condition other than UIP/NSIP, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year History of unstable or deteriorating cardiac or neurologic disease Pregnancy or lactation Treatment with cyclophosphamide, cyclosporine, interferon gamma or beta, anti-tumor necrosis factor therapy, anti-interleukin 1 (IL1) therapy or with endothelin receptor blockers within the last 8 weeks; experimental therapy for rheumatoid arthritis Creatinine > 1.5 X upper limit of normal range (ULN) at Screening", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation Congestive Heart Failure Left ventricular ejection fraction /=6 hours (duration of AF will be determined by history), within the past 6 months with electrocardiographic confirmation; or an episode lasting >/=10 minutes (by history) within the past 6 months with electrocardiographic confirmation in a patient with a prior electrical cardioversion for AF In the opinion of the clinical investigator, the patient must be eligible for long-term treatment with either treatment strategy of AF AF is known to be present and uninterrupted for more than 12 months prior to randomization. However, if such a patient is cardioverted and maintained in sinus rhythm for >/=24 hours, he or she becomes eligible Reversible cause of AF such as acute pericarditis, pulmonary embolism, hyperthyroidism, alcohol intoxication AF occurring and not persisting beyond 10 days of surgery or myocardial infarction Reversible cause of CHF such as severe aortic or mitral stenosis and tachycardia-induced cardiomyopathy Decompensated CHF within 48 hours of randomization Antiarrhythmic drugs other than calcium channel blockers, beta-blockers or digoxin required for other arrhythmias or other indications More than 7 days of amiodarone therapy within the last month prior to randomization Second or third degree AV block, sinus pause >3 seconds, resting heart rate <50 bpm without a permanent pacemaker History of drug-induced Torsades de Pointes or congenital long QT syndrome Prior AV nodal ablation or Maze surgery", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 75.0-999.0, All Heart Failure Acute exacerbation of chronic heart failure Age over 75 Appropriate care supervision at home Telephone connection Living in the hospital-at-home catchment area and informed consent Absence of family and social support Patients who need mechanical ventilation Severe dementia End-stage cancer History of severe renal impairment or hepatic failure with ascitis", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure diagnosis of NYHA I, II or III heart failure (as identified by any of the following physical findings of heart failure (jugular venous distension, crackles, edema, S3); pulmonary edema on chest x-ray; BNP > 100 pg/ml; or at least two of the following symptoms: paroxysmal nocturnal dyspnea, shortness of breath, swelling, fatigue previous chemotherapy that contributed to the development of heart failure (i.e., heart failure develops or worsens after receiving chemotherapy, with no other obvious explanation) oriented to person, place, and time living in the Houston area (Harris county or a contiguous county), or planning to stay in the area for at least the next 16 weeks 18 years of age or older diagnosis of cancer have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only remain in NYHA class IV heart failure despite therapy have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist cannot provide informed consent", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Congestive Heart Failure Male or female aged 18 or above Congestive Heart Failure with symptoms for more than 4 weeks before starting study Provision of informed consent Current low blood pressure with symptoms Liver disease considered significant by the study doctor Pregnant or lactating females", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Right Sided Cardiac Failure Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation Age greater than 18 years of age Right heart catheterization within the last year to rule out left-sided failure Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures Serum creatinine > 2.0 Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Heart Failure chronic stable heart failure renal dysfunction or under treatment with antidiabetic agents", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 21.0-90.0, All Heart Failure Male or female patient's > 21 years of age with a severe congestive heart failure (New York Heart Association class III or IV) requiring an immediate administration of intravenous vasodilators drugs, oxygen therapy, and no less than 160 mg of intravenous furosemide were eligible for inclusion Definite evidence of underlying heart failure was also required as shown by at least two of the following a) Orthopnea on admission b) X-ray showing evidences of elevated wedge pressure indicating congestive heart failure c) recent prior hospitalization (within the 30 days prior to the index hospitalization) because a congestive heart failure episode d) echocardiography data showing a poor left ventricular ejection fraction (0.40 or lower measuring with the biplane Simpson's method e) non-invasive ventilation to the maintenance of SaO2 above 90% f) wet rales in at least the lower half of the lungs fields Patients with a final diagnosis of Congestive Heart Failure as a consequence of necrotic or chronic ischemic heart disease, or infective origin such as chronic Chagas Disease, chronic valvular heart disease (surgically repaired or not), and idiopathic origin were also included for the present study Patients with a concomitant infective disease were excluded from the study Patients with evidence of evolving with multi organic failure (hepatic or renal dysfunction requiring dialysis), terminal disease, or any impeding cause of follow-up, including contraindications of vaccination, were excluded from the study Those with congestive heart failure following unstable coronary artery disease, or prior by-pass surgery, or angioplasty or congestive heart failure complicating myocardial infarction requiring urgent intervention were excluded also Those individuals who required mechanical ventilation on admission Patients with prior vaccinations were also excluded Pregnancy condition was an criterion Those patients who were unable or refused to give a written inform consent was also excluded of the present study", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 40.0-999.0, All Hypertension Self-identifies as African American Resides in Washington, DC or surrounding communities Has stage I hypertension, defined as systolic blood pressure between 140 and 159 mm Hg and/or diastolic blood pressure between 90 and 99 mm Hg, on average, without taking antihypertensive medications in the sympatholytic class (e.g., beta blockers, alpha antagonists, central nervous system agonists) Blood pressure levels of less than 140/90 mm Hg or greater than 160/100 mm Hg History of clinical cardiovascular disease (e.g., heart attack, angina, intermittent claudication, congestive heart failure, stroke) Long-term kidney failure Any other life-threatening illness (e.g., advanced cancer) History of major psychiatric disorder (e.g., psychosis, dementia, substance abuse disorder)", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-65.0, All Hyperglycemia Obese African American subjects (BMI equal or greater than 30) age 18-65 patients with a history of diabetic ketoacidosis as defined by the ADA patients admitted with hyperglycemia but without ketoacidosis (BG greater than 400ml/dl without evidence of ketosis/ketones obese nondiabetic controls (BMI >30; ruled out for diabetes with a 75g oral glucose tolerance test) patients with positive autoimmune markers [islet cell (ICA) or Glutamic acid decarboxylase (GAD) autoantibodies] patients with significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism patients with bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies patients with fasting hyperglycemia (blood glucose > 120 mg/dl) after discontinuation of insulin therapy, and 6) pregnancy", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 20.0-95.0, All Pulmonary Edema Patients in the intensive care unit using ventilator Asthma, COPD, non-ventilated patients", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure Patients with stable congestive heart failure on a prescription for diuretic drugs Acute heart failure Foreseeable need for further changes in medication Current medication containing vitamins Patients with a creatinine above 250 \u03bcmol/l", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 50.0-999.0, All Congestive Heart Failure subjects will be at least 50 years of age women who are post-menopausal clinical evidence of congestive heart failure, with ongoing management by conventional medical therapy a left ventricular ejection fraction below 40% as measured by echocardiogram performed within 6 months of study enrollment Left ventricular end-diastolic dimension greater than 60 mm as measured by an echocardiogram performed within 6 months of study enrollment regular heart rate/pacer hemodynamically stable and able to complete symptom-limited bicycle ergometry exercise test and be in New York Heart Association Classification II or III Subjects with hematocrit equal to or less than 33% body mass index equal to or greater than 40 unstable angina within six months inducible ischemia by exercise stress testing, radionuclide scintigraphy, or dobutamine echocardiography known or suspected myocarditis known or suspected restrictive or infiltrative cardiomyopathy coronary artery stenosis >70% and < 100% by catheterization should such data be available inadequate cardiac echo window primary diastolic dysfunction in heart failure inability to perform cycle ergometry", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Congestive Heart Failure Hypovitaminosis D Hypomagnesemia Hyperparathyroidism congestive heart failure pregnant hospitalized within one month taking calcium, vitamin D or magnesium supplements proteinuria > 1g/24h creatinine clearance <35 (MDRD)", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure Patients with documented heart failure (NYHA class II-IV) Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Congestive Heart Failure Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy Subject has severe heart failure (NYHA Class III or IV) Subject has experienced at least one heart failure event within six months prior to enrollment Subject continues to have heart failure symptoms despite receiving optimal medical therapy Schedule for implant of a CRT-D (Model 8770) Subject has signed and dated an informed consent form Any contraindication for standard cardiac pacing Any contraindication for ICD therapy Abdominal implantation site Hypertrophic or obstructive cardiomyopathy Acute myocarditis Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month Recent (within the last month) or planned cardiac revascularization or coronary angioplasty Correctable valvular disease that is the primary cause of heart failure Mechanical tricuspid valve Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intravenous infusion) more than twice per week", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure Normal subject without history, signs-symptoms or diagnosis of heart failure Age over 18 and willing and able to provide informed consent Known allergy to electrode gel and medical adhesive used on electrocardiographic electrodes Pregnancy (as any effect of this device use on pregnancy is not known) Patient belonging to a vulnerable population such as institutionalized persons, prisoners and persons with decisional incapacity or dementia Presence of severe aortic regurgitation Second degree Mobitz type II or third degree heart block, unless treated with a cardiac pacemaker Implantation of a left ventricular assists device, hemodynamic monitor, activated minute ventilation pacemaker, or biventricular pacemaker (Cardiac Resynchronization Therapy) with the V-to-V interval set at more than 5 milliseconds offset Implantation of a cardiac resynchronization device within the last 30 days HEART Patients over the age of 18 and able to give consent Ability to understand and willing to sign informed consent", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-80.0, All Sleep Apnea, Central Men and women 18 to 79 years of age who have New York Heart Association (NYHA) functional class I through IV heart failure due to ischemic, hypertensive, or idiopathic dilated cardiomyopathy and whose condition had been stabilized by means of optimal medical therapy for at least one month An LVEF of less than 40% and central sleep apnea, defined as 15 or more episodes of apnea and hypopnea per hour of sleep, more than 50 percent of which are determined to be central rather than obstructive Pregnancy Myocardial infarction Unstable angina or cardiac surgery within the previous three months", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension currently taking an ACEi, ARB or both no change in these medications during the two weeks prior to study enrollment scheduled for non-cardiac surgery requiring regional or general anesthesia minimum overnight anticipated length of stay age \u226518 years explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB significant hypertension in pre-operative assessment clinic (systolic blood pressure \u2265180 mmHg OR diastolic blood pressure \u2265110 mmHg) significant hypotension in pre-operative assessment clinic (systolic blood pressure < 90 mmHg) prior enrollment in the study participation in another research study of antihypertensive medications", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 60.0-999.0, All Heart Failure Age greater than or equal to 60 years of age Symptoms of congestive heart failure Able to understand and give informed consent Age <60 years Does not have CHF Significant change in cardiac medication <3 weeks Myocardial infarction <3 weeks CABG surgery <3 months Angina pectoris not controlled during daily activity by pharmacological therapy or at <4 METS activity Sustained hypertension with systolic> 190 and diastolic> 110 on medications Valvular heart disease as the primary etiology of CHF Significant aortic stenosis Stroke of <3 months or with any physical restriction impairment that would prevent participation in exercise programs", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Acute Decompensated Heart Failure >18 years old Severe systolic heart failure with ejection fraction <40% And Hospitalisation for decompensated heart failure And New York Heart Association (NYHA) III or IV And 1 of the following Jugular vein distension>6cm Tissue Doppler mitral annulus lateral>12 or medial>15 Chest X-ray: pulmonary edema or pleural effusion Need for inotropic or vasopressive agents Use of intravenous (IV) contrast media Acute coronary syndrome Need of dialysis Severe co-morbidity Contra-indications for anticoagulation Pregnancy", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 21.0-999.0, All Heart Failure hospitalized with admitting diagnosis of heart failure in prior 8 weeks self-identified as African American community-dwelling (i.e., not in a long-term care facility) residence within a predefined radius in Baltimore City working telephone in their home provide signed informed consent cannot speak or understand English severe renal insufficiency requiring dialysis acute myocardial infarction within preceding 30 days receiving home care services for HF post discharge legally blind or have major hearing loss screen positive for cognitive impairment on the Mini-cog at baseline unable to stand independently on a weight scale (limited ability to participate in HAT system) weigh more than 325 pounds (exceed scale capacity) serious or terminal condition such as psychosis or cancer (actively receiving chemo or radiation) pregnant", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 65.0-999.0, All Heart Failure Chronic Obstructive Pulmonary Disease patients aged 65 years and older must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires) patients with both confirmed COPD and heart failure (Spirometry performed < 1 year ago and heart failure confirmed by echocardiography) patients unable or unwilling to sign informed consent", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 19.0-999.0, All Cesarean Section Pregnancy greater than 37 weeks gestation ASA (American Society of Anaesthesiologists) I and II classification of health. Class I a normal healthy patient and II a patient with mild systemic disease (i.e. mild asthma) Mothers presenting to the assessment unit with ruptured membranes or in the early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery Potential subjects need to be able to read and understand English, unless an independent translator is available Women having general anesthesia Mothers in active labour m or more dilated with regular coordinated contractions (3 in 10 minutes) ASA classification 3 or above Emergency cesarean delivery for fetal heart rate abnormalities Maternal age <19 BMI >40. Obesity makes it more difficult to site the combined spinal epidural which could lead to delay in positioning the patient quickly following subarachnoid block. Obesity can result in increased venal caval compression in the supine wedge position causing epidural venous plexus engorgement and dural sac compression which may result in a high block. A later study will look at the effects of positioning in the obese patient Mothers with a history of known tolerance to opioids Uterine over distension polyhydramnios, twin pregnancy and estimated fetal weight of over 4kg by ultrasound scan -Uterine over distension can result in increased aortocaval compression which may lead to engorgement of the epidural venous plexus and dural sac compression which may result in a high block", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Overweight Obesity BMI of at least 25.0 self-identifies as Black or African-American able to do mild physical activity such as walking or chair exercises has insulin dependent diabetes is pregnant, nursing, or had a baby in the past 4 months has ever been treated for an eating disorder (e.g. anorexia nervosa, bulimia) had a heart attack in the past 2 years requiring hospitalization has ever had a stroke has congestive heart failure has uncontrolled hypertension currently participating in another study is on a doctor-prescribed diet that cannot be changed (e.g. very low protein diet for a person in liver failure)", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 70.0-999.0, All Chronic Heart Failure Verified diagnosis of heart failure Left ventricle ejection fraction < 50 Stable medical treatment with Angiotensin Converting Enzyme blockers and Betareceptor blockers (if no contraindications) experience of fatigue according to the Multidimensional Fatigue Inventory years or older Swedish speaking Instable angina pectoris Myocardial infarction within the last three months Cognitive impairment No experienced fatigue", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Heart Failure Advanced chronic heart failure (HF) will be defined as left ventricular ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart failure requiring adjustment of inotropic agents or diuretics within recent 6 months presence of mitral stenosis or prosthetic mitral valve any abnormality of atrial septum (e.g., atrial septal defect or aneurysm) inadequate image quality lack of informed consent", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Cardiovascular Diseases Cardiovascular Risk Factor African American adults > 18 years old ", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-90.0, All Bronchiectasis Bronchiolitis All patients with bronchiectasis or bronchiolitis All patients with severe lung disease other than bronchiectasis Active lung infection Active infection other site except the lung", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 20.0-999.0, All Heart Failure, Congestive Subjects admitted to hospital with systolic heart failure(LVEF under 45%) in 2009 Subjects, age 20 or/and above Subjects admitted to hospital (emergency area, to internal medicine or to cardiology wards, CCU or intensive care) with dyspnea and verification of heart failure based on following criteria Symptoms typical of heart failure : breathlessness at rest or on exercise, fatigue, tiredness, ankle swelling and Signs typical of heart failure : tachycardia, tachypnoea, pulmonary rales, pleural effusion, raised jugular venous pressure, peripheral oedema, hepatomegaly Objective evidence of a structural or functional abnormality of the heart at rest : cardiomegaly, third heard sound, cardiac murmurs, abnormality on the echocardiogram, raised natriuretic peptide concentration Subject who expired during hospitalization", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Congestive Heart Failure (CHF) Clinical diagnosis of heart failure at levels III and IV, according to the classification of the NYHA (New York Heart Association) for 3 months or more Clinical diagnosis of LVEF less than 50% or were on diuretic therapy for more than three months with at least one previous hospitalization due to heart failure disease uncertain prognosis for 12 months due to other conditions acute coronary disease in recent months existence of another life-threatening illness of the patient (such as active cancer, chronic kidney failure) severe neurological problem (Brain syndrome / orientation problem/ difficult peripheral neuropathy) severe mental illness (active psychosis / suicide risk / severe dementia) linguistic limitations (such as misunderstanding of the Hebrew language / stuttering / untreated audio impairment) a significant functional problem (such as unconsciousness / connection to respiration device / confined to a wheelchair or bed / severe walking disability / needs help with complete basic daily activities) objective limit that endangers liability for participation in the seven meetings (such as remote residential / tourist / convict / drug addict) subjects whose mother tongue is not Hebrew", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Acute Decompensated Heart Failure males and non-pregnant female patients over 18 years admitted to the hospital or treated in an outpatient heart failure clinic with the primary diagnosis of acute decompensated heart failure evidence of fluid overload more than 8 kg above their dry weight, and conforming to definition of hypervolemia (at least two of the following findings: more than 1+ pitting edema of the lower extremities, jugular venous pressure more than 10 cm water, pulmonary edema or pleural effusion on chest radiograph consistent with ADHF, ascites, paroxysmal nocturnal dyspnea, or equal or more than 2 pillow orthopnea acute coronary syndrome documented ischemic cardiomyopathy atrial fibrillation serum creatinine more than 3.0 mg/dL systolic blood pressure less than 90 mmHg hematocrit > 45% clinical instability likely to require intravenous vasopressors and/or intravenous vasoactive drugs (such as milrinone, dobutamine, nitroglycerin or nesiritide) during the present hospitalization severe pulmonary hypertension or use of pulmonary hypertension drugs (such as sildenafil, bosentan or other endothelin inhibitors) patients with documented hypertrophic obstructive cardiomyopathy or restrictive cardiomyopathy patients with severe valvular heart disease", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Acute Heart Failure Clinical diagnosis of acute heart failure Admitted to the participating hospitals Patients with acute heart failure who are discharged from the emergency room without admission Patients transferred from non-registry hospital Failure to obtain informed consent", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Juvenile Idiopathic Arthritis Subject has been diagnosed with JIA by a pediatric rheumatologist according to published criteria Person providing consent must be able to read English Subject (and/or parent/legal guardian) is able to provide informed consent and willing to comply with study procedures Subject/ legal guardian is unwilling to provide consent, cannot read English, or does not meet published for JIA Coexisting rheumatologic disorder Diagnosis of fibromyalgia Participation in a drug trial in the past 6 months", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 65.0-79.0, All Healthy Elderly Subject Pharmacokinetic of YM150 Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests Body weight: male: \u226545.0 kg, <85.0 kg; female: \u226540.0 kg, <75.0 kg BMI (at screening): \u226517.6, <30.0 Use of any other investigational drug in another clinical study or a post-marketing clinical study within 120 days before the administration of the study drug Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment Any surgical intervention (including tooth extraction) or trauma within 90 days before hospitalization until the administration, or plan of any surgical intervention within 10 week after the final administration A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG PT or aPTT on blood coagulation tests outside the upper or lower reference limits (PT: 9.9 to 15.4 sec.; aPTT: 22.5 to 49.5 sec.) Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study Concurrent or previous hepatic disease (e.g. viral hepatitis, drug-induced liver injury) Concurrent or previous heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring treatment) Concurrent or previous respiratory disease (e.g. serious bronchial asthma, chronic bronchitis; except for a history of childhood asthma) Concurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis; except for a history of calculus)", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 30.0-70.0, All Cervical Spine Degenerative Disc Disease Fusion of Spine, Cervical Region Men and women between the age of 30 to 70 years Individuals who have consulted one of the five participating spine surgeons and are scheduled for ACF surgery at Texas Spine and Joint Hospital Surgical candidates classified as Task Force category III, with neurologic deficit without major structural pathology, or IV, with major structural pathology - Musculoskeletal or systemic disorders with functional impairments that will limit tolerance of testing Pain greater than 8/10 on the NPRS that often indicates severe pathology and therefore limits testing tolerance Prior cervical spine surgeries More than two level cervical spine surgery planned. -", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Congestive Heart Failure Systolic Dysfunction Age =/or >18 Admitted to the Heart Failure Unit with acute decompensated heart failure Referred to the Congestive Heart Failure Disease Management Program Age<18 Mentally incapacitated Discharge to a skilled nursing facility", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-70.0, All Sickle Cell Disease Sickle Cell Anemia Regadenoson ARM Diagnosis of sickle cell anemia confirmed by hemoglobin analysis Ages 18 to 70 years Subjects must have laboratory indices as outlined by the protocol Reliable IV access as determined by physician Sickle Cell Controls ARM Diagnosis of sickle cell anemia confirmed by hemoglobin analysis Ages 18 to 70 years Sickle Cell CEU ARM Diagnosis of sickle cell anemia, confirmed by hemoglobin analysis Regadenoson ARM Hospitalization, emergency department visit or self-reported crisis within last 2 weeks for any reason or 4 weeks from acute chest syndrome Current physician diagnosis of active asthma (within last 12 months) or current use of asthma medications Second or third degree AV block or sinus node dysfunction Known or suspected right to left sided cardiac shunts History of a bleeding diathesis History of clinically overt stroke History of severe hypertension not adequately controlled with anti-hypertensive medications Receiving chronic anti-coagulation or anti-platelet therapy History of metastatic cancer", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure History of chronic heart failure Admission for acute decompensated heart failure There is no prespecified criterion with respect to heart failure etiology and/or ejection fraction Receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide) Other etiologies of fluid overload different from heart failure Hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l Unstable patients: acute coronary syndrome, cardiogenic shock or ICU admission Patients requiring inotropic agents or renal replacement therapies Life expectancy < 6 months Prior treatment with thiazide-type diuretics Aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation) Pregnancy or breastfeeding period Active alcoholism and/or other substance abuse", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-75.0, All Obstructive Sleep Apnoea males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI \u226515/h or sleep apnoea with an ODI \u22655/h plus an Epworth sleepiness score >10 morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with SpO2<90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants)", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 60.0-999.0, All Heart Failure Patients 60 years of age or older Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography An acute myocardial infarction or unstable angina pectoris within the last three months Valvular stenosis Dementia Severe concomitant disease Refusal to participate", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 40.0-80.0, All Hypertension Untreated hypertension: systolic BP \u2265 140 or diastolic BP \u2265 90 mmHg or Treated hypertension Current heart failure symptoms with NYHA class II Evidence of diastolic dysfunction showing any 2 of the following E/E' > 10, LV posterior wall thickness > 11 mm, BNP level > 40 pg/mL Planned cardiac surgery or planned major non-cardiac surgery within the study period Stroke or coronary revascularization in the past 6 months LV ejection fraction < 50% Hypertrophic or restrictive cardiomyopathy, moderate or severe valve disease, constrictive pericarditis Atrial fibrillation with a heart rate > 120/min Sitting systolic BP < 100 mmHg Sitting systolic BP > 160 mmHg or diastolic BP > 95 mmHg despite antihypertensive therapy Significant renal disease manifested by serum creatinine > 2.5 mg/dL Clinically significant pulmonary disease, coronary artery disease A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure, Congestive Cardiovascular Diseases Heart Diseases (PCP) 1. Provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s) (Patients) Participant has been diagnosed with Heart Failure (HF) Self reported family income is less than $30,000/year Has experienced at least one hospitalization for acute, decompensated, HF within the previous 6 months based upon Being admitted for symptoms of HF (ex: peripheral edema, shortness of breath and fatigue), and responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ACE Inhibitors, ARBs, or Beta blockers Has evidence of systolic dysfunction, defined by an ejection <50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year Age \u2265 18 years Currently resides in Cook County, Illinois (PCP) Health providers will be excluded from enrollment if they are Still in their residency or training period A member of the CHART research staff (Patients) Patients will be excluded from enrollment if they have An uncertain 12-month prognosis Listed for imminent cardiac transplant Has an advanced directive of \"Do not resuscitate\" Has uncertain 12-Month Prognosis, as adjudicated by the Principal Investigator", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-90.0, All Cardiovascular Diseases Age between 18 years and 90 years old Clinically significant functional mitral regurgitation (moderate-to-severe or severe mitral regurgitation), as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Assessed by the investigator to be on optimal standard of care therapy for heart failure for at least 4 weeks with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization Documented New York Heart Association Class III or Class IV heart failure, despite optimal standard of care therapy, within 90 days preceding randomization Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of at least 350 pg/mL for BNP or at least 1400 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Left ventricular ejection fraction (LVEF) \u226515% and \u226440% determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Left ventricular end diastolic diameter (LVEDD) \u226555 mm determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness Subject agrees to return for all required post-procedure follow-up visits The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative mitral regurgitation), as determined by transesophageal echocardiography Status 1 heart transplant or prior orthotopic heart transplantation Introduction of a new heart failure drug class within the last 4 weeks prior to randomization Cardiovascular hospitalization within the last 2 weeks immediately prior to randomization Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to randomization Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD) within 90 days prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization Need for any cardiovascular surgery Mitral valve surgery is considered a therapeutic option for the subject Renal replacement therapy", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-80.0, All Constipation Age 18-80 constipation defined by the Rome II Past history of abdominal surgery past history of diabetes mellitus past history of hypothyroidism past history of inflammatory bowel disease past history of significant psychiatric disturbances past history of drug abuse past history of cardiac pacemakers past history of metal implants patients who cannot travel to keep the follow up patients who are prisoners", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 60.0-999.0, All Heart Failure Men and women \u2265 60 years Admission to hospital for worsening HF History of uncontrolled hypertension Severe valve disease End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support Advanced malignancy or other medical condition with life expectancy less than 2 years or undergoing active chemotherapy or radiation therapy Advanced chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) < 20 mL/min/1.73 m2 based upon the Modification of Diet in Renal Disease (MDRD) study equation), or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months Chronic anemia with hemoglobin < 9 gm/dl for males, < 8 gm/dl for females or acute anemia requiring transfusion of 2 or more units of blood", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Acute Heart Failure Left Ventricular Dysfunction > 18 years of age Hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination Where available, NT-proBNP >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if BMI > 35 kg/m2, LVEF <45% assessed by echocardiography or other method within the previous 12 months Background therapy with at least ACE-inhibitor or angiotensin receptor blocker (ARB) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock) Available for regular follow up Currently being treated with Hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates . Any intravenous treatment for heart failure, except IV furosemide (eg. IV inotropes, pressors, nitrates or nesiritide) at the time of screening Systolic blood pressure <100 mmHg Plan for revascularization Greater than 96 hours after admission Reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction, arrhythmia. Acute MI is defined as symptoms and major electrocardiogram (ECG) changes(i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min Hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta) Severe aortic or mitral stenosis or severe rheumatic mitral regurgitation Renal impairment (defined by creatinine >3 mg/dL) at screening or on any type of dialysis", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-50.0, All Obstructive Sleep Apnea Pre-menopausal females aged \u2265 18 years Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry Diagnostic PSG available Diagnosis of mild-moderate OSA (AHI \u2264 30) Participants willing and able to give written informed consent Participants currently using Bi-level PAP Participants currently using supplemental oxygen Participants who are pregnant Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury) Participants who the researcher believes are unsuitable for because either they do not comprehend English they are unable to provide written informed consent they are physically unable to comply with the protocol", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-95.0, All Heart Rate Control in ICD Patients With Heart Failure Age \u2265 18 years Patients with stable chronic heart failure implanted with mono-cameral or bicameral ICD with a home monitoring remote control Moderate to severe left ventricular dysfunction (FE \u2264 40%) Any cause of heart failure was allowed apart congenital heart disease Bicameral ICD programmed in DDD or AAI/DDD with AV interval < 300 msec Rest ECG heart rate \u226570 bpm Sinus rhythm In therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin II receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless contraindicated Inability of providing informed consent Age < 18 years State of pregnancy or lactation Recent (<2 months) myocardial infarction Contraindications to beta-blockers and ivabradine Rest ECG heart rate < 70 bpm No sinus rhythm Administration of non-dihydropyridinic calcium channels antagonists, digitalis, class I antiarrhythmic drugs, strong inhibitors of cytochrome P450 3A4 at the time of enrollment", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Metabolic Syndrome Coronary Heart Disease Chronic Heart Failure Elderly healthy subjects : with no MetS and no-documented CHD, both males and females, aged>60 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living Patients with metabolic syndrome and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. MetS will be defined according to recent updated presence of at least three of five namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy) Patients with documented stable chronic heart failure will be recruited if they show the following \u226518 years Left ventricular ejection fraction (LVEF) <40% (measured within 6 months of their enrolment by MUGA Scan, echo or radiological ventriculography) NYHA functional class I-III Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation) Able to perform an symptom limited exercise test Capacity and willingness to sign the informed consent form For healthy elderly subjects age under 60 years lack of expressed written consent metabolic syndrome coronary heart disease chronic systolic heart failure resting left ventricular ejection fraction < 40 % symptomatic aortic stenosis chronic atrial fibrillation malignant exertional arrhythmias", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 21.0-130.0, All Heart Failure All 6 need to be met for enrollment of the patient in the study Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below dyspnea or respiratory distress or tachypnea at rest or with minimal exertion evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met) pulmonary congestion/edema at physical exam OR chest X-Ray plasma Brain Natriuretic Peptide (BNP) levels \u2265200 pg/ml invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months) The patient is now clinically stable and meets standard for hospital discharge as documented by all the 3 conditions listed below absence of dyspnea or pulmonary congestion/distress at rest Subjects will not be eligible if they meet any of the following 15 The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy or brady-arrhythmias Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries Previous or planned implantation of left ventricular assist devices or heart-transplant Chronic use of intravenous inotropes Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]) Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Acute Decompensated Heart Failure Heart Failure Patients \u2265 18 years of age and English-speaking who are admitted to the General Cardiology or Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure (ADHF) Patients deemed by the health care team to require hemodynamic monitoring with a pulmonary artery catheter and inotropic therapy. Patients receiving at least 3 doses of continued beta blocker therapy with carvedilol, metoprolol succinate, or metoprolol tartrate and patients receiving no beta blocker therapy or have missed at least 5 doses of beta-blocker therapy Concomitant treatment with other beta blockers, non-selective alpha blockers (e.g. terazosin, prazosin, doxazosin), non-dihydropyridine calcium antagonists, antiarrhythmic agents except for chronic stables doses of amiodarone, dofetilide or mexiletine Use of inotropes or IV vasoactive agents within 7 days or at time of enrollment Patients with hemodynamically unstable arrhythmias (e.g., Systolic Blood Pressure (SBP) < 80, Heart Rate (HR) > 110), uncorrected primary valvular disease, or current mechanical support including left ventricular assist device (LVADs), Impella devices and balloon pumps Patients who have missed more than 1 dose of beta blocker within 72 hours of starting inotrope No subjects will be excluded based upon race, gender or ethnicity", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 7.0-999.0, All Limb Girdle Muscular Dystrophy Type 2D (LGMD2D) Subjects age 7 or older; cohort 1A must be adult and wheelchair-dependent Proven alpha-sarcoglycan deficiency by muscle biopsy or DNA testing Onset of weakness by 5 years age based on history of difficulty running, jumping and climbing stairs Subject enrolled in Cohort 1A must be adult and wheelchair dependent Subjects enrolled in Cohorts 1B or 2 must be able to walk independently, but must exhibit signs of lower extremity weakness (i.e. a Gowers' sign, use a handrail for climbing stairs) and walk \u2264 80% of predicted distance on the 6MWT based on normative data Males and females of any ethnic group will be eligible Ability to cooperate with muscle testing Willingness of sexually active subjects with reproductive capacity to practice reliable method of contraception (If appropriate), during the first six months after gene therapy (females) or until two negative sperm samples are obtained post gene transfer (males) Active viral infection based on clinical observations The presence of SGCA mutations without weakness or loss of function Symptoms or signs of cardiomyopathy, including Dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales at the base of the lungs Echocardiogram with ejection fraction below 40% Serological evidence of HIV infection, or Hepatitis A, B or C infection Diagnosis of (or ongoing treatment for) an autoimmune disease Abnormal laboratory values considered clinically significant (GGT > 3XULN, bilirubin \u2265 3.0 mg/dL , creatinine \u2265 1.8 mg/dL, Hgb < 8 or > 18 g/Dl; WBC > 15,000 per cmm) Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer Pregnancy", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 40.0-90.0, All Congestive Heart Failure Congestive heart failure patients between tne ages 40 to 90,all stages of the disease non", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 20.0-75.0, All Obstructive Sleep Apnoea (OSA) Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h Currently >20/h oxygen desaturations (\u22654% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP download) and current ESS <10 Age between 20 and 75 years at trial entry Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa) Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg) Previously diagnosed with Cheyne-Stokes breathing Current professional driver; any previous sleep related accident Acute inflammatory disease Acute or chronic hepatic disease Renal failure or renal replacement therapy Use of inhaled drugs", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 21.0-999.0, All Congestive Heart Failure CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD) Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease Subjects with acute decompensated heart failure currently on nesiritide therapy Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and Subjects unable to or refusing to provide written informed consent", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Asthma Male or female patients aged >=18 years Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5 Pre-bronchodilator FEV1 \u226540% and <80% of their predicted normal value Pregnant or lactating women Diagnosis of COPD Patients treated for asthma exacerbations in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 75.0-999.0, All Heart Failure years or older diagnosis of previous or new heart failure based on signs and symptoms as defined by the 'European Society of Cardiology guidelines on acute and chronic heart failure' diagnosis had to be confirmed by a recent echocardiogram not Dutch speaking treatment restrictions had been applied on admission", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Beta Blocker Intolerance; Congestive Heart Failure Patients on optimal therapy for heart failure (diuretics, ACE inhibitors and aldosterone antagonists), with stable dose in the previous month Successfully implanted with CRT-D according to current European Society of Cardiology (ESC) guidelines New York Heart Association (NYHA) functional class: II, III and IV Left Ventricular Ejection Fraction (LVEF) \u2264 35% Duration of ventricular depolarization wave (QRS) \u2265 120ms (NYHA III or IV) or \u2265 150ms in NYHA II Patients with chronic atrial fibrillation will be eligible for the study only if they undergo ablation years or above Failure to comply with the scheduled follow-up Life expectancy less than 12 months Pregnant women Tricuspid valve mechanics Severe aortic stenosis or other valve disease Patients already receiving CRT", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease Male and female adults (40 \u2264 age \u2264 80 years) with a diagnosis of COPD Current smokers or ex-smokers A post-bronchodilator FEV1 < 60% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7 Positive response to the reversibility test at screening defined as change in FEV1 \u2265 5% BDI score \u2264 10 Patients free of exacerbations for at least 1 month Pregnant or lactating women Diagnosis of asthma Patients treated for exacerbations in the 4 weeks prior to screening visit Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia Known respiratory disorders other than COPD Patients who have clinically significant cardiovascular condition", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Disordered Breathing Heart Failure Heart failure with reduced ejection fraction (<40%) Either no significant sleep disordered breathing or moderate to severe CSA Able to consent to the study Ambulatory Aged 18-100 years Patients on Non-Invasive Ventilation Predominant OSA Unable to consent or attend for the study", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 12.0-999.0, All Gastroesophageal Reflux Disease GERD Gastroparesis Male or female Age 12 and older Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy Patients must have a comprehensive evaluation to eliminate other causes of their symptoms Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including increased prolactin levels extrapyramidal side effects breast changes cardiac arrhythmias including QT prolongation and death There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females) Clinically significant electrolyte disorders Gastrointestinal hemorrhage or obstruction Presence of a prolactinoma (prolactin-releasing pituitary tumor) Pregnant or breast feeding female Known allergy to domperidone", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Acute Decompensated Heart Failure Congestive Heart Failure Compensated Age \u2265 18 years, AND Written informed consent by patient or nearest relative where appropriate, AND Either Referred for echocardiography, OR At least one typical symptom and one typical sign consistent with possible heart failure, OR Healthy volunteers Age <18 years Prior enrollment in study Patients with known or suspected pregnancy", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-75.0, All Asthma History of asthma \u2265 5 years and diagnosed before 40 years old Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) \u22651.5 Pre-bronchodilator FEV1 \u226540% and <90% of their predicted normal value Positive reversibility test Pregnant or lactating women Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Patients treated for asthma exacerbation in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure years and older History of heart failure with an LVEF (less than OR equal to) < 0.35 for at least 6 months OR an LVEF < 0.45 with left ventricular internal end diastole (defined by a diameter of more than 2.9 cm per square meter of body surface area OR more than 6.5 cm on the basis of echocardiography) New York Heart Association (NYHA) Class II-IV Background heart failure therapy that includes angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs), and beta blockers (BBs) for at least 3 months (or documentation of intolerance to ACEi/ARBs and BBs) No history of intolerance to either nitrates or hydralazine No treatment with the combination of hydralazine and nitrates for the previous 3 months No revascularization or myocardial infarction within last 90 days Can not be enrolled for at least 90 days after receiving cardiac resynchronization therapy (CRT) AND must have an LVEF (less than OR equal to) < 0.35 at least 3 months after CRT Presence of clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension Women who are currently pregnant, planning on becoming pregnant in the next two years, or those who do not agree to prevent pregnancy", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Congestive Heart Failure Heart Failure, Diastolic Heart Failure, Systolic Elderly Frail Guideline Adherence All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham Patients who underwent heart failure treatment including intravenus drug ", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days Patients must be receiving an oral loop diuretic on their home regimen or have received intravenous loop diuretic during the index hospitalization at the time of enrollment Patients must have an assessment of left ventricular function within the previous 2 years Patients must have LVEF \u2264 40%, or LVEF >40 with evidence of left atrial enlargement (LA dimension > 40 mm), BNP > 200 ng/ml or PCW > 18 mmHg Prisoners Residents of long term nursing facilities Enrollment into a hospice program Receiving dialysis Patients with dementia Patients with dGFR less than 20ml/min Patients being worked up for heart surgery Patients being worked up for heart transplant Patients being evaluated for revasuculariztion Patients being evaluated for heart valve intervention", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure Patients admitted with symptomatic heart failure, diagnosed within 2 years Diagnosis of congestive heart failure using the modified Framingham Simultaneous presence of at least 2 major or 1 major criterion in conjunction with 2 minor or a previous clear diagnosis of heart failure Major Paroxysmal nocturnal dyspnea or orthopnea Neck vein distention Rales/Crackles (>10 cm from base of lungs) Acute pulmonary edema S3 gallop Increased central venous pressure (>16 cm H2O at right atrium) Patients unable to provide blood sample Patients unable to provide consent Patient with life expectancy of less than 6 months, or has major co-morbidities Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial Participants who have participated in another research trial involving an investigational product in the past 30 days", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-45.0, All Preeclampsia Exposed cases African American women who are admitted to the obstetrical unit with a concern for severe preeclampsia. Patients must be preterm (23-36 6/7 weeks) with a live singleton gestation and at least 18 years old. Women will baseline chronic hypertension and women on magnesium will be included Non-African American women, and African women with concern for severe preeclampsia who are admitted 23 weeks or 37 weeks. Women in labor will be excluded. Women with preexisting cardiovascular disease and women who are current smokers will be excluded Unexposed controls African American women obtaining prenatal care in our outpatient setting who meet matching as noted above Non-African American women and women who are not receiving care at our institution All women who do not speak English and who are unable to be consented will be excluded", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 21.0-999.0, All Heart Failure Hospitalized for heart failure Prescribed loop diuretic medication at discharge Age less than 21 years New York Heart Association Class IV heart failure Terminal illness (<6 mo prognosis) Unable to self-administer medications due to mental illness or cognitive impairment Non-English/Spanish speaking Discharged to an institutional setting (e.g., nursing home) Cardiologist or primary care provider refusal Unavailable for follow-up No access to telephone Enrolled in another cardiac trial", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure With Reduced Ejection Fraction Key Adult patients (18 years or older); must give written informed consent before any assessment is performed Patients with a diagnosis of Chronic heart failure (CHF) NYHA class II-IV and reduced ejection fraction (LVEF =< 35%) Patient had a hospitalization for HF within the last 12 months Patients must be on an angiotensin converting enzyme inhibitors (ACEIs) or an angiotensin receptor blocker (ARB) at a stable dose for at least 4 weeks Patients must be treated with a \u03b2-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks Key The patient is eligible for participation in any of the Investigational Medicinal Product's ongoing clinical trials The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or neutral endopeptidase (NEP) inhibitors; as well as known or suspected contraindications to LCZ696 Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer Previous history of intolerance to recommended target doses of ARBs Known history of angioedema Requirement of concomitant treatment with both ACEIs and ARBs Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy) Symptomatic hypotension and/or a SBP less than 100 mm Hg", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure 18 years or older patients with congestive heart failure Hypervolemic by at least 2 of the following 1) Peripheral edema; 2) jugular venous distention greater than 7 cm; 3) radiographic pulmonary edema or pleural effusion; 4) enlarged liver or ascites; 5) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea Diuretic resistance as defined by loop diuretic requirements of furosemide greater or equal to 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. ( 1 mg bumetanide = 10 mg torsemide = 20 mg furosemide) Estimated glomerular filtration rate (eGFR) of > 30ml/min. according to the MDRD Study equation at the time of admission Female patients of child bearing potential must have a negative urine pregnancy test to be eligible Acute coronary syndrome Patients with a baseline eGFR < 30 ml/min according to the MDRD equation Baseline potassium serum concentration 5.3 meq/L Requirement for intravenous pressors Systemic infection Patients with concomitant end-stage liver disease Significant valvular disease Patients with pulmonary embolism Patients with high output heart failure Pregnant patients", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Obstructive Sleep Apnoea Pregnancy Pregnant women Body mass index \u2265 40 at first midwife appointment Women \u2265 18 years of age Pre-existing obstructive sleep apnoea on treatment Pre-existing restrictive or obstructive respiratory disease Women with another cause of sleep apnoea (e.g. central sleep apnoea) Women under 18 years of age Women who do not provide or refuse consent Women lacking capacity to consent", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Heart Failure Patient with \"de novo\" heart Failure and LVEF <= 40% admitted in hospital, without contraindications for BB prescription with cardiologist up-titration prescription and without having achieved BB target dose previous discharge and signing informed consent Contraindications for BB Living in a nursing home Life expectancy < 6 months Unable to self-care or mental disease without caregiver Unable to weight Without phone Unable to go to clinic visit", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Bronchial Secretion Retention Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following Clinical and radiologic diagnosis of pulmonary infection Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data Stable of hydration status or positive fluid balance at least 2 days before collects the data Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 30 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia Good conscious and well cooperation Pneumothorax (nontreated) Massive hemoptysis Acute myocardial infarction (with angina chest pain) High intracranial pressure (>20 mm Hg) Major arrhythmia", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure age of 18 years or older hospital admission for hypervolemic decompensated heart failure complicated by loop diuretic resistance hour telemetry monitoring on an inpatient ward basic metabolic panel laboratory assessment twice daily during the study period Hypervolemia will be diagnosed by the admitting provider as either (i) pulmonary artery catheterization with a pulmonary capillary wedge pressure greater than 19mmHg plus a systemic physical exam finding of hypervolemia (peripheral edema, ascites, or pulmonary edema on auscultation) or (ii) in the absence of pulmonary artery catheterization data 2 of the following signs or symptoms: peripheral edema ascites, jugular venous pressure > 10mmHg, or pulmonary edema on chest x-ray Loop diuretic resistance is defined as a provider decision to pursue combination diuretic therapy because of failure to reach provider defined adequate diuresis (can not exceed urine output of 2 L in past 12 hours) despite receipt of an intravenous loop diuretic dose of a furosemide equivalent of at least 240mg/day over at least the past 12 hours (40mg furosemide = 20mg torsemide = 1mg bumetanide) decision to pursue hemodialysis by a nephrologist estimated glomerular filtration rate by the MDRD equation < 15ml/min/m2 systolic blood pressure < 85mmHg pregnancy serum potassium < 3.0mEq/L serum sodium > 145mEq/L or < 130mEq/L severe malnutrition advanced liver disease inability to perform standing weights inability to collect and measure urine with either a foley catheter or urine collection containers", "label": "1"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 0.0-999.0, All Breast Carcinoma Cardiovascular Complication European American patients with DNA available European American patients who developed CHF and patients who did not develop CHF following a full course of treatment with an anthracycline and bevacizumab African American cases (based on a drop in left ventricular ejection fraction [LVEF] < 50 or a drop from baseline > 20 points) and African American controls ", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Eisenmenger Syndrome Congenital Heart Disease Sleep-disordered Breathing Eisenmenger Syndrome (definition: Pulmonary \u2265 systemic vascular resistance with pulmonary-to-systemic shunt and cyanosis (periphery oxygen saturation < 92% at rest and/or < 87% during exercise) Stable for \u2265 3 months (no hospitalization, no change of medication, no deterioration) Down's syndrome Iron deficiency (definition: Ferritin < 12 \u00b5g/l and/or transferring saturation < 20%) Regular phlebotomy Suspicion of risk of non-compliance", "label": "0"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 18.0-999.0, All Acute Decompensated Heart Failure Age 18 years or older Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to inclusion Chronic heart failure will be defined as requiring treatment for a minimum of 30 days prior to current admission, NYHA Class III or IV at the time of hospitalization, and left ventricular ejection fraction less than 40% within one year or evidence of heart failure with preserved ejection fraction and evidence of diastolic dysfunction on echocardiogram Admitted with clinical decompensated heart failure based on history, physical exam, and parameters indicating extracellular volume expansion such as including JVP \u2265 8 cm of water and 1+ or greater peripheral edema Is able to be dosed with study medication within six (6) hours of first dose of IV diuretics Baseline severe hypotension (Mean arterial pressure < 55 mm Hg) Creatinine clearance less than 20 ml/min or creatinine greater than 2.5 mg/dl Serum sodium less than 128 meq/L Serum Potassium < 3.0 meq/L Known adverse reaction to metolazone Inability to take oral medications Severe Aortic Stenosis (AVA < 0.8cm2) History of Hypertrophic obstructive cardiomyopathy Metastatic Carcinoma per history Severe COPD, FEV < 1L", "label": "2"} +{"topic": "A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension.", "doc": "eligible ages (years): 21.0-999.0, All Congestive Heart Failure Age > 21 years of age Left ventricular ejection fraction \u2264 50% (at any time in the past) Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level) Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl United Organ Network Sharing status 1B for heart transplantation (outpatient inotrope use, LV assist device) Inoperable aortic valvular heart disease Life expectancy <1 year due to causes other than HF such as advanced cancer Cardiac transplantation or revascularization indicated or expected within 6 months Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care) Subject unable or unwilling to provide written informed consent Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Lung Disease Age greater than or equal to 40 years Cigarette smoking greater than or equal to 30 pack years Obstructive Spirometry First degree relative with smoking history willing to participate ", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 5.0-11.0, All Asthma Siblings of a birth cohort recruited 1997-1999 Age less than 11 years Physician diagnosed asthma Active symptoms (wheeze, persistent cough, chest tightness, shortness of breath) or medication use in the 12 months prior to enrollment ", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease COPD Patients must have moderate or severe COPD Patients must have at least one episode of COPD-related symptoms (eg, cough, sputum production, shortness of breath) within 2 months prior to screening Patients must not have asthma as main component of obstructive airway disease Patients must not have had a moderate or severe exacerbation of COPD within previous 1 month ", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 21.0-70.0, All Healthy Volunteers (Non-smoker) Healthy Volunteers (Smoker) Chronic Obstructive Pulmonary Disease Healthy non-smokers Normal spirometry (FEV1 >90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s) At risk (current smokers) Normal spirometry, with or without chronic symptoms (cough, sputum production) FEV1 reversibility of <15% after inhaled beta2-agonists* Moderate COPD FEV1 greater than or equal to 30% and < 80% FEV1/FVC < 70% predicted FEV1 reversibility of <15% after inhaled beta2-agonists With or without chronic symptoms (cough, sputum production, dyspnea) Concomitant use or pre-treatment within the last 4 weeks with oral steroids Respiratory infection within 4 weeks prior to entry into the trial Females who are pregnant or lactating History of current or past drug or alcohol abuse", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease (COPD) diagnosis of mild COPD OR healthy control subjects 80 years old able to perform all study procedures Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects) allergy to atrovent history of asthma, atopy or nasal polyps Oxygen desaturation < 80 % during exercise recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All COPD Osteoporosis Osteopenia Age > 18 years Men and women COPD according to the ATS-guidelines, divided in severity according to the GOLD Written consent Age < 18 years No written consent", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Respiratory Tract Infections General Conditions Outpatients Fulfillment of clinical diagnostic for one of the following indications Mild to moderate Community Acquired Pneumonia (CAP) Acute bacterial Exacerbation of Chronic Bronchitis (AECB) Acute Sinusitis (AS) For CAP The to be fulfilled are New onset of at least two of the following Cough General Conditions Subjects presenting with any of the following will not be included in the study Treatment required during the study with ergot alkaloid derivatives, pimozide, astemizole, terfenadine, cisapride, simvastatin, atorvastatin and lovastatin, and the oral use of the benzodiazepines midazolam, triazolam and alprazolam History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation Known hypersensitivity to telithromycin or to macrolide antibiotics Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry) Pregnant or breast-feeding women. For the women of childbearing potential it is left to the investigators discretion to establish a lack of pregnancy, e.g. with contraceptive use, menstrual pattern, urinary pregnancy test Subjects with severely impaired renal function (creatinine clearance <30 ml/min) Subjects that had received anti-bacterials for more than 24 hours within 7 days prior to enrollment in the study, unless the treatment has failed Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 35.0-999.0, All Pulmonary Disease, Chronic Obstructive Outpatient with the diagnosis or referral diagnosis of COPD COPD must be the primary reason for this outpatient contact (for both new patients and controls) Any co-morbidity that hampers the diagnosis and treatment of COPD in accordance with the COPD guidelines used locally (e.g. malignant disease, dementia or sequelae of apoplexy) Asthma without the presence of COPD", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-80.0, All COPD Acute Exacerbation COPD patients who were admitted to our pulmonary department for an acute exacerbation were prospectively enrolled in the study COPD patients hospitalized with specific reasons like pneumonia, pulmonary emboli, congestive heart failure, pneumothorax etc. as the cause of acute exacerbation, or patients with risk of imminent respiratory failure requiring mechanical ventilation or direct admission to the ICU were excluded", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease Established clinical history of moderate to severe COPD Post bronchodilator FEV1 of < 50% of predicted normal FEV1 / FVC ratio <70% Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1 Free from exacerbation in the 6 weeks prior to screening Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations Current asthma, eczema, atopic dermatitis and/or allergic rhinitis Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study Has undergone lung transplantation and/or lung volume reduction Female who is a nursing mother Requires regular (daily) long-term oxygen therapy (LTOT) Is receiving beta-blockers (except eye drops) Has a serious, uncontrolled disease likely to interfere with the study Has received any other investigational drugs within the 4 weeks prior to Visit 1 Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-75.0, All COPD Pulmonary Hypertension Confirmed moderate to severe COPD with or without pulmonary hypertension Male and female patients Aged 18 years Written consent Adequate contraception in female patients of childbearing age Negative pregnancy test (four-weekly test repetition) Lack of consent Pregnancy (four-weekly tests) Lactation Presumed non-cooperativeness Patients outside the stipulated age range Myocardial infarction within the last 12 months Stroke within the last 12 months Malignant diseases in anamnesis Legal incapacity Parallel participation in a clinical trial", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) diagnosis of COPD history of 15 pack-years or more of cigarette smoking evidence of irreversible obstruction (FEV1<70% of predicted value, ratio FEV1/FVC<70%, and improvement of FEV1of less than 20% after bronchodilator in previous respiratory tests done when they were stable) history of asthma or atopy need of being hospitalized use of oral or intravenous steroid within the preceding 30 days history of multiresistant bacterial infection (not applicable if absence of multi-resistant bacterial infection has been proved by a negative expectoration culture in the previous 6 months), bronchiectasis or recent COPD exacerbation (< 6 weeks) or diabetes oxygen-dependant COPD patients or patients previously known with hypercapnia (PCO2>45 mmHg) at steady state use of high doses of Advair (more than 50/500 bid) or Symbicort (more than 12/400 bid) known cardiac arrhythmia such as atrial fibrillation, supraventricular tachycardia or paroxysmal auricular tachycardia", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Asthma Pulmonary Disease, Chronic Obstructive No change from the MIA and LEUKO trials No change from the MIA and LEUKO trials", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 35.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. age >35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following Current smoking Suffering from COPD according to the GP's diagnosis In command of the Dutch language Too ill Under control of a chest physician Serious physical or psychological comorbidity", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-80.0, All Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Chronic Bronchitis Subject must have a diagnosis of moderate or severe COPD Subject must have a post-bronchodilator FEV1/FVC ratio < 0.7 Subject must have a post-bronchodilator FEV1 % predicted value \u2265 30% and < 70% Subject must be between 40 and 80 years of age, of either sex, and of any race Subject must be a current or ex-smoker, with a cigarette smoking history of \u2265 10 years or > 10 pack-years Subject has been diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer) Subject has been diagnosed with \u03b11-Antitrypsin deficiency Subject has a body mass greater than 150 kg (330 lb) or less than 40 kg (88 lb) Subject has active infection Subject has had a significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening Subject with clinically relevant uncontrolled medical condition not associated with COPD Subject has documented history of uncontrolled heart failure Subject has pulmonary hypertension due to left heart condition Subject has atrial fibrillation or significant congenital heart defect/disease Subject has initiated pulmonary rehabilitation within 3 months of screening", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 45.0-999.0, All Emphysema Pulmonary Disease, Chronic Obstructive for All Participants Able to read and write English At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years) Able to participate in the informed consent process Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry) for Participants with Emphysema Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR More than minimal emphysema on an acceptable-quality chest CT scan for Participants without Emphysema GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND Pregnant Prisoner Vulnerable populations Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment) Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant Congenital abnormalities of the lung or previous lung surgery Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated) CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease Phase 1 & Gene Expression: --Current hospitalization for COPD exacerbation Phase 1 & 2: COPD & ONE of the following History of hospitalization for COPD exacerbation, OR Currently on supplemental oxygen, OR History of evaluation for lung transplant or LVRS, OR >/= 6 months post-LVRS Phase 1 or 2 Current or former smoker, >/= 20 pack-yr. smoking history FEV1 6 months < 20 pack-yr. smoking history Diagnosis of pulmonary fibrosis, bronchiectasis, mediastinal mass, or presence of a pulmonary mass Asthma FEV1 > 70% or FEV1/FVC >70%", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All COPD COPD, smoker COPD, non smoker ", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-75.0, All Chronic Obstructive Pulmonary Disease Age 18-75 years Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 5 groups described above Able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour Physically and mentally able to undergo the total study protocol Written informed consent Participation in another study Alpha-1-antitrypsin deficiency Selected grade 1-3 co-morbidity listed in the ACE-27 Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,Acenocoumarol", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 0.0-4.0, All Asthma Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea) Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion Subject who requires or is expected to require any disallowed medications Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial Subject who has experienced significant blood loss within 60 days of study drug Subject with a clinical diagnosis of cystic fibrosis Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is <1 year of age at screening Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts [CDC 2000] Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 30.0-999.0, All Right Heart Failure Cor Pulmonale Hospitalized patients Adults Right heart failure secondary to pulmonary hypertension (cor pulmonale) Pronounced leg edema Patients in sepsis Hemodynamically unstable Renal failure (creatinine >2 mg%) Deep vein thrombosis Pregnancy Psychiatric/noncompliant patients Patients who will not sign the informed consent form", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-50.0, All Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Asthma Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog) for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below) Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable Use of daily theophylline within the past month Pregnancy or nursing a baby Cigarette smoking > 1 pack per month Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to prophylactic use of albuterol prior to exercise)", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 0.0-999.0, All Dyspnea Heart Failure Asthma COPD patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea) age <18 years history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea pneumonia pulmonary embolism carcinoma pneumothorax pleural effusion intoxications (drugs) anaphylactic reactions upper airway obstruction", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) Smoking Smoking Cessation Chronic Bronchitis Emphysema Group A Healthy nonsmokers Enrolled in the \"Normal\" protocol #0005004439 \"Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy\" Healthy according to the \"Normal\" protocol #0005004439 Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies Male and Female subject \u226518 years of age smoked < 100 cigarettes per lifetime and whose urine nicotine <2 ng/mL and urine cotinine <5 ng/mL, at entry into the study Group B Healthy current smokers Enrolled in the \"Normal\" protocol #0005004439 Groups A Unable to provide proper informed consent Drug and/or alcohol abuse within the past six months Individuals with asthma and with recurrent or recent (within three months) and/or acute pulmonary infection Allergy to lidocaine Significant kidney disease or subjects on dialysis Females who are pregnant or lactating or intending to become pregnant in the next 12 months Major depression or other significant psychiatric disorder HIV+ Subjects that have unstable coronary artery disease as evidenced by unstable angina, >Class II NYHA cardiac status, history of congestive heart failure or MI within the last 12 months", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease Cardiovascular Disease Smoking Bronchodilation COPD Gold stage II-III (FEV1/FVC<0,70 and FEV1 30-80% of predicted value) Current cigarette smoking (at the time of performing the study) Willing to provide written informed consent Refrain from smoking and bronchodilators > 8 hours (depends on treatment) before the test Registered in one of the recruitment institutes COPD gold stage I or IV Asthmatic component: History of asthma, present asthma by complaints, eosinophilia or reversibility \u2265 10% of predicted Unable to communicate Physically unable to perform any of the tests Non-COPD respiratory disorders Previous lung-volume reduction surgery and/or lung transplantation Evidence of alcohol, drug or solvent abuse Known \u03b1-1 antitrypsin deficiency", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease Nocturnal Desaturation Patients with a diagnosis of COPD supported by a history of past smoking and obstructive disease: FEV1<70% predicted, FEV1/FVC<70% and a total lung capacity by body plethysmography >80% predicted Stable COPD at study entry, as demonstrated by (1) no acute exacerbation and (2) no change in medications for at least 6 weeks before enrollment in the trial Non-smoking patients for at least 6 months before enrollment in the trial SpO2 at rest < 95% Patients fulfilling the current definition of nocturnal oxygen desaturation, i.e., >=30% of the recording time with transcutaneous arterial oxygen saturation <90% on at least one of two consecutive recordings Ability ot give informed consent Patients with severe hypoxemia fulfilling the usual for continuous oxygen therapy at study entry: PaO2 <=55 mmHg; or PaO2 <= 59 mmHg with clinical evidence of at least one of the following: (1) with right ventricular hypertrophy (P pulmonale on ECG:3 mm leads ll, lll, aVf); (2) right ventricular hypertrophy; (3)Peripheral edema (cor pulmonale); (4) hematocrit >=55% Patients with proven sleep apnea (defined by an apnea/hypopnea index of >=15 events/hour) or suspected sleep apnea on oximetry tracings Patients currently using nocturnal oxygen therapy Patients with known left heart or congenital heart diseases, interstitial lung diseases, bronchiectasis as the main cause of obstructive disease, lung carcinoma, severe obesity (body mass index >= 40 kg/m\u00b2), or any other disease that could influence survival", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All NSCLC Dyspnea Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2) New dyspnea or worsening dyspnea within the last 6 months per patient reporting Age < 18 An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator Life expectancy < 3 months Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure) Myocardial infarction within the previous month Heart rate \u2265 120 Active tuberculosis or tuberculosis receiving antibiotic therapy Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6) Sensitivity to atropine Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All COPD Signed informed consent Age \u2265 40 years Patients fulfilling for COPD according to the Global initiative for chronic obstructive pulmonary disease (GOLD) stage I or higher Smokers or ex-smokers of at least 10 pack-years Patients suffering an either Admitted to hospital due to (severe exacerbation) or Confirmed at GP (general practitioner) setting (moderate exacerbation) Definition Increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both Patients who have never smoked Patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.) Exacerbation of COPD due to other causes such as pneumothorax and acute decompensated congestive heart failure Difficulties in communication (cognitive deterioration, sensorial disability, language barriers) Severe disease with poor vital prognosis (life length expectancy less than one year)", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Type of subject: Outpatients Informed consent: Subjects must give their signed and dated written informed consent to participate Gender: Male or Female Age: 40 years of age or older at Visit 1 COPD diagnosis: Documented diagnosis of COPD at least 6 months prior to Visit 1 in accordance with the following definition by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guideline: Post bronchodilator FEV1/FVC < 0.7 History of exacerbations: At least one COPD exacerbation which required the use of any additional treatment in the last 12 months prior to Visit 1 For subjects who were diagnosed between 6 to 12 months prior to Visit 1, they should have at least one COPD exacerbation that required the use of any additional treatment since diagnosis Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis Non-compliance: Subjects unable to comply with any aspect of this study protocol or scheduled visits to the study centre", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-75.0, All Chronic Obstructive Airway Disease Asthma Chronic Cough General Adult subjects aged 18 years and over Meet for subject groups as outlined below (1) Healthy volunteers Non-smokers No history of respiratory disease (2) Healthy smokers Current smokers with smoking history of \u226510 pack years Spirometry within normal limits i.e. FEV1>80% predicted and FEV1/FVC ratio >75% predicted (3) Asthma Symptoms of upper respiratory tract infection within the last 6 weeks 2) Participation in another clinical trial of an investigational drug within the last 4 weeks 3) Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate, 4) Patients with severe respiratory disease i.e. FEV1 < 1 litre, 5) Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-80.0, All COPD Main Willingness to sign a written informed consent Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009 Chinese or Malay or Indian ethnicity History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0 Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) < 70% Forced expiratory volume in the first second (FEV1) (post-bronchodilator) < 50 % of predicted Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years Main Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at V0 Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0 History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0 Known alpha-1-antitrypsin deficiency", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease age 40-80 years old cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment non-smoking controls: no COPD (spirometry based) + < 1 pack year Respiratory disorder other than COPD \u03b11-antitrypsin deficiency Known history of significant inflammatory disease other than COPD COPD exacerbation within 4 weeks prior to study Lung surgery Recent diagnosis of cancer Therapy with oral corticosteroids in the last 6 weeks Significant cardiovascular comorbidity Significant orthopedic/musculoskeletal problems", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 21.0-70.0, All Pulmonary Disease, Chronic Obstructive Asthma A subject will be eligible for in this study only if all of the following apply All volunteers must be aged between 21 to 70 years inclusive and be competent to understand and give informed consent All female volunteers of child bearing potential must have provided a negative pregnancy test before and prior to any HRCT scan Body weight < 120 kg and BMI within the range 18 kg/m2 (inclusive) Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Available to complete the study Subject will then be included only if they fulfil all for the following relevant cohort Healthy: Cohort Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history and physical. A subject with a clinical abnormality or parameters outside the reference range for the population being studied may be included if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Non-smokers (never smoked or not smoking for >12 months with <1 pack year history) (Pack years = (cigarettes per day smoked/20) x number of years smoked)) A subject will not be eligible for in this study if any of the following apply As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study Any pregnant female Volunteers who have a past or present disease, which as judged by the Investigator, may affect subject safety or influence the outcome of the study The subject has received an investigational drug or participated in any other research trial within 30 days or five half-lives, or twice the duration of the biological effect of any drug (whichever is longer) The subject that has both asthma and COPD Previous in a research and/or medical protocol involving nuclear medicine Any Radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv in addition to natural background radiation, in the previous 3 years including the dose from this study) The subject has a history of alcohol or drug abuse The subject has had a respiratory tract infection within four weeks of the start of the study", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure With Preserved Ejection Fraction Pulmonary Disease Left Ventricular Hypertrophy/Hypertension Male or female; Age 18 or older Left ventricular ejection fraction \u2265 50% Symptomatic heart failure or appropriate comparator group Informed consent signed by the subject Symptoms of active ischemia Moderate or severe mitral or aortic stenosis, or severe aortic insufficiency Serum creatinine > 3.0 or chronic hemodialysis Known chronic hepatic disease; defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal as read at the local lab Severe renal dysfunction, i.e. glomerular filtration rate (GFR) <30 ml/min Atrial fibrillation Myocardial infarction within the last year Coronary bypass surgery within the last 6 months Stroke within the last 6 months Known aortic aneurysm", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive minimum age 40 years at index continuously enrolled in health plan diagnosis of COPD (ICD-9 codes of 491, 492, 496) at least one moderate exacerbation event as defined previously Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation Receipt of maintenance medication in the pre-period Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 0.0-15.0, All Asthma Bronchiolitis patient is admitted to the ER with shortness of breath patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including asthma management protocol bronchiolitis management protocol ages 0 patient's parent/guardian is able to comprehend and give informed consent for participating in the study patient has received any dose of inhaled bronchodilators in the hour prior to enrollment patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment ventilated patients, while ventilated chest skin lesions cystic fibrosis hemodynamic instability patient's parent/guardian objects to the study protocol concurrent participation in any other clinical study physician objection", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive at least 40 years of age continuously enrolled for medical and pharmacy benefits during their pre and post-period diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx) Patients were excluded if they had MTx in the pre-index period (to ensure of MTx-na\u00efve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation) Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose)", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) Inflammatory Disease Endothelial Dysfunction presence of COPD according to standard acute exacerbation of COPD according to recommended international over 40 years of age history of at least 10 py pneumonia history or signs of congestive heart failure acute myocardial infarction thoracotomy incl. resection of lungtissue interstitial lung disease acute or chronic renal failure active malignancy autoimmune disease", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 50.0-90.0, All Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Cor Pulmonale diagnosis of COPD stage II, III or IV according to the GOLD guidelines signed the informed consent ischemic cardiopathy severe valvular disease atrial fibrillation left bundle branch block", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Community Acquired Bacterial Pneumonia age 18 years or older met ATS/ISDA rule of CABP CABP requiring hospitalization and treatment with a IV antimicrobial anticipated hospitalization for > 48 hours received ceftaroline in combination with a macrolide (clarithromycin, or azithromycin) for > 48 hours within the first 24 hours after presentation to the hospital and must have remained on therapy for at least 48 hours after admission Pneumonia Patient Outcomes Research Team (PORT)risk class III or IV CABP PORT Risk class I, II, III CABP requiring admission to an ICU CABP suitable for outpatient therapy with an oral microbial agent confirmed or suspected respiratory tract infection attributed to a source other than CABP pathogens noninfectious case of pulmonary infiltrates or pleural empyema infection with a pathogen know to be resistant to ceftaroline or epidemiological/ clinical context suggesting a high likelihood of a resistant pathogen previous therapy with another intravenous beta-lactam for CABP for between 24 and 96 hours prior to randomization receipt of chronic concomitant systemic steroids > 40 mg of prednisone equivalent significant hepatic disease hematologic disease", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 6.0-999.0, All Filariasis Age 6 years or older of either gender Patients presenting with pulmonary symptoms a. Confirmed or suspected asthma patients: i. Patients presenting with symptoms consistent with an acute exacerbation of asthma, including Wheezing 2. Shortness of breath 3. Chest tightness 4. Cough ii. Disposition to the asthma room after triage and physician evaluation (disposition to other areas of the A&E allowed if due to no available space in the asthma room) iii. Patients are potentially eligible with or without a past history of health care provider diagnosed asthma iv. Patients are potentially eligible regardless of the number of previous episodes of wheezing (i.e. patients with a first episode of bronchospasm are potentially eligible) v. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if They have a dry cough (no production of purulent sputum) They have bronchospasm as manifested by wheezing or need for salbutamol (albuterol) breathing treatments vi. Patients with wheezing are not eligible if they Have purulent sputum production 2. Have known or suspected a. Tuberculosis b. Immunodeficiency c. Congestive heart failure d. Foreign body aspiration b. Patients presenting with a chief complaint of cough: i. Potentially eligible patients will have a cough of greater than one week (seven days) duration ii. Asthma room disposition is not required for these subjects iii. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if They have a dry cough (no production of purulent sputum) iv. Patients with cough are not eligible if Have purulent sputum production Have known or suspected Patients less than 6 years of age Patients who do not consent to the study Children (<18 years) without a parent/guardian present Prisoners Patients who appear to be medically or psychologically unstable or felt to be otherwise inappropriate for study enrollment, in the opinion of the investigator or any treating health care provider. This determination will be made on an individual basis, but some of the general to be used in making this determination will be i. The patient appears to be in significant pain ii. The patient appears acutely ill severe respiratory distress, diaphoretic, altered mental status, active bleeding, actively vomiting, etc iii. Those with respiratory difficulty to the point they cannot speak in complete sentences iv. Chief complaint of sexual assault v. The patient appears acutely intoxicated vi. The patient displays agitated, nervous, restless, or other behavior suggestive of an uncontrolled psychiatric emergency Patients with pulmonary findings felt to be secondary to congestive heart failure, foreign body, bacterial pneumonia, tuberculosis or other clearly defined cause Non-English speaking patients", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All COPD A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 \u2265 30% to <80% of the predicted value Current or former cigarette smokers with a smoking history of at least 10 pack-years History or current diagnosis of asthma Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1 Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1 Patients with any clinically significant respiratory conditions other than COPD", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) -Individuals over the age of 18 who have COPD or may be considered to be at increased risk for development of COPD -Individuals under the age of 18", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All COPD Aged \u226540 years at initial date of COPD diagnosis COPD diagnosis with Quality Outcome Framework (QoF) approved read code has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted) Patient has one year of data prior to initial date of COPD diagnosis Patient has a minimum of two years of data post initial date of COPD diagnosi Patients whose initial date of COPD diagnosis is before 1997", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Completion of informed consent Adults over the age of 18 Diagnosis of IPF per ATS guidelines Clinically stable at the time of enrollment defined as no antibiotics within the past month, with the exception of those patients currently listed for Lung Transplantation No changes in immunosuppressive regimens (if applicable) over past month Inability to understand or complete paper and pencil questionnaires Patient not planning to return to Stanford for clinic visits", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) patients with diagnosed COPD via the medical records with code J44 terminal illness cognitive impairments", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All COPD Continuous health plan enrollment for 12 months before and after index Rx, at least one prescription for BFC or FSC during intake period, naive to ICS/LABA therapies in year prior to first prescription claim, COPD diagnosis, aged 40 or over at time of first prescription ICS/LABA combination during pre-index period, patients with a claim for BFC and FSC on the same day, patients diagnosed with cancer, patients with long-term OCS medication use during pre-index period", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 45.0-999.0, All Insomnia COPD Chronic Obstructive Pulmonary Disease Fatigue mild to very severe COPD age \u2265 45 years of age with no other major healthproblems clinically stable at the time of enrollment into the study insomnia evidence of restrictive lung disease or asthma pulse oximetry reading of < 90% at rest or < 85% at night for > 5 min evidence of a major sleep disorder other than insomnia hypnotic use acute respiratory infection within the previous 2 months presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease a self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of > 11 currently participating in pulmonary rehabilitation", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-85.0, All Chronic Obstructive Pulmonary Disease Endothelial Dysfunction COPD patients in stable condition ( without exacerbation min 1 months ago) Over 40 years History of at least 10 py acute exacerbation of COPD active malignancy autoimmune disease acute myocardial infarction diabetes mellitus with late complications congestive heart failure women of childbearing potential", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease Chronic Bronchitis Written informed consent. 2. Age \u2265 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%. 4. FEV1 (post-bronchodilator) < 80% of predicted Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once)", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All COPD Chronic Obstructive Pulmonary Disease Diagnosis of stable COPD years or older Smoking history of at least 10 pack-years Forced Expiratory Volume in one second (FEV1) \u2264 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70 Dyspnea \u2265 2 on the Medical Research Council (MRC) scale At least 2 exacerbations requiring prednisone treatment in the past 3 years Using a written action plan and having demonstrated adequate use of the self-administered antibiotic & prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response) Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD History of asthma or allergic rhinitis before the age of 40 Regular use of oxygen, oral corticosteroids, antibiotics Unstable or life threatening co-morbid condition Medical conditions or taking medications known to affect tremor and/or heart rate (HR) Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole)) On theophyllines Colonized with pseudomonas aeruginosa", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Male or female patients 40 years of age or older All patients had to have a diagnosis of COPD and had to meet the following spirometric and static lung volume Patients had to have relatively stable, moderate to severe airway obstruction with FEV1 \u2264 50 % of predicted value FEV1/SVC \u2264 70 % All patients had to have the presence of lung hyperinflation as demonstrated by RV \u2265 125 % of predicted value Predicted normal values were calculated according to European Community Coal and Steel (ECCS) Males FEV1 predicted (L) = 4.30 x height (metres) 029 x age (years) Patients with a history of asthma, allergic rhinitis or atopy Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator may have either put the patient at risk because of participation in the study or a disease which may have influenced the results of the study or the patient's ability to participate in the study Patients with a recent history (i.e. one year or less) of myocardial infarction Patients with a recent history (i.e. three years or less) of heart failure, pulmonary oedema, or patients with cardiac arrhythmia requiring drug therapy Patients who regularly used daytime oxygen therapy for more than one hour per day and in the investigator.s opinion was unable to abstain from the use of oxygen therapy Patients with known active tuberculosis Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis Patients who underwent thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason were evaluated as per criterion No. 2 Patients with lower respiratory tract infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Age \u2265 40 years A diagnosis of relatively stable, moderate to severe COPD with Screening FEV1 \u2264 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS) and screening FEV1/FVC \u2264 70% Smoking history \u2265 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent) Ability to be trained in the proper use of the HandiHaler\u00ae device and Metered Dose Inhaler (MDI) Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak expiratory flow rate (PEFR) measurements, and maintenance of diary card records Ability to give written informed consent in accordance with Good Clinical Practice and local regulations Clinically significant diseases other than COPD Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an criterion, will be excluded All patients with a serum glutamic oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition A recent history (i.e., one year or less) of myocardial infarction Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day Known active tuberculosis History of cancer within the last five years (excluding basal cell carcinoma) History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis Patients who have undergone thoracotomy with pulmonary resection", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-90.0, All Chronic Obstructive Pulmonary Disease(COPD) Malnutrition Patients from Zhujiang Hospital affiliated from Southern Medical University Patients aged between 40 and 90 years old Patients gendered into male or female Patients with pulmonary function test of FEV1/FVC<70% and FEV1<80% predicted Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI <21 kg/m2 (or<23 kg/m2 in patients \u2265 65); unintentional weight loss >10% in the past 6 months; unintentional weight loss >5% in last month; FFMI <15 kg/m2 (women) or <16 kg/m2 (men) Patients able to answer question Patient able to eat and drink Patients who signed informed consent Patients with signs of an airway infection Patients with malignant disorders Patients with recent surgery Patients with gastrointestinal ,cardiovascular diseases,neurological diseases or endocrine disease Patients with bullae lung patients treated with oral steroids or immunosuppressors Patients requiring other nutritional supplements or parenteral nutrition Patients suffering from acute exacerbation over the previous 4 weeks Patients with lack of motivation or poor compliance", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 0.0-999.0, All COPD Primary Health Care Centers (PHCC): >10.000 patients listed. >70% permanent employed general practitioners Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the latest spirometry completed since 2008 ", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease Age\u2265 40years old The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease Chest radiography shows congestive heart failure Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases Serious cardiac failure, renal insufficiency or hepatic dysfunction", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Cough Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-80.0, All Pulmonary Disease, Chronic Obstructive A confirmed diagnosis of severe to very severe COPD medically stable Age between 40 and 80 years Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney with a two-week wash-out period prior to randomization Without participations in other interventional trials in the previous one month With the informed consent signed Pregnant or breast-feeding women Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis) Complicated with a neuromuscular disorder, which affected the respiration Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics Complicated with malignancy, congenital or acquired immune deficiency Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation) Participating in other trials or allergic to the used medicine", "label": "1"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Disease, Chronic Obstructive Clinical stable moderate to severe COPD (FEV1 <70%, FEV 1 / FVC <70%) total lung capacity (TLC> 80%) without conventional for LTOT, optimal medical therapy, mean SpO2 \u2264 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation Current smokers Presence of respiratory failure and for LTOT (PO2 <55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia) Presence of impaired mobility Cognitive impairment or intellectual disability to fill in questionnaires No acceptance of liquid oxygen Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) Participation in pulmonary rehabilitation programs", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 50.0-75.0, All Chronic Obstructive Pulmonary Disease male and female COPD with an FEV1 of under 60% of predicted non-smoker between 50 and 75 years old experiencing an acute exacerbation of COPD (24-48 hours, before treatment) all inflammatory disease (HIV, cancer, renal and cardiac deficiency) hormonal dysregulation inferior limb pathology neuromuscular pathology history of tobacco or alcool abuse oxygen dependent", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-60.0, All Asthma Participants must meet all of the following for enrollment Male or female, 18 to 60 years of age Must have clinical evidence of moderate-severe atopic asthma -self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms) within the past year, and a positive methacholine test confirming diagnosis [provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) < 16 mg/mL for participants on inhaled corticosteroids and < 8 mg/mL for participants not on inhaled corticosteroids] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and no other diagnosis that could explain symptoms If there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge Permanently resides within 50 miles of the CRU Able to present a valid government issued form of identification for entry to the NIEHS campus Participants meeting any of the following at screening will not be eligible for enrollment or to continue with study visits Women who are pregnant or lactating at the time of screening (this is in place because certain enrollment procedures, may pose an undue risk on the unborn fetus; women may rescreen at a later date once no longer pregnant or breastfeeding; women who are pregnant or lactating at the time of the baseline visit and are scheduled to complete the methacholine challenge will be withdrawn due to the potential risk to the fetus; women who become pregnant after completing the baseline visit will not be excluded from further participation but will also not be eligible for participation in the bronchoscopy sub-study) Current smoker, significant second-hand smoke exposure (defined by urine cotinine > 100 ng/mL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes piCO Smokealyzer value of > 11ppm History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension Allergy or history of adverse reactions to methacholine Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures Comorbid diseases that affect global health or survival such as DVT, pulmonary embolism, class III IV congestive heart failure, or a malignancy under treatment", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-85.0, All COPD, HEAD&NECK CANCER,SCREENING group of adult COPD patients Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine Patients with an acute disease or COPD exacerbation Pregnant patients Patients who were intubated \u22643 months prior to Patients with a medical history of surgical intervention in the upper airway Patients with a medical history of malignant disease in the upper airway Patients who underwent radiotherapy of head and neck", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Disease Heart failure Ambulatory patients", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All COPD Patients with a diagnosis of COPD (FEV1/FVC<0.7 confirmed based on the past medical records) Patients aged 40 years and over at the diagnosis of COPD Outpatient or more pack-years of current or former smokers Patients who have traceable medical records of COPD (including the results of spirometry) going back more than a year Patients who meet any of the following two Patients who have medical records of the results of spirometry at more than two different time points excluding the time point of COPD exacerbations* for the past 3 years Patients who can provide the results of reversibility testing for respiratory tract Patients who give written informed consent regarding the participation in this study Patients currently with COPD exacerbations Patients who currently enroll in the other interventional study including clinical trials Patients who concurrently develop or have a history of lung cancer Patients who are disabled to understand the study procedure or answer the questionnaire (i.e. due to the history of alcohol or drug abuse)", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-65.0, All Asthma COPD for Asthma History consistent with asthma: episodic wheezing, shortness of breath, or cough Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs FEV1 >40% predicted Never smoker, current smoker, or quit smoking \u22655 years ago for COPD History consistent with COPD: dyspnea with exertion, productive cough, progressive course Smoking history of at least 20 pack years Current smoker or quit smoking \u22655 years ago Age >18yrs FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol for Asthma Other respiratory illness other than asthma Chronic infectious process Significant other medical illness Inability to consent Pregnancy for COPD Other respiratory illness other than COPD Chronic infectious process Significant other medical illness Inability to consent", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-75.0, All COPD Asthma for Healthy Smoking Subjects Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Be between 18 and 75 years of age, inclusive, at informed consent Healthy as determined by a physician, based on medical history and physical examination Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of \u2265 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked) for All COPD Subjects Must have signed an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli, 2004). Symptoms must be compatible with COPD for at least 1 year prior to screening and post-bronchodilator spirometry readings at screening Post-bronchodilator FEV1/FVC ratio of <0.7 for Healthy Smoking Subjects Any potential subject who meets any of the following will be excluded from the participating study Upper or lower respiratory tract infection within 4 weeks of the screening visit Positive test for alcohol at screening Taking prescription medication in the 14 days before screening Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded but are not limited to pipes, cigars and e-cigarettes Subjects who are unable to produce a total weight of at least 0.1 grams (g) of selected sputum at screening Urinary cotinine levels at screening < 30 ng/ml Subject is mentally or legally incapacitated Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO Any other reason that the Investigator considers makes the subject unsuitable to participate", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Disease, Chronic Obstructive Patients Male of Female, aged 18 years or above Attended the clinic as a patient Participant is willing and able to give informed consent for participation in the study Patients The patient is unable or unwilling to give consent Health Care Professionals Male or Female, aged 18 or above Attended the clinic as a health care professional Participant is willing and able to give informed consent for participation in the study Health Care Professionals The health care professional is unable or unwilling to give consent", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Age: >=40 years of age at Visit 1 Diagnosis of COPD with a documented history of COPD for at least one year, in accordance with the definition by the American Thoracic Society/European Respiratory Society Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio <0.70 and FEV1 <=70% of predicted obtained within two years of Visit 1 Smoking History: Current or former (defined as subjects who have quit smoking for at least 3 months prior to Screening/Visit 1) cigarette smokers with a >10 pack-year smoking history (Number of pack years = [number of cigarettes per day divided by 20] x number of years smoked [e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]) Current COPD Therapy: Currently receiving maintenance (with one or more long-acting bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic) or long-acting beta 2-agonist (LABA) inhaler therapy (with no prior or ongoing use of inhaler) for the treatment of COPD. Subjects must be able to continue using their currently prescribed COPD maintenance inhaler therapy throughout the study and as needed short acting beta-adrenergic agonist (SABA) for rescue use Ability to Use Inhalers: Subject must be able to demonstrate correct use of inhaler within three attempts at Visit 1 Males Females who are not pregnant or not planning a pregnancy during the study or not lactating Informed Consent: Capable of giving signed and dated written informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the protocol Subject understands and is willing, able, and likely to comply with study procedures and restrictions A subject will not be eligible for in this study if any of the following apply Asthma: Subjects with a current primary diagnosis of asthma COPD medications: Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily COPD therapy (as needed [prn] or regularly scheduled); Has changed maintenance COPD treatment within 4 weeks prior to Screening/Visit 1 or plans to change COPD treatment within 4 weeks of Visit 1 COPD/Exacerbations/Hospitalization: Subjects that have experienced a COPD exacerbation requiring systemic corticosteroids (oral, parenteral or depot) and/or antibiotics within four weeks of Visit 1. A subject must not have had any hospitalization for COPD within three months prior to Visit 1; Subjects with uncontrolled COPD, in the investigator's judgment that would affect subject's ability to evaluate \"ease of use and correct use\" Other Respiratory Disorders: Subjects with other respiratory disorders, including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening/Visit 1 Oxygen: Use of long-term oxygen therapy (LTOT; defined as oxygen therapy prescribed for greater than 12 hours per day) or nocturnal oxygen Other Disease Abnormalities: Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study; Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current COPD medications Alcohol and Drug Abuse: A known or suspected history of alcohol or drug abuse within the last 2 years", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-84.0, All Pulmonary Disease, Chronic Obstructive Male and female subjects, \u2265 40 and less than 85 years of age Clinical diagnosis of at least moderate COPD as defined by the Global Initiative for Obstructive Lung Disease (GOLD) (53) Post bronchodilator FEV1/FVC < 70% (Forced expiratory volume in 1 second/ forced vital capacity) Post bronchodilator FEV1 < 80% predicted, with or without chronic symptoms (i.e., cough, sputum production) Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers To enrich the population for patients who are more likely to have acute exacerbations (54), each subject must meet one or more of the following 4 conditions Have a history of receiving a course of systemic corticosteroids for respiratory problems in the past year Visiting an Emergency Department for a COPD exacerbation within the past year, or Being hospitalized for a COPD exacerbation within the past year Be using supplemental oxygen for 12 or more hours per day A diagnosis of asthma established by each study investigator on the basis of the recent American Thoracic Society/European Respiratory Society and National Institute for Health and Care Excellence guidelines The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy < 2 years Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study Current tachy or brady arrhythmias requiring treatment Presence of a pacemaker and/or internal cardioverter/defibrillator Patients with a history of second or third degree (complete) heart block, or sick sinus syndrome Baseline EKG revealing left bundle branch block, bifascicular block, ventricular tachyarrhythmia, atrial fibrillation, atrial flutter, supraventricular tachycardia (other than sinus tachycardia and multifocal atrial tachycardia), or heart block (2nd degree or complete) Resting heart rate less than 70 beats per minute, or sustained resting tachycardia defined as heart rate greater than 120 beats per minute Resting systolic blood pressure of less than 100mm Hg Subjects with absolute (Class 1) indications for beta-blocker treatment as defined by the combined American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons Guidelines which myocardial infarction, acute coronary syndrome, percutaneous coronary intervention or coronary artery bypass surgery within the prior 3 years and patients with known congestive heart failure defined as left ventricular ejection fraction <40%.(29, 30)", "label": "2"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 0.0-999.0, All Cystic Fibrosis Volunteers with Cystic Fibrosis and lung disease with chest hemiper\u00edmetro \u2265 37 cm Episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used", "label": "0"} +{"topic": "A 66yo female with significant smoking history and chronic cough for the past two years presents with recent, progressive shortness of breath. She is in moderate respiratory distress after walking from the waiting room to the examination room. Physical exam reveals mildly distended neck veins, a barrel-shaped chest, and moderate inspiratory and expiratory wheezes. She has smoked 1 to 2 packs per days for the past 47 years.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease (COPD) Patients who have signed Informed Consent Form prior to initiation of any study-related procedure Male and female adults aged \u2265 40 years Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines Patients with a post-bronchodilator FEV1 \u226540 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 \u00b5g of salbutamol) Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or \u00bd pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for \u2265 6 months at screening Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS) Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1 Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation Other protocol-defined inclusion/", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 13.0-999.0, All Cytomegalovirus Retinitis HIV Infections Concurrent Medication Allowed Topical anti-Herpesvirus agents Zidovudine (AZT) for patients in deferral or foscarnet treatment groups mg every 4 hours. For patients on ganciclovir mg every 8 hours Dideoxyinosine (ddI) and other antiretroviral available via expanded access programs, investigational triazoles, granulocyte-macrophage colony-stimulating factor, and erythropoietin to treat marrow toxicity. The use of other investigational drugs will be considered on a drug by drug basis It is not recommended that patients receiving ganciclovir take AZT simultaneously. If AZT is prescribed for patients taking ganciclovir, it should be prescribed at reduced doses and discontinued if hematologic toxicity develops Patients must have Diagnosis of AIDS by CDC or a documented HIV infection Co-existing Condition Patients with the following conditions or symptoms are excluded Sufficient media opacities to preclude fundus photographs in both eyes Concurrent Medication Excluded Other systemic treatments for Herpesvirus infections Other anti-cytomegalovirus therapy Excluded with foscarnet Parenteral pentamidine, amphotericin B, or aminoglycosides Use of marrow toxic agents with ganciclovir and nephrotoxic agents with foscarnet is discouraged, and alternative treatment should be used whenever possible", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 13.0-65.0, All Cytomegalovirus Retinitis HIV Infections Concurrent Medication Allowed Zidovudine (AZT) 8/90 Other available antiretroviral therapy Pneumocystis carinii pneumonia (PCP) prophylaxis, either systemic or local (aerosolized) Chemotherapy for Kaposi's sarcoma Systemic therapy for intercurrent opportunistic infections Acyclovir or other treatment of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections Systemic therapy deemed necessary for appropriate medical management Patients must have AIDS and cytomegalovirus (CMV) retinitis in at least one eye, diagnosed by an ophthalmologist and verified by fundoscopy and fundus photography Co-existing Condition Patients with the following are excluded Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography Concurrent Medication Excluded Prophylactic acyclovir at time of study entry Other anticytomegalovirus (CMV) therapy, particularly systemic ganciclovir, foscarnet, or CMV hyperimmune globulin Topical ophthalmic medications should be avoided Cytomegalovirus (CMV) therapies and chronic acyclovir, including necessary therapies for an intercurrent opportunistic infection", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 13.0-65.0, All Cytomegalovirus Retinitis HIV Infections Concurrent Medication Excluded Acyclovir Zidovudine (AZT) Any potentially nephrotoxic agent, especially aminoglycosides, pentamidine, or amphotericin B Prior Medication Excluded Ganciclovir Foscarnet Excluded within 7 days of study entry", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 13.0-999.0, All Cytomegalovirus Retinitis HIV Infections Concurrent Medication Allowed Chemotherapy for Kaposi's sarcoma (excluding interferon) if patient is hematologically stable for at least 30 days prior to entry Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC) after first two weeks of study period if absolute neutrophil count is > 1000 cells/mm3 and hemoglobin = or > 8 g/dl Vancomycin Fluconazole or investigational triazoles (e.g., itraconazole, SCH 39304) for disseminated fungal infection Pneumocystis carinii pneumonia prophylaxis (except parenteral pentamidine) Acyclovir or other appropriate medication may be instituted in the event of the appearance of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections G-CSF or GM-CSF for grade 4 neutropenia Co-existing Condition Patients with the following conditions or symptoms are excluded Evidence of tuberculous, diabetic or hypertensive retinopathy Osteomalacia, neoplasm metastatic to bone or other bone disease Any clinically significant pulmonary or neurologic impairment (for example, patients who are intubated or comatose) Retinal detachment Corneal, lens, or vitreous opacification precluding funduscopic exam Concurrent Medication Excluded Immunomodulators, biologic response modifiers or investigational agents not specifically allowed", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 13.0-65.0, All Cytomegalovirus Infections HIV Infections Concurrent Medication Allowed Pentamidine aerosol for prophylaxis of recurrent Pneumocystis carinii pneumonia (PCP) in patients currently receiving such treatment Prior Medication Allowed Zidovudine (AZT) but only if patient has been taking the drug for > 6 weeks at a dose = or < 600 mg/day, and had < 10 percent decrease in hematocrit, neutrophils, and platelets in the last 30 days. Those off AZT must have been off it for > 1 month Patients must Have documented cytomegalovirus (CMV) viremia or viruria Have a diagnosis of HIV infection by ELISA or Western blot Be able to participate as an outpatient Co-existing Condition Patients with the following are excluded HIV wasting syndrome (involuntary weight loss > 10 percent of baseline body weight and/or chronic diarrhea or weakness and documented fever for at least 30 days) Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition Cytomegalovirus end organ disease Kaposi's sarcoma requiring chemotherapy Systemic fungal infection requiring amphotericin therapy Diagnosis of idiopathic thrombocytopenic purpura (persistent platelet counts < 100000 platelets/mm3 for = or > 3 months) Patients with the following are excluded", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All HIV Healthy Volunteers ALL Greater than or equal to 18 years old Ability to sign informed consent For women of child-bearing potential, negative result on a serum or urine pregnancy test within 1 week prior to the procedure Willingness to allow storage of blood or biopsy samples for possible future use to study HIV/AIDS, related diseases or the immune system; willingness to permit HLA testing FOR No medical contraindication to tonsillar, lymph node, or intestinal biopsy For tonsillar biopsy, presence of visible tonsillar tissue; for lymph node biopsy, palpable lymph nodes No aspirin or piroxicam (Feldene) for 10 days prior to the procedure; other non steroidal anti-inflammatory drugs (e.g. ibuprofen) must be discontinued the day prior to the procedure. Acetaminophen [Tylenol] is permitted at any time FOR FOR ALL Platelet count less than 75,000 platelets/mm(3) PT or PTT prolonged by greater than 2 seconds Known underlying bleeding disorder Pregnancy FOR HIV-POSITIVE OR ICL FOR LYMPH NODE Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy FOR ALL FOR Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy Significant heart valve abnormalities", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Atherosclerosis Chlamydia Infections Cytomegalovirus Infections Pneumonia, Bacterial Postmenopause Must be a postmenopausal woman 65 years of age or younger Time since last date of menses should be at least 12 months, with plasma estradiol less than 50 pg/ml and FSH greater than 50 pg/ml Women must be without clinical evidence of CAD as determined by history, cardiovascular physical examination, and EKG Must not have used hormone replacement therapy within past 6 months Must not have used dietary supplements and any medication (over-the-counter or prescribed) within 1 month. Acetaminophen use is allowed Must not have a history of alcoholism or binge-drinking Must not have diabetes mellitus or known abnormal glucose intolerance test Must not have a history of stroke, angina or myocardial infarction Must not have a history of deep venous thrombosis/pulmonary embolism Must not have a history of cancer (except for treated squamous cell and basal cell carcinomas) ", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.25-999.0, All Cytomegalovirus Infections Cytomegalovirus Retinitis HIV Infections Co-existing Condition Patients with the following are excluded Cytomegalovirus (CMV) disease who meet the for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency Hypersensitivity to acyclovir or ganciclovir Receiving antimetabolite treatment that cannot be discontinued Concurrent Medication Excluded", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-60.0, All HIV Infections Concurrent Medication Allowed All drugs used for the standard treatment of Pneumocystis carinii pneumonia (PCP) Other drugs for treatment of other AIDS conditions if they have been started more than 3 months prior to study entry Patients must have Diagnosis of AIDS Weight loss > 10 percent of premorbid body weight First or second episode of acute Pneumocystis carinii pneumonia (PCP) Co-existing Condition Patients with the following conditions or symptoms are excluded Do Not Resuscitate (DNR) status Biliary stasis Patients with the following are excluded Do Not Resuscitate (DNR) status Biliary stasis Prior Medication Excluded within 3 months of study entry Immunomodulators", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Cardiovascular Diseases Coronary Disease Cerebrovascular Accident Heart Diseases Myocardial Infarction Infection Chlamydia Infections Cytomegalovirus Infections Helicobacter Infections Atherosclerosis ", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 13.0-999.0, All Cytomegalovirus Infections Cytomegalovirus Retinitis Pneumonia, Pneumocystis Carinii HIV Infections Patients may be eligible if they Are HIV positive (except Group 3b) Are at least 13 years old (consent of parent or guardian required if under 18) Patients may be eligible for Group 1a if they Have acute PCP Have never received potent anti-HIV drugs or have not received potent anti-HIV drugs for at least 8 weeks prior to getting PCP Have a CD4 cell count below 200 cells/mm3 Patients may be eligible for Group 1b if they Have CMV disease Meet 1 of the following requirements: (1) have never received potent anti-HIV drug containing a protease inhibitor (PI) or a nonnucleoside reverse transcriptase inhibitor (NNRTI), (2) have not received potent anti-HIV drugs for at least 8 weeks before getting CMV disease, or (3) have been on stable anti-HIV therapy for at least 3 months with no new anti-HIV drugs started before CMV disease returned Patients will not be eligible if they Have received a vaccine within 14 days of study entry or plan to receive one during the study Have taken GM-CSF, any investigational drugs, or any drugs that might affect the immune system within 30 days of study entry or plan to take 1 of these medications during the study. (Prednisone for patients with PCP and G-CSF is allowed.) Abuse drugs", "label": "2"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Cytomegalovirus Infections Age 18-65 CMV seropositive Informed consent given CMV seronegative Abnormal blood counts (hemoglobin less than 12 g/dl, platelets less than 150,000/ul, absolute neutrophil count less than 1,500/ul, absolute lymphocyte count less than 1,000/ul) Known history of heart, lung, kidney, liver, or bleeding disorder Diagnosis of HIV infection Diagnosis or suspicion of immunodeficiency state History of intravenous drug use Currently pregnant", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Pneumonia All eligible patients undergoing diagnostic bronchoscopy who provide consent for proteomic analysis of BAL fluid supernatant and chart review of patient characteristics will be included in this study Patients undergoing bronchoscopy but not wanting to participate with either the chart review or the proteomic analysis of BAL fluid supernatant will be excluded", "label": "2"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All CMV Disease For Patient Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet Patients with HLA phenotype for which a relevant peptide for CMV exists For Donor Consenting sibling >18 years old HLA phenotype for which a relevant peptide for CMV exists For Patient Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes For Donor Consenting sibling >18 years old HLA phenotype for which a relevant peptide for CMV exists Donor with an infectious disease (e.g. HIV-1; HBV, etc.)", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All CMV Disease Viral Resistance Rejection Death Age greater than 18 years 2) WBC greater than 2000/mm3 with ANC greater than 500/mm3 3) Platelet count greater than 50,000/mm3 4) Hematocrit greater than 24 5) Life expectancy greater than 1 year as determined by investigator 6) Females must have a negative pregnancy test and any sexual partner must also agree to practice a barrier and/or hormonal method of birth control while participating in this study and for 90 days after. Females must agree to have a pregnancy test if a menstrual cycle is missed, and if positive, this must be reported Patients receiving systemic therapy for acute opportunistic infection at time of enrollment Patients receiving investigational drugs Patients with malignancies within the last 5 years with the exception of excised basal or squamous cell skin cancers Patients with active substance abuse or other condition that would impair compliance Patients who are unable to give informed consent Any patient with a creatinine clearance < 40 after delayed graft function and or post-transplant ATN has completely resolved, or the patient is deemed not to have the prospect of any further improvement of creatinine clearance (>40) as would occur with resolving ATN Persistent ANC < 1,000 for 2 consecutive weeks despite treatment with G-CSF Any female patient who plans to become pregnant within one year", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Cytomegalovirus Infections Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center An initial episode of CMV viremia At the time of randomization ANC greater than or equal to 1000 Age greater than or equal to 18 Adequate renal function with creatinine clearance greater than 10 ml/min Total bilirubin less than or equal to 3.0 Current GI graft versus host disease grade III-IV Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days Pregnant or nursing female patient Known hypersensitivity to ganciclovir", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Cytomegalovirus Infections Allogeneic stem cell transplant recipient Recipient or donor CMV seropositive Have transplant engraftment Able to swallow tablets CMV organ disease HIV infection Use of other anti-CMV therapy post-transplant", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 50.0-80.0, All Influenza No contraindications to vaccination as specified in the \"Green Book\" Immunisation Against Infectious Disease, HMSO Written informed consent obtained Subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrollment ", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 10.0-75.0, All Mycobacterium Infections, Atypical Granulomatous Disease, Chronic Job's Syndrome Influenza, Human FOR to 75 years of age Enrolled without regard to gender, race, or ethnicity NIH employees or non-employees eligible Able to provide proof of identity Able and willing to complete the informed consent process Able and willing to arrange to have another person drive them home after the procedure Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure Willing to donate blood and respiratory tract samples for storage to be used for future research In good general health without clinically significant medical history FOR AND Less than 18 or greater than 75 years old A smoking history of 10 pack-years or more, a current smoker, or tobacco free for less than a year Positive HIV status. Subjects must have a negative FDA-approved HIV blood test Acute or chronic hepatitis based on viral hepatitis serologies Pregnancy or breastfeeding Any active medical problems especially bleeding disorders, significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws, use of anticoagulants, or pulmonary disorders including asthma History of allergic reaction to lidocaine, sedative medications like Valium Trademark or Versed Trademark, or narcotic medications like morphine or fentanyl Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics is not excluded) Use of platelet inhibitors including aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days of procedure", "label": "2"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-12.0, All Ventilator Associated Pneumonia Children on mechanical ventilation for more than 72 hours and having simplified clinical pulmonary infection score more than 6 were included in study Age less than 1 month", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Cytomegalovirus Infections Orthotopic liver transplant recipient Donor CMV seropositive / Recipient CMV seronegative Enrolled within 10 days after liver transplant Able to swallow tablets Multiple organ transplant HIV infection CMV disease Use of other anti-CMV therapy at time of enrollment", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-1.0, All Infection Precancerous/Nonmalignant Condition Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs) CMV interstitial pneumonia based on the constellation of clinical and radiological findings Female Oxygen desaturation (pulse oximetry 85% on room air) Abnormal chest radiograph No CMV retinitis Prior ganciclovir and foscarnet sodium ", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Leishmaniasis DoD healthcare beneficiary of any age and gender Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection Able to provide informed consent or assent (children) All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period History of hypersensitivity to pentavalent antimonials Any of the following on screening examination QTc interval greater or equal to 0.5 sec Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias) History of recurrent pancreatitis Liver failure or active hepatitis with transaminases > 3x upper limit of normal Renal failure or creatinine > 2.5 mg/dL Thrombocytopenia (platelets <100,000/mm3) White blood cell count < 2000 / mm3", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Cytomegalovirus Infections Prior to receiving treatment, some patients may undergo diagnostic and/or other testing of their tissue, if available, to determine if their CMV infected cells are likely to respond to treatment with CMV specific T cells. Alternatively, blood samples may be required for research tests to ascertain that the CMV-specific T-cells do not contain any cells that could react against the patient. These patients will sign a separate pre-treatment consent. If it is determined that a patient will qualify for and might benefit from infusions of CMV CTLs, he/she will go on to sign the standard treatment consent for MSKCC IRB # 05-065 and be enrolled and treated on trial, if all other are met Each patient must satisfy at least one of the following The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis) or The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of CMV antigenemia or detection of levels of CMV DNA in blood or body fluids consistent with CMV infection The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV antigenemia or CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs The patient has developed CMV viremia as attested by viral culture, or detection of CMV antigenemia or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant. or the patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC < 1000 ul/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance < than or equal to 60ml/min/1.73m2 or creatinine >2 mg/dl]) Because CMV infections are life-threatening and may involve the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems, and antiviral drugs may also compromise renal and hematopoietic function, dysfunctions of these organs will not affect for this protocol However, to be eligible, the patients should meet the following clinical They must have a stable blood pressure and circulation, not requiring pressor support Patients requiring high doses of glucocorticosteroids (>0.5 mg/kg prednisone or its equivalent) as treatment for active (grade 2-4) acute graft vs. host disease (GVHD) or chronic GVHD Patients who are moribund Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T cell infusion Donor for Donation of Blood Lymphocytes for Generation of Donor-Derived CMV-Specific T cells Adequate health for donation as determined by institutional (related donor) or NMDP (unrelated donor) guidelines. Normal donors will be evaluated for evidence of prior sensitization to CMV by CMV serology. They will also be typed for HLA A, B, C and DR. For allogeneic hematopoietic progenitor cell transplant (HSCT) recipients, the marrow transplant donor will constitute the donor of choice, since those T-cells will grow and persist in a patient who has already engrafted with a transplant from that donor. However, if the HSCT donor is CMV seronegative or not available (e.g. a cord blood transplant or an unrelated donor who has not already donated T-cells for adoptive therapy), CMV-specific T-cells generated from a seropositive donor matched for at least 2 HLA alleles shared by the patient may be used Normal donors fulfilling these who consent to donate blood for the generation of CMV-specific T-cells for adoptive therapeutic purposes will receive a detailed clinical evaluation, including a medical history, physical examination, and serologic testing for transmissible diseases within 1 week of donation including hepBs Ag and hepatitis C antibody, HIV-1 and 2, HTLV-1 and 2, CMV (only if previously negative), VDRL, WNV, and Chagas An HIV+ donor will be rejected on medical grounds. Donors must have Hgb value > 10 gm/dl and must be capable of undergoing a single 3-6 unit leukapheresis (preferable) or a single unit of blood for T cells (for pediatric donors, no more than 5 ml/kg at any one blood draw) A prospective donor will be informed of the purposes of this study, and its requirements. If he/she consents, the donor will be requested to provide two blood samples i. An initial donation of 25ml blood anticoagulated with heparin or ACD. This blood is used to establish a B cell line transformed with the B95.8 laboratory strain of EBV. This EBV+ B cell line/ (EBVBLCL) will be used as an antigen-presenting cell. When loaded with the pool of CMVpp65 pentadecapeptides, the efficiently sensitize T cells from the same donors against CMV as well as EBV Because the establishment and testing of an EBV transformed B cell line suitable for use or as an antigen-presenting cell require 4-5 weeks of in vitro culture, it is important that this sample be obtained as early as possible for patients at risk for a CMV infection. Because patients receiving HSCT from unrelated or HLA disparate donors are particularly at risk for severe CMV infections in the first 2-3 months after transplant, this blood sample should be obtained from the donor prior to donation of the hematopoietic progenitor cell transplant whenever possible", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Cytomegalovirus Infection Age more than 18-year-old Informed consent minors pregnant or lactating women adults under guardianship immunosuppression at the entrance to resuscitation AIDS", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 40.0-999.0, All Chronic Obstructive Pulmonary Disease Men or women 40 years or above FEV1 between 40 and 80% of predicted normal value post-bronchodilator Clinical diagnosis of COPD Other clinically relevant disease or disorders Exacerbation of COPD within 30 days", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Cytomegalovirus Infection Male or female patients who fulfill the following are eligible for inclusion CMV D+/R liver, kidney, heart, pancreas, lungor combined transplant recipients All eligible patients must be scheduled to receive 3 months of either valganciclovir, oral ganciclovir, or intravenous ganciclovir prophylaxis Able to give written informed consent Are willing and able to comply with the protocol Age >=18 years Patient unwilling or unable to give informed consent", "label": "2"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-18.0, All Asthma years of age or younger Scheduled for bronchoscopy at National Jewish Health for persistent asthma, persistent, poorly controlled wheezing, chronic cough, GERD, atelectasis, bronchopulmonary dysplasia, infection Consent and assent from parent and patient [if appropriate] Unwillingness to consent/assent to retrieval of BAL fluid for research analysis", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-0.014, All Cytomegalovirus Disease All LBWIs whose weight is \u2264 1500 grams at birth LBWI is within first five days of life LBWI not expected to live past first seven days of life LBWI has a severe congenital abnormality LBWI has received a RBC or platelet transfusion at another institution prior to transfer LBWI has received an in-utero transfusion LBWI is clinically suspected of having toxoplasmosis, rubella, herpes infection(s) at birth Refusal by the mother to grant consent for herself and/or refusal to grant consent for her LBWI If the mother of the child has previously participated in this study", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-12.0, All Post Bronchoscopy Fever under twelve years of age all patients undergoing bronchoscopy and bronchoalveolar lavage children with immune deficiency allergy to previous exacerbation of asthma due to fever on the day of the examination current antibiotic treatment", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-80.0, All Chronic Beryllium Disease Diagnosis of chronic beryllium disease based on the below History of beryllium exposure, and Positive blood and/or bronchoalveolar lavage Beryllium Lymphocyte Proliferation Tests (BeLPT), and Biopsy-proven pathologic changes consistent with CBD-non-caseating granulomas and/or mononuclear cell interstitial infiltrates, and Positive bronchoalveolar lavage (BAL) BeLPT and > 15% lymphocytes in BAL fluid History of Hepatic disease History of Renal disease Hypersensitivity to Pentasa (5-ASA) or salicylates Pregnancy Presence of another disease that may be expected to significantly affect patient mortality (e.g., HIV), severe cor pulmonale) The use of blood thinners Current use of tobacco (smoking or otherwise) in the past 6 months Patient inability to participate in the study, such as inability to undergo venipuncture and BAL procedures (if undergoing bronchoscopy) that form part of the inclusion/ or part of the outcome measure If undergoing bronchoscopy", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Invasive Aspergillosis BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason Patients without fulfilling criteria Patients with some contraindication to perform a bronchoscopy", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 16.0-999.0, All Cytomegalovirus Infection Age 16 years or older cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor Patient Informed consent Prepared to undergo additional study procedures as per study schedule Patient has undergone counselling about risk Donor engraftment (neutrophils > 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion) Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion) The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure Donor must have met requirements of EU Tissue and Cells Directive(2004/23/EC) as amended and the UK statutory instruments pursuant therein Healthy, Cytomegalovirus (CMV)seropositive donor Pregnant or lactating women Co-existing medical problems that would place the patient at significant risk of death due to Graft versus Host Disease (GVHD) or its sequelae Human immunodeficiency virus infection Active acute Graft versus Host Disease (GVHD) > Grade I (to be assessed prior to CMV-specific T cell infusion ) Concurrent use of systemic corticosteroids(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion ) Organ dysfunction (to be assessed prior to cytomegalovirus-specific T cell infusion ) as measured by creatinine > 200 uM/l bilirubin > 50 uM/l alanine transferase > 3x upper limit of normal Donor pregnant or lactating", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Infections, Cytomegalovirus Subjects who the investigator believes that they can and will comply with the requirements of the protocol A pregnant female, 18 years of age or older at the time of study enrolment Women with confirmed primary CMV infection Written informed consent obtained from the subject Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product Previous vaccination against CMV infection Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination Major congenital defects, serious chronic illness or organ transplantation Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy Documented Human immunodeficiency virus (HIV)-positive subject Gestational age of more than 34 weeks, as determined by foetal ultrasound", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-60.0, All Mycoplasma Pneumonia Confirmed community acquired pneumonia 60ys\u2265age\u226518 ys Respiratory symptom (cough accompanied by little or no sputum) New infiltration showed by chest radiology(x-ray or CT) Lung signs was not obvious White blood cell<10,000/mm3 Without underlying diseases or mild Age<18ys or >60ys Pregnancy or breast-feeding Over one week after the onset of symptoms HIV infection Recent 90-day hospitalized history(length of stay greater than 2 days) Live in nursing homes or rehabilitation hospitals Taken macrolides or quinolones medicines before enrollment", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.5-6.0, All Infections, Respiratory Tract Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol A male or female child between, and including, six to 72 months of age at the time of enrolment Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject No antibiotic therapy within four weeks prior to the visit No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome No documented evidence or suspicion of gastroesophageal reflux disease No evidence of an upper viral respiratory infection four weeks prior to the visit In addition, all subjects regarded as 'cases' must satisfy all the following at study entry Persistent cough greater than eight weeks No response to five-day prednisolone treatment Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Child in care", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Drug Safety Patient age \u2265 18-year who received ventilator and agreed to participate by signing informed consent form Immunocompromised host (e.g. HIV infection, On immunosupressive agents, ANC \u2264 500 cell/ml), Pregnancy, History of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, Contraindication for enteral feeding, History of milk or milk-product allergy", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Congenital Cytomegalovirus Infection Maternal Cytomegalovirus Infection Diagnosis of primary maternal CMV infection on the basis of one of the following A positive CMV Immunoglobulin M (IgM) antibody and low-avidity maternal CMV Immunoglobulin G (IgG) antibody screen Evidence of maternal seroconversion with development of CMV IgG antibody following a prior negative CMV screen Gestational age at randomization no later than 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound; or no later than 27 weeks 6 days for women with a positive IgM, negative IgG initially screened before 23 weeks who are rescreened after 2-4 weeks and have evidence of IgG seroconversion Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 14 weeks by project gestational age is acceptable Maternal CMV infection pre-dating pregnancy as defined by a high IgG avidity index or a positive IgG in the presence of a negative IgM Known hypersensitivity to plasma or plasma derived products Planned termination of pregnancy Known major fetal anomalies or demise Maternal Immunoglobulin A (IgA) deficiency Planned use of immune globulin, ganciclovir, or valganciclovir Maternal renal disease (most recent pre-randomization serum creatinine \u2265 1.4 mg/dL; all women must have serum creatinine measured during the pregnancy and prior to randomization) Maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications) Findings on pre-randomization ultrasound suggestive of established fetal CMV infection (cerebral ventriculomegaly, microcephaly, cerebral or intra-abdominal calcifications, abnormalities of amniotic fluid volume, echogenic bowel or ascites). Abnormally low amniotic fluid volume is defined as no fluid prior to 14 weeks or maximum vertical pocket < 2 cm on or after 14 weeks gestation. Abnormally high amniotic fluid volume is defined as > 10 cm Positive fetal CMV findings from culture (amniotic fluid) or PCR", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Patients Scheduled for Bronchoscopy Patients undergoing Fiberoptic Bronchoscopy for any indication and signing an informed consent form Hypoxemia < 90% at Room air", "label": "2"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-55.0, All Respiratory Disorders Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests nd cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The investigator may discuss with GSK medical monitor as required Male or female between 18 and 55 years of age inclusive: A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the last follow-up visit Normal creatinine clearance values at screening (calculated from serum creatinine by a predicting equation using Cockcroft-Gault formula), normal serum creatinine value as defined by the local reference laboratory, normal urine microscopy and no significant proteinuria on dipstick testing Body weight greater than and equal to 50 kg and BMI within the range 19 9 kg/m2 (inclusive) No evidence of previous or active TB infection and a negative QuantiFERON TB Gold test taken within 7 days of dosing, and negative medical history with respect to active or latent mycobacterium tuberculosis complex infection Normal spirometry (FEV1 greater than and equal to 85% of predicted, FEV1/FVC ratio greater than and equal to 70%) at screening. Predictions should be according to ECCS equations, and race corrections should be made for non-caucasians Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Available to complete all study assessments Subjects who are able to use the inhaler device correctly A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones) A positive pre-study drug/alcohol screen History of and/or a positive test for toxoplasmosis consistent with active toxoplasmosis infection at the time of enrollment A positive RT-PCR test for influenza A/B Current evidence or history of an influenza-like illness as defined by fever (greater than 380C) and two or more of the following symptoms within the last 7 days: cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhoea in the absence of a known cause, other than influenza Corrected QT interval (QTc) >450msec History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits Subjects with a smoking history of greater than 5 cigarettes per day in the last 3 months (Part 1); smokers are not eligible to take part in Part 2", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Cytomegalovirus Each patient must satisfy at least one of the following The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of levels of CMV DNA in the blood or body fluids consistent with CMV infection Patient must also satisfy at least one of the following The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant Or c. The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000\u03bcl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance \u2264 60 ml/min/1.73 m2 or serum creatinine > 2 mg/dl]) Patient has CMV specific T-cells from the donor of his/her HSCT available. CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect for this protocol Patients must meet the following clinical to receive CMVpp65-CTL infusions Stable blood pressure and circulation, not requiring pressor support Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography A life expectancy of at least 3 weeks, even if requiring artificial ventilation Patients requiring high doses of glucocorticosteroids (\u2265 0.3 mg/kg prednisone or its equivalent) 2. Patients who are moribund 3. Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion 4. Patients who are pregnant 6.1.3 Donor 6.1.3a Donors in Group 1 (Historical Donors) Donors in Group 1 (Section 5.1) would have already been determined to be eligible and will have donated blood or leukocytes to establish CMV-specific T-cells under IRB # 05-065, 07-055, 95-024, or 11-130. There are no additional requirements for these donors 1.3b Donors in Groups 2 & 3 (Prospective and Volunteer Donors) Transplant donors and healthy HLA typed volunteers who agree to provide T-cells for Third-party donation (section 5.1, Groups 2 and 3) will need to meet the following requirements prior to donation Donors must satisfy the specified in FDA 21 CFR 1271 Donors must be typed for HLA-A, B, C and DR Donors must have a hemoglobin value > 10g/dl Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood 1.4 Donor HTLV/HIV(+) or Hepatitis B or C antigen(+) donors", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 13.0-49.0, All Influenza, Human HIV Malaria Tetanus Polio Resident of HDSS village Singleton pregnancy Second or third trimester (after quickening) but before 33 weeks of gestation by fundal height Does not plan to relocate out of the HDSS area or population-based surveillance site in the next 12 months and agrees to all follow-up visits/contact by phone Is not currently enrolled in another intervention study Provides informed consent by signature or thumb print Consents to HIV testing and counseling as required Willing to deliver in the labor ward of the study hospital No history of chronic illness requiring multiple hospitalizations or prolonged medical therapy (except HIV on ART) History of allergic reaction to any component of the study vaccines Residence outside the study area or planning to relocate out in the 9 months following enrollment Received immunoglobulin or blood products within 45 days of study entry Used immunosuppressive medication within 45 days of study entry (inhaled and topical corticosteroids permitted) High risk pregnancy including any pre-existing condition likely to cause complications of pregnancy (hypertension, diabetes, current asthma, eclampsia or pre-eclampsia, epilepsy, heart disease, renal disease, liver disease, fistula repair, leg or spine deformity) Unable to give informed consent (for example due to mental disability) Previous enrollment in a study with similar interventions Gestational age >32 weeks by last menstrual period or fundal height Acutely ill with temperature \u226537.5\u00b0C on the day of randomization/vaccination Hemoglobin <7.0 g/dL", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Aplastic Anemia Main diagnosis: aplastic anemia Absence of severe and/or uncontrolled comorbidities Confirmed iron overload (serum ferritin \u2265 1000 mkg/L) Serum creatinine is not higher than the upper limit of normal for the given age Absence of severe proteinuria. Protein/Creatinine ratio should be < 0.5 mg/mg Liver enzymes are < 5 ULN Completion of a scheduled cycle of immunosuppressive treatment program, with no severe infectious or generalized hemorrhagic complications WHO (ECOG) performance status \u2264 2 No signed informed consent form Patient is under 18 years old Severe concomitant condition Severe infectious and generalized haemorrhagic complication following regular planned cycle of programmed immune suppressive treatment History of increased sensitivity to active substance and any other ingredient of the medicinal product Creatinine clearance (CC) < 60 ml/min and/or creatinine concentration in blood serum is 2 or more times higher than upper limit of age normal by results of 2 tests at Visits 1 and 2 Severe liver disorders (class C by Child-Pugh scale) Patients with aplastic anaemia in which chelator treatment will be ineffective due to rapid progression of the disease Significant proteinuria basing on protein creatinine ratio > 1.0 mg/ml in urine sample from second urination at Visits 1 and 2 (or as an alternative in 2 of 3 urine samples at screening) Rare hereditary disorders related to galactose intolerance, severe deficit of lactase or glucose-galactose malabsorption", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Infection in Solid Organ Transplant Recipients Informed consent Male/female patients at least 18 years old who will be followed at our outpatient clinic for at least one year Recipients of first or repeat kidney transplants from living or deceased donors Recipients of any combined transplant (kidney/pancreas, kidney liver) Unlikely to comply with the requirements of the study", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-80.0, All Postoperative Complications Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded Lost to follow up", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 20.0-999.0, All Allogeneic Hematopoietic Cell Transplant Subject is planned to undergo either of the following Sibling Donor Transplant 8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DR\u00df1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DR\u00df1 match utilizing low or high resolution typing Unrelated Donor Transplant 8 or 8/8 HLA-A, -B, -C, -DR\u00df1 match utilizing high resolution typing Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS) Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3 Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA) Subject has received any of the following substances or treatments T-cell depletion of donor cell product Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial Administration of a CMV vaccine, including any prior exposure to ASP0113 Subject has received an allogeneic stem cell transplant within one year prior to transplant Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All EBV Infection CMV Infection Adenoviral Infection Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or single or double umbilical cord blood CMV, adenovirus or EBV infection persistent despite standard therapy For CMV infection Patients with CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates OR Failure of antiviral therapy: defined as the continued presence of pp65 antigenemia (>1+ cell/100,000 cells) or DNAemia (as defined by reference lab performing PCR assay but usually >400 copies/ml) after at least 7 days of antiviral therapy OR Relapse after antiviral therapy defined as recurrence of either pp65 antigenemia or DNAemia after at least 2 weeks of antiviral therapy For CMV infection, standard therapy is defined as 7 days therapy with Ganciclovir, Foscarnet or Cidofovir for patients with disease or recurrence after 14 days therapy For EBV infection EBV infection is defined as Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR OR Received ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment Uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection Received donor lymphocyte infusion (DLI) within 28 days Active acute GVHD grades II-IV Active and uncontrolled relapse of malignancy Pregnant or lactating in female patients, if applicable (childbearing potential who have received a reduced intensity conditioning regimen)", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 16.0-90.0, All Kidney Transplantation Recipients age 16 or more agree with written informed consent donor CMV IgG (+) and recipient CMV IgG (-)", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 16.0-99.0, All Bone Marrow Transplantation age 16 or more agree with written informed consent ", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Cytomegalovirus Kidney Transplantation CMV Specific Immune Response Patient receiving a kidney graft Recipient being CMV-seropositive prior transplantation and receiving a graft from either a CMV-seropositive or from a seronegative donor (intermediate risk groups, D+/R+; D-/R+,) Patient scheduled to follow the preemptive antiviral strategy with oral valganciclovir or intravenous ganciclovir after transplantation Patient receiving the standard triple immunosuppressive regimen (CNI, MMF/MPA or mTOR inhibitors, steroids), with or without induction therapy (except ATG) as start therapy after transplantation Male or female patient at least 18 years of age Written informed consent Patient is scheduled for the optional visit 1, but requires ongoing treatment with a systemic immunosuppressive drug already prior to kidney transplantation (except induction therapy other than ATG) Patient receiving ATG as induction therapy Patient is known to be positive for HIV or suffering from chronic hepatitis infections Patient has significant uncontrolled concomitant infections or other unstable medical conditions before transplantation that could interfere with the study objectives Patient is unable to comply with the visit schedule in the protocol Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All CMV Infection Persistent CMV Viremia Each patient must satisfy at least one of the following The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of levels of CMV DNA in the blood or body fluids consistent with CMV infection Patient must also satisfy at least one of the following The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant Or c. The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000\u03bcl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance \u2264 60 ml/min/1.73 m2 or serum creatinine > 2 mg/dl]) CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect for this protocol Patients must meet the following clinical to receive CMVpp65-CTL infusions Stable blood pressure and circulation, not requiring pressor support Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography Patients requiring high doses of glucocorticosteroids (\u2265 0.3 mg/kg prednisone or its equivalent) Patients who are moribund Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion Patients who are pregnant Donors in Group 1 (Historical Donors) Donors in Group 1 would have already been determined to be eligible and will have donated blood or leukocytes to establish CMV-specific T-cells under IRB # 05-065, 07-055, 95-024, or 11-130. There are no additional requirements for these donors Donor (Prospective Donors) Transplant donors and healthy HLA typed volunteers who give written consent to provide Tcells for Third-party donation (section 5.1, Groups 2 and 3), will need to meet the following requirements prior to donation Donors must satisfy the specified in FDA 21 CFR 1271 Donors must be typed for HLA-A, B, C and DR at high resolution Donors must have a hemoglobin value > 10g/dl Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Viral Pneumonia mechanical ventilation > 96 hrs and expected duration of mechanical ventilation of at least 2 days positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR age > 18 years informed consent negative pregnancy test < 18 years Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV Had received antiviral agent active against HSV/CMV during the previous month Hypersensitivity to aciclovir/ganciclovir Pregnancy Breast feeding Bone marrow failure Solid organ recipients Bone marrow recipients HIV positive patients", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-80.0, All HIV COPD Pulmonary Disease Aging Pregnancy or breast-feeding Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.) Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry Hospitalization within 4 weeks prior to study entry Uncontrolled hypertension at screening visit (systolic > 160 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled Active cancer requiring systemic chemotherapy or radiation Active infection of lungs, brain, or abdomen Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator HIV+ young HIV-1 infection, documented in medical record at any time prior to study entry Men and women age 45 years and below Ability and willingness to complete all tests Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community HIV+ old HIV-1 infection, documented in medical record at any time prior to study entry Men and women age 50 years and above Ability and willingness to complete all tests Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Cytomegalovirus Infection GVHD Patients receiving an allogeneic hematopoietic stem cell transplantation being either CMV seropositive or receiving a graft from a CMV seropositive donor or both, donor and recipient are CMV seropositive (D+/R-, D-/R+, D+/R+) Patients receiving a first allogeneic hematopoietic stem cell graft Patient at least 18 years of age Written informed consent Seronegativity for CMV both for patient and donor (D-/R-) Patients receiving standard anti-CMV prophylaxis Patients receiving a haploidentical allogeneic hematopoietic stem cell graft Patients receiving an umbilical cord blood graft Patients treated with Alemtuzumab (e.g. Campath) Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator Lack or withdrawal of informed consent Patient is unable to comply with the visit schedule in the protocol", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Transplantation Infection Cytomegalovirus Infection Age \u2265 18 years End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug Total ischemia time below 36 hours Capable of understanding the purpose and risks of the study Fully informed and having given written informed consent (signed Informed Consent has been obtained) Affiliation to the social security regimen CMV seronegative patient Historical or current TGI (French equivalence of calculated PRA) > 85 % Presence of historical or current anti-HLA donor specific antibodies Patient who received anti-CMV therapy within the past 30 days prior to screening Receiving or having previously received an organ transplant other than a kidney Receiving a graft from a non-heart-beating donor Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV; HBs Ag positive) or Hepatitis C (HCV; anti-HCV Ab positive).elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels \u2265 2 times the upper value of the normal range of the investigational site or receiving a graft from a hepatitis C or B positive donor Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients Severe hyperlipidemia defined by: total cholest\u00e9rol \u2265 9,1 mmol/L (\u2265 350 mg/dL) et/ou triglyc\u00e9rides \u2265 8,5 mmol/l (\u2265 750 mg/dL) in spite an adequate medication", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Cytomegalovirus Viraemia Adult solid organ transplant (SOT) recipient on at least one immunosuppressive medication Starting therapy for new onset asymptomatic CMV viremia OR starting therapy for new onset CMV disease CMV viral load \u2265 1000 IU/mL Known ganciclovir-resistant CMV Known intolerance to valganciclovir or ganciclovir Unable to comply with protocol", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 2.0-59.0, All Dengue Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age Agree with periodic contacts, either/or by phone, electronic means, and home visits Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history History of severe allergic reactions or anaphylaxis to the vaccine or to components of the vaccine in study History of asplenia Use of any investigational product within 28 days before or after receiving this study vaccination Has participated in another clinical trial six months prior to in the study or planning to participate in another clinical trial within 2 years following inclusion Use of immunosupressant drugs such as: antineoplastic chemotherapy, radiation therapy, imunossupressants to induce tolerance to transplants, and corticosteroids use (except topical or nasal). For this protocol will be considered for use of corticosteroids 3 months prior to the in the study and 6 months prior to the for the other therapies mentioned, and planned use of any immunesupressant therapy within 2 years following in the study. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose \u226520 mg of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for children for over 7 days", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 2.0-25.0, All Quadrivalent Live Attenuated Influenza Vaccine Age 2-25 Only supposed to get one dose of vaccine for upcoming influenza season No viral respiratory symptoms at time of immunization HIV-infected group: must have HIV-infection documented by 2 tests such as positive serology, positive HIV DNA or positive HIV RNA; must thave a CD4>25% or 500 OR must have CD4>15% or 200 and be on HAART Healthy controls:no major medical problems affecting the immune system Recruited among HIV-unifected clients of the Children's Immunodeficiency Program(CHIP), Children's Hospital Colorado Child Health Clinic and Adolescent Clinics History of reactive airway disease, recurrent wheezing, or asthma Active wheezing at time of immunization On any antiviral agents active against influenza (amantadien/rimantadine, zanamavir, oseltamivir)at time of immunization or planned over 21 days of shedding collection Receipt of IVIG within 3 months prior to enrollment Plan to receive IVIG during the 4 weeks after immunization Moderate to severely immunocompromised individual living in the home Pregnant Breastfeeding Plan to start immunosupressive medications or stop HAART over the 4 weeks following immmunization Temperature > 100F or 37.8C", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 20.0-70.0, All CYCLOSPORINE/TACROLIMUS Patients who received a kidney transplant at least 12 months ago prior to enrollment Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial Patients who are considered clinically stable by observer's judgment Patients must understand the purpose and risk of participating the the trial and signed on the written consent Patients who have previously received an organ transplant other than a kidney Patients diagnosed with congestive heart failure within 6 months (EF <35%) Patients with untreated ischemic heart disease Patients whose hemoglobin is in the level of <7.0 g/dL Patients who have a known hypersensitivity to tacrolimus Patients taking potassium sparing diuretics Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer Patients who are pregnant or lactating", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-80.0, All Bronchiectasis Age\u226518 years and \u226480 years Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT Are sensitive to amikacin Acute exacerbation of bronchiectasis Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc Willing to join in and sign the informed consent form Active bleeding without control\uff1b Receiving nasal or facial surgery recently\uff1b With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc Be allergic to amikacin", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Cardiac Surgery Patients admitted for cardiac surgery Age 18 and above Immunosuppressed patients including: HIV, active cancer, biological chemotherapy, steroid use equivalent to prednisone dosage above 1 mg/Kg a day, post organ transplantation", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 0.0-999.0, All Viral Infection Viral Reactivation Infection in an Immunocompromised Host Immunocompromised patient with evidence of viral infection or reactivation Age >1 day Recipients who have had a stem cell transplant must be greater than 28 days after stem cell infusion Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent Must be able to receive CTL infusion at CCHMC Informed consent obtained by PI or sub-investigator at CCHMC Active acute GVHD grades II-IV Uncontrolled bacterial or fungal infection Uncontrolled relapse of malignancy Infusion of ATG or alemtuzumab within 2 weeks of CTL infusion", "label": "1"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 51.0-76.0, All HRV and RSV Presence in the Lungs of Stable COPD Patients. stable COPD,indication for bronchoscopic procedure atopic history, asthma, extensive pleural effusions, bronchiectasis, immunosuppression due to chemotherapy or systemic corticosteroids and all the contraindications of the bronchoscopic procedures", "label": "0"} +{"topic": "A 62 yo male presents with four days of non-productive cough and one day of fever. He is on immunosuppressive medications, including prednisone. He is admitted to the hospital, and his work-up includes bronchoscopy with bronchoalveolar lavage (BAL). BAL fluid examination reveals owl's eye inclusion bodies in the nuclei of infection cells.", "doc": "eligible ages (years): 18.0-999.0, All Renal Failure Chronic Requiring Dialysis Patient being hemodialysis-dependent due to end-stage kidney disease Male or female patient at least 18 years of age Written informed consent Patient requires ongoing dosing with a systemic immunosuppressive drug Patient has received immunosuppressive therapy within the last three month Patient is known to be positive for HIV or suffering from chronic hepatitis infections Patient has significant uncontrolled concomitant infections or other unstable medical conditions that could interfere with the study objectives Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-999.0, All Cancer The patient must be at least 18 years of age (because of the nature of \"Dignity Psychotherapy,\" which presumes a relatively advanced level of social and psychological development) Have a terminal illness (Stage IV with a prognosis of less than 6 months, but expected to live at least 7 to 10 days, i.e. the average length of the protocol) Must be able to identify a family member/significant other who agrees to participate in the study (in the case of \"Dignity Psychotherapy,\" this family member/significant other will receive the generativity document) Be able to communicate with an English-speaking therapist (patients who are visually impaired will be offered assistance with the consent forms and surveys) In the investigator's judgement, participant is cognitively able to provide valid, informed consent Significant psychiatric disturbance sufficient to preclude participation in a psychotherapeutic intervention (e.g. acute, severe psychiatric symptoms which would require individual treatment and medication management rather than a psychotherapy intervention) Active psychotic mental disorder (e.g. schizophrenia, acute mania), or marked paranoid ideation. Patients who are on stable regimens of psychotropic medications (e.g. antidepressants for clinical depression) or who are in concurrent individual or group psychotherapy will not be excluded. This information regarding concurrent psychiatric treatment will be collected and utilized as a co-variate in data analysis Presence of a cognitive disturbance (i.e. delirium or dementia) sufficient to preclude participation in psychotherapy, and/or data collection Physical limitations or illness severity sufficient to preclude participation in psychotherapy", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 12.0-65.0, All Generalized Convulsive Epilepsy Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic clonic seizures on awakening must be included Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit 1 Male/female children \u2265 12 years of age or adult \u2264 65 years of age at Visit 1 Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1 Previous exposure to levetiracetam History of partial seizures History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit 1 Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet Subject taking any drug (except the concomitant AEDs) with possible CNS effects", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Cognitive Impairment Delirium years of age or older Hospitalized in a medical ward Able to speak English Cognitive impairment based on screening at time of hospital admission Previously enrolled in the study during prior hospitalization (for multiple admissions; only data from the first admission will be used) Enrolled in another clinical trial Does not have cognitive impairment based on screening at time of hospital admission", "label": "2"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-999.0, All Creutzfeldt-Jakob Disease Diagnosis of probable or definite sCJD: Definite--biopsy confirmed sCJD; Probable--a progressive dementia with either a typical EEG or a typical MRI consistent with sCJD, and at least two of the following clinical features: myoclonus, pyramidal or extrapyramidal signs, visual symptoms, cerebellar signs, akinetic mutism, other focal higher cortical neurologic signs (e.g. neglect, apraxia, aphasia) years of age or older Able to swallow Able to follow simple one-step commands Have had a brain MRI within 6 months and an EEG within 3 months ruling out other etiologies such as masses, strokes, or non-convulsive status epilepticus Consent to autopsy in the event of their death during or after the study History of other significant or life-threatening disease, including: cancer; end-stage liver or renal disease; severe heart disease History of other disease requiring regular supportive care Liver disease Active alcoholism Bone marrow suppression Severe hypotension Severe psoriasis Poorly controlled diabetes Women who are pregnant or breast-feeding Men, or women of childbearing age, not practicing reliable contraception", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Alzheimer's Disease Dementia Alzheimers Disease Inability to understand English No telephone", "label": "2"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 1.0-18.0, All Congenital Disorders Any patient between 1 \u2013 18 years of age (inclusive) Any patient with end stage heart disease Treated at Egleston Hospital, Children's Healthcare of Atlanta Followed by Sibley Heart Center Cardiology Those who do not meet", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Depression Meets Diagnostic and Statistical Manual for Mental Disorders(DSM)IV for unipolar major depression Severity of depression greater than or equal to 17 on MADRS Disability as determined by at least 1 impairment in instrumental activities of daily living Evidence of executive dysfunction or impairment in at least one of the following cognitive domains of Dementia Rating Scale (DRS): attention, construction, conceptualization, and memory ([scaled score less than 7] adjusted for age and race based on Mayo's older participants normative data) Family member or caregiver able and willing to participate in treatment Not currently taking antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 8 weeks prior to study entry with no medical recommendation for change of these agents in the near future High suicide risk Axis I psychiatric disorder or substance abuse other than unipolar major depression or nonpsychotic depression Axis II diagnosis of antisocial personality Moderate to severe dementia: DRS total score corresponding to moderate or more severe impairment (scaled score less than or equal to 5) Acute or severe medical illness (e.g., delirium; metastatic cancer; decompensated cardiac; liver or kidney failure; major surgery; stroke; myocardial infarction during the 3 months prior to entry) Currently taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids) Currently receiving psychotherapy Aphasia Sensory problems Inability to speak English", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 40.0-83.0, All Alzheimer's Disease Memory Decline Alzheimer's disease other neurologic disease", "label": "2"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 50.0-85.0, All Alzheimer Disease Diagnosis of AD Age 50-85 MMSE 14-26 Other Apply Significant Neurological Disease Major Psychiatric Disorder Clinically Significant Systemic Illness Other Apply", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 30.0-80.0, All Frontotemporal Dementia Pick Complex Outpatients with a clinical diagnosis of Frontotemporal Dementia or Pick Complex (PC/FTD) documented for at least 1 year with either primary progressive aphasia or frontotemporal dementia recent MRI or CT confirming frontotemporal lobar atrophy consistent with Frontotemporal Dementia or Pick Complex PC/FTD opportunity to perform certain activities of daily living as described in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory living with or having regular visits (least 4 days/week) from a responsible caregiver Mini Mental State Examination score > 5 and the ability to complete baseline neuropsychometric testing able to see, hear, and communicate sufficiently, and willing to complete serial neuropsychometric tests female subjects of childbearing age must be surgically sterile or practicing an effective method of birth control before entry and throughout the study No neurodegenerative disorders and other causes of dementia or cognitive impairment from acute cerebral injuries, cerebrovascular disease or hypoxic cerebral damage, vitamin deficiency states, infection cerebral neoplasia no primary memory disturbance or an amnestic syndrome more compatible with Alzheimer's disease or other primary degenerative dementia no uncontrolled epilepsy or clinically significant psychiatric disease, cardiovascular disease, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, active peptic ulcer and urinary outflow obstruction no use of any agent used for the treatment of dementia or other cognitive impairment no history of severe drug allergy or hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Dementia 65 years of age or older Diagnosed with dementia by a physician Mini-Mental State Examination score of 23 points or less Capable of participating at least once a week for 6 weeks in succession Management of a medical risk required Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis Never having been on a bicycle, and incapable of pedaling well", "label": "2"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 0.0-999.0, All Dementia GP and practice or district nurse must participate as a duo ", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 60.0-999.0, All Dementia Behavioral Symptoms Mental Health All probable cases will be examined by a trained clinician (AD) to confirm the diagnosis of dementia according to DSM IV and graded using the Clinical Dementia Rating (CDR) Scale CDR mild and moderate dementia The principal caregiver, as identified by the family, was enrolled for the trial. The principal caregiver was generally the spouse, although in some instances another family member was the principal caregiver, particularly when the spouse was not in a position to care CDR severe dementia or severe co-morbid physical health conditions", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 50.0-999.0, All Alzheimer's Disease Patients in the mild to moderate stages of Alzheimer's Disease : MMSE score between 16 and 26 ; and stages 3 to 5 of the Global Deterioration Scale Patients over 50 years of age Patients with social security affiliation Patients suffering other type of dementia Institutionalized patients Patients with psychiatric disorder Patients with severe pathology in the terminal stages Patients receiving non pharmacological therapies other than that proposed in the study Enrollment in a pharmacological trial in the first 6 months", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Dementia Participated in the WHIMS study Non-English speaking Hearing Impaired", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 0.0-999.0, All Dementia Patients with memory or other cognitive impairments suggestive of dementia syndrome those with a formal diagnosis of dementia, of any type Patients and carers who are already involved in concurrent research If the key professional feels that an approach to the person with dementia or their carer would be inappropriate, for example the dementia is very severe, or that an approach may increase distress and any other important reason that the key professional may have for why the person with dementia or their carer should not be contacted", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 40.0-999.0, All Alzheimer's Disease Dementia AD group Male or female patient, aged \u2265 40 years old included at entry Patients having a clinical diagnosis of probable AD according to DSM-IV TR [F00.xx] and National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the AD diagnosis, and that the results are compatible with AD diagnosis Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD Patient compliant with study procedures Non AD demented group Male or female patient, aged \u2265 40 years old included at entry Patients having a clinical diagnosis of dementia which can be one of the following AD group Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of probable AD, or that may rend the initial diagnosis of probable AD doubtful at entry, according to the opinion of the investigator Current or recent history of drug or alcohol abuse or dependence Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting AD diagnostic and not affecting daily living activities Current diagnosis of brain tumour Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator Pregnancy Patient who is not registered at \"S\u00e9curit\u00e9 Sociale\" Current participation in another study using an investigational non-marketed product Non-AD demented group ", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 51.0-999.0, All Alzheimer Disease Subject has completed study 3133K1-3000 and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease Mini-Mental Status Examination (MMSE) >=10 at screening Caregiver able to attend all clinic visits with subject Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response Any significant brain MRI abnormality Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Dementia dementia diagnosis advanced cognitive impairment feeding problem age >= 65 surrogate decision maker feeding tube decision made hospice BMI > 26 major psychosis or developmental delay", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 52.0-87.0, All Alzheimer's Disease Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all and non of the Screening brain MRI scan is consistent with the diagnosis of AD MMSE score 10 and above Significant neurological diseases other than AD Brain MRI evidence of vasogenic edema during the preceding studies Clinically significant illness", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-999.0, All Advanced Cancer FOR Able to speak and understand English Over age 18 NEW diagnosis, recurrence, or progression of an advanced stage cancer within days of the date the patient was informed of the diagnosis by his/her oncology clinician Estimated survival of 2 years or less Diagnosed with an advanced stage cancer such as one of the following Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell Breast Cancer: Stage IV with poor prognostic indicators including but not limited to: a) >2 cytotoxic regimens for MBC; b) diagnosis of MBC less then or equal to 12 months since completion of adjuvant or neoadjuvant treatment; c) triple negative disease (ER/PR and Her 2-);d) parenchymal brain mets and/or carcinomatous meningitis Gastrointestinal (GI) Cancers: Unresectable stage III or IV Dementia or significant confusion (Impaired cognitive status as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool 18) Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder) Patients will not be excluded if they do not identify a caregiver Prior involvement with palliative care service within the last year Minimum predicted survival of less than 12 weeks (3 months) Receiving chronic steroid hormones or unable to schedule specimen collection distant from chemotherapy from steroid pre-medications Unable to come to Norris Cotton Cancer Center (NCCC) for specimen collection times Unwilling to participate in study", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Gait Apraxia Alzheimer Disease Impaired Cognition Diagnosis of Alzheimer's disease (AD) (DSM-IV/NINCDS-ADRDA criteria) Age \u2265 65 years old Mild AD (Mini-Mental State Examination score between 21 and 25), moderate AD (Mini-Mental State Examination score between 10 and 20) and severe AD (Mini-Mental State Examination score between 3 and 9) Able to walk without any aid on 15 meters Near visual acuity \u2265 2 Absence of severe depression (score of the 15-item Geriatric Depression Scale \u2264 10) Written consent form to participate in the study (or trustworthy person or legal representative for severe AD) Being affiliated to a social security regime Musculoskeletal disorders not related to Alzheimer's disease Near visual acuity < 2 History of cerebrovascular accident or other cerebro-spinal pathology Poor workmanship of the written or oral French language Refusal to be informed on possible hanging bare anomaly during study Score of Mini-Mental State Examination < 3 Presence of severe depression (score of the 15-item Geriatric Depression scale > 10) Use of walking aid Subject suffering from pre-existing impellent disturbances Refusal to participate (or trustworthy person or legal representative)", "label": "2"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 60.0-999.0, All Alzheimer's Disease Clinical diagnosis of Alzheimer's Disease MMSE score of 14-26 Visual impairment Auditory impairment Psychiatric disorders", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 70.0-75.0, All Dementia Alzheimer Disease Vascular Dementia to be resident in Abbiategrasso to be born between 1935 and 1939 to refuse to participate te be not contactable in any way (mail, telephone) to be legally resident, but actually living somewhere else", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Depression Dementia Geriatrics Age: >64 (65 years and older) Diagnosis: Major depression, unipolar as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID), using Diagnostic and Statistical Manual for Mental Disorders (DSM)IV criteria Severity of depression: Montgomery Asberg Depression Rating Scale (MADRS) >=18 Disability, i.e. impairment in at least 1 Instrumental Activity of Daily Living as measured by Philadelphia Multilevel Assessment Instrument Instrumental Activities of Daily Living subscale (MAI-IADL) Evidence of at least mild cognitive impairment but not severe impairment (Dementia Rating Scale (DRS) total score between 90 and 133 inclusive) Caregiver (family member or professional) able and willing to participate in treatment Off antidepressants, cholinesterase inhibitors, or memantine or on a stable dosage for 12 weeks and no medical recommendation for change of these agents in the near future Command of English sufficient to participate in therapy and research assessments High suicide risk, i.e. intent or plan to attempt suicide in near future Axis I psychiatric disorder or substance abuse other than unipolar major depression, non-psychotic depression Axis II diagnosis of antisocial personality as determined by the SCID personality disorder section (using DSM-IV criteria) Moderate to Severe Dementia: We will participants with DRS Total Score corresponding to moderate or more severe dementia (DRS Total <=90) Acute or severe medical illness (i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry); drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids); or chronic addictive drug use Current involvement in psychotherapy Aphasia", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-999.0, All Dementia for Veterans with dementia English speaking diagnosed with dementia as above able to participate in at least two activities of daily living ADLs bathing dressing grooming toileting transferring from bed to chair Non English speaking Non-Veteran No caregiver No diagnosis of dementia", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 0.0-999.0, All Mild Cognitive Impairment Clinical diagnosis of Mild Cognitive Impairment Clinical diagnosis of dementia History of neurological conditions known to impair cognition History of alcohol or drug abuse History of chronic psychiatric illness Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15)", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Dementia Surrogate for nursing home resident with advanced dementia, paired with resident with advanced dementia Non-related legal surrogate without personal knowledge of resident", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-999.0, All Alzheimer's Disease Dementia Family Caregivers to be a family caregiver of an person diagnosed with possible or probable Alzheimer's disease or other advanced stage dementia show interest in participating Sign informed consent Alzheimer's or dementia person to have a probable or possible Alzheimer type dementia or other advanced dementia according to a diagnosis done by a Specialized Evaluation Unit GDS 5-6 and a minimental equal or lower than 12 to preserve a verbal comprehension of basic instructions to preserve the mobility of the arms, as well as the visual and auditive capacities that allow to conduct the activities Caregivers to have a negative attitude towards the emotional interaction with his/her Alzheimer or dementia family member Unavailability to participate in other socio-educative interventions during the study period Any other situation that makes the caregiver as not suitable according to investigator's Alzheimer's or dementia person Do not have the sensorial or motor capacities needed for the interaction Serious impairment of the verbal comprehension Disabling health conditions", "label": "2"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 50.0-999.0, All Alzheimer's Disease, Mild to Moderately Severe Stages of AD Community Dwelling Patients With Family Caregiver Quality of Life patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26) in community dwelling with an informal caregiver (person living with the patient or providing care 3 times a week or 8 hours per week) is informed and has given his/her consent whom caregiver is informed and has given his/her consent patient with other type of dementia living in nursing home or long term care with no caregiver not informed or has not given his/her consent whom caregiver is not informed or has not given his/her consent", "label": "2"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-999.0, All Critical Illness Chronic Disease Terminal Care Palliative Care Communication Advance Care Planning Neoplasm Metastasis Lung Neoplasms Pulmonary Disease, Chronic Obstructive Heart Failure End Stage Liver Disease Kidney Failure, Chronic Eligible primary clinicians will all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also nurse practitioners and physician assistants playing a \"primary role\" with eligible patients. A \"primary role\" denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated Eligible interprofessional team members will nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values <35% predicted or oxygen dependence or restrictive lung disease with a TLC < 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of >17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of < 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness. Additional PAH w. 6MWD <250m, restrictive lung disease (IPF, ILD) w/ TLC <50%, and cystic fibrosis with FEV1 < 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, \"family member\" is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires Reasons for for all subject groups legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 0.0-69.0, All Frontotemporal Dementia Alzheimer's Disease. Debut of dementia symptoms before the age of 65 years, but age at time of may be up to 70 years FTD (Neary et al 1998 criteria) Primary progressive aphasia (Mesulam 2003 criteria) AD (DSM-IV) Community living, excl. dementia-specific living facilities manned 24/7 Family member with regular contact at least x 1/week Lack of informed consent No close or appropriate family member Frontal lobe dysfunction due to non-progressive injury, i.e. cerebral infarction Frontal lobe dysfunction due to motor neuron disease (ALS) Other dementia specific condition with frontal lobe dysfunction (Huntington, HIV, Down syndrome, alcoholic dementia) Mental retardation Current substance abuse, incl. excessive alcohol consumption for the past 12 months", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 55.0-999.0, All Family Member Men and women ages 55 years and over English or Spanish speaking Interest in participating in a novel nutritional supplement program Willingness to follow recommendations, including going off of all vitamin-D and calcium containing supplements, multivitamins, or OTC medications (e.g., Tums) 2 weeks before starting the study and during the intervention Scoring 0-2 errors on the Short Portable Mental Status Questionnaire Less than 55 years of age Currently enrolled in another research trial for vitamin D dietary supplements or other bone disease treatments Unable to consent to the study Living in a skilled or intermediate care level nursing facility Women who are pregnant, during their period, or less than 2 days before or after their period at the time of the assessment Psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence Bleeding disorders Aphasia or sensory, motor, and/or visual disturbances that could interfere with assessments, including inability to walk 10 feet without a walking aid Gastrointestinal disorders that could lead to uncertain resorption of the study supplements Major conditions such as neurologic, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint that could interfere with vitamin D metabolism, psychometric tests, or body composition assessment (especially renal and heart failure)", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 0.0-999.0, All End Stage Heart Disease Heart Failure Ability to speak Cantonese Living within the hospital service area Ability to be contacted by phone Identified as end-stage heart failure eligible for palliative care, guided by Prognostic Indicator Guidance, National Gold Standards Framework,to fulfill at least two of the indicators below (i) Congestive heart failure New York Heart Association stage III or IV (ii) Patient thought to be in the last year of life by the care team (iii) Repeated hospital admissions with symptoms of heart failure (3 hospital admissions within one year) (iv) Existence of physical or psychological symptoms despite optimal tolerated therapy Discharged to nursing home or other institution Inability to communicate Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 1.0-16.0, All Dravet Syndrome Onset of seizures in the first year of life History of fever-induced prolonged seizures as determined by the Investigator These may prolonged (approximately 15 minutes or longer) hemi-clonic seizures Multiple seizure types which may generalised tonic-clonic (required for inclusion) clonic (required for inclusion) myoclonic jerks/seizures history of normal development prior to seizure onset followed by development delay or regression after seizure onset abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids The patient has received chronic treatment (\u22652 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy Other protocol-defined and", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 1.0-16.0, All Dravet Syndrome The and for the patients who participated in lead-in Study 14362A will be transferred from the 14362A study and for the patients who did not participate in lead-in Study 14362A the inclusion/exclusion is separately listed below The patient has a diagnosis of Dravet Syndrome supported by onset of seizures in the first year of life history of fever-induced prolonged seizures as determined by the Investigator these may prolonged (approximately 15 minutes or longer) hemi-clonic seizures multiple seizure types which may generalised tonic-clonic (required for inclusion) clonic (required for inclusion) myoclonic jerks/seizures history of normal development prior to seizure onset followed by development delay or regression after seizure onset", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 50.0-90.0, All Memory Disorders Mild Cognitive Impairment Aging Age > 50 years old Medical conditions that compromise survival or limit physical activity Geriatric Depression Scale-15 score of 6 or higher Alcohol intake > 4 units/day Mini Mental State Examination < 24 Clinical Dementia Rating score of 1 or more", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-100.0, All Dementia dementia, controls(lumbar puncture at our department) <18\u00e5r other CNS disease", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-80.0, All Parkinson Disease for Parkinson disease (PD) subjects with freezing of gait (FOG) Diagnosis of PD by United Kingdom Brain bank Hoehn & Yahr stage I-IV Levodopa treated and responsive Able to manage 12 hours off dopaminergic medication Age 18-80 years Presence of FOG by history and seen by examiner at their clinical office visit or in a video taken at home Able sign a consent document and willing to participate in all aspects of the study Able to have an MRI scan (no pacemakers or history of claustrophobia) for Parkinson disease (PD) subjects with freezing of gait (FOG) Dementia that precludes completing study protocol Stage V PD unable to walk independently when \"off\" History of FOG without ever being seen to have it Atypical parkinsonism: Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD), Vascular Parkinsonism Treatment with medications that cause parkinsonism: drug-induced parkinsonism Any neurological or orthopedic disorders that interfere with gait Treatment with medications that will interfere with NET-PET (norepinephrine transporter-positron emission tomography) ligand binding a. Noradrenergic drugs: methylphenidate, atomoxetine, serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine)", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 30.0-80.0, All Alzheimer's Disease Dementia 80years old Caregivers who spend their own time with dementia patients over 4 hours a day caregiver distress scores >= 2 caregivers of patients in Alzheimer's disease dementia ( mild to moderate stage of dementia, Mini-Mental Status Examination:10~26) illiterate severe hearing/visual acuity difficulty cognitive impairment", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 65.0-999.0, All Dementia Alzheimer Disease dementia known comorbid cognitive or neurological impairments", "label": "2"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-75.0, All Long QT Syndrome All Individuals Be a nonsmoker or consume < 20 cigarettes per day Have a calculated body mass index (BMI) from 18 to 36 kg/m^2, inclusive, at study screening Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator Screening labs within defined thresholds Individuals with mild, moderate, or severe renal impairment must also meet the following additional to be eligible for participation in this study Must have diagnosis of chronic (> 6 months), stable renal impairment with no clinically significant changes within 3 months (90 days) prior to study drug administration (Day 1) Individuals with severe renal impairment, creatinine clearance (CLcr) must be 15-29 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification Individuals with moderate renal impairment, CLcr must be 30-59 mL/min, inclusive (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification Individuals with mild renal impairment , CLcr must be 60-89, inclusive mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation. If an individual's score changes during the course of the study, the score at screening will be used for classification History of meningitis or encephalitis, epilepsy, seizures, migraines, tremors, myoclonic jerks, narcolepsy, obstructive sleep apnea, anxiety, syncope, head injuries or a family history of seizures Presence or history of cardiovascular disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, cardiomyopathy, or left ventricular ejection fraction < 40%), cardiac conduction abnormalities, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years Syncope, palpitations, or unexplained dizziness Implanted defibrillator or pacemaker Medical history of renal carcinoma or hepatorenal syndrome Individuals receiving or anticipating use of hemodialysis, peritoneal dialysis, or any other renal replacement therapy or other medical procedure that serves as a surrogate for renal function during the study Individuals with fluctuating or rapidly deteriorating renal function. Assessment of the stability of the individual's renal function will be determined by the investigator Renal allograft recipients Experienced hypertensive crisis, required the addition of \u22651 antihypertensive drug, or required more intensive antihypertensive therapy (eg, addition of a new drug class) in the last 3 months", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 45.0-999.0, All COPD ESRD Dementia Age 45 years or older Current hospitalization of at least 3 calendar days Diagnosis of one or more of the following End-stage renal disease (ESRD) on dialysis Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months Patients younger than 45 years old are excluded. The additional workload to screen patients younger than 45 years old is not justifiable given that only an extremely small percentage of people in this age range will have one of the three diagnoses of interest (ESRD, home oxygen dependent COPD, advanced dementia)", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 60.0-999.0, All Cognitive Deterioration Subjects with a diagnosis of Alzheimer's disease according to (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007) Score at Mini Mental Test (MMSE) \u226516 Subjects residing in nursing homes Subjects beneficiaries of a social security scheme Signature of free and informed consent Failure to pass the neuropsychological tests because of a sensory or motor deficit Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation Persons deprived of liberty (administrative or judicial)", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 6.0-12.0, All Duarte Galactosemia Healthy Children/Children with Duarte Galactosemia Age between 6-12 years Parents/Caregivers Primary caregiver to a child age between 6-12 years of age with/without Duarte Galactosemia Chronic illness Any condition unrelated to Duarte Galactosemia but known to cause developmental problems Children who did not have the current parent/guardian as the primary caregiver when the child was an infant", "label": "0"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 50.0-90.0, All Memory Disorders Mild Cognitive Impairment Alzheimer's Disease A diagnosis of mild cognitive impairment due to Alzheimer's disease (MCI due to AD) by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association (Albert et al., 2011) A diagnosis of mild Alzheimer's disease by the patient's referring clinician per recent National Institutes of Aging-Alzheimer's Association (McKhann et al., 2011) 90 years of age Younger than the age of 50 or older than the age of 90 Any self-reported history of substance abuse or alcohol abuse Any self-reported history of prior head trauma (e.g., stroke, traumatic brain injury) Any prior self-reported history of significant depression or other mood disorder", "label": "1"} +{"topic": "An 89-year-old man was brought to the emergency department by his wife and son after six months of progressive changes in cognition and personality. He began to have poor memory, difficulty expressing himself, and exhibited unusual behaviors, such as pouring milk onto the table and undressing immediately after getting dressed. He is unable to dress, bathe, use the toilet, or walk independently. On examination the patient's temperature was 36.5C (97.7F), the heart rate 61 bpm in an irregular rhythm, the blood pressure 144/78 mm Hg, and the respiratory rate 18 bpm. The patient was alert and oriented to self and city but not year. He frequently interrupted the examiner. He repeatedly reached out to grab things in front of him, including the examiner's tie and face. He could not spell the word \"world\" backward, could not follow commands involving multiple steps and was unable to perform simple calculations. His speech was fluent, but he often used similar-sounding word substitutions. He could immediately recall three out of three words but recalled none of them after 5 minutes. Examination of the cranial nerves revealed clinically significant paratonic rigidity. Myoclonic jerks were seen in the arms, with symmetrically brisk reflexes. The reflexes in the legs were normal.", "doc": "eligible ages (years): 18.0-999.0, All Dementia Patients aged 18 years and over Registered with a participating general practice during the study period Minimum one year of records prior to study entry meeting CPRD data quality Followed on or after 1 January 1997 Patients without recorded gender Less than 1 year of follow-up between study entry and date of administrative censoring", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 13.0-999.0, All Cryptosporidiosis HIV Infections Patients must have Documented HIV infection Intestinal cryptosporidiosis Willingness to undergo a 1 week washout phase of all anticryptosporidial medications and stabilization on a protocol directed, antidiarrheal regimen Greater than or equal to 4 stools per day, on average, for a minimum of 21 out of 28 days prior to study entry, secondary to cryptosporidiosis AS PER 2/10/97 Four or more stools per day, on average, during the 5-day screening period prior to baseline Co-existing Condition Patients with the following symptoms and conditions are excluded Inability to tolerate oral medications Life expectancy less than 3 months in the opinion of the investigator Active CMV colitis, C. difficile colitis, giardiasis, salmonellosis, shigellosis, campylobacteriosis, inflammatory bowel disease, diarrhea secondary to another documented intestinal pathogen, or active or uncontrolled MAC disease, defined as symptomatic MAC disease and/or a patient who is not on appropriate anti-MAC therapy in the presence of MAC disease NOTE Patients who have been treated for MAC disease for at least 4 weeks and have resolved their symptoms may be enrolled. Patients dually infected with microsporidiosis may be randomized to the study but will not count toward the sample size AS PER 2/10/97 Failure to record a minimum of four days of information on the use of antidiarrheal medication and the frequency of bowel movements in the daily diary during the screening period Allergy to corn or corn products", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infections Cytopenias Concurrent Treatment Allowed Minimal local irradiation for tumors Patients must have Diagnosis of AIDS or AIDS related complex (ARC) Neutropenia, due either to zidovudine (AZT) or HIV infection Life expectancy = or > 6 months Co-existing Condition Patients with the following conditions or symptoms are excluded Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following Serum carotene less than 75 IU/ml Vitamin A level less than 75 IU/ml More than 4 foul-smelling or greasy stools per day Other of malabsorption Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection Concurrent Medication", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infections Cytopenias Patients must have Serum antibody to HIV with or without evidence of HIV antigenemia White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week Qualifying indications for AZT therapy Life expectancy = or > 6 months Co-existing Condition Patients with the following conditions or symptoms are excluded Current or past history of malignancy including Kaposi's sarcoma Excessive diarrhea or significant malabsorption If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO) Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP) Active OI requiring systemic treatment Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia Concurrent Medication", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Protozoan Infections HIV Infections Concurrent Medication Required If coincident enteric pathogens that are not eradicable (i.e., Mycobacterium avium complex) are detected, they should be treated appropriately and the patient must be on a stable regimen of therapy for at least two weeks Allowed Patients taking antidiarrheal medications must be on a stable regimen for at least seven days prior to randomization Patients taking other concomitant medications, including antiretrovirals, must be on a stable regimen for two weeks prior to randomization Patients must have HIV positive status. Written documentation (for example, patient's chart) of HIV diagnosis is acceptable in lieu of repeat testing. Confirmation by Western blot is not necessary Biopsy-proven microsporidiosis of the fourth portion of the duodenum or proximal jejunum within 90 days before randomization Average of > 3 liquid bowel movements per day over 7 consecutive days immediately prior to randomization, with an average volume > 500 ml per day over three or more consecutive days immediately prior to randomization, as documented by data collected in a daily diary. NOTE Co-existing Condition Patients with the following symptoms or conditions are excluded Grade 4 neutropenia Decompensated liver disease Positive toxin analysis for C. difficile Positive microscopic examination for Giardia lamblia, Entamoeba histolytica, and Isospora belli Positive on culture for Shigella, Salmonella, Yersinia and Campylobacter Positive fluorescent antibody test for Cryptosporidium Evidence of CMV on small bowel biopsy, flexible sigmoidoscopic or colonoscopic biopsies within 90 days of randomization Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study entry", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Cryptosporidiosis HIV Infections Concurrent Medication Allowed Antidiarrheal compounds (if dose remains stable) Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry) Patients must have AIDS Cryptosporidium parvum enteritis Chronic diarrhea Life expectancy of at least 4 weeks Ability to tolerate food by mouth Co-existing Condition Patients with the following symptoms or conditions are excluded Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis Grossly bloody diarrhea Known allergy to milk or milk products (other than lactose intolerance) Prior Medication Excluded Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-65.0, All HIV Infections Patients must have AIDS diagnosis according to CDC criteria CD4 count less than or equal to 200 cells/mm3 or CD4 count greater than or equal to 200 cells/mm3 and documented cryptosporidiosis for a minimum of 4 weeks Cryptosporidial diarrhea as defined by (1) presence of Cryptosporidium oocytes in a stool specimen within 14 days of enrollment; and (2) chronic diarrhea (i.e., an average of at least 4 bowel movements per day for a minimum of 2 weeks) Life expectancy of at least 1 month Ability to tolerate food by mouth Prior Medication Required Any anti-diarrheal or anti-emetic medication for which the dosage regimen has been stable for at least 1 week prior to enrollment Co-existing Condition Patients with the following symptoms or conditions are excluded Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.) Patients with the following prior conditions are excluded Presence of Salmonella, Shigella, Campylobacter, Yersinia, Giardia lamblia, Entamoeba histolytica, Microsporidia, Isospora, Cyclospora, or Clostridium difficile toxin in stool (based on assessment within 14 days prior to enrollment by stool ova and parasite examination, culture, and C. difficile assay) History of intestinal Mycobacterium avium intracellular infection or intestinal Kaposi's sarcoma History of Cytomegalovirus colitis, unless 28 days of therapy with ganciclovir or foscarnet completed subsequent to diagnosis Prior Medication Excluded Investigational drug therapy within 14 days of enrollment, unless available under an FDA-authorized expanded access program", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 55.0-999.0, All Diarrhea Gastrointestinal Diseases years or older primary source of drinking water used at home is supplied by Sonoma County Water Agency without use of home filtration device or bottled water all individuals living in the home must sign informed consent and agree to have the water treatment device installed no known immunocompromising conditions (including HIV/AIDS, active cancer, or transplant recipients) persons with immunocompromising condition (including HIV/AIDS, active cancer, or transplant recipients) employees and family members of the Sonoma County Water Agency or a Sonoma County Water District", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Vaginosis, Bacterial Premature Birth Birth Weight Chorioamnionitis African American, Hispanic, Asian/Pacific Islander, Native American, and white women Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 6.0-17.0, All Crohn Disease Between the ages of 6 and 17 years Have had Crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy Have active Crohn's disease despite adequate current treatment with an immunomodulator (ie, AZA, 6-MP, or MTX) Disease complications for which surgery might be indicated Surgery for bowel diversion with placement of a stoma within 3 months prior to screening Positive stool examination for enteric pathogens including Giardia lamblia, Clostridium difficile, Shigella species, and Salmonella species", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Diagnosis of cancer of the biliary tract by 1 of the following methods Histologic confirmation Stenosis of the biliary tract by MRI, CT scan, or ECHO Unresectable disease Amenable to radiotherapy No visceral metastases by imaging Hepatic adenopathies that can be included in a radiation field allowed No known ampulla of Vater or pancreatic cancer involving the biliary tract WHO performance status 0-2 Creatinine < 1.5 mg/dL ", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-55.0, All Healthy Healthy male subjects Caucasian origin Age: between 18 and 55 years (inclusive) Body mass index (BMI) within 18-30 kg/m\u00b2 Body weight at least 50 kg, at most 100 kg Non-smoker (or ex-smoker \u22651 year), proven by urine cotinine <500 ng/ml Clinically acceptable supine blood pressure and pulse rate, i.e. BP 100-145 mmHg systolic, 60-90 mmHg diastolic and pulse rate 50-100 bpm Normal ECG Participants must perform an adequate contraception during the study and until 6 months after the last dose of the present trial Ability to communicate well with the investigator and comply with the requirements of the entire study Subjects with contraindications for budesonide Subjects with contraindications for metronidazole History or current clinical evidence of any cardiac, cardio-vascular, pulmonary, gastrointestinal, (cholangio-)hepatic, renal, endocrine, neurological, musculoskeletal, ophthalmological, infectious, haematological, oncological, psychiatric, or other acute or chronic diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption and/or pharmacokinetics History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables Current smoker or ex-smoker \u2264 1 year Excessive alcohol consumption (\u00b3 35 g/day in males) Abuse of drugs Positive drug screening Positive anti-HIV-test, HBsAg-test or anti-HCV-test", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 2.0-5.0, All Helminthiasis Criteria:The are age of the child is 2-5 years old he/she has not been suffering from serious chronic illness the child stool test must be positive for STH he/she had not been taken any antehelminthic drug in the previous six months parents/guardian are agree for their child participation in the study. e - age of the child less than 2 years old and more than 5 years old his/her stool test negative for any intestinal helminth he/she has been suffering from serious chronic illness parents/guardian are not willing to give consent for their child's participation in the study if he/she receives any antehelminthic drug after survey but before the study interventions", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 0.75-3.0, All Cryptosporidiosis Male and female children aged 9-36 months at the time of enrollment Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; >14 days duration for persistent diarrhea) Child's parent/guardian speaks English or Luganda Parent/guardian provides full and free informed consent for child to participate in study Unknown age Known cardiac, CNS, metabolic or endocrine disorders Moribund children Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-75.0, All Known or Suspected Focal Liver Lesions Patients between 18 and 75 years of age inclusive Patients (men or women) with at least one focal liver lesion, either identified or suspected by ultrasound (US), Computed Tomography (CT)/spiral-CT, conventional angiography, CT-angiography (CTA), CT-arterioportography (CTAP) or unenhanced / contrast-enhanced MRI* within 2 months before entering the study For reference, the following pathologies will meet the definition of 'focal liver lesions' Hepatocellular carcinoma Cholangiole carcinoma Metastasis Focal lymphoma Adenoma Focal nodular hyperplasia Hemangioma Patients who have previously entered this study Patients who have received any contrast material within 24 hours before injection with study drug, or who are scheduled to receive any contrast material within 24 hours after injection Patients who are, or suspected to be, nursing Patients who require emergency treatment Patients with severely impaired hepatic or renal functions (e.g. serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of reference range, acute renal failure) Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery, acute myocardial infarction) Patients with any physical or mental status that interferes with the signing of informed consent Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs Patients with a contraindication for MRI Patients who are scheduled for liver biopsy/surgery or other surgeries within 24 hours after injection with contrast media, or who would have a biopsy within 24 hours before planned injection with contrast media", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-50.0, All Bacterial Vaginosis All women of between 18-50 years of age Confirmed current diagnosis of BV using Amsel's criteria Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months Patient who received antibiotic therapy within the past two weeks Patients who had co-existing gonorrhea or Chlamydia infection Any contraindications or sensitivity to taking the vaginal gel Allergy to metronidazole Alcoholics or those unable to abstain from alcohol consumption Pregnancy", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-45.0, All Travelers' Diarrhea Male or female between 18 and 45 years of age, inclusive General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator (PI) or PI in consultation with the medical monitor and Sponsor Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade \u2265 70%) Willing to participate after informed consent obtained Available for entire inpatient portion of study and all outpatient study visits Negative serum pregnancy test at screening (initial visit and day -7 to and a negative urine pregnancy test on the day of admission to the inpatient phase for female subjects of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Alternatively, abstinence alone is acceptable. Female subjects who are unable to bear children must provide supporting documentation (e.g., prior tubal ligation or hysterectomy) Presence of a significant medical condition, (e.g., psychiatric conditions or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study Immunosuppressive illness or IgA deficiency (below the normal limits) Positive serology results for HIV, HBsAg, or HCV antibodies Significant abnormalities in screening laboratory hematology, serum chemistry, urinalysis, as determined by PI or PI in consultation with the medical monitor and Sponsor Allergy to fluoroquinolones, cotrimoxazole, or ampicillin/penicillin (excluded if allergic to two of three) Fewer than 3 stools per week or more than 3 stools per day as the usual frequency; loose or liquid stools other than on an occasional basis History of diarrhea in the 2 weeks prior to planned inpatient phase Regular use of laxatives or any agent that increases gastric pH (regular defined as at least weekly) Use of antibiotics during the 7 days before bacterial dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing Travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to dosing", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 0.75-1.0, All Cholera Diarrhea Vibrio Infections Healthy male and female infants aged 9 months will be recruited from Vellore, India and Dhaka, Bangladesh All subjects must satisfy the following at study entry Male or female infants aged 9 months whose parents or primary caretaker have given the written informed consent prior to study entry Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection) Healthy subjects as determined by Medical history Physical examination Clinical judgment of the investigator Parents or primary caregiver are unwilling or unable to give written informed consent to participate in the study Ongoing serious chronic disease Immunocompromising condition or therapy Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours Intake of any anti-diarrheal medicine in the past week Acute disease one week prior to enrollment, with or without fever. Temperature \u226538\u00baC (oral) or axillary temperature \u2265 37.5\u00baC warrants deferral of the vaccination pending recovery of the subject Receipt of antibiotics in the past 2 weeks Receipt of live or killed enteric vaccine in the last 4 weeks Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 7.0-60.0, All Exocrine Pancreatic Insufficiency Steatorrhea Malabsorption Syndromes Cystic Fibrosis Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess fat in the feces Have documentation of an abnormal COA-fat and a fecal elastase result of <100 micrograms fecal elastase/gram stool Must be on a stable diet and dose of pancreatic enzyme supplementation that has provided satisfactory symptom control for at least the past 1 month No extreme physical wasting with loss of weight and muscle mass No severe, acute, or chronic pulmonary disease unrelated to complications of CF No worsening of pulmonary disease in past 30 days No use of drugs known to affect blood uric acid concentrations (e.g., aspirin, diflunisal, allopurinol, probenecid, thiazide diuretics, phenylbutazone, sulfinpyrazone) No known congenital (present at birth) abnormalities of the gastrointestinal tract, heart, or liver No distal intestinal obstruction syndrome (DIOS)", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-45.0, All Cholera Vibrio Infections Diarrhea HIV-seropositive, non-pregnant adults, aged 18 years old who have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment or who have never started HAART regimen will be recruited in the study All subjects must satisfy the following at study entry Male and female HIV seropositive adults aged 18 to 45 years old who have given the written informed consent Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection) CD4 T-lymphocyte count >500/mm3 for at least 6 months prior to Subjects that have never started HAART regimen must satisfy the following additional at study entry Asymptomatic HIV infection as determined by: Medical history, Physical examination, Laboratory tests, Clinical judgment of the investigator Subjects that have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment must satisfy the following additional at study entry History of CD4 nadir >150/mm3 The following should be checked at the time of study entry, if any of the following is present then the subject will be excluded from the study Overt signs of immunodeficiency e.g. oral thrush, rapid weight loss, recurrent pneumonia (i.e. Stage 3 or 4 of the WHO clinical staging system for HIV infection and disease in adults and adolescents Ongoing serious chronic illness (e.g. with signs of cardiac or renal failure) Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours Presence of V. cholerae 01 or 0139, Shigella, or Cryptosporidium in stool at baseline Intake of any anti-diarrhoeal medicine in the past week Acute disease one week prior to enrollment, with or without fever. Temperature \u226538\u00baC (oral or otic) warrants deferral of the vaccination pending recovery of the subject Receipt of antibiotics in the past 2 weeks Receipt of live or killed enteric vaccine in the last 4 weeks Receipt of killed oral cholera vaccine in the past", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-40.0, All Bacterial Vaginosis women 18-40 yrs old abnormal vaginal discharge or malodor positive QuickVue test positive KOH whiff test Positive finding of clue cells greater than or equal to 20% on wet mount Able to give informed consent willing to abstain from alcohol during the 5 day therapy and 1 day following immunocompromised women symptomatic VVC pregnancy or positive pregnancy test menstruating or breastfeeding women other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks women with MPC, PID", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 14.0-50.0, All Clotrimazole Ovulen Vulvovaginal Candidiasis Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation) Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception Negative saline smear for Trichomonas vaginalis Subjects with known hypersensitivity to imidazoles or triazoles and their analogues Subjects presenting a protozoan infection as confirmed by microscopic investigation Pregnant, breast feeding or lactating subjects Subjects with suspected bacterial vaginal infection Subjects with abdominal pain, fever, or foul smelling vaginal discharge Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1 Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4) Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4) Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2)", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 65.0-999.0, All Aged Subject (male or female) is at least 65 years of age Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over Subject has Body Mass Index (BMI) > 20.0 but <30.0 Subject is ambulatory Subject agrees to maintain current activity level Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix Subject has stated immunodeficiency disorder Subject has stated history of diabetes Subject has stated presence of partial or full artificial limb Subject has stated kidney disease Subject has stated history of uncontrollable hypertension Subject had myocardial infarction within the last 3 months Subject had recent antibiotic use (within 1 week prior to screening) Subject has a history of allergy to any of the ingredients in the study products", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-40.0, All Healthy Males Only healthy male volunteers in the 18-40 age range will be included At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90 The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication History of hypersensitivity to sildenafil citrate or any components of its formulations", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-55.0, All Healthy Volunteers Healthy subjects Weight: BMI from 17.5 to 30.5 Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) A positive urine drug screen", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-55.0, All Healthy Volunteers Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight >50 kg (110 lbs) Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) A positive urine drug screen", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Traveler's Diarrhea Male and female patients 18 years of age or older Female and male patients of child-bearing potential must agree to use an effective method of birth control (this method must be approved by the investigator and may total abstinence from sexual intercourse) during the treatment and follow-up study periods; female patients of child-bearing potential must have a negative pregnancy test in the 72 hours before randomization; female patients who abstain totally from sexual intercourse are not required to take the pregnancy test Recent travel (i.e., must be within 30 days of randomization) from an industrialized country Experiencing signs or symptoms indicative of acute bacterial diarrhea (travelers' diarrhea), defined as at least three unformed, watery or soft, stools within the 24 hours preceding randomization and the duration of illness \u2264 72 hours before randomization, and able to provide an unformed stool sample during Screening (the latter can be the third unformed stool passed by the patient within the 24 hours preceding randomization); the bacterial cause of diarrhea will be confirmed by microbiology analysis of the stool sample Experiencing one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, or defecation urgency) Capable of and willing to give informed consent Fever (> 100.4\u00baF or 38\u00baC) or presence of signs and symptoms of systemic infection Note: antipyretic medication should not be administered in the 6 hours before this assessment Known or suspected infection with non-bacterial pathogen before randomization Presence of diarrhea for >72 hours duration Presence of grossly bloody stool Presence of moderate to severe dehydration (i.e., presence of orthostatic hypotension and/or dehydration requiring treatment with intravenous fluids) History of ulcerative colitis, diarrhea-predominant irritable bowel syndrome, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea. Note: lactose intolerance treated with lactase supplements or a lactose-free diet are not excluded if these regimens are maintained during the study Receiving more than two doses of an antidiarrheal medication (e.g., antimotility, absorbent, adsorbent, antisecretory, or probiotics) within 24 hours before randomization Receiving one or more of the following antibiotics within 7 days before randomization, which are active against gram negative bacteria trimethoprim/sulfamethoxazole, fluoroquinolone, azithromycin or rifaximin Females pregnant or breast feeding or not using adequate birth control", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-65.0, All Proctitis Adults, male and female, 18 to 65 years of age 2. Active, mild to moderate UP, with disease activity not to exceed 15 cm beyond the anal verge: the upper disease boundary will be confirmed by flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 3. Newly diagnosed or newly relapsed UP, where newly relapsed UP is defined as UP that has relapsed within less than and equal to 6 weeks prior to the Baseline Visit 4. A Disease Activity Index (DAI) score greater than or equal to 4 and less than or equal to 10 at the Baseline Visit; the DAI must a Physician's Global Assessment (PGA) sub-score of less than or equal to 2, a rectal bleeding sub-score of greater than or equal to 1 and a mucosal appearance sub-score of greater than or equal to 1 5. Histological confirmation of UP with a Histological Disease Activity Score > or equal to 1 for the biopsy taken from the most severe area of disease during the flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 6. For female patients of child-bearing potential, a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit; all female patients will be considered of child-bearing potential unless they are post-menopausal for at least one year or have been surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) 7. Female patients of childbearing potential must be practicing one of the following methods of birth control and must agree to continue with regimen throughout the study: hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of one full cycle (based on the patient's usual menstrual cycle period) before investigational product administration; total abstinence from sexual intercourse (since the last menses before investigational product administration); intrauterine device; double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream); Male patients must also agree to use acceptable methods of birth control with their female partners, and this may use of a male condom plus spermicide. 8. Ability to give written informed consent 9. Ability and willingness to comply with study requirements, including dosing procedures, diary completion, and study visits Known history of allergic reaction or clinically significant intolerance to aspirin or salicylate derivatives (including mesalamine) or non-active ingredients of the investigational product 2. Onset of UP relapse >6 weeks prior to the Baseline Visit for patients experiencing a relapse of their UP (i.e., patients who are not newly diagnosed) 3. Severe UP as defined by a DAI score of greater than or equal to 11 or a PGA sub-score of 3 4. Histological Disease Activity Score > or equal to 1 for the biopsy taken from the normal tissue above the disease margin during the flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 5. UP with disease involvement greater than 15 cm beyond the anal verge as confirmed on flexible sigmoidoscopy/colonoscopy 6. Prior unsuccessful treatment of active UP or active ulcerative colitis with rectally administered mesalamine preparations of any strength 7. Any prior treatment of UP or ulcerative colitis with any oral 5-aminosalicylic acid product if used at >2 g/day, regardless of treatment outcome 8. Use of local, rectally administered therapies for UP or ulcerative colitis (e.g., suppositories or enemas containing mesalamine, etc.) within 30 days of the Baseline Visit 9. Use of any of the following medications Biological therapies (e.g., infliximab) within 90 days of the Baseline Visit Immunosuppressive/immunomodulating (e.g., azathioprine) medications within 90 days of the Baseline Visit Oral, intravenous, intramuscular, or rectally administered corticosteroids within 30 days of the Baseline Visit; the use of intranasal and/or inhaled corticosteroids is permitted Oral 5-aminosalicylic acid products within 7 days of the Baseline Visit, if used at & less than or equal to 2 g/day Oral, intravenous, or intramuscular antibiotics within 7 days of the Baseline Visit Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 7 days of the Baseline Visit; low-dose aspirin (less than or equal to 325 mg/day) taken for cardio-protective reasons is permitted Antidiarrheals, antispasmodics, and iron therapy within 7 days of the Baseline Visit Transdermal nicotine products within 7 days of the Baseline Visit 10. A change in regimen (i.e., dosage or frequency of use) of permitted medications within 30 days of the Baseline Visit, or any plans to change the regimen during the course of this study 11. Use or treatment with an investigational drug, therapy, or device within 30 days of the Baseline Visit 12. A planned change in tobacco usage (e.g., smoking, oral tobacco) during the study 13. Female patients who are pregnant, planning a pregnancy, or who are breastfeeding 14. Diseases interfering with the DAI assessment, including but not limited to, hemorrhoids and anal fissures 15. History of Crohn Disease, short bowel syndrome, or bowel surgery (except appendectomy), or active peptic ulcer 16. A positive stool culture for enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, Vibrio, E. coli O157/H7), detection of Clostridium difficile toxin through immunoassay, or enteric parasites and their ova (including Giardia, Cryptosporidium, and Entamoeba histolytica) on routine microscopy at the Screening Visit 17. Significant impairment of renal or hepatic function, as defined by any of the following Creatinine >1.5 x Upper Limit Normal (ULN)", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-55.0, All Healthy Volunteers Healthy male and/or female literate subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) Body Mass Index (BMI) of 17.5 to 26.4 kg/m2; and a total body weight >50 kg (110 lbs) Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) A positive urine drug screen", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-65.0, All Functional Dyspepsia Gastric Emptying Gastric Accommodation All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III (1) will be considered Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology A normal upper abdominal ultrasound Willing to participate and give consent for participation in the study Age <18 years Helicobacter Pylori positive on gastric biopsy and / or UBT Taking other medications that alter gastric motility like macrolide anti-emetics and antibiotics Pregnant or breast-feeding females", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 1.0-999.0, All Cholera Diarrhoea Vibrio Infection Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 will be recruited in Kolkata Males or non-pregnant females aged 18 years and above and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection) Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 years Healthy subjects as determined by Medical history Physical examination Clinical judgment of the investigator Ongoing serious chronic disease For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening) Immunocompromising condition or therapy (for corticosteroids this would mean \u22650.5 mg/kg/day) Diarrhea (3 or more loose/watery stools within a 24-hour period) 6 weeks prior to enrollment One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months Intake of any anti-diarrhea medicine in the past week Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours Acute disease one week prior to enrollment, with or without fever. Temperature \u226538\u00baC warrants deferral of the vaccination pending recovery of the subject Receipt of immunoglobulin or any blood product during the past 3 months", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Peritonsillar Abscess referring doctor suspects peritonsillar abscess patient is voluntary patient has daily access to his/her e-mail patient speaks and understands Finnish of Swedish female patients have adequate birth-control method patient has peritonsillar abscess allergy to penicillin allergy to metronidazole use of metronidazole in preceding one month pregnancy breast-feeding renal insufficiency liver insufficiency alcoholism (drunk at least once a week) participant in another clinical trial at the moment treatment of peritonsillar abscess requires in-patient care", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Focal Nodular Hyperplasia of Liver Toxic Liver Disease With Focal Nodular Hyperplasia Liver Metastases patients diagnosed with de novo FLL at standard ultrasound age > 18 years, male and female gender informed consent for the contrast enhanced study patients with contraindication for contrast enhanced study: subjects with acute cardiac infarction, with class III/IV cardiac insufficiency, with rhythm disorders and pregnant women Patients diagnosed with simple cysts at standard ultrasound (biliary of hydatid) Patients with known FLL, for example after percutaneous treatment, in which the contrast study is used for the follow up of the patient", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 0.0-99.0, All Cystic Fibrosis Exocrine Pancreatic Insufficiency Pancreatic Diseases Digestive System Diseases Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis Patients with a history of hypersensitivity to the ingredient of LipaCreon Patients with a history of hypersensitivity to porcine protein", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-50.0, All Healthy Provision of signed and dated, written informed consent prior to any study-specific procedures Healthy male and female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture; female subjects must be post menopausal or surgically sterile Male subjects should be willing to use barrier contraception ie, condoms, from the first day of the investigational product administration until 3 months after the last administration of the investigational product Have a body mass index (BMI) between 19 and 30 kg/m2 Be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the Investigator History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs Known history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to carbapenem or cephalosporin antibiotics or other beta-actam antibiotics or any other investigational product to be administered as part of the study Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of investigational product Any clinically significant abnormalities in physical examination, ECG, clinical chemistry, haematology, or urinalysis results, as judged by the Investigator", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Clostridium Difficile Associated Diarrhea Male and female patients 18 years of age or older Mild to moderate C.difficile associated diarrhea (CDAD) with a positive stool C.difficile toxin (by ELISA) Either a first episode of CDAD or a first recurrence (patients with more than 1 recurrence are not eligible) Greater than 3 watery or unformed bowel movements in the prior 24 hours Females of child bearing potential having a negative pregnancy test and taking adequate birth control measures Patients should not consume alcohol at least 12 hours prior to dosing (i.e. in-house monitoring) and until 48 hours after the last dose of drug administration (until Day 14) Able to comprehend and give informed consent for the study and able to adhere to study schedules and protocol requirements Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives Life expectancy \u2264 60 days Sepsis, severe sepsis, or septic shock Signs or symptoms of peritonitis, megacolon or ileus History of ulcerative colitis or Crohn's disease Oral or parenteral antibiotic therapy with metronidazole or vancomycin or other drugs effective in treating DCAD (e.g., bacitracin, fusidic acid) within the 1 week prior to enrollment Recent history of significant drug or alcohol abuse within 1 year Any findings on physical examination, medical history, 12-lead ECG or clinical laboratory tests which, in the judgment of the Principal Investigator, would patients from participating in the study Patients with history of blood dyscrasias, porphyria and active non-infectious disease of the central nervous system Patients with history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption", "label": "1"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 0.0-63.0, All Malnutrition Diarrhea Child Development (1) Infants (target child) will be eligible to participate in the study if they are They are in utero at the baseline survey Their parents/guardians are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still be a candidate for enrollment) (2) Children < 36 months old at baseline that are living in the compound of a target child will be eligible to participate in diarrhea measurement if They are < 36 months old at the baseline survey Their parents/guardians are planning to stay in the study village for the next 12 months (3) Children 18 months old at baseline that are living in the compound of a target child will be eligible to participate in intestinal parasite specimen collection if They are 18 months old at the baseline survey ", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-70.0, All Acute Bacterial Infections Acute Viral Infections current acute infection age 18-70 male or female any race currently active symptoms ", "label": "2"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 0.0-999.0, All Malnutrition Diarrhea Child Development Study Population Description The subject population will be young children and their mothers/guardians living in several contiguous districts of Western Province, in the rural areas outside the towns of Bungoma and Kakamega. Communities must meet the following Located in a rural area (defined as villages with <25% residents living in rental houses, <2 gas/petrol stations and <10 shops) Not enrolled in ongoing WASH or nutrition programs No chlorine dispensers at water sources installed by programs separate from the present study Majority (>80%) of households do not have access to piped water into the home At least six eligible pregnant women in the cluster at baseline From enrolled communities, household compounds will be enrolled if they meet the following criteria One or more women who self-identify as pregnant at the time of the baseline survey The woman plans to stay in the community for the next 12 months (1) The study excludes households who do not own their home to help mitigate attrition during follow-up", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Newly Diagnosed High-Grade Glioma Patients must have histologically confirmed newly diagnosed high-grade glioma(WHO Grade III or IV) Age \u226518 years Karnofsky Performance Score (KPS) \u2265 60% Life expectancy greater than 12 weeks Patients must have adequate organ and marrow function Completed >80% of the prescribed radiation therapy and concurrent temozolomide according to the Stupp regimen without grade 3 or 4 hematologic toxicity Patients may have received Gliadel during surgery Ability to swallow pills and keep medication record women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation Ability to understand and willingness to sign a written informed consent document Patients must not have received prior therapy other than standard chemoradiation according to Stupp et al and Gliadel Patients may not be receiving any other investigational agents while on study Patients who have known allergy to mebendazole or benzimidazole Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic hepatitis, acute hepatitis, or psychiatric illness/social situation that would limit compliance with study requirements Pregnant women are excluded Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Fecal Incontinence age \u226518 years living in the community (not a nursing home or assisted living facility) self-report of usually having FI of loose or liquid consistency at least twice in a 2-wk period toilets independently ability to read and write in English Persons that regularly performed pelvic floor muscle exercises and/or biofeedback on a maintenance regimen for at least 20 wks or who took a steady dose of anti-motility medications on a regular schedule that still met the FI were also eligible difficulty swallowing a gastrointestinal (GI) tract altered by surgery a malabsorption disorder inflammatory bowel disease gastrointestinal cancer or active cancer treatment allergy to the fibers regularly used a laxative or enema, were tube-fed, or unwilling to discontinue taking periodic self-prescribed fiber supplements or anti-diarrheal medications a score \u226424 on the Mini Mental State Examination having/reporting fewer than two episodes of FI or being incapable of performing study procedures during the run-in baseline period", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Liver Transplant Rejection Patients of both sexes aged \u2265 18 years Standard analytical parameters, defined by Leukocytes \u2265 3000 Neutrophils \u2265 1500 Platelets \u2265 100,000 Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \u2264 1.5 standard range institution creatinine \u2264 1.5 mg / dl Patients with liver space occupying lesion (LOE) that require extended hepatic resection Patient selection should be cautious, covering basically 5 types of liver damage which must be submitted prior to liver volumetry Metastatic Disease subsidiary right hepatectomy extended to segment IV Different tumor records current disease or any disease hematologic Patients with uncontrolled hypertension Severe heart failure (NYHA IV) Patients with malignant ventricular arrhythmias or unstable angina Diagnosis of deep vein thrombosis in the previous 3 months Adjunctive therapy including hyperbaric oxygen, vasoactive substances, agents or angiogenesis inhibitors against Cox-II BMI> 40 kg/m2 Patients with alcoholic with active alcoholism Proliferative retinopathy Concomitant disease that reduces life expectancy to less than a year", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-75.0, All Glomerulonephritis, Membranous Age & Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent Histological diagnosis: Have clinical diagnosis of IMN, as verified by biopsy (either by light microscope with immuno-fluorescence, or by electron microscope) in the last 3 years (biopsy results [and slides where possible] should be available for independent evaluation). For patients with relapsed disease, a biopsy should be available within the preceding 7 years Proteinuria: Have clinically active disease (nephrotic range proteinuria) for at least 3 months prior to screening and no improvement (<30% reduction), despite supportive therapy (which must maximal tolerated doses of ACE inhibitor or ARB unless contraindicated, and may statins, diuretics, dietary salt restriction). During screening proteinuria must be >400 mg/mmol by uPCR (or >4.0 g per 24 hrs) as measured from a 24 hrs urine collection and/or spot urine sample (early morning where possible) on 2 occasions at least 7 days apart Proteinuria in patients with relapsed disease: Patients who previously achieved proteinuria <2 g per 24h for at least 6 months and have subsequently relapsed with proteinuria levels as documented above, may be eligible providing recurrence has been within the previous 3 years and patient is known to be anti-PLA2R positive Female Subject is eligible to participate if she is not pregnant or nursing; is non-childbearing potential. Females of child-bearing potential must agree to use one of the approved contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose French subjects: In France, a subject will be eligible for in this study only if either affiliated to or a beneficiary of a social security category for Long Term Follow-up: Subjects who have signed informed consent for the Long Term Follow-up and have completed 2 years study treatment and the 16 week follow-up visit, or who have withdrawn early from study treatment but completed the Week 104 Withdrawn visit Non-Idiopathic MN or other condition affecting the kidney: If the diagnosis of MN is secondary to other conditions, or the subject has renal impairment from a condition that is not MN. Causes of secondary MN (but are not limited to) Immune diseases (Systemic lupus erythematosus, diabetes mellitus; rheumatoid arthritis, Hashimoto's disease, Grave's disease, mixed connective tissue disease, Sjogren's syndrome, primary biliary cirrhosis, bullous pemphigoid, small bowel enteropathy syndrome, dermatitis herpetiformis, ankylosing spondylitis, graft-versus-host-disease, Guillain-Barre syndrome); or Infectious or parasitic diseases (Hepatitis B; Hepatitis C, syphilis, filariasis, hydatid disease, schistosomiasis, malaria, leprosy); or Drugs and toxins (Gold, penicillamine, non-steroidal anti-inflammatory agents, mercury, captopril, formaldehyde, hydrocarbons, bucillamine); or Miscellaneous(Tumors excluded with reasonable diligence, renal transplantation, sarcoidosis, sickle cell disease, Kimura disease, angiofollicular lymph node hyperplasia) Anti-PLA2R autoantibody: Patients known to be negative for anti-PLA2R autoantibody Severely reduced or deteriorating kidney function: An eGFR at screening <40 mL/min/1.73m^2 (as determined by 4 variable version MDRD equation) or kidney function not stable (as defined by >15% decrease in eGFR in 3 months before screening unless due to medication change) Blood Pressure: Uncontrolled hypertension defined as blood pressure (BP) >150/90 mmHg (treatment target <=140/80) Prior Therapy: Have received treatment with the following therapies at the times specified prior to Day 0: Therapy B-cell targeted therapy except rituximab (e.g., other anti CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI Fc, or belimumab), Time period: anytime; Therapy: Rituximab (subjects with rituximab treatment between 1 and 2 years prior to Day 0 are eligible if there is documented evidence of B-cell repopulation to >50% of pre-treatment levels), Period: 2 years; Therapy: Abatacept and any other biologic investigational agent other than B cell targeted therapy (i.e. not approved for sale in the country in which it is being used), Time Period: 364 days; Therapy: Cyclophosphamide or chlorambucil 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis). (Topical or inhaled steroids are permitted.), Time Period: 180 days; Therapy: Anti-tumour necrosis factor (TNF) or anti-IL-6 therapy (e.g. adalimumab, etanercept, infliximab, tocilizumab). Interleukin-1 receptor antagonists (e.g. anakinra). Other immunosuppressive/immunomodulatory agents (e.g azathioprine, 6-mercaptopurine, mycophenolate mofetil (PO)/ mycophenolate mofetil hydrochloride (IV), mycophenolate sodium (PO), methotrexate, tacrolimus, sirolimus, thalidomide, leflunomide, mizoribine, ciclosporin). Intravenous immunoglobulin (IVIG). Plasmapheresis, leukapheresis, Time Period: 90 days; Therapy: A non-biologic investigational agent (i.e. not approved for sale in the country in which it is being used). Intravenous corticosteroid, Adrenocorticotropic hormone (ACTH). Aliskiren. A change in dose of >50% for angiotensin pathway antihypertensive (e.g., ACE inhibitor, angiotensin receptor blocker), Time Period: 60 days; Therapy: A live vaccine. Greater than 30mg/day corticosteroid, Time Period: 30 days; Therapy: Greater than 10mg/day corticosteroid. A change in dose of a corticosteroid. Note: Changes to inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed, Time Period: 14 days Transplantation: Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix Acute or chronic infection: Have required management of acute or chronic infections such as currently on any suppressive therapy for a chronic infection such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); or hospitalisation for treatment of infection within 60 days prior to Day 0; or use of parenteral (IV or IM) antibiotics (anti-bacterials, anti-virals, anti-fungals, or anti-parasitic agents) within 60 days prior to Day 0", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-35.0, All Concentration-Time Profiles in Stomach & Intestine. Healthy volunteers age: 20-35 year Diseases Acute/chronic gastrointestinal disorders Medication use Possible pregnancy Frequent exposure to x-ray radiation during the past year HIV positive", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-55.0, All Healthy Apparently healthy; no medical conditions that might affect the study measurements Male or female Age between 18 and 55 years of age Body mass index (BMI) between 18.5 and 24.9 kg m-2 Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy) Known gastrointestinal disease Smoking History of alcohol or drug abuse Taking medication that is likely to affect gastrointestinal function Participation in night shift work the week prior to the study day. (Night work is defined as working between midnight and 6 am) Strenuous exercise greater than 10 hours per week Consumption of more than 21 units of alcohol in a typical week", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 5.0-39.0, All Diarrhea Healthy male or female adults from 18-39 years old, inclusive General good health as determined by the screening evaluation no greater than 30 days before admission Properly informed about the study, able to understand it and sign the informed consent form Normal bowel habits (< 3 grade 1 or2 stools each day; \u2265 1 grade 1 or 2 stools every 2 days) Free of obvious health problems as established by medical history and clinical examination before entering into the study Available for the entire period of the study and reachable by study staff throughout the entire follow-up period Females of childbearing potential who are willing to take a serum pregnancy test at screening and urine pregnancy tests before each vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable Signed Informed Consent Presence of a significant medical or psychiatric condition that in the opinion of the Investigator precludes participation in the study Known infection with Hep C or HIV History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder Participation in research involving another investigational product (defined as receipt of investigational product) 30 days before planned date of first vaccination or concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product Clinically significant abnormalities on physical examination Clinically significant abnormalities in screening hematology, serum chemistry, or urinalysis as determined by the PI or the PI in consultation with the Study Physician History of febrile illness within 48 hours prior to vaccination Known or suspected impairment of immunological function based on medical history and physical examination Prior receipt of any Shigella vaccine Fever at the time of immunization. Fever is defined as a temperature \u2265 37.5C (99.5F) on axillary, oral, or tympanic measurement", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 1.0-21.0, All Pilomyxoid Astrocytoma Pilocytic Astrocytoma Glioma, Astrocytic Optic Nerve Glioma Pleomorphic Xanthoastrocytoma Glioblastoma Multiforme Anaplastic Astrocytoma Gliosarcoma Diffuse Intrinsic Pontine Glioma DIPG Low-grade Glioma Brainstem Glioma Age > 1 year of age and \u2264 21 years of age Diagnosis 1. Group A Low-grade Glioma Group Histology: Biopsy-proven Pilocytic Astrocytoma Fibrillary Astrocytoma Pilomyxoid Astrocytoma Pleomorphic Xanthoastrocytoma Other low grade astrocytomas Age < 1 year or > 21 years Patients who have known allergy to mebendazole or benzimidazole class drugs Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy Pregnant female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females Lactating females must agree they will not breastfeed a child while on this study Males and females of reproductive potential may not participate unless they agree to use an effective contraceptive method and continue to do so for at least 6 months after the completion of therapy Patients who are unable to take oral medications because of significant vomiting will be excluded Group A Low-grade Glioma Group ONLY", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Diarrhea Renal transplant recipient (RTR) with proven diagnosis of chronic norovirus infection, whereas chronic virus shedding is defined as more than two polymerase chain reaction (PCR) positive samples in an interval of at least one month (case group) or chronic diarrhoea defined as more than three bowel movements per day since more than four weeks (control group) Missing informed consent Primary lactose intolerance Concomitant intestinal infection (other than norovirus) Subjects with galactosemia or patients requiring a low galactose diet Age < 18 years", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 21.0-70.0, All Chronic Periodontitis diagnosis of chronic periodontitis presence of at least 6 periodontal pockets with a clinical attachment loss of \u22655 mm bleeding on probing (BOP) radiographic bone loss probing pocket depth higher or equal to 5 mm in at least six teeth at least 20 teeth in mouth (third molars excluded) an established smoking habit (at least 10 cigarettes per day for the past 4 years) periapical alterations in qualifying teeth medical disorders requiring prophylactic antibiotic therapy or interfering with the treatment periodontal treatment in the past 6 months use of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) within the past 6 months orthodontic therapy pregnancy and lactation allergy to metronidazole any systemic diseases (e.g.: diabetes and immunological disorders)", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Clostridium Difficile Both genders are eligible for study Age 18 years and older Able to provide written, informed consent Confirmed diagnosis of severe CDAD as defined above (If any of the following apply, the subject MUST NOT enter the study) Pregnant or lactating women Need for prolonged antibiotics for other cause Other known etiology for diarrhea, or clinical infection with other known enteric pathogens Active, chronic conditions such as: Inflammatory bowel disease, Crohn's disease, Short bowel syndrome, Ulcerative or ischemic colitis Laxatives or motility-altering drugs within 12 hours of enrolment Clinically unstable. Hemodynamic instability defined as hypotension (mean arterial pressure < 60) not responsive to fluids Any condition that, in the opinion of the investigator, would preclude safe participation in the trial or compromise the quality of the data obtained Immune suppression, HIV, hematological or solid malignancy (chemotherapy in the past 3 months) Prior colon surgery", "label": "1"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Clostridium Difficile Patients > 18 years of age The patient has been treated with appropriate antimicrobial therapy for CDI The patient has documented relapse/recurrence of infection as demonstrated by positive stool culture, or cytotoxin assay, or PCR toxin assay Since this study does not involve treatments that have potential teratogenicity, and in general avoidance of antimicrobial treatment during pregnancy is advised (metronidazole is pregnancy category C), women of child-bearing age may be included in the study Patients will be excluded from study participation if one of the following categories of applies Patient is < 18 years of age Patient has an absolute neutrophil count < 750 cells/mm3 Stool donors must be > 18 years of age Complete a screening questionnaire a. One-time donors: Table 1 b. Designated, pre-screened donors: Table 2 Be tested for communicable blood-borne and enteric pathogens One-time donors: Table 3", "label": "1"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 6.0-999.0, All Lymphatic Filariasis Onchocerciasis Soil Transmitted Helminth (STH) Infections Study areas should be endemic for filariasis and onchocerciasis Study population have limited or no prior experience with MDA. Males and Females greater than 5 years of age Children less than 6 years of age Children who weigh less than 15 kg (33 lb)", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-70.0, All Gastrointestinal Symptoms Small Intestinal Overgrowth recent onset of typical reflux symptoms (heartburn and regurgitation) age <18 or >70 yrs pregnancy or breast-feeding evidence of major concomitant diseases (i.e., tumors, cardiovascular disorders and hepatic and/or renal failure) use of PPIs or H2-antagonists, non-steroidal anti-inflammatory drugs (NSAIDs) or antibiotics in the previous 3 months presence of Helicobacter pylori (H. pylori) infection erosive esophagitis presence of bowel symptoms such as bloating, flatulence, abdominal pain, diarrhea and constipation in the last 6 months or irritable bowel syndrome (IBS) according to Rome III criteria", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 1.0-999.0, All Soil-transmitted Helminthiasis Schistosomiasis Strongyloidiasis Shigellosis Intestinal Salmonellosis Campylobacteriosis Aeromonas Spp. Infections Giardiasis Amoebiasis Dientamoebiasis Cryptosporidium Spp. Infections Individuals aged \u22651 year presenting with persistent diarrhoea (\u22653 loose stools per days for \u22652 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for \u22652 weeks, with possible intermittence/recurrence) Individuals with written informed consent provided Individuals in need of immediate intensive or surgical care Individuals who are unable or unwilling to give written informed consent Individuals who do not meet the for being a case or control (e.g. people with acute diarrhoea) Individuals with clinical jaundice (assessed by direct observation of the conjunctivae) Individuals who are unable, in the study physician's opinion, to comply with the study requirements Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials", "label": "2"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-75.0, All Dyspepsia Peptic Ulcer Participants with non-investigated/functional dyspepsia or scarred peptic ulcer with indication of H pylori eradication treatment Ability and willingness to participate in the study and to sign and give informed consent confirmed H pylori infection by at least one of the following methods: C13-urea breath test, histology, rapid urease test or bacterial culture patients with peptic ulcer previous H. pylori eradication therapy Age below 18 years major systemic diseases previous gastric surgery pregnancy or breastfeeding allergy to any of the study drugs receipt of anti-secretory therapy, antibiotics or bismuth salts 4 weeks prior to", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 1.917-7.0, All Healthy To be attending one of the SOSEP systems assigned daycare centers To maintain an attendance of 80% during the 8 weeks of the fieldwork Aged 23 to 84 months Being apparently healthy and with no dietary restrictions related to the foods offered with the SOSEP menu Children whose parents of caregivers did not sign a consent form Children who refused to participate in the study Children who refused to adhere to the collections routines", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-45.0, All Neurocysticercosis Males and females of non-childbearing potential between the ages of 18 and 45 years, inclusive.* *Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who have been postmenopausal for >/=1 year confirmed by LH and FSH levels In good health, as judged by the investigator and determined by vital signs* Temperature < 38 degrees Celsius, heart rate 50 bpm, systolic blood pressure 89 mmHg, diastolic blood pressure /= 60 mm Hg, medical history and a targeted physical examination. BMI >/=18 and /= 45 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator Acceptable screening laboratories* *Hemoglobin, white blood cell (WBC) count, neutrophil, eosinophil and platelet counts within normal ranges. AST < 44 and ALT < 44 and total bilirubin, creatinine must be equal to or below the upper limit of normal (for eosinophil count, AST, ALT, creatinine, and total bilirubin values below the normal range are acceptable). Random blood glucose must be <140. Urine dipstick testing must be negative for glucose and negative or trace for protein. The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. HIV and hepatitis C viral load PCR testing may be performed for individuals suspected of having indeterminate antibody testing Male participants must be willing to ensure use of condoms and spermicides for 4 months after study drug administration Provide written informed consent before initiation of any study procedures Willing to be available for all study-required procedures, and visits for the duration of the study Able to provide a home phone number, and the name, address, and/or email of a person willing to assist with making contact during the follow-up phase of the study History of residing for 6 or more months in regions with endemic cysticercosis as determined by the principal investigator or a designated study physician Breastfeeding females Body temperature >/=100.4 degrees Fahrenheit (>/=38.0 degrees Celsius) or acute illness within 3 days before administration of study drug (subject may be rescheduled) Chronic or acute medical disorder* *Disorders of the cardiac, pulmonary, liver, kidney, neurologic, gastrointestinal or other system, such that in the opinion of the investigator participation in the study creates additional risk to the subject, or to the validity of the study Use of chronic systemic medications* *Intermittent use of over the counter medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for enrollment (please see section 5.6 for instructions on medication use during the study).Topical medications, nasal steroids are permitted throughout the study. Use of the prescription medications used less than once per week on average are permitted for enrollment (see section 5.6 for instructions on medication use during the study). If the subject has taken a short term prescription medication within the past 30 days (e.g. an antibiotic), they should be postponed from enrollment until 30 days have elapsed since the last dose Has history of sensitivity to related benzimidazole compounds (e.g., albendazole, mebendazole) A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt A history of treatment for any other psychiatric disorder in the past 3 years.* *Past treatment for ADHD does not participants from enrollment as long as the medications have been discontinued for a minimum of 3 months and symptoms are well controlled", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-80.0, All Intestinal Diseases Travelers who intended to travel to tropical areas Good general health Medication consumption Background diseases", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-65.0, All Diarrhea Participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container) Participant's most recently produced stool must be unformed stool Participant must give a positive answer to the following question: \"Have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour\" Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal Participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis Participant shows an axillary temperature greater than (>) 38.2 degrees Celsius (C) or an oral temperature > 38.6 degrees C Participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at > 3 per high power field Participant shows a sitting systolic blood pressure less than (<) 90 millimeter of mercury (mmHg) and/ or diastolic blood pressure < 60 mmHg Participant is unable to take medication orally or tolerate oral rehydration", "label": "1"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 0.0-4.0, All Diarrhea Helminthiasis Children normally resident in households with access to new shared sanitation (the intervention) as selected by implementing organisation (WSUP) or control children normally resident in households sharing existing shared sanitation within geographically delimited project bounds and meeting WSUP site selection (including number of people served) Refusal to participate", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Neoplasm Wounds and Injuries Age \u2265 18 years Diagnosis of malignat wound with odor, regardless of location, etiology and tumor staging; well as in treatment or palliative care Confirmation of participation in the study by signing the Instrument of Consent, personally or through responsible caretaker not smell", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 0.5-1.917, All Diarrhea Signed informed consent from at least one parent or primary caregiver Age 6-23 months initially Permanent resident of study area Planned availability during the period of the study Acceptance of home visitors Weight-for-height z-score (WHZ) <-3Z with respect to WHO 2006 standards Presence of bipedal edema Severe illness warranting hospital referral Congenital abnormalities potentially interfering with growth Chronic medical condition (e.g. malignancy) requiring frequent medical attention Known HIV infection of index child or child's mother Hemoglobin <70 g/L Currently consuming zinc supplements Current participation in any other clinical trial", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-75.0, All Diarrhea Adult male or nonpregnant female aged \u2265 18 years non-indigenous travelers (e.g., visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least three unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal At least three unformed stools recorded within the 24 hours immediately preceding randomization At least one of the following signs and symptoms of enteric infection abdominal pain or cramps nausea vomiting fecal urgency excessive gas/flatulence tenesmus Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study Pregnant, breast feeding, or planning a pregnancy Immediately prior to randomization, acute diarrhea for > 72 hours Presence of fever (\u2265 100 \u00b0F or \u2265 37.8 \u00b0C), or hematochezia (blood in stool), or clinical findings suggesting moderate or severe dehydration Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, GI tract (other than infectious diarrhea in travelers), or central nervous system Administration of any of the following any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization more than two doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization", "label": "2"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-60.0, All Gingivitis Dental Plaque Recent Punjabi immigrants who are Montreal residents Having minimum 20 natural teeth Be in good general health Will give written informed consent Non permanent residents e.g. refugees Presence of orthodontic appliances Presence of partial removable denture Having any disease of soft/ hard oral tissues e.g. advanced periodontitis Having any systemic disease e.g. diabetes On certain medications such as phenytoin", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-54.0, All Signs and Symptoms, Digestive Subject is male or female, 18-54 years of age, inclusive Subject has a body mass index (BMI) \u226518.50 and \u226439.99 kg/m2 at visit 1 (day -7) and has been weight stable (\u00b1 4.5 kg) for the previous 3 months Subject is judged to be in good health on the basis of medical history Subject is willing to maintain his or her habitual diet and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period Subject is willing to avoid foods/beverages that cause GI-distress, as well as high-fiber foods for 24 h prior to, and following, visits 2, 4, 6, 8, and 10 Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators Subject reports any clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, gastroparesis, and clinically important lactose intolerance) History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results Recent history (within 6 weeks of screening, visit 1) of constipation (defined as <3 bowel movements per week), and/or diarrhea (defined as \u22653 loose or liquid stools/d) Recent (within 6 weeks of screening, visit 1) episode of acute GI illness such as nausea, vomiting or diarrhea Daily use of non-steroidal anti-inflammatory drugs (NSAIDS) Daily use of antacids, proton pump inhibitors, H2 blockers Recent use of antibiotics (within 3 months of visit 2, day 0) Use of medications (over-the-counter and prescription) or dietary supplements (within 3 weeks of visit 2, day 0) known to influence GI function such as constipation medications and supplements (including laxatives, enemas, fiber supplements and/or suppositories); anti-diarrheal agents; anti-spasmodic; prebiotic and probiotic supplements Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet Known allergy or sensitivity to food ingredients such as: soy, dairy (milk), wheat, egg, peanuts, tree nuts, fin fish and crustacean", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-65.0, All Celiac Disease Coeliac Disease Celiac Sprue Gluten Enteropathy Patients newly diagnosed with coeliac disease Male or female Able to give informed consent Able to schedule the first MRI scan (Visit 2 of the study) within a month of having had a duodenal biopsy and not yet commenced on a gluten free diet Pilot study in healthy volunteers Healthy volunteers (without any comorbidities) Able to give informed consent Pilot study in patients Any past serious, unstable medical condition, unstable/uncontrolled diabetes mellitus, major psychiatric diagnosis Any reported history of gastrointestinal surgery that could affect gastrointestinal function (colectomy, small bowel resection) ", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-70.0, All Dyspepsia Signed Informed Consent Participants aged 18 years Clinical diagnosis of functional dyspepsia according to Rome III criteria Minimum score of 15 points in PADYQ questionnaire Diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological Positive diagnosis for Helicobacter pylori Clinically significant organic diseases in the HDE (High Digestive Endoscopy) prior to randomization History of esophageal surgery, gastrointestinal or other intra-abdominal surgery Hypersensitivity to the components of the formulations Allergy tartrazine yellow dye Allergy to aspirin Use of PPIs, H2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit Use of NSAIDs or aspirin more than two days a week (except AAS <325mg / day), other drugs that induce gastrointestinal symptoms Pregnant women or women without adequate contraception", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 8.0-18.0, All Irritable Bowel Syndrome Males and non-pregnant females between 8 years and 18 years at the time of consent Able to obtain parental or legal guardian informed consent from subjects as applicable d-IBS determined by ROME III criteria. A Rome III diagnosis consists of recurrent abdominal pain or discomfort at least 2days/week in the last 3 months prior to enrollment associated with two or more of the following10 Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool Children taking pharmacologic treatment for d-IBS will be excluded Children who are unable to articulate symptoms of IBS will be excluded Non-English speaking children will be excluded Children with known allergy or hypersensitivity to beef or any component of SBI Pregnancy", "label": "0"} +{"topic": "A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei.", "doc": "eligible ages (years): 18.0-999.0, All Travel Medicine Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada Travellers with an expected return date after September 1, 2016 Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 0.0-999.0, All Acquired Immunodeficiency Syndrome Aspergillosis HIV Infections Immunologic Deficiency Syndromes Neutropenia Males and females of greater than 12 years of age with any of the following conditions Allogeneic or autologous bone marrow/ peripheral stem cell transplant Hematological malignancy (including lymphoma) Aplastic anemia and myelodysplastic syndromes (currently on immunosuppressive treatment) Solid organ transplantation Solid organ malignancy (after cytotoxic chemotherapy) HIV infection/AIDS High dose prolonged corticosteroid therapy (greater than or equal to 20 mg daily of prednisone or equivalent for greater than 3 weeks) or prolonged therapy with other immunosuppressive agents (e.g., azathioprine, methotrexate) WITH a diagnosis of definite or probable acute invasive aspergillosis The fungal infection at baseline should represent a new episode of acute invasive aspergillosis. Any course of systemic treatment with amphotericin B (conventional or lipid formulation) or itraconazole should have been completed at least 8 weeks prior to study entry ", "label": "2"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 2.0-999.0, All Tuberculosis Males or nonpregnant, non-nursing females > 2 years old Tuberculin (PPD) skin test reactors at high risk for developing TB but without evidence of active TB. High-risk reactors are defined as Household and other close contacts of persons with culture-confirmed TB who are TST-positive as part of a contact investigation conducted within two years of the date of enrollment. Close contact is defined as > 4 hours in a shared airspace during a one-week period. Among close contacts, a positive TST is defined as > 5 mm induration after 5 TU of PPD placed intradermally using the Mantoux technique TST converters--converting from a documented negative to positive TST within a two-year period. This is defined as persons with a tuberculin skin test of > 10 mm within two years of a nonreactive test or persons with an increase of > 10 mm within a two-year period HIV-seropositive, TST positive (> 5 mm induration) persons Persons with > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray, no prior history of TB treatment, > 5 mm induration on TST, and 3 sputum cultures negative for M. tuberculosis on final report HIV-seropositive close contacts of persons with culture-confirmed TB, regardless of TST status. In addition, HIV-seropositive close contacts of persons with culture-confirmed TB who have a documented history of completing an adequate course of treatment for active TB or latent TB infection, are also eligible Willing to provide signed informed consent, or parental consent and participant assent Current confirmed culture-positive or clinical TB Suspected TB (as defined by the site investigator) Tuberculosis resistant to isoniazid or rifampin in the source case A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years A documented history of a completing an adequate course of treatment for active TB or latent TB infection in a person who is HIV-seronegative History of sensitivity/intolerance to isoniazid or rifamycins Serum aminotransferase aspartate (AST, SGOT) > 5x upper limit of normal among persons in whom AST is determined Pregnant or nursing females Persons currently receiving or planning to receive HIV-1 protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 90 days after enrollment Weight < 10.0 kg", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 2.0-999.0, All Infection Unspecified Adult Solid Tumor, Protocol Specific Proven or probable invasive aspergillosis or other filamentous fungal infection by cytology, histopathology, or culture within the past 7 days Presenting with 1 of the following Cancer Aplastic anemia Inherited immunodeficiencies Autoimmune deficiency disorders Acquired immunodeficiencies Recipient of autologous peripheral blood stem cell or bone marrow transplantation CNS aspergillosis or other filamentous fungal infection allowed No invasive zygomycosis infection ", "label": "1"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 0.083-999.0, All Invasive Aspergillosis Other Fungal Infections Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less than 20 mg of Prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for IFI. Evidence of Proven, Probably or Possible IFFI by modified EORTC criteria. Continued treatment with study drug is contingent upon confirmation of diagnosis of Proven or Probable IFI within 4 working days after study entry Life expectancy of less than 30 days; chronic IFI (defined as signs/symptoms of IFI present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented IFI. Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (ULN), serum ALT or AST less than 5 x ULN; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-80.0, All Invasive Aspergillosis Patients fulfilling all the following will be eligible for enrolment 1. Aged 18-80 years 2. Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL) 3. Has given written informed consent Patients with any of the following will be ineligible for enrolment 1. Other immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune conditions treated with immunosuppressants etc.) besides those outlined in the above 2. Currently enrolled in an antifungal treatment trial (not an antifungal prophylaxis trial) 3. Past history of proven or probable IA (as per standardized definitions) during a previous cycle of chemotherapy 4. Currently have active IA or other active invasive fungal infection 5. Prior enrolment in this study", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-75.0, All Arthritis, Rheumatoid Diagnosis of RA according to the revised 1987 of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed at least 6 months prior to screening Active disease at the time of screening and pre-infusion as defined by >=6 swollen joints >=6 tender joints and 2 of the following morning stiffness >=45 min ESR >=28 mm/h CRP >=20 mg/L Men and women, >=18 to <=75 years of age Men and women of childbearing potential must be using adequate birth control measures (abstinence, oral contraceptives, IUD, barrier method with spermicide or, surgical sterilization) and should continue such precautions for 6 months after receiving the last infusion Patients must have been using oral or parenteral MTX for at least 3 months with no break(s) in treatment of more than 2 weeks total during this period. Patients must have been on a stable dose of >=12.5 mg/wk (maximum 20mg/wk) for at least 4 weeks prior to screening Pregnant women, nursing mothers or a planned pregnancy within 1.5 years of enrollment Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the Infliximab therapy, eg Lyme disease, or a rheumatic disease other than RA Use of DMARDs other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.) Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab) Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months Treatment with any investigational drug within the previous 3 months Prior use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-75.0, All Psoriasis Adult male and female subjects (>= 18 to 75 years of age) with a diagnosis of moderate to severe plaque-type psoriasis for at least 6 months prior to study screening (subjects with concurrent psoriatic arthritis may also be enrolled) Subjects must be eligible for phototherapy or systemic therapy for their psoriasis and must have a Baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved at Baseline Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study Subjects must also meet the tuberculosis (TB) assessment and screening as follows: Have no history of latent or active TB prior to screening; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB Specific parameters must also be met with regard to screening laboratory test results and liver enzymes in order to be eligible to participate in the study Subjects who have non-plaque forms of psoriasis, current drug-induced psoriasis, are pregnant, nursing, or planning pregnancy Subjects previously treated with MTX or infliximab; subjects who are taking specific drugs within the specified time frame prior to Baseline as follows: any therapeutic agent targeted at reducing tumor necrosis factor (TNF) or any biologic, live virus or bacterial vaccinations within 3 months; any systemic medications or treatments that could affect psoriasis or PASI evaluations, or any systemic immunosuppressants or lithium within 4 weeks; any topical medications or treatments that could affect psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for psoriasis are shampoos (containing tar or salicylic acid only) and topical moisturizers. Subjects should not use these topical agents during the morning prior to a study visit. Non-medicated shampoos may be used on the morning of a visit Subjects with poor health, including concomitant congestive heart failure (CHF); history of chronic or recurrent infectious disease, as specified; human immunodeficiency virus, hepatitis B, or hepatitis C; demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis; systemic lupus erythematosus; or who have had serious infections (eg, hepatitis, pneumonia, or pyelonephritis], or who have been hospitalized or received IV antibiotics, or who had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB), or a transplanted organ within specified time frames; or other conditions as specified in the protocol Subjects who have used any investigational drugs within 4 weeks of Screening, who are participating in other clinical studies, staff or family members of study staff are excluded from participation in the study", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Aspergillosis Male or female hospitalized patients aged > 18 yr The patient has a hematologic malignancy or will receive a bone-marrow transplant The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission The expected duration of severe neutropenia (PMN<0.5x10*9/L) following study entry is > 10 days The patient is receiving oral antibiotic prophylaxis and fluconazole Written informed consent has been obtained The patient shows evidence of a pulmonary fungal infection or a fungal sinusitis at trial entry The concomitant use of systemic anti-aspergillus treatment such as itraconazole or any intravenous formulation of amphotericin B at study entry Known hypersensitivity to amphotericin B Any evidence of pneumonia or pneumonitis at trial entry Any impossibility to use a nebulizer properly Expected survival < 3 months at entry Pregnancy", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-85.0, All Non-small Cell Lung Cancer Histologic confirmation of non-small cell lung cancer, mesothelioma or a radiographic lesion highly suspicious for malignancy Written informed consent Must be scheduled for a biopsy or surgical resection Subjects with any \"other\" prior cancer (other than lung) within 5 years of date of surgery are NOT eligible (unless there is preoperative pathologic confirmation that the lung mass is a second primary cancer) Subjects with any type of lung cancer other than non-small cell lung cancer(NSCLC)", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 10.0-999.0, All Invasive Aspergillosis Adults and children > 10 years old The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtain prior to the initiation of any study procedures Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (\u2265 20 mg Prednisone or equivalent for \u2265 3 weeks) or treatment with other immunosuppressant medications Evidence of Proven or Probable Invasive Aspergillosis, by modified EORTC (Appendix 2), as modified below: \u2022 Proven Invasive Aspergillosis \u2022 Histopathologic or cytopathologic examination showing hyphae consistent with the presence of aspergillus from needle aspiration or biopsy specimen with evidence of associated tissue damage (either microscopically or unequivocally by imaging); or \u2022 Positive culture result for aspergillosis from a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with infection, excluding urine and mucous membranes \u2022 Probable Invasive Aspergillosis \u2022 At least 1 host factor criterion; and \u2022 1 microbiological criterion; and major (or 2 minor) clinical from abnormal site consistent with infection; and \u2022 No other pathogens detected to account for the clinical or radiographic signs of infection Or (Modification of EORTC Criteria): \u2022 Patients with recent Neutropenia (absolute neutrophil count < 500 cells/mm3 within 14 days of study enrollment); and \u2022 Chest CT scan positive for \"Halo\" or \"Air Crescent\" Sign (see Section 4.2.1, Diagnostic Considerations, below) and \u2022 No other pathogens detected to account for the clinical or radiographic signs of infection Females of childbearing potential must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline Life expectancy < 30 days Allogenic stem cell transplant in the 6 previous months Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study Prior anti-fungal systemic therapy of \u2265 96 hours for the current, documented IA. (On the other hand, is permissible prior systemic anti-fungal therapy for prophylaxis or as empiric therapy for febrile neutropenia) Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug \u2022 Serum creatinine > 2x upper limit of normal (ULN) Serum ALT or AST > 5 x ULN Pregnant or lactating women History of allergy or serious adverse reaction to any polyene anti-fungal agent or echinochandin derivatives", "label": "2"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 12.0-999.0, All Aspergillosis Patients with newly diagnosed acute leukemia or high risk myelodysplastic syndrome (MDS) receiving induction chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days Patients with relapsed acute leukemia or MDS receiving salvage chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days Patients with severe aplastic anemia (SAA) receiving chemotherapy or immunosuppressive therapy using antithymocyte globulin Patients receiving allogeneic/autologous hematopoeitic stem cell transplant (HSCT) using myeloablative conditioning regimens Patients are at least 12 years of age, with Karnofsky score of 70%.? Patients on consolidation chemo regimens like HIDAC and HyperCVAD type B with expected duration of neutropenia (ANC < 500/ml) of at least 10 days Patients who are human immunodeficiency virus (HIV) infected Patients with uncontrolled bacteremia or active pulmonary infection at the time of randomisation Patients with pre-existing proven and probable invasive fungal infections, according to the definitions of the invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Disease [10] Patients receiving concomitant piperacillin/tazobactam or co-amoxyclavulinic acid Patients on palliative chemotherapy Patients with history of allergy to triazoles Patients with prior history of anaphylactic reaction to conventional amphotericin B Patients with serum levels of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin more than 5 times the upper limit of normal or renal impairment with calculated creatinine clearance < 30ml/min Patients with expected life-expectancy < 72 hours", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Acute Myeloid Leukemia Allogeneic Haematopoietic Progenitor Cell Transplant Patient has decided voluntary to consent his or her participation signing the consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Patients with Acute myeloid Leukemia (AML), that will start induction chemotherapy or those patients submitted to an Allogeneic haematopoietic progenitor cell transplant The patient is >18 years old Patient with prior Invasive Pulmonary Aspergillosis (IPA) history History of allergy or hypersensitivity to Amphotericin B Patient with intellectual deficit or patients with psychological alterations that make impossible the trial understanding Pregnancy or breastfeeding Patient has received other investigational drug or non traded product within 30 days before trial beginning Patient is enrolled in another clinical research study or/and is receiving an investigational agent for any reason Patient had major surgery within 4 weeks before enrollment", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 19.0-65.0, All Rheumatoid Arthritis Patients aged >35 and <=65 years with a diagnosis of rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) for at least 1 year and no more than 10 years prior to start of therapy; have active disease (Disease Activity Score [DAS] 28 >2.8 and <3.5), with changes in the DAS 28 score <0.6 within the 6 weeks before inclusion; have stable RA basic therapy according to standard for at least 3 months; have a chest X-ray within 1 month prior to first infusion with no evidence of malignancy, infections, or fibrosis; and have screening laboratory test results that meet prespecified criteria. Patient must have at least one swollen joint. Patient must have evidence of erosive disease by x-ray at baseline Patients were excluded if they met any of the following Women who are pregnant, nursing, or planning pregnancy within 15 months after screening (i.e., approximately 6 months following last infusion) Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer History of any other therapeutic agent targeted at reducing tumor necrosis factor (TNF) History of previous administration of infliximab History of receiving human/murine recombinant products or has a known allergy to murine products Serious infection (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator Active tuberculosis (TB) or evidence of latent TB (positive purified protein derivative [PPD] skin test, a history of old or latent TB or chest X-ray without adequate therapy for TB initiated prior to first infusion of study drug), or evidence of an old or latent TB infection without documented adequate therapy. Patients with a current close contact with an individual with active TB and patients who have completed treatment for active TB within the previous 2 years are explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies Hepatitis B surface antigen or Hepatitis C (HCV) antibody positive; documented Human Immunodeficiency Virus (HIV) infection Have an opportunistic infection, including but not limited to evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterium infection, etc, within the previous 6 months", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 6.0-999.0, All Cystic Fibrosis Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations Patient must be known to be chronically colonized with Aspergillus fumigatus Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization Patients must weigh at least 20 kg Post-menarche females must be using an effective form of contraception Inability to give informed consent Respiratory culture positive for B.cepacia complex Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization Neutropenia, absolute neutrophil count< or = 1000 within a 3-day period prior to randomization History of biliary cirrhosis documented by liver biopsy or imaging History of portal hypertension Investigational drug use within 30 days of randomization date History of alcohol, illicit drug or medication abuse within 1 year of randomization Women who are pregnant, breastfeeding or trying to conceive", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-75.0, All Arthritis, Rheumatoid Patients received placebo in main double-blind study (P04280, NCT00202852) Patients received Infliximab-containing regimen showing clinical response at week 30 in main double-blind study (P04280) [Main double-blind study (P04280, NCT00202852) criteria] Diagnosis of rheumatoid arthritis (RA) according to the revised 1987 of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed >6 months prior to screening Active disease at the time of screening and pre-infusion as defined by >=6 swollen joints >=6 tender joints and of the following morning stiffness >=45 min erythrocyte sedimentation rate (ESR) >=28 mm/h below of main double-blind study (P04280, NCT00202852) [Main double-blind study (P04280, NCT00202852) Pregnant women, nursing mothers, or a planned pregnancy within 1.5 years of enrollment Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from infliximab, eg Lyme disease, or a rheumatic disease other than RA Use of disease modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.) Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab) Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months Treatment with any investigational drug within the previous 3 months", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Hidradenitis Suppurativa Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following HS >1 year duration with multiple ER or doctors visits related to HS Intralesional kenalog injection >5/year, however none within 2 weeks of entry Failed systemic retinoids, but not within 3 months of entry Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment) History of surgery (reconstructive), but not within 3 months of entry Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection) Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent) If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly Have a concomitant diagnosis or history of congestive heart failure Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 16.0-999.0, All Hematological Diseases Invasive Aspergillosis Age > 16 years Allogeneic HSCT for a haematological disease Written informed consent to the study Pediatric patients", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer Diagnosis of non-small cell lung cancer Stage I-IIIB disease No prior surgical tumor resection Respiration-induced tumor motion > 5 mm Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals Not pregnant No insufficient lung function or other parameters prohibiting a bronchoscopy Not a prisoner or institutionalized See Disease Characteristics Concurrent chemotherapy allowed ", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 4.0-45.0, All Cystic Fibrosis, informed consent age between 4 and 45 years well-known Cystic fibrosis Lung function: FEV1 (% pred.) \u2265 70% age < 4 and > 45 years lung function: FEV1 (% pred.)< 70% other chronic diseases or infections (e.g., HIV, tuberculosis, malignancy) pregnancy known alcohol, drug and/or drug abuse inability to capture the scale and scope of the study participation in another study", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 1.0-999.0, All Immunocompromised Host Invasive Pulmonary Fungal Infection Invasive Pulmonary Aspergillosis Invasive Pulmonary Zygomycosis Patients currently enrolled in any NIH IRB approved Clinical Center protocol or under treatment at the CNMC who are undergoing bronchoscopy or lung biopsy for diagnosis of possible invasive pulmonary aspergillosis or invasive pulmonary zygomycosis Informed consent of the patient or the patient's legally authorized representative Fulfillment of one or more of the following EORTC/MSG host History of neutropenia (ANC < 500/mm(3)) within the past 3 months temporally related to the onset of radiographic changes Receipt of an allogeneic HSCT Receipt of solid organ transplantation Prolonged use of corticosteroids at an average minimum dose of 0.3 mg/kg/day prednisone equivalent for > 3 weeks Treatment with other recognized T-cell immune suppressants such as cyclosporine, TNF alpha blockers, specific monoclonal antibodies such as alemtuzumab, nucleoside analogues during the past 90 days Myelodysplastic syndrome Severe aplastic anemia Interstitial or diffuse infiltrates on chest CT or radiograph Inability to provide informed consent Children weighing less than 10 kg Any other concomitant condition, which in the opinion of the investigator would place the patient at risk by participating in the study", "label": "1"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infection Pulmonary TB Age above 18 years HIV-1/2 infected patients with Pulmonary TB. This includes sputum smear positive disease Initially smear negative but (Becton-Dickinson) culture positive (e.g. miliary TB, Mediastinal adenitis and Chest x-ray with persistent abnormality after antibiotics) Persistent X-ray abnormality will be included for allocation. However final into both ITT and efficacy analysis will depend on positivity in LJ culture Living within 40 km radius from the nearest sub centre of TRC and willing for attendance as prescribed Likely to remain in the same area for at least one and half years after start of treatment Willing for house visits and surprise checks Willing to participate and give informed consent after going through the terms and conditions of the trial Patients with known hypersensitivity to rifampicin Pregnancy and lactation at initial presentation Major complications like HIV encephalopathy, renal dysfunction (serum creatinine > 1.5 mg% in the absence of dehydration) or jaundice (serum bilirubin > 2 mgs% along with SGOT /SGPT elevation > 2.5 times the upper limit of normal) Previous anti-tuberculosis treatment for more than 1 month. Prophylaxis (non-rifampicin containing regimen) will not be considered as prior antituberculosis treatment Moribund, bedridden or unconscious patients Co-morbid conditions like uncontrolled diabetes mellitus, cardiac failure, and malignancy at initial presentation Major psychiatric illness Patients on second line ART, mainly protease inhibitors, at initial presentation", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 0.0-999.0, All Allergic Bronchopulmonary Aspergillosis Diagnosis of ABPA Presence of all the following three immediate cutaneous hyperreactivity on aspergillus skin test elevated total IgE levels > 1000 IU/mL A fumigatus specific IgE levels > 0.35 kU/L, AND Presence of two of the following presence of serum precipitating antibodies against A fumigatus fixed or transient radiographic pulmonary opacities absolute eosinophil count > 1000/\u00b5L central bronchiectasis on HRCT If they have taken glucocorticoids for more than three weeks in the preceding six months Failure to give informed consent Enrollment in another trial of ABPA", "label": "1"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-65.0, All Liver Transplantation Aspergillus Interleukin-17 Treg Cell Immune Tolerance Liver transplantation patients Psychopath", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 0.0-999.0, All Invasive Aspergillosis BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason Patients without fulfilling criteria Patients with some contraindication to perform a bronchoscopy", "label": "2"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 35.0-85.0, All Osteoarthritis, Knee Adults \u2265 age 35 but \u2264 age 85 Painful knees for 3-60 months VAS joint pain score greater than 30 mm (scale 0-100) Knee radiograph showing minimal to moderate change (early OA) No NSAID therapy for at least one week Have the capacity to understand and sign an informed consent form Gender: Male or female Women must be postmenopausal (no menstrual period for a minimum of 1 year) or surgically sterilized and have a negative serum pregnancy test on entry in the study. Men must agree to use adequate birth control during the study for 6 months after the infusion of study agent Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion The screening laboratory test results must meet the following Moderate to Severe OA, as determined by severe joint space narrowing (Kellgren grade IV) (7) in medial and lateral compartments Insulin-dependent diabetes mellitus Systemic inflammatory illness, e.g. rheumatoid arthritis Intra-articular injections within 3 months Prior treatment with infliximab or other anti-TNF drug Acute injury to knees (< 2 weeks) Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion) Have had any previous treatment with monoclonal antibodies or antibody fragments History of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an criterion Documentation of a positive test for hepatitis B surface antigen or hepatitis C", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-90.0, All Invasive Aspergillosis proven or probable invasive aspergillosis with positive GM antigen test Seronegative aspergillosis", "label": "2"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 16.0-999.0, All Hematologic Disease Solid Organ Transplantation IPA cases with solid organ transplant recipients and hematologic disease patients proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG under 16 years old possible cases of invasive pulmonary aspergillosis", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Aspergillosis The patient or legally authorized representative has signed an informed consent/assent Assent will be obtained as required by the UAMS IRB The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (\u22650.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI The patient is 18 years of age or older The patient is being treated with an unlicensed investigational drug for aspergillosis The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for > 7 days immediately prior to randomization for treatment of the Probable, or Proven invasive aspergillosis for which the patient is being enrolled Patient has invasive aspergillosis but with negative Aspergillus GM index The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal The patient has hepatic cirrhosis Patients with creatinine > 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours) The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents The patient has previously enrolled into this study", "label": "2"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 16.0-999.0, All Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis A. Fumigatus Male or female \u2265 12 years of age at enrollment Confirmed diagnosis of CF based on the following One or more clinical features consistent with the CF phenotype AND (b or c) Positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) two identifiable mutations consistent with CF Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Clinically stable at enrollment as assessed by the site investigator Past or present respiratory culture positive for Aspergillus fumigatus IgE \u2265 250 and/or presence of class II or higher aspergillus specific IgE on enrollment Ability to comply with medication use, study visits and study procedures as judged by the site investigator - Systemic corticosteroids (1 mg/kg if < 20 kg or > 20 mg of prednisone per day) Investigational drug use within 30 days of screening 3. Laboratory abnormalities at screening a. Serum Calcium > 11 mg/dl b. 25(OH) D > 50 ng/ml at screening. c. Creatinine \u2265 1.5, or estimated GFR <60 by Cockcroft-Gault or MDRD equation. d. LFT\u2265 3xULN History of transplantation or currently on lung transplant list 5. Positive serum pregnancy test at screening (to be performed on all post-menarche females) 6. Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study 7. Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data 8. Diagnosis of HIV and a CD4+ T cell count below 500 cells/ml or active hepatitis B or C infection Undergoing therapy for non-tuberculous mycobacterial infection", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 16.0-999.0, All Invasive Pulmonary Aspergillosis hospitalisation in the hematology or intensive care department age > 16 years informed consent proven or probable IPA (EORTC/ MSG criteria) galactomannan positivity in BAL or serum age < 16 years", "label": "1"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Lung Transplant Recipient Single or double lung transplant recipients who are at least one year out of transplantation Age >18yrs of age Able to understand and complete informed consent Pregnant woman or woman capable of bearing children, who will not perform urine pregnancy test Nursing mothers Subjects with hypersensitivity to Amphotericin deoxycholate or liposomal Amphotericin Subjects with a past history of bronchospasm associated with aerosol drug use Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications Subjects treated with cytolytic medications (Campath /Thymoglobulin) within the last month Subjects with an FEV1< 30% Predicted or FVC% <30% Subjects requiring supplemental oxygen Receipt of Inhaled or IV Amphotericin B within last 30 days Subjects with known fungal infection as per MSG on therapy with antifungal drugs or diagnosed on the day of bronchoscopy", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 14.0-80.0, All Chronic Cavitary Pulmonary Aspergillosis Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting \u2265 six weeks Radiological findings Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species The diagnosis of CCPA will be made if Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria FNAC from the cavity wall will be considered in atypical cases Invasive aspergillosis Allergic broncho-pulmonary aspergillosis (ABPA) Active tuberculosis or malignancy Pregnant females", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Infection The for participants to enter the study mandates that each patient have received a standard (current clinical practice) diagnostic evaluation that includes a CT scan of the chest to document bronchiectasis, prior to enrolling in the Consortium study. To enter this protocol, adults must have bronchiectasis and meet the following Males or females, age greater than or equal to18 years Chronic cough An available CT of the chest (on a CD) that shows evidence of dilated airways fulfilling radiographic for bronchiectasis in more than one lobe Ability to provide informed consent, including HIPAA consent A participant should not be in the study if they have not had a standard clinical evaluation to rule out other potential causes of chronic sino-pulmonary disease Known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing CFTR mutations History of tuberculosis or other known explanation for bronchiectasis, such as alpha 1-antitrypsin deficiency (ZZ or ZS), confirmed or probable PCD, inflammatory bowel disease, rheumatoid arthritis, Sjogren s syndrome, allergic bronchopulmonary aspergillosis, or documented primary or acquired immunodeficiency Current smoker or > 10 pack-year history of tobacco use Prior solid organ transplant", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 0.083-14.0, All Tuberculosis Any child with at least one of the following Unexplained weight loss or documented failure to thrive or stagnant weight or Growth faltering on the growth charts over the past 3 months despite adequate nutrition and deworming Non remittent cough or wheeze for more than 2 weeks Night sweats persistent or intermittent during the last 2 weeks Prolonged fever (temperature > 38\u00b0C) for 7 days, after common causes such malaria or pneumonia has been excluded Wheeze/Stridor persistent, non remitting during the last 2 weeks Chest pain Persistent, localized, pleuritic in nature during the last 2 weeks Current TB treatment (patient who received < 3 days of treatment or patients receiving IPT could be still included) or TB treatment completed within the past 6 months Absence of informed consent Living outside of Greater Mbarara region Unable or unwilling to attend to the follow-up visits", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 5.0-80.0, All Invasive Aspergillosis hematological patients with lung infiltrates at high risk for invasive aspergillosis patients without informed consent", "label": "1"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 5.0-85.0, All Invasive Aspergillosis immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates informed consent Children under the age of 5 years Informed consent not available", "label": "2"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-80.0, All Ventilator Associated Pneumonia All adult patients above 18 years old admitted into the Intensive Care unit and who is to be intubated and likely to receive more than 72 hours of ventilation would be admitted into the trial presence of cavitary lung disease based on chest x-ray findings primary lung cancer or another metastatic malignancy to the lungs, or known or suspected viral or fungal etiology pneumocystis carinii pneumonia legionella OR Mycoplasma pneumonia or active tuberculosis", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Psoriasis Subjects are non-immunocompromised males or females 18 years of age or older Subjects have moderate-to-severe (\u226510% total body surface area) plaque psoriasis Subject diagnosed at least 6 months prior to entering the study Negative urine pregnancy test within 7 days before the first dose of ustekinumab in all women (except those surgically sterile or at least 5 years postmenopausal) Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study Are considered eligible according to the following tuberculosis (TB) screening Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent Within 1 month prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. The QuantiFERON-TB Gold test are not required at screening for subjects with a history of latent TB and ongoing treatment for latent TB or documentation of having completed adequate treatment as described above; Subjects with documentation of having completed adequate treatment as described above are not required to initiate additional treatment for latent TB Subject is younger than 18 years of age Subject has less than 10% body surface involvement of his/her psoriasis Subjects with erythrodermic, pustular, or guttate psoriasis History of known or suspected intolerance to any of the ingredients of the investigational study product Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits Subject has a history of listeriosis, untreated TB, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, or oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening Refer to for information regarding with a history of latent TB Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-65.0, All Cystic Fibrosis Healthy control subjects Age 18-65 No history of lung disease Cystic fibrosis subjects Age 18-65 No history of lung disease other than cystic fibrosis Diagnosis of CF if sweat chloride values > 60 mM on two separate pilocarpine iontophoresis sweat tests and/or two allelic CF-producing mutations in genetic analysis Use of recreational drugs within 30 days prior to enrollment Use of tobacco within 30 days prior to enrollment, or > 10 pack-year tobacco history Pregnant or lactating females", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Scalp Psoriasis Plaque Psoriasis Capable of giving informed consent and the consent must be obtained prior to any study related procedures Be 18 years of age or older at the time of consent; may be male or female Have had a diagnosis of plaque psoriasis at least 6 months prior to administration of study agent Presence of moderate or severe psoriasis on the body other than the scalp At least 30% of scalp affected with erythema, induration and desquamation and s-PGA score greater than or equal to 4 Be candidates for phototherapy or systemic treatment of psoriasis Women of childbearing potential and all men must be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue use of such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent Be able to adhere to protocol requirements and study visit schedule Must agree not to receive a live virus or live bacterial vaccination during the trial and 12 months after last study injection Must agree not to receive a BCG vaccination during the trial and up to 12 months after the last injection Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB Have screening laboratory test results within the following parameters Hemoglobin > 10g/dL White Blood Cells > 3.5 x 109 /L Neutrophils > 1.5 x 109 /L Platelets > 100 X109 /L Serum Creatinine < 1.5 mg/dL ( or 133 micromol/L ) AST,ALT, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range for the laboratory conducting the test Subjects meeting any of the following may not be enrolled in the study Currently have non-plaque forms of psoriasis (erythrodermic, guttate, or pustular)", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 12.0-999.0, All Cystic Fibrosis Aspergillus Infections Patient with cystic fibrosis men or women age equal greater to 12 years presenting with a positive sputum culture for Aspergillus confirmed twice within 6 months before study entry and at initial visit written informed consent patients with a contraindication to one of the antifungal agents evaluated pregnant women or nursing mothers absence of an effective method of contraception in women of child-bearing potential patients with signs or symptoms of invasive aspergillosis patients with signs or symptoms of aspergilloma patients with an infection caused by Burkholderia complex Cepacia or to mycobacteria lung transplant patients, registered on a transplantation waiting list or whose registration is imminent patients who received systemic antifungal therapy for more than 5 days within 2 months prior to patients currently enrolled in another clinical drug trial ongoing treatment with medicinal products contraindicated with itraconazole and voriconazole or with major interactions which reduce azole concentrations", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 3.0-17.0, All Invasive Pulmonary Aspergillosis Lymphoblastic Leukaemia Myeloblastic Leukaemia Lymphoblastic Leukemia Myeloblastic Leukemia Age: patients between 3 and 18 years Diagnosis of myeloblastic or lymphoblastic AL during intensive chemotherapy Informed consent of parents/guardians and/or assent of the patient has been obtained Probable or proven invasive pulmonary fungal infection before entering the trial Previous chronic renal impairment or baseline serum creatinine > 2.5 mg /dL Severe hepatic impairment Moderate-severe asthma being treated pharmacologically Antifungal treatment for filamentous fungi in the last 4 weeks Participating or have participated in a clinical trial during the last 4 weeks Mentally retarded Known allergy or hypersensitivity to the active ingredient of the study drug or to any of its excipients Any serious concomitant disease that in the investigator's opinion could compromise the completion of the trial or affect the patient's tolerability to this treatment Pregnancy (in women of fertile age)", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-75.0, All Pulmonary Tuberculosis (TB) HIV negative patients, adult patients >18 years who has not started anti-TB therapy Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment) Patients who have already started treatment with anti-TB drugs for more that 5 days HIV-positive patients History of anti-TB treatment in the past 2 years Local extra-pulmonary TB in the absence of lung manifestations Hypercalcaemia (serum calcium > 2.6 mmol/L) identified at baseline Pregnant and breast feeding women Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Infections Signature of informed consent to participate in the study Adult patients (> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation) Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively Background of IFI proven / probable prior Probable IFI / tested at the time of in the study will cause a lack of compliance with the criteria Patients who have a lack of follow biweekly with galactomannan or PCR. Have a bacterial infection not properly treated and controlled before starting empirical antifungal treatment (according to the definition given above). And finally they have a neutropenia of short duration that it creates a significant risk of IFI. This information will not be known logically to the patient in the study", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 1.0-16.0, All Pediatric Urinary Lithiasis The patients with pediatric urinary lithiasis Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Survival After IPA Risk Factors for IPA > 18 years positive aspergillus culture in respiratory tract sample OR positive aspergillus galactomannan in respiratory tract sample no inform consent age < 18 years", "label": "2"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Immunocompromised Patient Aspergillosis Fusarium Any adult \u226518 years old Patients where a new course of voriconazole is indicated for suspected or confirmed invasive aspergillosis or other serious fungal infections that is deemed by the treating physician to be susceptible to voriconazole Patients must have venous access to permit the administration of voriconazole and enable the procurement of multiple plasma samples to measure voriconazole concentrations Estimated creatinine clearance \u2265 50 mL/min Able to give written informed consent Considered fit to receive the trial treatment Able to remain in the hospital for at least 5 days or until they complete their trial treatment Female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception Men must also use adequate contraception Patients with an estimated creatinine clearance < 50 mL/minute (this precludes the use of intravenous voriconazole) Patients receiving any form of renal replacement therapy i.e. haemodialysis or haemofiltration Patients with hepatic insufficiency Female patients that are pregnant, breast feeding or planning pregnancy during the study Past history of intolerance to voriconazole Age <18 Evidence of a clinically relevant fungal isolate that is resistant to voriconazole QT prolongation on ECG Use of other medications that contraindicate the use of voriconazole Patients receiving any other medications that are contraindicated with the use of voriconazole i.e. terfenadine, long acting barbiturates, ergot alkaloids, etc. (Refer to SMPC). Only patients on rifampicin, rifabutin, phenytoin, and carbamazepine would have voriconazole precluded. Voriconazole influences with the pharmacokinetics of many additional agents", "label": "1"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Lung Transplant Infection Lower Respiratory Tract Infection. Post bilateral sequential lung transplant Capable of performing airway clearance techniques / nebulisers Pulmonary exacerbation as defined by Fuchs et al Must be productive of sputum Able to provide informed consent within 48 hours of presentation *Fuchs Scale(8): Treatment with / without parenteral antibiotics for 4/12 signs and symptoms Change in sputum New or increased haemoptysis Increased cough Increased dyspnoea Paediatric transplant <18yrs Single lung transplant native lung physiology may confound outcome measures Interstate unable to complete follow up Unable to perform lung function testing Unable to complete subjective outcome measures unable to read English fluently Critically unwell / ICU / ventilator dependent Within 2 months of transplant date *Cystic Fibrosis will be stratified", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-40.0, All Healthy Aged from 18 to 40 years old, age difference is not more than 10 years old within the same batch of healthy volunteers, the male to female ratio of cases is 1:1. Body mass index should be in the range of 20 to 27 Body Mass Index BMI: weight (Kg)/ height (M2) Agreed to participate in the test and sign the informed consent Subjects should comply with the requirements of the clinical trial protocol and be followed Subjects have no history of TB (Tuberculosis)or family history of tuberculosis People have no pulmonary tuberculosis or extrapulmonary tuberculosis,respiratory symptom or systemic symptoms People have no tuberculosis focus after examination by X-ray chest radiograph and sputum bacilli Subjects have no acute or chronic disease, acute infectious diseases, dermatoses or skin allergy caused by various reasons Physical condition: have no history of heart, liver, kidney, gastrointestinal tract, nervous system, or metabolic disturbance, etc. ECG, blood pressure, heart rate, respiratory status and lab test indexes including blood, urine, liver and kidney function, etc are all normal within 4 weeks before screening No close contacts of tuberculosis Subjects have not participated in other clinical drug trials or inoculated against other prophylactic and immune globulin in the nearly 3 months Health people have close contacts of TB (Tuberculosis)patients, especially excreter in 3 weeks before selection Suffering from any other serious disease, e.g. during cancer treatment, autoimmune disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc People have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs Patients who have impaired or abnormal immune function, e.g. patients treated with immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood products or plasma extraction outside the gastrointestinal tract in 3 months, human immunodeficiency virus or related diseases Acute febrile illness and infection Taking part in other clinic trials Subjects have participated in any other clinical drug trials in 3 months before our clinical tests Allergic constitution, e.g. patients have allergic history to two or more kinds of drugs or food, or drug components Substance abuse and alcoholics Pregnant or breast feeding women", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-65.0, All Dental Caries Two approximal carious lesions on different teeth with at least one tooth in between Both study lesions must not require an invasive treatment Size and form of the lesions: the lesions must be fully visible and assessable on radiographs The two carious lesions must fall into classes D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction) Able and willing to observe good oral hygiene throughout the study Age \u2265 18 years and \u2264 65 years Willing and able to attend the on-study visits Willing and able to understand all study-related procedures The two study test lesions are located on adjacent teeth Fluoride varnish application < 3 months prior to study treatment Tooth with numerous carious lesions Evidence of tooth erosion History of head and neck illnesses (e.g. head/neck cancer) Any pathology or concomitant medication affecting salivary flow or dry mouth Any metabolic disorders affecting bone turnover Patient suffers from diabetes Concurrent participation in another clinical trial Women who are breast-feeding, pregnant or who plan a pregnancy during the study", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-65.0, All Dental Caries Two approximal carious lesions on different teeth with at least one tooth in between Both study lesions must not require an invasive treatment Size and form of the lesions: the lesions must be fully visible and assessable on radiographs The two carious lesions must fall into classes D1 (outer half of enamel) D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction) Able and willing to observe good oral hygiene throughout the study Age \u2265 18 years and \u2264 65 years Willing and able to attend the on-study visits Willing and able to understand all study-related procedures Written informed consent before participation in the study The two study test lesions are located on adjacent teeth Fluoride varnish application < 3 months prior to study treatment Tooth with numerous carious lesions Evidence of tooth erosion History of head and neck illnesses (e.g. head/neck cancer) Any pathology or concomitant medication affecting salivary flow or dry mouth Any metabolic disorders affecting bone turnover Patient suffers from diabetes Concurrent participation in another clinical trial Women who are breast-feeding, pregnant or who plan a pregnancy during the study", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 30.0-60.0, All Type 2 Diabetes Mellitus Pulmonary Tuberculosis Age 30 to 60 years Patients having both TB and type 2 DM Patients consenting to participate No history of previous ATT Plane to have ATT and DM treatment Age less than 30 years or greater than 60 years Pregnant women Patients having either TB or type 2 DM Patients refuse to participate Patients having extra-pulmonary TB or Multi-drug resistant MDR TB or relapse cases Patients having hepatic or renal diseases or HIV infection Patients having hypo or hyper-parathyroidism Patients on corticosteroids or immunosuppressive or thiazides diuretics or any other drugs known to interfere with vitamin D levels", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-65.0, All Influenza with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR (rRT-PCR), age between 18-65 years old, axillary temperature \u226538\u00baC and with at least two constitutional symptoms (headache, chill, myalgia \uff0cor fatigue) and one respiratory symptom (cough \uff0csore throat,or coryza) . Illness onset had to be within 36 hours, and informed consent was obtained age younger than 18 or older than 65 years old patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) Blood routine screening tests shows numeration of leukocyte 10.0\u00d7109/L or Neutrophil percentage \u226580% Those have got suppurative tonsillitis or cough purulent sputum Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease\uff08FEV1/FVC\uff1c70\uff05\uff0cFEV1/ predicated value\uff1c50\uff05\uff1b or respiratory failure or right heart failure\uff09\uff0c hepatic disease\uff08ALT or AST\u2265triple ULN\uff09, renal disease\uff08Serum Creatinine\uff1e2mg/dL\uff09,chronic congestive heart failure( NYHA \u2162-IV) Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more) Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization Two weeks before the test , those with acute respiratory Infection\uff0cotitis,or nasosinusitis Those already vaccinated or who will receive influenza vaccine. 14.other reasons not suitable for enrollment based on the investigator's discretion", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 30.0-85.0, All Invasive Pulmonary Aspergillosis COPD Cases of invasive pulmonary aspergillosis secondary to COPD Use of voriconazole or itraconazole or amphotericin B or caspofungin or micafungin within 4 weeks prior to enrollment Known allergy to voriconazole Severe impairment of live or kidney function Septic shock Unwilling to sign informed consent", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Cholecystitis Signed informed consent All patients deemed to have a clinical and surgical indication to undergo a LESS cholecystectomy Pregnancy Breastfeeding BMI>35 Serious comorbidities precluding a LESS cholecystectomy Known or suspected neuromuscular disorders impairing neuromuscular function Allergies to muscle relaxants, anesthetics or narcotics utilized for this study A (family) history of malignant hyperthermia A contraindication for neostigmine administration Chronic opioid use Prolonged QT syndrome", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 40.0-75.0, All COPD(Chronic Obstructive Pulmonary Disease) Clinical diagnosis of COPD according to GOLD 2013 A history of asthma or other chronic lung diseases Take Antioxidant therapy There are new or recurrent symptomatic myocardial ischemia, severe arrhythmia, cardiac insufficiency cerebrovascular disease Senile dementia or cognitive impairment cancer Severe liver and kidney and other viscera function insufficiency Language communication barriers Limb activity disorder The last 3 months participated in sports training", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Obstructive Pulmonary Disease Established diagnosis of COPD by medical doctor (based on clinical history or pulmonary function test) Smoking history of at least 10 pack-years CT Thorax available for assessment of bronchiectasis FEV1 >= 30% Mechanical or non-invasive ventilation Other main respiratory diagnosis other than COPD Active mycobacterial disease Immunosuppression other than steroids Active cancer treatment", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-65.0, All Tuberculosis Age 18 to 65 years with body weight from 30 kg to 90 kg Sputum acid-fast bacilli (AFB) smear positive (at least 1+ on the WHO International Union Against Tuberculosis and Lung Disease scale) Likely able to produce approximately 10 mL of sputum per day Xpert MTB/RIF-confirmed M.tb Rifampin-sensitive pulmonary tuberculosis as indicated by Xpert MTB/RIF Isoniazid urine screen negative ALT < 3X upper limit of normal, creatinine < 2X upper limit of normal Willingness to have samples stored Clinically suspected disseminated TB or acuity of illness too much as deemed by clinicians Has been treated for tuberculosis within the past 3 years Treatment with agents known to have anti-tuberculosis activity (e.g., fluoroquinolones, linezolid) for any indications during the current episode of clinical illness or within 2 months prior to screening, whichever is longer Cirrhosis or chronic kidney disease Disease complications or concomitant illness that might compromise safety or the interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g., sarcoidosis, rheumatoid arthritis, and connective tissue disorder) Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within 2 weeks prior to screening Subjects with diabetes, point of care HbA1c above 6.5, or random glucose over 200 mg/dL Conditions which compromise the subject s ability to take or absorb oral drugs Normal PA-Chest radiograph, determined during screening Total lung (left or right) collapse on PA-Chest radiograph", "label": "0"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 18.0-99.0, All Tuberculosis At least 18 years of age Diagnosis of TB (and/or NTM for NIH clinical center subjects) Ongoing signs and/or symptoms of pulmonary TB (and/or NTM at the NIH CC) Suspected drug resistance (drug susceptible allowed at the NIH CC) Available to provide at least 3 sputa over 2 or more days Taking anti-tuberculosis medicines (or NTM meds at NIH CC) during the time sputa are provided Thought likely to be Mycobacterium culture positive (including NTM infected for the NIH CC) by enrolling physician GeneXpert MTB/RIF sputum TBpositive (China subjects only) Likely able to produce sputum samples while on study Willing to provide blood samples Acute liver or kidney disease Conditions which compromise the subject s ability to take or absorb oral drugs", "label": "1"} +{"topic": "A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.", "doc": "eligible ages (years): 15.0-999.0, All Cystic Fibrosis Patient Patient Without Treatment Against A.Fumigatus Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier Patient aged 15 or over Patient able to understand the nature, purpose and methodology of the study Patient and his legal representative for minors who have given their free and informed consent Affiliate or beneficiary of a social security scheme Patients on antifungal treatment at the time of sampling Pregnant or breastfeeding Major protected by law (guardianship, curator or under Backup Justice) Inability to understand the nature and goals of the study and / or communication difficulties with the investigator Subject attending another search including a period of still going to run-in", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 14.0-19.0, All Healthy Adolescents ages 14-19 ", "label": "2"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-85.0, All Malaria, Falciparum Females and males >=18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites/mL b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection) Positive rapid diagnostic test (Binax NOW ICT) for P. falciparum Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness, seizures or abnormal neurologic exam b.) Jaundice c.) Respiratory distress d.) Persistent vomiting e.) Hematuria, as reported by the patient f.) Parasite density > 100,000 parasites/mL g.) Presence of non-falciparum species on microscopy Pregnant or breast-feeding women History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia) History of epilepsy or psoriasis History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) serum creatinine > 2.0 x ULN b.) ALT and/or AST > 3 x ULN Inability to swallow oral medication in tablet form Treatment with other investigational drugs within 30 Days prior to enrollment into the study Alcohol and/or any other drug abuse", "label": "1"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-50.0, All Dengue Fever Willing to be followed for the duration of the study Willing to use acceptable methods of contraception Good general health Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study Liver, renal, or hematologic disease Alcohol or drug abuse within 12 months of study entry History of severe allergic reaction or anaphylaxis Emergency room visit or hospitalization for severe asthma within 6 months of study entry HIV-1 infected HCV infected Hepatitis B surface antigen positive Known immunodeficiency syndrome", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-40.0, All Viremia Able to understand and give informed consent Age 18-40 years old No medical contraindications to participation discovered at the screening visit Negative serologic test for HIV, HCV and Hepatitis B surface antigen at the screening visit Female volunteers of childbearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to any injection Must weigh at least 110 lbs Any history of allergy or history of anaphylaxis to any of the vaccine components Any history of allergic reaction to human immune globulin or a history of IgA deficiency History of hypersensitivity to ingestion of eggs or allergic reaction to vaccines prepared in eggs or chick embryo cell cultures (e.g. influenza, measles) Known or suspected immunodeficiency (e.g. HIV infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids> 10 mg prednisolone/prednisone, or equivalent, for mare than 14 days in the last three months). Persons with previous skin cancer or cured non-lymphatic tumors are not excluded from the study Any clinically significant chronic medical condition that is considered progressive including: hypertension, diabetes, gastrointestinal abnormalities (e.g. active peptic ulcer disease), cardiac, pulmonary, hepatic, renal, or neurologic disease History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions, or occupational requirements that in the opinion of the investigator would preclude compliance with the trial Receipt of any live or inactivated vaccine between the screening visit and the day 0 visit, or any vaccine within 30 days of a vaccination visit Any subject found to be HIV positive, hepatitis B surface antigen positive, or hepatitis C antibody positive at the time of screening Any contraindication to intramuscular injection Women who are pregnant, nursing or expect to become pregnant during the study period", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 11.0-14.0, All HIV Infections Clinically-identified HIV-1 infected participants 11-14 years of age and their primary caregivers HIV status has been disclosed to the adolescent Caregiver is the legal guardian of the adolescent as indicated by the medical team Adolescent lives with the caregiver Adolescent and caregiver speak and understand English Caregiver consent or permission denied or adolescent does not assent Adolescent diagnosed as mentally retarded as previously reported or confirmed through chart review Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-50.0, All Dengue Available to participate for the duration of the study (approximately 12 months) Completion and review of knowledge assement quiz Pregnant (by history or as ascertained by pregnancy test) or lactating female Female who intends to become pregnant during the study Plan to have elective surgery during the study period HIV infection Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed) History of splenectomy Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination Evidence of active (acute or chronic) hepatitis B or C infection Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-50.0, All Dengue Hemorrhagic Fever Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine General good health Available for the duration of the study Willing to use accepted forms of contraception Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study Certain abnormal laboratory values Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry History of severe allergy or anaphylaxis Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry HIV infected Hepatitis C virus infected Hepatitis B surface antibody positive Known immunodeficiency syndrome", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 11.0-70.0, All Adolescent Sexual Risk Behaviors Parents of adolescents in grades 6-10 Parents must spend at least two days per week with their adolescents One parent per household/family ", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-50.0, All Dengue Good general health Available for the duration of the study (23 weeks for Cohort 1 and 32 weeks for Cohort 2) Willing to use acceptable forms of contraception for the duration of the study Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study Significant laboratory abnormalities Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry History of severe allergic reaction or anaphylaxis Severe asthma HIV-1 infected Hepatitis C virus (HCV) infected Hepatitis B surface antigen positive Known immunodeficiency syndrome", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-55.0, All Typhoid Fever Healthy Males or Females aged 18 to 55 years, inclusive Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-45.0, All Dengue Fever Dengue Hemorrhagic Fever Dengue Virus Healthy, as determined by medical history, clinical examination, and biological safety parameters Aged 18 to 45 years on the day of inclusion Provision of informed consent signed by the subject or another legally acceptable representative For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination Able to attend all scheduled visits and to comply with all trial procedures Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test Breast-feeding woman Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids are allowed Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 12.0-18.0, All Post-traumatic Stress Disorder Alcohol Abuse Alcohol Dependence The investigators will screen all English speaking female and male adolescents ages 12-18, who present to Harborview Medical Center with injuries so severe that they require inpatient admission and/or > 24 hour observation in the emergency department All patients where both parents and adolescents consent to the study will be enrolled in the study and randomized Adolescents who have suffered head, spinal cord, or other severe injuries that prevent participation in the baseline interview will be excluded from the protocol Patients who require immediate intervention (e.g., self-inflicted injury, active psychosis, mania, and victims of family abuse) will be excluded and referred to the Harborview Inpatient Psychiatric Consult Service Patients who are currently incarcerated or are likely to face criminal charges will be excluded", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 0.0-999.0, All Dengue Clinical diagnosis of Dengue Fever ", "label": "2"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 2.0-11.0, All Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases Aged 2 to 11 years on the day of inclusion Subject in good health, based on medical history, physical examination and laboratory parameters Provision of Assent Form signed by the subject (for subjects \u22658 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]) Subject and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures For a female subject of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination Documented receipt of yellow fever vaccine since at least one month before the first vaccination Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia For a female subject of child-bearing potential (girls post-menarche), known pregnancy For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the trial Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 4.0-11.0, All Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases Aged 4 to 11 years on the day of inclusion Subject in good health, based on medical history and physical examination Provision of assent form signed by the subject (for subjects \u2265 7 years old) and informed consent form signed by the parent or another legally acceptable representative Subject and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures Subject attending one of the schools involved in the trial and living in the Ratchaburi Province For a female subject of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination Febrile illness (temperature \u2265 37.5\u00b0C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator Receipt of blood or blood-derived products in the past 3 months Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 12.0-18.0, All Anorexia Nervosa Adolescents with anorexia nervosa Ability to preform lung function tests Parents signing informed concent and adolescents signing informed ascent A history of a lung disease Intercurrent lung illness", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 12.0-17.0, All Depression Suicide for Adolescents Lives at home with at least one parent or guardian Speaks English Must have made a suicide attempt and be diagnosed with major depressive disorder (MDD) for Primary Caretakers Speaks English Current diagnosis of MDD and a history of suicidality for Adolescents Judged to have developmental or cognitive delays or psychotic disorders on the basis of a standard psychiatric exam Diagnosis of bipolar disorder or a substance dependence (people with a diagnosis of substance abuse are eligible) Only one adolescent per family is eligible for Primary Caretakers Diagnosis of bipolar disorder or substance dependence If taking antidepressants, not on a stable dose for 3 months", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-999.0, All HIV Infections Pneumococcal Infections Male or female subjects aged 18 years or older at the time of enrollment All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment CD4+ T-cell count >= 200 cells/\u00b5, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination HIV-infected subjects with viral load <50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before investigational product vaccination, are eligible.) Subjects with active AIDS related illness, including opportunistic infections or malignancy Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment Contraindication to vaccination with pneumococcal conjugate vaccine Previous anaphylactic reaction to any vaccine or vaccine-related component History of culture-proven invasive disease caused by Streptococcus pneumoniae within the last year Current anticoagulant therapy or a history of bleeding diathesis or any condition associated with prolonged bleeding time that would contraindicate intramuscular injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is permitted.) Pregnant or breastfeeding women, as defined by history or positive human chorionic gonadotropin (hCG) urine test. All women of childbearing potential must have a urine pregnancy test History of active hepatitis with elevation in pretreatment aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal within the last 6 months Serious chronic disorder or any other disorder that, in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives. (Note: Serious chronic disorders metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease)", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-48.0, All Japanese Encephalitis All aspects of the protocol explained and written informed consent obtained from the participant Aged \u226518 to < 49 years In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results Participant must be available for the study duration, including all planned follow-up visits Participant must agree to take the following precautions to avoid insect bites for 7 days following vaccination by using N,N-diethyl-meta-toluamide (DEET)-containing insect repellent, where appropriate For female participants: Negative pregnancy tests at Screening and Day 0, in conjunction with a menstrual and contraceptive history indicating a low probability of pregnancy in the opinion of the physician. Females of childbearing potential will be required to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before randomisation and during the on-study phase to Day 30. Barrier methods of contraception will not be considered acceptable for study entry. Female participants of child-bearing potential will sign an agreement that contraception will be correctly practised during the specified periods and will specify the method used. Female participants unable to become pregnant must have this documented (e.g., tubal ligation, hysterectomy or postmenopausal [at least one year since last menstrual period]) A history of vaccination or infection to Japanese encephalitis (JE) or yellow fever (YF) or other flaviviruses (including Japanese encephalitis, tick-borne encephalitis, St Louis encephalitis, West Nile virus, dengue fever, Murray Valley encephalitis). Previous vaccination will be determined by history (interview of subject) Previous or current military service History of residence in or travel to flavivirus endemic areas in the tropics (Cape York region of Northern Queensland, India, Southeast Asia, Central America, Caribbean or South America) for periods of 4 weeks or more Known or suspected immunodeficiency (e.g., human immunodeficiency virus [HIV] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids > 10 mg prednisone, or equivalent, in the last three months or during the trial (up to Day 30) History of thymoma, thymic surgery (removal) or myasthenia gravis Clinically significant abnormalities on laboratory assessment (i.e., meeting the mild, moderate or severe described in the toxicity gradings for laboratory values) Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, hymenoptera (bee family) stings, or drugs (including vaccines) Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30 Administration of another vaccine or antiviral within 30 days preceding the screening visit or up to Day 30 (these subjects will be rescheduled for vaccination at a later date) Physical examination indicating any clinically significant medical condition", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 17.0-65.0, All Crimean-Congo Hemorrhagic Fever Lassa Fever An individual will be enrolled in this study if the patient Meets the case definition for a probable or a suspected case of CCHF or LF (see below) Has read and signed the Informed Consent Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Agrees to collection of required specimens Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (\u00b12 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy Has known intolerance to Ribavirin Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission) Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major) Has history of autoimmune hepatitis Has a calculated serum creatinine clearance of < 30 mL/min History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome A sinus bradycardia of less than 40 beats per minute Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin Relative", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-45.0, All Dengue Male or female at least 18 and less than or equal to 45 years old at time of screening In good health as determined by medical history, physical examination including height and weight, and clinical safety laboratory examinations. For creatinine and alkaline phosphatase levels the applicable cut-offs for determination are the upper limits of normal only, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values. For aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the applicable cut-offs for determination are less than 1.5 times the upper limits of normal, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values or with mild elevations above the upper limits of normal Laboratory values not listed in Table 3 which are obtained as part of a reference laboratory pre-determined panel will be considered as acceptable for enrollment if they are either within reference laboratory normal range or within the ranges specified for a grade I AE per the protocol Toxicology Tables in Appendix B. Values within reference laboratory normal ranges or within ranges specified for a grade I AE per the Toxicology Tables in Appendix B will be considered as discussed with the medical monitor and may be enrolled with no further discussion. Values with deviations outside the ranges specified for a grade 1 AE in the Toxciology Tables in Appendix B will be discussed further between the PI and the medical monitor prior to vaccination and assessed for impact on volunteer safety. Urinalyses obtained from female volunteers on their menses may be repeated after their menses have concluded without discussion with the medical monitor. Laboratory values which are not listed in the Toxicology Tables in Appendix B and which are out of the reference laboratory normal range will be discussed with the DMID medical monitor to determine its relevance for safety and impact on enrollment and follow-up vaccinations Blood tests negative for antibodies to human immunodeficiency virus (HIV)-1, Hepatitis C, dengue, West Nile, and negative for Hepatitis B surface antigen No history of dengue or West Nile infection or participation in a previous dengue or West Nile vaccine trial Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until after the last blood sample (at day 270) Willing and able to give written informed consent to participate Willing and able to communicate with the investigator and understand the requirements of the study Electrocardiogram (ECG) in absence of clinical significance (e.g., complete left or right bundle branch block, incomplete left bundle branch block or sustained ventricular arrhythmia, or two premature ventricular contraction's (PVC's) in a row, or ST elevation consistent with ischemia) Weight: greater than or equal to 110 lb Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular, thromboembolic, autoimmune, coagulopathic, or gastrointestinal disorders or history of such disorders Any history of malignancy with the exception of basal cell carcinoma Previous history , or current diagnosis of diabetes mellitus Pulse >95 or <40 at rest or irregular, systolic blood pressure (bp) >170 or <90 at rest or diastolic bp >90 or <50 at rest, body temperature >100 F, respirations >25 per minute at rest History of allergy to penicillin, neomycin, streptomycin or gentamicin History of hypersensitivity to any vaccine History of previous vaccination with Yellow Fever (YF) vaccine or Japanese Encephalitis (JE) vaccine or planned receipt of either YF or JE vaccine during the course of the study Previous history of infection with dengue or West Nile or seropositive antibody status to dengue or West Nile virus or participation in a vaccine trial for either of these Travel or planned travel to a dengue-endemic area including the Caribbean, Mexico, Central America, South America or Asia during the study period or in the month prior to screening. An updated map of dengue endemic areas is available at the CDC Yellow Book 2010 website (http://wwwnc.cdc.gov/travel/yellowbook/2010/chapter-5/dengue-fever-dengue-hemorrhagic-fever.aspx) and a list of dengue endemic countries is provided in the Manual of Procedures (MOP)", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 0.115-45.0, All Typhoid Fever Main Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment) Written informed consent will be obtained by the all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial ", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 1.0-1.083, All Dengue Dengue Hemorrhagic Fever Yellow Fever Aged 12 to 13 months on the day of inclusion Born at full term of pregnancy (\u226537 weeks) and with a birth weight \u22652.5 kg as reported by the parent/legally acceptable representative Subject in good health, based on medical history and physical examination Subject has completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by 2 independent witnesses if required by local regulations) Subject and parent/legally acceptable representative/tutor able to attend all scheduled visits and to comply with all trial procedures Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Planned receipt of any vaccine in the 4 weeks following first trial vaccination Previous vaccination against yellow fever (YF), hepatitis A, or measles, mumps and rubella Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 weeks or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Personal known seropositivity for human immunodeficiency virus (HIV) as reported by the parent/legally acceptable representative History of previous maternal vaccination against YF as reported by the parent/legally acceptable representative Personal history of YF or dengue infection/disease as reported by the parent/legally acceptable representative Known systemic hypersensitivity to any of the vaccine components of the vaccines that will be used in the trial, or history of a life-threatening reaction to the vaccines used in the trial or to vaccines containing any of the same substances", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-50.0, All Chikungunya Virus Vaccines, Virus-like Particles Viral Vaccines Humoral Immunity Chikungunya Fever A participant must meet all of the following < TAB> 18 to 50 years old < TAB> Available for clinical follow-up through Week 44 < TAB> Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process < TAB> Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly < TAB> Able and willing to complete the informed consent process < TAB> Willing to donate blood for sample storage to be used for future research < TAB> In good general health, with a BMI less than or equal to 40, without clinically significant medical history, and has satisfactorily completed screening < TAB> Physical examination and laboratory results without clinically significant findings within the 56 days prior to enrollment Laboratory within 56 days prior to enrollment A participant will be excluded if one or more of the following conditions apply Female-Specific < TAB> Woman who is breast-feeding or planning to become pregnant during the time projected for individual study participation < TAB> Systemic immunosuppressive medications or cytotoxic medications within 12 weeks prior to enrollment [with the exceptions that a short course of corticosteroids (less than or equal to10 days duration or a single injection) for a self-limited condition at least 2 weeks prior to enrollment will not study participation] < TAB> Blood products within 16 weeks prior to enrollment < TAB> Immunoglobulin within 8 weeks prior to enrollment < TAB> Prior vaccinations with an investigational CHIKV vaccine < TAB> Investigational research agents within 4 weeks prior to enrollment < TAB> Live attenuated vaccines within 4 weeks prior to enrollment < TAB> Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 2 weeks prior to enrollment", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-50.0, All Dengue Disease Dengue Fever Male or female age 18 to 50 (inclusive) years old at the time of enrollment Have negative anti-dengue, Japanese encephalitis, West Nile, and yellow fever ELISA serological tests Be informed of the nature of the study and provide written informed consent If the subject is of child-producing potential, he/she agrees to practice adequate birth control or abstain from sex Have access to the WRAIR Clinical Trials for at least 270 days, and be willing to refrain from participation in other investigational clinical trials Be in good general health -Subjects meeting any of the following will be excluded from the study History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, yellow fever, and dengue Have a known or suspected hypersensitivity or adverse reaction to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0 Have a positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV antibody Are pregnant or breastfeeding Have donated or received blood, blood products, or plasma within 30 days prior to Day 0 Have any acute illness, including an oral body temperature >100.4\u00b0F, within 7 days before the initial injection on Day 0 Have a past or current history of malignant disease except for adequately treated skin cancer Exclusions but are not limited to conditions pertaining to or evidence of immunodeficiency; allergies requiring treatment with antigen injections; autoimmune disease; severe migraine headaches; unstable asthma; clinically significant cardiac arrhythmias, diabetes mellitus, thyroid disease, a bleeding disorder or a seizure disorder", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 11.0-17.0, All Immunization Rate Age 11-17 years old Active patient (visit in last 2 years) of clinics in study Need one or more vaccines or well-care visit Up to date on vaccines and well-care", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 65.0-999.0, All Pneumococcal Vaccines Pneumococcal Conjugate Vaccine Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component Previous vaccination with any licensed or experimental pneumococcal vaccine Documented Streptococcus pneumoniae infection within the past 5 years Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 1.0-14.0, All Japanese Encephalitis Children aged between 1 and 14 years who had clinically diagnosed encephalitis on the basis of history of fever that lasted less than 14 days, altered consciousness with or without a history of new onset seizures with CSF finding of white cell count less than 1000 cells/mm3 with no organisms on Gram stain and a CSF: plasma glucose ratio > 40% admitted in Kanti Children's Hospital and BP Koirala Institute of Health Sciences, Nepal Asexual Plasmodium falciparum parasites in blood Coma appears secondary to other systemic condition, eg hepatic failure, cardiac failure, toxins Patients who have documented antibiotic treatment before admission and in whom partially treated bacterial meningitis appears more likely than encephalitis Children with simple febrile convulsions, defined as a single seizure lasting less than 15 minutes followed by full recovery of consciousness within 60 minutes Pregnant or breastfeeding females Children with a GCS of 3/15, who were receiving artificial ventilation without signs of spontaneous respiration, and with absent oculocephalic reflex", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 7.0-16.0, All Dengue Dengue Fever Dengue Hemorrhagic Fever Ongoing participation in study CYD23 at the time of enrollment Assent form has been signed and dated by the subject (for subjects \u2265 7 years old), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by 2 independent witnesses Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures Planned participation in another dengue clinical trial during the present study Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-999.0, All Diabetic Foot Ulcer Infection Non-hospitalized subjects with Type 1 or Type 2 diabetes mellitus as defined by the American Diabetes Association diagnostic (ADA, 2010). Diabetes may be treated with insulin, oral hypoglycemic agents, diet, or a combination of these therapies. Subjects whose diabetes is considered \"controlled\" by diet or medication in the opinion of the physician Males or females at least 18 years old Subjects must be considered by the investigator to be reliable, willing and able to give signed informed consent, and must sign the informed consent form Subjects must have a full thickness (i.e., extending through dermis but not involving tendon, bone, or joint capsule) ulcer on the foot distal to the malleoli with a surface area \u22651 cm2 after the wound has undergone appropriate debridement. Subjects must have localized mild infection of the ulcer, as defined by the IDSA as per Appendix C, with in the PGN1300 Protocol, which the investigator believes would ordinarily be treated on an outpatient basis IDSA mild infection of an ulcer is defined as The presence of \u22652 of the following items Local swelling or induration Erythema Local tenderness or pain Local warmth Subjects with IDSA-defined moderate infection as per Appendix C, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; osteomyelitis; gangrene; muscle, joint, or bone involvement Subjects with IDSA-defined severe infection as per Appendix C, within PGN1300 Protocol including systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, hyperglycemia, or azotemia) Subjects with systemic inflammatory response signs, as manifested by \u22652 of the following Temperature >38\u00b0C or <36\u00b0C Heart rate >90 beats/min Respiratory rate >20 breaths/min or PaCO2 <32 mm Hg White blood cell count >12 000 or <4000 cells/\u03bcL or \u226510% immature (band) forms Subjects with local wound complications (e.g., prosthetic materials) Subjects currently receiving antibiotic treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment Subjects requiring concurrent systemic antimicrobials during the study period for any infection, including diabetic foot ulcer", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 14.0-17.0, All Overweight Adolescent Behavior Family Research Weight Loss Adolescent ages 14-17 years old living at home with at least one parent/guardian BMI \u2265 85th percentile assent from adolescent consent from a parent/guardian willingness of one parent/guardian living with adolescent to participate in the study English speaking Adolescent BMI \u2265 40 (requires additional medical attention the intervention is unable to provide) previously diagnosed type 1 or type 2 diabetes blood pressure in the range of stage 2 hypertension which requires medication treatment which interferes with outcomes related to blood pressure and glucose medications that significantly interfere with weight gain such as oral steroid use greater than two consecutive weeks antipsychotic medications participation in a standardized weight loss program within the previous 6 months inability to provide informed assent no parent/guardian consent insufficient reading ability to comprehend the self-administered assessment instruments (approximately 5th grade reading level)", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 0.25-16.0, All Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 45.0-999.0, All Infected by Chikungunya Virus Age at onset of symptoms \u2265 45 years Seen in consultation at the University Hospital of Fort-de-France Suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees) Duration of symptoms suggestive of infection chikungunya less than or equal to 10 days Presence of joint pain on the day of No history of inflammatory arthritis Absence of steroidal or non-steroidal anti-inflammatory drugs taken within two weeks prior to Ability to participate in the study throughout its duration (12 months) Patient affiliated or beneficiary of a social health care Acceptance to participate in the study and monitoring proposed and signed informed consent Age at onset of symptoms <45 years Duration of symptoms suggestive of chikungunya for more than 10 days Lack of joint pain on the day of History of inflammatory arthritis Nonsteroidal anti-inflammatory drugs or Taking in the two weeks preceding the Inability to participate in the study throughout its duration (12 months) Patient is not affiliated or beneficiary of a social health care Refusal to participate in the study or to sign a consent", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-999.0, All Influenza clinical presentation that suggest influenza virus infection, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose positive to influenza virus by PCR test anti viral treatment was indicated Immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs Pregnant women Patients who were treated with oseltamivir in the previous 6 months", "label": "1"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 0.0-999.0, All Dengue Fever Stage 1 Discharge diagnosis with International Classification of Disease (ICD) code A90 A99 Availability of minimal dataset (name, IC, age, sex, diagnosis, date admit, date discharge, discharge status) Stage 2 Laboratory confirmed dengue (Non-structural 1 antigen, dengue IgM, high-titre dengue IgG, and dengue polymerase chain reaction (PCR) positive) ", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 0.5-50.0, All Dengue Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit[s] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.) Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form [IAF] when applicable) will be countersigned by an impartial witness Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child Male or female aged between and including 6 months and 50 years at the time of enrolment Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period Child in care Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement Terminal illness based on investigator's judgement Mental incapacity based on investigator's judgement", "label": "0"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 18.0-65.0, All Dengue Fever Dengue patients confirmed by dengue virus NS1 or RNA Pregnant women Fever diseases caused by other viruses Combined bacterial infection Without complications such as diabetes and tumor", "label": "1"} +{"topic": "An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.", "doc": "eligible ages (years): 13.0-22.0, All Dengue Fever Dengue Hemorrhagic Fever Has been identified as a potential subject by the Sponsor and is included in the list provided to the Investigator (i.e., aged 9 to 16 years on the day of first vaccination of CYD dengue vaccine in CYD13/CYD30 and has a post-dose 3 serum sample available [at least 400 \u00b5L of serum]) Presently in good health, based on medical history and physical examination Assent form or informed consent form (ICF) has been signed and dated by the subject (based on local regulations), and ICF has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations) Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures Subject who received any other dengue vaccination that was not part of the CYD13 and CYD30 trials Subject is pregnant, or lactating, or of childbearing potential (to be considered of non childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination) Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia, Pneumocystis Carinii HIV Infections Co-existing Condition Patients with the following are excluded Previous history of adverse reaction to pentamidine History of asthma Pulmonary Kaposi's sarcoma Patients with the following are excluded Previous history of adverse reaction to pentamidine History of asthma Pulmonary Kaposi's sarcoma Inability to understand the consent procedure", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.0-999.0, All Spinal Cord Injuries Spinal cord injury of >= 1 year in duration, and no other neuromuscular diseases ", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia Sepsis Current diagnosis of community-acquired pneumonia Evidence of systemic inflammatory response to infection Atypical or viral pneumonia based on clinical or epidemiologic suspicion by the investigator Presence of organ failure", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 19.0-120.0, All Lung Cancer Histologically or cytologically confirmed non-small cell lung cancer Stage IIIA (T1-3, N2) Positive (pathological) ipsilateral mediastinal node Selective stage IIIB meeting all of the following No pleural/pericardial effusion or superior vena cava syndrome T4 due to invasion of carina, trachea, or mediastinal structures Mediastinal N3 nodes (without supraclavicular or cervical adenopathy) Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration) Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry Measurable disease by contrast CT scan allowed ", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia years of age or older acute respiratory tract infection patients from outpatient clinics and the emergency department under the age of 18 suspected hospital-acquired pneumonia suspected aspiration pneumonia inpatients", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia Greater than or equal to 18 years of age Orally/nasally intubated and receiving mechanical ventilation for <24 hours prior to scheduled randomization and administration of the first dose of Study Drug, and in the judgment of the attending physician, expected to remain intubated and mechanically ventilated for at least 48 hours Expected to survive for at least 21 days and to remain at the investigational site and not transferred to another institution while intubated during the 21-day study period Willing and able to provide written informed consent, or if unconscious or have altered sensorium, have a surrogate provide written informed consent as approved by the institution Negative pregnancy test within 7 days prior to randomization if a female of childbearing potential (Negative pregnancy test results [urine or serum] obtained for reason other than the purposes of this study are acceptable.) Current diagnosis of pneumonia (Patients currently receiving antibiotics for treatment of pneumonia and patients who meet the study definition of clinically defined pneumonia at the time of screening will be excluded.) Absolute neutrophil count less than 1000/mm3 Human immunodeficiency virus infection with a last known CD4 count less than 500/mm3 Recipient of organ transplantation and receiving immunosuppressive therapy Current hematologic malignancy Previously documented cystic fibrosis Severe cranio-facial trauma or other medical condition expected to require imminent tracheostomy Patient, patient\u2019s family and/or physician not in favor of aggressive medical management or presence of an advanced directive to withhold life-sustaining treatment Moribund state or expected to survive less than 21 days due to an uncorrectable medical condition Participation in a clinical trial of any unlicensed drug, biologic or device within 30 days prior to the first dose of study drug", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-35.0, All Respiratory Tract Infections Chronic Bronchitis Pneumonia Subjects meeting all of the following will be considered for enrollment into the study Male and female adult outpatient subjects diagnosed with AECB or CAP Female subjects must be either postmenopausal for \u2265 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow \u2264 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the for acceptable birth control Informed consent must be obtained in writing for all subjects upon enrollment Subjects will have a diagnosis of AECB or CAP, as defined below AECB-Specific Subjects greater than or equal to 35 years of age Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70% Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume Subjects producing spontaneous sputum Subjects presenting with any of the following will not be included in the study Subjects with a known history of congenital long-QTc syndrome Subjects who are pregnant or breast-feeding Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax) Subjects who have previously participated in this study Subjects with a previous history of myasthenia gravis Subjects with current acute respiratory failure or subjects who require aggressive airway management Hospitalized subjects and subjects from institutional care facilities", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 64.0-999.0, All Pneumonia Lower Respiratory Tract Infection Symptoms or signs of lower respiratory tract infection as defined by standardized criteria Residents were excluded if they were not expected to live longer than 30 days from the date of enrollment, had a previous anaphylactic or serious allergic reaction to quinolones, had advanced directives that they are not be transferred to hospital for treatment", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Mycoplasma Pneumoniae Working at hospital facility where outbreak of Mycoplasma pneumoniae occured Pregnant, on antiseizure medications, allergic to macrolide antibiotics", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 8.0-17.0, All Asthma Allergy Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97) Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6 Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2) Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16) Positive house dust mite skin prick test, with a more than 3 mm infiltrate Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial Active smoking Dogs or cats in the home Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.167-17.0, All Bacterial Infection Parent or legal guardian has signed the informed consent Age greater than 48 weeks post-conception and less than 18 years of age Requiring mechanical ventilation in the intensive care unit (subjects will not be intubated solely for the purpose of this study) Presence of an abnormal chest x-ray (CXR) as determined by the primary care team (Note: if the attending radiologist disagrees with the reading of \"abnormal CXR,\" the subject will be followed for safety and replaced for analysis) Initiation of antibiotics by the assigned health care providers for suspected bacterial pneumonia (must be less than or equal to 12 hours prior to undergoing non-bronchoscopic bronchoalveolar lavage [NB-BAL]) Presence of severe hypoxia (PaO2/FIO2 < 120) Documented or suspected increased intracranial pressure Hemodynamic instability, defined as one of the following in the 4 hours preceding study entry Initiation of any inotropic or vasopressor agents at any dose to improve blood pressure or tissue perfusion Increase in infusion rate of any inotropic or vasopressor agents to improve blood pressure or tissue perfusion Receipt of intravenous (IV) or oral (PO) antibiotics for suspected bacterial pneumonia for greater than or equal to 12 hours prior to non-bronchoscopic bronchoalveolar lavage (NB-BAL) Treatment for a previous episode of suspected bacterial pneumonia within three days prior to NB-BAL Coagulopathy Documented platelet count <50,000 x 10^6/mL at the time of enrollment (Exception: The subject may be enrolled if he/she receives a platelet infusion as a part of routine care that is completed within one hour of NB-BAL initiation) Extra-corporeal circuit, requiring anticoagulation, or", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Community-Acquired Pneumonia Age: 18 years and above Clinical and radiological diagnosis of community-acquired pneumonia Informed consent of patient Hospital admission Prior hospital admission (less than 15 days) Alternative diagnosis at the discharge Immunosuppression (HIV infection, immunosuppressive therapies, neutropenia) Risk factors for unusual etiologies Patient is pregnant", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Community Acquired Pneumonia Community acquired pneumonia Hospitalization Immunocompromised patients Patients under chemotherapy treatment Patients under steroids treament", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Ventilator Associated Pneumonia Respiratory Infection Tracheobronchitis be on mechanical ventilation greater than 3 days greater than or equal to 18 years of age survival greater than 14 days greater than 2 ccs of tracheal secretions/4 hours allergy to drugs, pregnancy", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-70.0, All Spinal Cord Injury Chronic spinal cord injury that occurred more than 6 months ago An impaired ability to cough (cough peak flow less than 300 L/min) Oxygen saturation greater than or equal to 95% when awake and not receiving supplemental oxygen End-tidal carbon dioxide level less than 43 mm Hg Without a fever or other signs of an acute illness for the previous 2 weeks Able to learn the treatment protocol and have someone available at home to assist if needed to help set-up and use the equipment Under 18 years of age Currently have a tracheotomy tube Have a history of an acute illness in the last 2 weeks Have lung disease as seen on chest x-ray that results in a baseline oxygen saturation decreasing below 95% during daytime hours and cannot be normalized by usual way of coughing Already utilizing an oximetry protocol Have a significant medical complication and psychiatric condition that would interfere with the conduct of the study or interpretation of the study results", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.167-4.917, All Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate \u2265 50 breaths per minute for children aged 2-11 months and \u2265 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site)", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Community Acquired Pneumonia Symptoms of lower airway infection and radiologic sings of pneumonia Age<18 Serious psychiatric illness Mentally retarded Hospitalized last 14 days", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 5.0-999.0, All Anemia, Sickle Cell Diagnosis of sickle cell anemia (Hgb SS) or sickle-\u03b20-thalassemia (Hgb S\u03b20) Current episode of ACS, defined as a new lobar or segmental pulmonary infiltrate seen on a chest radiograph and two or more of the following findings Temperature of 38.5\u00b0C or higher Tachypnea (i.e., rapid breathing) Dyspnea or increased work of breathing Chest wall pain Oxygen saturation of less than 90% in room air by pulse oximetry Current episode of ACS diagnosed in the 24 hours prior to study entry Ability to take medication in capsule form Prior participation in this study Diagnosed with any medical condition that will likely be worsened by corticosteroid therapy, including any of the following conditions Diabetes mellitus High blood pressure Esophageal or gastrointestinal ulceration or bleeding Known avascular necrosis Diagnosis of ACS in the 6 months prior to study entry Treatment with oral or parenteral corticosteroid therapy for any reason in the 14 days prior to study entry Use of inhaled corticosteroids or systemic corticosteroids for respiratory illness in the 3 months prior to study entry Long-term lung condition that requires treatment with corticosteroids", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia, Bacterial Provide signed and dated informed consent Adults, 18 years of age or older of either gender and of any race weighing up to 150 kg. Female patients of childbearing potential MUST be nonpregnant (confirmed by negative serum pregnancy test), nonlactating, and must be willing to practice reliable birth control measures during and for at least 30 days after treatment with study drug(s) Have a new pulmonary infiltrate on chest radiograph Exhibit at least two of the following clinical symptoms of pneumonia on history or physical Cough Production of purulent sputum or change in character of sputum Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness to percussion, bronchial breath sounds, or egophony) Dyspnea or tachypnea Documented fever, defined as body temperature >38.0 \u00baC (100.4 \u00baF) taken orally; >38.5 \u00baC (101.2 \u00baF) tympanically; or >39.0 \u00baC (102.2 \u00baF) rectally or hypothermia, defined as core body temperature of <35.0 \u00baC (95.0 \u00baF) An elevated total peripheral white blood cell count (WBC >10,000/mm3); or >15% immature neutrophils (bands), regardless of total peripheral white count; or leukopenia with total WBC <4500/mm3 Patients with Grade V pneumonia (based on Fine Score; Attachment 8) Patients in respiratory failure or incipient respiratory failure if the patient is not a candidate for mechanical ventilation (for any reason) Any of the following pulmonary conditions that may preclude interpretation of study results Cystic fibrosis Primary lung cancer or another malignancy metastatic to the lungs Known bronchial obstruction or a history of post-obstructive pneumonia Known or suspected active tuberculosis Severe shock (systolic blood pressure <90 mm Hg for >30 minutes not corrected by fluid bolus) Clinical evidence of bacterial meningitis (based on lumbar puncture results) Severe renal impairment (calculated creatinine clearance <30 mL/min)", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Post Nasal Drip Postnasal Drip with chronic cough Postnasal drip by rhinoscopy Cough by visual analog scale Patients have to be 18 years old or older Cough-variant asthma must be excluded by a negative methacholine challenge test within one year, or documented failure of chronic cough to resolve after administration of inhaled corticosteroid (> one-month duration). Asthma is defined by the ATS guidelines Subjects must have a negative chest radiogram or Chest CT scan within 6 months No active GERD symptoms (< 7 RSI score) & a stable dose of Proton Pump Inhibitor (4 weeks) of Postnasal Drip without cough Postnasal drip by rhinoscopy No cough by visual analog scale Subject for Postnasal Drip with Chronic Cough Presence of nasal polyposis and/or sinusitis or active GERD symptoms on examination Current smokers (smoking within the 2 months prior to the study) will be excluded Patients with an upper respiratory tract infection within the preceding 8 weeks Patients taking angiotensin converting enzyme inhibitors Patients on leukotriene receptor antagonist and/ or nasal topical corticosteroids or inhaled corticosteroids. Patient must be off nasal or inhaled corticosteroid by at least 4 weeks Same for Post Nasal Drip without cough except A chest radiogram is not necessary in this group Patients taking leukotriene inhibitors, or using nasal steroid therapy", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 13.0-999.0, All Ventilator Associated Pneumonia Etiological Organisms Antimicrobial Drug Susceptibility Pattern Stress Ulcer Prophylaxis Age greater than 12 years Those on mechanical ventilation for more than 48 hours Pre-existing pneumonia at the beginning of ventilation or Developing pneumonia within 48 hours of ventilation Patients on oral antibiotics", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 1.0-45.0, All Respiratory Sounds Patient and/or parents/guardian signed informed consent Patients with cough or shortness of breath Chest tubes Skin lesions precluding attachment of sensors Respiratory distress Pregnant women", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.0-16.0, All Bacterial Infections Bacteremia Meningitis Urinary Tract Infection Mastoiditis Lobar Pneumonia Septic Arthritis Cellulitis Osteomyelitis Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture Cellulitis, lobar pneumonia, osteomyelitis ", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.167-5.0, All Pneumonia, Bacterial Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital Informed consent obtained from parents or legal guardian ", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.167-4.917, All Acute Respiratory Infections Pneumonia Children aged 2 to 59 months attending the outpatient's clinics of participating sites WHO defined non-severe pneumonia Accessibility for follow-up Written informed consent by a parent or legal guardian WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following Cyanosis Inability to drink Convulsions Abnormally sleepy or difficult to wake Severe malnutrition recognised by weight for age less than third percentile by the NCHS (National Child Health Statistics) growth chart and/or oedema (see chart) All patients with a previous history of 3 or more episodes of wheeze or diagnosed to have asthma Known or clinically recognisable congenital heart disease with cyanosis or, congestive heart failure or cardiomegaly Known or clinically recognisable acute/chronic organ system disorders including jaundice, nephrotic syndrome, severe anaemia manifested as extreme pallor etc Other infectious conditions requiring antibiotic therapy at the day of contact including meningitis, tuberculosis, dysentery, osteomyelitis, septic arthritis etc", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-80.0, All Chronic Cough Healthy Volunteers Over 18 years old Measurable cough reflex sensitivity No current or past history of chronic cough or chronic respiratory disease No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip Chronic Cough Patients Over 18 years old Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease Normal CXR Normal lung function Recent Upper Respiratory Tract Infection (4 weeks) Pregnancy/breast feeding Current smokers or ex-smokers with < 6 months abstinence or cumulative history of > 10 packyears Diabetes Mellitus Opiate or ACE Inhibitor use Any centrally acting medication which has the potential to alter cough reflex sensitivity Significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness Drug or alcohol abuse History of allergy or reaction to ketamine of other NMDA receptor antagonists", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.493-999.0, All Pneumonia presumed community-acquired pneumonia as diagnosed by the attending emergency department physician age > 6 months immunodeficiency (primary, advanced HIV) cystic fibrosis malignancy known cardiac or lung defects bronchiectasis previous pneumonia or lung abscess in past 6 months conditions requiring treatment with immune suppressants", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia CAP Those pneumonia patients have not been admitted within 14 days before diagnosing pneumonia Those pneumonia patients are not met the of HCAP as stated below HCAP Regular hemodialysis, peritoneal dialysis or infusion therapy (ex TPN, repeated blood transfusion etc ) at a hospital or hemodialysis clinic Receive radiation therapy or chemotherapy at out-patient clinics within 90 days to be admitted to an acute care hospital for two or more days within 90 days before the onset of pneumonia Resided in a nursing home or long-term care The patients with HAP: pneumonia developed two days after admission or within 14 days after discharge (except RCW) VAP: HAP and with mechanical ventilation for at least 48h (except RCW patients) HIV positive with a CD4+ < 200", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia Adult (age>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria pregnancy lactating woman colistin allergy severe renal impairment epilepsy", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 50.0-999.0, All Community Acquired Pneumonia Adult subjects 50 years of age or older Subject must reside in the surveillance area Subjects who present to a study healthcare facility where the treating physician clinically suspects CAP Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital) Hospital Acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more)", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Cough Healthy Controls Healthy volunteers Over 18 years Measurable cough reflex sensitivity \u2212 required as is the primary end\u2212point No current or past history of chronic cough or chronic respiratory disease Chronic Cough Patients Over 18 years Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post\u2212nasal drip and gastro\u2212oesophageal reflux Normal chest radiograph \u2212 primary respiratory cause for cough excluded Normal lung function \u2212 primary respiratory cause for cough excluded Measurable cough reflex sensitivity \u2212 required as primary end\u2212point Recent upper respiratory tract infection (<4 weeks) \u2212 this can lead to increased sensitivity of the cough reflex which resolves as the infection settles Pregnancy/breast\u2212feeding \u2212 unknown effects of oesophageal acid infusion Current smokers or ex\u2212smokers with < 6 month abstinence or history > 20 pack years \u2212 smoking can alter the sensitivity of the cough reflex Opiate or ACE inhibitor use or centrally acting medication \u2212 can alter the cough reflex sensitivity Symptomatic gastro\u2212oesophageal reflux, post\u2212nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) \u2212 these conditions are known to cause cough and alter cough reflex sensitivity Significant ongoing chronic respiratory/cardiovascular/gastro\u2212intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 1.0-12.0, All Pneumonia Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours) Severely ill patients (hospitalized in intensive care units) Pleural effusion treated with chest drainage Atelectasis detected by x-ray Pneumonia or pleural effusion in the previous six months Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-80.0, All Sleep Apnea Syndrome Polygraphy Community Acquired Pneumonia Infections Group A Hospital admission and Community acquired pneumonia Nosocomial infections Low level of conscientiousness Neurological disease Impossibility to complete the questionnaires Group B Hospital admission and other infections different to respiratory infections", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Respiratory Tract Infection Adults, equal to or more than 18 years years of age Patients with respiratory tract infections, including any of the following Acute tracheitis, acute tracheobronchitis Acute sinusitis Chronic sinusitis Acute tonsillopharyngitis Acute bronchitis Mild community-acquired pneumonia Acute exacerbation of chronic bronchitis Known hypersensitivity to or previously intolerant of macrolides Illness severe enough to warrant hospitalization or parenteral therapy Concomitant use of any of the following medications Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir Severe immunodeficiency and chronic disease conditions Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm) Mental condition rendering the subject unable to understand the nature of the study", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Ventilator Associated Pneumonia All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine Requiring mechanical ventilation for more than 48 hours Includes all patients with structural or metabolic coma Pregnant women History of allergic reactions to ampicillin sulbactam Patients admitted as potential organ donors Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously Hospital stay for more than 48 hours before intubation", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.167-4.917, All Severe Pneumonia Age between 2 to 59 months who present to LHWs with severe pneumonia Informed consent given by a legal guardian Very severe disease Persistent vomiting Parental or caretaker refusal to participate in the study Children currently being treated for non-severe pneumonia who advance to severe pneumonia Suspected or known kerosene oil ingestion Prior enrollment in the study within 2 weeks of last follow up Children with severe malnutrition . Children with severe diarrhea with signs of dehydration", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia Male or female patients aged \u226718 years old Patients with nosocomial bacterial pneumonia at least 48 hours after hospitalization or patients with healthcare-associated pneumonia(HCAP*) Clinical findings At least two of the following signs Cough Fever: axillary temperature > 37.5\u2103 or tympanic temperature > 38.5\u2103 Hypothermia: axillary temperature < 34\u2103 or tympanic temperature < 35\u2103 Purulent sputum production or respiratory secretion Total peripheral white blood cell (WBC) count > 10,000/mm3; or > 15% band forms, regardless of total peripheral white count; or leucopenia with total WBC < 4500/mm3 Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony) Woman who are pregnant (determined by urine test) or lactating state Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not patients who have chronic obstructive pulmonary disease) A neutrophil count <1000/mm3 Patients with pneumonia due to viral, fungal, or mycobacterial infection Patients who were known to have been infected with human immunodeficiency virus Documented Legionella pneumonia Patients were infected with gram negative (G-) microorganism known to be resistant to one of the study antibiotics during trial Subjects with sputum gram stain of PMN>25, epithelial cell <10, and gram positive (G+) cocci in cluster predominant and phagocytosis Patients who have received any other investigational drug within 30 days prior to enrollment Patients who have received medications like cefoperazone, cefoperazone/sulbactam and cefepime within 30 days prior to enrollment", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.5-1.917, All Pneumonia Laboratory Confirmed Influenza Children will be included if they are de jure residents 6 months to 23 months old at the time of first dose vaccination residing in households under surveillance Children will be excluded if they have known chronic respiratory, cardiac, or neurological (including seizure disorders) illnesses, are severely malnourished or require hospitalisation for any other reason, are suspected of having tuberculosis (WHO guidelines) [83], are known to have egg allergy, or parents withhold consent", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Stage III Non-small Cell Lung Cancer Adult patients 18 years and older with histology proven NSCLC with inoperable stage III A or IIIB disease Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on computed tomography (CT) scan such that in opinion of treating investigator, the patient was not a candidate for surgical resection N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission tomography (PET), and or CT scan if nodes are more than 2 cm Stage IIIB patients must have N3 or T4 status. N3 status must be documented by presence of contralateral (to the primary tumor) mediastinal lymph node or supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET, or more than 2 cm on CT scan No prior treatment for lung cancer ECOG Performance status of 0-1 Initiation of consolidation chemotherapy within 4-8 weeks of concurrent chemo-radiotherapy without progression Adequate organ function leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL Patient who have had prior treatment for lung cancer Prior history of radiation to chest Known malignancy other than the current cancer Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study) Patient with documented or symptoms of peripheral neuropathy History of allergic reaction to compounds similar to the ones used in this study Malignant effusions (pleural or pericardial) Superior sulcus (Pancoast) tumors Any condition that would hamper ability to give informed consent or ability to comply with study protocol", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.25-5.0, All Streptococcus Pneumoniae Nasopharyngeal Carriage To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than5 years To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children To evaluate the possible impact of vaccination policy in the referenced population", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.0-2.0, All Wheezing Bronchiolitis Age less than or equal to 24 months Presenting to the pediatric ED with wheezing On home oxygen at baseline Cyanotic congenital cardiac disease (including: ToF, TAPVR, HLHS, d-TGA, TA, pulm atresia, critical pulm stenosis, but not including VSD, ASD, Coarctation of the Aorta) Endotracheal tube or tracheostomy in place and/or receiving mechanical ventilation Transferred from an outside hospital", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Novel H1N1 Influenzal Acute Respiratory Infection > 18years Suspected or confirmed influenza (Appendix A) Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of >50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor Age less than 18 years", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia Severe community acquired pneumonia treated with azithromycin age over 18 years Azithromycin initiated before hospitalization technically undecipherable ECG Permanent pacemaker", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia, Bacterial New diagnosis of pneumonia Patient in medical or surgical intensive care unit Age greater or equal than 18 years old Neutropenia Recipient of a solid organ or bone marrow transplant Bacteremia Presence of Acinetobacter baumannii or Stenotrophomonas maltophilia from a respiratory tract culture Presence of a second infection requiring antibiotic therapy Pregnancy Enrollment in another clinical study Patient or surrogate unable to provide informed consent Attending intensive care unit physician declined enrollment in the study", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 20.0-999.0, All Pneumonia Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage [BAL], protected brushing specimen [PBS]), or should have appropriate specimens highly likely to identify the pathogens sampled. (However, the patients with Legionellosis is enrolled when the test of Legionella antigen is positive.) The following severe bacterial pneumonia meeting the diagnostic of pneumonia or secondary infection of chronic respiratory disease Severe pneumonia Community-acquired pneumonia: PORT score III, IV or V Hospital-acquired pneumonia [HAP]-Group B and with a low risk for multidrug-resistant pathogens Patients with [HAP]-Group A whose pathogen is suspected to be Pseudomonas aeruginosa Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with-Group A or B who don't respond to or have a poor response to other antimicrobials over 3day's treatment.2 Secondary infection of chronic respiratory disease Patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease Creatinine clearance (Ccr) \u2264 30 mL/min or nephrotic syndrome Patient with chronic treatment of immunosuppressive drug Decompensated congestive heart failure Subject who received more than 24 hours of an antibacterial drug for the current infection Patient who requires Intensive Care Unit (ICU) management [In case subjects who don't correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded] Patients with infections other than pneumonia or secondary infection of chronic pulmonary disease Lung abscess, or empyema Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis Known or suspected bacteremia secondary to Staphylococcus aureus Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Bacterial Pneumonia Written informed consent by the subject/subject's LAR Hospitalized males or females \u2265 18 yrs with respiratory failure requiring mechanical ventilation and clinical suspicion of HABP, HCAP or VABP Onset or exacerbation of pneumonia at least 48 hours after admission to any patient health care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility Women of childbearing potential if their pregnancy test is negative Subjects who have received previous antibacterial therapy within 14 days of pre-treatment bronchoscopy entry may be entered only if the subject has not responded clinically.). While less than 24 hours of pre-treatment antibiotics is preferential, recovery of >104 CFU/ml in the quantitative Bronchoscopic BAL will be seen as primary evidence that the prior therapy was not efficacious and enrollment will be allowed.) Patients should have clinical findings that support a diagnosis of HABP/VABP/HCAP Within 48 hours before starting empiric therapy a subject's chest radiograph should show the presence of a NEW or progressive infiltrate, cavitation, or effusion suggestive of pneumonia Within 36 hours before the start of empiric study therapy, a quantitative culture of Bronchoscopic BAL fluid must be obtained Patients with VABP should have a Clinical Pulmonary Infection Score of >/= 5 Subjects with pneumonia caused by pathogens resistant to meropenem (MIC greater than or equal to 16\u00b5g/ml) or a prior meropenem therapy failure Subjects with contra-indications to ANY study medication, in particular with known or suspected allergy or hypersensitivity Women who are pregnant or lactating Subjects taking anticonvulsant medications for a known seizure disorder.Patients with a history of seizures, AND who are stabilized on anti-seizure medication, may be enrolled into the study at the discretion of the site investigator Subjects with known or suspected community acquired bacterial pneumonia (CABP) or viral pneumonia; or Subjects with acute exacerbation of chronic bronchitis without evidence of pneumonia Subjects with primary lung cancer or another malignancy metastatic to the lungs Subjects who were previously enrolled in this study Subjects who have had an investigational drug or have used an investigational device within 30 days prior to entering the study Subjects with another focus of infection requiring concurrent antibiotics that would interfere with evaluation of the response to study drug Subjects with cystic fibrosis, AIDS with a CD4 lymphocyte count <200 cells/\u00b5l, neutropenia (absolute neutrophil count <500 cells/ml), known or suspected active tuberculosis", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 19.0-92.0, All COPD Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948) Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years Agrees to volunteers for the study and willing to sign the informed consent form There were negative/normal screening tests for the following Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition \"Normal\" spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69% Impedance oscillometry were within normal limits \"Negative\" physical examination of the chest with absence of wheezing and crackles on auscultation of the chest Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups men of: ages < 18, 31-54 and >92 years old current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years refusal to volunteer for the study and not willing to sign the informed consent form screening test not considered \"normal\" by physician/PI and showing one or more of the following one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.) Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%) \"Positive\" physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest Impulse oscillometry >4 times normal limits Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 2.0-18.0, All Community-acquired Pneumonia Children hospitalized for community-acquired pneumonia 18 years old Pulmonary chronic disease (including asthma) Immunodeficiency Diseases wich requires corticosteroids therapy (i.e. rheumatic diseases) Wheezing in current disease Previous hospitalization (14 days prior to admission) Pleural effusion on admission Malnutrition", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Community Acquired Pneumonia or older admitted with CAP will be included sequentially. Pneumonia is defined as pulmonary infiltrate shown in a thoracic X-ray not known to be old patients with human immunodeficiency virus infection immunosupressed patients (with a solid organ transplant, spelenectomy, treated with a prednisone dose of 10 mg/day or equivalent for longer than 30 days or with other immunodepressors, with neutropenia) those hospitalized in the 14 days prior and those living in assisted care facilities pneumonia cases caused by infrequent agents (i.e. P. aerouginosa, S. Aureus) will also be excluded, as well as infectious processes requiring an extended treatment with antibiotocs (i.e. bacterial endocarditis, abscesses) pneumonia cases with pleural effusion requiring a drainage tube patients who were deceased or admitted to ICU before randomization and those not giving their informed consent", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Community-acquired Pneumonia \u25cf Adult patients greater than age 17 years who are initially evaluated in the ED with symptoms of CAP. This includes those who will be treated as outpatients and those admitted to the hospital (both ward and ICU) The definition of CAP is as follows Presence of pulmonary infiltrates on chest radiography. (Initial reading may be performed by the ED physician but has to be confirmed by board certified radiologist for in the study) At least 2 of the following: new onset of cough, productive sputum, shortness of breath, chest pain, fever > 380C, abnormal chest auscultation, WBC > 12,000 cells/mL Able to provide informed consent Read, signed, and dated informed consent document Available for follow-up for the planned duration of the study Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia, transplant recipient, cystic fibrosis, receipt of immunosuppressive medications including corticosteroids, (equivalent of prednisone > 10 mg) cancer chemotherapy, or anti-tumor necrosis factor agents Patients residing in long-term care facilities", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-75.0, All Healthy Volunteers and Asthma Understanding of the study and a signed informed consent form before any study-related procedures Willing and able to adhere to the restrictions specified in the protocol Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels \u22642 x ULN; serum aspartate aminotransferase (AST) levels \u22642 x ULN Part 1 (healthy participants) a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive b). Healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram (ECG) performed at Screening Visit 2 Part 2 a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on physician assessment at Screening Visit 2 b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (<)2.5 at Screening Visit 2 c). Have a prebronchodilator forced expiratory volume in the first second (FEV1) greater than or equal to (>=) 65 percent of predicted normal value at Screening Visit 2 Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1 Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1 Part 2 (asthmatic patients): Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1 Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids Is receiving a high-dose inhaled corticosteroid (ICS) (>500 \u00b5g/day to fluticasone or equivalent). Use of low or medium dose ICS (\u2264500 \u00b5g/day fluticasone or equivalent) with or without permitted controller medications, eg, long-acting Beta2 agonists (LABA), leukotriene receptor antagonists (LTRA), is allowed", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 1.0-10.0, All Pneumonia children aged 1-10 y presenting to the emergency department must fulfil definition of 'pneumonia', ie any one of fever in the ED a recorded fever at home in the 48h prior to presentation, or WBC > 12 or WBC < 5 in the ED any one of tachypnoea on exam cough on exam or by history increased work of breathing on exam; or or more episodes of emesis in the emergency history of CF, anatomic lung disease, bronchiectasis, congenital heart disease, repeated aspirations, malignancy, immune suppression, recent prolonged admission to hospital, pneumonia diagnosed within the last month, lung abscess within the past six months, > 24 hours of beta-lactam antibiotic therapy prior to presentation, allergy to penicillin, allergy to food colouring evidence of empyaema or necrotizing pneumonia on chest radiograph", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia, Bacterial Nosocomial Infection Intraabdominal Infections Urinary Tract Infection Patients who are diagnosed with nosocomial pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections or complicated urinary tract infection Patients who are eligible for doripenem treatment Pregnant or lactating females Patients with hypersensitivity to doripenem and/or its derivatives Known at study entry to have an infection caused by pathogen(s) resistant to doripenem Patients taking probenecid History of severe allergies to certain antibiotics such as penicillins, cephalosporins, and carbapenems Severe impairment of renal function including a calculated creatinine clearance of less than 10 mL per minute, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours)", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-45.0, All Neonatal Infection Pregnant women (aged 18 to 45 years) in labour attending a health centre in western Gambia for delivery Known HIV infection Any chronic or acute conditions of the women that might interfere with the study as judged by the research clinician Planned travelling out of the catchment area during the following 2 months (follow-up period) Planned caesarean section Known required referral Known multiple pregnancy Known severe congenital malformation Intrauterine death confirmed before randomization Known allergy to macrolides Consumption of antibiotic within the week before randomisation", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Lung Transplant Infection Lower Respiratory Tract Infection. Post bilateral sequential lung transplant Capable of performing airway clearance techniques / nebulisers Pulmonary exacerbation as defined by Fuchs et al Must be productive of sputum Able to provide informed consent within 48 hours of presentation *Fuchs Scale(8): Treatment with / without parenteral antibiotics for 4/12 signs and symptoms Change in sputum New or increased haemoptysis Increased cough Increased dyspnoea Paediatric transplant <18yrs Single lung transplant native lung physiology may confound outcome measures Interstate unable to complete follow up Unable to perform lung function testing Unable to complete subjective outcome measures unable to read English fluently Critically unwell / ICU / ventilator dependent Within 2 months of transplant date *Cystic Fibrosis will be stratified", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.0-5.0, All Pneumonia Bronchiolitis Asthma All children below 5 exceeding WHO age-dependent tachypnea criteria ", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 40.0-999.0, All Idiopathic Pulmonary Fibrosis Males/females aged 40 years and over, at the time of signing the informed consent A female patient is eligible to participate if she is of: Non child-bearing potential, where females are post-menopausal, defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units per milliliter (MlU/mL) and estradiol < 40 picograms per mililiter (pg/mL) (<147 pmol/L) is confirmatory. Peri-menopausal or pre-menopausal, and have a negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test, confirmed at screening, and then at each subsequent clinic visit before the CT scanning is conducted BMI within the range 18 kilogram per meter^2 (kg/m^2) (inclusive) Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Patients will have a diagnosis of IPF as determined by a responsible and experienced Respiratory physician and based on established defined by the American Thoracic Society/European Respiratory Society: American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias Patient's lung function measurements of Forced vital capacity (FVC) and Diffusing capacity of the Lung for Carbon Monoxide (DLCO) at screening must fall within the category below to be included in this study: FVC >=40 % predicted and DLCO >=30 % predicted Patients with a current Idiopathic Pulmonary Fibrosis (IPF) exacerbation Patients with a known underlying cause of pulmonary fibrosis Patients that have both IPF and Chronic obstructive pulmonary disease (COPD) that requires therapy with more than an intermittent bronchodilator or a long acting muscarinic antagonist, or where the Forced Expiratory Volume in One Second (FEV1)/ Forced vital capacity (FVC) ratio is <0.65 Patients with an upper or lower respiratory tract infection within four weeks of Visit 1 Patients with a recognised co-existing respiratory disorder other than usual interstitial pneumonia (UIP) (e.g. significant COPD, asthma, sarcoid, lung carcinoma) that in the opinion of the investigator would confound the study outcomes Patients with poorly controlled left ventricular heart failure Serious or uncontrolled medical, surgical or psychiatric disease that in the opinion of the investigator would compromise patient safety or confound the study data (e.g. congestive cardiac failure [CCF], asthma, angina, neurological disease, liver dysfunction and blood dyscrasia) Patients found to have clinically significant anaemia until adequately treated Patients that have a history of alcohol abuse Patients who are currently taking Pirfenidone for IPF or who have received Pirfenidone within the previous 30 days prior to Visit 1", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia Be 18 years of age Having the diagnosis of ventilator-associated pneumonia Be under 18 years of age", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Community Acquired Pneumonia Pleuritis Pulmonary Embolism Lung Cancer patient aged 18 years and older patient affected by thoracic pleuritic pain patient affected by a chronic condition causing thoracic pain patient affected by acute cardiovascular diseases (e.g. acute coronary syndrome)", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.0-21.0, All Community Acquired Pneumonia All intubated pediatric patients Age 1 day to 21 years Admitted to the LLUCH PICU with suspected pneumonia for the next 6 months Have received antibiotics for less than 12 hours Have been intubated for less than 24 hours Patients must be English or Spanish speaking for consent purposes Patients who have received antibiotics for greater than 12 hours Patients who have been intubated for greater than 24 hours Patients who are unable to tolerate non-bronchoscopic bronchoalveolar lavage", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia Streptococcus Pneumoniae Immune Response Patients who participated in the Ovidius or Triple-P study (2004-2009) Diagnosis in these studies with pneumococcal pneumonia or pneumonia due another identified organism Age \u2265 18 years Signing of informed consent Diagnosis of pneumonia without an identified causative organism Fever at time of vaccination Previous/known allergic reaction to any of the components of the vaccine given Mentally incompetent Previous pneumococcal conjugate vaccination Pneumococcal polysaccharide vaccination within 6 months prior to inclusion Clinical pneumonia within 1 month prior to inclusion", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Ventilator-Associated Pneumonia Mechanical ventilation for at least 48 hours New or evolving infiltrate on chest radiograph (CXR) or computed tomography (CT), and A minimum of two of the following clinical Body temperature \u2265 38.5\u00b0 C (101\u00b0 F) or < 36\u00b0 C (97\u00b0 F) White blood cell count > 10,000/ml or < 4,000/ml or > 10% immature cells Partial pressure of oxygen in arterial blood < 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio < 300 Purulent respiratory secretions Known ongoing pneumonia Patient younger than 18 years old Mechanical ventilation <48 hours Contraindication to bronchoscopy", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.25-4.917, All Pneumonia Children admitted with severe pneumonia as defined by the presence of all the following as defined as below months to 59 months old History of cough and/or shortness of breath Unwell for <= 7 days -Increased respiratory rate ( \u2265 50/min if \u226412 months old, \u2265 40/min) or retractions,- Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy Documented fever (axillary /central temp \u2265 38/38.5\u00b0C) within 24 hrs of admission Abnormal CXR with presence of alveolar infiltrates Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia have a positive Febrile Respiratory Illness (FRI) screen on admission to hospital (http://www.health.gov.on.ca/fr/public/programs/emu/sars/reports/dir_122303_acute_care_nonoutbreak.pdf) diagnosed with pneumonia by the admitting physician (Acute exacerbations of chronic obstructive lung disease are considered within the definition of pneumonia for the purposes of this study as they are commonly treated with the same antimicrobial regimens as patients with pneumonia) admitted to a medical ward hospitalized for \u2265 48 consecutive hours in the preceding 3 months receiving immunosuppressants [defined as \u2265 40 mg prednisone daily (or steroid equivalent) for \u2265 2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection] neutropenic [defined as a polymorphonuclear count \u2264 0.5 x 109 cells/L] from any cause immunocompromised [defined as having leukemia, lymphoma, HIV with CD4 cell count \u2264 200, splenectomy or on cytotoxic chemotherapy] admitted to high acuity units such as intensive care units require mechanical ventilation, either non-invasive or invasive have a life expectancy of \u2264 3 months (palliative)", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Pneumonia Community-acquired pneumonia Immunocompetent Age > 18 years Admitted to an intensive care unit or high intensity unit Requiring invasive or non-invasive ventilation Life expectancy less than 3 months Hospitalization within the previous 3 months for at least 48 consecutive hours Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count <=200, splenectomy or on cytotoxic chemotherapy Neutropenic [defined as a PMN count<=0.5x109 cells/L] from any cause Receiving immunosuppressants [defined as >=40 mg prednisone daily (or steroid equivalent) for >=2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Coughing Cough is the main or only clinical symptom and was persistent for 3-8 weeks Chest X-ray reveals no noticeable pathological changes \u226518 year old, regardless of gender and ethical background Not taking angiotensin-converting enzyme inhibitor Patients must join the programme voluntarily and are able to attend examination and follow-up sessions Patients diagnosed with rhinallergosis, chronic nasosinusitis or bacterial respiratory tract infections Patients diagnosed with severe reportorial disease of other severe systemic disease Patients who are allergic to any drugs to be tested Patients who are non-cooperative during examination sessions or other steps of the trial Patients who are not able to or refuse to sign consent", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Cough Cough is the main or only clinical symptom and was persistent for 3-8 weeks Chest X-ray reveals no noticeable pathological changes year old, regardless of gender and ethical background Not taking angiotensin-converting enzyme inhibitor Patients must join the programme voluntarily and are able to attend examination and follow-up sessions Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections Patients diagnosed with severe reportorial disease of other severe systemic disease Patients who are allergic to any drugs to be tested Patients who are non-cooperative during examination sessions or other steps of the trial Patients who are not able to or refuse to sign consent", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.167-4.917, All Pneumonia Tachypnea History of cough or difficult breathing < 14 days (observed or reported) AND Respiratory rate \u2265 50 breaths per minute in children 2 to <12 months (on two consecutive readings by independent physicians) OR respiratory rate \u2265 40 breaths per minute in children12 months (on two consecutive readings by independent physicians) AND Written informed consent by a legal guardian Previously enrolled in study Pedal edema History of hospitalization in last two weeks With severe lower chest wall in-drawing Known asthmatics,TB or other severe illness Antibiotics taken in last 48 hours Bulging fontanel Congenital heart disease Any surgical condition requiring hospitalization Out of catchment area", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 21.0-59.0, All Respiratory Failure Healthy male or female volunteers in the age group Any acute or chronic cardiopulmonary disorder including a simple common cold", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.083-2.0, All Bronchiolitis Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB) Presence of cyanotic congenital heart disease no longer for comparing the constants Relative or absolute contraindication CPT techniques included in the protocol Patients diagnosed with moderate or severe gastroesophageal reflux since the PSE gastroesophageal reflux can accentuate a previously exist Patients with laryngeal diseases caused because the cough is a technique that is applied directly to the tracheal wall and can affect the larynx Absence of cough reflects and presence of laryngeal stridor is a contraindication to chest physiotherapy in general Systematic presence of gag reflex as the aspiration of secretions and coughing caused nasobucales stimulate this reflex", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 65.0-999.0, All Pneumonia Patients above 65 years old AND at least one infectious sign: T\u00b0 >38\u00b0C or <35\u00b0C; C-reactive protein (CRP) >10 mg/L; leucocytes >10,000/mL with >85% polynuclear neutrophils or left deviation AND at least one respiratory sign: cough; purulent sputum; chest pain; localized crackles; recently appeared dyspnea; oxygen saturation (SpO2) <90%; respiratory frequency >20/min AND who will be prescribed antimicrobial therapy for suspicion of low respiratory tract infection AND who will give consent himself or through his support person Diagnosis of pneumonia in the previous six months AND/OR more than 48h of antimicrobial treatment given before hospitalization AND/OR thoracic CT scan performed before hospitalization or of the patient Each patient will be included only once", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 14.0-999.0, All Community Acquired Pneumonia Patients > or = 14 years of age Patient meets the of community acquired pneumonia Patient meets the of healthcare-associated pneumonia Patients <14 years of age Patient meets the of hospital acquired pneumonia Known active tuberculosis or current treatment for tuberculosis Non-infectious pulmonary diseases HIV positive", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 14.0-999.0, All Community Acquired Pneumonia Patients > or = 14 years of age Patient meets the of community acquired pneumonia Patient meets the of healthcare-associated pneumonia Informed consent to participate in the study is provided Patients participating in a clinical trial or other intervention studies Patients <14 years of age Patient meets the of hospital acquired pneumonia Known active tuberculosis or current treatment for tuberculosis Non-infectious pulmonary diseases \uff08e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia\uff09 HIV positive", "label": "2"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 18.0-999.0, All Community Acquired Pneumonia Be male or female at least 18 years of age Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening) Dyspnea New or increased cough Purulent sputum production Chest pain due to pneumonia Have at least 2 of the following vital sign abnormalities Fever (body temperature >38.0\u00b0C (100.4\u00b0F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature <35.0\u00b0C (95.0\u00b0F) measured orally or equivalent temperature from an alternate body site) Hypotension (systolic blood pressure <90 mmHg) Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 24 hours before randomization Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung) Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis) Have confirmed or suspected pleural empyema (does not sterile parapneumonic effusions) Require mechanical ventilation", "label": "1"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 17.0-70.0, All Cough chronic cough group cough lasting \u2265 8 weeks,characterized by irritating dry cough sensitive to fumes\uff0cdust,the odorous and cold air with normal chest x-rays. 4.17-70 years old without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result chronic cough group and healty controls group with respiratory tract infection within 8 weeks with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week women during pregnancy or lactation patients with malignant tumours", "label": "0"} +{"topic": "A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field.", "doc": "eligible ages (years): 0.5-3.0, All Acute Otitis Media Male or female aged < 407 days or less than/equal to 36 months old and meets recurrent acute otitis media Child has received full ( 3 dose ) infant series of Prevnar 13 Parent/guardian willing to bring to all study visits Any major illness/condition that in investigator opinion would put subject at risk during study Participation in another investigational/interventional trial within 28 days prior or during study. ( Observational study is permitted ) Direct descendant of study site personnel", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Kidney Cancer Sarcoma Diagnosis of peripheral primitive neuroectodermal tumor, including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR Not specified ", "label": "1"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Neuroblastoma Sarcoma Histologically confirmed GD2 positive tumors which High risk neuroblastoma (stage IV, or N-myc amplified, or localized neuroblastoma multiply recurrent) Recurrent or metastatic osteosarcoma Recurrent or metastatic GD2 positive sarcomas If free of disease, patient must be fully recovered from toxic effects or complications of prior treatments (chemotherapy or surgery) No greater than 6 months since last chemotherapy or surgery before first injection of A1G4 Age Any age Performance status Not specified ", "label": "1"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Sarcoma Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin Measurable disease Immunohistochemical evidence of 2+ overexpression of HER2 Age Any age Performance status Karnofsky 80-100% Life expectancy Not specified Hematopoietic ", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 16.0-999.0, All Lung Cancer Adult Soft Tissue Sarcoma Colorectal Cancer Bone Cancer Ovarian Sarcoma Melanoma Colon Cancer Rectal Cancer Breast Cancer Eye Cancer Uterine Sarcoma ENTRY --Disease Characteristics- Histologically documented metastatic cancer of one of the following types: Cutaneous melanoma Ocular melanoma Colorectal carcinoma Non-small cell lung cancer Breast carcinoma Sarcoma HLA-Cw*0702 positive MAGE-12 expression by RT-PCR amplified tissue analysis Failed prior standard therapy Measurable or evaluable disease No renal carcinoma Hormone receptor status: Not specified --Prior/Concurrent Therapy- Biologic therapy: At least 3 weeks since prior biologic therapy for cancer No other concurrent biologic therapy for cancer Chemotherapy: At least 3 weeks since prior chemotherapy for cancer and recovered No concurrent chemotherapy for cancer Endocrine therapy: At least 3 weeks since prior hormonal therapy for cancer No concurrent hormonal therapy for cancer No concurrent steroids Radiotherapy: At least 3 weeks since prior radiotherapy for cancer and recovered No concurrent radiotherapy for cancer Surgery: Prior surgery for cancer allowed --Patient Characteristics- Age: 16 and over Sex: Male or female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 Hepatic: Bilirubin no greater than 1.6 mg/dL AST/ALT less than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac ischemia, myocardial infarction, or cardiac arrhythmias (if receiving interleukin-2 (IL-2) therapy) Pulmonary: No obstructive or restrictive pulmonary disease (if receiving IL-2 therapy) Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No autoimmune disease, known immunodeficiency disease, or active primary or secondary immunodeficiency Hepatitis B surface antigen negative HIV negative No other active major medical illnesses (if receiving IL-2 therapy) ", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 2.0-21.0, All Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Leukemia Liver Cancer Neuroblastoma Ovarian Cancer Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific Meets 1 of the following Histologically confirmed solid tumor (closed to accrual as of 10/4/2007) that relapsed after or failed to respond to front-line curative therapy and for which no other potentially curative treatment options exist Curative therapy may surgery, radiotherapy, chemotherapy, or any combination of these modalities Eligible tumor types but are not limited to, the following Rhabdomyosarcoma Other soft tissue sarcomas Ewing's sarcoma family of tumors Osteosarcoma Neuroblastoma Wilms' tumor ", "label": "1"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Arthritis Septic Patients with acute onset of symptoms of less than or equal to two weeks' duration Patients with infection of only the following joints: ankle, knee, hip, wrist, elbow, or shoulder Patients with proven bacterial infection by positive gram stain or culture of synovial fluid and with white blood cell count in synovial flood consistent with infection (75,000 000 cells/mm3.) Cases with negative synovial fluid cultures if positive blood cultures are present and associated with typical inflammatory synovial fluid changes without other identifiable sources of infection and if antibiotic therapy had been initiated earlier to explain negative synovial fluid cultures Monoarticular arthritis Gonococcal infections Infected prosthetic joints Adjacent osteomyelitis preceding joint infection Septic arthritis occurring as an incidental event late in the course of otherwise fatal illness Patients that are 17 years old or less Polyarticular arthritis", "label": "1"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-75.0, All Thromboembolism Knee Replacement Hip Replacement Patients undergoing either an elective major hip or knee replacement or revision Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child History of serious active bleeding in last 3 month Concurrent or history of thrombocytopenia ( Platelet< 100x109/L) History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product Acute bacterial endocarditis Congenital or acquired bleeding disease in last 3 months Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye Conditions need to leave a tubule in intradural or extradural Contraindication to anticoagulant or condition required to take long term oral anticoagulant Abnormality in hepatic (>1.5x UNL), renal (Clcr < 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 50.0-999.0, All Knee Osteoarthritis Aged 50 years or over of either gender Radiographic tibiofemoral OA grade 2 or higher, unilateral or bilateral Demonstrated knee OA related dysfunction per WOMAC score Not engaged in a regular exercise program for minimum of 6 months Inability to obtain physician release for exercise High risk health status e.g., uncontrolled medical conditions such as hypertension, diabetes, heart disease, pulmonary disease, high cholesterol, anginal type pain, dizziness or syncope, orthopnea or paroxysmal nocturnal dyspnea, ankle edema, heart palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue or shortness of breath with usual activities Unresolved balance disorder Unresolved neurological disorder History of knee surgery or major knee trauma injury Hip or ankle instability, excessive weakness, surgery or major trauma injury Intra-articular joint injection within 4 weeks of the study", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 16.0-999.0, All Edema knee replacement surgery pacemaker cardiac defibrillator other metallic implant than knee arthroplasty", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-45.0, All Familial Mediterranean Fever Fulfilling the Tel Hashomer for the diagnosis of FMF [5] Suffering from episodes of exertional leg pain and or exertional ankle edema 18-45 years old On a stable (\u2265 2 weeks) dose of oral colchicine therapy Non-smokers with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) Suffering from muscular or neurological diseases not related to FMF With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-80.0, All Osteoarthritis Male or female subjects aged between 18 and 80 years inclusive Subjects who require a primary total knee replacement and are considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol Subjects who are able to give and have given voluntary, written informed consent to participate in this clinical investigation Subjects who have given consent to the transfer of his/her information to DePuy Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups Subjects who have a pre-operative limb deformity of equal to or greater than 10\u00b0 varus or 15\u00b0 valgus as defined using the anatomical axis Subjects who have a fixed flexion contracture of greater than 10\u00ba Subjects who are clinically obese i.e. BMI \u226530 Subjects who have, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study Female subjects who are pregnant or lactating Subjects who are known drug or alcohol abusers or have a psychological disorder that could affect follow-up care or treatment outcomes Subjects who have participated in a clinical investigation with an investigational product in the last 3 months Subjects currently involved in any personal injury litigation, medical-legal or worker's compensations claims Subjects who have previously had a prosthetic knee replacement device (any type) of the affected knee Subjects who present with ankylosis of the hip joint on the side to be treated or previous ipsilateral Upper Tibial Osteotomy/High Tibial Osteotomy", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-21.0, All Neuroblastoma Melanoma Osteosarcoma Ewing Sarcoma Diagnosis Part A: Recurrent or refractory neuroblastoma or melanoma Part B: Recurrent or refractory neuroblastoma or melanoma Part C: Recurrent or refractory osteosarcoma and Ewing sarcoma Age: \u2264 21 years of age at the time of enrollment (i.e. participants are eligible until they reach their 22nd birthday) Does not have a clinically significant neurologic deficit or objective peripheral neuropathy (greater than or equal to grade 2). Peripheral (sensory or motor) neuropathy related to limb sparing procedure or amputation is allowed Life expectancy: at least 8 weeks Organ Function: Must have adequate organ and marrow function Performance status: Karnofsky \u2265 50 for > 10 years of age; Lansky \u2265 50 for children < 10 years of age Prior Therapy: Patient must have fully recovered from the acute toxic effects of all prior therapy prior to enrolling on study Prior monoclonal antibody: Participants having received in vivo monoclonal antibodies for biologic therapy or for tumor imaging are eligible provided they did not experience a severe allergic reaction with the antibody Pregnancy or Breast Feeding: Study participants who are pregnant are not eligible for this study. Pregnancy tests must be obtained in girls who are > 10 years of age or post-menarchal within 7 days prior to study enrollment. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during participation in the trial. Breast feeding should be discontinued if a mother wishes to participate in this study Allergy: known hypersensitivity to other recombinant human antibodies An uncontrolled infection", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-90.0, All Reduced Knee Flexion Reduced flexibility in AROM of knee extension Pain that is worsened by bending over while legs are straight Impaired gait pattern Ability to understand informed consent and experiment responsibilities Fractures Knee sepsis Osteomyelitis or any orthopedic infection Extensor mechanism dysfunction Psoriasis Knee joint neuropathy Previous Stroke or Brain Injury", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Total Knee Arthroplasty Knee Pain Primary, bilateral TKA Age 18 years or older Postoperative analgesic pain includes bilateral continuous femoral nerve blocks Chronic, high-dose opioid use History of opioid abuse Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles Pregnancy Incarceration", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 1.0-50.0, All Osteosarcoma Age > 1 year and < 50 years First osteosarcoma relapse, either local or metastatic, or second relapse after exclusive surgery NB: Whenever possible, only patients with histological evidence of relapse will be included Indication for chemotherapy confirmed by a multidisciplinary committee Surgical resection of all tumor sites must be possible, either as first-line therapy or after chemotherapy Lansky score \u2265 60%, or ECOG Performance Status \u2264 2 \u2265 21-day interval after first-line chemotherapy Blood tests, renal and liver functions within the normal range for age with, in particular, 7 days prior to study entry, blood or serum values as follows blood: neutrophil count > 1 G/L; platelets >100 G/L renal: serum creatinine \u2264 1.5 x ULN depending on age; patients with serum creatinine values > 1.5 x ULN are eligible if creatinine clearance is > 70 mL/min/1.73 m\u00b2 liver: total bilirubin < 2 x ULN; ASAT and ALAT \u2264 5 x ULN Patients with multiple relapses for whom surgical resection seems impossible, even after chemotherapy Patients already treated with high-dose chemotherapy regimens Patients with a contra-indication to the treatment proposed Patients not eligible for leukapheresis Two-year follow-up impossible due to social, family, geographic or psychological reasons Patient included in another protocol of clinical research Pregnant or lactating women", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 40.0-76.0, All Osteoarthritis of the Knee Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to entry into the Screening Period (Day -3) Subject has OA pain of the Target Knee with a WOMAC Pain Subscale baseline value of > 9 at the Baseline/Randomization Period (Maximum score is 20 for 5 questions with 0 = none; 4 = extreme Subject must have a Functional Capacity Classification of I-III Subject has taken a stable dose of NSAIDs or COX-2 inhibitor agents for OA pain for at least 22 of the previous 28 days and for each of the 2 days prior to the Screening Period (Day -3) and for at least each of the 2 days prior to the Baseline/Randomization Period (Day 1). Subject must also, agree and be expected to remain on this stable daily dose throughout the study Subject is between 40-75 years of age Diagnosis of OA is present for at least 6 months according to the ACR for OA of the knee Radiographic evidence of OA of the Target Knee (within the last 3 years) with a Kellgren-Lawrence scale of 2 or 3 Subject is generally in good health Subject is expected to be compliant with study procedures Females of child-bearing potential must have a negative urine pregnancy test at Screening Presence of tendonitis, bursitis, partial or complete joint replacement of Target Knee Presence of active skin disease, erythema, infection, wound or irritation near the treatment area of the Target Knee Subject has history of frequent headache or other painful conditions (other than OA) that is expected to require any use of systemic opiates or derivatives, or more than twice a week additional administration of different oral NSAIDs or COX-2 inhibitors (see Section 6.1, Table 2) Subject experiences regular significant pain due to osteoarthritis or other conditions in the non-target knee or other joints while on stable doses of their current analgesic therapy Subject has an anticipated need for any surgical or other invasive procedure that will be performed on the Target Knee or other part of the body during the course of the study OA secondary to local joint disorders (e.g., mechanical disorder, internal derangement of the knee), systemic metabolic disease, endocrine disorders, bony dysplasia, calcium crystal deposition disease, neuropathic arthropathy, frostbite, congenital abnormalities Subject has history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease Subject has active (redness, swelling, fever, etc.) gout/pseudogout within 6 months prior to screening Subject has Type I or Type II diabetes with peripheral neuropathies Subject is extremely obese with BMI \u2265 39", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 21.0-999.0, All Dengue Fever Age \u2265 21years Probable or confirmed dengue a) Confirmed dengue: laboratory confirmation of acute dengue by either i) positive polymerase chain reaction (PCR) for viral ribonucleic acid (RNA), or ii)positive NS1 antigen test with a compatible clinical syndrome b) Probable dengue: Positive acute dengue serology and clinical presentation fulfilling either WHO 1997 or 2009 for probable dengue i) 1997 Acute febrile illness and two or more of the following headache retro-orbital pain myalgia arthralgia rash hemorrhagic manifestations ", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Urinary Incontinence Subject is a male IC user able to self-catheterise Subject has used hydrophilic-coated ICs for at least 1 month Subject is at least 18 years old Subject has provided informed consent Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease) Subject has known abnormalities in the lower urinary tract", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Sarcoma Diagnosis of localized or metastatic osteosarcoma Banked snap-frozen tumor tissue samples and paired blood DNA samples available Not specified Not specified ", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-75.0, All Healthy Healthy males or females Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation A history of chronic gastrointestinal or systemic illnesses that could affect gastrointestinal motility Any history of hypertension Use of medications that may alter gastrointestinal motility or interact with the study medications Use of any of the study medications within the past 30 days Pregnancy Chronic renal insufficiency (serum creatinine >1.5 mg/dL) Psychiatric or psychologic dysfunction", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Joint Disease Patient is of legal age and skeletally mature Patient requires primary total knee arthroplasty due to non inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis) Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk The patient will be available for follow up throughout the duration of the study Patient is unable to have an MRI scan due to the following conditions Cardiac pacemaker Surgical clips in head (aneurysm clips) Some artificial heart valves Electronic inner ear implants Metal fragments in eyes Electronic stimulators Implanted pumps Patient has active infection or sepsis (treated or untreated) Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 15.0-30.0, All Knee Instability The anterior drawer laxity of the knee joint in this study was defined as anterior displacement over 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force anterior displacement less than 3 mm discrepancy between bilateral knee joints by a KT-2000 test under 20-pound force", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Osteoarticular Infections Patient are more than 18 years old Patient who do not declined to have his medical records reviewed for research Spondylodiscitis (S) group Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context. Spinal biopsies will be justified by one or more clinical or imaging findings Clinical presentation Spinal pain unrelieved by rest Localized tenderness, Neurological deficits or limited range of motion Fever > 38\u00b0C Imaging findings (plain radiographs, MRI or CT) Erosions of end plates on adjacent vertebral bodies Patients already include Patient without health insurance Antibiotic treatment before sampling does not constitute an criterion for control groups Patient with one or more Suspicion of concomitant infection defined by a fever >38\u00b0C and CRP > 10mg/l Arthrosis treated by infiltration in the 6 months which preceding Rapidly progressive arthrosis Prosthesis loosening or bone necrosis presumed to be aseptic Patients with prior spinal instrumentation or surgery", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Overactive Bladder Women >18 years of age A score of > 4 on the OAB-q short form for urgency (question 1) Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary Self-reported bladder symptoms present > 3 months Self-reported failed conservative care (e.g., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) or use of antimuscarinics Off all anti-muscarinics for at least 2 weeks prior to enrollment Capable of giving informed consent Ambulatory and able to use a toilet independently, without difficulty Capable and willing to follow all study-related procedures The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.) The patient has an active urinary tract infection Neurogenic bladder Botox use in bladder or pelvic floor muscles in the past year Pacemakers or implantable defibrillators Primary complaint of stress urinary incontinence Current vaginal infection Current use of InterStim Current use of Bion Current use of TENS in the pelvic region, back or leg", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 2.0-35.0, All Osteosarcoma Lung Metastases Must be between 2 and 35 years of age at time of diagnosis Must have biopsy-proven, high-grade osteosarcoma Patients with metastases are eligible as long as the lung is the only site of metastatic disease The primary tumor and all pulmonary metastases must be deemed to be potentially resectable. There must be a commitment by the surgical team to resect the primary tumor at week 12, and pulmonary nodules at any point, unless the clinical situation indicates these interventions are not in the patient's best interest Patients must have normal laboratory values and cardiac function as defined below Creatinine clearance or radioisotope GFR of > or equal to 70ml/min/1.73 m2 OR A serum creatinine based on age/gender as follows Age Maximum Serum Creatinine (mg/dL) Male Female month to < 6 months 0.4 0.4 6 months to < 1 year 0.5 0.5 to < 2 years 0.6 0.6 Patients with any low-grade osteosarcoma, post-radiation osteosarcoma, and osteosarcoma associated with Paget's disease are not eligible Patients with metastases other than lung metastases are not eligible Patients may not have received prior chemotherapy", "label": "1"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 45.0-79.0, All Knee Osteoarthritis A female is eligible if she is of Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post menopausal Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly Pregnancy test result of negative at screening Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria ACR : With Knee pain and satisfied at least 1 of 3 (\u2460 age > 50 years, morning stiffness < 30 minute, \u2462 Presence of Crepitus and Osteophytes on motion) Appropriately signed and dated informed consent has been obtained Rheumatoid arthritis or inflammatory arthritis Bilateral total knee replacement already treated, or planning for the procedure Knee prosthesis already implanted, or foreseen within the next year Clinically significant hip osteoarthritis Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula) Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.) MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc Allergic reaction to Clinical trial medication Other clinical trial drugs during the 1 month prior to the screening visit", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Arthrogryposis Craniofacial Abnormalities Syndrome Group Freeman-Sheldon syndrome Sheldon-Hall syndrome Distal arthrogryposis type 1, or Distal arthrogryposis type 3 Deceased patients with enough clinical information available to satisfy study requirements Syndrome Group Individuals not confirmed to have a condition under study Deceased patients without enough clinical information available to satisfy study requirements Patients with other anomalies, not having one of the above syndromes Patients or parents of minor children not willing to give consent Mature female patients who are pregnant or breast-feeding will be reassessed for consideration for enrolment Mature female patients who are currently experiencing menses will be reassessed for consideration for enrolment Patients with active, acute comorbid illness will be reassessed for consideration for enrolment Control Group Subjects must be healthy and free of active disease Subject or parent of minor child must be willing to give consent", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Linear or Emi-linear Incisions Total Hip Arthroplasty Total Knee Arthroplasty Subject must be \u2265 18 years of age Subject must, at the treating physician's determination and definition, be an appropriate Candidate for primary total hip or knee arthroplasty Subjects who undergo primary total knee or hip arthroplasty must have a linear or semi-linear incision whose length and curvature should fit within the dimensions bound by the polyurethane foam (10 inches in length by 2.5 inches in width) Subject is able and willing to provide written informed consent and comply with visit schedule Subject must agree to avoid application of tanning lotions or exposure of ultraviolet radiation from sun or artificial sources such as a tanning bed on operative area for the duration of study participation Subject must not be pregnant if of child-bearing potential, or otherwise must be surgically sterilized or unable to conceive. All females, regardless of child-bearing potential, will receive a urine hCG test 2 weeks prior to surgery and the test result must be negative for pregnancy Subjects who are of child-bearing potential must be utilizing an acceptable method of birth control (eg, birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) and be willing to continue birth control for duration of study participation. If birth control method is the form of birth control pills, shots, implants skin patches, or IUD, the method must have been utilized for at least 30 days prior to study participation Subject must be willing to wear loose fitting clothing for duration of treatment period Subject must be willing to comply with visit schedule for the duration of the study Positive pregnancy test confirmed by hCG in urine Current or past (30 days prior to surgery) within time of screening attempts to become pregnant Current local or systemic infection (eg, skin infections, sinus infections, urinary tract infection, sepsis, etc) Current or past (14 days prior to surgery) within time of screening topical treatments on operative area (eg, laser hair or tattoo removal, sunless tanning lotions) Current or past (14 days prior to surgery) steroid topical therapies on operative area Current or past (30 days prior to surgery) use of oral steroids (NOTE: Use of non-topical, ophthalmic or aerosol types of steroids (ie, inhaled corticosteroids) are permitted at screening and throughout the clinical trial) Current or past (72 hours prior to surgery) within surgery use of antihistamines Current or past (30 days prior to surgery) within time of screening use of oral Tetracycline or AcutaneTM or topical Tetracycline or AcutaneTM on the operative area Presence of skin lesions or abnormalities on operative area Current or past malignancy requiring immunosuppressant therapy or chemotherapy within 5 years within time of screening", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-75.0, All Arthroscopic Meniscal Surgery Male and female patients between 18 and 75 years of age Good general health condition Signed written informed consent Patients with necessity for arthroscopic meniscal surgery Ensured compliance of subject over the whole study period Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion Knee joint arthroscopy in study relevant joint within 6 months prior to study inclusion Patients with known hypersensitivity to the investigational device (i.e. active compound and excipients) or any component or procedure used in the study Contraindication for the use of the investigational product or for the scheduled arthroscopy, used anesthesia and post-surgical treatment Concomitant disease of sufficient severity (e.g. uncontrolled diabetes mellitus, carcinoma, etc.), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study Concomitant disease of sufficient severity at study relevant joint (e.g. known or suspected infection, peripheral neuropathy or presence of hemarthros) List of concomitant medications not allowed which interfere with the functional assessments of this study Use of medication contraindicated for arthroscopic surgery Intra-articular treatment with a sodium hyaluronate-based product within the last 6 months or use of corticosteroid containing substance within the last 3 months at study relevant joint Recent history of drug and/or alcohol abuse (within the last 6 months) or patients with severe mental illness or suicidal tendency", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-99.0, All Urinary Incontinence includes English-speaking women over the age of 18 who have been admitted to the Rehabilitation Institute of Chicago with reports of urinary incontinence in the past 3 months. Those who report \"yes\" to the screening questions who fit the above will be screened by the principal investigator to ensure they fall into the criteria Non-English speaking women under the age of 18, or those that do not give consent to participate in the study will not be enrolled. Also excluded will be any woman who has any chance of being pregnant or having an active urinary tract infection. No women with active infection lesions, unknown vaginal bleeding or those who have never had any kind of pelvic examination will be included in the study. Other women with a neurogenic bladder or admission FIM scores on sections Comprehension and Memory of below 4. Women with reports of significant pelvic pain or recent pelvic surgery or radiation or post-partum in last 6 months will be excluded", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 2.0-4.917, All Influenza Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area and who intends to be present in the area for the duration of the trial A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination Has any serious chronic disease including progressive neurologic disease, tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system Is receiving immunosuppressive agents including systemic corticosteroids during the two weeks prior to study vaccination Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before Lives in household with somebody currently participating in a respiratory vaccination or antiviral study Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-75.0, All Irritable Bowel Syndrome Age 18-75 years Positive for IBS symptoms by Rome III No prior abdominal surgery (except appendectomy or cholecystectomy Score of 10 or less on either Anxiety or Depression on the Hospital Anxiety/Depression Inventory Patients with significant depression (score of greater than 10 on Hospital Depression Inventory Patients with anxiety (score of greater than 10 on Hospital Anxiety Inventory. However, patients on stable doses of selective serotonin inhibitors (SSRIs) or low dose of tricyclic antidepressants will be eligible", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-39.0, All Localized Osteosarcoma Metastatic Osteosarcoma Recurrent Osteosarcoma Tissue samples from patients with osteosarcomas obtained from the CHTN P9754 clinical trial for patients with non-metastatic osteosarcoma AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma ", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Osteosarcoma Samples from the COG tissue repository ", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Sarcomas Procurement Diagnosis of refractory or metastatic GD2-positive sarcoma not responsive to standard treatment. Patients with osteosarcoma do not require GD2 testing of their tumor as osteosarcomas are uniformly GD2 positive Either previously infected with varicella zoster virus(VZV; chicken pox) or previously vaccinated with VZV vaccine Karnofsky/Lansky score of greater than or equal to 50 Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Treatment Diagnosis of refractory or metastatic GD2-positive sarcoma not responsive to standard treatment. Patients with osteosarcoma do not require GD2 testing of their tumors as osteosarcomas are uniformly GD2 positive Recovered from the acute toxic effects of all prior chemotherapy Karnofsky/Lansky score of greater than or equal to 50 Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, Serum creatinine less than or equal to 2x upper limit of normal, Hgb greater than or equal to 9.0 g/dl, ANC>500/uL, platelets > 50,000/uL Procurement \u2022 Known primary immune deficiency or HIV positivity Treatment Severe intercurrent infection Known primary immune deficiency or HIV positivity Pregnant or lactating History of hypersensitivity reactions to murine protein-containing products Known allergy to VZV vaccine", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-30.0, All Hyperalgesia Asymptomatic subjects who met the criterion of being between 18 and 30 years old rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment development of systemic or degenerative diseases subjects with symptoms of depression according Beck's questionnaire pain in any area between the lower back and head in the last 9 months traumatic event in the past 12 months history of neck or face pain in the last 6 months", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Septic Arthritis Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes, of La Roche sur Yon and of Saint-Nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative Presence of material on the targeted joint Age < 18 years old Patients under guardianship Pregnancy", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 50.0-999.0, All Total Knee Arthroplasty Pain Nerve Blocks Age > 50 years Patients set to cemented Total knee arthroplasty in spinal block Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully Illness score 1-3 Patients who can not cooperate with the investigation Patients who do not understand or speak Danish Patients receiving immunosuppressive therapy Patients with a treatment-dependent diabetes mellitus Patients with known neuropathy in the lower limbs Allergy to those drugs used in the study Alcohol and / or drug abuse the investigator's opinion Patients who can not tolerate Non steroid analgesic drugs Use of strong opioid several times a day (morphine, ketogan, Oxynorm, methadone, fentanyl)", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 45.0-80.0, All Osteoarthritis Pain Age 45 to 80 years old, inclusive Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) Knee Pain At least 1 of 3 Age > 50 years Morning stiffness lasting < 30 minutes Crepitus on motion Osteophytes on radiograph Symptoms associated with osteoarthritis of the knee (including pain) for \u2265 6 months prior to Screening Knee pain associated with osteoarthritis, which required NSAID or other therapy for \u2265 15 days during the preceding month General Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if They are or intend to become pregnant (including use of fertility drugs) during the study They are nursing They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for \u2265 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.) Body Mass Index (BMI) over 40 A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 1.0-35.0, All Sarcoma Osteosarcoma Neuroblastoma Melanoma Diagnosis (a) Osteosarcoma, neuroblastoma and melanoma that have been treated with standard frontline therapy and are judged to be incurable with standard therapy, based upon the fact that they are unresectable, metastatic, progressive/persistent or recurrent Evaluable disease must be present i) For all histologies except osteosarcoma and neuroblastoma, pathologic review of frozen tissue must document GD2+ expression. Positive expression is defined as at least 2+ expression (0-4+ scale) in > 50 percent of the tumor cells using anti-GD2 mAb 14G2a. If adequate archived frozen tissue is available, this may be utilized, or if not, patients may undergo biopsy following enrollment to obtain tissue to assess GD2 expression, with the following restrictions ii) Patients with histologies other than osteosarcoma or neuroblastoma must have adequate accessible tumor for biopsy (at least 1 cm diameter) iii) Procedures employed to acquire biopsies for tumor lysates will be limited to percutaneous needle or core biopsies, thoracoscopic excision or open biopsies of readily accessible lesions. Pulmonary lesions may be biopsied but extensive surgery such as thoracotomy or laparotomy should not be employed iv) Patients who will require biopsy should not be enrolled if in the opinion of the principal investigator, the tumor site places the patient at substantial risk from the biopsy procedure Weight greater than or equal to 15 kg Age less than or equal to 35 years old at the time of enrollment Prior Therapy Concurrent Illnesses Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the PI would compromise the patient s ability to tolerate protocol therapy or significantly increase the risk of complications Peripheral nerve symptoms from prior therapies or from tumor compression > grade 1 Untreated CNS metastasis Extradural masses that have not invaded the brain parenchyma or parameningeal tumors without evidence for leptomeningeal spread will not render the patient ineligible. Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible Prior Therapy Previous treatment with genetically engineered GD2-CAR T cells. Previous vaccine therapy, anti-GD2 mAb therapy or therapy with other genetically engineered T cells is not an Lactating or pregnant females (due to risk to fetus or newborn) Active HIV, HBV or HCV infection Immune Therapies", "label": "1"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 5.0-12.0, All Cerebral Palsy age 5 to12 years inclusive assessed as GMFCS Levels II or III able to follow testing instructions, and participate in a minimum of 30 minutes of active PT able to reliably signal pain, fear and discomfort have passive range of motion (ROM) of hips and knees within minimum range requirement for Lokomat (hip and knee flexion contracture < 10 degrees, and knee valgus < 40 degrees) client of Child Development Program at Holland Bloorview able to commit to attendance of twice weekly for eight weeks (to support the primary efficacy analysis) a fixed knee contracture > 10 degrees, knee valgus >40 degrees such that robotic leg orthosis will not be adaptable to lower limbs hip instability/subluxation > 45% orthopaedic surgery within the last 9 months (muscle) or 12 months (bone) Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months inability to discontinue BTX-A for period of 6 months (during trial) due to concerns about ROM or pain severe spasticity may be a contraindication any weightbearing restrictions seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months) open skin lesions or vascular disorder of lower extremities not able to co-operate or be positioned adequately within the Lokomat as shown during the two Lokomat fitting/acclimatisation sessions", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-65.0, All TBI Traumatic Brain Injury Age > 18 years Brain injured patients with a diagnosis of NHO around the hip and/ or knee for a period of greater than one year Patients who are able, or legal guardians who are willing, to provide informed consent after both oral and written information Pregnancy Rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures Elevated serum alkaline phosphatase (SAP) levels and/or evidence of active bone remodelling in bone scan", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 16.0-65.0, All Osteochondral Lesion of Talus Degenerative Lesion of Articular Cartilage of Knee single osteochondral lesion in knee/ankle (2-4 sq cm) multiple osteochondral lesions pre-existing injuries/arthropathies", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 50.0-100.0, All Peripheral Nerve Block Pain Age> 50 years Patients set to cemented Total knee arthroplasty in spinal block ASA 1-3 Patients who can not cooperate with the investigation Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully Patients who do not understand or speak Danish Patients receiving immunosuppressive therapy Patients receiving glucocorticoid daily Patients with a treatment-dependent diabetes mellitus Patients with known neuropathy in the lower limbs Allergy to those used in the study drugs Alcohol and / or drug abuse the investigator's opinion", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Osteoarthritis of Hip Osteoarthritis, Knee Planned primary unilateral THA or TKA Patients (male/female) \u2265 18 \u00e5r Patients giving written informed consent and authority Patients receiving spinal anaesthesia Patients with intolerance to trial medications Rejection of or contraindicated spinal anaesthesia Patients with rheumatoid arthritis Patients with Body Mass Index (BMI) \u2265 35 Patients that do not read or write Danish", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 16.0-40.0, All Primary Hypertrophic Osteoarthropathy diagnosed with primary hypertrophic osteoarthropathy clinically over 16 years old no other medication intake informed consent signed below 16 years old active gastric ulcer inflammatory bowel disease New York Heart Association classification\uff08NYHA\uff09 II to IV liver or renal failure allergic to nonsteroid anti-inflammatory drugs not willing to participate", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 1.0-49.0, All Recurrent Osteosarcoma Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse Patients must have measurable disease according to 1.1, and have relapsed or become refractory to conventional therapy Patient must have archival tumor specimen available for submission Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea) Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment Must not have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment Patients with > grade 2 neuropathy according to the Modified (\"Balis\") Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery Patients who have previously received glembatumumab vedotin (CR011-vcMMAE; CDX-011) or other monomethyl auristatin E (MMAE)-containing agents Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent Female patients who are pregnant are ineligible Lactating females are not eligible unless they have agreed not to breastfeed their infants Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met", "label": "1"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 1.0-6.0, All Caudal Block Patients aged 1-6 years, classified as American Society of Anesthesiologist (ASA) 1 and 11 who are undergoing herniotomy and whose parents or legal guardian has duly signed an informed consent form Patients with hypersensitivity to any local anesthetics Children with Bleeding diathesis Presence of Infections at puncture sites Preexisting neurological disease Patients with diabetes mellitus Failure to consent by parents", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 1.083-40.0, All Recurrent Osteosarcoma Patients must have recurrent high-grade OS verified by histopathology review by MSKCC's Department of Pathology Patients must be in a \u22652nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry Patients must be older than 1 year of age and less than or equal to 40 years of age Prior therapy: \u22653 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery Adequate hematopoietic function defined as Absolute neutrophil count \u2265 500/ul Absolute lymphocyte count \u2265 500/ul Platelet count \u2265 50,000/ul (transfusion independent) Adequate hepatic function as defined by Total bilirubin of \u2264 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is \u2264 3 times upper limit of normal) Patients with OS in first complete remission Presence of overt metastatic disease at any site Active life-threatening infection Pregnant women or women who are breast-feeding Inability to comply with protocol requirements", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Infection Immune Deficiency Hypogammaglobulinemia Septic Arthritis Mycoplasma Hominis Adult with decision making capacity afflicted with chronic mycoplasma hominis septic arthritis despite standard treatments ", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 18.0-999.0, All Periprosthetic Joint Infection Septic Arthritis adult of 18 or more years written consent to participate in study suspicion of septic arthritis or periprosthetic joint infection joint aspirate minimum of 5 ml is not able to understand the aim or purpose of this study empty joint aspirate", "label": "0"} +{"topic": "A 10-year-old boy comes to the emergency department for evaluation of right knee pain. The child's guardians stated that he had been complaining of knee pain for the past 4 days and it had been getting progressively worse. There was no history of trauma. The day before the visit the boy developed a fever, and over the past day he has become increasingly lethargic. On physical examination blood pressure was 117/75 mm Hg, HR 138 bpm, temperature 38.1 C (100.5 F), respiration 28 bpm, oxygen saturation 97%. There was edema and tenderness of the right thigh and knee, as well as effusion and extremely limited range of motion. Sensation and motor tone were normal. Plain radiography and CT showed an osteolytic lesion.", "doc": "eligible ages (years): 0.0-999.0, All Childhood Solid Tumor for the safety and feasibility testing of AV0113 Male and female patients with a malignant neoplasia shall be eligible for this protocol provided they have no more \"conventional\" treatment options and have measurable disease. There is no age limit for participation in this study provided that the tumour is typical for the group of refractory solid neoplasias of childhood Patients must not be HIV-positive Patients must have primary tumour tissue or cells available at sufficient number to allow treatment according to the protocol Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form for patients included in the long-term follow up and comparison with historic controls Patients suffering from bone or soft tissue sarcoma that received treatment with AV0113 or are documented in the database of the Medical University Vienna's Department of Orthopaedics At least one disease recurrence after first CR or worse disease condition (e.g.: never reached CR) Diagnosis between 1992-2003 and/or \"inclusion time point\" during the years 2000-2004 Availability of date of death or of confirmation that patient is still alive (for the currentness of confirmation that patients are still alive only the time span from 1 April 2014 to 1 April 2015 is accepted) for the safety and feasibility testing of AV0113 Any of the not met Any condition which, in the investigator's opinion, may pose a risk to the patient or will interfere with the study objectives for patients included in the long-term follow up and comparison with historic controls Date of \"inclusion time point\" and death or confirmation that patient is still alive at time of evaluation not available", "label": "1"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 0.0-999.0, All Ectopic Pregnancy Confirmed diagnosis of ectopic pregnancy via D&E without products of conception identified on frozen pathology or VABRA without products of conception identified with pathologic evaluation or Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole the subject is hemodynamically stable without signs of hemoperitoneum laparoscopy has not been performed the subject is able to return for frequent follow-up care normal renal and liver function have been documented within 2 days normal white blood count and platelet count have been documented as per laboratory standard normal chest x-ray was obtained if the subject has a history of pulmonary disease breastfeeding laboratory evidence of immunodeficiency alcoholism or chronic liver disease the concomitant use of non-steroidal anti-inflammatory drugs blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia active pulmonary disease hepatic, renal, or hematological dysfunction adnexal mass > or = 3.5 cm presence of fetal cardiac motion active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction", "label": "1"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 21.0-40.0, All Infertility Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict or >5 million total motile sperm on IUI prep Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube Patients with surgically corrected stages I and II endometriosis will be included Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study) Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for prior to any gonadotropin therapy Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin Female body mass index \u2264 38 Previous tubal reconstructive surgery in which the pelvis was not restored to functional Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET) Female body mass index > 38", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-80.0, All Elective Laproscopic Bilateral Inguinal Hernia Elective Laproscopic Cholecystectomy Local ethic committee approval Written informed consent ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH Difficulty in communication Allergy to oxycodone and/or morphine Allergy to local anesthetic History of alcohol and substance abuse Treated depression Chronic use of opioid or tramadol or Pregnancy Obstructive sleep apnea Anticipated fiber optic intubation Severe hepatic or renal impairment", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-45.0, All Bilateral Ovarian Disease Female patients aged 18-45 years at screening Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease Pregnant (including ectopic pregnancy) or breastfeeding patient Patients with a documented diagnosis of cancer Patients with a lymphatic, hematologic or coagulation disorder Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil\u2122 Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants Patients who have participated in another clinical study within 30 days of enrolment Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 11.0-21.0, All CHLAMYDIA INFECTIONS Female to 21 years of age at the time of enrollment Positive for Chlamydia infections by urine or cervical PCR h Chlamydia-negative subject who fits all other Negative pregnancy test Written informed consent provided Signed a HIPAA authorization form Willingness to comply with all the requirements of the protocol Positive pregnancy test Negative for Chlamydia, unless 5th negative subject to be in the control group Any condition that in the opinion of the investigator would interfere with the ability of the potential subject to complete the study or would result in significant risk to the subject", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 21.0-24.0, All Chlamydia Trachomatis Infertility Ectopic Pregnancy born in 1974, 1974 or 1976 AND living in Aarhus County October 1007 ", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-45.0, All Ovarian Cysts Endometriosis Adhesions Female patients aged 18-45 years at screening Patients undergoing elective laparoscopic surgery involving at least one adnexa Pregnant (including ectopic pregnancy) or breastfeeding patient Patients with a documented diagnosis of cancer Patients with a lymphatic, hematologic or coagulation disorder Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil\u2122 Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants Patients who have participated in another clinical study within 30 days of enrolment Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 20.0-90.0, All Adhesive Capsulitis shoulder discomfort for at least one month limited range of motion of the glenohumeral joint in at least two directions systemic inflammatory joint disease radiological evidence of bony abnormality of the shoulder full-thickness rotator cuff tear acute systemic medical illness history of major trauma or surgery involving the shoulder contraindication to intra-articular, local anesthestic injection", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 21.0-45.0, All Unplanned Pregnancy Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia Desires to use intrauterine contraception (IUD) after delivery Anticipates having a vaginal delivery No intention to leave the area 7 months after enrollment Able to consent to participate in the study in English Has no known uterine anomalies Has no allergies to any components of the intrauterine contraception Prior cesarean delivery Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy Allergic to betadine Allergy to lidocaine Medical or personal conditions which in the judgment of study staff contradict participation in the study Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following Endometritis or chorioamnionitis during the intrapartum period Membranes ruptured for greater than 24 hours prior to delivery Fever greater than or equal to 38C", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-60.0, All Clinically Severe Obesity Gastroesophageal Reflux Disease Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements Met NIH for bariatric surgery With functional or failed antireflux surgery (Nissen fundoplication) Laparoscopic approach for revisional surgery Any other type of revisional bariatric procedure Nonstandard revisional RYGB surgery Open approach for revision surgery Missing records and/or unreachable patients with scant information for analysis", "label": "1"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-999.0, All Morbid Obesity The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic sleeve gastrectomy The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic gastric bypass Subjects having any other obesity surgical procedure", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-45.0, All Contraception Intrauterine Devices Pilot Study Africa Primary Ages 18-45 attending prenatal care Greater than 34 weeks estimated gestational age Desire to use the CuT380A-IUCD for contraception postpartum Plan to stay in the area for at least 5 months postpartum If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport No prior cesarean delivery No treatment for pelvic inflammatory disease within 3 months prior to pregnancy No known uterine anomalies No known pelvic tuberculosis prior cesarean section fever during labor and delivery AIDS, not well on antiretroviral therapy genital tuberculosis known uterine abnormalities or genital tract cancer history of ectopic pregnancy within 3 months of current pregnancy", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-60.0, All Morbid Obesity Age: 18 years BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2 Willingness to comply with dietary restrictions required by the protocol History of obesity for at least 5 years History of at least 6 months of documented failures with traditional non-surgical weight loss methods Willingness to follow protocol requirements which signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire If female with childbearing potential, using an appropriate form of contraception Age less than 18, age greater than 60 Pregnancy History of major depressive disorder or psychosis Previous bariatric surgery or previous gastric surgery Presence of achalasia Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 15.0-40.0, All Ectopic Pregnancy Criteria:The criterion was the presence at transvaginal ultrasound of an extraovarian adnexal mass in women with a suspected ectopic pregnancy (amenorrhea, bleeding and pain) with positive test for beta-hCG The criterion was non-tubal ectopic pregnancy (cervical, cesarean scar, ovarian, and abdominal)", "label": "1"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 29.0-38.0, All Endometriosis Infertility Infertility Mild endometriosis (until stage II) ovarian endometrioma > 2 cm FSH > 12 mIU/ml Mail factor infertility", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-40.0, All Cesarean Section; Complications Placenta Previa Placenta Accreta Singleton pregnancy Term (> 37 weeks) pregnancy Cervical dilatation < 4 cm Kerr incision Age > 18 years old Being in active phase of labor Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa ) Having a history of uterine surgery (myomectomy, hysterotomy) other than CS Extension of Kerr incision Multiple pregnancy Maternal diabetes mellitus Maternal connective tissue disease Uterine malformation Uterine fibroids on Kerr incision line Chorioamnionitis", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 12.0-55.0, All Ectopic Pregnancy pregnant females in 1st trimester present to emergency department complaint of abdominal/pelvic pain or vaginal bleeding previous ultrasound diagnostic of location of pregnancy", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 20.0-36.0, All Endometriosis Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure No other infertility factors Normal serum basal hormone levels as well as documented ovulation Moderate or severe endometriosis Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery Age more than 36 years, BMI more than 30 kg/m2 women with a previous pregnancy", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 39.0-65.0, All Obesity Insulin Resistance Diabetes Mellitus Type 2 No major organ disease Fasting blood glucose < 126 mg/dL BMI 25-35 kg/m2 Nonpregnant/nonlactating pregnancy/lactation major organ disease drugs that influence insulin resistance unstable body weight or active weight loss program outside BMI range or age range diabetic by fasting glucose 126 mg/dL or higher", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 20.0-40.0, All Polycystic Ovary Syndrome Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days History of at least one year of infertility Age between 20 and 40 years old Normal semen analysis based on World Health Organization (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration \u226515 \u00d7 106/mL and total motility \u226540% in the semen analysis of the husband was required for the woman to be included Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy History of significant system diseases such as heart, lung, or kidney diseases History of other endocrine disorders Use of hormonal therapy, including metformin, in the past 3 months Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-65.0, All Obesity Subject is willing to give consent and comply with evaluation and treatment schedule 18 to 65 years of age (inclusive) Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may but are not be limited to - Hyperlipidemia Type 2 diabetes Mild obstructive sleep apnea Hypertension Osteoarthritis of the hip or knee Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial HbA1C < 11% Previous malabsorptive or restrictive procedures performed for the treatment of obesity Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery Any condition which precludes compliance with the study History or presence of pre-existing autoimmune connective tissue disease Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion)", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 20.0-65.0, All Obesity Weight Loss Diet Age (years): 20-65 Body Mass Index (kg/m2): 28-35 Non-smokers Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1) marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female) planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator blood donation within the past 2 months prior to the study weight change of >3 kg within 2 months prior to the study psychiatric disease (based on medical history only) pregnant or lactating women, or women planning to become pregnant within the next 12 months surgically treated obesity participation in other clinical studies within the last 3 months drug abuse (based on clinical judgment)", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 19.0-39.0, All Polycystic Ovarian Syndrome Age > 18 years but < 40 years old Was diagnosed PCOS Normal husband's seminal fluid analysis (SFA) Not having medical problems eg renal disease, tyhroid disorder, hyperprolactinemia, liver disease Other causes of anovulatory infertility", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-50.0, All Ectopic Pregnancies Patients with pregnancy of unknown location (PUL) diagnosed 22 days after oocyte retrieval, at first ultrasound routine control (A \"pregnancy of unknown location\" (PUL) is a term used to classify a women with a positive pregnancy test and an empty uterus with no signs of an intrauterine or extrauterine pregnancy on a transvaginal ultrasound scan.) Patients with Intrauterine pregnancy : Viable intrauterine pregnancy (IUP) An intrauterine gestational sac containing a fetal pole with visible cardiac activity Patients with Ectopic pregnancy (Tubal ectopic pregnancy): An empty endometrial cavity with: (i) an inhomogeneous adnexal mass or (ii) an empty extrauterine gestational sac seen as hyperechoic ring or (iii) an extrauterine gestational sac with a yolk sac and/or fetal pole with or without cardiac activity ", "label": "2"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-46.0, All Complication Following Ectopic Pregnancy Patients who suspected ectopic pregnancy hemodynamically unstable patient healthy pregnancy (a healthy increase in \u00df HCG) missed abortion incomplete abortion The patient who need immediate surgical treatment", "label": "2"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-50.0, All Ectopic Pregnancy patients with ectopic pregnancy healthy hemodynamic stable first ectopic hemodynamic non-stable abnormal liver or kidney function allergy reaction to MTX", "label": "2"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-65.0, All Type 2 Diabetes patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass age:18-65yr HbAlc>8% diabetes (applies for control patients) chronic inflammatory disease malignant disease pregnancy prior gastric, duodenal, proximal jejunal surgery or pancreas resection current use of thiazolidinediones treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months HbAlc<8% any condition felt by the investigator to interfere with ability to complete the study", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-999.0, All Persistent Pregnancy of Unknown Location Ectopic Pregnancy Female with a persisting pregnancy of unknown location A pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization Persistence of hCG is defined as at least 2 serial hCG values (over 4-14 days), showing < 50% rise, or < 50% fall between the first and last value Patient is hemodynamically stable, hemoglobin >10 mg/dL Greater than or 18 years of age Hemodynamically unstable in need of acute treatment Most recent hCG > 5000 mIU/mL Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion) Diagnosis of gestational trophoblastic disease Subject unwilling or unable to comply with study procedures Presence of clinical contraindications for treatment with MTX Prior medical or surgical management of this gestation", "label": "1"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 25.0-55.0, All Postoperative Nausea and Vomiting Patients undergoing elective laparoscopic cholecystectomy for gallstone disease Patients with age range of 25 to 55 years H/O chronic illness like DM, IHD, CRF, CLD H/O acute or chronic psychiatric or psychological illness H/O APD (acid peptic disease) or regurgitation H/O of any chemotherapy (cancer drugs, opioids), radiotherapy, any history of repeated infection H/O use of hepatotoxic drugs like acetaminophen, ciprofloxacin, ATT, valproic acid etc. in last one month H/O alcohol intake in last one month Previous hepatobilliary surgery Complicated cholecystectomy in which laparoscopic cholecystectomy is converted to open cholecystectomy Patients who are given opioids in postoperative period Patients who need epidural analgesia in postoperative period", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 30.0-50.0, All Obesity Overfeeding Muscle Mass Body Composition Ectopic Fat Body mass index 25-32 Type 2 diabetes Type 1 diabetes Kidney disease Liver disease Abnormal clinical chemistry at screening Intense physical exercise > 2 hours per week Use of statins or drugs affecting energy metabolism Use of extreme diets", "label": "1"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-999.0, All Cholecystitis Signed informed consent All patients deemed to have a clinical and surgical indication to undergo a LESS cholecystectomy Pregnancy Breastfeeding BMI>35 Serious comorbidities precluding a LESS cholecystectomy Known or suspected neuromuscular disorders impairing neuromuscular function Allergies to muscle relaxants, anesthetics or narcotics utilized for this study A (family) history of malignant hyperthermia A contraindication for neostigmine administration Chronic opioid use Prolonged QT syndrome", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-45.0, All Hysteroscopic Adhesiolysis Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis Willing to use additional contraception throughout study Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study Has suffered or currently suffers from a gynaecological malignancy Has undergone a previous hysteroscopic surgery (such as removal of fibroids)", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-40.0, All Vaginal Bleeding During Pregnancy Postcoital Bleeding women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the \"Women E.R.\" due to vaginal bleeding age >40 or <18 women with history of more then 3 abortions women with history of more then 2 pre term labor ectopic pregnancy placental previa women who takes anticoagulation therapy women with known pathology at cervix women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-35.0, All Infertility Age: between 18-35 years Period of infertility > 2 years Serum level of FSH <10 U/L in the early follicular phase All women were CC-resistant PCOS, as they failed to ovulate with a dose of CC of 150 mg/day for 5 days per cycle for at least three consecutive cycles All women had patent Fallopian tubes proved by hysterosalpingography or laparoscopy and their partners satisfied the normal parameters of semen analysis according to the modified WHO Infertility due to causes other than CC resistant PCOS or due to combined factors Body mass index (BMI) \u226535 Kg/m\u00b2 The use of metformin, gonadotropins, hormonal contraception or diet regimen within the last 6 months Women with congenital adrenal hyperplasia, hyperprolactinaemia or abnormal thyroid function Hypersensitivity or contraindications to Letrozole or clomiphene treatment Previous LOD", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-40.0, All Infertility Pregnancy Infertile women age ranges from 18 to 40 years at the time of treatment at the MUHC reproductive centre Patients undergoing IUI Fresh and frozen sperm treatment cycles Hormone induced and natural cycle (no hormonal stimulation) Patients speaking English or/and French Patients able to consent Patients younger than 18 years or older than 40 years of age Patients undergoing ovarian stimulation without IUI Patients who have been recruited in our study in a previous IUI cycle Patients who don't speak English or French Patients who are not able or refuse to consent Patient who are recruited in a different IUI research study", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-60.0, All Morbid Obesity BMI >40 and < 60 kg/m2 No contraindication to any of the procedures No contraindication to general anesthesia No known addiction Patient able to provide informed consent Contraindication to general anesthesia Known psychiatric pathology Pregnancy Previous major digestive surgery Immunosuppressive treatment including corticoids Coagulopathy (INR>1.5) or platelets < 50 000/\u00b5l Anemia (Hb<10g/dl) Severe comorbidity Malabsorptive disease or gastro-intestinal disease Myocardial infarction in previous year, angina, cardiac failure", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 18.0-49.0, All Hysterectomy Age: 18 to 49 years at index date Gender: Female Diagnosis: Women who underwent hysteroscopic device sterilization procedure Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy Patients undergoing in-vitro fertilization (IVF) procedures Embryo transfer, intrauterine Follicle puncture for oocyte retrieval, any method", "label": "0"} +{"topic": "A 28 yo female G1P0A0 is admitted to the Ob/Gyn service for non-ruptured ectopic pregnancy. Past medical history is remarkable for obesity, a non-complicated appendectomy at age 8, infertility treatment for the past 3 years, and pelvic laparoscopy during which minor right Fallopian tube adhesions were cauterized. Her LMP was 8 weeks prior to admission. Beta HCG is 100 mIU. The attending physician usually treats unruptured ecoptic pregnancies laparoscopically but is concerned about the patient's obesity and history of adhesions.", "doc": "eligible ages (years): 20.0-35.0, All Anovulation Polycystic Ovary Syndrome Age between 20-35 Primary or secondary infertility Patients diagnosed as PCOs according to Rotterdam (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.,2003) Any patients have any causes of infertility other than which mentioned in the as Hyperprolactinemia Male factor of infertility WHO Guidelines 2010 for Normal seminal fluid analysis Volume> 1.5 ml ph 7.2 to 8.0 Liquefaction time 20 to 30 min Sperms concentration >15 million/ml Total motility 40%(Progressive motility + non progressive motility) Progressive motility 32%", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.25-9.0, All Anemia Age: 3 months to 9 years Haemoglobin concentration 7g/dl on admission to hospital Residence within 30 km of the study centre and availability for the duration of the study period Informed consent to participate in the study given by the parent or guardian Simultaneous participation in any other trial Allergy to sulpha drugs Residence > 30 km from the recruitment site Lack of consent", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 8.0-18.0, All Chest Pain 18 years of age Pediatric patients with referrals for innocent heart murmurs Pediatric patients experiencing chest pain English speaking Non English speaking patients", "label": "2"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 12.0-18.0, All Anemia Age between 12 and 18 History of Chronic Renal Failure requiring HD or PD Hgb 37.5oC plus asexual forms of P. falciparum in the peripheral blood film of 500/\u03bcl or above; and Hb <110g/l and >69g/l (Our choice of the upper limit of moderate anaemia (70 /l) is to enable us assess the response to our interventions of severer forms of anaemia while at the same time reducing the risk of adverse events which might occur with lower levels of Hb) Refusal of parent or guardian to give consent to the child's participation in the study Inability of the subjects to take oral medications Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia & gallop rhythm, tender hepatomegaly Children with known haemoglobinopathy Children with a weight for height Z score below -3SD of WHO/NCHS standard Enrolment in another research project", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 5.0-999.0, All Sickle Cell Disease Hemolytic Anemia Established Diagnosis of Hemolysis Sickle Cell Disease (e.g., HbSS, HbS/\u03b2-thalassemia, HbSC) Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH) Age SCD participants: 5 years of age up to 19th birthday All other participants: 5 years of age and up (no age limit) Previous cardiac surgery Known left ventricle dysfunction (i.e. shortening fraction < 28%) Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 12.0-18.0, All Chronic Fatigue Syndrome Adolescents (12 years) with Chronic Fatigue Syndrome Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children Score greater than or equal to 20 on the Children's Depression Inventory No availability of computer and/or internet Risk of suicide Mental retardation", "label": "1"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-65.0, All Chronic Hepatitis C Male and female patients aged 18-65 years Elevated liver enzymes levels Compensated liver disease Available liver histology confirming F2 fibrosis Written consent to participation Age <18, >65 Prior ribavirin treatment Intolerance towards ribavirin, PegIFN or erythropoetin Pregnancy or breast feeding Relevant cardiovascular or pulmonary disease Kidney insufficiency (creatinine clearance <50ml/min) Coinfection with HIV or hepatitis B virus Hepatic comorbidities (hemochromatosis, Wilson's disease, autoimmune disorders) Alcohol consumption > 40g/day Psychiatric disorders", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.0-20.0, All Thalassemia Alpha Hemolytic Anemia All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center ", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.0-18.0, All Anemia Adolescents (ages 11-18 y) and their newborns will be eligible to participate if the adolescent is carrying a singleton pregnancy, does not have any preexisting medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) Individuals with pregnancy induced hypertension or elevated diastolic blood pressure (>110) will not be eligible to participate in the study. In addition, adolescents who have been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study Data from infants that experience perinatal asphyxia, pathologic neonatal hyperbilirubinemia, respiratory disease, antibiotic therapy (aminoglycosides), CNS infection, sepsis, congenital or middle or external ear lesions, craniofacial anomalies, chromosomal disorders, TORCH (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex infection) or those that were clinically unstable with the first 48 h post-delivery will be excluded from ABR studies. Infants born to mothers with positive drug abuse screens at delivery will also be excluded from further study (these screens are automatically run among this age group). Infants that are identified with hearing deficits at birth using the OAE screening will be excluded from the ABR measures", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 21.0-999.0, All Coronary Artery Disease Subjects who are undergoing routine screening coronary CT angiography Willingness to sign informed consent form Inability to provide informed consent form Age less than 21 years Any contraindications to coronary CT angiography Known atherosclerotic heart disease, including a history of prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery or an established diagnosis of CAD by prior X-ray or CT angiography Supraventricular or ventricular arrhythmias that would be expected to affect CT-angiography image quality (e.g., atrial fibrillation, atrial flutter, ventricular tachycardia, bigeminy, and trigeminy). Patients with isolated premature atrial contractions and premature ventricular contractions may enroll Use of intravenous vasodilators Any pulmonary conditions that would create abnormal physical findings that would interfere with the fidelity of the cardiac sound recording (e.g., obstructive pulmonary disease, such as asthma or COPD, with audible wheezing) Presence of audible aortic or pulmonic diastolic murmurs, tricuspid or mitral flow diastolic murmurs, or continuous murmurs", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 19.0-999.0, All Cardiovascular Risk Factors Age \u2265 65 years Hypertension (HTN) Diabetes Obesity (body mass index [BMI] >35) Renal insufficiency Tobacco usage Hypercholesterolemia Sleep apnea/heavy snoring at night Clinical diagnosis of CHF as defined by Dyspnea on exertion Patients expected to say in the hospital for less than 24 hours Inability of undergo TEE and TTE Clinical evidence or suspicion of elevated intracranial pressure Preoperative shock or systemic sepsis Emergency Operation ASA Class V Inability of give informed consent Participation in another clinical trial Prisoner", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-999.0, All Iron Deficiency Signed informed consent prior to study specific procedures Premenopausal, regularly menstruating women Age \u226518 years Body weight between 50 and 90 kg Haemoglobin \u2265115 g/L Iron deficiency at screening defined as follows S-ferritin level <50 ng/mL, AND, TfS <20%, OR S-ferritin level <15 ng/mL Serum C-reactive protein <5 mg/L if not on oral contraception, OR Haemoglobin level <115 g/L Haemoglobinopathy Haemochromatose Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores \u22652; one of which corresponds to question number 1 or 2) Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) >3-fold upper limit), angina (Class IV) Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease) Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea Intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness) Important recent weight loss (>10% within the past month)", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-999.0, All Anemia, Hemolytic, Autoimmune Age 18 years or over Clinical and biochemical signs of haemolytic anaemia Positive Coombs test with anti-IgG on its own or with anti-CD3d Adequate contraceptive measures (intrauterine device, contraceptive pill or gestagen deposit) for women of childbearing potential Performance status > 2 Previous treatment with Rituximab Other immune suppressive or anti neoplastic treatment including prednisolone within 3 months Auto immune haemolytic anaemia within 6 months Other serious disease Pregnant women and nursing mothers. Adequate contraceptive measures must be taken for the duration of the study Contraindication for treatment with Rituximab, i.e. patients that develop hypersensitivity/allergy to the contents of the drug or have antibodies against murine proteins Active infection which requires antibiotic treatment", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 10.0-16.0, All Human Papillomavirus Infection Criteria:schoolgirls, attending the 6th and 7th grades of the elementary school Pregnant and breastfeeding adolescents and girls who did not attend classes", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-999.0, All Warm Autoimmune Hemolytic Anemia Age > 18 years AIHA defined at time of diagnosis by a Hgb level \u00a3 10 g/dL, with a reticulocytes count > 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern) Disease duration equal or less than 6 weeks at time of --> removed by amendment n\u00b04 and substituted by :First episode of AIHA to \"hot\" antibody previously untreated or treated corticosteroids for less than 6 weeks Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be eligible for the study if the platelet count is over 30 x 109/L at inclusion Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion Absence of detectable lymph nodes on a total body CT-scan (to be performed before if not performed at diagnosis) Effective means of contraception during treatment and for six months after completion of treatment for all women of child bearing age Negative serum pregnancy test within 14 days prior to study entry Written informed consent Previous treatment with rituximab AIHA diagnosed and treated more than 6 weeks prior to removed by amendment n\u00b04 and substituted by AIHA relapsed or newly diagnosed but treated with corticosteroids for more than 6 weeks Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment administered within 2 weeks prior to the beginning of the study treatment Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years Autoimmune disorder such as SLE with at least one extra-hematological manifestation requiring a treatment with steroids and/or immunosuppressive drugs Any other associated cause congenital or acquired hemolytic anemia (except thalassemia trait or heterozygous sickle cell anemia) Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of a monoclonal IgM with cold agglutinin properties Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen (HbsAg) Neutrophils count < 1,000/mm 3 at inclusion", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.5-4.917, All Malaria, Falciparum Malnutrition Child Age between 6 and 59 months Weight \u22655kg P. falciparum monoinfection confirmed on a thick blood film Parasitic density between 1,000 and 200,000 asexual forms/uL of blood Measured axillary temperature \u226537.5\u00b0C or history of fever during the previous 24 hours Severe malnutrition (defined as a weight/height ratio less than -3 z-scores) High probability of compliance with follow-up visits (home is within two hours of walk from the outpatient department, no near-term travel plans, etc..) Consent of a parent or guardian who is at least 18 years of age Signs of a critical illness as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11) Signs of severe or complicated malaria as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11) Severe anaemia (haemoglobin <5 g/dL) Known history of hypersensitivity to any of the study medications Symmetric oedema in the feet Concomitant febrile illness not originating from malaria, which could alter the outcome of the study (measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscesses, severe diarrhea with dehydration, etc.) History of a full treatment course with the study drug in the past 28 days", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-999.0, All Autoimmune Hemolytic Disease (Cold Type) (Warm Type) Newly diagnosed \"warm\" or \"cold\" AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria) Idiopathic \"warm\" or \"cold\" AIHA relapsed after first line treatment with oral prednisone Aged >18 years ECOG performance status grade 0, 1 or 2 No psychiatric illness that precludes understanding concepts of the trial or signing informed consent Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice Cell or humoral immunologic deficit (congenital or acquired) Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients History of malignancies within 3 years prior to study entry Concomitant immunosuppressive or cytotoxic treatment Positive pregnancy test. Lactation The presence of associated organ-specific autoimmune diseases do not constitute Previous splenectomy does not constitute", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-75.0, All Non ST Segment Elevation Myocardial Infarction Unstable Angina ICF signature The research subject must agree about following all instructions and perform the procedures and study visits Men and women over the age of 18 and below the age of 75 History of angina of rest with a minimum duration of 20 minutes in the last 24 hours at the beginning and at least for 10 days Patient Randomization up to 6 hours after the arrival at the emergency sector Evidence of or unstable angina due to one or more of the following Dynamic alterations on the T-wave (ST-segment depression or elevation > 1 mm, and/or T-wave inversions which are solved at least partially when the symptoms are relieved) or 2. Unevenly ST-segment (depression or elevation) in a transitional way under continuous derivations (V1+V2 or V3+V4 or V5+V6 or D1+AVL or D2+D3+AVF) or 3. Biochemical alteration on the myocardial necrosis markers (CKMB mass, troponin T or I and CPK), with the appearance of enzymatic curve, characterizing myocardial injury or 5. Pulmonary Edema; or 6. Angina associated to murmur of mitral regurgitation; or 7. Angina with heart sound to cardiac auscultation or throes; or 8. Angina with hypotension derivation-ECG with persistent ST-segment elevation Diagnosis of angina by secondary cause (e.g., anemia, fever, hypovolemia, dehydration, use of cocaine) Use of non-fractionated heparin or low-molecular weight heparin in the prior 48 to the randomization Concomitant diseases, such as severe renal failure (creatinine clearance lower than 30ml/min.) and hepatic, or other significant comorbidities under investigator judgment Recent hemorrhagic cerebrovascular accident (last 12 months) Patient scheduled for cardiac surgery of myocardial revascularization Use of drugs, alcohol abuse Pregnancy or lactation Recent neurosurgery or ophthalmic surgery (last 3 months) History or diagnosis of coagulopathy", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.0-1.0, All Anemia Chronic Kidney Disease Girls and boys between birth and < 1 year of age at the time of enrollment Body weight \u2265 3 kg at screening and enrollment Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening Hemoglobin \u2264 9.0 g/dL within 7 days prior to enrollment Transferrin saturation \u2265 20% at screening Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother's last menstrual period) Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment History of cardiovascular events or thromboembolism History of upper or lower gastrointestinal bleeding History of seizures Active liver disease or history of liver disease Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmHg for a subject's age Major surgery 12 weeks prior to enrollment Red blood cell transfusions 12 weeks prior to enrollment Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-90.0, All Skin Closure of Surgical Incisions by Tissue Glue vs Suture Living kidney donor with informed consent Approved comprehensive work-up/evaluation at local hospital Allergy towards acrylate or similar chemicals Unable to communicate in norwegian language", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 12.0-999.0, All Iron Deficiency Non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study Pregnant, lactating, severe anemia, low BMI would be excluded", "label": "1"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.0-72.0, All Congenital Heart Disease all consecutive live newborn infants between 6-72hours of age declining the screening early discharge before the screening missing", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 10.0-16.0, All Myopia Visual acuity: 20/20 or better in each eye Spherical error ranging from +0.5 D to -6.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes Contact lens No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development Currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on) Unable to cooperate with the ocular examination and questionnaire survey", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 12.0-17.0, All Acne Quality of Life Between 12 and 17 years of age diagnosis of acne by a pediatric dermatologist ability to read and understand English age appropriate development \u2022 developmental delay", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.5-0.917, All Iron Deficiency Anaemia Stunting Aged 6-11 Residing within the project catchment area, and plan on remaining in the same household for the 12 month study duration Parent/guardian willingness to give consent for the child's participation in the study Weight-for-height Z score <3 SD Mid-upper arm circumference < 11.5 cm Presence of bilateral oedema Severe anaemia (Hb < 7.0 g/dl) HIV positive", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 16.0-70.0, All Sickle Cell Anemia (HbSS, or HbS\u03b2-thalassemia0) Diagnosis of HbSS, or HbS\u03b2-thalassemia0, confirmed by hemoglobin analysis Males and females age 16 years to 70 years old Greater than 2 episodes of pain in the last 12 months On a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin Judged not likely to be study compliant by his/her hematologist History of adverse reaction to montelukast or any of the components of montelukast Have used medications known to interact with montelukast such as rifampin, phenobarbital, and gemfibrozil within 4 weeks of enrollment Currently being treated with a leukotriene antagonist (montelukast or zileuton) or have used montelukast/zileuton within the last 60 days Chronic blood transfusion therapy defined as regularly scheduled transfusions Hemoglobin A greater than15% on hemoglobin analysis Individuals with a current physician diagnosis of asthma (within last 12 months) or requires continuous supplemental oxygen, or predicted or current use of asthma medications (inhaled corticosteroids, but participants taking bronchodilators will be allowed to participate) Current participation in another therapeutic trial for SCD Known current pregnancy Known history of HIV", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.0-15.0, All Malnutrition Anemia household with infant < 12 mo or adolescent 10-15 y Living in selected communities of Upper Manya Krobo District (Ghana) infant or adolescent has medical condition that limits dietary intakes or growth", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-999.0, All Sickle Cell Disease Sickle Cell Anemia SCD Patients must have one of the following inherited hemoglobin gene disorders Hemoglobin SS Hemoglobin SC Hemoglobin S-Beta-zero-Thalassemia or Hemoglobin S-Beta-plus Thalassemia Disease Morbidity For matched sibling donor grafts (low-risk e.g., matched sibling donor), patients must have evidence for morbid disease that has failed conventional therapy 2 or more painful episode/year (requiring Emergency Department or inpatient care) x 3 years or 2 or more diagnoses of Acute Chest Syndrome within 5 years, or 2-year mortality 5-10% eGFR <50 ml/min \u22652.0 liter-per-minute pm home oxygen requirement An estimated Left Ventricular Ejection Fraction \u226440% (echo or MUGA) Hepatic cirrhosis (Biopsy Proven) HIV positive, ineligible because of the increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated Red cell alloimmunization to a degree that precludes extended transfusion Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or breastfeeding women are excluded from this study because the immunomodulatory treatment, preparative regimen, and anti-GVH therapy contain agents with the potential for teratogenic or abortifacient effects. Further, this treatment, if indicated, is for a chronic condition, and can be delayed until the pregnancy has been successfully concluded. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study Subjects must not have evidence for impaired liver function due to iron overload, +/ hepatitis. Patients will be evaluated by hepatology if ferritin >1500, if history of hepatitis, or ALT/ALP are >1.5 X ULN", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.0-0.014, All Heart Murmurs Mitral Valve Prolapse Systolic Murmurs any premature baby or newborn parental approval for study participation ", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 16.0-999.0, All Autoimmune Hemolytic Anemia Patients diagnosed with primary warm Autoimmune Hemolytic Anemia Secondary Autoimmune Hemolytic Anemia (infections, hemopathy, systemic diseases) Naive to any treatment for hemolytic anemia or in relapse Older than 16 years of age Able to understand written and spoken French who have provided written informed consent \u2022 for Persons without an auto-immune disease, or cancer or an active infection Older than 16 years of age Able to understand written and spoken French Cold agglutinin disease Pregnant women Persons not covered by national health insurance Non-Inclusion controls Persons treated with corticoids or immunosuppressants Pregnant women Persons not covered by national health insurance", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.654-0.788, All Anemia Iron Deficiency Neonatal Jaundice Late preterm or term pregnancy (gestational age 34 to 41 weeks) Vaginal delivery Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-999.0, All Anemia Critical Illness Hospitalized for 5 Days or More Hospitalized man/woman in reanimation unit for at least 5 days Age \u2265 18 years old Patient having an anaemia such as defined by the WHO (World Health Organization) (for man: Hemoglobin < 13 g/dl, for woman: Hemoglobin < 12 g/dl) Signed inform consent by the patient or a close person Subject affiliated to a national health insurance Known iron metabolism pathology (such as primitive or secondary hemochromatosis, \u2026) Chronic anaemia (Hemoglobin \u2264 10 g/dl for more than 3 months) Current chemotherapy Patient having an organ transplant Expected survival < 28 days post Intensive Care Unit discharge Pregnancy Patient deprived of freedom, by judicial or administrative order Major protected by the law Contra-indication to the injectable iron treatment (allergy to ferric carboxymaltose, infection derivates (bacteriamy < 48 hours) untreated) Non speaking French patient, or patient unable to answer a questionnaire because of any neurologic disorder (stroke, brain trauma\u2026.)", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-999.0, All Autoimmune Hemolytic Anemia Adults (18 years old) wAHAI defined by the presence of hemolysis and positive coombs test (IgG +/-C3) Absence of infection or other hematologic disease wAHAI not responding to conventional steroids despite a dose over 10 mg No treatment with rituximab for a minimum of 6 months Signed informed consent form Less than 18 years old Cold AHAI IL2 allergy Chemiotherapy or immunosuppressive treatment Treatment with rituximab for less than 6 months Neoplasia or hematologic malignancy Aplastic anemia Neutropenia \u2264 1000 mm3 Infection Hepatitis B or C", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.083-0.25, All Biliary Atresia persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%) elevated liver enzymes ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis with radionuclide imaging confirmation of obstructed biliary excretion concomitant cardiovascular or abdominal organ malformations", "label": "1"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 0.0-18.0, All Heart Murmurs Mitral Valve Prolapse Systolic Murmurs outpatient parental approval for study participation ", "label": "2"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 12.0-17.0, All Cancer Teenagers at the ages 12-17 Four or five (dependent on their overall plan of medical treatment) consecutive courses of chemotherapy administrated at the involved child cancer units and (administered) over a period of minimum 24 hours incl. hydration with assumed moderate to severe nausea and vomiting The specific type of chemotherapy may vary across the four/five consecutive courses but shall one of the following moderate and/or highly emetogenic types of chemotherapy Moderate emetogenic chemotherapy Carboplatin Cyclophosphamide <1500 mg/m2 Cytarabine >1 g/m2 Daunorubicin Doxorubicin Epirubicin Previous and/or acute psychiatric diagnosis Cognitive and mental deficits or impaired functioning", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-65.0, All Nicotine Dependence Have no known serious medical conditions Are 18-65 years old Smoke an average of at least 10 cigarettes per day Have smoked at least one cumulative year Have an expired air CO reading of at least 10ppm Are able to read and understand English Potential subjects must agree to use acceptable contraception during their participation in this study. Potential subjects must agree to avoid the following during their participation in this study Participation in any other nicotine-related modification strategy outside of this protocol Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco Use of e-cigarettes other than the ones provided during the study Intent to quit smoking with FDA approved pharmaceutical products within the next 90 days Hypertension (systolic >160 mm Hg, diastolic >100 mm Hg. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety Coronary heart disease Lifetime history of heart attack Clinically significant cardiac rhythm disorder (irregular heart rhythm) Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source) Clinically significant cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure) Clinically significant liver or kidney disorder (except kidney stones, gallstones) Clinically significant gastrointestinal problems or disease Active ulcer in the past 30 days", "label": "0"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-999.0, All Warm Antibody Autoimmune Hemolytic Anemia Subject must have had a diagnosis of primary or secondary warm antibody AIHA Must have previously received at least 1 prior treatment regimen for AIHA and have evidence of relapse Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria Subject with a platelet count of < 100,000/\u03bcL Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure \u2265 140 mmHg, or diastolic blood pressure \u2265 90 mmHg", "label": "1"} +{"topic": "A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.", "doc": "eligible ages (years): 18.0-120.0, All Atypical Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura Microparticles Microangiopathic Hemolytic Anemia Patients with MAHA, TTP, and/or aHUS Prisoners", "label": "1"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 0.0-999.0, All Lyme Disease Tick-Borne Diseases Ferry passengers traveling to Nantucket Island Foreign (non-U.S.) residence", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-65.0, All Lyme Disease You may be eligible for this study if you Are between 18 and 65 years of age Are a resident of Long Island or greater NY metropolitan area Are fluent in English Have a history of Lyme Disease Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study Have severe fatigue Are not pregnant or planning to be pregnant You will not be eligible for this study if you Have or have had major medical, neurologic, or psychiatric disorder Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease Have had Fibromyalgia Syndrome Have a history of sleep apnea, narcolepsy, or other serious sleep disorder Have a learning disability Have had head trauma requiring hospitalization Have symptomatic gallbladder disease Are anemic Abuse alcohol or illicit drugs", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Lyme Disease You may be eligible for this study if you Are at least 18 years of age Are seronegative for antibodies against B. burgdorferi antigens by Western Blot at enrollment Have documented history of acute Lyme disease Have had a rash (erythema migrans) that resembles a bullseye. This skin aberration usually occurs after a tick bite in late spring, summer, or early fall and is sometimes accompanied by fatigue, fever, headache, mild stiff neck, arthralgia or myalgia Have had one or more clinical features typical of Lyme disease acquired in the United States (see technical summary) Have had one or more of the following symptoms and conditions that have persisted for at least 6 months (but less than 12 years) and are not attributable to another cause or condition: a) widespread musculoskeletal pain and fatigue that began coincident with or within 6 months following initial infection with B. burgdorferi. b) certain neurologic symptoms including memory impairment and nerve pain, beginning within 6 months following initial infection with B. burgdorferi Have had a physician-documented history of prior antibiotic treatment with a currently recommended antibiotic regimen You will not be eligible for this study if you Have previously enrolled in this study Are pregnant, lactating, or unable to use birth control measures during the treatment period of this study Are taking chronic medication that could interfere with evaluation of symptoms Are taking or have taken various medications that could interfere with the evaluation of symptoms (see technical summary) Are hypersensitive to ceftriaxone or doxycycline Have active inflammatory synovitis Have another disease that could account for symptoms of acute Lyme disease Have another serious or active infection Are unable to tolerate an IV", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 13.0-999.0, All Lyme Disease Screening Age greater than or equal to 13 years old Suspect of suffering from Lyme disease Post-Treatment Lyme Disease Syndrome (PTLDS): For the purposes of this study, PTLDS is defined as occurring in male or female patients age 13 and above who have been diagnosed with confirmed Lyme disease, have received recommended antibiotic therapy and have persistent or relapsing symptoms and/or signs for at least six months after therapy. They also should have no other documented explanation for their signs and symptoms and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC (IgG immunoblot is considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC), 28 kDa, 30 kDa, 39 kDa, 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa) Lyme arthritis controls: For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise healthy male or female aged 18 and above who have intermittent episodes of arthritis involving one or few joint, without any other cause being documented, and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC criteria Recovered Controls: For the purposes of this study, a recovered control is defined as an otherwise healthy male or female aged 18 and above who has had Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case Definition and who had received accepted antibiotic treatment for Lyme disease (at least 3 months since the end of antibiotic therapy before protocol evaluation) and who are currently asymptomatic Seropositive Controls: For the purposes of this study, a serpositive control is defined as an otherwise healthy male or female aged 18 and above who has positive serum IgG antibody to B.burgdorferi by Western blot according to the CDC and are asymptomatic and who recall no episodes of disease compatible with Lyme infection and have not received antibiotic therapy for Lyme disease OspA vaccinated control: For the purposes of this study, a OspA vaccinated control is defined as an otherwise healthy male or female aged 18 and above who has received at least two doses of the OspA vaccine for Lyme disease (Lymerix [R]). These controls may have a positive ELISA for B.burgdorferi but a negative (or unreadable) IgG western blot Multiple sclerosis controls: For the purposes of this study, a multiple sclerosis control is defined as an otherwise healthy male or female aged 18 and above with relapsing-remitting or progressive multiple sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis Society and no evidence of prior exposure to B.burgdorferi as indicate by negative history for Lyme disease and negative Western blot for B.burgdorferi in the serum by the CDC criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between 1 to 5 Healthy Volunteers: For the purpose of this study, a healthy volunteer is defined as healthy male or female, age 18 and above, with no history compatible with acute or chronic Lyme disease and negative western blot to B.burgdorferi in the serum by the CDC criteria General Age less than 18 (less than 13 for patients with chronic Lyme disease) Weight less than 70 Lb (35 kg) Pregnancy or lactation Women with childbearing potential who are sexually active and unwilling to use effective contraception Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV Chronic medication use will be evaluated in a case-by-case basis Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation FOR PTLDS AND LYME In addition to the general", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Erythema Migrans Lesions Erythema Migrans Patients Age greater than or equal to 18 years Diagnosis of EM an expanding annular lesion, at least 5 cm in diameter on a person with a history of exposure to the disease Exposure is defined as having been (less than or equal to 30 days before onset of EM) in wooded, brushy, or grassy areas (i.e., potential tick habitats) in an area in which Lyme disease is endemic A history of tick bite is not required The area of the erythema migrans lesion is suitable for biopsy. This excludes biopsies on the face, neck, scalp, and over the tibia Not know to be positive for RPR, HIV, HBsAg or HCV Able to give consent Healthy Volunteers Patients Antibiotic therapy for the current episode of Lyme disease Oral corticosteroids within the past 2 weeks History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year Diagnosis of diabetes, active cancer, or autoimmune diseases Investigational drugs in the past month History of forming large thick scars after skin injuries or surgery History of excessive bleeding after cuts or procedures or on anticoagulation Use of steroid cream/ointment at the rash Healthy Volunteers", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Lyme Neuroborreliosis Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled Intrathecal production of borrelia antibodies White cell count in cerebrospinal fluid (CSF) > 5/mm3 Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval Verified acrodermatitis chronica atrophicans Allergy to the contents in the medication, or earlier type I reaction to penicillin Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days Pregnancy or breastfeeding Age < 18 years", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Encephalitis, Tick-Borne Subjects who participated in Study 223 will be eligible for participation in this study if they understand the nature of the study, agree to its provisions and provide written informed consent they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223 blood was drawn after their first booster vaccination in Study 223 Subjects will be excluded from participation in this study if they received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Subjects will not be eligible for booster vaccination if they are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial) suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination) have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 7.0-12.0, All Lyme Disease Child age 7-12 and their parents living in the selected endemic areas No exclusions ", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 15.0-999.0, All Nervous System Lyme Borreliosis erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old pregnancy lactation history of adverse reaction to a beta-lactam antibiotic", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 15.0-999.0, All Erythema Chronicum Migrans solitary erythema migrans in patients > 15 years a history of Lyme borreliosis in the past pregnancy or lactation immunocompromised status serious adverse event to doxycycline taking antibiotic with antiborrelial activity within 10 days multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 15.0-999.0, All Suspected Early Lyme Neuroborreliosis age >15 years erythema migrans in 4 months period before neurologic symptoms normal CSF cell count absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy) pregnancy lactation allergy on doxycycline and ceftriaxone immune deficiency", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis adult patients >/= 18 years of age active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA functional class IV by ACR classification history of inflammatory joint disease other than RA previous treatment with cell-depleting therapies, abatacept or rituximab active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 17.0-65.0, All Crimean-Congo Hemorrhagic Fever Lassa Fever An individual will be enrolled in this study if the patient Meets the case definition for a probable or a suspected case of CCHF or LF (see below) Has read and signed the Informed Consent Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Agrees to collection of required specimens Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (\u00b12 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy Has known intolerance to Ribavirin Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission) Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major) Has history of autoimmune hepatitis Has a calculated serum creatinine clearance of < 30 mL/min History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome A sinus bradycardia of less than 40 beats per minute Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin Relative", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 10.0-999.0, All Anaplasmosis Tick-borne Disease Ehrlichia patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite- patient with fever with at least one of following : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities patient with tick-borne encephalitis, or primary stage Lyme borreliosis children less that 10 years pregnancy patients with an other diagnosis that can explain clinical symptoms or biological abnormalities antibiotherapy with cyclins during the days before", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Tick-Borne Encephalitis Encephalitis, Tick-Borne Tick-Borne Disease Glycoprotein E, Flavivirus NSI Protein, Flavivirus All subjects must meet the following at study entry Be engaged in activities that place them at potential risk of occupational exposure to TBEV in its viable form at one of the participating intramural laboratories of NIAID Be 18 years of age or older at the time of the first immunization Comprehend the study requirements Provide written informed consent to participate in this study Be in good health as determined by the Investigator, based upon medical history and a targeted physical examination Have a stable health status as determined by the Investigator Have access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common use phone serving multiple rooms or apartments) Express availability for the required study period, and ability to attend scheduled visits The following should be checked at the time of the study entry. If any apply, the subject will not be included in the study The subject must not be participating in any other trial of an investigational drug or vaccine for 1 month prior to the first injection through until 21 days after the third injection. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case by case basis after discussion between the Investigator and the IRB.) The presence on the day of immunization of an oral temperature of > 101.2 degrees F or acute symptoms other than mild severity Active systemic infectious process as determined by review of systems and physical examination. The subject may be enrolled at a later date once the illness has resolved Known immune suppression, such as that associated with human immunodeficiency virus infection, or other condition, to the extent that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. This information will be obtained by history only. Serologic screening for these diseases will not be performed Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the Investigator to render the potential subject unable/unlikely to report promptly any adverse reactions to the vaccine Current diagnosis of leukemia, Hodgkin s disease, non-Hodgkin s lymphoma, or any other cancer, autoimmune disease such as lupus, which is in and of itself a cause of immunosuppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine Currently receiving systemic immunosuppressive chemotherapy or immunotherapy (including glucocorticoids) resulting in immune suppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine Any neurological condition in which (in the opinion of the Investigator) the integrity of the blood brain barrier may have been compromised Licensed vaccines are not exclusionary but should be given at least 14 days before or after immunization (applies to each of the 3 scheduled TBEV injections) for inactivated vaccines and 30 days before or after immunization with any live vaccines. This is in order to avoid potential confusion of adverse reactions. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case-by-case basis after discussion between the Investigator and the IRB.)", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Lyme Neuroborreliosis patients with typical clinical manifestations of Lyme neuroborreliosis and intrathecal antibody production against Borrelia burgdorferi patients with typical clinical manifestations of Lyme neuroborreliosis and erythema migrans within three months patients with some clinical manifestations of Lyme neuroborreliosis and presence of antibodies against Borrelia burgdorferi bacteria in blood pregnancy lactation use of any antibiotics two weeks before study treatments begins an allergy to ceftriaxone or doxycycline", "label": "1"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 0.167-3.0, All Urinary Infection Children aged 2 months Non-toilet-trained children Indication to bag urine collection with the following fever \u2265 38.5 \u00b0C unexplained fever and at least 1 of the following for girls and uncircumcised boys, at least 2 for circumcised boys age \u2264 12 months fever \u2265 48 hours poorly tolerated fever (chills \u00b1 cyanosis \u00b1 pronounced weakness\u2026) Parents opposed to the participation of their children in the study Diarrhea Current antibiotic treatment or during the 8 preceding days of the urine collection Genitals / perineal anomaly", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 8.0-14.0, All Duchenne Muscular Dystrophy Diagnosis of Duchenne muscular dystrophy confirmed by at least one of the following Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical presentation consistent with typical DMD Positive gene deletion test (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as \"out-of-frame\", and clinical presentation consistent with typical DMD Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) definitively associated with DMD, and clinical presentation consistent with typical DMD Age between 5 yrs old (inclusive) Positive Gower sign (indicating ability to rise from the floor & presence of proximal muscle weakness) Able to walk 10 meters in <12 seconds Able to stand upon WBVT plate (with knees flexed) for entire treatment protocol (i.e. 15-minutes) Stable absolute dose of glucocorticoids (i.e. prednisone or deflazacort) for at least 3 months prior Clinical presentation, genetic testing and/or muscle biopsy consistent with Becker muscular dystrophy History of recent surgery (within past 6-months) History of a recent fracture (long-bone or vertebral) within past 6-months Acute inflammatory processes of lower extremities (e.g. cellulitis, etc) due to risk of pain and/or worsening inflammatory process History of venous thrombosis (theoretically risk of inducing thromboembolic event) History of kidney or bladder stones History of uncontrolled seizures or severe migraines History of cardiac arrhythmia Intracranial pathology or hardware (e.g. ventriculoperitoneal shunt, cochlear implant) Use of any investigational or experimental products within last 6-months and/or concomitant participation in another study", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Acute Injury of Upper Extremity All new patients (>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion) English fluency and literacy Able to take informed consent Pregnant women", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 7.0-9.0, All Duchenne Muscular Dystrophy Diagnosis of DMD confirmed by clinical history with features before the age of five physical examination elevated serum creatine kinase level absence of dystrophin expression, as determined by immunostain or Western blot (<2%) and/or DNA confirmation of dystrophin mutation Age 7 to 9 years: a lower age limit of 7 years was selected, since in our experience children younger than 7 years are likely unable to cooperate and comply with all of the exercise measures as needed. An upper age limit of 9 years has been set as boys with DMD tend to reach a rapid progression into a late ambulatory phase soon after this age Ambulatory at the time of the first visit, defined as the ability to walk for at least 100 m without an external assistive device and able to climb four stairs Currently using corticosteroids (prednisone or deflazacort) as prescribed by a physician Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants) Presence of a condition in control subjects or a secondary condition in boys with DMD that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease) Secondary condition leading to developmental delay or impaired motor control (e.g. cerebral palsy) Secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease) Unstable medical condition (e.g. uncontrolled seizure disorder) Behavioral problems causing an inability to cooperate during testing", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Tick-borne Encephalitis years or older clinical picture compatible with tick-borne encephalitis clear cerebrospinal fluid cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus positive serum IgG antibodies against Lyme borreliae isolation of B.burgdorferi sensu lato from cerebrospinal fluid positive intrathecal borrelial antibody production index seroconversion of borrelial IgG antibodies presence of erythema migrans and/or borrelial lymphocytoma in the last month Bannwarth syndrome", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-130.0, All Lung Cancer Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures Adults (according to each country regulations for age of majority) Locally advanced (stage IIIB) or metastatic (stage IV) EGFRm NSCLC, not amenable to curative surgery or radiotherapy, with confirmation of the presence of the T790M mutation Prior therapy with an EGFR-TKI. Patients may have also received additional lines of treatment World Health Organization (WHO) performance status 0-2 Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline (please refer to IB for guidance) ECG recording at baseline showing absence of any cardiac abnormality as per criterion #6 Female patients of childbearing potential must be using adequate contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to start of dosing. Otherwise, they must have evidence of nonchildbearing potential Male patients must be willing to use barrier contraception, i.e., condoms Previous (within 6 months) or current treatment with AZD9291 Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, active infection including hepatitis B, hepatitis C, and human immunodeficiency virus, or significantly impaired bone marrow reserve or organ function, including hepatic and renal impairment, which in the investigator's opinion would significantly alter the risk/benefit balance Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids to manage CNS symptoms within the 2 weeks prior to start AZD9291 administration Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD Any of the following cardiac Mean resting corrected QT interval (QTcF) > 470 ms using Fredericia's formula Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events Any unresolved toxicity from prior therapy CTCAE > grade 3 at the time of starting treatment", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 0.0-0.019, All Microbiota Eczema Atopy Term-born babies (\u2265 36 weeks gestational age) (Short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment Signed informed consent by the parents Congenital illness or malformations Severe perinatal infections for which transfer to the neonatal intensive care unit is needed Maternal probiotic use \u2264 six weeks before delivery Insufficient knowledge of the Dutch language", "label": "0"} +{"topic": "A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.", "doc": "eligible ages (years): 18.0-999.0, All Tick Bites Tick-borne Diseases over 18 years of age spending an average of 10 or more hours of outdoor work per week during peak tick season, and completion of written informed consent pregnancy or a planned pregnancy during the follow-up period (since exposure to an insecticide is involved) non-English speakers, or having a known allergy or sensitivity to insecticides", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 1.0-17.0, All Cardiovascular Diseases Coronary Aneurysm Heart Diseases Mucocutaneous Lymph Node Syndrome Boys and girls who met the CDC for Kawasaki Syndrome. Subjects were excluded if they presented themselves to the participating centers after the tenth day of illness ", "label": "2"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 4.0-12.0, All Obsessive-Compulsive Disorder OCD Participants (N = 72) Aged 4-12 years and living within a four-hour commute from NIH Currently meet DSM-IV for OCD Recent onset of symptoms (less than 6 months.) Healthy Controls (N = 60-72) Age and sex matched to ODC participants Must be free of current or past psychopathology OCD Participants Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever Significant or unstable medical illness Full scale IQ less than 80 Healthy Controls Full scale IQ less than 80 Significant or unstable medical illness", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 12.0-999.0, All Pharyngitis Tonsillitis Give informed consent, assent and patient authorization Age 12 and over A clinical diagnosis of acute pharyngitis or tonsillitis A positive rapid Strep test Can swallow the oral study dosage forms Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active Chronic or recurrent odynophagia Need for hospitalization or IV antimicrobial therapy Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials Known carrier of S. pyogenes Allergies to penicillin or other beta-lactam antibiotics Any serious illness or concomitant condition that the investigator judges will preclude to the study Seizure disorder Pregnant or nursing Expectation of additional systemic antibacterials would be required for another condition Current drug or alcohol abuse", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 0.5-12.0, All Pharyngitis Give informed consent, assent, and documentation of patient authorization for disclosure of study results Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian Age > = 6 months -12 years A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following Tonsillar or pharyngeal exudate Tender cervical lymph nodes Fever or history of fever treated with antipyretics Odynophagia Uvular edema Pharyngeal Erythema of moderate or greater intensity Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology The need for hospitalization or I.V. antimicrobial therapy Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials Patients who are known carriers of S. pyogenes Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also Any rapidly progressive underlying disease with a shortened life expectancy The inability to swallow the study dosage form Unable to understand the requirements of the study Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 3.0-15.0, All Streptococcus Group A All children 3 to 15-years old with pharyngitis who are seen at a participating site will be invited to participate Subjects whose parents are unable or unwilling to provide informed consent will be excluded from the study Children who are 13 years or older and unable or unwilling to provide informed consent will be excluded form the study", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 12.0-999.0, All Sore Throat Pharyngitis Tonsillitis Informed consent/assent Age 12 and older A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat and pharyngeal erythema with at least one of the following Odynophagia Tonsillar or pharyngeal exudates Tender cervical lymph nodes Fever or history of fever treated with antipyretics Chills Uvular edema Elevated white blood cell count Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior to baseline visit Pharyngitis known or suspected to be due to a pathogen resistant to \u03b2-lactam antimicrobials Subjects who are known carriers of S. pyogenes Previous allergies, serious adverse reaction to, or intolerance to penicillin or any other member of the \u03b2-lactam class of antimicrobials, including cephalosporins Any serious illness or concomitant condition that the Investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also Any rapidly progressive underlying disease with a shortened life expectancy The inability to swallow the study dosage form Unable to understand the requirements of the study Neutropenia (<1000 PMNs/mm3) or other immunocompromised state", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 18.0-999.0, All Streptococcal Infections Patients diagnosed with GAS infection/isolation in the past 3 years (2003-2005) ", "label": "1"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 0.5-13.0, All Tonsillitis Pharyngitis Age 6 months to less than 13 years of age (<13) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs Tonsil and/or pharyngeal erythema and/or exudate Cervical adenopathy Uvular edema Fever Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Females of childbearing potential (ie, have reached menarche) Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm) Myasthenia gravis Known impaired renal function, as shown by creatinine clearance \u226425 mL/min The subject", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 13.0-999.0, All Tonsillitis Pharyngitis Age equal to or over 13 years For female subjects, the following conditions are to be met Subject is premenarchal or surgically incapable of bearing children Subject is of childbearing potential and all of the following conditions are met Have normal menstrual flow within 1 month before study entry Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and Must agree to use an accepted method of contraception throughout the study (if sexually active) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (\u22643 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm) Known impaired renal function, as shown by creatinine clearance \u226425 mL/min Myasthenia gravis History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins Previous enrollment in this study or previous treatment with telithromycin", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 3.0-999.0, All Pharyngitis Streptococcus Pyogenes Infection Streptococcus Pyogenes Identification sore throat at least two Centor fever > 38 deg C or history of fever enlarged cervical lymph nodes tonsillar exudate lack of cough age 3-14 years antibiotic treatment in preceding 7 days no informed consent", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 2.0-11.0, All Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases Aged 2 to 11 years on the day of inclusion Subject in good health, based on medical history, physical examination and laboratory parameters Provision of Assent Form signed by the subject (for subjects \u22658 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]) Subject and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures For a female subject of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination Documented receipt of yellow fever vaccine since at least one month before the first vaccination Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia For a female subject of child-bearing potential (girls post-menarche), known pregnancy For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the trial Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 16.0-999.0, All Bacteremia lip/tongue piercing for at least six month in situ pregnancy and lactating women medication with known effects on gingival tissues antibiotic medication in the last six months or need for antibiotic prophylaxis chlorhexidine use in the last six months non-plaque induced gingival disease prior diagnosis of periodontitis", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 2.0-999.0, All Atopic Dermatitis Secondary Infection Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception Secondary infection of atopic dermatitis with S.aureus or S.pyogenes as the probable causative agent An infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age Skin Infection Rating Scale score greater than or equal to 8 Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization Forms. Subjects under the legal age of consent must also have the written informed consent of parent or legal guardian Female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control Allergic to any component of the test medication Clinical diagnosis of impetigo, folliculitis or minor soft tissue infection Use of topical antibacterial medication to the study treatment area within 1 day of Visit 1 Signs of systemic infection or evidence of abcess or cellulitis at the site to be treated Medical condition that,in the opinion of the investigator, contraindicates the subject's participation in the clinical study Recent alcohol or drug abuse is evident History of poor cooperation, non-compliance with medical treatment or unreliability Participation in an investigational drug study within 30 days of Baseline Visit", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 1.0-14.0, All Hand, Foot and Mouth Disease Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes Age of 1-14 years Patients or their guardians agree to participate in this study and signed the informed consent form Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc With history of allergies on traditional Chinese medicine Patients or their guardians suffering from Psychiatric diseases Attending other clinical studies on HFMD after diagnosed", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 4.0-13.0, All Obsessive-Complusive Disorder Children Anxiety Disorder Autoimmune Disease PANDAS Male and female children 4-13 years of age Presence of (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) DSM-IV TR OCD with or without a tic disorder Moderate or greater severity of symptoms, with a score of greater than or equal to 20 on the Children s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and greater than or equal to 4 on the Clinical Global Impression Severity scale (CGI-S) The acute onset within the previous six months of symptoms in a child previously well, or the first acute recurrence within the previous six months, after a period of relatively complete remission of symptoms. The acuity of symptom onset/exacerbation is key and must be severe, dramatic in onset, and proceed from no/minimal symptoms to maximum severity within 24-48 hours Symptom onset or first exacerbation preceded within four months by a GAS infection, as documented by positive throat culture, exposure to documented GAS infection (in a close contact, such as a sibling sharing a bedroom), and/or documented two-fold rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB, anti-carbohydrate antibodies and others Onset/exacerbation of OCD is accompanied by at least three of the following 7 clinical signs and symptoms. The acuity of the comorbid symptoms must be similar to the OCD symptoms and occur in the same time interval Markedly increased level of anxiety, particularly new onset of separation anxiety Emotional lability, irritability, aggressive behavior and/or personality change Sudden difficulties with concentration or learning Developmental regression (\"baby-talk,\" temper tantrums; behaviors atypical for actual chronological age) History of rheumatic fever, including Sydenham chorea (the neurologic manifestation) Presence of symptoms consistent with autism, schizophrenia, or other psychotic disorder (unless psychotic symptoms have onset coincident with the possible and are attributed to OCD) Presence of a neurological disorder other than a tic disorder IQ < 70. Child subjects need to be able to contribute meaningfully to baseline and follow-up ratings, to report adverse effects, and to assent to participation Presence of serious or unstable medical illness or psychiatric or behavioral symptoms that would make participation unsafe or study procedures too difficult to tolerate IgA deficiency (< 20mg/dL). Intravenous immunoglobulin may contain trace IgA, which may very rarely lead to life-threatening anaphylaxis in IgA-deficient participants with anti-IgA antibodies (Misbah 1993) Hyperviscosity syndromes, which can increase risks associated with IVIG administration Need for live virus vaccine within six months after receiving IVIG (which may be 7.5 months from randomization) since IVIG can interfere with effectiveness of such vaccines. IVIG should not be administered sooner than two weeks after administration of a live virus vaccine, for the same reason Taking nephrotoxic drugs. Every concomitant medication will be subject to scrutiny and possible consultation with pediatric safety monitors before randomization to study drug. See below as well Recent (less than eight weeks) initiation of cognitive-behavior therapy (CBT)", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 18.0-70.0, All Oral Health Oral Cancer Gum Disease Submit to a 24 hour urine cotinine test which will be used to determine smoking status Meet one of the following smoking Non-smoker Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL Does not currently smoke but has quit smoking for more than 10 years and smoked less than 1 pack/day of cigarettes when they were actively smoking and has a urine cotinine (less than 100 ng/mL) Smoker Smokes habitually at least 10 cigarettes/day and a urine cotinine level of >1000 ng/mL. Cigar and pipe smokers who smoke at least 10 grams of tobacco daily are also eligible Agree to consume a standardized vitamin and mineral supplement and avoid other nutritional, dietary, or alternative medications/supplements for the duration of the study No history of malabsorptive, gastrointestinal or other metabolic disorders requiring special diet recommendations Body mass index (BMI) between 20 and 35 kg/m2 Have a known allergy to strawberries, corn, and wheat products or those who have never consumed any of these products Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, ileus, IBS), renal insufficiency, hepatic insufficiency, hyper or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone, insulin) or other endocrine disorders requiring hormone administration Have significant loss of gastrointestinal organs due to surgery, except for appendix Have altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias Heavy alcohol consumers defined as >15 glasses/week (one glass = 1.5 oz. liquor, 5 oz. wine, or 12 oz. beer) Antibiotic use in the last 6 months or on medications that will accelerate or decrease bowel motility Are receiving or in need of dental treatment during the study period Have noticeable open lesions, sores that have not healed for more than 3 months, have had any active oral lesions or maladies within the last month, or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 0.083-15.0, All Invasive GAS Infection Age \u2265 1 month to <15 years at the time of Group 1 : Children hospitalized for invasive GAS infection Subgroup 1A ( N = 75 ): Children with invasive infection without known risk factor Subgroup 1B (N = 75) : Children with invasive infection with known risk factor GAS Invasive infections are defined by a) Proved infection : Bacteriological isolation of S. pyogenes from a liquid or a normally sterile site, except from a blister of a simple erysipelas, without necrosis . This is sometimes associated with a shock with multiorgan failure (streptococcal toxic shock syndrome ( STSS )) b ) Probable infection . Bacteriological isolation of S. pyogenes from a normally non-sterile site ( eg skin, upper respiratory tract ) associated with extensive soft tissue necrosis . Bacteriological isolation of S. pyogenes a site or a biological sample usually non-sterile ( eg skin , upper respiratory tract ) associated with a evocative shock syndrome STSS and no other cause found Contributing factors for invasive infection are defined by cutaneous effraction (wounds , burn , chicken pox ), the use of corticosteroids or other treatment, immunosuppressive and recent surgery Group 1: Children with a known immune deficiency unrelated to the risk factors described above Group 2: Children with a known immune deficiency", "label": "1"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 10.0-999.0, All Kawasaki Disease Aneurysm, Coronary Clinical diagnosis of Kawasaki Disease with giant aneurysm Must be older than 10 years old Subjects ever received coronary artery bypass graft (CABG) surgery Subjects have active hepatitis or persistent abnormal liver function such as elevated GOT and GPT Subjects have the past history of rhabdomyolysis Female subjects are pregnant or plan for child-bearing during study periods", "label": "0"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 0.0-999.0, All Kawasaki Disease (both 1 and 2) All subjects are children who fulfilled the for Kawasaki Disease (American Heart Association criteria) Fever > 5 days, and 4 of the 5 following symptoms Diffuse mucosal inflammation (strawberry tongue, dry and fissured lips) Bilateral non-purulent conjunctivitis Dysmorphous skin rashes Indurative angioedema over the hands and feet Cervical lymphadenopathy. (One or more nodule at lease 1.5 cm in diameter) 2. KD patients are treated with IVIG at each hospital after informed contents are obtained Patients whose symptoms did not full fit the Kawasaki Disease criteria Had an acute fever for < 5 days and >10 days Incomplete collection of each followed-up data (CBC/DC, GOT/GPT, BUN/Cr, Albumin, ESR, C-Reactive Protein, 2D echocardiography) IVIG treatment at other hospital before refers to study centers Treatment with corticosteroids, other than inhaled forms, in the previous 2 weeks before enrollment The presence of a disease known to mimic Kawasaki disease Previous diagnosis of Kawasaki disease Inability to take aspirin", "label": "2"} +{"topic": "A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.", "doc": "eligible ages (years): 18.0-999.0, All Cirrhosis Coagulopathy Patients 18 and older, admitted to the hospital Patients who have clinically documented cirrhosis Patients who are coagulopathic (INR > 1.5 and/or platelets < 50,000) Patients undergoing an endoscopic procedure or neurosurgical procedure Patients must not be pregnant Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis) Patients must not have an active infection (per PI discretion) Patients must not have any known hemostatic disorder", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 50.0-80.0, All Osteoporosis 80 years of age, inclusive years since last menses Dx femoral neck osteoporosis No vertebral fractures Poor candidate for study drugs Hx of diseases affecting bone metabolism Hx of breast/estrogen-dependent cancer Current use of osteoporosis drug therapy Hx/high risk of VTE", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Small Cell Lung Cancer Written informed consent (patient's written understanding of and agreement to participate in this study) Patients with confirmed extensive small cell lung cancer (SCLC) No prior chemotherapy within 5 years of the diagnosis of SCLC Presence of either measurable or non-measurable SCLC by X-ray or physical examination At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient) At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting Laboratory Patients must have adequate bone marrow reserve and adequate kidney and liver function Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids Any active infection Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC Use of an investigational drug within 30 days before the first dose of study medication Women who are pregnant or lactating Patients of child-bearing potential who refuse to practice an adequate form of birth control Patients with clinical evidence of any stomach or intestinal (GI) condition Patients requiring treatment with the drug cyclosporin A", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Sepsis Adult patients with severe sepsis Presence of a suspected or proven infection One or more sepsis-associated organ failure Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country Platelet count <30,000/mm3 Are receiving therapeutic heparin", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 10.0-50.0, All Pneumothorax All patients requiring VATS caused by recurrent, persistent, or contralateral spontaneous pneumothorax as well as by spontaneous hemopneumothorax were eligible for this study greater than 50 years of age, with underlying pulmonary disease, previous ipsilateral thoracic operation, allergy to tetracycline or minocycline, and unwilling to receive randomization", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Critical Illness Deep Venous Thrombosis Patient is >/= 18 years of age Actual body weight is >/= 45 kg Admission to ICU expected to be >/= 72 hours in duration Neurosurgery within last 3 months Ischemic stroke within last 3 months Intracranial hemorrhage within last 3 months Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion Major hemorrhage within last week unless definitively treated Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening Thrombocytopenia defined as platelet count 180 mmHg or a diastolic blood pressure > 110 mmHg Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times ULN Renal insufficiency as defined by a creatinine clearance <30ml/min A need for oral or intravenous or subcutaneous therapeutic anticoagulation Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT) Receipt of >2 doses of UFH or LMWH in ICU Pregnant or lactating", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 16.0-999.0, All Deep Vein Thrombosis Pulmonary Embolism Age > 16 years Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus Isolated fractures of the fibula including fibular head, fibular diaphysis,distal fibula and lateral malleolus Combined fractures of the tibia and fibula Tibia and/or fibula fractures may be accompanied by fractures of the patella and/or foot as well as ligamentous injuries as long as either the tibia or the fibula is involved Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission Patients presenting greater than 72 hours after injury Major injury involving other site(s) Lower extremity vascular injury requiring surgical repair Known systemic bleeding disorder or INR > 1.5, aPTT > 40 sec, or platelets < 50 x 109/L at baseline Active, uncontrolled bleeding (as determined by the attending surgeon or delegate) Intracranial or other major bleed in the previous 4 weeks Ongoing need for anticoagulation for other reasons Previous DVT or PE (objectively proven or treated with anticoagulants) Known molecular hypercoagulable state Active cancer", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.0-999.0, All Quality of Health Care Pulmonary Embolism patient with suspected pulmonary embolism prescription of a specific paraclinical diagnostic investigation or start of a specific treatment for pulmonary embolism confirmation or of pulmonary embolism before admission in emergency department confirmation of deep venous thrombosis before admission in emergency department suspicion of pulmonary embolism during hospitalization (in-patient) suspicion of pulmonary embolism without investigation realization patient already included in the study patient refusing the utilization of his data for the study", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 30.0-85.0, All Total Hip Replacement Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower Not able to speak dutch communication problems dementia mental retardation", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis (must meet 1, 2 and 3) At high risk for thromboembolism (any one of the following) Age > 35 years Obesity (> 80 kg) Para 4 Gross varicose veins Current infection Pre-eclampsia Immobility prior to surgery (> 4 days) Major current disease: includes heart or lung disease, cancer, inflammatory bowel disease, and nephrotic syndrome (must not meet any of the following criteria) Greater than 36 hours since delivery Need for anticoagulation, including Women with a confirmed thrombophilia Women with paralysis of lower limbs Women with personal history of VTE Women with antiphospholipid antibody syndrome (APLA) Women with mechanical heart valves Contraindication to heparin therapy, including History of heparin induced thrombocytopenia", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Diabetes Mellitus, Type 2 Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months BMI <= 45.0 kg/m2 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Right Heart Strain Referred from clinical departments at Odense University Hospital Referred to the Departments of Nuclear Medicine or Radiology for diagnostic evaluation of suspected pulmonary embolism Referred for lung scintigraphy, spiral computer tomography, or pulmonary angiography Age below 18 Contrast allergy Pregnancy S-Creatinine above 200 micromol/L Metformin treatment Fibrinolytic or surgical therapy between examinations No informed consent Withdrawn consent Failed logistics (more than 24 hours between examinations) No conclusive pulmonary angiography", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 40.0-999.0, All Embolism Hospitalization due to an acute non-surgical disease Significant decrease in mobility Indication for anticoagulant or thrombolytic therapy Major surgical or invasive procedure within the 4 weeks that precede randomization Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization Immobilization due to cast or fracture of lower extremity Immobilization lasting longer than 3 days in the period prior to randomization Heparin administration longer than 36 hours in the period prior to randomization Acute ischemic stroke Other protocol-defined inclusion/", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 16.0-999.0, All Adult Respiratory Distress Syndrome Pulmonary Hypertension After obtaining informed consent the following patients will be included All patients admitted to the ICU with pulmonary hypertension (mean PA > 35 mmHg) All patients in ICU with post operative pulmonary HTN (mean PA > 35 mm Hg) All patients with ARDS (PaO2/FiO2 < 200 arterial hypoxemia, bilateral infiltrates on Chest X-ray infiltrates on CXR and a wedge < 20 mm Hg on swan ganz parameters) or signs of heart failure Patients to be excluded will be those with Pulmonary embolus Cor pulmonale Ejection fraction of < 30%, wedge > 20 mm Hg Non-intubated patients Pediatric patients (< 16 yrs of age)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis of Lower Limb Pulmonary Embolism (PE) Bleeding Adult patient (Age >18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form Patient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 40.0-80.0, All Chronic Obstructive Pulmonary Disease Established clinical history of moderate to severe COPD Post bronchodilator FEV1 of < 50% of predicted normal FEV1 / FVC ratio <70% Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1 Free from exacerbation in the 6 weeks prior to screening Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations Current asthma, eczema, atopic dermatitis and/or allergic rhinitis Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study Has undergone lung transplantation and/or lung volume reduction Female who is a nursing mother Requires regular (daily) long-term oxygen therapy (LTOT) Is receiving beta-blockers (except eye drops) Has a serious, uncontrolled disease likely to interfere with the study Has received any other investigational drugs within the 4 weeks prior to Visit 1 Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Patients enrolled into the trial must meet all of the following At least 18 years of age and able to provide informed consent Objectively confirmed symptomatic APE [intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography, or high probability ventilation-perfusion (V/Q)lung scan Stable and low risk defined as Hemodynamically stable (HR\u2264120, no hypotension, no tachypnea, no mental status change, no shock state) O2 supplement \u22644 L/NC Lack of electrocardiographic or echocardiographic evidence for new RV strain Radiographically non-massive PE (absence of saddle emboli on PA gram or spiral CT, perfusion defect on V/Q scan <50% No significant cardiac abnormalities (EF<35%, unstable angina, positive stress test within the past 3 months without revascularization) or pulmonary disease (severe COPD, pulmonary HTN) Patients meeting one or more of the following are not eligible for enrollment into the trial In the opinion of the clinician, the patient should receive in-patient standard medical therapy Contraindication for anticoagulation therapy (active or recent bleeding, recent surgery, bleeding diathesis, recent neurologic event) Is receiving therapeutic doses of UFH or LMWH for >24 hours Thrombolytic or glycoprotein IIb/IIIa agents administered within 24 hours prior to enrollment Platelet count <100,000 Creatinine clearance <30 mL/min at time of enrollment Presence of neuraxial anesthesia and/or post-operative indwelling epidural catheter Known history of antiphospholipid antibody syndrome Weight >150 kg (330.7 lbs) or <45 kg (99.2 lbs)", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis Pulmonary Embolism Symptomatic acute deep venous thrombosis and/or pulmonary embolism confirmed by venous ultrasound and/or CT scan Pulmonary embolism patients with normal right ventricular size on chest CT scan Age greater than 18 years Anticipated discharge within 72 hours of admission Written informed consent Pregnancy or intend to become pregnant Patients requiring ongoing hospitalization > 72 hours Hypersensitivity to heparin, pork products or enoxaparin Creatinine > 2.0 mg/dl Recurrent DVT and/or PE with oral anticoagulation Surgery or medical procedure planned during the study that may pose a significant bleeding risk Prior history of heparin-induced thrombocytopenia Inability to participate for follow up appointments and study visits Life expectancy < 30 days High risk of bleeding", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis Pulmonary Embolism Recurrent venous thromboembolism despite anticoagulation with warfarin(Or) Clinically important bleeding complications due to warfarin(Or) Inability to achieve the target INR on warfarin(Or) Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or) Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE and Require at least 90 days of anticoagulation Require anticoagulation for objectively confirmed DVT and/or PE Age greater than 18 years Written informed consent Patients with renal insufficiency, defined as creatinine > 1.5 mg/dl Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk Pregnancy Known hypersensitivity to fondaparinux", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Distal (Calf) Deep-vein Thrombosis All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and and they have signed an informed consent form Age less than 18 years Previously objectively diagnosed DVT or PE Distal DVT involving the tibioperoneal trunk (i.e. calf trifurcation) Clinically suspected pulmonary embolism Active cancer, receiving cancer treatment or cancer considered cured for <6 months Ipsilateral or contralateral proximal DVT Indication for long-term anticoagulation (e.g. atrial fibrillation, mechanical heart valve...) Pregnancy Thrombocytopenia (platelet count < 100 g/l)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism age >18 years objectively confirmed diagnosis of pulmonary embolism patients at low-risk (Pulmonary Embolism Severity Index score <=85) patients at high-risk (Pulmonary Embolism Severity Index score >85) presence of hypoxemia (arterial SO2 <90% measured by pulse oximetry or an paO2 on room air of <60 mm Hg measured by blood gas analysis) systolic blood pressure of <100 mm Hg chest pain necessitating parenteral opioid administration active bleeding or at high-risk of major bleeding (stroke during the preceding 10 days, gastrointestinal bleeding during the preceding 14 days, or platelets <75,000 per mm3) renal failure (creatinine clearance of <30 ml/minute based on the Cockcroft-Gault formula) body mass >150 kg history of HIT or allergy to heparins therapeutic oral anticoagulation (INR \u22652)at the time of pulmonary embolism diagnosis potential barriers to treatment adherence or follow-up (alcoholism, illicit current or recent drug use, psychosis, dementia, homelessness, lack of telephone access, transportation time to nearest ED >45 minutes)", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 70.0-999.0, All Thromboembolism Hospitalized medical patients 70 years of age or older Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) written informed consent immobilization longer than 3 days prior to randomization prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system expected major surgical or invasive procedure within the next 3 weeks after randomization LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization immobilization due to cast or fracture indication for anticoagulatory or thrombolytic therapy acute symptomatic DVT / PE known hypersensitivity to any of the study drugs or drugs with similar chemical structures Acute or history of heparin induced thrombocytopenia type II (HIT II) Other protocol-defined inclusion/", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-75.0, All Musculoskeletal Chest Pain Non-cardiac Chest Pain Undiagnosed Chest Pain To be included in the project the participant must Have chest pain as their primary complaint Have an acute episode of pain of less than 7 days duration before admission Consent to the standardized evaluation program at the chest pain clinic Have pain the in the thorax and/or neck Be able to read and understand Danish. Be between 18 and 75 year of age Be a resident of the Funen County Patients will not be included if any of the following conditions are present ACS Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG) Participants will be excluded following baseline evaluation if any of the following conditions are present Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below) New incidence of any of the above mentioned conditions/pathologies", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Obesity patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus according to SPC", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Lung Cancer biopsy confirmed primary lung cancer undergoing radiotherapy or chemoradiotherapy able to perform adequate deep inspiration breath hold patients of childbearing potential must practice adequate contraception signed study-specific informed consent form unable to perform adequate deep inspiration breath hold prior tumor resection prior chest or neck RT pregnant", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-65.0, All Cervical Degenerative Disc Disease Male or female subjects, aged between 18 and 65 years inclusive Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups Objective evidence of cervical disc disease in one vertebral level between C3-C7 defined as one or more of the following Shoulder and/or arm pain in a radicular distribution resulting from herniated disc or bony osteophytes (Consistent w diagnostic imaging including Axial CT, CT Myelogram, MRI and/or plain films) Subjects with myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement Unresponsive to documented non-surgical management for \u2265 6 weeks and/or presents with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management (e.g., physical therapy, medication therapy, corticosteroid injections, etc.) Minimum Neck Disability Index score of \u226530 % (15/50 points) Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation Subjects who are pregnant, lactating or wishes to become pregnant within the duration of the study Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes Subjects who have participated in a clinical investigation with an investigational product in the last 30 days Subjects who are currently involved in any injury litigation claims Subjects with significant degeneration at more than one cervical level (e.g. DISH, ankylosing spondylitis, congenital abnormality, rheumatoid arthritis) Subjects who have had any prior surgery at the level to be treated (subjects with a prior Laminotomy at the level to be treated may be included in the study) Subjects who have marked cervical instability on lateral or flexion/extension x-rays defined as translation \u22653mm and/or \u226511 degrees of rotational difference to either adjacent level Subjects who have presence of systemic infection or infection at the site of surgery Subjects who have been diagnosed with malignancy", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Obstructive Pulmonary Disease Asthma Pulmonary Embolism Pneumonia Pulmonary Hypertension Presenting to the Emergency Department with signs and symptoms of dyspnea (short of breath, tachypnea, hyperventilation, etc) within the last 24 hours Normal cardiac output as measured by noninvasive bioimpedance Greater than or equal to 18 years of age Patient or legal representative willing and able to provide informed consent and comply with study procedures A history of congestive heart failure and a BNP > 500pg/mL (or NTproBNP > 900pg/mL) if obtained by the treating physician Treating physician suspects patient has new onset congestive heart failure ECG changes diagnostic of acute myocardial ischemia/infarction Ischemic chest pain within the prior 24 hours by history Obvious chest trauma", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-75.0, All Deep Vein Thrombosis Pulmonary Embolism Be >= 18 years of age Have had ONE episode of unprovoked proximal DVT and/or PE Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0) Another indication for long-term anticoagulation (e.g., atrial fibrillation) A high risk of bleeding as evidenced by any of the following Age greater than 75 years Previous episode of major bleeding where the cause was not effectively treated Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10^9 /L Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl) Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl) Active peptic ulcer disease Poor compliance with, or control of, anticoagulant therapy during initial treatment Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel)", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Patients with a first episode of idiopathic pulmonary embolism who have been treated during 6 months (Plus 30 days or minus 15 days) using Vitamin K antagonist with a INR between 2 and 3 Age < 18 warfarin hypersensibility unwilling or unable to give written informed consent distal or proximal deep vein thrombosis Pulmonary embolism which was provoked by a reversible major risk factor major thrombophilia (protein C, S or antithrombin deficiency, antiphospholipids antibodies, homozygous factor V Leiden) previous documented episode of proximal deep vein thrombosis or pulmonary embolism other indication for anticoagulant therapy (e.g.:atrial fibrillation, mechanic valve) patient on antithrombotic agent in whom antithrombotic agent should be started again after stopping anticoagulation pregnancy", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Chest Pain Ischemia Patient referred for elective coronary angiography because of a reasonable clinical suspicion of coronary ischemia Presence of angina or an anginal equivalent (including chest, back, shoulder, arm, neck, jaw discomfort, or shortness of breath brought on by physical exertion, emotional stress, or certain times of day/month) Asymptomatic (such as a pre-op cath) Status-post heart transplant Status-post coronary artery bypass grafting Age <18 Renal insufficiency (creatinine >1.5) Presence of an acute coronary syndrome (STEMI or Tako-tsubo, an abnormal ejection fraction (EF<55%), cardiogenic shock, or recent VT/VF Presence of another likely explanation of chest pain, such as pulmonary hypertension or aortic stenosis History of adverse reaction to any of the medications being used (acetylcholine, nitroglycerin, adenosine, or heparin) Currently taking vasoactive medication (such as nitroglycerin) Inability to provide an informed consent, including an inability to speak, read, or understand English, Spanish, Chinese, Farsi, Japanese, Korean, Russian, or Vietnamese", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 19.0-999.0, All Chest Tube Removal Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND Have at least one chest tube Less than 19 years old With interstitial lung disease, OR Any patient intubated", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.0-999.0, All Dyspnea Heart Failure Asthma COPD patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea) age <18 years history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea pneumonia pulmonary embolism carcinoma pneumothorax pleural effusion intoxications (drugs) anaphylactic reactions upper airway obstruction", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Age > 18 years first episode of objectively documented symptomatic idiopathic VTE, either proximal lower extremity deep vein thrombosis (DVT) and/or pulmonary embolism (PE) Unprovoked or idiopathic , or associated with one or more of the following favouring factors minor general surgery, arthroscopy or laparoscopy pregnancy or puerperium hormonal treatment (contraceptive or replacement therapy) travel minor traumas hospitalization in a medical ward reduced mobility (non complete immobilization) at least six months of VKA therapy ( or other type) for at least 3 months and not longer than 12 months ability to provide informed consent Two or more episodes of objectively documented proximal DVT and or PE ( previous distal of superficial vein thrombosis are not Index event was isolate distal ( calf) vein thrombosis Index event was PE associated with shock or prolonged hypotension at high risk Index event was DVT in sites different from the lower limbs Pregnancy or puerperium ( first 6 weeks after delivery) at the time of the visit Solid or haematological malignancy in the active phase or undergoing chemotherapy or radiotherapy Antiphospholipid antibody syndrome, diagnosed according to the Sydney Hereditary antithrombin deficiency Necessity to prolong anticoagulation for any reason (due to the thrombotic event or other clinical indications Severe respiratory or heart failure (NYHA classes: III or IV)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 21.0-80.0, All Arthroplasty, Replacement, Knee The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment The subject requires a primary cemented total knee replacement The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN) The subject has intact collateral ligaments The subject has signed the IRB approved, study specific Informed Patient Consent Form The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation The subject has inflammatory arthritis The subject is morbidly obese, BMI > 40 The subject has a history of total or unicompartmental reconstruction of the affected joint The subject has had a high tibial osteotomy or femoral osteotomy The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device The subject has a systemic or metabolic disorder leading to progressive bone deterioration The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration) The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis The subject has had a knee fusion at the affected joint The subject has an active or suspected latent infection in or about the knee joint", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Idiopathic Venous Thromboembolism First episode of major unprovoked VTE VTE objectively proven VTE treated for 5-12 months with anticoagulant therapy authorized for the II study (initial or ongoing therapy) Absence of recurrent VTE during the treatment period Less than 18 years of age Patients who have already discontinued anticoagulant therapy Patients requiring ongoing anticoagulation for reasons other than VTE Being treated for a recurrent unprovoked VTE Patients with high risk thrombophilia patients who plan on using exogenous estrogen(OCP,HRT)if anticoagulant therapy is discontinued Patients with pregnancy associated VTE Geographically inaccessible for follow-up Patients unable or unwilling to provide informed consent", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Acute Pulmonary Embolism acute (symptoms <24 hrs) with right ventricular dilatation (>30 mm end diastolic, systolic PAP > 50 mmHg absence of right ventricular wall hypertrophy) age below 18 years or above 70 years body mass index >35 kg/m2 duration of symptoms >24 hours (since onset or acute increase in symptoms) severe circulatory shock (systemic blood pressure systolic <80 mmHg, or diastolic blood pressure <45 mmHg) or respiratory failure, requiring mechanical ventilation patients who, in the opinion of the supervising physician, require thrombolytic therapy severe pre-existent cardiopulmonary disease (heart failure, obstructive pulmonary disease, emphysema) atrial fibrillation refusal or inability to give informed consent", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 40.0-75.0, All Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease) Able to provide a written informed consent <75 years of age, but >40 years of age Able to hold breath for at least 10 seconds Sinus rhythm New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) Greater than 6 hours since presentation to ED BMI >40 kg/m2 Impaired renal function as defined by serum creatinine >1.5 mg/dL* Elevated troponin-T (> 0.09 ng/ml) Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) Known allergy to iodinated contrast agent Currently symptomatic asthma Documented or self-reported cocaine use within the past 48 hours (acute)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 14.0-999.0, All Lower Abdominal Pain Right Iliac Fossa Pain Acute Appendicitis Age >14 years Lower / RIF Abdominal Pain Clinical Suspicion of Acute Appendicitis i.e Alvarado Score 5-6 (equivocal for acute appendicitis) Alvarado Score 7-8 (probably appendicitis) Alvarado Score 9-10 (highly likely appendicitis) Informed consent (patient or legal representative) Diffuse peritonitis Antibiotic (Penicillin) documented allergy Ongoing previously started antibiotic therapy Previous appendectomy Positive pregnancy test IBD history or suspicion of IBD recrudescence", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Must be Age greater than or equal to 18 Obtain informed written consent Diagnosed with acute pulmonary embolism (PE) (< 14 days) Catheter-directed therapy (CDT) was performed to treat acute PE ", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.0-999.0, All Femoral Neck Fracture femoral neck fracture partial hip replacement r/o infection reoperation mental change", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-65.0, All Postoperative Pain laminectomy r/o infection reoperation mental change allergy to local anesthetics", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Medical Prevention Therapy Objectively confirmed VTE Initiation of enoxaparin treatment within Day 0-10 after diagnosis of VTE Outpatients who will be treated with enoxaparin + VKA in combination are permitted to receive initial treatment other than enoxaparin for a maximum of 48 hours or 2 treatment doses preceding entry into the study Outpatients on enoxaparin monotherapy are permitted to receive up to 10 days of treatment other than enoxaparin preceding entry into the study Medical or psychiatric disorders associated with altered cognition or mentation that precludes understanding of the informed consent process", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Nonalcoholic Fatty Liver Disease Coronary Artery Disease Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease Male and female 18years or older Able to provide written informed consent Intermediate Risk patients for having significant CAD is de\ufb01ned as chest pain or dyspnea in the presence of negative stress tests the absence of chest pain but positive stress tests the absence of chest pain and of positive stress tests but intermittent arrhythmias Acute coronary syndrome presentation ST segment deviation on ECG and/or Cardiac troponin elevation Chest pain in combination with positive tests for myocardial ischemia Hemodynamic instability on presentation Inability to write inform consent Age <18 years Participation in an investigational study within the previous 30days", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Neoplasms Patients with cancer and confirmed pulmonary embolism (PE) or deep vein thrombosis (DVT) of the leg who have been treated for minimally 6 and maximally 12 months with therapeutic doses of anticoagulants, i.e. LMWH or VKA or a new anticoagulant in a trial Written informed consent Indication for long-term anticoagulant therapy (e.g. because of metastasized disease, chemotherapy) Legal age limitations (country specific), minimum age at least 18 years Indications for anticoagulant therapy other than DVT or PE Any contraindication listed in the local labeling of LMWH or VKA Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding Life expectancy <3 months", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Knee Arthroscopy Analgesia those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy age over 18 years American Society of Anaesthesiologists (ASA) grade \u22653 arthroscopic assisted osteotomies a history of two or more prior procedures on the ipsilateral knee post-operative morbidities indirectly linked to the procedure (e.g. anaesthetic complications, DVT or PE) systemic steroid requirements previous intra-articular anaesthetic or steroid injection within the last three months intra-articular HA injection within the last nine months intra-articular sepsis within the previous three months prior history of knee arthroplasty, peri-articular fracture, ligamentous instability, inflammatory arthritis or a previous diagnosis of Complex Regional Pain Syndrome", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Osteoarthritis, Hip Total hip replacement for osteoarthrosis Living within 30 km from the hospital Motivated to attend training 2 times/week in 10 weeks Reduced functional ability measured as: HOOS score < 67 written informed consent Comorbidities such as cancer, neuromuscular diseases, heart diseases etc Cognitive impairment Body mass index > 35 Resurfacing prosthesis Scheduled additional prosthetic surgery in lower extremity within 6 months", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-65.0, All Fracture Fixation Intra-Articular Fractures Acetabulum Acetabular fracture deemed to require open reduction and internal fixation by one of the three principle attending surgeons Fixation must require a single non-extensile posterior approach (Kocher-Langenbeck) Posterior wall, Posterior column, certain simple transverse and transverse associated with a posterior wall, T-type, and posterior wall-posterior column fracture types Ages 18-65 Patient or family must consent to the research protocol Not meeting the aforementioned Unstable hemoglobin levels for three days prior to acetabular surgery (i.e. no other bleeding sources) Revision surgery Surgery occurring more than two weeks post-injury History of blood dyscrasias or immunocompromised patients Patients with medical conditions requiring anticoagulation or INR above 1.5 Obese patients (BMI >35) Known ongoing infection (local or systemic) Pregnant women", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.0-0.077, All Newborn Pain Respiratory Therapy Techniques Newborns up to 28 days with any weight and gestational age in ventilatory support or oxygen therapy and clinical indication for Physical Therapy Newborns with contraindication of respiratory therapy, those that had problems during any of the study procedures and changes in those suffering from respiratory support or oxygen therapy during data collection If there was failure to collect any of the parameters for evaluating the newborn also was no longer part of the sample", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.083-2.0, All Acute Respiratory Failure PaO2/FiO2 ratio <300 Respiratory rate >50 breaths/min Chest x-ray compatible with pulmonary infection No clinical improvement after breathing oxygen at 8 l/min or more for at least 15 min Presence of an endotracheal tube or a tracheostomy before PICU admission Facial deformities Upper airway obstruction Cyanotic congenital heart disease Facial trauma Recurrent apnea Neuromuscular weakness Pulmonary hypoplasia Pulmonary vascular anomalies Imminent respiratory or cardiac arrest", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 60.0-85.0, All Knee Osteoarthritis Osteoarthritis (OA) of the knee for >6 months moderate to severe pain immediately following a 50-foot walk knee pain primarily due to tibiofemoral OA and not from patellofemoral OA bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee willing and able to participate in regular exercise for four months free from musculoskeletal limitations that would preclude resistance exercise participation free of abnormal cardiovascular responses during the screening graded maximal walk test unable to walk regular resistance exercise training (>3X week) within the past 6 months specific low back pain or acute back injury spinal stenosis that precludes walking one block due to neurogenic claudication any major injury to either knee within the prior 12 months any surgery to either knee within the last 12 months lumbar radiculopathy vascular claudication significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee have had corticosteroid or viscosupplement injections within three months of study participation", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Postpartum Women must be at high risk for thromboembolism for one of the following reasons Known low risk thrombophilia (Known = diagnosed prior to enrollment and low risk thrombophilia includes heterozygous factor V Leiden or prothrombin gene variant or protein C deficiency or protein S deficiency. If not previously tested then assumed not to have thrombophilia) Immobilization (defined as >90% of waking hours in bed, of a week or more at any point in the antepartum period) OR any two of the following reasons Postpartum infection (fever (temperature>38.5oC) and clinical signs/symptoms of infection and elevated neutrophil count (higher than local lab normal)) Postpartum hemorrhage (Estimated blood loss >1000 ml during delivery and postpartum) Pre-pregnancy BMI >25 kg/m2 Emergency cesarean birth (emergency = not planned prior to onset of labour) Smoking >5 cigarettes per day prior to pregnancy Preeclampsia (blood pressure \u2265 140mmHG systolic and/or \u226590 mmHg diastolic on at least one occasion and proteinuria (1+ on urine dipstick or 300mg/dl or total excretion of 300mg/24 hours) or typical end-organ dysfunction Less than 6 hours or more than 36 hours since delivery at the time of randomization Need for anticoagulation as judged by the local investigator, may but not limited to Personal history of previous provoked or unprovoked VTE (DVT or PE) Continuation of LMWH that was started in the antenatal period for VTE prophylaxis Mechanical heart valve Known high-risk thrombophilia (Known = diagnosed prior to enrolment and high-risk thrombophilia includes deficiency of antithrombin (at least 1 abnormal lab result), persistently positive anticardiolipin antibodies (> 30U/ml on two measurements a minimum of six weeks apart), persistently positive Anti B2 glycoprotein antibodies (> 20U/ml on two measurements a minimum of six weeks apart), persistently positive lupus anticoagulant (positive on two measurements a minimum of six weeks apart), homozygous factor V Leiden (FVL), homozygous prothrombin gene mutation (PGM), compound heterozygosity factor V Leiden (FVL) and prothrombin gene mutations (PGM), more than 1 thrombophilia (any combination of 2 or more: FVL, PGM, protein C deficiency, protein S deficiency). If not previously tested then assumed not to have thrombophilia) Contraindication to heparin therapy, including History of heparin induced thrombocytopenia (HIT) Platelet count of less than 80,000 x 106/L on postpartum Complete Blood Count(CBC) Hemoglobin \u2264 75 g/L on postpartum CBC", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Thoracotomy Chronic Pain Age > 18 Able to cooperate able to speak and read Danish repeat surgery cognitive dysfunction other nerve injury on the thorax abuse (medicine/ alcohol etc)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 40.0-75.0, All Lung Cancer Pulmonary Complications medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy aged between 40 and 75 years Patients who refused to participate in the survey lung resection with incisions other than posterolateral patients who had contraindications to the use of noninvasive ventilation", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-65.0, All Postoperative Pain Tonsillectomy mental change allergy to local anesthetics", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Axial Spondyloarthritis Male and female subjects aged 18 years and over at the time of consent to the study Diagnosis of SpA, as defined by the ASAS for axial SpA Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit Active axial involvement defined by mini Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial Subjects who have received any previous treatment with etanercept or other TNF\u03b1 inhibitors or biologic agents Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 17.0-999.0, All Venous Thromboembolism Delivery of Health Care Quality Improvement Inpatients with age > 17 years old Outpatients Inpatients with age less than or equal to 17 years old", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 15.0-999.0, All Pain Pain, Postoperative Funnel Chest Patients undergoing minimally invasive repair of pectus excavatum Age > 15 years old Previous thoracic surgery interventions Disorders affecting the central or peripheral nervous system Chronic pain (pain intensity assessed by numerical rating scale > 3) Inability to speak and understand Danish (instructions, questionnaires) Inability to understand and participate in experimental pain modulation Psychiatric disorders (ICD-10) A history of frostbite in the non-dominant upper limb Sores or cuts on non-dominant upper limb Cardiovascular disease A history of fainting and/or seizures", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Total Hip Arthroplasty Patients scheduled for unilateral total hip replacement Consent to spinal anaesthesia ASA Grade I to III Patient refusal Mini-Mental Score < 25 Allergy to bupivacaine, morphine, paracetamol, diclofenac Skin lesions/infection at site of injection Uncorrected renal dysfunction Coagulation disorders chronic pain condition other than hip pain", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Ovarian Carcinoma Fallopian Tube Cancer Primary Peritoneal Cancer Subjects who have received at least one vaccine under protocol UPCC-19809 or UPCC-29810 ECOG performance status 0 or 1 Subject has sufficient vaccine (2 vaccine doses are sufficient) Must be at least 4 weeks post-operative Blood coagulation parameters: PT such that international normalized ratio (INR) is less than1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT less than1.2 times the upper limit of normal Subject must be 18 years of age or older Life expectancy of greater than 4 months Normal organ and bone marrow function as defined by: Absolute neutrophil count greater than 1,000/microliter, Platelets greater than 100,000/microliter, Hematocrit greater than 30%, AST (SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal, Bilirubin less than 2.0 mg/dL unless secondary to bile duct blockage by tumor, and Creatinine less than 1.8 mg/dL Subjects who require or are likely to require more than a two-week course of corticosteroids for intercurrent illness. Subjects must complete therapy prior to enrollment. Topical corticosteroids should be stopped at least 2 weeks prior to enrollment and systemic corticosteroids should be stopped at least 4 weeks prior to enrollment Subjects with any acute infection that requires specific therapy. Acute therapy must have been completed at least seven days prior to study enrollment Subjects with any underlying conditions, which would contraindicate therapy with, study treatment (or allergies to reagents used in this study) Subjects with prior history or symptoms suggestive of partial or complete bowel obstruction Subjects receiving class III antiarrythmic medications Subjects receiving medications that might affect immune function. Additionally, H2 blockers are excluded, as are all antihistamines five days before and five days after each injection of study drug. NOTE: The following are exceptions: Proton pump Inhibitors (PPIs), including COX-2 inhibitors, acetaminophen Subjects who are allergic to Aspirin are excluded Development of clinically significant co morbid disease that would contraindicate study therapy or confuse interpretation of study results Subjects with a History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess Subjects with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 40.0-80.0, All Pulmonary Disease, Chronic Obstructive Type of subject: outpatient Informed consent: Subjects must give their signed and dated written informed consent to participate Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to or women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception Age: >=40 and <=80 years of age at Screening (Visit 1) Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 Airflow Obstruction Subjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of <=0.70 at Screening (Visit 1) Subjects with a measured post-albuterol/salbutamol FEV1 >=50 and <=70% of predicted normal values calculated using III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1) Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1) Pregnancy: Women who are pregnant or lactating Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD) alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable) Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD) Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal) Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-85.0, All Postoperative Pain level posterior lumbar fusion mental change allergy to local anesthetics chronic analgesics user", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism patients with acute pulmonary embolism diagnosed in the emergency departement patient under guardianship patient without social insurance pregnant women refusal to sign the consent myocardial infarction in the 10 days before pulmonary embolism", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Malignant Pleural Mesothelioma Subjects must have histologically confirmed MPM (epithelial or biphasic) Subjects must have completed standard first line therapy with a platinum-based double regimen and had PD or they must have chosen not to pursue primary standard of care therapy ECOG performance status 0 to 1 Age greater than 18 years Life expectancy > 4 months At least 2 weeks since prior and no other concurrent chemotherapy, radiotherapy, or immunotherapy (e.g., interferons, tumor necrosis factor, interleukins, or monoclonal antibodies). In addition, the patient must have fully recovered from any adverse events related to these agents More than 4 weeks since prior and no other concurrent investigational agents Subjects must have measurable disease as defined by accepted MPM measurement techniques (modified criteria) Blood coagulation parameters: PT such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT < 1.2 times the upper limit of normal Subjects must have adequate venous peripheral access for apheresis. Patients must also have adequate venous access for subsequent modified CIR T-cell administration which can be done through a central venous access (e.g. port of systemic chemotherapy) Previously treated with any investigation therapy within 1 month prior to screening Sacromatoid MPM histology which does not express mesothelin Prior invasive malignancies unless surgically and medically cured without evidence of recurrent disease for 5 years with the exception of non-melanoma skin cancer, prostate cancer with PSA level < 1.0 Prior hematologic malignancy with bone marrow transplantation or immune modifying therapy within the past 4 weeks with the exception of thyroid replacement Use of immunosuppressive drugs with 4 weeks prior to study entry, or anticipated use of immunosuppressive agents Any clinically -significant pericardial effusion, CHF (NY Heart Association Grade II-IV ), or cardiovascular condition Any clinically -significant pleural effusion or ascites that cannot be drained with standard approaches or with pre-enrollment in dwelling drainage device placement Forced vital capacity < 50% predicted, DLCO < 40% predicted Underlying lung disease requiring supplemental oxygen therapy Have a recognized immunodeficiency disease including cellular immunodeficiency, hypogammaglobulinemia, or dysgammaglobulinemia; patients who have acquired hereditary, congenital immunodeficiency", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-99.0, All Urinary Incontinence includes English-speaking women over the age of 18 who have been admitted to the Rehabilitation Institute of Chicago with reports of urinary incontinence in the past 3 months. Those who report \"yes\" to the screening questions who fit the above will be screened by the principal investigator to ensure they fall into the criteria Non-English speaking women under the age of 18, or those that do not give consent to participate in the study will not be enrolled. Also excluded will be any woman who has any chance of being pregnant or having an active urinary tract infection. No women with active infection lesions, unknown vaginal bleeding or those who have never had any kind of pelvic examination will be included in the study. Other women with a neurogenic bladder or admission FIM scores on sections Comprehension and Memory of below 4. Women with reports of significant pelvic pain or recent pelvic surgery or radiation or post-partum in last 6 months will be excluded", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-75.0, All Pulmonary Thromboembolisms Pulmonary Embolism 18 y\u2264Age\u226475y Acute PE (first symptoms occurred 14 d or less before randomization) confirmed by lung scan, or a positive computed tomographic pulmonary angiogram, or a positive selective pulmonary angiogram Hemodynamic stability, diastolic pressure>90mmHg RV dysfunction confirmed by echocardiography (\u22651 criterion), except left-side heart disease, congenital heart disease and mitral valve disease Increase of the right ventricle showed presented with RV end-diastolic anteroposterior diameter >25 mm, Right/left ventricular end-diastolic diameter >1 (apical or subcostal 4-chamber view) or Right/left ventricular end-diastolic anteroposterior diameter >0.5 Hypokinesis of RV-free wall (range of motion less than 5 mm) Tricuspid regurgitation pressure >30mmHg RV anterior wall thickness > 5mm confirmed by echocardiography Active internal bleeding and spontaneous intracranial hemorrhage in preceding 6 months Major surgery, organ biopsy or non-compressible punctures within 2 weeks Ischemic stroke occurred within 2 months Gastrointestinal bleeding within 10 days Severe trauma occurred within15 days Neurosurgery or eye surgery within 1 months Severe hypertension difficult to control (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg) Cardiopulmonary resuscitation Platelet count less than 100\u00d7109 / L", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 19.0-999.0, All Air Embolism as A Complication of Medical Care Subject is undergoing ERCP as part of their medical care Subject will be of age 19 or older Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE Subject intolerance of the pressure of the TTE probe Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-70.0, All Degenerative Joint Disease of Hip and Knee. Undergoing a hip arthroplasty, total knee arthroplasty, hip fracture repair American Society of Anesthesiologist rating I-III as determined by your anesthesiologist Pregnancy and breast feeding An allergy to any of the drugs to be used in the study (midazolam, Celecoxib, gabapentin, hydromorphone, bupivacaine) History of a sleep disorder (Obstructive sleep apnea or daytime somnolence) History of taking chronic narcotic pain medications or gabapentin History of rheumatoid arthritis, a psychiatric disorder, or diabetes with impaired renal function History of alcohol or illicit drug abuse History of a kidney or liver problem Inability or unwilling to use patient-controlled analgesia Unable to meet the for removal of the endotracheal tube in the Operating Room History of asthma, hives or an allergic type reaction following an aspirin or other drug such as Ibuprofen", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Traumatic Rib Fracture A subject must meet the following to take part in the study Subjects 18 years of age and greater Inpatient on the BWH SICU, MICU, or hospital floor ward Non-intubated at the time of block placement Traumatic Rib Fractures three or greater Block able to be placed within 12-24 hours of presentation to the emergency room Ability to provide written informed consent Compliance with all ASRA and BWH Regional Anesthesia in Anticoagulated Patient guidelines for coagulation status Subject is pregnant Subject not expected to survive 48 hours due to traumatic injuries Allergy to Ropivacaine or other local anesthetic Any significant concomitant injuries potentially confounding data acquisition (e.g., traumatic brain injury, long bone fractures, intra-abdominal injuries) Known allergy to lidocaine Inability to provide written, informed consent Known opioid medication dependence Non-compliance with ARSA and BWH Regional Anesthesia in Anticoagulated Patient Guidelines", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Acute Pulmonary Embolism consecutive patients with acute pulmonary embolism age <18 years", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-65.0, All Postoperative Pain Total thyroidectomy mental change allergy to local anesthetics", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-65.0, All Postoperative Pain Laparoscopic cholecystectomy mental change allergy to local anesthetics", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.0-999.0, All Pulmonary Embolism Pulmonary Embolism Without Mention of Acute Cor Pulmonale all patients referred to the ICU with suspected APE ", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Patients with clinical suspected pulmonary embolism Simplified Well's score>4 (PE likely) or D-dimer value \u2265500ng/ml Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism Refused consent Less than 18 years old Not possible to perform ultrasound scan within 3 hours before MCTPA", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 40.0-80.0, All Coronary Disease non-acute chest pain those who underwent CT calcium scoring availability of all relevant risk factor information previous coronary disease i.e., myocardial infarction or revascularization", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention patients with mild or moderate renal impairment age >= 18 years at enrollment severe renal impairment (Creatinine Clearance < 30 ml/min)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 16.0-999.0, All Chest Pain All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich Missing informed consent Cardiopulmonary unstable patients No self reported chest pain Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Hyperglycemia Hypercholesterolemia Persistent Postoperative Pain Hip Replacement Knee Replacement Primary hip and knee replacement for osteoarthritis Enrolled previously into study NCT01021826 Arthritis other than osteoarthritis (based on study NCT01021826) Medication affecting glucose metabolism (excl. antidiabetic agents) (based on study NTC01021826) Died before follow-up phase Did not undergo the planned hip or knee replacement", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Deep Vein Thrombosis Pulmonary Embolus \u2265 18 years Investigator judges caval filtration clinically indicated for prevention of pulmonary embolism in patient with venous thromboembolic disease or at high risk for venous thromboembolic disease. Patient must meet at least one of the following Anticoagulant therapy is contraindicated, has failed, cannot be achieved or maintained, must be interrupted, resulted in complication, or places the patient at high risk of complication and the patient has Pulmonary embolus Iliocaval deep vein thrombosis (DVT) Severe trauma with high risk of venous thromboembolism including closed head injury, spinal cord injury, or multiple long bone or pelvic fractures Surgery planned with high risk of venous thromboembolism including procedures such as bariatric, orthopedic, or pelvic surgery Past history of thromboembolic disease undergoing surgery Therapeutic anticoagulation can be achieved, but the patient has Venous thromboembolism such as pulmonary embolism or DVT with limited cardiopulmonary reserve Condition that inhibits radiographic visualization of the IVC Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC including occlusion of the SVC or jugular veins Known IVC transverse diameter at target implant site > 28 mm Known obstructing abdominal mass or anatomy that is not suitable for infra-renal placement of IVC filter Known duplication of IVC or left-sided IVC Severe kyphosis or scoliosis Known IVC thrombosis extending to renal veins, or renal or gonadal vein thrombosis Risk for septic pulmonary embolism Confirmed bacteremia Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, or dialysis dependent", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Subjects must provide informed consent Men or women aged 18 years or more Ongoing cancer disease recent diagnosis of veinous thromboembolism treatment with Low Molecular Weight Heparin before entry into the study Contraindication to the use of Low Molecular Weight Heparin", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 16.0-999.0, All Cancer Thrombosis Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolus Receiving LMWH for treatment of CAT for five months Locally advanced or metastatic cancer Able to self-administer LMWH, or have LMWH administered by a carer Able to give informed consent Age \u226516 years Receiving drug other than LMWH for CAT Contraindication to anticoagulation Fitted with a prosthetic heart valve Pregnant and/or lactating females", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-99.0, All Breast Cancer signed an Institutional Review Board (IRB)-approved informed consent document for protocol age >= 18 years histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy stage 0-III left-sided breast cancer (including DCIS) SPECT score of 0 at baseline radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators concurrent chemotherapy prior receipt of mediastinal radiation therapy pregnant or lactating women inability to understand and follow breathing instructions for the DIBH procedure", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolism age 18 years or above after study start index date on or after study start signed, informed consent patients treated for DVT or PE patients with non-valvular AF (with one or more risk factors) treated for prevention of stroke and systemic embolism any use of univalent direct thrombin inhibitor or direct factor Xa inhibitors use of anticoagulant therapy or other vitamin K antagonists recorded within one year prior to index date", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism years of age or greater Agrees and able to participate in the study Room air SpO2 (oxygen saturation) less than 92% and newly-diagnosed PE (or controls with no PE) based on CT angiogram result Clinical concern for instability Systolic blood pressure less than 100 mm Hg Heart rate \u2265140 beats per minute Oxygen saturation less than 85% with more than 4 L supplemental oxygen Unable to participate/comply with instructions for using the incentive spirometer Patients from the Federal Medical Center in Rochester, Minnesota Patients who do not speak English (due to the need for expediency) Patients will be under the care of the Emergency Department team who have the skills and resources to monitor and treat patients if they were to become unstable", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Multiple Pulmonary Emboli Patients referred for CT pulmonary angiogram to pulmonary embolus Class 3 or 4 Congestive Heart Failure Supraventricular tachycardia History of contrast allergy Unable to give informed consent Patients with serum creatinine >1.28 mg/dl without referring physician approval", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 50.0-999.0, All Diabetes Diabetes Mellitus, Type 2 Type 2 diabetes Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day One or more oral or injectable antidiabetic agent(s) An acute coronary or cerebrovascular event in the previous 60 days Planned coronary, carotid or peripheral artery revascularisation Chronic heart failure NYHA (New York Heart Association) class IV Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-80.0, All Acute Pancreatitis Complication of Ventilation Therapy Diagnosis of pancreatitis:typical pain, increase in serum lipase or amylase, onset of abdominal pain within 72h before admission The diagnosis of Severe Acute Pancreatitis is according to Atlanta revisited in 2012 the diagnosis of ARDS meets the of Berlin definition chronic respiratory disease as chronic obstructive pulmonary disease (COPD), asthma organic cardiopathy pregnancy", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-75.0, All Cardiac Disease Patients aged 18-75 years inclusive and American Society of Anesthesiologists physical status 2-4 Undergoing minimally invasive cardiac surgery Subjects must be physically and mentally able to participate in the study and complete all study assessments Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of thoracotomy and chest tube sites infiltration History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a thoracotomy and chest tube sites infiltration Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of nonsteroidal antiinflammatory drugs Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-75.0, All Chest Pain patients undergoing removal of a chest tube after lung surgery patients able to indicate the pain score pregnancy, lactation insulin-dependent diabetes with dysautonomia central or peripheral neurological disease, agitation inability to understand the protocol inability to use the Pain Monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities contra-indication to oral morphine respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations recent administration of neostigmine or of atropine", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.25-16.0, All Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Hip Pain Patients undergoing surgery for painful external snapping hip years or older Inability to comply with the protocol (e.g. due to dementia)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 15.0-999.0, All Postoperative Pain Elective minimally invasive surgical correction of funnel chest (pectus excavatum age \u226515 years Previous thoracic surgical interventions Presence of diseases affecting the central and/or peripheral nervous system Presence of chronic pain conditions Inability to speak and/or understand Danish Inability to understand and participate in the experimental pain session Presence of psychiatric disorders History of frostbite in the non-dominant upper limb Presence of sores or cuts on non-dominant upper limb Presence of cardiovascular disease History of fainting and/or seizures", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 21.0-85.0, All Ischemic Stroke Patients 21-85 years old, male or female Suspected acute ischemic stroke based on clinical and radiographic evidence as determined and documented by the Stroke Neurology team at University of Kentucky Patients must meet for intra-arterial thrombolysis as determined and documented by Interventional Neuroradiology attending physician (JF or AA) Patients must have an acute thromboembolus within an intracranial artery (internal carotid, anterior cerebral, middle cerebral, posterior cerebral, basilar, vertebral) which undergoes pharmacologic (tissue plasminogen activator tPA) and/or mechanical (eg. Merci or Penumbra clot retrieval) thrombolysis Patients with impaired capacity may be included, as the pathology to be studied (stroke) may impair their capacity (please see attached required documentation regarding impaired capacity) Patients must have a TICI 2A or better revascularization via intra-arterial thrombolysis For reference, the TICI Scale is defined below = No Perfusion = Perfusion past the initial obstruction but limited distal branch filling with little or slow distal perfusion Pregnant women (would not qualify for intra-arterial thrombolysis as standard of care) Patients who undergo intra-arterial thrombolysis for acute stroke, in whom only TICI 0 or 1 revascularization is obtained Patients with occlusion of the cervical common or internal carotid artery will be excluded from the study", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Patients aged 18 years or older with an objectively verified diagnosis of DVT and/or PE and treated according to routine clinical practice with Rivaroxaban Patients in whom follow-up is unlikely or impossible Patients unable to give consent Patients who receive heparin therapy for more than 48 hours Patients who receive more than one dose of warfarin Patients with an indication for anticoagulation other than DVT and/or PE All contraindications listed in the local product information (SmPC) will form part of the", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thrombosis Pulmonary Embolism Lung Neoplasms Patient At least 18 years of age Either gender Diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy Undergoing one of the following surgeries: Segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy Competent to understand and sign consent documents Patient Known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH) Under current anticoagulation for venous thromboembolism or other medical conditions Known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2 as calculated by the Cockroft-Gault method History of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites Pregnant or planning to become pregnant Diagnosed or treated for VTE in the past 3 months prior to surgery Present or previous increase risk of haemorrhage History of previous HIT (heparin induced thrombocytopenia) Platelet count must be below 75,000 Previously inserted Inferior Vena Cava Filter (IVC) filter", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.0-999.0, All Venous Thromboembolism all patients undergone primary total knee arthroplasty renal insufficiency, contrast allergy, simultaneous bilateral TKA, hemorrhagic disorder, sever liver disease", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pain, Postoperative Anesthesia, Conduction Arthroplasty, Replacement, Hip Primary total hip replacement general anaesthesia Allergy to local anesthetics of the amide type Revision surgery Bilateral surgery Chronic pain patient Women in the fertile age", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Lung Neoplasms Pulmonary Embolism Patients must be at least 18 years of age Patient may be of either gender Patients must be diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy Patients must be undergoing one of the following surgeries: Segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy Patients must be competent to understand consent documents All patients with known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH) Patients must not be under current anticoagulation for venous thromboembolism or other medical conditions Patients must not have known renal impairment (defined as estimated glomerular filtration rate of less than 30ml/min/m2 as calculated by the Cockcroft-Gault method) either pre-operatively or as identified based on blood work obtained prior to the scheduled 30-day post-operative scan Patients must not have known hepatic failure, with international normalized ratio (INR) of >1.5 Patients with history of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites Patients must not be pregnant or planning to become pregnant Patients must not have been diagnosed or treated for VTE in the past 3 months prior to surgery Patients must not have a known, objectively confirmed bleeding disorder Patients must not have a present or previous increase risk of haemorrhage Patients must not have a history of previous heparin induced thrombocytopenia", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan Total Pulmonary Embolism Severity Index (PESI) score <86 Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram Sustained Systolic Blood Pressure (SBP) <95 mmHg during Emergency Department or observation stay Age <18 Pregnant Renal insufficiency (Creatinine Clearance <30) Hepatic Dysfunction (AST/ALT/ALP > 3 times upper limit of normal) Unreliable social situation or inability to follow up Contraindication to enoxaparin, warfarin and rivaroxaban Atrial or ventricular dysrhythmia(s)", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Concern for PE by attending physician and CTPA ordered If patient is under the age of 18, a prisoner, or a ward of the state CTPA ordered but not performed", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Emergency Patients Acute onset of, or worsening of dyspnea Or chest pain Low clinical pretest probability of PE, empiricially estimated by the gestalt Other obvious cause than PE for dyspnea or chest pain Acute severe presentation Contra-indication to CTPA Concurrent anticoagulation treatment Current diagnosed thrombo-embolic event Inability to follow up Prisoners Pregnancy No social security Participation in another intervention trial", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-65.0, All Pleural and Lung Ultrasound Twenty healthy male volunteers aged between 18 and 65 years-old with no history of respiratory or cardiovascular pathologies will be enrolled Females and all subjects with history of respiratory or cardiovascular diseases will be excluded", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolism All patients on the four trial floors who miss at least one dose of VTE prophylaxis will be included in the study ", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-85.0, All Postoperative Pain Patients undergoing unilateral THR and TKR who are between the ages of 18 and 85 regardless of the anesthesia and postoperative analgesia type Patients participating in other studies may participate in this study as well Patients with Motor Activity Assessment Scale (MAAS) Score of 3 and 4 Age <18, >85 History of chronic pain as defined by use of long acting opioid medication > 6 months duration MAAS Score of <3 and >4 Anticholinergic agent use Patients with the following conditions Autonomic neuropathy Pacemaker/AICD Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated) Allergy to adhesive tape Communication barriers", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Anticoagulation For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Patients aged 18 or older over the study period Patients with a diagnosis for NVAF or VTE anytime in their medical records Patients having at least one year of enrolment in the database prior to the index date Patients newly initiated with VKA during the study period (index date) Patients with a diagnosis for both NVAF and VTE anytime in their medical records", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 14.0-40.0, All Groin Pain Diagnosis of athletic groin pain Professional athlete in full time training with groin pain diagnosis Post infective osteitis Bone tumour Acute injury", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Orthopaedic Decision Making Patients 18 year old or older daily smoker patients within 1 week post orthopaedic operation patient that have never received an orthopaedic related smoking cessation discussion Younger than 18 patients unable to provide consent patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker patients in severe acute pain", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Stroke Ischemic Stroke Eligible patients will be Adults (\u226518years) with the final diagnosis of an acute ischemic stroke CT-Angiogram proven, large artery occlusion (LAO) in the internal carotid artery (ICA), middle cerebral artery (MCA -M1 or M2 site) locations NIH Stroke Scale \u22656 (NIHSS) OR proven LAO on imaging (must be from designated LAO listed on #2) LSN (last seen normal) to groin puncture (\u2264 8 hours) in thrombectomy arm; LSN to presentation to endovascular capable center (\u2264 8 hours) in medical arm Baseline modified Rankin Scale score of 0-3 Signed Informed Consent obtained Subject willing to comply with the protocol follow-up requirements Anticipated life expectancy of at least 3 months IV-tPA eligible patients must meet AHA guidelines Patients are excluded if Inability to undergo CT-Angiography and/or CT-Perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy) Co-morbid psychiatric or medical illnesses that would confound the neurological assessments", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 50.0-80.0, All Osteoarthritis, Knee End-stage arthritis of the knee Failure of medical treatment or rehabilitation Hemoglobin > 10g/dl No use of non-steroid anti-inflammatory agent one week before operation Preoperative Hemoglobin \u226610 g/dl History of infection or intraarticular fracture of the affective knee Renal function deficiency (GFR < 55 ml/min/1.73m2)which is relative contraindicated for venography Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant) History of deep vein thrombosis, ischemic heart disease or stroke", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Missed Pulmonary Embolism at the Emergency Department patients 18 years of age or older presented to the ED between January 2011 and March 2014 who received an ECG or any form of thoracic imaging patients below 18 years of age, as well as patients referred to the ED with suspected PE by departments within UHBS, other hospitals, or other healthcare providers", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 16.0-999.0, All Pregnancy Suspected Deep Vein Thrombosis Compression Ultrasound D-dimer Unselected pregnant women (preciously documented positive beta hCG on urine or serum pregnancy tests) with Suspected acute symptomatic deep vein thrombosis Defined as new leg swelling or edema with onset in the last month or new leg pain (buttock, groin, thigh or calf) with onset in the last month Prior major VTE (proximal DVT or segmental or greater PE) Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada) Unable or unwilling to provide informed consent Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia) Need or plan for ongoing anticoagulant therapy (>2 weeks), at any dosage (i.e. prophylaxis or treatment dosage), throughout the ante-partum period Need for therapeutic anticoagulant therapy in the post-partum period (i.e. patients that are/will be treated for superficial phlebitis, mechanical valves, atrial fibrillation or other indications)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 75.0-999.0, All Acute Dyspnea Admission to the Emergency Department Age \u2265 75 years AND of acute dyspnoea Breathe rate \u2265 25 cycles/minute or PaO2 \u2264 70 mmHg or SpO2 \u2264 92% in room air or PacO2 \u2265 45 mmHg and pH \u2264 7.35 AND Electrocardiogram in sinus rhythm at admission ", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 35.0-90.0, All Chronic Obstructive Pulmonary Disease A clinical diagnosis of COPD Aged between 35 and 90 years Able to fluently read and speak English Willing and able to sign informed consent Be able to comply with the procedures outlined for the study Cardiac disease (including arrhythmias) A medicinal requirement for rate limiting calcium antagonists or beta blockers Cerebrovascular disease Peripheral vascular disease Requirement for supplemental oxygen therapy CO2 (carbon dioxide) retention Malignancy Orthopaedic or neurological conditions effecting the ability to exercise Clinically apparent heart failure Renal, hepatic or inflammatory disease", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 19.0-999.0, All Venous Thromboembolism Adult (\u226519 years of age) patients who are initiating treatment with Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time in accordance with the Korean package insert will be enrolled in the study Patients with prior treatment with Eliquis before enrollment in this study Patients receiving Eliquis treatment for an indication not approved indication in Korea Patients meeting any of the following will not be included in the study i) Hypersensitivity to the active substance or to any of the excipients ii) Clinically significant active bleeding iii) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk iv) Patients with increased bleeding risk due to such as following diseases Recent gastrointestinal ulceration history Recent intracranial or intracerebral haemorrhage history Intraspinal or intracerebral vascular abnormalities", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 21.0-85.0, All Peripheral Arterial Disease Patients with peripheral arterial disease (PAD) Capable of giving informed consent Men and women age 21 years Diagnosed with PAD (i.e., ankle-brachial index below 0.9) Fontaine stage II or less no pain while resting Satisfactory history and physical exam Children Pregnant or nursing women Patients taking nitroglycerine or nitrate preparations Patients taking phosphodiesterase inhibitors such as sildenafil or tadalafil Patients taking proton pump inhibitors Ejection fraction < 40% Uncontrolled hypertension Uncontrolled diabetes Myocardial infarction within past 6 months or unstable angina Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers)", "label": "0"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.0-999.0, All Venous Thromboembolism Patients who start rivaroxaban for VTE \uff08pulmonary embolism, deep vein thrombosis) anticoagulation therapy Patients who are contraindicated based on the product label and have already received Xarelto treatment", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Age \u226518 years Objectively confirmed diagnosis of acute PE by multidetector CT angiography, ventilation/perfusion lung scan, or selective invasive pulmonary angiography, according to established diagnostic with or without symptomatic deep vein thrombosis Absence of hemodynamic collapse, or decompensation, at presentation; Hemodynamic collapse or decompensation Intermediate-risk category of PE severity indicated by a positive (score \u22651) simplified pulmonary embolism severity index (sPESI), in combination with the presence of at least one of the following at presentation At least one sign of RV pressure overload/dysfunction on CT angiography or echocardiography Signs of myocardial injury as indicated by elevated troponin levels Signs of (RV) failure as indicated by NT-proBNP levels >600 pg/ml at baseline Ability of the subject to understand the character and individual consequences of the clinical trial; signed and dated informed consent of the subject available before the start of any specific trial procedures Pregnancy (a negative serum or urine pregnancy test should be available for women of child-bearing potential before study inclusion) or lactation Women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product Participation in another clinical trial during the present clinical trial or within the last three months Medical or psychological condition that would not permit completion of the trial or signing of informed consent Use of a fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE Treatment with any therapeutically dosed anticoagulant for more than 48 hours prior to enrolment Need for long-term treatment with a low molecular weight heparin, vitamin K antagonists or NOAC, for an indication other than the index PE episode, or for antiplatelet agents except acetylsalicylic acid at a dosage \u2264100 mg/day Active bleeding or known significant bleeding risk (e.g., gastrointestinal ulcer, malignant neoplasms, injuries or recent surgeries of the brain, spinal cord or eyes, recent intracranial bleedings, known or suspected esophagus varices, aneurysms or intraspinal or intracranial vascular abnormalities) Artificial heart valves requiring treatment with an anticoagulant", "label": "2"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 18.0-999.0, All Pulmonary Embolism Consecutive out patients with suspected PE in whom PE has been considered ruled out by negative D-dimers using an age-adjusted cut-off Life expectancy less than 3 months Geographic inaccessibility for follow-up Therapeutic anticoagulation for any indication Pregnancy Age less than 18", "label": "1"} +{"topic": "A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.", "doc": "eligible ages (years): 0.0-999.0, All Anterior Cruciate Ligament Reconstruction Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center Patients willing and able to provide written informed consent Parents willing and able to provide written informed consent for minors Patients who are pregnant or lactating Patients with liver dysfunction or renal failure Patients with a known allergy to ropivacaine Patients with a local infection Patients who take chronic pain medications Patients with an opioid tolerance Patients with known coagulopathy or bleeding risk Patients who are getting neuraxial anesthesia for surgery", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 6.0-16.0, All Narcolepsy Inclusions written informed consent/assent is obtained meet minimal established by the International Classification of Sleep Disorders (ICSD) manual of the American Academy of Sleep Medicine (AASM) for narcolepsy (or presumed narcolepsy) or OSAHS OR have a previous diagnosis of narcolepsy or OSAHS before the screening visit have a complaint of ES are in good health as determined by a medical and psychiatric history, physical examination, ECG, and clinical laboratory tests have blood pressure values greater than those for the 5th percentile and less than the 95th percentile on the National High Blood Pressure Education Program guidelines for blood pressure levels for boys and girls ages 6 to 16 years girls who are postmenarchal or sexually active, have a negative urine pregnancy test at screening, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 2 cycles after participation in the study); acceptable methods of birth control barrier method with spermicide; steroidal contraceptives (oral, transdermal, implanted, or injected) in conjunction with a barrier method; intrauterine device (IUD); or abstinence able to swallow a tablet similar in size and shape to the study drug tablet negative urine drug screen (UDS) for any illicit drug, alcohol (ethanol), stimulants at screening; if positive for stimulants (prescribed for excessive sleepiness) at screening, UDS to be repeated after a washout period and before baseline have a parent or legal representative who is willing to participate in the study have self-induced sleep deprivation/poor sleep hygiene have a past or present seizure disorder (except history of single febrile seizure), a history of psychosis, or of clinically significant head trauma (eg, brain damage) or past neurosurgery have a history of suicide attempt, or are at suicidal risk a clinically significant drug sensitivity to stimulants such as amfetamine, dexamfetamine, or methylphenidate; and/or modafinil or any of its components use of any monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRIs) within 2 weeks of the baseline visit (NOTE: SSRIs will be allowed for cataplexy if the patient has been on a stable dose for at least 1 month.) received any investigational drug (except modafinil) within 4 weeks of the baseline visit any disorder that could interfere with drug absorption, distribution, metabolism, or excretion (including previous gastrointestinal surgery) active, clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other major clinically significant disorder/disease any clinically significant deviation from the normal range(s) in the physical examination or ECG findings, or clinical laboratory test results (ie, serum chemistry, hematology) at the screening or baseline visit absolute neutrophil count (ANC) below the lower limit of normal at screening (NOTE: If the ANC is below the lower limit of normal at the baseline visit, the medical monitor will be consulted for continued in the study.)", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 14.0-999.0, All Shoulder Dislocation Ages 14 years or greater Diagnosis of MDI or MDL-AII. Diagnosis will require two or more of the following Symptomatic translation (pain or discomfort) in one or more directions: anterior, inferior and/or posterior Ability to elicit unwanted glenohumeral translations that reliably produce symptoms with one of the following tests: the anterior and posterior apprehension tests, the anterior and posterior load and shift tests, the fulcrum test, the relocation test, the Fukuda test, and/or the push-pull or stress test with the patient supine Presence of a positive sulcus sign of 1 centimetre or greater gap that reproduces the patient's clinical symptoms of instability and should be both palpable and visible Symptoms of instability: subluxation or dislocation Written informed consent Failed at least 6 months of non-operative treatment Confirmed capsular-ligamentous redundancy as determined by diagnostic arthroscopy examination Neurologic disorder (ie: axillary nerve injury; syringomyelia) Cases involving third party compensation Patients with primary posterior instability A bony abnormality (Hill Sachs/bony Bankart) on standard series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view Presence of a Bankart lesion on arthroscopic exam of the joint Presence of an unstable biceps anchor (ie: superior labral anterior and posterior [SLAP] lesion) on arthroscopic exam of the joint Presence of a full-thickness rotator cuff tear", "label": "1"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 14.0-999.0, All Joint Instability Shoulder Dislocation Clinical Age 14 years or greater Diagnosis of traumatic anterior shoulder instability, made by meeting all of the following Radiographic evidence or documented physician assisted reduction of anterior shoulder dislocation following a traumatic injury Ability to elicit unwanted glenohumeral translation which reproduce symptoms with one of the following tests: anterior apprehension, relocation test, or anterior load and shift test Radiological Closed growth plate on a standardized series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view Clinical Diagnosis of multidirectional instability (MDI) or multidirectional laxity with anteroinferior instability (MDL-AII), made by two or more of Symptomatic (pain or discomfort) in inferior or posterior direction Ability to elicit unwanted posterior glenohumeral translation that reproduces symptoms with posterior apprehension tests, or posterior load and shift test Positive sulcus sign of 1cm or greater that reproduces patient's clinical symptoms Previous surgery on the affected shoulder other than diagnostic arthroscopy Cases involving litigation Significant tenderness of acromioclavicular/sternoclavicular joints on affected side Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfan)", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 14.0-999.0, All Southern Tick-Associated Rash Illness Enrolled in protocol 02-I-0055 A person who is at least 14 years old Acute onset (within 14 days of visit to NIH) of an annular, erythematous, expanding erythema migrans (EM)-like rash that attains a size of at least 5 cm in diameter, when no alternative explanation for the rash can be found, and thought by the study physician to have a high likelihood to be due to STARI (due to exposure history, tick identification) History of tick bite at the rash site, or potential exposure to ticks in the southeastern and south central United States within 14 days prior to rash onset (including Maryland and Virginia) Consent to storage of biologic samples for later testing A person who, in the judgment of the investigator, would be at increased risk from the skin biopsy procedure and unlikely to be able to mount a serological response to the agent (for example, bone marrow transplant, B cell deficiency) FROM SKIN OF STUDY A person who meets the case definition but whose EM-like rash occurs on the face, neck, scalp, or over the tibia will not be enrolled for purposes of obtaining a skin biopsy specimen. Such a person may enroll for purposes of providing a clinical history and blood samples only. This also applies to patients with a history of forming large thick scars after skin injuries or surgery, or who have a history of excessive bleeding after cuts or procedures or are taking anticoagulants, or have severe skin disease. Also, patients who have received more than 24 hours of antibiotic treatment for the rash will be excluded from the biopsy. Patient with a history of allergy to lidocaine will also be excluded from the biopsy portion of the study", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 0.0-15.0, All Fracture Forearm Midshaft Child Treatment both-bone forearm fracture age < 16 years dislocation stable fracture older than 1 week no informed consent refracture open fracture (Gustillo 2 and 3)", "label": "1"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 0.0-15.0, All Fracture Forearm Distal Child Treatment both-bone forearm fracture distal dislocated unstable after reposition age < 16 years fracture older than 1 week no informed consent refracture open fracture (Gustillo 2 and 3) both fractures of type torus", "label": "1"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 15.0-18.0, All Forearm Injuries Children that had had Ulna or Radius X-rays Signing Informed consent Unwillingness to sign informed consent", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 0.0-999.0, All Degenerative Conditions of the Radial Head/Neck Post-traumatic Conditions of the Radial Head/Neck The will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with Joint destruction and/or subluxation visible on x-ray Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty The device is intended for single use with or without bone cement Modular Radial Head replacement prostheses have received FDA clearance for cemented and non-cemented application Patient selection factors to be considered 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity The will be the same as the contraindications stated in the FDA cleared labeling (510(k) K040611) and (510(k) K051385) for the device. These contraindications Absolute contraindications Infection Sepsis Osteomyelitis Relative contraindications Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions Osteoporosis Metabolic disorders which may impair bone function", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 19.0-999.0, All Patellar Dislocation An acute primary traumatic patellar dislocation Previous dislocation or subluxation of the patella Pre-existing ipsilateral or contralateral knee pathology Previous knee trauma or patellar fracture", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-999.0, All Heterotopic Ossification Subjects aged 18 years or greater Operative treatment of one of the following injuries An elbow dislocation with or without associated fractures An olecranon fracture-dislocation, but not simple olecranon fractures A distal humerus fracture An existing diagnosis of one of the following conditions Injury to the central nervous system, thorax, or abdomen precluding the immediate use of non-steroidal anti-inflammatory medications Fracture of any long bone since non-steroidal anti-inflammatory medications may increase the risk of nonunion History of gastritis, peptic ulcer disease, or upper gastrointestinal bleeding Impaired renal function (creatinine > 2.0), hypovolemia, heart failure, high blood pressure ( > 160/90), fluid retention, asthma, liver dysfunction (bilirubin > 2.0), or a coagulation disorder Allergy to non-steroidal anti-inflammatory medications Asthma, nasal polyps, urticaria, and hypotension associated with the use of NSAIDs Considerable dehydration Pregnant or breast-feeding women Concomitant use of one of the following drugs", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 14.0-30.0, All Shoulder Dislocation to 30 years of age Willing to participate in follow-up for at least two years Acute, first-time, traumatic, isolated anterior dislocation of the shoulder Previous instability of the affected shoulder A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments Incompetent or unwilling to consent A medical condition making the patient unable to wear a sling Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%) Neurovascular compromise of the affected limb Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 50.0-85.0, All Osteoarthritis Diagnosis of osteoarthritis Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael Dayton (University of Colorado Hospital) Minimum of 110 degrees of active knee flexion No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10 degrees flexion contracture Body mass index less \u2264 40 kg/m2 Any brain, circulation, or heart problems that limit function Severe osteoarthritis or other orthopedic conditions that limit function in the lower extremity that is not undergoing the TKA", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 17.0-38.0, All Shoulder Instability Surgical documentation of Pan Labral Lesion of shoulder Pre-operative documentation of outcomes scores lacking a Pan labral lesion other confounding pathology such as nerve deficit, chondral damage, rotator cuff tear", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 0.0-999.0, All Rotator Cuff Tear Medium to large sized cuff tear (2-4 cm) Yes subscapular partial fraying or longitudinal split side to side Yes acromioplasty Yes AC arthritis with mumford procedure Yes biceps tenotomy or tenodesis No arthritic changes of glenohumeral joint No combined infection No mini-open procedures No complete subscapularis tear No incomplete repair No small tears or side to side repairs without anchors No pregnancy", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-999.0, All Distal Radius Fracture Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium) Radial nerve entrapment Arthrodesis Traumatic dislocation of the distal ulna", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 0.0-18.0, All FEVER The estimates and the measurements will be carried out on children who are referred to an emergency unit and who are hospitalized in the pediatric department- both boys and girls of all ages. A patient might be measured several times ", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-70.0, All Distal Radius Fracture All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA) All patients between the age of 18 and 70 diagnosed with a C2 or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion Gustillo-Anderson type III open fractures Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity Dementia Congenital anomaly Bilateral radius fracture Pathological fracture other than osteoporotic fracture Congenital bone disease (for example osteogenesis imperfecta) Age below 18 and above 70 Disabling nury to other parts og the movement apparatus at the same time as the current injury", "label": "1"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-60.0, All Acromio-clavicular Joint Dislocation (Type III) men or women \u2265 18 years-old AC joint dislocation type III with Zanca X-ray view demonstrating CC distance of 200% trauma-surgery delay of less than 14 days consent form signed AC joint dislocation type I, II, IV, V or VI associated neuro-vascular damage men or women > 60 years-old open dislocation local skin damage dislocation in a polytrauma patient floating shoulder fracture of the ipsilateral or controlateral arm or shoulder girdle fracture of the coracoid process of the scapula history of previous surgery to the shoulder", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-99.0, All Lyme Disease Borrelia Burgdorferi for the diagnosis of Lyme disease can be found at The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America (4) Patients With EM (N=35), Post Treatment Age 18 or older EM diagnosed by the study physician or, with a diagnosis of EM that is thought to be highly likely by the study physician Treatment with at least 1 course of antibiotics that fulfills the Infectious Diseases Society of America guidelines for the recommended therapy for Lyme disease. There must be at least 1 month and up to 4 months between the end of the therapy and the study procedures High C6 Antibody Titer (N=35) Age 18 or older Diagnosed with confirmed or probable early or late Lyme disease as per Centers for Disease Control and Prevention (CDC) case definition (http://www.cdc.gov/ncphi/disss.nndss/caseded/lyme disease 2008.htm), have received recommended antibiotic therapy and have a high C6 ELISA titer (index above 3) at least 6 months after therapy Post Lyme disease syndrome (N=20) Age 18 or older History of allergy to surgical tape or Nitex nylon mesh History of severe reactions to tick bites (granuloma or systemic reactions) Inability to maintain the dressing for any reason Currently receiving any antibiotic or having received antibiotics in the last month (3 months for patients with post Lyme disease syndrome and high C6 titer) (except patients with EM on treatment) Pregnancy or lactation Unwillingness to use an effective method of birth control for 3 months after tick placement (women of child-bearing potential only) Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation Investigational therapy during the time of the study and/or in the month prior to signing the informed consent Active severe skin disease, uncontrolled diabetes, cancer other than non-melanoma skin cancers, autoimmune disease requiring immunosuppressive therapy, or history of HIV, chronic viral hepatitis, or syphilis Oral steroids in the previous 2 weeks (nasal steroids and replacement doses of steroids are not exclusions)", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-999.0, All Traumatic Knee Dislocation Ambulation without aids in pre-morbid condition Multi-ligament knee injury with or without associated peri-articular fracture Operative management within three weeks of the injury Poly-trauma with life-threatening injuries preventing rehabilitation Patients unable to comply with intensive rehabilitation Patients unable or unlikely to maintain follow-up", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 0.5-1.0, All Influenza Boys or girls and aged >= 6 months old to <= 12 months old on the day of first vaccination Subject's parent(s) or legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits Subject must be in good physical health on the basis of medical history, physical examination Subject's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure Subjects had received influenza vaccine History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication Personal or family history of Guillain Barre' Syndrome An acute febrile illness within 1 week prior to vaccination Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours Subjects with influenza-like illness as defined by the presence of fever (temperature >= 38'C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination History of wheezing or bronchodilator use within 3 months prior to study vaccine Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 8.0-35.0, All Adolescent Developement Brain Developmental Biology Sample 1 Child volunteers will qualify for if they meet the following Good general health and normal IQ Age 8 years Body Mass Index (kg/m2) between the 15th and 85th percentiles for age and sex according to the US Centers for Disease Control and Prevention 2000 growth charts (103) A normal tempo of growth as determined by skeletal age within +/ 64 standard deviations of chronologic age according to the Greulich and Pyle radiographic atlas (102) (i.e., no evidence for precocious puberty or abnormal delay of maturation); Research for determining bone age will be performed by the collaborating pediatric endocrinologist. This criterion is required only for the initial entry into this study and is not one of the for subsequent visits No history of significant neurologic or cognitive disorders. Examples neonatal anoxic encephalopathy, seizure disorders, autism, and most learning disorders including attention deficit hyperactivity disorder Able to provide assent. Parents will provide consent Child volunteers will be excluded for the following reasons Presence of any medical condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in eye or other body part, dental braces) Presence or history of medical conditions known to affect cerebral anatomy Children who are not pre-pubertal as indicated by the presence of Tanner stage 2 development (i.e., areolar development in girls and testicular volume > 3 cc in boys) Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or any other condition which, in the opinion of the investigators, would impede the ability to give informed consent or possibly hinder completion of the study; presence of any psychiatric disorder in the subject, sibling, or other first-degree relative Subjects who regularly use prescription medications (the use of over-the-counter medications will be reviewed on a case-by-case basis.) For females who have reached menarche: Pregnancy, lactation, or inability or unwillingness to undergo pregnancy testing (a urine pregnancy test will be performed prior to all MRI and X-ray procedures for girls who have had the onset of menses) Current or past use of psychiatric medication I.Q. < 70 Sample 2", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 0.5-6.0, All Nursemaid Elbow Pulled Elbow Pulled elbow suspected in any child presenting one of the following History of an adult or bigger person that had pulled the child's elbow non-intentionally Presence of intense pain at the arrival at the emergency department and unwilling to move the arm Any suspect of injury that could be intentional (child abuse) Any suspicion child of suffering a possible fracture (the mechanism of the injury was not from pulling the child's arm, the arm presents obvious deformity, ecchymoses, edema, etc.) The mechanism was from multiple trauma Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.)", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 8.0-12.0, All Metabolic Syndrome X Pupils in 3rd and 4th grades Primary Schools in the Zealand Region and Capital Region of Denmark Schools with an available school kitchen, that can be approved by the food authorities Schools where at least 60 % of the pupils in three or more classes signs up to participate in the Study The children should not participate in a scientific study or have participated in a scientific study within the last 4 weeks. This, however depends on the character of the other study The children must not suffer from serious food allergies or food intolerance The children must not suffer from diseases or conditions that makes them ill-suited for participation in the study, eg. malabsorptive conditions or serious mental disorders The schools must not offer an well-established common meal plan, that provides most of the pupils with healthy food on a daily basis", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-80.0, All Distal Radius Fracture Wrist Contracture Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium) Radial nerve entrapment Arthrodesis Traumatic dislocation of the distal ulna", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-85.0, All Elbow Trauma Requiring Operative Management Terrible Triad Radial head fracture surgical treatment Monteggia and Trans-olecranon Fracture Dislocations Distal Biceps Tendon Injuries Distal Humerus Fractures Coronoid Fractures Capitellar-Trochlear fractures Olecranon Fractures Associated Traumatic Brain Injury Burn Injuries associated with elbow trauma History of Gastric Ulcers Documented allergies to any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Severe Asthma Previous operative fixation to affected elbow Participation in other research study Inability to speak / understand English", "label": "1"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 1.0-17.0, All Fracture Treatment Children age 1-17 with buckle fractures of the distal radius and/or ulna. - Patients are excluded if there is any other injury to the upper limb or serious bodily trauma that might complicate pain scores. Children with suspected or proven metabolic bone disease, or pathologic fractures are excluded due to resultant abnormal bone healing", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 4.0-18.0, All Cerebral Palsy Patient Undergoing Hip Surgery Quality of Life Ages 4-18 Undergoing surgical treatment for hip subluxation or dislocation Diagnosis of cerebral palsy or similar condition causing motor impairment Consent to participate Diagnosis of neuromuscular disorders other than cerebral palsy younger than 4, older than 18 Reimer's migration percentage <40%", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 9.0-14.0, All Female Puberty Female volunteers in early to mid-puberty (i.e. late Tanner 1 [estradiol level >20 pg/ml], Tanner 2, or Tanner 3) Premenarcheal BMI-for-age > 85th percentile or < 5th percentile Pregnancy Inability to comprehend what will be done during the study or why it will done Hyperandrogenism (e.g., hirsutism, elevated free testosterone level) History of allergy to progesterone (which is extremely rare) Hemoglobin less than 12 g/dl and hematocrit less than 36% Persistently abnormal sodium, potassium, or bicarbonate (i.e. confirmed on repeat) Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat) Total bilirubin > 1.5 times upper limit of normal (i.e. confirmed on repeat) Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 0.25-15.0, All Sinusitis, Acute Child with ABRS with inflammation as bacterial infection who has the following symptoms/signs on the day of or the day before the first dose of the investigational product: Redness of the nasal mucosa; nasal or postnasal discharge is purulent or mucopurulent; Pathological shadow in the paranasal sinus on a radiogram (only for reference). Patient with surgical history should be excluded but patient with a pervious surgery more than 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy more than 90 days before may be enrolled in the study Child with ABRS whose severity is classified as moderate or severe (total score >=4) based on the nasal cavity findings and symptoms Boy or girl aged >=3 months to <15 years Body weight >=6 kilograms (kg) to <40 kg Written informed consent has been obtained from the child's legally acceptable representative. If the child is 12 years or older, the child him/herself should have also provided written informed consent. The investigator (or sub-investigator) should attempt to obtain written informed consent from the child him/herself as far as possible even if the child is less than 12 years of age Severe infection that requires surgical treatment (e.g., child with systemic symptoms such as fever associated with swelling face, child with almost full nasal obstruction due to a large nasal polyp) Serious complication such as acute mastoiditis, facial palsy, bacterial meningitis, and brain tumor Congenital disorder such as maxillofacial dysplasia Need of concomitant use of other antibiotics Serious underlying disease (e.g., cardiac disease, malignancy, juvenile diabetes) Concurrent infection associated with gastrointestinal symptoms (e.g., diarrhoea, vomiting) that may affect safety assessment Known hypersensitivity to any component of CVA/AMPC or penicillin or cephem antibiotic, or past history of a serious adverse reaction possibly related to any of these agents Infectious mononucleosis Current hepatic impairment, or past history of jaundice or hepatic impairment due to any component of CVA/AMPC Past or current renal impairment (e.g., serum creatinine >=1.5 \u00d7 Upper Limit of Normal, creatinine clearance of less than 30 milliliter/liter [mL/L])", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 50.0-999.0, All Osteoarthritis, Hip Age greater than 50 years Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre Any previous surgery about the ipsilateral hip Patients being considered for simultaneous bilateral total hip arthroplasty Patients with a neuromuscular disorder or recognized hypermobility syndrome Patients without sufficient language skills to communicate in spoken and written English", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-45.0, All Lateral Epicondylitis Individuals who meet all of the following are eligible for enrollment into the study Adult between 18-45 years of age Pain over the lateral humeral epicondyle provoked by at least two of the following: gripping, palpation, stretching of forearm extensor muscles and resisted wrist or middle finger extension Persistent pain for at least 3 months despite conservative treatments including medication (oral nonsteroidal antiinflammatory drugs (NSAIDs) and analgesics), brace application, or physiotherapy Patients with structural tendon changes at the origin of the extensors, demonstrated during musculoskeletal ultrasound Individuals who meet any of the following are disqualified from enrollment of the study Patients with a history of advanced cervical arthrosis in the C4-C6 segments Bilateral LE with central sensitization Symptoms compatible with posterior interosseous nerve entrapment Previous surgery, fractures, trauma or previous history of rheumatic disorders in the area of the lateral epicondyle History of corticosteroid injection at the lateral epicondyle within the last 3 months Two experienced professionals performed recruitment and examination of subjects in order to assess for criteria. All eligible patients provided written informed consent", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 70.0-999.0, All Distal Radius Fracture Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture Low energy injury Patient 70 years old or older hours or less since injury at time of diagnosis Patient registered in the Stockholm region Patient understands spoken and written swedish Intraarticular displacement in radiocarpal joint of more than 1 mm Ulna fractured proximal to the base of the styloid process of ulna Earlier unilateral functional impairment of hand/wrist Injury to tendon, nerve or skin besides the fracture Rheumatoid arthritis or other severe systemic joint disease Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less) Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle Medical illness that makes general anesthesia impossible", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-65.0, All Arthritis Female Sexually active Heterosexual years undergoing THR (prospective) or having undergone THR surgery within the last year Sexually inactive pre-operatively and wishing to remain sexually inactive post-operatively Unable to comprehend English and with capacity to consent and follow instruction Unable to sign and date the ethics committee approved consent documentation", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-65.0, All Spinal Cord Injuries Shoulder Impingement Syndrome Above 18 years old Have paraplegia as a result of a spinal cord injury morn than one year Able to perform push-ups independently and raise the arm above the head Self-propel a manual wheelchair as the primary means of mobility Have history of fractures or dislocations in the shoulder, elbow, or wrist from which you have not fully recovered Have upper limb pain as a result of a complex regional pain syndrome Have a implant or pacemaker within the torso or upper arm Pregnant female", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 18.0-70.0, All Basilar Invagination Associated With Atlantoaxial Dislocation Age between 18-70 Patients with cervical CT display that atlanto occipital fusion or partial fusion, Atlantoodontoid interval(ADI)>>3mm, odontoid tip over Qian line(CL)>>3mm Agreed to the surgical operation treatment The patient can carry out clinical follow-up and agree to long-term clinical follow-up Signed informed consent Patients with traumatic atlanto-axial dislocation Patients with rheumatoid atlantoaxial dislocation Patients with a history of occipital cervical junction operation Patients with severe cerebellar tonsillar hernia (reach the C2 margin), needed to remove tonsil of cerebellum Patients during pregnancy and the postpartum period within 3 months The life expectancy of < 1 years Severe dementia(MMSE<18) Severe renal failure (CR > 2.5mg/dl) Serious cardiovascular disease (such as unstable angina, heart failure) Atrial fibrillation and other severe arrhythmia", "label": "0"} +{"topic": "A 47 year old male who fell on his outstretched left arm presents with pain and bruising on the inside and outside of the elbow, swelling, and inability to bend the arm. On the x-ray, the ulna has dislocated posteriorly from the trochlea of the humerus. The radius has dislocated from the capitulum of the humerus.", "doc": "eligible ages (years): 13.0-18.0, All Contraception Ages 13 to 18 years old Speaks English or Spanish Has menstrual periods Has Medicaid insurance Seeking contraception as their primary complaint Currently pregnant based on urine or serum pregnancy testing Has an IUD or contraceptive implant (Implanon/Nexplanon) Critically ill, hemodynamically unstable, altered mental status, developmentally delayed, severe pain or distress, or have major trauma In juvenile justice custody", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Atherosclerosis Cardiovascular Diseases Hypertension, Renovascular Renal Artery Obstruction Either Documented history of hypertension on two or more anti-hypertensive medications OR Renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate [GFR] less than 60 mL per minute per 1.73 m^2, calculated by the modified Modification of Diet in Renal Disease [MDRD] formula) One or more severe renal artery stenoses by any of the following pathways a. Angiographic: greater than or equal to 60% and less than 100% by renal angiogram OR b. Duplex: systolic velocity of greater than 300 cm/sec OR c. Core Lab approved Magnetic Resonance Angiogram (MRA) (refer to the protocol for specific criteria) demonstrating stenosis greater than 80% OR stenosis greater than 70% with spin dephasing on 3D phase contrast MRA OR stenosis greater than 70% and two of the following: i. Ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Ischemic kidney enhances less on arterial phase iii. Ischemic kidney has delayed Gd excretion iv. Ischemic kidney hyper-concentrates the urine v. 2-D phase contrast flow waveform shows delayed systolic peak vi. Post-stenotic dilatation d. Clinical index of suspicion combined with a Core Lab approved Computed Tomography Angiography (CTA) demonstrating Stenosis is greater than 80% by visual assessment on high quality CTA Stenosis is greater than 70% on CTA by visual assessment and there are two of the following i. The length of the ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Reduced cortical thickness of ischemic kidney iii. Less cortical enhancement of ischemic kidney on arterial phase iv. Post-stenotic dilatation Unable to provide informed consent Unable or willing to comply with study protocol or procedures Must be greater than 18 years of age Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization Pregnancy or unknown pregnancy status in female of childbearing potential Participation in any drug or device trial during the study period, unless approved by the Steering Committee Prior enrollment in the CORAL study History of stroke within 6 months, if associated with a residual neurologic deficit* Any major surgery, major trauma, revascularization procedure, unstable angina, or myocardial infarction 30 days prior to study entry* Any planned major surgery or revascularization procedure, outside of the randomly allocated renal stenting indicated by the protocol, after randomization*", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 10.0-16.0, All Heterozygous Familial Hypercholesterolemia Mixed Dyslipidemia 16 years old Heterozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study Other protocol defined and", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 40.0-80.0, All COPD Criteria:Participants with COPD with an FEV1 of 80\u221230% predicted. This will incorporate the majority of participants with COPD seen within the chest clinic. Patients with an FEV1 > 80% predicted are not generally severe enough to warrant hospital follow up. These patients are also unlikely to have severe enough disease (and therefore airway inflammation) which may be modified by the therapeutic agents we are studying Patients with an FEV1 < 30% tend to have more severe symptom limitation and generally (though not always) find participation in a clinical trial involving 4 visits to the clinic difficult. Their airway disease is also generally less responsive to therapeutic intervention and as a consequence finding measurements which show changes to these therapeutic interventions is more difficult COPD patients All participants will be classified to Stage 2\u22123 of the GOLD (Global initiative for Obstructive Lung Disease) guidelines Male or female, aged 45-80 years (according to GOLD guidelines) < FEV1 < 80% predicted FEV1/FVC < 70% Cigarette exposure of >10 pack\u2212years# With or without chronic symptoms (cough, sputum production, dyspnea) Steroid therapy will be stopped before run\u2212in, but long acting bronchodilators are acceptable Any history or evidence of asthma Pregnancy, breast\u2212feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator Hospital admission with respiratory infection within the last 6 months Upper respiratory infection within the last 4 weeks Participants who have received research medication within the previous one month Participants unable to give informed consent Any mental condition rendering the participant unable to understand the nature, scope and possible consequences of the study Known or suspected hypersensitivity to study therapy or excipients Participants with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 65.0-999.0, All Atrophy community living elderly females >/=65 years live expectation > 2 years secondary osteoporosis CVD-events including stroke participation in other studies medication and illness affecting bone metabolism within the last 2 years medication with impact on falls low physical performance (<50 Watt during ergometry) excessive alcohol-intake", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-80.0, All Coronary Artery Disease Acute Myocardial Infarction Age 18 to 80 Anterior myocardial infarction with Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new CK peak>5 times the upper limit of normal with positive MB bands Ejection fraction <=40% or anterior dyskinesis or documented LV Thrombus MI onset < 7 days from randomization Inability to give written informed consent Medical conditions that would prohibit discharge within 48 hours with the exception of need for anticoagulation Cardiogenic shock, rest angina unresponsive to medical therapy or serious ventricular arrhythmia in the 24 hours prior to randomization Patients scheduled for surgical procedure in the next 4 months that would prevent use of enoxaparin or warfarin Anemia: Baseline Hgb<=9 gm for women, <=10 gm for men or platelet count<100,000 Renal insufficiency (creatinine >2.0 mg/dl) Serious liver disease as reflected by INR>1.3 Stroke within past 6 months or a prior documented intracranial or subarachnoid hemorrhage Active bleeding or major surgery within 2 weeks prohibiting the use of anticoagulants Acute pericarditis", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 30.0-80.0, All Acute Myocardial Infarction Patients will be eligible if presenting all characteristics described below ST segment elevation myocardial infarction, according to the WHO definition (two from the following three) i) Presence of chest pain. ii) Presence of ST segment elevation in two or more contiguous leads. iii) Elevation of the myonecrosis markers Age between 30 and 80 years old Invasive ventriculography presenting ejection fraction <50% (Dodge method) and segmentary dysfunction of the infarction area, measured immediately before PCI. Among patients submitted to thrombolytic therapy, the angioplasty of the related artery should be preferably done up to 24h after thrombolysis, with a maximum deadline of 48h after thrombolysis. This recommendation is based on the last Percutaneous Coronary Intervention guideline published by the European Society of Cardiology, in April 2005.68 IA recommendation degree Patients will be ineligible if presenting any of the characteristics described below AMI related artery presenting TIMI < 3 at the moment f cell injection Left Main Coronary Artery Lesion of >50% or multivessel coronariopathy (>70% lesion in vessels with >2,0mm diameter in left anterior descending, circumflex and right coronary territory) indicating the need for CABG or angioplasty with three or more stents implant Coronary anatomy, after thrombolytic reperfusion, presenting no need for angioplasty with stent implant Final Diastolic Pression of the LV higher than 30 mmHg during ventriculography for evaluating EF for the research protocol (item \"c\" of criteria) Cardiac arrest or Killip IV AMI at admission with need of ventilatory support Cardiogenic shock persisting up to the third day after AMI (with need of Intra-aortic balloon pump or vasopressors) AMI mechanical complications (ventricular septal defect, papillary muscle rupture, and left ventricular free wall rupture) Significant valve disease, defined as aortic stenosis (mean systolic pressure gradient across the aortic valve >50mmHg), mitral stenosis with a valvar area less than 1,5 cm,2 moderate to severe aortic and/or mitral regurgitation Chronic use of immunosuppressive agents", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 30.0-999.0, All Hypertension Atherosclerosis Every patient referred fo abdominal CT aged 30-100 Contraindication for IV contrast injection failure to demonstrate renal arteries with contrast refusal to sign an informed consent", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Neuralgia Spinal Cord Injuries Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas) Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months Pain score at least 4 in 4 of 7 days prior to receive treatment Pregabalin use in the last 60 days, prior intolerance to pregabalin Creatinine clearance <60 mL/min White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm3 Abuse of drugs or alcohol Unstable medial conditions Clinically significant abnormal electrocardiogram (ECG) Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-75.0, All Acute Anterior Myocardial Infarction Each eligible patient must meet the following Have ECG evidence of ongoing acute anterior myocardial infarction, involving a large area of myocardium, as defined by the following ECG a. Anterior infarct: ST-segment elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous precordial leads, V1 through V4; and/or >0.2mV in lead V5 V6 Present to the RAPID MI-ICE site within six (6) hours of the onset of acute cardiac ischemic signs or symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea, nausea/vomiting, or syncope) Be a candidate for PCI and have PCI planned as the immediate intervention Be willing and able to comply with study procedures, including returning for the MRI scan at 4 \u00b12 days and return for the clinical examination on Day 30 Provide written informed consent prior to the initiation of study-specific procedures Be in Killips Class I Patients are not eligible for the study if they meet one or more of the following Age less than eighteen (<18) years of age Age greater than seventy-five (>75) years of age Are pregnant Have a suspected aortic dissection History of a prior anterior myocardial infarct or prior large myocardial infarct The suspected etiology of myocardial infarction is primarily related to substance abuse (e.g., cocaine, methamphetamine, etc.) Acute administration of a thrombolytic agent for the qualifying MI If (during the screening process) the determination is made by site-study personnel that initiation of cooling prior to diagnostic coronary angiography is technically not feasible for any reason (should the patient be randomized to the Hypothermia Arm), the prospective subject should not be enrolled Require an immediate surgical or procedural intervention other than PCI (e.g. CABG)", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Myocardial Infarction Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by chest pain suggestive for acute myocardial infarction symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia ECG with ST-T segment elevation > 1 mV in 2 or more leads TIMI flow 0/1 before primary PCI on diagnostic coronary angiography Hemoglobin levels > 10.6 mmol/L Anticipated additional revascularisation within 4 months Cardiogenic shock Presence of other serious medical conditions Pregnancy/breast feeding Malignant hypertension End stage renal failure (creatinin > 220 micromol/l) Previous treatment with rh-EPO Blood transfusion <12 weeks prior to randomisation Polycythemia vera", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 65.0-999.0, All Dementia 65 years of age or older Diagnosed with dementia by a physician Mini-Mental State Examination score of 23 points or less Capable of participating at least once a week for 6 weeks in succession Management of a medical risk required Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis Never having been on a bicycle, and incapable of pedaling well", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 55.0-999.0, All Bone Loss Osteoporosis Breast Cancer elderly postmenopausal women (ages 55 and older) osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study with breast cancer on aromatase inhibitor therapy with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history) type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not patients Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits Women with stage 4 breast cancer (presence of distant metastases) Women with normal bone density by DXA (T-score > -1.0 SD)bone density by DXA, except in the instance of a fragility fracture Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption Women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine) Those with untreated active peptic ulcer disease Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period) Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study Use of fluoride for more than 1 month ever (except for dental treatment)", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 21.0-999.0, All Contrast Induced Nephropathy Age > 21 year Glomerular Filtration Rate (GFR) 15-60ml/min calculated by MDRD formula Scheduled to undergo elective PCI Able to receive 12 hours of pre-hydration Written informed consent GFR less than 15ml/min or patients diagnosed with end stage renal failure Increase in serum creatinine levels of > 0.5mg/dl or 44umol/l in the previous 24 hours Preexisting dialysis Pulmonary edema or moderate to severe congestive heart failure (New York Heart Association [NYHA] III-IV) Patient unable to withstand the fluid load and hemodynamics compromise Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 100mmHg.) Emergency cardiac catheterization (i.e. patient presenting with ST segment elevation myocardial infarction undergoing primary angioplasty) Recent exposure to radiographic contrast (within two days of the study) Allergic to radio-contrast", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-75.0, All Cardiovascular Disease Signed informed consent to 75 years of age, inclusive Male or female Negative pregnancy test for women of child-bearing potential, or surgically sterile, or post menopausal Acute MI defined as Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following Ischemic symptoms Development of pathologic Qwaves on the ECG ECG changes indicative of ischemia (ST segment elevation or depression) First anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 [posterior leads]) History of CHF, Class I to Class IV, as per NYHA History of prior LV dysfunction At time of application of study device Killip III-IV (pulmonary edema, cardiogenic shock hypotension systolic < 90 mmHg and evidence of peripheral hypoperfusion oliguria, cyanosis, sweating) or HR > 100 bpm Prior CABG Prior MI History of stroke Significant valvular disease (moderate or severe) Patient is a candidate for CABG or PCI on non-IRA", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 19.0-999.0, All Acute Renal Failure Male or female > or equal to 19 yrs of age ARF defined by at least one of the following Volume overload from inadequate urine output despite diuretic agents Oliguria (urine output < 200 ml/12hrs) despite fluid resuscitation and diuretic administration Anuria (urine output < 50 ml/12 hrs) Acute azotemia (BUN > or equal to 80 mg/dl) Acute hyperkalemia not responsive to medication (K+ > or equal to 6.5mmol/L) An increase in serum creatinine of > 2.5 mg/dl from normal values or a sustained rise in serum creatinine of > or equal to 1 mg/dl over baseline Patients with end stage renal disease Patients who have had more than one previous dialysis session for acute or chronic renal failure during the current hospitalization Patient weight greater than 125 kg Patient weight less than 50 kg Pregnancy Prisoner Non-candidacy for continuous renal replacement therapy (CRRT) Patient/surrogate refusal", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Cardiovascular Disease Men and women admitted for an IHD event (acute coronary syndrome or revascularization procedure) who are at low or moderate risk.91 Regular Internet access (home, work or other environment) Over 18 years of age Permission of the attending physician Able to read, write and understand English without difficulty No physical limitations to regular activity Previous experience with a cardiac rehabilitation program Patients with depression, uncontrolled diabetes and other significant co-morbidities that may interfere with effective IHD management Those patients, who in the mind of the attending physician, are unsuitable for participation Those unable to provide informed consent Pregnant women High-risk patients for safety considerations (future studies will high-risk patients)", "label": "2"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Ischemic Stroke Myocardial Ischemia Coronary Arteriosclerosis Age \u2265 18 years old Symptoms suggestive of an acute ischemic stroke Informed consent Present intracerebral or subarachnoid haemorrhage Present intracerebral vascular malformation Present transient ischemic attack Prior coronary bypass surgery or percutaneous coronary intervention Pacemaker Allergy to contrast Lack of cooperation", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Primary Hypercholesterolemia Homozygous Familial Hypercholesterolemia Outpatient men or women, age 18 years and above Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia Known hypersensitivity to Ezetimibe Moderate to severe hepatic insufficiency Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal Pregnancy or lactation Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Renal Artery Stenosis PAD and unilateral ostial >60% RAS and hypertension Conditions which imply RAS stenting (bilateral significant renal disease, single functioning kidney, or patients whose conditions cannot be managed medically or by intervention) Allergy to contrast agents or medication administered for best medical treatment (in particular ASA and statins)", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 30.0-80.0, All Myocardial Infarction First anterior myocardial infarction Low systolic ventricular function Bleeding tendency Contraindication to G-CSF Cardiogenic shock Hemodynamic instability Hepatic or renal disease Multivessel disease", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Hyperplasia Restenosis Patients must meet all of the following The patient must be > 18 years of age Diagnosis of stable angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or ACS (except STEMI) Treatment of de novo lesion in a major coronary artery in patients with single or two-vessel disease Target vessel diameter at the lesion site is >2.50mm and <3.50mm in diameter (QCA) Target lesion is >10mm and <24mm in length (visual estimate) Target lesion stenosis is >50% and <100% (visual estimate) Acceptable candidate for coronary artery bypass surgery (CABG) Patient is willing to comply with the specified follow-up evaluation Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee Patients will be excluded if any of the following conditions apply multiple lesions in the same vessel ACS with STEMI (within 48 hours) vessel size < 2.50mm and >3.50mm reference diameter length of the lesion > 24 mm unprotected left main coronary disease with >50% stenosis have an ostial target lesion have a target lesion in a venous graft angiographic evidence of thrombus within target lesion calcified lesion which cannot be successfully predilated", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 50.0-999.0, All Cataract Subjects must have a clinically documented diagnosis of age-related cataract Subjects must have clear intraocular media other than cataract Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated Subjects with diagnosis of degenerative visual disorder Subjects who have any inflammation or edema (swelling) of the cornea Subjects with immunodeficiency disorders Subjects who have had previous intraocular surgery in the study eye Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture Subjects with chronic use of systemic steroids or immunosuppressive medications", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-65.0, All Obesity, Morbid Ischemic Heart Disease Morbidly obese patients who fulfill the NIH for surgical intervention Patients deemed unfit for surgery Pregnant women, or who are attempting conception Subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion > 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography History of drug or alcohol abuse Chronic liver disease", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Hyponatremia Acute Decompensated Heart Failure Presents to emergency department with documented history of CHF and symptomatic ADHF, will be treated for ADHF, and primary reason for admission to the hospital is ADHF Dyspnea at rest or with minimal exertion and must have moderate shortness of breath (SOB) in any of the first three Provocative Dyspnea Assessment positions Severe pulmonary congestion as evidenced by jugular venous distention or lower extremity/sacral edema or rales upon chest auscultation or chest x-ray BNP > 400 or NT-pro BNP > 1500 drawn during Screening Systolic blood pressure >= 100 mmHg to < 180 mmHg at time of start of study drug Serum sodium value >= 115 mEq/L (115 mmol/L) and < 135 mEq/L (135 mmol/L) during Screening Clinical evidence of volume depletion Active ongoing acute coronary syndrome or acute ST segment elevation myocardial infarction (or has experienced a myocardial infarction within 30 days of Screening) In cardiogenic shock Calculated creatinine clearance < 30 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) equation, has received intravenous (IV) contrast agent within 72 hours prior to randomization or is expected to receive IV contrast agent within the first 72 hours of study participation Ultrafiltration within the past 72 hours Currently using or expected to use inotropic therapy Cardiac bypass grafts in the past 60 days Cerebrovascular accident in the past 30 days Uncontrolled brady or ventricular tachyarrhythmias requiring emergent pacemaker placement or treatment", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndrome typical chest pain ST segment elevation or depression in ECG indication for coronary angiography; if necessary with PCI and 4) signed inform consent known past history of a myocardial infarction not signed informed consent", "label": "2"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Hypercholesterolemia Outpatient men or women, age 18 years and above Patients with primary (heterozygous familial and non-familial) hypercholesterolemia Known hypersensitivity to Ezetimibe and Simvastatin Moderate to severe hepatic insufficiency Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal Pregnancy or lactation Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-80.0, All Ventricular Tachycardia Coronary Artery Disease Left Ventricular Dysfunction Coronary artery disease For the purpose of this study, coronary artery disease will be defined as the presence of a 50 % or more diameter stenosis of the left main coronary artery, or 75 % or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure, or history of successful thrombolysis, or a history of prior myocardial infarction (e.g.: documented by Q-wave, R-reduction, aneurysm) Left ventricular ejection fraction \u2264 50 % as estimated by echocardiography or contrast ventriculography within the previous 30 days and evidence for old myocardial infarction (ECG, echocardiographic or venticulographic) One episode of documented stable clinical VT without any reversible causes Written informed consent Age < 18 years or > 80 year Protruding LV thrombus on pre-ablation echocardiogram Acute myocardial infarction within the preceding 1 months Class IV NYHA heart failure Valvular heart disease or mechanical heart valve precluding access to the left ventricle Unstable angina Cardiac surgery involving cardiotomy (not CABG) within the past 2 months Serum creatinine > 220 mmol/L (2.5 mg/dL) Thrombocytopenia or coagulopathy Contraindication to heparin", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 2.0-90.0, All Aged elderly subjects over the age 65 years who had not received pneumococcal vaccination adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination) children subjects over the age of 2 years with no previous history of pneumococcal vaccination immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris Patients with any episode > five minutes of chest pain being admitted to rule out acute coronary syndrome Positive initial troponin or CK-MB tests Diagnostic ECG changes (ST segment elevation or horizontal ST segment depression in more than two contiguous leads) Unstable clinical condition (hemodynamically unstable, ventricular tachycardia, persistent chest pain despite adequate therapy) Creatinine Clearance <50 mL/min Known allergy to iodinated contrast agents Patients on metformin therapy unable or unwilling to discontinue therapy for 48 hours after CT scan procedure Known asthma, reactive airway disease Patients currently in atrial fibrillation", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Myocardial Reperfusion Injury clinical evidence of myocardial infarction defined by the presence of ischemic chest pain lasting more than 30 minutes, with a time interval from the onset of symptoms less than 6 hours before hospital admission, associated with typical ST-segment elevation on the 12-lead ECG angiographic-detected culprit lesion with stenosis diameter >70% and TIMI flow grade <=1 previous acute myocardial infarction previous myocardial revascularization (angioplasty or coronary bypass) previous heart valve replacement previous heart transplant clinical instability precluding the suitability of the study cardiogenic shock or persistent hypotension (systolic blood pressure <100 mmHg) rescue angioplasty after thrombolytic therapy evidence of coronary collaterals (Rentrop grade>0) in the risk area advanced atrioventricular block significant bradycardia", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-75.0, All Cocaine Dependence meet DSM-IV for lifetime cocaine dependence and have used cocaine in the prior 6 months be > 18 years of age be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment have no regular IV heroin use during the past year have access to a telephone be willing to be randomized and participate in research; and no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will be required to be metropolitan area residents, and be able to provide the name, verified telephone number, and address of at least two contacts who can provide locator information on the patient during follow-up. We will patients with dependence on other substances, provided that they are cocaine dependent and meet other criteria have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment have acute medical problem requiring immediate inpatient treatment; or are currently participating in methadone or other forms of DA treatment, other than IOP", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 19.0-999.0, All Cardiovascular Risk Factors Age \u2265 65 years Hypertension (HTN) Diabetes Obesity (body mass index [BMI] >35) Renal insufficiency Tobacco usage Hypercholesterolemia Sleep apnea/heavy snoring at night Clinical diagnosis of CHF as defined by Dyspnea on exertion Patients expected to say in the hospital for less than 24 hours Inability of undergo TEE and TTE Clinical evidence or suspicion of elevated intracranial pressure Preoperative shock or systemic sepsis Emergency Operation ASA Class V Inability of give informed consent Participation in another clinical trial Prisoner", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 10.0-999.0, All Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time ", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 70.0-999.0, All Mild Dementia elderly (> 70 years) with mild dementia in presence of a carer ", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 40.0-75.0, All Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease) Able to provide a written informed consent <75 years of age, but >40 years of age Able to hold breath for at least 10 seconds Sinus rhythm New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) Greater than 6 hours since presentation to ED BMI >40 kg/m2 Impaired renal function as defined by serum creatinine >1.5 mg/dL* Elevated troponin-T (> 0.09 ng/ml) Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) Known allergy to iodinated contrast agent Currently symptomatic asthma Documented or self-reported cocaine use within the past 48 hours (acute)", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Mellitus, Type 2 years of age or older Newly prescribed Saxagliptin or an OAD in a class other than DPP4 inhibitors Enrolled in the respective database for at least 180 days prior to the first prescription for Saxagliptin or other OAD in a class other than DPP4 inhibitors Patients identified with a diagnostic code for any of the cardiovascular outcomes of interest within the 180-day baseline period Patients prescribed a DPP4 inhibitor during the baseline period", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 65.0-999.0, All Distal Radius Fracture All patients older than 65 years old with an acute DRF were considered for for this study. criterion of this study was an unacceptable closed reduction after one attempt of closed reduction. The of unacceptable closed reduction included dorsal angulation of > 100, volar angulation of > 200, an articular gap or step off of >2 mm, radial inclination of <100, or radial shortening of > 5mm A preexisting severe illness An ipsilateral upper extremity injury A previous wrist injury Surgical delay of more than 2 weeks A concomitant ulnar neck fracture", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 0.0-999.0, All Hypertension Angina Pectoris Hypercholesterolemia Familial Hypercholesterolemia Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet\u00ae) Combination Tablets by their Physicians Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet\u00ae) Combination Tablets before", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 20.0-999.0, All Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Subject must be at least 20 years of age Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia) Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery Subject must agree to undergo all protocol-required follow-up procedures Subject must agree not to participate in any other clinical study for a period of one year following the index procedure Angiographic One (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel Lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of \u2265 50% and < 100% with a TIMI flow of \u2265 1 Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of \u2265 2.25 mm and < 2.5 mm Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB \u2265 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes Subject has current unstable cardiac arrhythmias associated with hemodynamic instability Subject has a known left ventricular ejection fraction (LVEF) < 40% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary) Subject has received coronary brachytherapy in any epicardial vessel Subject has received any organ transplant or is on a waiting list for any organ transplant Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) Subject is receiving chronic anticoagulation therapy (e.g., heparin, warfarin)", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-75.0, All Renal Artery Stenosis Hypertension At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography Hypertension defined according to WHO Age 18-75 years Signed informed consent obtained Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney Contraindications to percutaneous renal angioplasty with stenting Atrophy of the kidney supplied with stenosed artery Other well known secondary reason for hypertension Chronic heart failure NYHA II-IV Significant valvular heart disease qualified for surgery Persistent atrial fibrillation Renal failure with GFR below 30ml/min", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 0.0-999.0, All Mitral Valve Insufficiency Atrial Fibrillation Heart Failure Patients with severe mitral regurgitation are admitted for surgical intervention and are willing to participate in this study Presence of mitral stenosis More than mild severity of aortic valvular problem Any abnormality of atrial septum (e.g., atrial septal defect or aneurysm) Rhythm other than sinus rhythm Inadequate image quality Lack of informed consent", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-85.0, All Renal Artery Stenosis Left Ventricular Hypertrophy ischemic heart disease angiographic diagnosis of atherosclerotic RAS >50% and \u226480% Atherosclerotic RAS>80% RAS secondary to fibromuscular dysplasia AMI single functioning kidney and/or sCr >4 mg/dl severe aortic valve stenosis aortic aneurism necessitating surgery", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Chronic Coronary Occlusion Unprotected Left Main Coronary Artery Disease Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis * for RCT Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) \u226570% requiring revascularization, or ULMCA disease with angiographic DS \u226550% but <70% requiring revascularization, or Left Main Equivalent Disease Clinical and anatomic for both PCI and CABG Silent ischemia, stable angina, unstable angina or recent MI Ability to sign informed consent and comply with all study procedures including follow-up for at least three years * Clinical Prior PCI of the left main trunk at any time prior to randomization Prior PCI of any other coronary artery lesions within one year prior to randomization Prior CABG at any time prior to randomization Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed Any recent MI with CK-MB levels still elevated Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year Subjects requiring or who may require additional surgery within one year The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Hypercholesterolemia Patients with hypercholesterolemia currently receiving a lipid lowering agent Pregnancy and lactation", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Renal Artery Stenosis RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation AND resistance index (RI) < 0.55 or > 0.55 but < 0.80 with evidence of intrarenal heterogeneity of the RI as revealed by a CV > 10% in the RI across the upper, mid and lower third of each kidney refusal to participate to study previous endovascular or surgical treatment of RAS fibromuscular RAS planned or actual pregnancy, or childbearing potential without measures adequate to prevent pregnancy life expectancy < 2 years patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study co-morbid conditions limiting participation and follow-up", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 65.0-80.0, All Osteoporosis women from 65 to 80 yrs of age diagnosis of osteoporosis classified according to the of the World Health Organization, with bone mineral densitometry reduced by at least 2.5 SD when compared with young adults (region of lumbar spine) severe visual deficiency physically incapable of participating in the tests neurological disorders, amputations, or prostheses individuals with regular physical activity (twice or more per week) or who had recently participated in exercise programs for muscular strength or balance", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Hypercholesterolemia Patients on lipid lowering drug treatment Lipid lowering drug treatment lasting at least 3 months No lipid lowering drug/dose change for a minimum 6 weeks prior to enrolment to the study Lack of patient's signed informed consent form Lack of the blood sample taken for lipid profile and glucose within 10 days before or after assessment of the patient", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 50.0-999.0, All Type 2 Diabetes, Hispanic/Latinos, Diabetes Self-management Education Self-identification as Hispanic/Latino, over the age of 18 years of age, diagnosis of type 2 diabetes and willingness to participate in the diabetes self-management education class non-diabetic persons, non English-speaking Hispanic/Latinos with type 2 diabetes", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 0.0-70.0, All Ischemic Heart Disease Obesity obesity Ischemic Heart disease Signed informed consent Visual or manual limitations that preclude reading and writing Unwilling to participate", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure Coronary Artery Disease Ischemic Cardiomyopathy Non-ischemic Cardiomyopathy Age >18 years Known or highly suspected coronary artery disease (CAD) documented by coronary angiography or by history of previous MI or evidence of moderate ischemia or scar based on prior imaging LV dysfunction most likely attributable to ischemic heart disease with EF <45% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class II-IV symptoms within the past 12 months LV dysfunction most likely attributable to ischemic heart disease with EF \u226430% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class I within the past 12 months Severe medical conditions that significantly affect the patient's outcome (eg. severe COPD, active metastatic malignancy) and would preclude revascularization < 4 weeks post ST segment elevation myocardial infarction (STEMI) Already identified as not suitable for revascularization Emergency revascularization indicated Severe valvular heart disease requiring surgery Contraindications to CMR (eg metallic implant, claustrophobia, renal failure (GFR <30 ml/min/1.73m2),). However patients with permanent pacemakers or implanted defibrillators or GFR <30 ml/min/1.7m2, will be randomized only to standard imaging (SPECT) versus PET or entered into the registry if only 1 modality is available Pregnancy Potential for non compliance to tests involved in this protocol Incapacity to provide informed consent", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Disease Coronary Artery Disease Coronary Artery Stenosis Coronary Artery Restenosis Patient must be at least 18 years of age Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the V\u00ae EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site Patient has been diagnosed a MVD, as documented by coronary angiography, i.e. presenting a severe stenosis (>50%) amenable to PCI in at least 2 major epicardial vessels or their principal bifurcation branches (diagonal or obtuse marginal) Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram -ECG consistent with ischemia) Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery Patient must agree to undergo all protocol-required follow-up examinations Angiographic Patients may receive up to 4 planned V\u00ae EECSS stents, depending on the number of vessels treated and their respective lesion length. When multiple lesions are present in one or more main coronary branches, complete revascularization should be attempted with the implantation of a maximum of 4 planned stents Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy) Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (non-procedural/spontaneous MI, CK-MB > or = to 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure Patient has current unstable arrhythmias Patient has a known left ventricular ejection fraction (LVEF) <30% Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) Patient is receiving chronic anticoagulation therapy (e.g. coumadin) Patient has a known hypersensitivity or contraindication to aspirin, paclitaxel, either heparin or bivalirudin, clopidogrel or ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated Elective surgery is planned within the first 9 months (+/ days) after the procedure that will require discontinuing either aspirin or clopidogrel", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 75.0-999.0, All the Elderly of 75 Years and Older Living at Home years of age and older man or woman Patient covered by the health care system Patient coverd by a complementary health system or supported by 100% by the health care system Patient having the intellectual skills to understand the study, to respect its imperatives and accept the UPSAV's plan or subject with mild to moderate dementia (MMSE > 10) but with a caregiver at home capable of understanding the protocol and of making respect its imperatives written consent signed by the patient Nursing-home resident Mild to moderate dementia (MMSE > 10) without caregiver Severe dementia (MMSE < 10) Diseases with vital short-term endpoint", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-85.0, All Myocardial Infarction Multivessel Coronary Artery Disease All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised Left main stem disease (stenosis > 50%) STEMI due to in-stent thrombosis Chronic total occlusion of a non-IRA Severe stenosis with TIMI flow \u2264 II of the non-IRA artery Non-IRA stenosis not amenable for PCI treatment (operators decision) Complicated IRA treatment, with one or more of the following Extravasation Permanent no re-flow after IRA treatment (TIMI flow 0-1) Inability to implant a stent Known severe cardiac valve dysfunction that will require surgery in the follow-up period", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Heart Failure Men and women age 18 or older referred for invasive evaluation of possible renal artery stenosis will be screened for enrollment Patients must be inpatients admitted for heart failure exacerbation, or have been admitted to a hospital for heart failure exacerbation within the past 90 days. Heart failure is defined as physician documentation or report of any of the following clinical symptoms of heart failure described as dyspnea on exertion, dyspnea occurring in the supine position, fluid retention; or the description of rales, jugular venous distension, pulmonary edema on physical exam, or pulmonary edema on chest x-ray; without being clearly attributable to liver, kidney, or lung disease. Patients must have one of the following: 1. an ejection fraction of 50%; 2. an ejection fraction of 25-50% in the setting of a systolic blood pressure of at least 160 mmHg; or 3. an ejection fraction of 25-50% and a systolic blood pressure of at least 140 mmHg while being treated with at least 2 antihypertensive medications. Patients who meet these and have a proven hemodynamically significant renal artery stenosis (as described in the procedure section) will be included Patients with heart failure from structural heart disease (including greater than moderate dysfunction of the mitral or aortic valve), acute coronary syndrome, post-partum cardiomyopathy, or acute rejection of a transplanted heart will be excluded. Patients who are considered unlikely to survive to hospital discharge will be excluded. Patients with fibromuscular dysplasia, prior renal stenting, or anatomy unsuitable for renal stenting (i.e. prior vascular surgery making stent delivery impossible) will be excluded. Patients who are unable to take aspirin and clopidogrel will be excluded. Patients with a creatinine clearance <30 mL/min or a history of renal transplantation will be excluded. Pregnant women will be excluded", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 60.0-999.0, All Femoral Neck Fracture Age of 60 years or more, ambulatory with/without walking aids before trauma Femoral neck fracture eligible for hemi-arthroplasty in accordance with the algorithm for femoral neck fracture patients used at the University hospital Basel Informed consent Refusal of consent by the patient or legal representatives to participate in the study More than one fracture Suspicion of a pathological fracture in the context of known or unknown malignancy Previous surgery of the proximal femur on the same side Follow-up not possible (Tourist etc.)", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Myocardial Infarction History of anterior MI within the prior 4 weeks to 12 months due to coronary artery atherosclerotic disease and evidenced by typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and elevated troponin or CK-MB >5 times the upper limit of normal with at least one of the following, based on standardly accepted definition of acute MI: development of pathological Q wave ECG changes, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities History of percutaneous coronary intervention (PCI), with stent placement resulting in TIMI flow = 3, in the left anterior descending coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused At least one historical assessment of left ventricular ejection function (LVEF) \u22640.45 as determined by any one of the standard modalities (echocardiography, ventriculogram, nuclear imaging, CT and/or MRI). For subjects that fulfill the of Recent MI (i.e., within 90 days of MI) at time of screening visit: assessment must be post-reperfusion after index MI and be the most recent test prior to signing informed consent. For subjects that fulfill the of Chronic MI (i.e., greater than 90 days from MI) at time of screening visit: assessment must be at least 21 days post-reperfusion after index MI and the most recent test prior to signing informed consent. Note: subjects may screen as a Recent MI but be randomized into the Chronic MI strata if the infusion date is > 90 days post-MI Left ventricular infarct size of \u2265 15% of left ventricular mass as determined by screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no large aneurysmal area in the anterior/anterolateral/anteroseptal regions . In subjects with infarcts in >1 myocardial wall, >50% of the total LV scar should be in the anterior/anterolateral/anteroseptal regions No further revascularization clinically indicated at the time the subject is assessed for participation in the clinical trial Ability to provide informed consent and follow-up with protocol procedures Age \u226518 years Subjects with a history of coronary artery bypass surgery, and a graft (left internal mammary artery or saphenous vein graft) attached to the left anterior descending coronary artery Diagnosed or suspected myocarditis History of cardiac tumor, or cardiac tumor demonstrated on screening MRI History of acute coronary syndrome in the 4 weeks prior to study infusion History of previous stem cell therapy History of radiation treatment to the central or left side of thorax Current or history (within the previous 5 years) of systematic auto-immune or connective tissue disease including, but not limited to, giant cell myocarditis, cardiac or systemic sarcoidosis, Dressler's syndrome, chronic, recurrent or persistent pericarditis History of or current treatment with immunosuppressive, anti-inflammatory, or other agents to treat manifestations of systemic immunologic reactions, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs, anti-VEGF, or chemotherapeutic agents within 3 months prior to enrollment Prior of planned ICD and/or pacemaker placement Estimated glomerular filtration rate < 30 mL/min", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-30.0, All Osteoporosis Participants young and healthy women between the ages of 18-30, who have not engaged in strength training for the last 6 months Subjects will be excluded from the study if they have any condition that preclude them from taking part in the exercise testing procedures or the 24 week exercise program or if they fail to obtain the required amount of training sessions", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 45.0-999.0, All Chest Pain Shortness of Breath Suspected Acute Coronary Syndrome Patients with chest pain or SOB admitted for rule out acute coronary syndrome Age \u226545 years EKG non-diagnostic for acute coronary syndrome At least 1 set of negative troponin I Patient with ST elevation myocardial infarction Patients with non-ST elevation myocardial infarction Patients with known CAD Patients with serum creatinine > 1.5 Atrial fibrillation or marked irregular heart rhythm Patients in whom heart rate cannot be controlled Patient with allergies to iodinated contrast agents Pregnant women Patients unable to give informed consent", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Acute Coronary Syndrome Non-ST-segment elevation ACS patients [ischemic symptoms suspicious of non-ST-segment elevation ACS (unstable angina or non-ST-segment elevation AMI) defined as clinical presentation compatible with a new manifestation of worsening of chest pain characteristic of ischemia, at rest or at minimum effort, lasting more than 10 minutes, and at least one of the following items: (a) ECG changes compatible with new ischemia (ST segment depression of at least 1 mm, or transient ST segment elevation, or ST segment elevation \u2264 1 mm, or T wave inversion > 2 mm in at least 2 contiguous shunts); (b) cardiac enzymes (CK-MB or troponin T or I) above the upper normality range limit; (c) patients > 60 years of age without ECG or myocardial necrosis markers changes, however with previous documentation of coronary atherosclerotic disease (CAD), confirmed by previous hospitalization due to AMI, previous percutaneous or surgical myocardial revascularization procedure, significant CAD confirmed by coronary angiography, or positive functional test for myocardial ischemia] Intention to submit patient to early invasive strategy consisting of coronary angiography immediately followed by PCI, when applicable, in the first 72 hours after admission Signed informed consent Patient eligible for transradial and transfemoral coronary angiography and PCI, being pre-requisites: (a) palpable radial artery with normal Allen test or/and oximetry tests, (b) familiarity of the operator with the radial and femoral techniques using AngioSeal, (c) agreement of the operator to use the access route determined by the randomization process Less than 18 years of age Pregnancy Chronic use of vitamin K antagonists or direct thrombin inhibitors, or oral Xa-factor antagonists Hypersensitivity to antiplatelet and/or anticoagulant drugs Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100.000 mm3) Uncontrolled systemic hypertension Cardiogenic shock Previous myocardial revascularization surgery with \u2265 1 internal mammary or radial artery graft Documented chronic peripheral arterial disease preventing the use of the femoral technique Severe concomitant disease with life expectancy below 12 months", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Renal Artery Stenosis Hypertension, Renovascular General Age \u2265 18 at the time of informed consent Subject or subject's legal representative have been informed of the nature of the trial, agrees to participate, and has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) Subjects that have bilateral kidneys or a solitary functioning kidney with Renal Artery Stenosis in at least one kidney and an average Systolic Blood Pressure (SBP) \u2265 155mmHg Subject has a history of maximum tolerable dose of \u2265 3 anti-hypertensive medications of different classes, one of which must be a diuretic (for at least two weeks prior to Medical Documentation Screening period) a. A documented history for a minimum of 3 months showing reasonable and aggressive efforts to manage hypertension prior to consent. This must the use of a broad variety of medications that have been used and failed or not tolerated Subject must have documented clinical evidence to support likelihood of angiographic findings > 80% whether it is DUS, CTa, MRa or other medical evidence New York Heart Association (NYHA) class I, II, or III the time of trial enrollment NOTE: When a subject has bilateral Renal Artery Stenosis both of which require stenting, it is recommended to treat both kidneys with an iCAST\u2122 RX Stent System during the index procedure. In the event that a subject needs a renal stenting procedure staged for renal protection, it is important that the Investigator treats the second renal artery with an iCAST\u2122 RX Stent System after 30 days of the index procedure. If subjects with bilateral stenosis have only one lesion that meets protocol that lesion should be treated per protocol. The recommendation is to NOT treat the second non-qualifying lesion, however if the operator feels strongly it is indicated, then they should treat per standard of care after 30-days post index procedure in order to comply with #10 Subjects with flash pulmonary edema are allowed into the trial should they meet all other and Angiographic Anatomic Angiographic diameter renal artery stenosis \u2265 80% involving unilateral or bilateral renal arteries a. The degree of percent diameter stenosis for all lesions intended to be treated, must be confirmed via one of the following methods: i. Manual or automated measurement with calipers ii. Measured Flow Fraction Reserve (FFR) < 0.8 using a pressure wire iii. Measured translesional peak pressure gradient of > 21mmHg after induced hyperemia via dopamine or papaverine using a 4Fr or less catheter or pressure wire b. Subjects with 60-79% angiographic stenosis who have confirmed FFR < 0.8 may be enrolled Renal pole-to-pole length > 8cm (per visual estimate) Target lesion length \u2264 16mm per vessel (per visual estimate) Renal artery vessel diameter \u2265 5.0mm and \u2264 7.0mm (per visual estimate) Lesion originating \u2264 15mm of the renal ostium General Subject's estimated life expectancy is < 12 months", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 20.0-999.0, All Acute Coronary Syndrome Subject must be at least 20 years of age Subject must have evidence of acute coronary syndrome (e.g., unstable angina, or STEMI) Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving 6-month or 12-month or longer duration of DAPT and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment Patients with cardiogenic shock Subjects who have dialysis Women who are pregnant or breast feeing Less than 2years life expectancy by previous medical history Patients with hypersensitivity or contraindications for aspirin or clopidogrel Patients who need long-tem clopidogrel taking due to cerebral infarction or other diseases Patients who can not give written consent such as mental illness", "label": "2"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 45.0-75.0, All Ischemic Heart Disease Obesity Stable Ischemic Heart Disease BMI 28 kg/m2 Known Diabetes Mellitus Repeated Fasting plasma glucose \u2265 7 mmol/L or Hba1c > 7 % Severe or moderate valve disease Main stem stenosis Severe heart failure, Ejection Fraction < 35 % Physical or mental disability which are expected to prevent completion of intervention Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 < 50 % of expected) or asthma Active cancer Severe kidney (GFR < 40 ml/hour) or severe liver disease Severe ischemia or arrhythmias during exercise test", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-65.0, All Injury Due to Endoscopic Examination Transnasal Endoscopy Induced Epistaxis Transnasal Endoscopy Induced Nasal Pain All outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligible for this study Patients who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study. Patients who are allergic to an anesthetic agent and who have uncontrolled hypertension or coronary artery disease are not recruited. Those who are uncooperative and unable to answer questions are also excluded", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Acute Myocardial Infarction High risk ST elevation myocardial infarction evidenced by: \u22652 mm ST elevation in 2 anterior or lateral leads; or \u22652 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of \u22658 mm; or New left bundle branch block with at least 1 mm concordant ST elevation Multivessel CAD as evidenced by \u22651 significant (\u226570% by visual assessment or FFR<0.80 for 50-70% stenosis) stenosis in non-IRA Successful IRA-PCI with <10% residual angiographic stenosis and TIMI III flow Written informed consent Age \u2264 18 years Prior coronary artery bypass graft (CABG) surgery Administration of thrombolytic therapy Non-IRA stenosis is a chronic total occlusion or located in left main artery Hemodynamic instability evidenced by BP<90 mmHg, Killip class \u22652, need for inotropes/vasopressors Known renal insufficiency (estimated GFR < 50ml/min) Contraindication to CMR", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Ventricular Tachycardia \u2265 18 years of age Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.) Planned for catheter-based ablation of VT All patients will have an existing ICD Accessibility of renal vasculature (determined by renal angiography) Ability to understand the requirements of the study Willingness to adhere to study restrictions and comply with all post procedural follow-up requirements MI or CVA within 30 days Coronary Artery Bypass Graft (CABG) within 30 days of this procedure Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis) GFR <30 ml/min (unless receiving dialysis) Life expectancy <1 year for any medical condition Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding) Inability to give informed consent Known pregnancy or positive -HCG within 7 days of procedure", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-70.0, All Dilated Cardiomyopathy Diagnosis of dilated cardiomyopathy Left ventricular ejection fraction < 35% NYHA Functional classes of II-IV Symptomatic but not rapidly deteriorating 1 month before enrollment Signed informed consent Contradictions and intolerance of the studied drugs supine systolic arterial blood pressure < 90 mmHg renal artery stenosis >50% pregnancy or lactation impaired renal function (estimated glomerular filtration rate < 60 ml/min/1.73m2 impaired liver function (total bilirubin >2 times upper limit of normal serum aspartate AST or alanine ALT >3 times the upper limit of normal) hemoglobin less than 8 mg/dl, hyperkalaemia (serum potassium >5.5mmol/l) obstructive lung disease advanced atrioventricular block", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease Coronary Artery Stenosis Coronary Disease Coronary Stenosis Subject must be at least 18 years of age at the time of signing the informed consent form Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery Female subject of childbearing potential does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential, a pregnancy test must be performed with negative results known within 14 days (\u226414 days) prior to the index procedure per site standard test Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated Subject has a known allergic reaction, hypersensitivity or contraindication to Aspirin; or All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or Heparin and bivalirudin Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes Subject has a cardiac arrhythmia as identified at the time of screening which at least one of the following is met Subject requires coumadin or any other agent for chronic oral anticoagulation", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All ST-elevation Myocardial Infarction. Multi Vessel Disease. Age \u2265 18 years Acute onset of chest pain of < 12 hours' duration ST-segment elevation \u2265 0.1 millivolt in \u2265 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block Culprit lesion in a major native vessel MVD (non-culprit vessels with angiographic stenosis >50%) Successful primary PCI Pregnancy Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast Inability to understand information or to provide informed consent Haemorrhagic diathesis or known coagulopathy Stent thrombosis Significant left main stem stenosis Cardiogenic shock at admittance", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 70.0-999.0, All Vitamin D Deficiency Osteoporosis Osteopenia Age 70 or older woman African American ethnicity Non-institutionalized De-compensated hepatic insufficiency Renal insufficiency with GFR estimated to be < 30 ml/min Gastrointestinal disorders that might affect absorption such as known malabsorption, celiac sprue, short gut or blind loop syndrome Institutionalized", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 65.0-999.0, All Dementia Diagnosis of dementia or having a cognitive deficit measured as a score less than 25 on Mini-Mental State Examination Fear of dogs, dog allergy or need of wheel chair", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-90.0, All Type II Diabetes Mellitus age 18 or older type II diabetes poorly controlled diabetes (HbA1C >8 x 2 measurements, with goal < 8) pregnancy non-English speaking or reading", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All ST Elevation (STEMI) Myocardial Infarction of Anterior Wall first time ST elevation anterior STEMI Significant chest discomfort and /or shortness of breath ST segment elevation (1.5 mV total) in two or more adjacent anterior precordial leads Successful reperfusion therapy (>TIMI grade 2 flow) either with thrombolytics or PTCA within 24 hours of onset of symptoms as documented by coronary angiography No previous history of an anterior AMI or previous ECG suggesting an old anterior AMI Cardiogenic shock, acute heart failure or hypotension (Systolic BP < 90 mmHg) Previous MI Previous known decreased EF < 40% Atrial Fibrillation Persistent signs and symptoms of Post MI ischemia Requirement of pressors for maintenance of blood pressure Intra-aortic blood pump use Significant (moderate-severe) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension Severe congenital heart diseases Sustained ventricular tachycardia or ventricular fibrillation", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Coronary Artery Disease Candidates for this study must meet ALL of the following Subject is at least 18 years old Subject requires single or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). N.B. staged procedure will not be considered to meet the endpoint component of repeat revascularization if either of the following pre-catheterization procedure qualifying clinical laboratory values are met eGFR is less than 60 ml/min or creatinine is greater than 1.5 mg/dl Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents Subject is an acceptable candidate for non-emergency, urgent or emergency CABG Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms Documented stable angina pectoris [Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test) Subjects will be excluded from participation in the Cohort Study (and non-emergency PCI may not be performed in these patients at the non-SOS site) if ANY of the following conditions apply The patient is pregnant or breastfeeding Evidence of ST segment elevation myocardial infarction within 72 hours of the intended treatment on infarct related or non-infarct related artery Cardiogenic shock on presentation or during current hospitalization Left ventricular ejection fraction less than 20% Known allergies to: aspirin, clopidogrel (Plavix), prasugrel (Effient), and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated) A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm3 Acute or chronic renal dysfunction (creatinine less than 2.5 mg/dl or less than 150\u00b5mol/L) Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials)", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 60.0-85.0, All Computerized Assessment Feasibility and Validity Men and woman between the ages of 60-85, inclusive Cognitive function/impairment within appropriate ranges for the study (Mini-Mental State Exam scores of 10-30, inclusive) Unable to complete computerized and standard pencil-and-paper based assessments", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 60.0-999.0, All Malnutrition Man or woman aged more than 60 years old Living in a nursing home for at least 2 months Malnourished or at risk of malnutrition (MNA<23.5 or BMI<24 or albumin<35 g/l or weight loss of more than 5 kg in the last 6 months) Without dementia or with moderate dementia (MMSE > or =10/30) Able to walk without human assistance (technical assistance allowed) No vitamin D supplementation Able to follow the study procedures and agreed to consume oral supplement Severe dementia (MMSE < 10/30) Enteral nutrition Severe renal or hepatic impairment Cancer with chemotherapy Uncontrolled diabetes Lactose intolerance Cow's milk protein allergy", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 65.0-999.0, All Plaque, Amyloid Cognitive Deficits Participation in the AMI or 3C cohorts Group 1 Controls MMSE > 24 or > 26 for low and high levels of education, respectively Without memory impairment (for episodic memory) on the Free and Cued Selective Reminding Test RL/RI-16 items (FCSRT), free recall > 22 and total recall >42, according to the thresholds for population-based studies Without memory complaint Without dementia Group 2 Cognitively-impaired subjects without dementia and without memory complaints Mini Mental State Evaluation (MMSE) < 24 or < 26 for low and high levels of education, respectively With memory impairments according to the RL/RI-16 test (free recall\u226422 and/or total recall \u226442), according to the thresholds for population-based studies defined by Auriacombe et al., 2010 Without memory complaint Being left handed Presence of dementia (based on the clinical diagnosis) Presence of stroke Presence of Parkinson's disease Presence of a counter-indication for MRI Presence of a counter-indication for PET Scan with [18F]-Flutemetamol Presence of any health problem preventing travel to the imaging service of the University Hospital Being under the legal guardianship of another person or being unable to provide consent to participate Pregnant or breastfeeding woman", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 60.0-999.0, All Alzheimer's Disease Elderly patients who are assisted in CRIA, diagnosed with Alzheimer's in use of rivastigmine or donepezil or galantamine, assisted by the \"Program for special drugs\" Be resident in the city of Araraquara / SP Accept part of pharmacotherapeutic follow-up Sign the Statement of Informed Consent Form (ICF) Fold over pharmacotherapy follow-up Being institutionalized Patients unable to respond to collection instruments MMSE and CDR data Patient without phone contact", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Cough Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 30.0-80.0, All Myocardial Infarction Patients who underwent primary PCI for acute STEMI and had >1 lesion in the culprit artery Presence of LMCA lesion Cardiogenic shock Previous CABG operation Decision for CABG operation after primary PCI Severe valvular disease including aortic stenosis of mitral insufficiency Severe kidney disease (serum creatinine >2.5 mg/dl or patients on maintenance hemodialysis) Rejection of second PCI by the patient after the index event", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 21.0-999.0, All Myocardial Infarction Inflammation Critical Illness \u226521 years of age admitted to the Medical Intensive or Coronary Care Units sepsis or respiratory failure clinically indicated troponin measurement within 24 hours of ICU admission unstable angina or Type 1 MI percutaneous or surgical coronary revascularization within 7 days heart failure exacerbation primary valvular disorder aortic dissection infiltrative heart disease or hypertrophic cardiomyopathy myocarditis pulmonary embolism electrocardiogram with >1mm ST segment elevation in two consecutive leads serum cardiac troponin >99th percentile URL but no clear rise or fall pattern", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-999.0, All Ventricular Rhythm From Artificial Pacing Indication for cardiac pacing renal insufficiency iod allergy claustrophobia significant valvular disease recent acute coronary syndrome planned cardiac surgery ejection fraction of left ventricle less than 50% live expectancy less than 3 years expected non-compliance of the patient", "label": "1"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 11.0-999.0, All Dental White Spots Dental Caries age 11 or older good health either gender present with at least two active white spot lesions on his/her anterior teeth at the start of the study have a moderate or high caries risk according to (Caries Management By Risk Assessment) rules require at least 12 additional months of full fixed appliance therapy from the time they are recruited for the study able to cooperate for treatment in the dental chair and follow at-home instructions have an understanding of the study willing to comply with all study procedures and protocols patient participant is able to provide written informed consent in English; if the participant is a minor, the parent/guardian is able to provide written informed consent in English and the patient participant is able to provide written assent in English untreated cavitated lesions extensive composite fillings on buccal surfaces of front teeth/first bicuspids or more than one dental crown on front teeth/first bicuspids has sealants or fluoride releasing cements on the buccal surface of the anterior teeth in-office fluoride treatment in the last three months history of using any products containing CCP-ACP (casein phosphopeptides and amorphous calcium phosphate; MI paste, chewing gums or candies, etc.), prescription Fluoride products, and Chlorhexidine use in the last three months intrinsic or extremely heavy extrinsic staining any signs of fluorosis in the dentition any signs of morphologic/anatomical/developmental deviations in the teeth previous history of in office bleaching treatment subject not willing to stop the use of any other oral hygiene product than those prescribed/suggested", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 50.0-80.0, All Osteoarthritis of the Hip unilateral, noninflammatory end-stage osteoarthritis of the hip willingness and ability to cooperate in the required post-operative therapy willingness and ability to provide written informed consent age 50-80 years inflammatory arthropathies prior hip surgery prior infection of the hip severe morbidity severe osteoporosis inability to tolerate general anesthesia no contraindications to MRI e.g. pacemakers, claustrophobia neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care known alcohol or drug abuse unwillingness to participate", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 18.0-80.0, All Rib Fracture Trauma must have above and be notated in our medical record missing data", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 35.0-65.0, All Myocardial Infarction Signed Informed Consent Form Patients having physical and mental ability to participate in the study Patients of both sexes aged 35 to 65 years Presence of documented ST-elevation myocardial infarction confirmed by ECG, as well as troponin I and CK-MB levels Presence of hemodynamically relevant stenosis of one artery (i.e., the infarct-related artery) confirmed by coronary angiography (CAG), with the occlusion of other arteries not exceeding 30% A history of repeat or recurrent myocardial infarction A history of chronic heart failure (CHF) III-IV by New-York Heart Association (NYHA) Presence of left ventricular hypertrophy confirmed by echocardiography QRS complex exceeding 1.0 Ejection fraction less than 40% Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG Type 1 diabetes mellitus Type 2 diabetes mellitus requiring pharmacotherapeutic correction with insulin Any severe concurrent disease A history of acute cerebrovascular accident (ACVA) within the 6 month period preceding the study", "label": "0"} +{"topic": "An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.", "doc": "eligible ages (years): 40.0-75.0, All Hypertension Age between 40 Diameter of stenosis of renal artery or main branch of renal artery \u226560\uff05. If diameter of stenosis is 60% , pressure difference between proximal and distal end \u226520 mm Hg (1mmHg=0.133kPa) or Captopril renography positive Systolic blood pressure before taking antihypertensive \u2265180mmHg and/or diastolic blood pressure \u2265110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure \u2265140mmHg and/or \u226590 mmHg length of ipsilateral kidney is greater than 7.0cm Estimated glomerular filtration rate (eGFR) \uff1c30 ml/ (min\ufe521.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11] unstable condition and unable to tolerate interventional therapy anatomy of renal artery pathology not suitable for interventional therapy allergic to dihydropyridines III degree atrioventricular block contrast allergy any known malignant tumor non-compliant, history of alcoholism or drug abuse", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 0.0-999.0, All Mental Disorder Diagnosed in Childhood Obsessive Compulsive Disorder Streptococcal Infection Tic Disorder Ages 4 years Fulfill for membership in the subgroup Presence of OCD and/or tic disorder Prepubertal symptom onset Abrupt onset and episodic (relapsing-remitting) symptom course Association between symptom exacerbations and GABHS infections Presence of choreiform movements or other neurological abnormalities during symptom exacerbations Because \"time to relapse\" is one of the primary outcome variables, children will not be eligible for randomization until their symptoms are in (at least partial) remission. At the time of randomization, symptom severity scores should be less than 50% of the child's previous maximum score on both the CY-BOCS and YGTSS, and no higher than a total score of 20 on the CY-BOCS or 30 on the YGTSS Personal history of penicillin allergy History of rheumatic fever, including Sydenham's chorea Diagnosis of autism, schizophrenia or other psychotic disorder Chronic illnesses, particularly neurologic and immunologic disorders", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis Psoriatic Arthritis Polyarthritis Native English speaker Patient at the Rheumatology Clinic at Brigham and Women's Hospital, Boston, Massachusetts Diagnosis of rheumatoid arthritis, psoriatic arthritis, or seronegative polyarthritis ", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Inflammation Familial Mediterranean Fever Still's Disease, Adult-Onset Male or female subjects with inflammatory disease greater than or equal to 18 years of age Participation in NIH study number 94-AR-0105 (\"Genetics and Pathophysiology of FMF and Related Disorders\") Subjects presenting with active NOMID, MWS, FCAS, FMF, or adult Still's disease based on clinical signs/symptoms and/or biochemical markers such as acute phase reactants (CRP, SAA or ESR). Subjects need not have both clinical features and biochemical markers of disease to be enrolled. However, both clinical and laboratory responses will be evaluated in each subject for improvement as outcome measures (even improvement of laboratory values found to be within the normal range at baseline) NOMID, MWS, and FCAS: Diagnosis will be based on the history of classical features of disease including fevers, rash, joint involvement, CNS involvement. Approximately half of all subjects with these clinical syndromes are mutation negative; however, in the experience of the principal investigator these subjects show favorable clinical response to IL-1 blockade with anakinra. Therefore, subjects with or without recognized mutations in CIAS1 will be eligible to enroll in this study. Active disease will be defined as either the presence of aforementioned classical features, or a history of such features that became quiescent in the setting of therapy with anakinra. However, before a patient who has quiescent disease and is currently taking anakinra can receive study drug, he/she must fulfill for active disease after anakinra has been discontinued FMF will be diagnosed on the basis of documented presence of one or two mutant alleles of MEFV as well as the history of classical clinical features of FMF such as periodic fevers, rash, arthritis, arthralgia, or episodes of serositis. Subjects must be considered non-responsive to colchicine (up to 2 milligrams per day) on the basis of continued symptoms or flares (greater than or equal to one per month) or elevated acute phase reactants (ESR, CRP or SAA greater than or equal to 1.5 times the upper limit of normal between attacks) despite treatment with maximally tolerated doses of colchicine. Positive genetic test will be required for FMF to rule out the possibility that non-response to colchicine is due to misdiagnosis Adult Still's disease will be diagnosed on the basis of history of classical clinical features such as fevers, evanescent salmon-pink rash, arthritis, arthralgia, and myalgia. Active disease will be defined as presence of one or more of these features and/ or elevation of acute phase reactants (ESR, CRP or SAA greater than or equal to 1.5 times the upper limit of normal) Subjects currently treated with anakinra may be enrolled in this study even though autoinflammatory disease may be quiescent. For these subjects a history of active autoinflammatory disease prior to treatment with anakinra will be sufficient. Subjects must be greater than 48 hours from their last dose of anakinra before beginning IL-1 Trap therapy, and will not take anakinra for the remainder of their enrollment in the study. However, before study drug is administered subjects have to manifest signs of active disease as described above Stable dose of steroids, NSAIDs, DMARDs, or colchicine for four weeks prior to enrollment visit Females of childbearing potential (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at screening and a negative serum pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication Women of childbearing age and men able to father a child, who are sexually active, who agree to use a form of effective birth control, including abstinence Treatment with a live virus vaccine during 3 months prior to baseline visit. No live vaccines will be allowed throughout the course of this study Current treatment with TNF inhibitors or recent discontinuation of TNF inhibitors (use within less than 5 half-lives of TNF inhibitor agent) Presence of active infections or a history of pulmonary TB infection with or without documented adequate therapy. Subjects with current active TB, or recent close exposure to an individual with active TB are excluded from the study Chest x-ray read by a radiologist with pleural scarring and/or calcified granuloma consistent with prior TB Positive test for or prior history of HIV, Hepatitis B or C History or concomitant diagnosis of congestive heart failure History of malignancy. Subjects deemed cured of superficial malignancies such as cutaneous basal or squamous cell carcinomas, or in situ cervical cancer may be enrolled Known hypersensitivity to CHO cell derived biologicals or any components of IL 1 Trap Presence of any additional rheumatic disease or significant systemic disease. For example, major chronic infectious/ inflammatory/ immunologic disease (such as inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, SLE in addition to autoinflammatory disease) Presence of any of the following laboratory abnormalities at enrollment visit: creatinine greater than 1.5 times the upper limit of normal, WBC less than 3.6 x 10(9)/mm(3); platelet count less than 150,000 mm(3); ALT or AST greater than 2.0 x ULN (ALT/AST greater than 2.0 x ULN in an adult Still's disease patient would prompt a hepatology consult prior to enrollment unless these abnormalities are considered by the Principal Investigator to be reflective of the underlying Still's disease)", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis adult patients at least 18 years of age with moderate to severe active RA for at least 6 months inadequate response to a stable dose of MTX patients of reproductive potential must be using reliable methods of contraception major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study prior treatment failure with an anti-tumor necrosis factor agent women who are pregnant or breast-feeding", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 3.0-15.0, All Streptococcus Group A All children 3 to 15-years old with pharyngitis who are seen at a participating site will be invited to participate Subjects whose parents are unable or unwilling to provide informed consent will be excluded from the study Children who are 13 years or older and unable or unwilling to provide informed consent will be excluded form the study", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Scaphoid Fracture Mature skeleton Isolated, acute complete fracture of the mid third of the scaphoid acute fractures of both hands one hand missing other injuries than scaphoid fractures rheumatoid, osteoarthritis or polyarthritis previous soft tissue injuries of the hand drug or alcohol abuse participant in trial during the previous month", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 0.0-999.0, All Streptococcus Group A Informed consent will be obtained from all study participants. Children between 0 -17 years of age will be enrolled in the APSGN study. Children between 3-17 years of age and adults between 18-40 years will be enrolled in the ARF study. Children and adults of all ages will be enrolled in the RHD and invasive GAS studies ", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Arthritis, Psoriatic, Psoriasis Eighteen years of age or older Inflammatory arthropathy associated with psoriasis meet the ACR for PsA Patients with diagnosis of active and progressive PsA who have failure with conventional treatments Significant concurrent medical diseases including cancer or a history of cancer, uncontrolled congestive heart failure, myocardial infarctions within 12 months or other clinically significant cardiovascular diseases, immunodeficiency syndromes or concomitant infectious diseases", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 2.0-20.0, All Systemic-Onset Juvenile Idiopathic Arthritis SO-JIA (Edmonton's revision of Durban's consensus conference criteria) Age: at least 2 years and less than 20 years at treatment initiation Disease duration of at least 6 months Failure of corticosteroid treatment or requirement for corticosteroid treatment at a daily dose equal to or over 0.3 mg/kg (10 mg in patients whose weight is over 34 kg) Active and severe systemic symptoms and/or arthritis as assessed by an experienced pediatric Rheumatologists, with at least 3 of the following when assessing Giannini's core-set items: 1) physician global assessment of disease activity of at least 20/100; 2) parent/patient assessment of disease effect on overall well-being of at least 20/100; 3) functional disability with a Children Health Assessment Questionnaire (CHAQ, Ref [9]) score equal to or higher than 0.375/3; 4) 2 joints or more with active arthritis 5) 2 joints or more with non-irreversible limited range of motion (irreversible limited range of motion will be defined by radiological evidence of irreversible joint damage and ankylosis) 6) erythrocyte sedimentation rate (ESR) equal to or higher than 20 In the absence of disease-related fever, either CRP or first hour ESR or both have to be over the upper limit of normal values so that treatment effect on the systemic part of the disease can be objectively evaluated Patients with polyarthritis (at least 5 joints with inflammation and/or limitation of motion) will be eligible for this study only if at least 50% of the affected joints do not present radiological evidence of irreversible damage Informed consent signed by the parents or the person legally responsible for the patient if the patient is less than 18, and by the patient if old enough Teenager girls or young women with childbearing potential must use a contraceptive method (including abstinence tuberculin test performed before Day 1 and must either be negative or positivity must be related to previous immunization and of normal intensity according to the investigator's judgment Previous treatment with IL-1Ra intra-articular injection or change in the doses of non-steroidal anti-inflammatory drugs and corticosteroids in the 4 weeks preceding the initiation of anakinra treatment Treatment with another immunosuppressive or disease-modifying drugs that could not be stopped before (for a duration depending on the drug pharmacokinetic properties) Contra-indication to the use of anakinra including ongoing active infection or allergy to E Coli's derivate or other components of the drug Previous history of malignancy or heart insufficiency Patients with asthma require to be previously assessed by a pneumonologist Obvious need of therapeutic intervention before study completion such as surgery, intra-articular injection, life vaccine administration Any of the following: leucocyte counts < 3.6 x 10e9/L, polymorphonuclear neutrophil counts < 1.5 x 10e9/L, platelets < 150 000/mm3, serum creatinin > 1.5 the upper limit of normal range for age, serum alanine and aspartate transaminases > 2 times the upper limit of the normal range, serum bilirubin > 2 times the upper limit of the normal range", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 0.0-20.0, All Group A Beta Hemolytic Streptococcal (GAS) Infection All students (approximately 225-250) attending four classes in four rural schools, grades 2-5, in rural villages near Chandigarh, and all students in classes 2-6 approximately 225-250 attending one rural village school near Vellore were asked to participate Approximately an equal number of boys and girls participated Selection of the schools for the study was determined by such factors as the accessibility to a rural regional clinic, housing facilities for medical staff, and passable tertiary roads to the villages and the schools All volunteers had a history of acute rheumatic fever and acute glomerulonephritis and evidence of rheumatic fever and rheumatic heart disease on physical examination at the initial survey were excluded from the study Excluded also was a child with a compromising illness such as cystic fibrosis that might require frequent or intermittent antibiotic treatment", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-70.0, All Ankylosing Spondylitis Active and severe ankylosing spondylitis Ankylosing spondylitis refractory to standard anti-rheumatic treatment Between 18 and 70 years of age Prior exposure to any TNF-inhibitor, including etanercept DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation Dose of NSAIDs changed within two weeks of study drug initiation", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-70.0, All Rheumatoid Arthritis Diagnosis of RA Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA Active RA at time of screening and baseline Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents Concurrent treatment with a DMARD, other than MTX, at screening Receipt of any DMARD, other than MTX, within 3 months before screening", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 1.5-19.0, All Juvenile Idiopathic Arthritis Fulfills International League Against Rheumatism (ILAR) for SJIA Duration of SJIA lasting at least 6 weeks since onset Active disease as defined by at least two joints with active disease Not currently receiving methotrexate OR if taking methotrexate, the dose has remained stable or has been discontinued for 4 weeks prior to screening Has never received certain biologics OR if previously received biologics, discontinued etanercept for at least 4 weeks prior to screening and discontinued infliximab or adalimumab for at least 8 weeks prior to screening Not currently receiving corticosteroids OR if taking oral corticosteroids, the dose has remained stable between 2 and 60 mg/day for at least 2 weeks prior to screening Past treatment with anakinra, rilonacept, or other biologic IL-1 inhibitor Treatment with other disease-modifying antirheumatic drugs (DMARDs) including, but not limited to, azathioprine, sulfasalazine, cyclosporine, and thalidomide within 4 weeks of screening Treatment with leflunomide without cholestyramine washout at the end of therapy Treatment with cyclophosphamide within 3 months of study entry Treatment with tacrolimus or tocilizumab within 4 weeks of study entry Treatment with rituximab within 6 months of study entry Treatment with intravenous immunoglobulin (IVIG) within 4 weeks of screening Kidney disease AST or ALT levels more than two times the upper limit of normal Bilirubin levels higher than 1.5 mg/dl", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) and in accordance with local guidelines Patients eligible to anti-TNF therapy Patients na\u00efve to anti-TNFa drugs Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method [Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form Patients with tumors Patients already included in clinical trials", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 50.0-999.0, All Polymyalgia Rheumatica Rheumatoid Arthritis Rheumatic Disease Patients signing Informed Consent Patients less than 50 years old", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis adult patients >/= 18 years of age active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA functional class IV by ACR classification history of inflammatory joint disease other than RA previous treatment with cell-depleting therapies, abatacept or rituximab active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 0.0-999.0, All Polymyalgia Rheumatica clinical diagnosis of polymyalgia rheumatica decompensated diabetes mellitus decompensated arterial hypertension", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Abnormality Inflammation Rheumatism gp Suspects or affected by rheumatoid polyarthritis Morning articular Stiffness of at least 15 minutes Arthalgias or Arthritises of at least three joints(articulations), among which those of the hand Possible rheumatoid Presence of a factor(mailman) and\\or Antibody anti peptides positive citrullin\u00e9s Typical possible radiological Hurts on the standard clich\u00e9s(pictures) of the reached(affected) joints(articulations) gp Affected by stiffening spondylitis with axial and peripheral infringement Lumbago and steepness lumbar vertebra inflammatory. 2. Arthralgias and\\or peripheral arthritises 3. Possible presence of an all\u00e8le HLA 4. Possible presence of a sacro-illite 5. Absence of the other rheumatic markers gp Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis gp Healthy control gp Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control Claustrophobia metallic foreign bodies pacemakers The pregnant women parturients or who breast-feed are excluded from the study", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis Signed, IRB-approved, written informed consent Subjects can be of either gender but must be more than 18 years old Subjects must fulfill the disease activity for RA and a DAS28 will be assessed at baseline and at 2 months after rituximab therapy Aim A Eligible subjects must meet for RA and have an inadequate response to MTX defined as DAS28 >5.1. They must have been on a steady dose of MTX (between 15 and 20 mg /week for a minimum of 8 weeks). Subjects must have evidence of knee synovitis on exam to enter the study Aim B Subjects must have demonstrated a response to a TNF antagonist as evidenced by a DAS score <2.8 or <4 tender and swollen joints. Flare will be defined as a DAS 28 >5.1 of more than 8 swollen and tender joints. Subjects must have evidence of knee synovitis to enter the study. Subjects will be off etanercept, infliximab or adalimumab for 4 weeks before starting BCDT. All subjects must also be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine) for 8 weeks before entry into the study Patients will be excluded for medical or other reasons at the discretion of the investigators. The reasons for the must be recorded, e.g. risk of non-compliance, vulnerability, medically unstable, etc Active systemic disorders or inflammatory conditions (i.e., chronic infection with hepatitis B, hepatitis C or HIV) other than the conditions being studied Patients with a plasma creatinine > 1.5 mg/dl Aim B Subjects with an allergy to corticosteroids will be excluded from the study Anyone answering yes to the following questions will be excluded Do you have a history of Cardiac (Heart) pacemaker or defibrillator? Cardiac (Heart) valve replacement or prosthesis? Aneurysm clips from brain surgery?", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Recurrent Melanoma Stage IV Melanoma Patients with metastatic melanoma who have measurable disease ECOG PS 0 or 1 Adequate bone marrow function WBC >= 3,000 Hgb >= 9 Plt >= 100 Adequate hepatic function, defined by the following parameters Total bilirubin WNL unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin =< 2 x ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN unless associated with hepatic metastases, then ALT and AST =< 5 x ULN Signed, written informed consent ", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 50.0-999.0, All Polymyalgia Rheumatica patients with PMR, diagnosed according to the of Bird et al patients with arthritis patients with giant cell arteritis patients with Parkinson's disease patients with hypothyroidism patients with scapulohumeral periarthritis patients with fibromyalgia patients unable to cooperate", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-49.0, All Spondylitis, Ankylosing Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or = 4 Axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks Evidence of current or recent episode of uveitis Evidence of IBD flare within 6 months Previous treatment with an anti Tumor necrosis factor(TNF) Active tuberculosis Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Patients aged \u2265 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following must be fulfilled unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis Patients who meet contraindications as outlined in the latest version of the Humira syringe\u00ae summary of product characteristics and Humira Pen\u00ae summary of product characteristics Patients participating in another study program or clinical trial Patients who have been treated with Humira before", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis Must have a documented diagnosis of Rheumatoid Arthritis (1987 American College of Rheumatology Criteria) with onset of signs/symptoms of disease \u2265 4 months of duration from randomization Must be receiving treatment on an outpatient basis Must have active disease despite current methotrexate treatment as defined below \u2265 6 swollen joints (66 swollen joint count) AND \u2265 6 tender joints (68 tender joint count) -. Must meet at least one of the four lab requirements below High Sensitivity C-Reactive Protein (hsCRP) \u2265 10 mg/L Erythrocyte Sedimentation Rate (ESR) > 28 mm after the first 1 hour Positive for Rheumatoid Factor (RF) Positive for Anti-cyclic Citrullinated Peptide (anti-CCP) antibodies Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization Rheumatic autoimmune disease other than Rheumatoid Arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis or significant systemic involvement secondary to Rheumatoid Arthritis (eg, vasculitis, pulmonary fibrosis or Felty syndrome). Sj\u00f6gren syndrome secondary to Rheumatoid Arthritis is allowable Functional Class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis Prior history of, or current, inflammatory joint disease other than Rheumatoid Arthritis (eg, gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis, Lyme disease) Receiving treatment with Disease-modifying antirheumatic drugs (DMARDs) (other than methotrexate), including biologic Disease-modifying antirheumatic drugs (DMARDs)Previous use is only allowed after adequate washout prior to randomization Inadequate response to treatment with an anti-tumor necrosis factor (anti-TNF) agent. Patients who terminated previous anti-tumor necrosis factor (anti-TNF) treatment due to cost or safety reason, such as discomfort with the subcutaneous injections, may participate in this study after adequate washout Treatment with any investigational agent within four weeks (or five half-lives of the investigational drug, whichever is longer) of screening Previous treatment with any cell depleting therapies, including investigational agents Treatment with intravenous gamma globulin, plasmapheresis or Prosorba\u00ae column within 6 months of baseline Intra-articular or parenteral corticosteroids are not allowed within 6 weeks prior to randomization", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 50.0-999.0, All Osteoarthritis Clinical diagnosis of primary osteoarthritis of the knee(s) Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment Arthritis other than primary osteoarthritis Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics Subtotal or total joint replacement in the affected knee Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Axial Spondyloarthritis Male and female subjects aged 18 years and over at the time of consent to the study Diagnosis of SpA, as defined by the ASAS for axial SpA Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit Active axial involvement defined by mini Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial Subjects who have received any previous treatment with etanercept or other TNF\u03b1 inhibitors or biologic agents Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-25.0, All Exercise Anaphylaxis Young healthy females Between 18-25 years old No on medication (this includes contraceptives) Medication use (including oral contraceptives) Amenorrhoea High blood pressure Very active (>3 hours per week of organized physical activity)", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 20.0-95.0, All Osteonecrosis Osteoarthritis Osteoarthritis of hip joint requiring total hip arthroplasty Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism Multi-systemic inflammatory arthritis which debilitates patients other than hip joint", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 50.0-999.0, All Polymyalgia Rheumatica (PMR) Disease Specific Patients must meet the following to be eligible for study entry Diagnosed with polymyalgia rheumatica and enrolled within one month of diagnosis Disease Specific Patients will be excluded from the study based on the following Symptoms or diagnosis of temporal arteritis, including headache, jaw claudication, hyperesthesia of scalp, abnormal palpated temporal artery, visual disturbances, temporal artery biopsy positivity Concurrent rheumatoid arthritis Presence of rheumatoid factor and CCP Other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, polymyositis, dermatomyositis, mixed connective tissue disease Treatment of polymyalgia rheumatica with more than 20mg of daily prednisone or its equivalent at the time of screening Treatment with more than 30mg of daily prednisone or its equivalent since diagnosis. Treatment with 30mg of daily prednisone or its equivalent since diagnosis for more than 2 weeks More than 4 weeks of corticosteroid therapy prior to enrollment History of bowel perforation within the past five years Active diverticulitis", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-50.0, All Polymyalgia Rheumatica PMR patients that after 2 years of corticosteroid treatment are not able to reduce the dose of prednisone below 5 mg/day or equivalent PMR patients that after 6 months of corticosteroid treatment are not able to reduce the dose of prednisone below 7,5 mg/day or equivalent PMR patients should fulfill the proposed by Chuang et al (8) Age \u2265 of 50 years Development of bilateral moderately/severe aching and stiffness persisting for 1 month or more, involving two of the following areas: neck or torso, shoulders or proximal regions of the arms, and hips or proximal aspects of the thighs ESR \u2265 40 mm/h Complete clinical response to low-dose of steroids (prednisone or equivalent \u2264 20mg/day) -Patients with biopsy-proven GCA or those with cranial symptoms or signs suggestive of GCA but without biopsy-proven arteritis Patients with clinical features suggestive of RA or other connective tissue disorders Chronic infections such as HIV, hepatitis B or C, active mycobacterial or fungal infections, etc Neoplasm or a history of malignancy in the preceding 5 years Patients with multiple sclerosis or other demilinizating disorders Patients with cytopenias: leukopenia (leukocytes \u2264 3.5x109/L.), thrombocytopenia (platelets \u2264 100x109/L.) and/or anemia (\u2264 10 g./dl.) Patients with cardiac failure (functional class III / IV) Any other condition that contraindicates Infliximab therapy", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 20.0-89.0, All Allergic Rhinitis Geographic Tongue rhinitis and non-rhinitis patients willing to complete the study no limitation of tongue movement more than 90 years old or younger than 20 years old unable to complete the study", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Adenocarcinoma Pancreas Histological documentation of primary adenocarcinoma of the pancreas Surgically eligible for tumor resection with curative intent Age> 18 years old ECOG PS 0 or 1 Adequate bone marrow function (WBC>3,000; Hgb>9; Plt>100) Adequate renal function (Cr<1.5ULN) Adequate hepatic function (total bilirubin WNL unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin <2x ULN; and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN Signed, written informed consent Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms. In addition adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded Patients with M1 disease Patients with any type of recurrent pancreatic adenocarcinoma Prior therapy such as chemotherapy or radiation therapy for pancreatic cancer Patients with a previous history of active malignancy within 5 years prior to study entry, except 1) in situ cervical carcinoma or 2) non-melanoma skin cancer Previous treatment with any other compound that targets CD40 Concurrent treatment with any anticancer agent outside of this protocol Prior allogeneic bone marrow transplant History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjorgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis. Vitiligo is allowed History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 50.0-999.0, All Flu Common Cold First Men and women aged 50 + years It is accepted that the subjects can be treated for medical diseases It is also accepted that the subjects receiving daily medication such as diuretics and medication for Hypertension, hypercholesterolemia and blood glucose-lowering treatment, medicine that strengthens the heart, symptom-relieving medication for joint disease, etc Subjects may also use n-3 fatty acids (fish oil), as long as the fixed dosage Subjects who have been treated with rose hip extracts or powder within 3 months before screening Subjects who have been treated with ginger, avocado / soy, large doses of vitamins (including vitamin C) or other known dietary supplements within 3 months before screening Subjects that have been deemed to be have a hard time collaboration Subjects who abuse narcotics Subjects who abuse alcohol Subjects with a current mental illness Subjects with known allergy to rose hips Subjects participating in another clinical trial, or have participated in another clinical trial within 3 months before this trial started", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 5.0-15.0, All Rheumatic Heart Disease Schoolchildren in Southeast Nepal aged 5-15 years Written informed consent by the principal of the school Passive consent from the parents No formal apply", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). for the exposed cohort subjects are Patients aged 18 years and over at the time of diagnosis Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and \u22645.1) Patients who have given informed consent for long term follow-up and access to all medical records Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel) for RA The Control Group Patients aged 18 years and over a the time of diagnosis Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and \u22645.1) Patients who have given informed consent for long term follow-up and access to all medical records; Patients are receiving at least one traditional DMARD and have never been prescribed a biologic agent Per BSRBR registry since data is retropsectively being analyzed", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Patient Harboring Glioblastoma That Will Undergo Surgery Patients harboring Glioblastoma Patient will undergo surgery BMI > 30 Liver and Kidney Function so compromised that medication is prescribed", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-80.0, All Systemic Sclerosis Systemic sclerosis fulfilling ACR or LeRoy's Active polyarthritis defined by > 6/53 tender joints and > 4/53 swollen joints Ongoing first line therapy by prednisone (max 10 mg/d) and (methotrexate, leflunomide, azathioprine or mycophenolate) Birth control if applicable Overlap syndrome defined by clinical symptoms and positive specific auto-antibodies (anti-CCP, anti-SSA, anti-DNA DNA anti-Sm) (Rheumatoid factors and anti-RNP are not Past therapy with Rituximab Severe and uncontrolled disease with renal, liver or haematological (neutropenia < 1500 / mm3) failures, pulmonary (FVC < 50%) or cardiac insufficiencies (LVEF < 50%) Not stable corticosteroid therapy or cyclophosphamide use in the last 6 months Infectious risk : viral infections by B or C hepatitis or HIV, hypogammaglobulinemia (< 6 G/L), opportunistic infection or infection requiring IV antibiotics in the last 3 months Neoplastic solid tumor in the last 5 years Drug or alcool abuses Receiving patient or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible beyond 3 months)", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Rheumatoid Arthritis A patient will be enrolled in this study if he/she fulfills ALL of the following Male or Female patients \u2265 18 years of age with diagnosis of RA Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines Patient is na\u00efve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study Patient has no history of inflammatory arthritis other than rheumatoid arthritis Patient has no history of lymphoma or leukemia or other malignancies Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression Susceptibility to infections including TB, as judged by the investigator Patient is carrier of Hepatitis B virus Patient is a pregnant or lactating female at the time of screening", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 50.0-999.0, All Polymyalgia Rheumatica Males or females, 50 years of age or older who provided written informed consent Females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner) Subjects newly diagnosed with polymyalgia rheumatica and previously untreated with glucocorticoids for PMR. The diagnosis of polymyalgia rheumatica must be confirmed by all of the following New onset bilateral shoulder pain or new onset bilateral shoulder and hip girdle pain PMR VAS score over the last 24 hours before the Screening Visit \u2265 50 (on a 0 scale) Morning stiffness duration of \u2265 45 min on the day before the Screening Visit Acute phase response shown by elevated C-reactive protein (CRP; \u2265 2 times ULN) Subjects willing and able to participate in all aspects of the study and comply with the use of study medication Females who are pregnant (positive \u03b2-hCG test) or lactating Subjects with any contraindication/history of hypersensitivity to predniso(lo)ne or other ingredients Significant renal impairment (serume creatinine > 150 \u00b5mol/L) Significant hepatic impairment (ALT, AST and GGT > 2.5 ULN) Subjects suffering from another disease which requires glucocorticosteroid treatment. Topical glucocorticosteroids, e.g. intra-nasal or inhaled glucocorticosteroids are allowed but should be kept at a stable dose throughout the study Continued use of systemic glucocorticoids within 4 weeks prior to the Screening Visit Joint injections with glucocorticoids within 6 weeks prior to the Screening Visit Subjects who require treatment with non-permitted concomitant therapies Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease at the time of screening, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results Active alcohol or drug abuse", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-75.0, All Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis Patient 18-75 years of age, inclusive Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis collagen disorders and/or avascular necrosis of the femoral condyle post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy moderate valgus, varus, or flexion deformities the salvage of previously failed surgical attempts that did not partial or total knee arthroplasty of the ipsilateral knee Patient has participated in a study-related Informed Consent process Patient is willing and able to complete scheduled study procedures and follow-up evaluations Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling Patient is currently participating in any other surgical intervention studies or pain management studies Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint Insufficient bone stock on femoral or tibial surfaces Skeletal immaturity Neuropathic arthropathy Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb Stable, painless arthrodesis in a satisfactory functional position Severe instability secondary to the absence of collateral ligament integrity Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin Patient has a known or suspected sensitivity or allergy to one or more of the implant materials", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 5.0-17.0, All Acute Rheumatic Fever For the study subjects, diagnosis of ARF was made according to the Modified Jones (4) and appropriate treatment was started. Patients were divided into three groups by clinical findings. Group 1 included patients with only chorea, while patients with arthritis and carditis were involved in Group 2 and patients with only carditis were included in the Group 3. A group with only arthritis was not established since the patients with isolated arthritis are usually followed up at primary and secondary healthcare facilities rather than referring those patients to our tertiary healthcare center ", "label": "2"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 21.0-99.0, All Joint Pain Breast Cancer Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks Experiencing more than mild joint pain/symptoms or older have permission from physician to engage in moderate intensity physical activity Undergoing chemotherapy and/or radiation therapy at any time during the study period Scheduled for major surgery during the study period Presently engaged in high levels of physical activity on a daily basis Less than 21 years of age Unable to walk or engage in moderate intensity physical activity", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 0.0-999.0, All Degenerative Joint Disease The following diagnostic for patient selection are to be used Patients will need to have a history of chronic pain (at least 3 months) refractory to conservative therapy with non-steroidal anti-inflammatory medications, muscle relaxants, diet modifications and splint therapy Patients will also need to have imaging findings (radiography or magnetic resonance imaging) that show mild to severe degenerative changes of the temporomandibular joint will Patients with systemic disorders such as rheumatic diseases, hematologic diseases, active infections, immunosuppression Patients receiving therapy with anticoagulants", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-75.0, All Rheumatoid Arthritis Age 18 Patients with Rheumatoid Arthritis undergoing primary total hip replacement surgery Satisfy American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) 2010 classification and/or the 1987 RA (see below) and be diagnosed with RA Diagnosis of any other systemic rheumatic disease Diagnosis of or crystalline arthropathy Unable to understand or read English Unable to follow the study protocol in a reliable manner Age < 18 or >75", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 5.0-999.0, All Rheumatic Heart Disease Clinical and echocardiographic signs of RHD using WHF Congenital heart disease", "label": "1"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-85.0, All Cardiovascular Diseases For the group 1 and 2 Men having an age ranging between 18 and 35 years Unhurt subject of any acute pathology for more than 7 days Consent signed by the subject Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg) or any cardiovascular history Subject presenting a known renal insufficiency Subject presenting a known anaemia (Hb < 12g/dl) Subject presenting a known diabetes Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer Subject presenting a chronic liver disease Subject presenting a connectivite: Rhumatoid polyarthritis Crohns disease Current tuberculosis Any medicinal treatment", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 0.0-999.0, All Osteoarthritis of Hip Congenital Hip Dysplasia Avascular Necrosis Patients scheduled for primary, unilateral total hip replacement (THR) with no previous history of hip replacement and/or fracture surgery Patients with arthritis secondary Noninflammatory Degenerative Joint Diseases (NIDJD), including osteo/degenerative arthritis, congenital hip dysplasia, and avascular necrosis Patients who do not meet any of the Patients with previous fusions, acute femoral neck fractures, above knee amputations, or previous total knee replacement Patients who had previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device Patients with neuropathic joints Patients who required structural bone grafts Patients with an ipsilateral girdlestone Patients who otherwise met the study but for which appropriate clinical follow-up data is not available (i.e. patients deceased prior to 2-year follow-up, patients refused to return for follow-up)", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 5.0-999.0, All Rheumatic Heart Disease Mitral Stenosis Cases Diagnosis of rheumatic heart disease based on one of World Heart Federation definite echocardiographic World Heart Federation borderline echocardiographic and history of acute rheumatic fever Mitral stenosis with valve area less than 2.0 cm2 Previous surgery for rheumatic heart disease Age less than five years Inability to give consent New Controls Healthy individual living in a community where cases were identified Past medical history or systems suggestive of rheumatic heart disease, acute rheumatic fever or other valvular heart disease Age less than five years Inability to give consent", "label": "1"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 5.0-17.0, All Juvenile Idiopathic Arthritis Diagnosis of JIA (ILAR classification) Age 5 to 17 years Ability to speak/read French or English; one caregiver per child will be recruited Presence of pain, defined as: pain reported by the child and/or caregiver, and/or joint tenderness and/or stress pain in at least 1 joint during physical examination performed by rheumatologist. Pain reported by the child/caregiver is not a prerequisite because some children develop behaviors and guarding postures to avoid pain Absence of anticipated change in treatment. If, during the study, a change in treatment is necessary, the change will be recorded but the child will not be withdrawn Stable dosages of medications and absence of intra-articular corticosteroid injections for 4 weeks prior to enrolment confirmed by child's rheumatologist No current MT Systemic arthritis with quotidian fevers Acute infection Open skin lesion Fibromyalgia Sleep apnea Medications: anticoagulants, muscle relaxants, analgesic medications (acetaminophen allowed) Pregnancy", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-50.0, All Patellofemoral Pain Syndrome Age between fifteen and thirty-five years Presenting unilateral PFPS with six months of evolution Presenting anterior or retro knee pain that presents itself when undergoing two or more of the following activities (squatting, running,kneeling, jumping,climbing stairs,physically active patients, with at least thirty minutes of physical activity at least three times per week.) Patients with previous knee surgeries Chronic pain with more than one year of evolution Pregnancy or suspected pregnancy Application of intra-articular steroids in the three months prior to their evaluation Patients with meniscal injuries Ligament or intra-articular knee structures Degenerative diseases such as diabetes Rheumatoid arthritis OA of the knee, hip or ankle History of dislocation or subluxation of patella", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 5.0-16.0, All Rheumatic Heart Disease Acute Rheumatic Fever Schoolchildren aged 5 to 15 years Written informed consent ", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 6.0-16.0, All Rheumatic Fever Rheumatic heart disease with recommended strep prophylaxis less than one year from first diagnosis refusal to take the tablets", "label": "1"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Arthritis Vasculitis Healthy volunteer or Recent diagnosis of rheumatoid arthritis within 1 month or New diagnosis of giant cell arteritis within 1 month or New diagnosis of anti-neutrophil cytoplasm antibody associated vasculitis within 1 month or Flare of anti-neutrophil cytoplasm antibody associated vasculitis within one month Unable to provide written informed consent", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 25.0-40.0, All Theca Lutein Cyst of Left Ovary Criteria:Sub-fertile women with confirmed diagnosis of pelvic endometriosis women with Pelvic inflammatory disorders and other forms of benign cysts", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-50.0, All Healthy Male and female healthy adults ages 18 to 50 years inclusive Good general health as determined by screening evaluation no greater than 42 days before the first immunization For women of childbearing age, use of adequate birth control from enrollment until 180 days after the last injection Written informed consent, after reading the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee Presence of any febrile illness or any known or suspected acute illness on the day of any first immunization Any chronic illness, whether or not active treatment is required Any immunodeficiency (congenital or acquired) Any history of cardiac pathology (acquired or severe/persistent congenital) Any history of congenital malformation syndromes associated with congenital heart disease (syndrome complexes, e.g. VATER association; chromosomal disorders, e.g. Down's Syndrome; teratogenic agents, e.g. fetal alcohol syndrome; others, e.g. Noonan's) Any history of clinical manifestations of auto-immune or systemic diseases (inflammatory disorders, e.g. JRA, SLE, Kawasaki disease; inborn errors of metabolism, e.g. Fabry; connective tissue disorders, e.g. Marfan syndrome; neuromuscular disorders, e.g. Friedreich ataxia; endocrine-metabolic disorders, e.g. hypothyroidism; hematologic disorders, e.g. sickle cell anemia) Any history of acute rheumatic fever (ARF), post-streptococcal glomerulonephritis (PSGN), undiagnosed acute self-limiting polyarthritis (swelling, heat, redness or tenderness or pain and limitation of motion in >2 joints), or chorea (purposeless, involuntary rapid movements of the trunk and/or extremities) Any previous echocardiogram suggestive of cardiac pathology Any immediate family history (parents, siblings) of ARF, PSGN, self-limiting polyarthritis, chorea, or a collagen-vascular disease such as Lupus or Sj\u00f6gren's syndrome Receipt of systemic glucocorticoids (a dose \u2265 20 mg/day prednisone or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within six months", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Pancreatic Cancer Histological documentation of primary adenocarcinoma of the pancreas Surgically eligible for tumor resection with curative intent Age \u226518 years ECOG PS 0 or 1 Adequate bone marrow function (ANC \u22651,500; Hgb >9; Plt >100) Adequate renal function (Cr <1.5 ULN) Total bilirubin \u22641.5 x ULN; and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN (values post biliary stenting allowed for eligibility) Signed, written informed consent Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms. In addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded Patients with M1 disease or a history of M1 disease Patients with any type of recurrent pancreatic adenocarcinoma Prior therapy such as chemotherapy or radiation therapy or anti-tumor experimental therapy for pancreatic cancer Previous treatment with any other compound that targets CD40 Concurrent treatment with any anticancer agent outside of this protocol Prior allogeneic bone marrow transplant History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sj\u00f6rgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis,. (Vitiligo is allowed) History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure History of deep venous thrombosis or migratory thrombophlebitis (Trousseau)", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 2.0-17.0, All Juvenile Idiopathic Arthritis Male or female aged 2 to <18 years. *IMPORTANT NOTE * Initial enrollment in the study will be limited to subjects \u22656 years of age and subjects weighing \u226515 kg. Following enrollment and PK analysis of subjects to <6 years of age with JIA in the ongoing Phase 1 PK study (A3921103), enrollment will be opened to this age group. The Sponsor will notify investigator sites when it is permissible to enroll subjects 2 to <6 years of age, as well as the corresponding dosage for this age group Must meet International League Against Rheumatism (ILAR) JIA diagnostic for one of the following categories with active disease for at least 6 weeks Extended oligoarthritis Polyarthritis (RF+) Polyarthritis (RF) Systemic JIA with active arthritis but without active systemic features in the prior 6 months and at the time of enrollment Psoriatic arthritis Enthesitis related arthritis. Subjects with polyarticular course JIA (ie, extended oligoarthritis, polyarthritis RF+, polyarthritis RF, systemic JIA with active arthritis but without active systemic features) must have a minimum of 5 active joints (an active joint is defined as a joint with swelling or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness) at baseline to be eligible for study entry Subjects with psoriatic or enthesitis related arthritis must have a minimum of 3 active joints (an active joint is defined as a tender/painful and/or swollen joint) at baseline to be eligible for study entry Treatment with stable doses of Non Steroidal Anti inflammatory Drugs (NSAIDs), oral glucocorticoids (at a maximum dose of 0.2 mg of prednisone equivalent per kilogram per day or 10 mg per day for 2 weeks before baseline, whichever is lower), or methotrexate (10 mg and 20 mg per square meter of body surface area for 3 months before baseline) are permitted Subjects with any of the following characteristics/conditions will not be included in the study Previous JIA treatment with tofacitinib Systemic JIA (sJIA) with active systemic features (including subjects with characteristic sJIA fever and rash or serositis within 6 months of enrollment) Persistent oligoarthritis Undifferentiated JIA Infections Latent or active tuberculosis (TB), or any history of TB Chronic infections Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug Any treated infections within 2 weeks of Baseline visit", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 45.0-999.0, All Osteoarthritis, Knee Osteoarthritis, Hip years of age or older McMaster employee Sedentary job (stand or walk for <1/3 of work day) Able to safely climb two flights of stairs Hip pain Hip pain during internal rotation and hip flexion Knee pain Less than 30 minutes of morning stiffness in the knee Crepitus in the knee with active range of motion Bony enlargement around the knee Any other forms of arthritis Osteoporosis-related fracture History of patellofemoral symptoms Active non-arthritic hip or knee disease Hip or knee surgery Use of cane or walking aid Unstable heart condition Neurological conditions Hip, knee or ankle injuries in past 3 months Physician-advised restriction to physical activity", "label": "0"} +{"topic": "A 31-year-old woman with no previous medical problems comes to the emergency room with a history of 2 weeks of joint pain and fatigue. Initially she had right ankle swelling and difficulty standing up and walking, all of which resolved after a few days. For the past several days she has had pain, swelling and stiffness in her knees, hips and right elbow. She also reports intermittent fevers ranging from 38.2 to 39.4 degrees Celsius and chest pain.", "doc": "eligible ages (years): 18.0-999.0, All Psoriatic Arthritis Must have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist according to ClASsification for Psoriatic Arthritis (CASPAR) Must be starting or any approved tumor necrosis factor alpha inhibitor (TNFi) (including TNFi biosimilars) as a first, second or third line of biologic disease-modifying antirheumatic drug (bDMARD) therapy for PsA at the time of enrollment into the observational study or within a maximum 1-month window after the baseline visit Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements Participant is starting or a TNFi therapy as fourth or further line of biologic treatment Participant is unwilling or unable to participate in long-term data collection Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point Participant is currently enrolled in an interventional study", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-60.0, All Heart Diseases Obesity Vascular Diseases Men and women, ages 18 to 60. Body weight was 130 to 180 percent of ideal body weight ", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 17.0-999.0, All Liver Cancer Histologically confirmed primary hepatocellular carcinoma (HCC) Completely resected disease with clear margins No residual disease by postoperative CT scan No metastatic disease Age and over Performance status Karnofsky 60-100% Life expectancy Not specified ", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Recurrent Thyroid Cancer Stage IVA Follicular Thyroid Cancer Stage IVA Papillary Thyroid Cancer Stage IVB Follicular Thyroid Cancer Stage IVB Papillary Thyroid Cancer Stage IVC Follicular Thyroid Cancer Stage IVC Papillary Thyroid Cancer Histologically confirmed papillary thyroid or follicular thyroid carcinoma Differentiated disease Metastatic disease documented by ultrasound, computed tomography (CT) scan (without iodinated contrast), or MRI All metastatic disease foci =< 10 mm in all dimensions Must have been treated with total or near-total thyroidectomy AND at least 1 course of iodine I 131 (131I)(>=29.9 mCi) OR demonstrated negative uptake on a postoperative low-dose131I scan Must have undergone whole body 131I scan 1-3 days after administration of =< 5.5 mCi of 131I demonstrating no visible iodine uptake within the lesions unless demonstrated negative uptake on a postoperative low-dose131I scan within the past 12 weeks Must have 24-hour urine iodine excretion =< 500 mcg within 1 week of 131I scan Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level =< 0.5 mU/L No known brain metastases Performance status ", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Thyroid Neoplasms Total or near total thyroidectomy performed for papillary or follicular thyroid cancer R0-1 resection, no macroscopic cancer left behind at surgery Physically and emotionally able to undergo radioiodine treatment A written informed consent Pregnancy Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Benign Nontoxic and Toxic Goiter Graves' Disease Healthy volunteers with an intact thyroid gland Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography Patients with toxic nodular goiter Patients with Graves' disease Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion) Prior 131I treatment Alcohol, medicine or drug abuse Pregnancy or lactation No safe contraception Participation in another clinical trial Allergic reaction towards rhTSH Fine needle biopsy without valid diagnostic for benign disease Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin Incontinence", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Graves\u00b4 Disease Thyroid Associated Ophthalmopathy Graves\u00b4 disease Adequate anticonception in women Performance status >2 Previous rituximab treatment Immunosuppressive treatment Serious concomitant disease Active infections Pregnancy / breast feeding", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-85.0, All Toxic Nodular Goitre Graves' Disease Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves' disease or toxic nodular goiter Age < 18 yrs Allergy to anti-thyroid drugs Substernal or large (> 100ml) goiter Severe endocrine ophthalmopathy Pregnancy or lactation Suspicion of thyroid malignancy Unsafe contra-conception Physical or mental condition that hinders corporation", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-85.0, All Toxic Nodular Goitre Graves Disease Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves\u2019 disease or toxic nodular goiter Age < 18 yrs Allergy to anti-thyroid drugs Substernal or large (> 100ml) goiter Severe endocrine ophthalmopathy Pregnancy or lactation Suspicion of thyroid malignancy Unsafe contraconception Physical or mental condition that hinders corporation", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-40.0, All Obesity healthy males Normal weigh, e.i. BMI between 18,5-25 kg/m2 age 18-40 years donation of blood 3 monhts prior or during the study gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease smoking consumption of more than 21 alcoholic drinks/week elite athletes on mediation diet supplements", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 40.0-65.0, All Obesity BMI greater than 30 African American 46 years old bariatric surgery within the previous 5 years", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 21.0-60.0, All Graves Ophthalmopathy Confirmed TED (as defined by Bartley and Gorman19) Eyelid retraction (upper eyelid margin at or above the superior corneoscleral limbus in primary gaze without frontalis muscle contraction) in association with any one of the following Thyroid dysfunction or abnormal regulation (increased serum thyroxine or triiodothyronine level, decreased serum thyroid stimulating hormone level, absence of thyroid radioiodine uptake suppression after administration of triiodothyronine, or the presence of thyroid stimulating immunoglobulins in serum) Exophthalmos (Hertel measurement of at least 20mm) Extraocular muscle involvement (restrictive myopathy or objective evidence of enlarged muscles) Optic nerve dysfunction (abnormal visual acuity, colour vision, pupillary reaction or perimetry not attributable to other causes) Thyroid dysfunction or abnormal regulation in association with any one of the following -Exophthalmos Extraocular muscle involvement Optic nerve dysfunction Previous treatment for TED Oral steroids (e.g. immunosuppressive dose) for last 3 months, radiotherapy Intravenous pulsed steroid or methrotrexate therapy Medically unfit to receive I/V high-dose pulsed methylprednisolone or methotrexate History of cardiac arrthymias, recent acute myocardial infarction History of seizure History of acute bleeding peptic ulcer History of pulmonary tuberculosis, Hepatitis B carrier, Hepatitis C positivity, HIV Uncontrolled diabetes or hypertension (to be eligible for the trial, random blood glucose must be < 11.1 mmol/L and blood pressure must be 140/90 or lower#. If above these limits, patients can be treated and reviewed at 2 weeks for enrolment when are met provided the patient does not have optic neuropathy)", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-85.0, All Aging Balance Sleep Males and females Aged 18 to 35, or 60 to 85 Lived at Denver altitude or higher for at least one year Stable treated diseases: thyroid dysfunction (including hypothyroidism and hyperthyroidism), hypertension, hypercholesterolemia, urinary incontinence, prostate enlargement, gastroesophageal reflux disease, irritable bowel syndrome Aged 36 to 59, under 18, or over 85 BMI less than 18.6 or greater than 30 kg/m2, women below 95 pounds regardless of BMI Sleep duration is less than 5 or more than 9 hours Sensitivity to sleeping medications Night work in the preceding 6 months Transmeridian travel (across more than 2 time zones) in the last 1 month Bone mineral density DXA T-score of less than -1.75 Orthostatic intolerance Prior history of falls in past year Prior history of injurious fall in past 5 years", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 0.0-999.0, All Thyroid Neoplasms Thyroid Nodules Graves Disease Goiter Patients underwent thyroidectomy in Srinagarind hospital, Khonkaen University Patients with cervical lymph nodes metastases requiring neck dissection Patients that tissue pathology shown anaplastic carcinoma Patients with clinical or laboratory indicators of coagulation disorders", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Carcinoma, Islet Cell Carcinoma, Pancreas Well-differentiated advanced/metastatic pancreatic islet cell tumor Tumor has shown progression within the past year Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues Prior treatment with any tyrosine kinase inhibitors or anti-VEGF[Vascular endothelial growth factor] angiogenic inhibitors Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 14.0-61.0, All Graves Disease Graves disease Anticoagulant usage Previous thyroid operation Refused to participate in this study", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-75.0, All Subclinical Hypothyroidism Hyperthyroidism Thyroid Dysfunction patients with subclinical hypothyroidism or hyperthyroidism patients with thyroid nodules and normal thyroid function patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone patients who had thyroid surgery or radioiodine therapy patients with NYHA class 3 or 4 heart failure", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 0.0-999.0, All Thyroid Cancer histologically confirmed differentiated thyroid cancer status after total thyroidectomy status after subsequent high-dose radioiodine treatment regular follow-up by a board-certified dentist a minimum follow-up of 1 year after radioiodine therapy anaplastic thyroid cancer", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-50.0, All Obesity healthy meals BMI 24-31 kg/m2 age between 18-50 years hemoglobin >8 mmol/L donation of blood 6 months before and under the study milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease use of dietary supplements 3 months before and under the study smoking elite athletes use of medication", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 0.0-999.0, All Hyperthyroidism Cardiovascular Diseases Atrial Fibrillation Patients: Radioiodine treatment for hyperthyroidism given in the Tampere University Hospital between January 1969 and June 2002 Controls: age and gender-matched control subject identified for each patient from the Population Register Centre. The control subject had to be alive at the time when the patient received the first RAI treatment ", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 20.0-999.0, All Neoplasms, Gastrointestinal Tract Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject is provided in the Investigator's Brochure (IB) Pilot Part Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following Signed informed consent Male or female; \u2265 20 years (at the time of giving consent) Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of \u226550% required if normal range of LVEF is not provided by institution) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Able to swallow and retain oral medication Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study Subjects meeting any of the following must not be enrolled in the study Pregnant or lactating female at anytime during the study Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2) Peripheral neuropathy of Grade 2 or greater Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety Life threatening infection Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Advanced Cancer Anorexia Weight Loss Insomnia Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS Patients > 18 years of age Karnofsky Performance score of > 40 at time of into study Ability to provide informed consent and comply with study procedures Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/ days), 8 (+/ days), 16 ( +/ days), and 22 (+/ days) and return to outpatient clinic for evaluation on days 15 (+/ days), and 29 (+/ Patients who have known dementia or delirium at time of enrollment as determined by a physician Known hypersensitivity to any ingredient of Mirtazapine Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting Ongoing use of tube feeding or parenteral nutrition Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment Pregnancy or lactation or unwillingness to use contraceptives A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of > 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation Patients on chronic use of benzodiazepines are excluded", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 2.0-999.0, All Graves' Disease Graves' disease patients ", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-65.0, All Stroke Immobilization Myofacial Pain Hyperthyroid Myopathy Normals Healthy individuals Stroke a first stroke (i.e., a unilateral, ischemic hemispheric stroke) within the previous one to two months, ability to cooperate and follow simple commands, and gastrocsoleous strength in the affected lower extremity of between trace and 50% of normal Immobilization immobilized in a cast (typically 6 weeks) following sugical repair of a severe Achilles tendon tear or rupture, ankle injury or plantar fascial pain Myofascial Pain history of pain in trapezius confirmed by clincal examination. The examiner will perform snapping palpation over the MFTP. If a localized, transient contraction is observed, the response is considered to be positive and the subject will be considered eligible for entry into the study Hyperthyroid Myopathy clinical assessment in combination with a serum hormone profile of increased Free Thyroxine (FT4) and Triiodothyronine (T3) in the face of suppressed levels of Thyroid Stimulating Hormone (TSH) ", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-75.0, All Dyslipidemia Signed informed consent Males or females aged 18 to 75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfil the following Non-nursing and non-pregnant 12 months prior to enrolment Not of child bearing potential ie, either documented irreversible surgically sterile (bilateral oophorectomy or hysterectomy is acceptable, but not tubal ligation) or post-menopausal. Post-menopausal is defined as serum follicle-stimulating hormone (FSH) levels in the post-menopausal range combined with amenorrhea for more than 1 year in a woman above 50 years of age, or amenorrhea for more than 2 years below 50 years of age Patients with hypercholesterolemia treated with stable doses of the below listed lipid lowering medication for at least 3 months prior to randomization Atorvastatin not more than 20 mg/day or Simvastatin not more than 40 mg/day LDL-cholesterol > 3.0 mmol/L (Week -1) Subject able and willing to comply with all study requirements At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study Cholesterol lowering agents other than the defined statins History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator Chronic (> 3 months) pain condition requiring daily medication with pain killers Glycosylated haemoglobin (HbA1c) > 7.0% Diabetes requiring medication other than metformin Clinically abnormal physical findings and laboratory values as judged by the investigator and abnormal resting ECG, eg, QTc interval > 450 msec Body Mass Index of \u2265 40 kg/m2 Resent history (< 3 month) of stroke or transient ischemic attacks History of seizure disorder, except febrile convulsions", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Turner Syndrome Turner syndrome verified by karyotyping untreated hypothyroidism or hyperthyroidism present or past malignant diseases clinical liver disease treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids)", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 20.0-60.0, All Graves Disease Patients with newly diagnosed hyperthyroid Graves' disease If the patient had been treated previously diabetes, kidney, or liver disease", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-60.0, All Electric Stimulation Therapy Obesity Weight Loss Eating BMI greater than or equal to 30 kg/m(2) Age 18-60 years. Women who are post-menopausal will be excluded from the study due to changes in their metabolism that could affect weight loss. We will set the cutoff at age 60 so that the age difference between the men and women is not too great for analysis purposes. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules. Additionally, while the risks of TDCS are minimal, there haven t been studies showing how TDCS might affect the growing brain Healthy, as determined by medical history, physical examination, and laboratory tests Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only in right-handed individuals) Weight stable (plus or minus 5 percent) for last 3 months Weight less than 350 lbs, as this is the weight limit of the DXA machine Type 2 diabetes (according to the World Health Organization diagnostic criteria) Endocrine disorders (Cushing s disease, pituitary disorders, and hypo and hyperthyroidism) Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for 1 week before study entry) Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease) Hypertension (blood pressure measurement higher than 140/90 mmHg on 2 or more occasions or use of anti-hypertensive medications) Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g. Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 1.5 times normal) Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or overt proteinuria)", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-85.0, All Healthy Body mass index (BMI) < 30 kg/m2 Age 18-45 yr; or Age 65-85 yr Those taking medications known to affect substrate metabolism or medications that may confound the findings from our study (synthetic steroids, glucocorticoids etc.) Those with evidence of significant organ system dysfunction (e.g. diabetes mellitis, cirrhosis, hypo or hyperthyroidism; hypertension) Body mass index > 30 kg/m2 Age <18 yr, 45-65 yr or > 85 yr Those performing >1.5h of exercise/wk", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Graves Disease Hyperthyroidism Graves hyperthyroidism in remission after ATD Age < 18, severe concomitant disease", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-85.0, All Helicobacter Pylori Infected Patients Thyroid Cancer Patients Hyperthyroidism Adult patients between the ages of 18 and 80 Patients with diagnosed thyroid disease referred for thyroid scan or treatment with radioactive iodine (131I) Patients who provide informed consent Patients without diagnosed thyroid disease Patients who are pregnant or breast feeding Patients who have received previous treatment for H. pylori infection Patients taking proton pump inhibitors Patients with recent or current use of antibiotics Patients allergic to iodine (131I)", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-80.0, All Atrial Fibrillation Heart Failure Age \u2265 18 years, < 80years NYHA II-IV symptoms Impairment of left ventricular systolic function (left ventricular ejection fraction estimated as \u2264 35% by radionuclide ventriculography) Documented AF lasting for at least 7 days (persistent or permanent AF) CRT or ICD device implanted in the previous 6 months AV nodal ablation within previous 3 months Prior AV nodal ablation or complete heart block with a single chamber pacemaker Contraindication to anticoagulation Persistent thrombus in the left atrium despite anticoagulation Active malignancy Cerebrovascular accident within the previous 6 months Reversible causes of AF including thyroid disorders, alcohol, recent surgery Reversible causes of heart failure including acute myocarditis or alcohol Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Graves Disease Hyperthyroidism Adult patients with a clinical diagnosis of Graves Disease Patients who have selected surgical resection as treatment of their Graves Disease Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid Patients deemed unfit for surgery by operating surgeon or anesthesist Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-65.0, All Goiter Criterion a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes multinodular goiter involving posterior aspect/s of thyroid lobe/s suspicion of thyroid cancer previous thyroid surgery thyroiditis subclinical or clinically overt hypothyroidism or hyperthyroidism pregnancy or lactation age < 18 years or > 65 years ASA 4 grade (American Society of Anesthesiology) inability to comply with the follow-up protocol", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Thyroid Cancer for patient participants Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi [subtotal] with completion thyroidectomy)on or after September 1, 2009 Age at time of first thyroid cancer surgery must be at least 18 years or older The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report) Must be able to communicate in spoken and written English Must be able to use a computer Must be able to provide informed consent on one's own (without any need for translation) for patient participants Participants not meeting Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma Prior radioactive treatment for thyroid cancer Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study for the physician feedback component of this study Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-85.0, All Multinodular Goitre Grave's Disease Thyroid Nodule multinodular goiter Grave's disease thyroid nodule thyroid carcinoma reoperative surgery", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Thyroid Neoplasm Advanced/poorly differentiated thyroid cancers of follicular cell origin that have no uptake (less than 1%) on radioiodine scan or are unresponsive to radioiodine therapy. Unresponsiveness to radioiodine therapy is defined as a patient s thyroglobulin not falling to less than 2ng/ml within 6 months after previous radioiodine ablative treatment Extensive (invasive) loco-regional tumor mass and/or metastatic spread, rendering patient inoperable Thyroglobulin (Tg) levels greater than or equal to 100 ng/ml in the absence of Tg antibodies. Patients who are Tg-antibody (Tg-Ab) positive may be included despite a lower Tg level if they have detectable disease on cross sectional imaging. (The presence of Tg-Ab may lead to falsely low Tg levels and therefore render the Tg a less sensitive marker of disease. However, Tg-Ab has been shown to also act as a tumor marker, and will be used as an endpoint for the study in patients who are Tg-Ab positive.) Within 18 months of enrollment, patients must have had an RAI scan, showing no or therapeutically insignificant RAI uptake (less than or equal to 1%) Initial therapy must have included total/near-total thyroidectomy and RAI ablation therapy Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions Greater than or equal to 18 years of age Must be able to understand and sign the Informed Consent Document Clinical performance status of ECOG less than or equal to 1 Life expectancy of greater than three months Allergy to valproic acid Current coexisting malignancy other than basal cell carcinoma Women of child-bearing potential who are pregnant or breastfeeding Valproic acid is a known teratogen, causing primary neural tube defects, facial abnormalities, and skeletal malformation; therefore pregnant women will be excluded. Additionally, patients that become pregnant while on study protocol will be discontinued immediately Active systemic infections, coagulation disorders or other major medical illnesses Patients taking tolbutamide, warfarin, zidovudine, benzodiazapines, clonazepam, diazepam Seizure disorder", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 16.0-60.0, All Graves' Disease Graves' disease patients. Healthy people Pregnancy. <16 years old or > 60 years old", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 8.0-90.0, All Hypothyroidism Exophthalmos a typical clinical symptoms of Graves disease, diffuse goiter, eye signs (including exophthalmos), thyroid function (FT3, FT4, rTSH) and thyroid autoantibodies and imaging examinations to confirmed treatment contraindications, those who have not signed the informed consent, failure to complete treatment and follow-up estimates of patients and patients not suitable for radionuclide therapy", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 15.0-85.0, All Thyrotoxicosis Peak Systolic Velocity of Superior Thyroid Artery Thyroiditis Graves Disease newly diagnosed without taking any antithyroid drug or beta receptor blocker with TSH level below the lower limits of reference range is willing to be enrolled unwilling taking antithyroid drug or beta receptor blocker taking foods or medicine rich in iodine in 8 weeks women with pregnant or lactation", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-55.0, All QoL Before and After 9 Month of Medical Treatment of Graves\u00b4Thyrotoxicosis Potential Effect of Selenium New diagnose of autoimmune thyrotoxicosis biochemically proven with increased thyroxin low TSH and elevated TRAb/or positive scintigraphy Age 18 Willing to participate - No previous head trauma No difficulties with swedish language No medication which could affective neuropsychological testing No planned or ongoing pregnancies Normal intellectual capacity No severe ophthalmopathy, or other severe disease", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 20.0-64.0, All Irritable Bowel Syndrome Patients meeting the Rome III Diagnostic Loose (mushy) or watery stools within the last 3 months Abdominal discomfort and/or pain during their non-menstrual period Patients with a history of surgical resection of the stomach, small intestine or large intestine Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative) Patients with a history or current diagnosis of colitis ischemic Patients with a current diagnosis of enteritis infectious Patients with a current diagnosis of hyperthyroidism or hypothyroidism Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study Patients with a history or current diagnosis of malignant tumor Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-40.0, All Healthy Middle-aged Subjects Age Range Was 18 to 31 Years Caucasian Whites Males and Females healthy middle-aged subjects volunteers with systemic or ocular diseases", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 40.0-69.0, All Overweight and Obese by BMI women aged 40-69 overweight or Class I & II obese (BMI 28 to 39.9)or BMI 40 to 45 with physician clearance state a commitment to losing weight speak and read English able to communicate over the telephone able to use a computer with minimal assistance and complete electronic forms and surveys have access to and are able to access the Internet commitment to access the website as required by the research intervention including weekly self-reporting of calories and fat grams, weekly self-reporting of physical activity, pedometer steps, and body weight, and weekly (or more often) participation in other website components as determined by group to which randomized and phase of intervention have or are willing to obtain an email account have access to a DVD player diagnosed with Type 1 diabetes diagnosed with Type 2 diabetes and require insulin \u2265 10% weight loss in last six months enrolled in a weight loss management program enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation taking medications that affect weight loss or weight gain other physical or medical restrictions that would preclude following the minimum recommendations for moderate physical activity and healthy eating", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-85.0, All Thyroid Nodule Goiter Thyroiditis Graves Disease The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 12 months of follow-up The patient is a candidate for total thyroidectomy because of a nodular pathology, a diffuse goiter, thyroiditis, or Basedow's disease Patient has calcitoninemia < 9 ng/pl Patient has normal calcemia Patient has PTH level between 5 ng/l and 75 ng/l The subject has a normal laryngeal mobility The patient is participating in another study The patient is in an period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant The patient is breastfeeding The patient is not available for 12 months of follow-up Subject has a preoperative diagnosis of cancer on fine needle aspiration biopsy of the thyroid or cervical lymph node Lymph node metastasis strongly suspected clinically and/or sonographically", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Graves Ophthalmopathy Clinical diagnosis of Graves Orbitopathy Clinical activity score higher than 2 Must be able to swallow tablets sight-threatening Graves Orbitopathy Diplopia in primary gaze Macrolide allergy or intolerance", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 2.0-16.0, All Paediatric Thyrotoxicosis All patients with thyrotoxicosis aged between 2 and 16 years at the time of diagnosis. Thyrotoxicosis will be diagnosed by the paediatrician on the basis of the clinical picture and the biochemistry (suppressed TSH with high thyroid hormone levels) Child has consented/assented or consent via parent/guardian has been gained prior to any study specific procedures Known toxic adenoma / toxic hyperplasia (germline activating TSHR mutation) McCune Albright Syndrome Previous episodes of Thyrotoxicosis Known allergic response to any of the study medication or ingredients as per SmPC Previous participation in this study", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 23.0-45.0, All Pregnancy Complicated by Hyperthyroidism Hypothyroidism in Pregnancy Autoimmune hyper or hypothyroidism, diagnosed by an endocrinologist, treated, based on clinical and laboratory tests and ultrasound thyroid examination Patients were included if they were seen by gynecologist at Clinic for Gynecology up until 20th week of gestation and not later healthy pregnant women in control group were directed for cordocentesis due to age Any other chronic diseases", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Papillary Thyroid Carcinoma Histologically confirmed papillary thyroid carcinoma, including its variants, such as tall cell PTC or poorly differentiated thyroid carcinoma, that is metastatic or unresectable AND harbors a BRAF V600E mutation Evaluable disease, as defined by at least one lesion that can be accurately measured in at least one dimension on CT scan or ultrasound, if present in the neck Radioiodine-refractory disease Life expectancy > 6 months Able to swallow and retain oral medication Normal organ and marrow function Pregnant or breastfeeding Previous treatment with a specific BRAF or MEK inhibitor Receiving any other study agents Known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to GSK2118436, bovine TSH, mannitol or iodine Active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs History of known glucose-6-phosphate dehyrogenase (G6PD) deficiency Corrected QT interval >/= 480 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; Class II, III, or IV heart failure, abnormal cardiac valve morphology; or history of known cardiac arrhythmias Taking herbal remedies Subjects with significant symptoms from their thyroid cancer, or have a large burden of rapidly progressive iodine-refractory PTC who are in need of other systemic therapy, as judged by their treating physician", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-37.0, All Infertility Obesity Indication for IVF/ICSI for the couple Woman's age >18< 38 years at randomization First, second or third IVF/ICSI treatment BMI > or = 30.0 <35.0 kg/m2 Willing to participate and to sign informed consent Diabetes mellitus treated with insulin Oocyte or sperm donation planned Preimplantation genetic diagnosis (PGD) treatment planned Azoospermia known at randomization Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires) QEWP-R questionnaire indicating binge eating disorder for the woman Previous participation in the study", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Lacrimal Apparatus Disease Thyroid carcinoma Previous thyroidectomy Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic) Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL Lacrimal gland / ocular trauma Radiation therapy for other diseases or radiotherapy of head and neck Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Graves' Hyperthyroidism Age 18 years or older Active Graves' hyperthyroidism (suppressed TSH (< 0.1) and positive TRAb) measured within the last two months prior to the date Written informed consent Major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period Previous treatment with radioactive iodine Current ATD treatment having been received for more than two months Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, cyclophosphamide Allergy towards the components in the selenium and placebo pills Pregnant or breast-feeding women Intake of selenium supplementation above 70 \u00b5g per day (70 \u00b5g corresponds to the amount in a multivitamin tablet) Unable to read and understand Danish Lack of informed consent", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-70.0, All Obesity Major Depressive Disorder Dysthymic Disorder Cardiovascular Disease Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2 Age 18 years old Presence of current major depressive disorder or dysthymic disorder At least 2 CVD risk factors, as characterized by the metabolic syndrome, including Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm) Fasting blood glucose 100 mg/dL Blood pressure 130/85 mm Hg Triglycerides 150 mg/dL Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL) Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.) Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months Weight loss of 5% or more in past 6 months Enrollment in weight reduction program in prior 3 months Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (Note: participants in couples or family counseling will be allowed.) Severe depression or severe impairment of functioning as judged by the assessor or PI Presence of active suicidal ideation Diabetes Alcohol/drug abuse/dependence", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 21.0-65.0, All Overweight and Obesity age 21 to 65 BMI 25 to 45 sleep 7 hours or less most nights use of medications affecting sleep sleep apnea shift work", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-80.0, All Hypothyroidism radioiodine therapy after total thyroidectomy in differentiated thyroid cancer age over 18 kidney failure, liver failure, heart failure infection inflammation autoimmune disease other chronic disease", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 6.0-9.0, All Hyperthyroid A-For the child born to hyperthyroid mother during pregnancy oOld from 6 to 9 years included oAge of gestation between \u226537 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyro\u00efd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age B-For hyperthyroid mother during pregnancy oHyperthyro\u00efd during pregnancy (transitory gestation hyperthyroid or disease of Basedow) oEuthyro\u00efd at the time of the entry in the study C-For the child born to euthyroid mother during pregnancy oOld from 6 to 9 years included oAge of gestation between \u226537 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyro\u00efd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age D-For euthyroid mother during pregnancy Euthyro\u00efd at the time of the entry in the study A-For the child born to hyperthyroid mother during pregnancy Discovered of a thyroid dysfonction at the time of the entry in the study B-For hyperthyroid mother during pregnancy Discovered of a thyroid dysfonction at the time of the entry in the study C-For the child born to euthyroid mother during pregnancy Discovered of a thyroid dysfonction at the time of the entry in the study D-For euthyroid mother during pregnancy oDiscovered of a thyroid dysfonction at the time of the entry in the study oCarrying anti-TPO antibody at the time of the entry in the study", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation Subclinical Hyperthyroidism Atrial fibrillation or AV-nodal reentry tachycardia Fulfills for ablation (severe arrhythmia symptoms; for atrial fibrillation patients, having tried at least one antiarrhythmic agent with poor effect) Admitted for ablation for the first time Has left blood samples for thyroid status (TSH, free T4, free T3) Atrial flutter Overt hyperthyroidism", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-65.0, All Obesity, Morbid volunteers from Central Norway if female: taking oral contraceptives or post-menopausal body mass index 30-45 kg/m2 stable weight (<2kg variation in the last 3 months) not currently dieting to lose weight Pregnancy breast feeding drug or alcohol abuse within the last two years current medication known to affect appetite or induce weight loss enrollment in another obesity treatment program history of psychological disorders history of eating disorders history of diabetes type 1 or 2 gastrointestinal disorders (particular cholelithiasis) kidney -, liver -, lung", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 21.0-75.0, All Focus of Study: Prevent Pulling Sensation and/or Swallowing Difficulty in Patients Received Total Thyroidectomy. Age 21-75 Histological confirmation of differentiated thyroid cancer requiring surgery, symptomatic goiters, thyroid nodules requiring histological analysis, or thyrotoxicosis poorly controlled by medication Undergoing total thyroidectomy Previous neck surgery Previous neck radiotherapy Patients with a known history of keloids Patients with a known history of motility disorders in the upper gastrointestinal tract and preexisting swallowing difficulty Patients with metastatic disease; patients with disease that would require postop radiation therapy, radionuclide iodine therapy and any adjuvant therapies Patients with advanced disease that would require radical or modified neck dissection Patients with lobe larger than 10 cm, or nodule larger than 8 cm which require extensive dissection that may confound the study Patients with connective tissue diseases and chronic diseases on long-term medications that may interfere with wound healings such as steroids", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 20.0-45.0, All Healthy Pharmacokinetics of ASP7991 Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration Body weight: \u226550.0 kg, <80.0 kg BMI: \u226517.6, <26.4 Serum corrected calcium concentration: \u22659.0mg/dL, <10.4 mg/dL Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication A deviation from normal range of 12-lead ECG (QT evaluation) A deviation from the normal range in clinical laboratory tests Highly sensitive cardiac troponin T (at screening): \u22650.014 ng/mL History of drug allergies Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury) Concurrent or previous endocrine disorders (e.g., hyperthyroidism, aberration in growth hormone)", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Graves' Disease Out-patients 18 years of age or over, who have given written informed consent to participate in the study Diagnosed with Graves' disease Received radioiodine for treatment of Graves' disease Had a minimum of 12 months follow-up after RI Most recent RI dose 5 years ago or less at the time of enrollment Patients unable to give informed consent Age 17 years or younger Cause of thyrotoxicosis other than Graves' disease Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 45.0-999.0, All Hypertonia Resistant Hypertension > 140 / > 90mmHg age : 45 + Regular monitoring of blood levels considered pre-medication to lower blood pressure for at least 3 weeks before the preliminary investigation consistent Men and Women derailed diabetes renal impairment , renal creatinine clear <50 ml Non austherapierte cancer / tumor patients Non adjusted thyroid dysfunction BMI> 35 LVEF Stage II", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 25.0-55.0, All Obesity MRI compatibility 55 yrs old 40 BMI weight stable right handed MRI incompatibility left handed", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Other Impaired Renal Function Disorder Normal Renal Function Abnormal Renal Function Renal metastasis", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-85.0, All Hyperthyroidism Hypothyroidism informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder pregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, T-score below -3.5, thyroidea ophthalmopathy with indication for steroids", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 25.0-70.0, All Pre-diabetes Obesity Age 25 years and 55 years Overweight or obesity status BMI>25 kg/m2 Pre-diabetes. The from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal i.e. having: Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l. Due to potential between-lab variation (local assessments), HbA1c is not used as an in the screening Informed consent required Ethnic group No restrictions Based on interview and/or questionnaire, individuals with the following problems will be excluded Medical conditions as known by the subjects: Diabetes mellitus (other than gestational diabetes mellitus); Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease; Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months; Advanced chronic renal impairment; Significant liver disease e.g. cirrhosis (fatty liver disease allowed); Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed); Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption; Previous bariatric surgery; Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program); A recent surgical procedure until after full convalescence (investigators judgement); Transmissible blood-borne diseases e.g. hepatitis B, HIV; Psychiatric illness (e.g. major depression, bipolar disorder) Medication: Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months Personal/Other: Engagement in competitive sports; Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening; Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed; Severe food intolerance expected to interfere with the study; Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women); Use of drugs of abuse within the previous 12 months; Blood donation or transfusion within the past 1 month before baseline or CID's; Self-reported eating disorders; Pregnancy or lactation, including plans to become pregnant within the next 36 months; No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase); Adequate understanding of national language; Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol Laboratory screening: If all of the above are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation ONLY IF the glucose tolerance test meets the entry for the study, the remaining samples are sent to the local laboratory for a safety check, with the following Hemoglobin concentration below local laboratory reference values (i.e. anemia); Creatinine >1.5 times Upper Limit of Normal (local laboratory reference values); Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values); Or any other significant abnormality on these tests which in the investigators opinion may be clinically significant and require further assessment Electrocardiography (ECG). Any abnormality which in the opinion of the investigator might indicate undiagnosed cardiac disease requiring further assessment (e.g. significant conduction disorder, arrhythmia, pathological Q waves). This is done in adults 55-70 years of age After LCD phase (in adults): Failure to reach at least 8% weight reduction during the LCD phase. This leads to from the intervention", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-55.0, All Obesity Diabetes Cardiovascular Disease Aged 18 to 55 years BMI \u2265 25 kg/m2 BMI < 40 kg/m2 and weight \u2264 300 lbs (136 kg) Medical clearance from a primary care provider Plans to matriculate as a student at Framingham State University or work on campus throughout the academic year of enrollment in the study Willingness to eat and drink only the foods and beverages on the study menus during participation, with no food allergies or aversions Willingness to eat in the dining hall Willingness to abstain from consuming alcohol during participation Change in body weight exceeding \u00b110% during prior year Recent adherence to a special diet Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport) Chronic use of any medication or dietary supplement that could affect study outcomes Current smoking (1 cigarette in the last week) Heavy baseline alcohol consumption (> 10 drinks/week) or history of binge drinking (\u2265 5 drinks in 1 day, anytime in past 6 months) Physician diagnosis of a major medical/psychiatric illness or eating disorder Abnormal blood glucose, TSH, CBC, BUN, Creatinine ALT greater than 150% of the normal upper limit Plans for a vacation during the study that would preclude adherence to prescribed diet", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-60.0, All Asthma years of age or older Known Asthma The exacerbation is defined as moderate or severe Not currently enrolled as an active participant in another clinical trial of a medical therapy or device The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy years of age or older Known thyroid disorders Subject where thyrotoxicosis is suspected Known heart disease Heart rate > 140", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-55.0, All Hyponatremia -Triathletes with previous experience in half-ironman -Potential participants (triathletes) with a previous history of muscle disorder, cardiac or kidney disease or those taking medicines or supplements during the two prior weeks were discarded", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Graves' Disease Thyroid Disease Hyperthyroidism Adults \u2265 18 years Diagnosis of Graves Disease Appointment with endocrinologist to discuss treatment options for Graves Disease Major barriers to participate in shared decision making or to providing informed consent (i.e. dementia, severe hearing or visual impairment)", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-65.0, All Obesity Male or Female 65 years old (inclusive) Weigh less than 350 lbs Body mass index (BMI) between 25-43 kg/m2 Willing to fast for 10 hours prior to examination Right handed Diagnosis (by self report) of diabetes Diagnosis (by self report) of neurological condition Current or past alcohol or drug abuse problem Smoking Have internal metal medical devices including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws/clips, metal plates, metal fragments in your eye, or non-removable metal jewelry such as rings Unable or unwilling to complete the imaging procedures for the duration of the MRI scan due to claustrophobia or other reason", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-55.0, All Oxidative Damage Healthy, non-pregnant subjects between 18 and 55 years of age. Apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association http://circ.ahajournals.org/content/97/22/2283/T6.expansion.html Subjects have to achieve a classification of \"local class\" based on age-graded time USA Track & Field. The age-graded time is the finish time adjusted to that of an open division participant using a factor for age and gender. Thus, the times for women and older participants are adjusted downward, while the times for most open division participants (such as 25-year-old men) remain the same. For example, a 55 year old woman has to run 29 minutes 45 seconds or better to be in the study http://www.usatf.org/statistics/calculators/agegrading/ For a man the same age, the equivalent time would be 25 minutes 2 seconds. This is approximately 60% of the speed of the current world record time for that age Subjects who will abstain from taking any nutritional supplements for the duration of the study, including vitamins and mineral supplements (Exception, ferrous sulfate, elemental iron, Vitamin D, Calcium). Subjects will also abstain from taking any over the counter products (herbals, melatonin, St. John's Wort, etc\u2026) for the duration of the study The will be the following Under 18 and over 55 years of age; those who are not apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association Subjects who are not able to run 5-km in the time required for their age and gender Subjects that will continue to take nutritional supplements, including over the counter products, for the duration of the study, including vitamins and mineral supplements (exception: Ferrous sulfate, Elemental iron, Vitamin D, Calcium) Subjects that are taking prescription medications with the exception of birth control Known allergy or sensitivity to milk thistle, Bacopa monnieri, Ashwagandha, turmeric (or ginger), tea, its parts, caffeine, tannins, or members of the Theaceae family", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Hypothyroidism Subclinical Hypothyroidism Hyperthyroidism Subclinical Hyperthyroidism Graves Disease Hashimoto's Thyroiditis Iodine Deficiency Genetic Susceptibility Aged equal or more than 18 years old at the time of sampling Malaysian citizen Respondents who did not give consent", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 0.0-999.0, All Thyroid Goiter Thyroid Carcinoma Multinodular Goiter Graves Diseases Patients affected by benign thyroid disease undergoing thyroidectomy ", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-60.0, All Graves Ophthalmopathy Graves Disease Eye Diseases Thyroid Diseases Endocrine System Diseases Eye Diseases, Hereditary Hyperthyroidism Autoimmune Diseases Immune System Diseases Clinical diagnosis of Graves' Orbitopathy Mild GO According to statemnt, patients with mild GO usually have any one or more of the following\uff1amild soft tissue involvement, exophthalmos\uff1c18mm, temporary, or no diplopia Clinical activity score lower than 3 Being euthyroid for at least 1 month before the date of No previous specific therapy for GO, except for local measures in 1 month before the date of Written informed consent is obtained moderate-sever Graves' Orbitopathy Sight-threatening Graves' Orbitopathy Clinical activity score \u2265 3 Pregnant females as determined by positive (serum or urine) hCG test at screening or prior to dosing, or lactating females Uncontrolled diabetes or hypertension History of mental / psychiatric disorder Hepatic dysfunction (Alb, AST, ALT and Alkaline phosphates levels must be within normal range for eligibility) Renal impairment (Urea and Creatinine levels must be within normal range) Doxycycline allergy or intolerance", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Thyroid Neoplasms Goiter, Nodular Thyroid Nodule Graves' Disease Hyperparathyroidism Patient \u2265 18 years old Surgical indication for parathyroidectomy or thyroidectomy Patients < 18 years old Patient with history of chronic opioid use Patient with chronic pain syndromes Patient with allergy to marcaine", "label": "1"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 20.0-999.0, All Graves Disease Patients with Graves disease ", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-65.0, All Graves' Disease Group A: Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment) definition hyperthyroidism: TSH decreased, FT4 and /or FT3 increased definition Graves': diffusely enlarged thyroid gland either by palpation or echograpy, and/or homogeneous thyroid uptake at scintigraphy, or positive TSHRAb first episode or recurrence of Graves' hyperthyroidism minimal or no eye signs, defined as lid retraction / lid lag but no other signs Planned treatment with antithyroid drugs either titration regimen or block-and-replace regimen for 18 months Group B. Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment) with overt signs of GO as defined by Mild GO: patients whose features of GO have only a minor impact on daily life insufficient to justify immunosuppressive or surgical treatment. They usually have only one or more of the following: minor lid retraction (<2 mm), mild soft tissue involvement, exophthalmos <3 mm above normal for race and gender, transient or no diplopia, and corneal exposure responsive to lubricants) Moderate-to-severe GO: Patients without sight-threatening GO whose eye disease has sufficient impact on daily life to justify the risks of immunosuppression (if active) or surgical intervention (if inactive). Patients with moderate-to-severe GO usually have any one or more of the following: lid retraction R2 mm, moderate or severe soft tissue involvement, exophthalmos >3 mm above normal for race and gender, inconstant, or constant diplopia Sight -threatening GO: Patients with dysthyroid optic neuropathy (DON) and/or corneal Previous or planned treatment with 131I or thyroidectomy (A&B); sight threatening GO requiring decompression (B); drugs interfering with the natural course of GO (A&B): steroids, immunosuppressants, thiazolidinediones, antibiotics / antifungals / antivirals (both topical and systemic for at least 4 weeks prior to recruitment to the study); acute diarrhea illness (gastroenteritis for at least 4 weeks prior to recruitment to the study); Drugs interfering with thyroid function (A&B): amiodarone, lithium, iodine supplements; Drug or alcohol abuse (A&B); no informed consent (A&B); Age less than 18 (A&B); Pregnancy (A&B)", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 3.0-55.0, All Xerostomia Hyperthyroidism Thyroid Cancer Patients who have been treated with radioiodine therapy Patients who have never received radioiodine therapy (negative control group) Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way", "label": "2"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-70.0, All Ophthalmopathy, Thyroid-Associated \u25e6Man or woman between 18-70 years TAO with CAS of \u2265 4 (less than 3 months) Euthyroid for at least 6 weeks Dysthyroid optic neuropathy (DON) Ulcerative Keratitis Previous treatment with steroids for TAO (do not prophylaxis for TAO in connection with radio iodine treatment) Previous Treatment with Rituximab (MabThera\u00ae) Positive Hepatitis B or C serology Receipt of a live vaccine within 4 weeks prior RTX+MTX to randomization History of recurrent significant infection or history of recurrent bacterial infections Patient who may not attend to the protocol according to the investigators opinion Pregnancy or lactation Significant cardiac, including significant or uncontrolled arrhythmia, or pulmonary disease (including obstructive pulmonary disease)", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 8.0-999.0, All Obesity Eating Behaviors Healthy Volunteers Volunteers will qualify if they meet the following criteria Age 8 17 years Weight, height and BMI greater than or equal to 5th percentile for age and sex according to Centers for Disease Control and Prevention 2000 US standard Cognitively capable of completing study procedures (FSIQ greater than or equal to 70) Good general health based on a normal history and physical examination (with the exception of overweight and minor, well-controlled illnesses) Individuals will be excluded (and provided treatment referrals as needed) for the following reasons History of major cardiovascular disease or any other serious obesity-related complication as assessed during history and physical exam. Individuals with untreated or major illnesses relating to the endocrine and/or cardiovascular systems are excluded because these illnesses will likely influence outcomes. Such obesity-related comorbidities hypertension (defined by age sex and height specific standards, and fasting hyperglycemia consistent with diabetes (fasting glucose > 126 mg/dL) Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis Regular use of any medication known to affect body weight or eating behavior (e.g., many medications prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis Current pregnancy or a history of pregnancy. A negative pregnancy test before starting the study will be required for postmenarcheal girls Current and regular use of tobacco products and/or alcohol", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Poorly Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Stage IVA Thyroid Gland Follicular Carcinoma Stage IVA Thyroid Gland Papillary Carcinoma Stage IVB Thyroid Gland Follicular Carcinoma Stage IVB Thyroid Gland Papillary Carcinoma Stage IVC Thyroid Gland Follicular Carcinoma Stage IVC Thyroid Gland Papillary Carcinoma Histological or cytological confirmation of thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); note: medullary and anaplastic thyroid cancers are excluded; Hurthle cell carcinomas are excluded (defined as having an invasive tumor composed of > 75% oncocytic [Hurthle] cells lacking the nuclear features of papillary carcinoma, tumor necrosis, and marked mitotic activity); patients with oncocytic (Hurthle cell) variants of papillary thyroid carcinoma (defined as a tumor composed of a majority of oncocytic [Hurthle] cells having the nuclear features of papillary carcinoma) are eligible to participate RAI-avid lesion on a radioiodine scan (a diagnostic, post-therapy, or post-ablation scans) performed =< 12 months prior to registration, which suggests that therapy with 131I is justifiable in the judgment of the investigator Measurable disease; (NOTE: a malignant lymph node is considered measurable if 1) it is noted to be RAI-avid on radioactive iodine imaging [diagnostic or post-therapy whole body scans acceptable] and it measures >= 1 cm in the long axis, 2) it is pathologically proven to be involved with thyroid cancer [by cytology or pathology] and it measures >= 1 cm in the long axis, or 3) its short axis is >= 1.5 cm when assessed by computed tomography [CT] scan) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 Able to swallow and retain orally-administered medication with no clinically significant gastrointestinal abnormalities that may alter absorption Absolute neutrophil count (ANC) >= 1500/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin > 9.0 g/dL Total bilirubin =< 1.5 x upper limit of normal (ULN) Aspartate transaminase (AST) =< 2.5 x ULN (or =< 5x ULN in presence of liver metastases) therapy =< 6 months prior to registration; note: A diagnostic study using < 10 mCi of 131I is not considered 131I therapy External beam radiation therapy =< 28 days prior to registration; note: previous treatment with radiation is allowed if the investigator judges it will not compromise patient safety on the study Having been treated with a total cumulative (lifetime) 131I therapeutic activity > 800 mCi (excluding 131I activity administered for diagnostic scans) Treatment with chemotherapy or targeted therapy (e.g. tyrosine kinase inhibitor) =< 28 days prior to registration Prior exposure to mitogen-activated protein kinase kinase (MEK), RAS, or RAF inhibitors (note: previous exposure to sorafenib is allowed) OR history of hypersensitivity to selumetinib, thyrotropin alpha (Thyrogen), or any excipient agents Unresolved toxicity > Common Terminology for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia Cardiac conditions as follows Uncontrolled hypertension (blood pressure [BP] >=150/95 mmHg despite medical therapy) Left ventricular ejection fraction < 55% measured by echocardiography Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiogram (ECG) at rest", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-79.0, All Thyroid Neoplasms patients with differentiated thyroid cancer recently underwent total thyroidectomy (within 6 months) pathological T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci) T3N0 : Tumor size <=2cm with microscopic extension (less than strap muscle) T1-3N1a : 3 or less micrometastatic lymph node differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer more than 2cm size of tumor gross extension (strap muscle or more) Number of dissected lymph node <3 thyroid cancer with distant metastasis previous remote history of thyroid cancer surgery history of cervical external beam radiation therapy previous history of comorbid cancer renal insufficiency (Ccr <30ml/min) women with pregnancy or breast feeding", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 18.0-999.0, All Cardiac Arrest Unconscious (Glasgow Coma Scale \u22646) \u226518 years old Admitted in ICU after successful resuscitation from CA Treated with TH targeted to 33\u00b0C unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability) Traumatic or neurological origin of CA Previous cerebrovascular disease Facial trauma affecting the orbits and/or eyeballs Previous history of ocular pathology such as exophthalmia, glaucoma or cataract", "label": "0"} +{"topic": "A 46-year-old woman presents with a 9 month history of weight loss (20 lb), sweating, insomnia and diarrhea. She reports to have been eating more than normal and that her heart sometimes races for no reason. On physical examination her hands are warm and sweaty, her pulse is irregular at 110bpm and there is hyperreflexia and mild exophthalmia.", "doc": "eligible ages (years): 20.0-85.0, All Graves' Disease aged between 20 and 85 years euthyroid Graves' disease Patients who were not capable to complete the questionnaire due to severe cognitive dysfunction or under education were excluded from this study", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-60.0, All Depressive Disorders Depression Must meet for Major Depression Must be free of other mental or physical disorders that could cause depression, and also free from conditions that would typically participants from trials involving pharmacologic antidepressants Cannot be receiving other treatments or require immediate clinical attention ", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-60.0, All Mood Disorder Bipolar Disorder Depression MDD Seventy subjects (ages 18 to 60) with MDD will be selected who additionally meet for one of 3 subgroups A) MDD, Currently depressed with FPDD, as defined by DSM-IV for recurrent MDD, currently in a major depressive episode, who have a first degree relative with MDD but no first degree relatives with mania, alcoholism, or antisocial personality disorder B) MDD, Currently in remission with a history of FPDD, defined as a period of at least six months with no more than one clinically significant symptom, and during which time subjects were not taking an AD agent. Subjects will thus meet the historical for recurrent MDD (DSM-IV). We will also require that subjects previously had a least one antidepressant drug trial, to ensure that the severity of previous episodes warranted treatment C) MDD, Currently depressed, non-FPDD. To assess the specificity of the findings in MDD to FPDD, a sample meeting for MDD, currently in a depressive episode, but not FPDD will also be imaged Forty five subjects (ages 18 to 60) who meet DSM-IV for bipolar disorder and are currently in a major depressive episode. Subjects may be inpatients or outpatients. Because effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry LOW RISK One hundred and four subjects (ages 18 to 60) who have not met for any major psychiatric disorder. The control subjects will have no known first or second degree relatives with mood disorders Ten subjects (ages 18 to 60) with probable Cushing's Disease will be recruited who have both clinical and biochemical evidence of hypercortisolism (including urinary free cortisol excretion higher than the upper limit of normal (greater than 248) nmole/day, and marked central adiposity, cutaneous atrophy, proximal myopathy, and large purple striae). The diagnosis of probable Cushing's Disease will also have been established prior to referral via CRH and ACTH (n equals 12; ages 18-50). These females are recruited, screened and diagnosed by collaboration under protocol number 81-M-0126, previously approved by IRB, entitled 'The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavioral Disorders', principal investigator, David Rubinow, M.D. As described in that protocol these subjects must have a regular menstrual cycle lasting 21 Subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular function for at least 3 weeks (8 weeks for fluoxetine) prior to scanning. Subjects being scanned at two points or the same point twice in their menstrual cycle must not have taken birth control pills for at least 6 months prior to scanning. However, effective medications will not be discontinued for the purposes of this study. Instead, subjects will be recruited who are not currently receiving psychotropic drugs. Subjects will also be excluded if they have serious suicidal ideation or behavior psychosis to the extent that the ability to provide informed consent is in doubt medical or neurological illnesses likely to affect physiology or anatomy a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria) current pregnancy current breast feeding general MRI previous exposure to ecstasy (i.e. MDMA) which has neurotoxic effects on 5-HTT expressing neurons Subjects beyond age 50 are excluded from the MRMD sample due to peri-menopausal status and subjects beyond age 60 are excluded to reduce the biological heterogeneity encompassed by the MDD since depressives whose age-at MDD-onset is later than 60 have a far greater likelihood of having MRI correlates of cerebrovascular disease than age-matched, healthy controls or age-matched, early-onset depressives", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depressive Disorder Signed the informed consent Meet for major depressive disorder without psychotic features Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel Have had at least one other major depressive episode prior to the one being experienced at study entry You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry Any women who are pregnant or breast feeding If you have any serious medical illnesses other than major depressive disorder If you have previously participated in a clinical trial for duloxetine Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Seasonal Affective Disorder Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern Patient has a current or past history of seizure disorder or brain injury Patient has a history or current diagnosis of anorexia nervosa or bulimia Patient has recurrent summer depression more frequently than winter depression Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders Patient has initiated psychotherapy within the last 3 months", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 10.0-55.0, All Involutional Depression Anxiety Disorders Age: 10-30 Can give consent/assent. Parents will provide consent for all minors All subjects will have IQ greater than 80 High risk Psychopathology: Offspring of adults with a history of MDD Low risk Psychopathology: Offspring of adults with no history of MDD and low developmental levels of emotion dysregulation. Subjects born to parents with only anxiety disorders will be included in this group Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye) Pregnancy Both groups: All subjects will be free of current impairing affective disorders, separation anxiety disorder, social anxiety disorder, panic disorder, generalized anxiety disorder, PTSD, ADHD, as well as lifetime history of substance dependence, psychosis, pervasive developmental disorder, major affective disorder, obsessive compulsive disorder, conduct disorder, anorexia. All subjects will be born to parents with no history of schizophrenia or bipolar disorder Age: 18-55 Can give consent/assent Offspring: All subjects will have offspring participating in this same protocol Have an IQ greater than 80 Past history of MDD No lifetime history of MDD ADULT", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depression Palliative Care Cancer Mental Disorder Either enrolled in the OHSU radiology/oncology clinic or VA palliative care, and living within 120 miles of the Portland VAMC Life-limiting disease is any type of solid or blood cancer Eighteen years of age or older Life expectancy of 1 year or less as reflected by hospice admission or palliative care status. Although exact life expectancy can not be predicted, actively dying patients with estimated life expectancy of < 10 days are unlikely to be enrolled Diagnosis of major depression disorder as determined by the Structured Clinical Interview for Diagnosis (SCID) Significant depressive cognitive symptomatology as determined by a MADRS greater than 19 Currently taking an SSRI but still depressed enough to meet or not taking SSRI but depressed enough to start on SSRI Willing and able to give informed consent to participate in this study as demonstrated by the MacArthur Competence Assessment Tool for clinical research Speaks/understands English For patients at home who cannot self-administer medications, has a caregiver who can assist with administering medication Dementia or Delirium as determined by the Short Portable Mental Status Questionnaire (SPMSQ) score of less than 7 Diagnosis of delirium as determined by the Confusional Assessment Method (CAM) Any of the following Brief Psychiatric Rating Scale (BPRS) items rated 4 -, elated mood, suspiciousness, hallucinations, excitement, distractibility or motor hyperactivity Severe insomnia Severe anxiety Significant suicidal ideation History of current mental disorder in which depressive symptoms occur, but for which psychostimulants are contraindicated (schizophrenia and bipolar disorder will be based on history; active psychotic symptoms on selected BPRS items) History of stimulant abuse or other active, severe substance abuse Contraindications to methylphenidate or an SSRI including significant cardiac arrhythmias; uncontrolled, severe hypertension; moderate-severe angina; seizure disorder; severe COPD; use of medications such as Levodopa, monoamine oxidase inhibitors, and lithium; diagnosis of narrow-angle glaucoma; or history of SSRI-induced hyponatremia Physical symptoms including increased blood pressure (DBP greater than 115, SBP greater than 180), pulse greater than 120, irregular pulse, or chest pain consistent with angina", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 14.0-75.0, All Depression (1) age 14-18 years and (2) one risk factor for developing depression in the next two years: sub-clinical depressed mood (not meeting of major depression) a family history of depression in a parent or sibling, or past personal history of depression or personal perception of risk depression and desire to participate meeting or undergoing active treatment for major depression (5 or more symptoms nearly every day with functional impairment, minor depression) bipolar disorder panic disorder conduct disorder substance abuse or having suicidal ideation Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode Those who meet DSM-IV for minor depression (3-4 symptoms) or who report significant functional impairment (very difficult or above on the Prime MD functional impairment scale) will be notified and offered a referral for an evaluation by a mental health specialist (and will be strongly encouraged to attend) Those with 1-2 symptoms of depression will also be offered evaluation and treatment from a mental health specialist. In each case, the primary care physician will be notified and the parents (if under the age of 19)", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 14.0-25.0, All Depressive Disorder, Major Cannabis Abuse DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD DSM-IV diagnosis of current major depressive disorder, confirmed by the K-SADS Marijuana use of at least two days within the week prior to enrollment Demonstrated adequate levels of depressive symptoms within the week prior to enrollment DSM-IV diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia Hypo or hyperthyroidism Significant cardiac, neurological, or kidney impairment Liver disease (SGOT, SGPT, or gamma-GTP greater than 3 times the normal level) Use of antipsychotic or antidepressant medication in the month prior to enrollment DSM-IV dependence on any substance except marijuana or nicotine; alcohol dependence, or history of drug use History of significant medication side effects from any SSRI antidepressant Pregnant Unable to use adequate contraceptive methods for the duration of the study Inability to read or understand English", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Major Depressive Disorder. Hepatitis C, Chronic Patients with chronic hepatitis C who are going to initiate treatment with peginterferon alfa2a + ribavirin Age 18-65 years Signed informed consent If female, they are not in fertile period or they use barrier contraceptives Patients able to understand and fill written questionnaires Hepatic cirrhosis or carcinoma Less than 4000/mm3 leucocytes, or less than 70000/mm3 platelets Hemoglobin less than 11 g/dL (females) or 12 (males) Any risk factor for hemolysis Comorbid severe medical conditions (kidney, immune system, lung, heart, thyroid, etc) Baseline mental disorders that require antidepressants (depressive disorders and anxiety disorders) Other baseline mental disorders (delirium, substance use disorders) Mental disorders at any time (dementia, psychotic disorders, bipolar disorders Contraindications of escitalopram (hypersensibility, diabetes, patients using serotoninergic agents, drugs that enhance the risk of bleeding, or monoamineoxidase inhibitors -MAOIs-)", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Unipolar Depression Male or female 18 years or older DSM-IV diagnosis of major depressive disorder of at least moderate severity, but without psychotic features Ham-D 17 score of 18 or above Have a documentable history of 2 prior adequate trials of antidepressants including an SSRI without sufficient response. A clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms Must be currently on an serotonin uptake inhibitor (to venlafaxine or duloxetine) at an adequate dose for at least 3 weeks Ability and willingness to provide consent for participation in the study Any medical condition that would preclude treatment with an SSRI, risperidone, or bupropion ER Any clinically significant unstable medical condition Diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder Current psychotic symptoms (hallucination or delusions) Alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month Documented non-response to the combination of a novel antipsychotic or bupropion ER and a SSRI Concomitant use of any psychotropic other than an SSRI or zolpidem (PRN for sleep) Score of 4 on the suicide item of the Ham-D scale and determination by the investigator of significant suicide risk Known sensitivity to risperidone or bupropion ER", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-55.0, All Major Depressive Disorder (All three groups) age 18-55 years satisfactory physical health education level and a degree of understanding to communicate effectively with the investigator c capable of providing informed consent female subjects of childbearing potential, a medically accepted means of contraception Additional for the patient groups DSM-IV-TR for a diagnosis of BD or MDD currently meeting for an MDE and a Hamilton Depression Rating Scale 17 Item (HDRS-17) score of > 17 (All three groups) DSM-IV-TR for substance abuse or dependence (except nicotine or caffeine) within the past 6 months comorbid neurological or other major psychiatric disorders as defined in the DSM-IV-TR history of neurological trauma resulting in loss of consciousness uncorrected hypothyroidism or hyperthyroidism, including elevated thyroid stimulating hormone (TSH) other unstable medical condition female subjects who are pregnant or nursing Additional for the BD and MDD group prior failure to respond to fluoxetine and olanzapine in combination at adequate dose and duration", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Atypical Depression adults 18-65 years of age DSM-IV for major depressive episode with atypical features as assessed by the Atypical Depression Diagnostic Scale minimum score of 18 on the Hamilton Depression Scale (29-item version) at baseline baseline Clinical Global Impressions Severity score of 4 or more written informed consent negative serum pregnancy test for women of childbearing potential any current primary DSM-IV Axis I disorder other than depression history of DSM-IV diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition history of substance abuse or dependence within the last 3 months suicide risk or serious suicide attempt with the last year clinically significant medical condition or laboratory or EKG abnormality history of non-response to three prior adequate trials of antidepressants women of childbearing potential who are unwilling to practice an acceptable method of contraception history of hypersensitivity to modafinil use of an investigational medication within the last 28 days use of antidepressant medication with 28 days of screening", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Diabetes Diabetes Mellitus, Type 2 Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months BMI <= 45.0 kg/m2 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Major Depressive Disorder Male or female patients 18-65 years of age, inclusive ", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Atypical Depression DSM-IV Major Depression or Dysthymia with Atypical Features Age 18-65 Physically healthy HAMD(24) > 14 Prior experience with Duloxetine History of Psychosis or Bipolar Disorder, Borderline Personality Disorder Unstable medical disorder; any history of Epilepsy Currently taking medication that can interact with Duloxetine Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine) Pregnancy Currently breast feeding Fecund women failing to use acceptable birth control", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 0.0-999.0, All Depression Anxiety Student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting) Not a student in a participating school Not a student in grades six through eight", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Advanced Cancers Have weight loss of > 5% within the last 6 months Present with anorexia, fatigue and one of the following: anxiety, depression or sleep disturbances, during the preceding 24 hours, with an average intensity of each symptom >/= 3 on a scale of 0 to 10, in which 0=no symptom, and 10= the worst possible symptom Describe the symptoms as being present every day for a minimum of 2 weeks Have no clinical evidence of cognitive failure Must be 18 years or older Expect to live at least >/= 4 weeks Must have negative serum pregnancy test within 24 hours of study enrollment in women of childbearing potential. FDA for the status of not of childbearing potential, hysterectomy, or menopausal for 24 consecutive months Understand and sign written informed consent Have no concurrent steroids with the exception of steroids used concurrently with chemotherapy as part of a regimen or to reduce nausea Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and Prescribing Safety] Have major contraindication to thalidomide, i.e. hypersensitivity Present with National Cancer Institute (NCI) Common Toxicity Grade 3 or more peripheral neuropathy Are not able to complete the baseline assessment forms Are pregnant or lactating Patients with clinical history of seizures Patients with an ANC of 2.0 mg/dl at baseline will be excluded (to be drawn within 29 days prior to registration) Patients on Revlimid (lenalidomide) Patients on investigational chemotherapy/agents", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 21.0-45.0, All Depression Anxiety Disorders No more than 28 weeks pregnant at the time of study entry History of depression or anxiety Current symptoms of distress Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS) English-speaking Plans to move away from the area prior to giving birth Current use of steroids for medical conditions", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Major Depressive Disorder Not currently participating in a drug or medical device clinical trial Male or female over the age of 18 DSM IV Diagnosis of major depression Positive family history of bipolar disorder or completed suicide Not able to give informed consent Pregnant or breast-feeding Current additional psychiatric diagnoses including Panic Disorder, Post -Traumatic Stress Disorder (PTSD) or Psychosis History of mania or hypomania Active substance abuse or dependence in the last 6 months Current depressive episode less than 4 weeks or greater than 12 months in duration Current or prior adequate trial of lithium or paroxetine Current use of other medications such as antidepressants for the treatment of depression Clinically significant medical illness, in particular kidney problems", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Advanced Cancer Anorexia Weight Loss Insomnia Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS Patients > 18 years of age Karnofsky Performance score of > 40 at time of into study Ability to provide informed consent and comply with study procedures Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/ days), 8 (+/ days), 16 ( +/ days), and 22 (+/ days) and return to outpatient clinic for evaluation on days 15 (+/ days), and 29 (+/ Patients who have known dementia or delirium at time of enrollment as determined by a physician Known hypersensitivity to any ingredient of Mirtazapine Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting Ongoing use of tube feeding or parenteral nutrition Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment Pregnancy or lactation or unwillingness to use contraceptives A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of > 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation Patients on chronic use of benzodiazepines are excluded", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-50.0, All Circadian Dysregulation Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study Willing to travel from Hawaii to the East Coast and have a minimum stay of 6 days at the destination in a sleep laboratory during the entire study Has lived in Hawaii for at least 12 months and has not been traveling outside of Hawaii for 4 consecutive days within 30 days prior to the Outpatient Screening Visit History of sleep disturbance associated with jet lag symptoms, with at least two occurrences in the last three years, as defined in the International Classification of Sleep Disorders Habitual bedtime should be determined by sleep history as between 9:00 PM and 12:00 AM as determined by sleep history prior to randomization Have regular bedtime (within 1 hour) for 1 week prior to travel The subject has a subjective sleep latency of less than 30 minutes and a subjective total sleep time of 6.5 hours but less than 9 hours, as determined by sleep history Mean subjective sleep latency of less than 30 minutes and a mean subjective total sleep time of greater than 6.5 hours but less than 9 hours in 3 of 5 nights after the outpatient screening visit, as determined by post-sleep questionnaire Willingness and ability to comply with study procedures, including travel time, sleep, and waking-hour activities, light-exposure restriction, and food intake Body mass index between 18 and 34, inclusive Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds History of primary sleep disorders as determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised within the past 6 months Current sleep disorder as assessed by presence of sleep apnea, period leg movement syndrome, insomnia, daytime napping of more than 20 minutes, chronic fatigue Ever had a history of seizures, sleep apnea, restless leg syndrome, periodic limb movement syndrome, or chronic obstructive pulmonary disease History of psychiatric disorder (including schizophrenia, bipolar disorder, mental retardation, or cognitive disorder, anxiety, or depression) within the past 12 months Current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week History of drug abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised Positive urine drug screen or a positive urine drug screen or alcohol breathalyzer test Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of single blind study medication", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Breast Cancer Fatigue Gastrointestinal Cancer Patient diagnosed with breast, gastrointestinal, lymphoma, myeloma or lung cancer undergoing chemotherapy or hormonal treatment Patient is > or = 18 years of age Patient has Brief Fatigue Inventory \"fatigue worst\" score of > or = 4 at baseline Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2 at baseline Patient has a life expectancy > or = 6 months from the start of the study Patient is using acceptable birth control methods. Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Medically acceptable methods of contraception abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization Patient must speak and understand English Patient has provided written informed consent to participate in the study prior to enrollment to the study History of hypersensitivity reaction to methylphenidate History of or current seizure disorder, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, tension or agitation History of clinically significant cardiac disease Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently (defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg History of fibromyalgia Use of alcohol while participating in the study Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential (see protocol for criteria) Moderate to severe depression (> or = 20 on Beck Depression Index II) If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days Currently taking psychostimulants (including appetite suppressants), monoamine oxidase (MAO) inhibitors, anticoagulant or anticonvulsant therapy", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Obsessive Compulsive Disorder primary OCD diagnosis according to DSM IV current symptoms were responsible for significant distress previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol current substance dependence or abuse current psychotic symptoms current suicide risk and current pregnancy or intention to get pregnant before the end of the treatment protocol", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Atypical Depression age 18 to 65 years DSM-IV episode of Major Depression non-psychotic with atypical features \u226519 score on the 29-item HAM-D ability to give informed consent, if patients are of child-bearing potential A minimum 2-week washout from existing psychotropics (5 weeks for fluoxetine) bipolar depression Any Axis I psychotic disorder currently suicidal or suicide risk history of substance abuse in the previous 12 months history of hypersensitivity to escitalopram, or citalopram serious or unstable medical disorders starting or terminating psychotherapy during the previous 12 weeks ECT treatment in the previous 3 months pregnancy or planning pregnancy", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Postpartum Depression Major Depressive Disorder adult female subjects age 18 and above if onset of depression within 4 weeks of delivery,or onset of depression antenatally either during pregnancy or before pregnancy must score greater than or equal to 12 on the Edinburgh Postnatal Depression Scale speak English or Spanish have access to a telephone provide written and verbal consent have current or lifetime psychosis an unstable medical condition hypertension narrow-angle glaucoma liver disease seizure disorders bulimia anorexia mania substance abuse disorders", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-70.0, All Obsessive-Compulsive Disorder Meets DSM-IV-TR for a principal current diagnosis of OCD which is confirmed by both clinical evaluation and by structured interviews. OCD subjects with other comorbidities will be included provided OCD is judged to be the chief complaint Subjects must continue to experience clinically significant symptoms of OCD (Y-BOCS score \u226519 and a rating of \"moderate\" or greater on the Clinical Global Impressions (CGI) scale) despite at least two adequate SRI monotherapy trials. One unsatisfactory trial can the SRI currently being taken by the patient provided that the duration of treatment is 12 weeks or more and that the dose has been adequate. Subjects must be taking a clinically effective dose of a SRI (i.e., clomipramine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) for at least 12 weeks. Subjects must be on their current dose for at least 12 weeks and must maintain their current dose throughout the study Between the ages of 18-70 years of age Only subjects with OC symptoms of at least one-year duration will be included Eligible subjects must be in good physical health. Screening procedures will detailed medical history, complete physical and neurological exams, routine blood studies (CBC, liver function tests, electrolytes), ECG, urine toxicology screen, and serum pregnancy test in women of child-bearing potential Primary depression, schizophrenia or other psychotic disorders Active bipolar disorder Non-responder in the past to atypical antipsychotic augmentation. This criterion was chosen to prevent recruiting a sample of chronically refractory OCD cases that would otherwise be suited for more extreme interventions such as deep brain stimulation Non-responder in the past to an adequate trial (> 20 hours) of cognitive-behavioral therapy that will be assessed by records review Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention Alcohol or other significant substance abuse within the last 6 months History of neurosurgery, encephalitis or significant head trauma or a significant medical condition such as heart, liver, or renal disease Nursing mothers or women of childbearing potential who do not use adequate contraception will be excluded Subjects at an increased risk for seizures will also be excluded from this study (e.g., subjects with a history of seizures [other than childhood febrile seizures], subjects taking concomitant medications known to lower the seizure threshold) Estimated IQ < 80, mental retardation, dementia, brain damage, or other cognitive impairment that would interfere with the capacity to participate in the study and complete measures. If needed, the WASI will be used to assess this at screening", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 0.0-999.0, All Depression Anxiety Female Student in grades 6 through 8 Student in participating school Male", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Major Depressive Disorder All subjects will meet DSM-IV for depression on the basis of a SCID-P interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2) Subjects will meet both at recruitment and after a one-week single blind placebo wash-in. Study includes outpatients only All subjects will have no serious medical illness. The investigators will patients also meeting for the following groups of axis I diagnoses delirium or dementia substance-related disorders schizophrenia or other psychotic disorders, or eating disorders In addition, patients meeting for cluster A or B axis II diagnoses will be excluded Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the study", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-75.0, All Sleep Initiation and Maintenance Disorders Depression Meets for Major Depressive Disorder Between 18 and 75 years of age and adequately fluent in English Meets for an insomnia disorder Women who are currently pregnant, breast-feeding, or not using a reliable birth control method People for whom the antidepressant medication(s) provided in the study is not indicated People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications People with uncontrolled medical conditions People with moderate or severe sleep disorders other than insomnia Individuals on a fixed night shift or rotating work schedule that requires a night shift Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Schizophrenia Key The patient has a diagnosis of schizophrenia according to the DSM-IV-TR and the patient has been clinically stable in a nonacute phase of their illness Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits Key The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale The patient has any Axis I disorder according to DSM-IV-TR including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study The patient has moderate to severe depressive symptoms, as indicated by the CDSS The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies The patient is a pregnant or lactating woman The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Arthritis, Rheumatoid The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria The patient has active disease at both Screening and Baseline, as defined by both: \u22656 joints tender or painful on motion; and \u22656 joints swollen; and fulfills 1 of the following 2 at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis Patient has washed out of all DMARDs other that antimalarials Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L History of any other autoimmune rheumatic disease other than Sjogren's syndrome No malignancy or history of malignancy History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 13.0-18.0, All Major Depressive Disorder for Major Depressive Disorder Participants Participants must meet DSM-IV-TR for Major Depressive Disorder, with current mood state depressed for \u2265 2 weeks Participants must be females Participants must be between the age of 13 and 18 years Participants must have had an adequate trial of fluoxetine, defined as a trial of \u2265 8 weeks of treatment, with a dose of \u2265 40mg daily for \u2265 4 weeks. If the participant had a trial of 40mg daily and was unable to tolerate it, a dose of 20mg for \u2265 8 weeks is acceptable; OR Participants must have had an adequate trial of escitalopram, defined as a trial of \u2265 8 weeks of treatment, with a dose of \u2265 20 mg daily for \u2265 4 weeks. If the participant had a trial of 20 mg daily and was unable to tolerate it, a dose of 10 mg for \u2265 8 weeks is acceptable Participants must have a CDRS-R score of \u2265 40 and a CGI-S score of \u2265 4 Participants must be able to give informed consent or assent, and where applicable, parent(s)/guardian(s) must be able to give informed permission for study participation for Healthy Control Participants Participants must be females for Treatment-Resistant Major Depressive Disorder Participants Unstable co-morbid medical, neurological or psychiatric disorder Pre-existing renal disease Proteinuria or microalbuminuria Pregnant females, nursing mothers, or females of childbearing potential who are unable or unwilling to practice birth control during the study. Participants who are of child-bearing potential must have a negative urine pregnancy test before each MRI/MRS brain scan High risk for suicidal behavior, homicidal behavior or self-harm Adolescents who are unlikely to be able to comply with the study protocol DSM-IV-TR for current substance abuse or substance dependence, with the exception of nicotine abuse or dependence Contraindication to MRI/MRS brain scans, such as ferromagnetic implants or claustrophobic anxiety Documented or suspected history of intellectual disability (Full-Scale I.Q. < 70)", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 20.0-50.0, All SSRI-Refractory Obsessive-Compulsive Disorder Male or female, 18 years of age or over Patients were diagnosed as having obsessive-compulsive disorder by the Structured Clinical Interview for DSM-IV Patient version (SCID-P) They received standardized treatment for at least 1 year at the OCD clinic in our university hospital Each subject gave written informed consent to take part after receiving a complete description of this study All subjects were free of medical illness based on results of physical examination and screening tests of blood and urine, and no subjects received any lipid lowering or hypoglycemic agent during the 1-year study period Current clinically significant medical conditions such as diabetes", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Epilepsy Depression Healthy For Control Group Healthy adults of 18 years of age or older Subject has no history of affective disorders Subject scores higher than 5 on Hamilton Depression Rating Scale Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder Subject is pregnant Subject is unable to undergo a MRI Epilepsy Only Group Subject is at least 18 years of age Subject has confirmed temporal lobe epilepsy (TLE) Subject has a history of depression Subject scores higher then 5 on Hamilton Depression Rating Scale", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-70.0, All Atypical Depression Main Mild to moderate depression (ICD-10 F32.0, F32.1) with atypical features according to DSM-IV, lasting at least 3 months Female and male Caucasians aged 18 to 70 years At least one of HAMD-28 scale items 22-26 scores >1 ", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-30.0, All Obesity Diabetes Normal weight Healthy Normal sleep times Sleep disorders Overweight Diabetes Other health conditions Excessive caffeine and alcohol intake Smoking", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Major Depressive Disorder Adults between ages 18 to 64 years who meet the for a depressive episode as measured by a score of \u2265 16 on first 17 items of HAM-D (Urdu version Patients with low normal B12 levels in serum (>191 but < 300 pg/ml) Those who will provide informed consent Patients with concurrent unstable medical illness History of manic episodes or psychotic illness Psychotic symptoms within depressive episode", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 14.0-19.0, All Community Adolescents at Risk for Depression and Suicide willing to participate group assignment and grant consents unwilling to participate potential group activity and grant consents severe physical or psychiatric disorders", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 0.0-999.0, All Serotonin Syndrome Male or female patients with a diagnosis of PD Rasagiline treatment as mono or adjunct therapy for PD with concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period, OR Rasagiline treatment as mono or adjunct therapy for PD without concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period. OR Antidepressant therapy (SSRIs, SNRIs, St. John's wort and/or TCAs) and any other dopaminergic anti-PD treatment besides rasagiline or selegiline at any time during the specified review period Willing to consent to review of office chart and to review of records of ER visits and/or hospitalizations corresponding to the review window, if required Patients previously participating in a rasagiline clinical trial (and their follow-up protocols) are eligible, provided that they did not receive antidepressant therapy during trial participation In addition to the above each group has specific stated below Group R+AD: Enrollment in this group requires that patients must have taken rasagiline and an antidepressant (SSRIs, SNRIs, St. John's wort and/or TCAs, regardless of indication) within 14 days of each other (or five weeks, if fluoxetine preceded rasagiline) Group R: Enrollment in this group requires patients must have at least 2 months of rasagiline use Group AD: Patients must be taking an approved dopaminergic medication for PD. Enrollment in this group requires that patients must have at least 2 months of treatment with an antidepressant medication Use of rasagiline for any indication other than PD Patients taking a monoamine oxidase inhibitor (MAOI) antidepressant and/or selegiline Inability or unwillingness to request records of ER visits and/or hospitalizations corresponding to the review period", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Major Depressive Disorder Diagnosis of Major Depressive Disorder Allowed comorbidities: Dysthymia, Anxiety Disorders years old or older Males + Females English-speaking Women of reproductive age must be on adequate birth control, either oral contraceptives or using condoms or other barrier methods with spermicidal agents Subjects may be undergoing psychotherapy, but must maintain current psychotherapy status. Must not start therapy if not already in therapy. If in therapy, must have received at least 6 sessions prior to entering the study Subjects may continue taking herbals or supplements during the study, but they may not start any new herbals or supplements during the study or more failed trials of antidepressants (adequate dose and duration, and documented) Substance dependence in the past 6 months Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial Psychosis Bipolar Affective Disorder Type I, II or NOS Pregnancy (current or planned) Unstable medical illness (pt has to be stable for at least 3 months, and may be excluded per investigator discretion) Dementia Mental retardation Traumatic Brain Injury", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Advanced Cancer Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) of < 70 ng/dL Male patients who have fatigue present every day for the last two weeks and have an Edmonton Symptom Assessment System (ESAS) fatigue score during the last 24 hours of >/= to 4 on a 0 to 10 scale (in which 0 = no fatigue and 10 = worst possible fatigue) Male patients who are willing to receive intramuscular injections every 2 weeks and are 18 years of age or older are eligible for this study Participants must be willing to have blood samples drawn at screening and/or baseline and every two weeks until the end of treatment Prostatic Specific Antigen (PSA) level must be lower than 4.0 ng/mL to be eligible for this study and Digital Rectal Exam (DRE) must be normal ECOG PS /= 9 g/dL. If the patient has not had blood drawn for a hemoglobin level in the past 28 days, one will be done to determine eligibility. Patients with a hemoglobin < 9 g/dL will be referred for treatment of their anemia Patients who are determined incapable of completing questionnaires due to cognitive or physical deficits are ineligible for this study Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) >19 Patients with a history of prostate cancer, a history of breast cancer or adenocarcinoma of unknown origin A history of untreated obstructive sleep apnea Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac arrhythmia or severe COPD requiring home oxygen Patients who have evidence of pre-existing hypopituitarism/hypogonadism including status post bilateral orchiectomy, for which replacement therapy is mandated, are ineligible for this study Patients exhibiting clinically diagnosed severe dehydration are ineligible Patients with a history of uncontrolled arrhythmia Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA) Diabetics with a history of frequent episodes of hypoglycemia or uncontrolled diabetes mellitus (DM) defined as a fasting glucose over 200 mg/dL or HbA1c above 8%", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-40.0, All Self Concept Body Fat Composition Depression Perceived Social Support Healthy males aged 18-40 years Available twice a week for 10 weeks and willing to participate in moderate intensity exercise for 50 minutes at each session Not regularly physically active (i.e., engages in a structured exercise session once or less per week) Willing to participate in the internet-based CBT intervention once per week for 10 weeks Current illness or history of clinical conditions that prevents participation in exercise Currently alcohol/drug abusing Major cognitive or psychiatric impairments Currently receiving medication for major psychiatric disorders, including depression", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 25.0-999.0, All Breast Cancer over the age of 25 enrolled in one of the following protocols IRB # 08-005522: Evaluation of Molecular Breast Imaging in Patients with a High Likelihood of Ductal Carcinoma in Situ. 07-004241: Molecular Breast Imaging in the Preoperative Evaluation of Women with Biopsy Proven Breast Cancer. 1204-03: Evaluation of a Small Field of View Gamma Camera for Scintimammography in Patients with Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia, and Lobular Carcinoma In Situ. 07-003397: Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation. 17-05: Determination of the Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions Digital mammogram at the Mayo Clinic within the past 30 days They are unable to understand and sign the consent form They are pregnant or lactating They are physically unable to sit upright and still for 40 minutes Recently enrolled on one of the ongoing tomosynthesis vs. mammography studies (rationale avoid performing duplicate tomosynthesis studies in the same patient)", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Anemia years or older Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome karyotype except del 5q[31] Anemia that requires red blood cell transfusions Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level > 500 mU/mL Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \u2264 2 Must agree to follow pregnancy precautions as required by the protocol Must agree to receive counseling related to teratogenic and other risks of lenalidomide Must agree not to donate blood or semen Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or deoxyribonucleic acid (DNA) modulation agents Allergic reaction to thalidomide Renal insufficiency creatinine clearance (CrC1)<40 mL/min by Cockcroft-Gault method) Prior history of cancer, other than MDS, unless the subject has been free of the disease for \u2265 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed) Absolute neutrophil count (ANC) < 500/uL Platelets < 50,000/uL Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3X upper limit of normal Uncontrolled hyperthyroidism or hypothyroidism Significant neuropathy Prior stem cell transplantation", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 8.0-11.0, All Sleep Obesity Age 8-11 years old BMI for age and gender > 5th percentile (but no greater than 100% overweight) Sleep approximately 9-10 hours nightly Attend elementary school Like at least 1 food and 1 activity used in the reinforcement paradigm Able to understand and complete the reinforcement paradigm Existence of a diagnosable sleep disorder Medical or psychiatric condition that could influence sleep or weight Onset of menarche Inability to complete study materials, including diagnosed disabilities Dietary restrictions/allergies to foods used in the study that preclude them from study participation", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depression and over with chronic pain and score of 27 or higher on CES-D scale or younger, no chronic pain cognitively unable to participate in programming", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 65.0-999.0, All Acute Myeloid Leukemia Diagnosis of one of the following Newly diagnosed de novo acute myeloid leukemia (AML) AML secondary to myelodysplastic syndromes (MDS) AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years Bone marrow blasts >30% Age \u2265 65 years Easter Cooperative Oncology Group (ECOG) 0-2 Previous cytotoxic or biologic treatment for AML (except hydroxyurea) Previous treatment with azacitidine, decitabine or cytarabine Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors) AML French American British subtype (FAB M3) AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes Prior bone marrow or stem cell transplantation Candidate for allogeneic bone marrow or stem cell transplant Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, \"in-situ\" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure) Malignant hepatic tumors Uncontrolled systemic infection", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depressive Disorder Cancer Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period) Any antidepressant use within 6 months of January 1, 1996", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-80.0, All Gastroesophageal Disease Male/Female or more episodes of heartburn a week for last 3 months Previous upper GI surgery Underlying co-morbidity Narcotic medications Psychotropic's and Benzodiazapines medications Hx of psychological abnormalities Hx of ETOH in previous 6 mos Diabetes Mellitus Neuropathy Seizures Sleep Apnea", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 16.0-25.0, All Depression A score of 19 or more on the Beck Depression Inventory Currently enrolled at the University of Santo Tomas Able to read, understand, and complete forms ", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 12.0-18.0, All Depression Overweight Adolescents must: 1) be between the ages of 12 and 18 years (18 year olds must still be in high school and living at home); 2) be at or above the 85th percentile with reference to age and gender-specific Body Mass Index (BMI); 3) have at least one parent available to participate in the treatment protocol; 4) speak English; 5) agree to study participation and random assignment; and 6) be available for follow-up. In order to meet the depressed mood criterion, adolescents must have a primary diagnosis of major depressive disorder (single or recurrent), based on the KSADS-PL with a CGI-Severity \u2265 3 for depression and CDRS \u2265 36. Participants must be healthy, as established by their primary care physician, in order to participate in the exercise program - Adolescents will be excluded if: 1) they are currently receiving psychotherapy or participating in another weight loss program (only can have been in a weight loss program in the past); 2) they have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity; 3) they are developmentally delayed such that the intervention materials will not be appropriate; 4) they are actively suicidal at intake; 5) they have not been on a stable dose of a psychostimulant for 6 months to ensure that a recently prescribed psychostimulant is not contributing to weight loss; 6) teens on an SSRI will not be allowed to participate due to potential effects of medication on weight loss; 7) they have a substance abuse or dependence diagnosis; or 8) they have failed a medication or psychotherapy trial for depression in the past", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-64.0, All Depressive Disorder, Major Patients who meet the following will be included in the study aged 18 to 64 years diagnosis of major depressive disorder during the study timeframe (ICD 9 codes 296.2, 296.3, 311) evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as \u226415 days gap) must be continually enrolled during the study timeframe and have both medical and pharmacy benefits evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as \u226415 days gap) evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic After at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months Patients are excluded if they have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period have Electroconvulsive therapy (ECT) during the study period new augmentation with mood stabilizers, L-thyroxine (T4), L-Thyronine (T3), buspirone, stimulant, or others during the post-period (table 1) are pregnant during the study period patients with Medicare or Medicaid", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-90.0, All Major Depression A primary psychiatric diagnosis of Major Depressive Disorder as defined by: a score of 18 or above in the 17-item Hamilton Depression Scale; Male or female ages 18+ Ability to give consent Diagnosis of Breast Cancer Patients may be either English or Spanish speaking Lifetime history of psychosis or bipolar disorder Patients meeting diagnostic statistic manual for mental disorder for alcohol or substance use disorders who require acute detoxification Current suicide risk Advanced cancer or other condition that limits remaining life expectancy to less than 6 months Patients who are receiving effective medication for Depression", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 0.0-999.0, All Depression h and 8th grade students at 4 participating middle schools Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%) No imminent plans to move or change to non-participating school At minimum 6th grade language skills Agree to participate in random assignment and research interviews One Parent/caregiver willing to complete research interviews Student with past or current Major Depressive Disorder (MDD) or Probable MDD Students with parents who do not speak English or Spanish Students in concurrent treatment Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member Parent not willing to complete research interviews", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Insomnia Depression Clinical level of Insomnia (more than 10 on ISI) Meets for Insomnia according to DSM-IV-TR Enough language skills Only Trial 2: Meets for Major Depressive Disorder according to DSM-IV-TR Sleep disorders requiring other treatment High consumption of alcohol/drugs that affect sleep Started to use or changed the dose of antidepressant drug during the last 2 months Somatic or psychiatric conditions requiring acute care Working night shifts Only Trial 1: Meets for Major Depressive Disorder according to DSM-IV-TR", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depressive Disorder, Major \u22651 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 November 2008 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period) \u22651 medical claim with a primary International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis for MDD (296.2x, 296.3x, 311.xx) during the pre-index period Age \u226518 years as of the year of the pre-index period No pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period No medical claims with primary or secondary diagnoses for non-MDD episodic mood disorders or schizophrenia during the pre-index or post-index periods", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Deprivation All subjects will be sedentary. Sedentary will be defined as those with an occupational calorie expenditure that is not estimated at greater than 50% above basal (desk job or light activity at work: on feet 30-50% of the work day) and whose exercise activity is defined as sedentary according to a self-reported activity questionnaire, and confirmed by actigraphy measurements. Sedentary lifestyle will be defined as fewer than four 20 min episodes of moderate or vigorous intensity activity in the previous four weeks We will subjects who have any medical or psychiatric disorders, including history of anxiety or depression, and those taking any medications Those found to have depression on a depression screening tool (BDI-II) will be excluded Current smokers will be excluded All female subjects will undergoing a screening pregnancy test and excluded if positive Subjects found to have significant sleep disorders will be excluded. - Subjects found to have occult coronary artery disease by exercise treadmill testing will be excluded", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Major Depressive Disorder DSM-IV for major depressive disorder Age being age 18-65 Capacity and willingness to give written informed consent Any major medical illnesses A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Advanced Cancers Solid Tumors All patients with a histological diagnosis of cancer Rate fatigue on a numerical scale during the previous 24 hours as >/= 4 on a 0 to 10 scale (0 = no fatigue and 10 = worst possible fatigue) Describe fatigue as being present every day for most of the day for a minimum of 2 weeks Memorial delirium assessment scale /=8 g/dL within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the previous two weeks, one will be performed to determine eligibility. Patients with a hemoglobin level <9g/dL will be evaluated for treatment of anemia Able to understand and sign the informed consent No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment) Controlled pain and depression symptoms, if present ( defined as no change in the Morphine equivalent dose of 30% or change in the dose of antidepressant medication in the past 2 weeks) Patients should have a Zubrod 200mg/dl not being monitored by their primary care physician No concurrent full dose anticoagulant therapy. 20 and HDRS-24 > 24 negative pregnancy test for women of childbearing potential not breast feeding stable on current dose of psychotropic medication or free from all psychotropic medications for 4 weeks prior to EUH CIN admission (8 weeks for fluoxetine) no suicide attempt within six months of screening evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease history of CNS trauma or active seizure disorder requiring medication unless otherwise approved by principle investigator autoimmune or inflammatory disorder of any kind chronic infection (e.g. hepatitis B or C or HIV) chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 1 year, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) (within the past 2 weeks) and statins (within the past 1 month) unless otherwise approved by principle investigator hemoglobinopathies (e.g. thalassemia) a positive pregnancy test organ transplants cancer of any type a score of <28 on the Mini Mental Status Exam (MMSE)unless otherwise approved by principle investigator", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-45.0, All Borderline Personality Disorder Major Depression age between 18 and 45 female noncontrols diagnosis: major depression &/or borderline personality disorder Control participants should have neither major depression or borderline pers meet Structured Controlled Interview for DSM II cut off scores meet Beck Depression Inventory (BDI)cut off scores meet Borderline Evaluation of Severity Over Time(BEST) cut off scores based on having none of the below diagnoses from patient history, prior clinical records and based on MINI Plus International Neuropsychiatry Interview schizophrenia psychosis Attention Deficit Hyperactivity Disorder Obsessive Compulsive Disorder bipolar disorder mental retardation dementia CNS disease Post-Traumatic Stress Disorder in non-borderline personality disorder groups", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 20.0-999.0, All Depressive Disorder, Major Age over 20 years DSM-IV episode of MDD non-psychotic with atypical features characterized by mood reactivity and 2 or more symptoms of vegetative reversal (including overeating, oversleeping, severe fatigue or leaden paralysis, and a history of rejection sensitivity) More than 19 score on the 29-item HAM-D Ability to give informed consent Bipolar depression Any Axis I psychotic disorder A history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage) Patients with more than 3-point score of suicide (HAM-D-29 Item 18) or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (sub-investigator), are at significant risk for harming self or others A history of substance abuse in the previous 12 months A history of hypersensitivity to bupropion or any other components of the preparations used in the study (Wellbutrin SR 150mg and Wellbutrin XL 300 mg tablets) Serious or unstable medical disorders Starting or terminating psychotherapy during the previous 12 weeks ECT treatment in the previous 3 months Subject has a life time diagnosis of anorexia nervosa or bulimia within the past 12 month", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-55.0, All Major Depressive Disorder Outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) for major depressive disorder Those who are in remission, which is defined as a MADRS score 8 on two consecutive visits at a 4-week interval Their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of Korean red ginseng for residual symptoms Those who have a history of substance abuse or dependence within 1 month Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results Those who have a past history of hypersensitivity or intolerance to Korean red ginseng Those who participated in clinical trials within 1 month before entering the study entry Those who are pregnant or are breast feeding Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded in the study The patients unable/unlikely to comprehend/follow the protocol", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Fatigue Traumatic Brain Injury mTBI GROUP Diagnosis of at least one mTBI during deployment At least six months from time of injury Age range 18 or older A self-report of somatic or behavioral symptoms that developed within 3 months following mTBI and were not present before injury, and may or may not be present at enrollment Easy fatiguability Sleep disturbance Headache or other chronic widespread pain that does not seem related to extremity injury Emotional lability Lack of spontaneity or apathy mTBI GROUP Daily use of stimulants, narcotics, hypnotic or anxiolytics Diagnosis of sleep apnea, thyroid disorder, or rheumatoid arthritis Any history of head injury associated with a loss of consciousness that lasted longer than 24 hours (not including sedation) Daily use of more than 600mg caffeine (equivalent to approximately five cups of coffee) Headaches more than once a month prior to deployment Pregnancy Claustrophia Inability to comfortably lie supine for two hours companion group", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All MDD Management Strategies MDD Diagnosis Participants of the PismaEP study 18 yo. or older No specific", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 25.0-999.0, All Major Depressive Disorder Has body mass index (BMI) [weight in kilograms / (height in meters x height in meters)] between 18 and 30 kg/m2 For young healthy participants: female, 25 to 45 years of age; elderly healthy participants: female: \u2265 65 years of age & with baseline C-reactive protein (CRP) > 5 mg/mL; (partially) remitted MDD patients: female, 25 to 45 years of age specific for patients with MDD: -Patients with a history (within 24 months) of MDD must have a Montgomery-Asberg Depression Rating Scale (MADRS) total score < 15 and symptom remission (temporary absence of disease symptoms) relative to the acute episode must have been present for at least 3 months Has a current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I diagnosis (other than MDD) Has recently experienced a psychosocial stressor within 6 months Has acute symptoms of suicidality (the likelihood of an individual completing suicide) Has a DSM-IV diagnosis of substance abuse or dependence within 6 months prior to screening evaluation Has been exposed to an experimental medication or experimental medical device within 90 days before screening Has a serology (scientific study of blood serum and other bodily fluids) positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV antibodies at screening Has been exposed to typhoid or typhoid vaccine within 5 years before screening Has been prior exposed to the Trier Social Stress Test (TSST) Has received electroconvulsive therapy (shock therapy) within 3 months before screening Has been involuntarily committed to psychiatric hospitalization", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-50.0, All Perinatal Depression, Substance Use pregnant or has delivered in the past year reports the use of an illegal drug and/or consumption of 4 or more drinks on one occasion within the last 6 months; if postpartum, report the use of an illegal drug and/or consumption of 4 or more drinks on one occasion or 7 or more drinks in a week within the last 6 months; if pregnant, report the use of an illegal drug within the last 6 months and/or the consumption of 2 or more drinks in one month while pregnant, along with a history of consumption of 4 or more drinks on one occasion or 7 or more drinks in a week within 3 months pre-pregnancy meets DSM-IV of current Major Depressive Disorder (MDD) by Structured Clinical Interview for the DSM-IV(SCID) interview has a 17-item Hamilton Rating Scale for Depression (HRSD) score > 16, indicating moderate to severe depression is between 18 and 50 years old; and is able to speak and read English sufficiently to be able to complete the study procedures meets lifetime for bipolar disorder a primary psychotic disorder anorexia nervosa bulimia nervosa has started an SUD or MDD medication dose within the 8 weeks prior to enrollment is imminently suicidal", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-55.0, All Major Depressive Disorder For Patients with Major Depressive Disorder \u2022 Male and female outpatients, aged 18-55 years Subjects meeting full for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician HAM-D17 score of 14 or higher Able to provide informed consent Right handed, normal (corrected) vision and normal hearing \u2022 Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD) Substance use disorder (abuse or dependence with active use within the last 6 months) Significant sensory deficits such as deafness or blindness Severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders Pregnant or nursing females who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods) Clinically significant abnormal laboratory values or electrocardiogram For Healthy Controls Males and females, aged 18-55 years Subjects who do not meet full for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (ADHD), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician Right handed, normal (corrected) vision and normal hearing Any current primary psychiatric, or medical condition determined to be clinically significant", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depressive Disorder, Major Depressive Disorder, Minor Dysthymic Disorder Males and Females, ages 18 and older who are self-reporting generally good health Newly started on an antidepressant medication, switched to a different antidepressant medication or prescribed an increased dosage of antidepressant medication within the past 2 weeks A Hamilton Depression Rating Scale (HAM-D) score of greater than 10 A Patient Health Questionnaire (PHQ-9) score of 10 or greater, with endorsement of depressed mood or anhedonia, and endorsement of impaired daily function Meets diagnostic for Major Depressive Disorder, persistent Minor Depressive Disorder (i.e., > 1 month duration), or Dysthymic Disorder via a structured interview with the PRIME-MD Able to read, understand, and sign the Informed Consent in English Willing and able to comply with study requirements Well-versed in using a personal computer and the internet and must have easy access to a computer connected to the internet everyday (both weekdays and weekends) Enrollment in Surescripts Pharmacy benefit plan Currently under care with a Provider in Family Medicine at Cheshire Medical Center / Dartmouth-Hitchcock Keene Subjects must not have a major psychiatric co-morbid condition (schizophrenia, bipolar affective disorder, obsessive-compulsive disorder, PTSD, or a depressive disorder with psychotic features, as determined from chart review and patient report) Subjects must not have a substance use disorder or dependence as assessed by: CAGE Alcohol Dependence Questionnaire score >3 Subjects must not have a history of treatment -resistant depression as defined by the following: Psychiatric hospitalization within the past year; More than 2 clinically ineffective antidepressant medication trials, of adequate duration and adequate dose, within the current depressive episode; Any history of Electroconvulsive Therapy (ECT); A trial of Monoamine Oxidase inhibitor (MAO) within the past year Subjects must not report being actively suicidal Subjects must score 4 or greater on the Callahan Six-Item Cognitive Screening assessment Subjects must not be diagnosed with a terminal or near terminal medical illness such that their primary care provider has estimated the patient has less than 6 months to live Subjects reporting any medical condition that would make it unsafe to participate in a research study Participation in any other clinical research study within the past 30 days Participation in any on-line depression-related coaching or lifestyle improvement program within the past 5 years", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-24.0, All Depression Alcohol Abuse Currently enrolled in college as an undergraduate student Ages 18-24 years (inclusive) Presence of two binge drinking episodes in the past month (defined as consumption of 5 or more drinks in 2 hours for males and 4 for females; NIAAA, 2004) BDI-II 12 (12 is often used to indicate the presence of at least mild depressive symptoms) and <30 (indicating severe depression) Meeting for substance dependence or abuse (any substance) in the past six months (students with alcohol abuse will not be excluded) Diagnosis of bulimia, psychosis, or bipolar disorder Having received any psychosocial treatment for depression or substance abuse in the past month Having received CBT for depression and/or alcohol use in the previous 6 months If receiving pharmacological treatment for depression or substance abuse, has not been on a stable dose for at least 4 weeks Discontinued an antidepressant medication less than 1 month ago Meeting for severe depression or posing a serious suicide or homicide risk", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 21.0-65.0, All Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, Followed Placebo Body Mass Index (BMI) > 22 kg/m(2) Score of 15 or higher on the Dietary Restraint Scale, with endorsement of the Restraint Scale item Do you give too much time and thought to food? Age 21 years (4a) For women of childbearing potential: must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug, and agree to use an adequate method of contraception to avoid pregnancy for a period of 6 months beginning from first dose of randomized treatment. Women of childbearing potential any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Adequate methods of contraception for sexually active women are having a male sexual partner(s) who is surgically sterilized prior to inclusion; having a sexual partner(s) who is/are exclusively female; using oral contraceptives (either combined or progesterone only) with a single-barrier method of contraception consisting of spermicide and condom or diaphragm; using double-barrier contraception, specifically, a condom plus spermicide and a female diaphragm or cervical cap; or using an approved intrauterine device (IUD) with established efficacy (4b) Men, unless surgically sterilized (vasectomy with documentation of azoospermia), must agree to practice abstinence or use barrier contraception, and not donate sperm, for a period of 6 months beginning from first dose of randomized treatment Current employment at NIDA IRP or Bristol-Myers Squibb (BMS), or being in the immediate family of an employee. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted Current participation in another clinical study that includes exposure to an investigational or non-investigational drug or device Participation in a clinical study for a condition related to weight or dieting within the preceding month Any history of participation in a trial involving pexacerfont or closely related compounds Any medical condition or laboratory finding that, in the judgment of the investigators, could adversely affect safety or study integrity. Examples but are not limited to diabetes type 1 and type 2, ischemic heart disease, uncontrolled hypertension, and history of cerebrovascular accident or transient ischemic attack For women: pregnancy, breastfeeding, or planning to become pregnant within 6 months from the administration of first dose of study drug Past or present diagnosis of any eating disorder, including Anorexia Nervosa, Bulimia Nervosa, and Eating Disorder NOS (e.g., Binge-Eating Disorder). (Eating-disordered individuals probably represent a distinct population and should therefore be studied separately.) Past or present diagnosis of schizophrenia, bipolar disease, or any psychotic disorder; past or present diagnosis of dementia or any other disorder that has led to a clinically significant cognitive impairment; present diagnosis of any mood or anxiety disorder; any other psychiatric condition that presently requires, or in the past month has required, pharmacological intervention Past or present diagnosis of any substance-use disorder except nicotine dependence Urine tests positive for illegal drugs", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Insomnia Major Depression Minor Depression Clinical level of Insomnia (more than 10 on ISI) Meets for Insomnia according to DSM-IV-TR Enough language skills Only Trial 1: Meets for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required) Sleep disorders requiring other treatment Alcohol/drugs abuse Started to use or changed the dose of antidepressant drug during the last 2 months Somatic or psychiatric conditions requiring acute care Working night shifts Only Trial 2: Meets for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required for exclusion)", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Acute Mountain Sickness Healthy adults History of serious illness Current smoker or Hemoglobin >15.5gm/dL Uncontrolled hypertension", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Major Depressive Disorder Metabolic Syndrome Thyroid Dysfunction patient with major depressive disorder age over 18 years subject who cannot give information", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Major Depressive Disorder Neoplasms Diagnosed with a malignancy Informed consent obtained and signed Greater than or equal to 18 years of age Life expectancy determined to be greater than or equal to 6 months Diagnosed with Major Depressive Disorder based on clinical examination and the DSM-IV-TR PHQ-9 depression assessment completed by subject, with a score of 10 or greater Able to take whole or crushed tablets by mouth or by feeding tube Unable to complete self-report instruments due to illiteracy, neurologic illness, visual problems, inability to speak or read English, or other causes Treatment with antidepressants or antipsychotics within the last 3 months Psychotic or manic behavior Active suicidal ideation or plan Current illicit substance abuse Severe renal impairment as defined by creatinine clearance of <15 milliliters/minute/1.73 meters squared (mL/min/m2) Severe hepatic impairment as defined by Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) >5x the upper limit of normal, or a total bilirubin > 3.0 milliliters/deciliter (mL/dL) History of congenital long QT syndrome Clinically significant congestive heart failure or bradyarrhythmias Treatment with a concomitant medication that is known to have a strong association with corrected QT interval (QTc) prolongation AND a QTc >460 for men or >470 for women. Applicable to the citalopram arm only", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 12.0-999.0, All Major Depressive Disorder Adult Cohort A. MDD Mothers Cohort Current or past Major Depressive Disorder English as first language or English fluency Biological daughter who meets inclusion/ for High Risk Female Adolescent B. Healthy Control Mothers Cohort No history of psychopathology English as first language or English fluency Biological daughter who meets inclusion/ for Healthy Female Adolescent Adolescent Cohort General for Adolescent Cohorts Female Ages 12-14", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Depression All those who fulfil the diagnostic of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on interviews using SCAN Urdu version) Are between the ages of 19-60 Score 8 or more on HADS, Depression Subscale, and Who live within traveling distance of the psychiatry department will be approached Excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) Significant cognitive impairment (for example learning disability or dementia) and Active psychosis", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All College Student Mental Health for Counselors Currently working at a College Counseling Center Willingness to take the ACT guided self-help training through the counselor portal until reaching a passing criterion of 80% Willingness to distribute flyers about the study to five students, in an attempt to recruit 3 clients to participate in the self-help modules for Counselors Prior participation in this study for Student Clients Currently being treated at a College Counseling Center Willingness to participate in three half-hour modules as part of a web-based guided self-help program and complete pre and post assessments across a period of 4 weeks Referred to the study/self-help modules by counselor Participation will comply with targeted enrollment plans, and attention will be paid to selecting an ethnically/racially diverse group Student is clinically stable as per counselor judgment (e.g., not actively suicidal, psychotic, or disruptive) for Student Clients Under 18", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 15.0-19.0, All Depression Beck Depression Inventory > o = 10 Meets diagnostic of a depressive disorder according Kiddie Sads Present and Lifetime Version interview (K-SADS-PL) Parent or caregiver giving informed consent and adolescent giving informed assent Suicidal risk requiring in-patient care Bipolar Disorder Current substance dependence Current alcohol dependence Current psychosis Low intellectual abilities Current treatment with antidepressant and/or psychotherapy", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Treatment Resistant Depression Primary diagnose of unipolar treatment resistant depression Patients diagnose of: bipolar disorder, psychosis, high suicide risk, Intellectual disability, illicit drug dependence Currently in or having received psychotherapy in the last 4 weeks", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 12.0-17.0, All Depression Currently in the 6th to 11th grades Adolescent and parent must be English-speaking Parental consent and adolescent consent Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis Suicide attempt in the past week or significant suicidal ideation in the past week Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depression Anxiety Suicidal Ideation Eating Disorders Student enrolled in a participating campus as a full-time, residential undergraduate during the 2009-2010 or 2010-2011 academic years. Student must have been living in a participating residence hall Students under 18 years of age", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-55.0, All Depressive Disorder, Major Age between 18-55, male or female The diagnosis of MDD consistent with DSM-IV (M.I.N.I) First-episode or relapsed Certain ability of reading and writing to complete the questionnaire survey and psychological assessment All participants provide written confirmation of informed consent prior to engaging the study protocol Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors Not signed the informed consent Been engaging other studies", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Dementia English speaking Have a family member or friend with dementia who resides in Long Term Care persons who are non-autonomous adults cognitively impaired as determined by the Registered Nurse (RN) researcher unable to participate, in the opinion of the RN researcher non-English speaking does not have a family member or friend with dementia in Long Term Care", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-80.0, All Multiple Sclerosis Definite diagnosis of MS (14,15) or CIS (16);according to the most recent standard Expanded Disability Status Scale (EDSS) score < 7.0 (17) Last magnetic resonance imaging (MRI) within the previous 12 months Male or female >18 years old Willing to perform the study procedures Signed Informed consent Mini Mental Status Examination (MMSE) score < 24 Relapse within the last 3 months Radiologically isolated syndrome (RIS) History of drug and/or alcohol abuse Any serious general medical condition like decompensated cardiopulmonary disease, cancer or decompensated renal failure, as well as any neurological condition (other than MS) that can interfere with the correct execution of the study design", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depression Anxiety Fatigue Sleepiness Sleep Disruption Being a first year medical student Good academic standing after the first module Reporting attending morning lectures regularly No reported history of psychiatric illness,sleep illness, ophthalmic illness No current use of photosensitizing medications", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-80.0, All Healthy Young and Older Adults right handedness unobtrusive neuropsychological screening ability to provide written informed consent no pathological findings in head MRI age: 18 to 35 years (young adults) or 50-80 years (older adults) Highly effective contraception (Pearl Index < 1) or reliable abstinence from any heterosexual relationships in women of childbearing potential severe internal or psychiatric disease (especially depression or suicidal thoughts) epilepsy cognitive impairment (< SD under age adjusted norm in neuropsychological testing) concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors concurrent taking of tramadol or triptans concurrent taking of pimozide or linezolid concurrent taking of other drugs prolonging the QT-interval long-QT-syndrome hypokalemia or hypomagnesemia known intolerance of the study medication", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 12.0-18.0, All Adolescent - Emotional Problem Depression Prevention Harmful Effects enrolled in one of the participating schools parental consent and student assent is required for the web-based survey not enrolled in the participating schools", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Marital Relationships Family Relations Low-Income Population Child Behavior Adolescent Behavior To be eligible for the study, couples were supposed to be low income, married, at least 18 years old, and either expecting a child or parents of a child under age 18 who was living in their home - though couples were not required to provide any documentation verifying that they met these criteria They also had to understand one of the languages in which SHM services were offered (English or, in some locations, Spanish) Indication of domestic violence in the relationship", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Depressive Disorder, Major Moderate to severe major depressive disorder Prior treatment with botulinum toxin of any serotype for any reason Use of antidepressant medication for depression within 2 weeks of study Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depression Anxiety Alcohol Abuse Tobacco Abuse English-speaking US residents ages 18 and older below 50% of the area median income have a regular Internet connection non-English speakers non-US residents children history of or current enrollment in other incentivized savings programs", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-24.0, All Physical Activity be currently enrolled in full-time university coursework be between 18 and 24 years old understand and respond to screening questions in English be able to read at a Grade 6 level have adequate health, as assessed by having a body mass index between 18.5 and 29.9 (anyone with a BMI of 30+ is considered obese; National Heart, Lung, & Blood Institute, 2012) to ensure that regular, moderate to intense exercise activity will not negatively affect health identify as individuals who have tried to initiate and continue an exercise regimen sometime in the past but have been unable to maintain the activity indicate the desire to initiate physical activity at the current time be willing to attempt to maintain an exercise schedule during the three-week intervention period to which they will be randomly assigned be willing to participate in the 2-month and 6-month follow up periods not already be meeting current physical activity recommendations (i.e., at least 150 minutes of moderate-intensity exercise per week) not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions) not report consuming more than three (women) or four (men) alcoholic drinks per day (as this may interfere with their ability to engage in physical activity and confound study results) not be pregnant not have children not have preexisting physical limitations or recent injuries not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions)", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depression Participant \u2265 18 years Participant meets for a DSM-V Major Depressive episode. are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan MADRS score of 20 or more DSM-V psychotic disorder Drug or alcohol abuse or dependence (preceding 6 months) Inadequate response to ECT (current episode of depression) Regular benzodiazepine medication Rapid clinical response required, e.g., due to high suicide risk Clinically defined neurological disorder or insult Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites Pregnancy", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 45.0-60.0, All Cardiovascular Diseases Diabetes Dyslipidemias Metabolic Syndrome Quality of Life Age: 45-60 years Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer \"no\" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q) Not to be engaged in regular physical activity >20 min on >3 days/week Able to ambulate, with or without assistance Able to communicate Informed consent: Must be capable and willing to provide consent Acute or terminal illness Myocardial infarction in the past 3 months Not capable to ambulate Unstable cardiovascular disease or other medical condition Upper or lower extremity fracture in the past 3 months Severe dementia (MMSE < 10) Unwillingness to either complete the study requirements or to be randomised into control or training group Presence of neuromuscular disease or drugs affecting neuromuscular function", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Schizophrenia Major Depressive Disorder Bipolar Depressive Disorder Parkinson's Disease With Hallucinations at least 18 years-old have a diagnosis of schizophrenia, major depressive disorder, bipolar depressive disorder, parkinson's disease with hallucination such patients should receive antipsychotics as their usual treatment they should give informed consent before participating no treatment with atypical antypsichotics other diseases", "label": "0"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depressive Disorder, Major Being 18 years of age or older \u2022 Meet DSM-IV diagnostic for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0 Informed Consent \u2022 Having access to a PC and Internet connection \u2022 Having a Smartphone that is compatible with the mobile component of the intervention \u2022 Understanding of the German language spoken and written \u2022 Current high risk for suicide according to the MINI Interview section C \u2022 Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview \u2022 Currently receiving psychological treatment for depression \u2022 Being unable to comprehend the spoken and written language (German) \u2022 Not having access to a PC and fast Internet connection (i.e. broadband or comparable) \u2022 Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 20.0-65.0, All Major Depressive Disorder For MDD subjects Subject meets the DSM-IV for MDD Subject has a minimum score of 18 on the 17-item HAMD total score Subject has a minimum score of 2 on item 1, depressed mood, of HAMD Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives For healthy subjects Subject without past or current neuropsychiatric illnesses based on a clinical interview including Mini-International Neuropsychiatric Interview (M.I.N.I.) and a physical examination Subject without exposure to psychotropic medication or other substances known to affect the brain serotonin system within 1 year prior to entering the study Subject with history of any co-morbid neuropsychiatric disease Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication Subject with history of alcohol or substance dependence or abuse Subject with allergic history to the investigational products Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study Subject with malignancy within past 5 years Subject with any diseases judged by investigators as inappropriate for this study Female subject being pregnant, nursing, or lactating Female subject of childbearing potential not using a medically acceptable form of birth control Subject is unable to undergo MRI scan to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Depression Depressive Disorder patients referred to the recruitment sites for treatment for depression mild, moderate or severe depression mild, moderate or severe episode of recurrent depression bipolar or psychotic depression psychotic disorder severe substance abuse disabilities in senses that affect functioning and severely threat completing the trial diseases that affect vitamin D metabolism (such as sarcoidosis, hypercalcemia, hypofunction of kidney) pregnancy or lactation current use of high dose vitamin D supplementation current use of high dose calcium supplementation", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Major Depressive Disorder Bipolar, Depression We will recruit up to 80 participants who are adults (\u226518yrs) have a confirmed psychiatric assessment of Major Depressive Disorder (MDD) and/or Bipolar II, depressive are of moderate or higher severity (PHQ-9 >14) are community-dwelling and able to attend Group Medical Visits in the Lower Mainland are able to comply with scheduled visits, treatment plan, and other procedures read, write, and speak English with acceptable auditory and visual acuity provide signed/dated informed consent; and able to walk independently Active psychotic symptoms a primary active diagnosis of substance abuse Participants will need to have a working proficiency in English as group discussions, accompanying texts, and instructions will all be in English. To provide adequate translation services for these elements in one or more other languages is beyond our budget and may also influence the dynamics of the GMV. It could be considered in a future iteration of this research program", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-65.0, All Major Depressive Disorder Bipolar I Disorder Bipolar II Disorder Bipolar Depression Suicidal Ideation Provision of written informed consent [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) Both females and males, aged 18 to 65 years Inpatient status Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active The ability to understand and comply with the requirements of the study and capable of providing informed consent Suffering from suicidal ideation/attempts as evidenced by a score of >0 on either of the SSI or CSSRS or both Current or past psychotic symptoms Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV within 4 weeks prior to enrollment Any pervasive developmental disorder (according to DSM-IV criteria) Diagnosis of dementia (according to DSM-IV criteria) Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator Significant medical condition that would contraindicate the use of ketamine, midazolam or that is untreated and would need urgent attention (as determined by treating physician) Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator", "label": "1"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 18.0-999.0, All Depression Anxiety Stress Participants must be at least 18 years of age. Participants must have self-reported mild to severe symptoms of depression (5-27+) according to PHQ-9, self-reported mild to severe symptoms of anxiety (5-21+) according to GAD-7, or self-reported mild to severe symptoms of stress (15-34+) according to the stress sub-scale of DASS-21 Students who currently are in face-to-face therapy at UCCS or BHS will be excluded. Students who score in the \"red zone\" in terms of risk of self-harm on the screening questions routinely used at UCCS will not be referred to the study. Students who score greater than 0 on the PHQ-9 self-harm item during the initial screening phase will be automatically directed to be further evaluated and alerted that a counselor will try to reach them. Based on this further evaluation, they may be recommended to seek help from their health/counseling service and may/may not be eligible to participate in the study. They will be telephoned within 1 working day and contacted by email if they cannot be reached by phone", "label": "2"} +{"topic": "A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.", "doc": "eligible ages (years): 20.0-65.0, All Major Depression unipolar major depressive disorder neurological diseases or relevant psychiatric diseases other than major depressive disorder current medication other than SSRI or Mirtazapine manic episodes (lifetime) psychotic symptoms (lifetime) treatment with psychotherapy within the past 2 years treatment with electroconvulsive therapy (lifetime)", "label": "2"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 0.0-999.0, All Lung Diseases Sleep Apnea Syndromes ", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 1.0-18.0, All Obstructive Sleep Apnea Syndrome Cleft Lip/Palate children with cleft lip/palate and signs and symptoms of OSAS, parents who can read and write English Parents who cannot read and write English, children with severe neurological compromise", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 5.0-10.0, All Attention Disorder With Hyperactivity (ADHD) We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 mental retardation -", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 3.0-12.0, All Sleep Sleep Apnea Syndromes Sleep Disordered Breathing Assent of child (if over the age of 9 or younger but able to understand the nature of the study) At least one parent or guardian must sign an informed consent Child must be either a healthy volunteer or scheduled for an adenotonsillectomy for any reason Children scheduled for adenotonsillectomies must be referred to the program by a treating otolaryngologist who practices at the University of Michigan or St. Joseph Mercy Hospital in Ann Arbor, Michigan Mental or physical limitations that would prevent proper interpretation of neurobehavioral tests Medical history that could confound interpretation of EEG or behavioral data, including epilepsy, psychiatric diagnoses (other than disruptive behavior disorders), head trauma with loss of consciousness for more than 30 seconds, or chronic medication use (e.g., benzodiazepines, other hypnotics, or antihistamines) Current treatment by a physician or past surgical treatment for SDB A known medical condition that carries independent high risk of SDB (e.g., Pierre Robin syndrome, Down syndrome, or neuromuscular disorders) or excessive daytime sleepiness (e.g., narcolepsy) Inability to schedule polysomnography, a Multiple Sleep Latency Test, and neurobehavioral testing before the surgical date Determination by any of the patient's physicians that sleep testing is required before surgery can be scheduled (to avoid the possibility that study enrollment itself could affect ability to complete the study) Prior enrollment of a sibling in the study Expectation that the child will no longer have convenient access to University of Michigan facilities within 6 months or expectation of further surgery within that period Additional for healthy volunteers", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 20.0-80.0, All Obstructive Sleep Apnea Age 20 to 80 yrs Apnea hypopnea index (AHI) > 10/hr on Polysomnograph (PSG) with symptoms of obstructive sleep apnea (OSA) as described previously Epworth Sleepiness Scale (ESS) >10 Patients with hypertension will still be eligible to enter and continue the study as long as there is no alteration of anti-hypertensive medications during the study period Patients having problems staying awake during driving, shift work Recent myocardial infarction Unstable angina Underlying malignancy", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-999.0, All Seasonal Allergic Rhinitis Must be >=18 years of age and older, of either sex, and of any race Clinically symptomatic at Screening (Day -7 to -4)and at Baseline (Day 1) At Screening Visit, must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis (SAR) and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8) At the Baseline Visit, must have complaints of sleep disturbance and daytime somnolence while symptomatic with SAR and with a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11) Must have a 2-year or longer history of SAR occurring during the same season as the current study Must have skin tests positive for outdoor allergens common in subjects with SAR prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at Screening if not done within 12 months prior to the Screening Visit Must be free of clinically significant disease that would interfere with study evaluations Women of childbearing potential need to use a medically accepted method of birth control prior to Screening and during the study, or provide documentation of surgical sterilization. Women who are not sexually active at enrollment must consent to the use of a medically accepted method of birth control if/when they become sexually active during study participation Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit Women who are pregnant, intend to become pregnant during the study, or are nursing Evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow Acute or chronic sinusitis being treated with antibiotics and/or topical or oral nasal decongestants Acute respiratory infection within 2 weeks of the Screening Visit Diagnosis of clinically relevant sleep problems unassociated with allergies Complaints (within 12 months of the Screening Visit to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing SAR symptoms, and continue with these complaints Snoring associated with an enlarged uvula or other upper airway pathology Had episodes of snoring associated with gasping or choking Awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit, with a gasping or choking feeling Requires the use of oral appliances at night for bruxism (teeth gnashing) or temporomandibular joint problems", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Apnea, Obstructive Experiences symptoms of OSA, including snoring and sleepiness Stable medical history with no change in medications that could affect sleepiness Suspected diagnosis of a sleep disorder other than OSA (i.e., periodic leg movements, narcolepsy, insomnia, central sleep apnea, sleep hypoventilation syndrome) Medically unstable health conditions (e.g., heart attack, congestive heart failure) Use of psychotropic medications that cause sedation in the 3 months prior to study entry Recent or confirmed history of recreational drug use or alcohol abuse Pregnant Inability to communicate verbally, write, or read Visual, hearing, or cognitive impairment", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 45.0-85.0, All Parkinson's Disease 85 years of age and living in the community Male or female of non-child bearing potentials (non-child bearing is defined as at lease 6 months post-menopause or surgically sterile) Must have a diagnosis of Parkinson's disease Must have complaints of sleep disturbance Patients with diagnosis of or those meeting DSM-IV for major depression, schizophrenia or schizoaffective disorder, bipolar disorder, substance abuse disorder, other mental illness that is known to contribute to sleep disturbance, epilepsy, other medical conditions that are known to cause or contribute to sleep disturbances Patients currently using melatonin or ramelteon, hypnotics, benzodiazepines, antidepressants, blood-brain barrier permeable beta blockers, steroids, antipsychotics Patients with clinically significant blood or urine abnormalities Patients who have taken any investigational drug less than 1 month prior to the baseline visit Patients with multiple concomitant disorders with or without medications thought to produce sleep disturbances Patients with pre-existing sleep disturbances unrelated to Parkinson's disease Patients with severe hepatic impairment (Child-Pugh Class C) Patients with severe COPD (those with elevated pCO2 levels or those needing nocturnal oxygen therapy Patients with severe sleep apnea Patients who have sensitivity to ramelteon or any constituents of the Rozerem preparation", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 2.0-18.0, All Insomnia Sleep Disorder Male or female between the ages of 2 years and 18 years Written consent must be obtained form the parent/legal guardian for all minors. Written assent must be obtained from all minors > 6 years of age Female subjects of child-bearing potential must not be pregnant and if females are fertile and sexually active, must have documented a negative urine HCG and assure use of effective contraception acceptable to the investigator (abstinence accepted) during the study period Subjects must meet the following for a diagnosis of insomnia as determined by the subject's private physician or study investigator and subject's history the complaint is significant difficulty (defined by frequency, severity, and/or chronicity) initiating or maintaining sleep;. The problem is viewed problematic by the child and/or caregiver the sleep disturbance causes clinically significant impairment in school performance, behavior, learning, or development for the child as reported by the child and/or caregiver the sleep disturbance does not occur exclusively in the context of an intrinsic dyssomnia such as narcolepsy, restless legs syndrome, or sleep-related breathing disorders; a circadian rhythm disorder; or a parasomnia the sleep disturbance is not attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication Pregnancy and/or breastfeeding The presence of any untreated (where treatment is available), or unstable, progressive, or evolving clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, neurologic, hematologic, immunologic, cerebrovascular disease or malignancy Elevations in screening blood tests of renal (SCr) and liver (ALT, AST and/or bilirubin) > 2 times the upper limit of normal for age Receiving any medications that may modulate Zolpidem metabolism, primarily drugs that will enhance or reduce the activity of CYP450 3A, 2C9, or 2D6 activity. Note: If patient is receiving a medication that might be considered an inducer or an inhibitor, please discuss with the PI prior to excluding them Receiving any medications with sleep-impairing properties at a dose/dose interval that would be judged by the study investigator as to interfere with the assessment of Zolpidem sleep response Currently using any systemic contraceptive steroids including: oral contraceptives, transdermal patch, vaginal insert, levonorgestrel implant and medroxyprogesterone acetate contraceptive injection", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 30.0-80.0, All Sleep Apnea, Obstructive Continuous Positive Airway Pressure OSA confirmed by polysomnography (PSG) CPAP is the prescribed form of treatment for OSA Judged by sleep physician to respond to CPAP Apnea/hypoxia index (AHI) less than 15 and no daytime functional symptoms or associated cardiovascular disease Diagnosis of another sleep disorder that causes arousals from sleep Past treatment for OSA Current substance abuse problem Diagnosis of a serious medical condition that would interfere with involvement in the study History of a major psychiatric disorder, other than depression Change in antidepressant medication in the 3 months before study entry", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 4.0-9.0, All Sleep Problems Diagnosis of ASD Age greater than or equal to 4 or less than or equal to 9 years Current sleep problems, as defined as a composite score of greater than 41 on the CSHQ Failed sleep hygiene, as described below Parents must be fluent in English in order to complete CSHQ and ABC, validated in English only Parents have given informed consent Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.) Current or use within the last month of beta-blockers or melatonin Current use of sleep aids Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease (GERD)) 5) Blindness", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-65.0, All Schizophrenia Key The patient has a diagnosis of schizophrenia according to the DSM-IV-TR and the patient has been clinically stable in a nonacute phase of their illness Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits Key The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale The patient has any Axis I disorder according to DSM-IV-TR including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study The patient has moderate to severe depressive symptoms, as indicated by the CDSS The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies The patient is a pregnant or lactating woman The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 9.0-14.0, All Sleep Difficulties in Pediatric Anxiety Disorder Generalized Anxiety Disorder Separation Anxiety Disorder Social Phobia Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP) Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled, \" Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)\" The child/adolescent must have a \"sleep problem\" defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains difficulties going to sleep difficulties waking during the night difficulties getting up on time for school because of tiredness/sleepiness daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep erratic sleep-wake schedules IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI) Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants Acutely suicidal or at risk for harm to self or others Any motor impairments or eye-hand coordination problems Sleep disorder or parasomnia Taking any medication that might interfere with sleep Has a medical problem that might interfere with sleep", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 21.0-999.0, All Obstructive Sleep Apnea Consenting adults over the age of 21 Diagnosed obstructive sleep apnea Unstable cardiovascular disease Uncontrolled hypertension (BP > 190/110) Severe intrinsic lung diseases (supplemental O2 > 2 L/min during the day) History of chronic renal insufficiency History of hepatic insufficiency Pregnancy Bleeding disorders or Coumadin use Sleep Disorders other than OSA Tracheostomy Allergy to lidocaine", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 21.0-999.0, All Obstructive Sleep Apnea years or older Patient of the Weill Cornell Pulmonary Associates and Cornell Center for Sleep Medicine practices Clinically indicated for an overnight sleep study within six months prior to or after the outpatient office visit Pregnancy", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-65.0, All Resistant Hypertension Obstructive Sleep Apnea Age 18 known hypertension on \u2267 3 anti-hypertensive drugs Apnea-hypopnea index \u226715 able to give informed written consent moderate renal impairment (glomerular filtration rate <30 mL/min/m2 ) endocrine/renal/cardiac causes of secondary HT congestive heart failure and clinically fluid overloaded On drugs that elevates BP e.g. NSAID, steroid Non-compliance to anti-hypertensive medications Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months Active inflammatory/infective conditions e.g. rheumatoid arthritis Excessive sleepiness that can be risky e.g. occupational driver, machine operator Modification/changes of anti-hypertensive regimen within 8 weeks", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 4.0-10.0, All Autistic Disorder Insomnia Children with autism ages 4-10 years Diagnosis of autism based on Autism Diagnostic Observation Schedule (ADOS) Time to fall asleep of 30 minutes or longer by parent report at least 3 nights/week in the last 3 months Children may take seasonal allergy medications Children may take the following medications for the same dose at least 3 months: Citalopram (Celexa), Escitalopram (Lexapro), Amphetamine-dextroamphetamine (Adderall), Atomoxetine (Strattera), Methylphenidate(Ritalin), Dextroamphetamine(Dexedrine), Risperidone (Risperdal Children taking medications other than those in the criteria Children with primary sleep disorder other than insomnia (such as sleep-disordered breathing) Children with non-febrile unprovoked epileptic seizure within the last two years Children with liver disease or high fat diets, as melatonin metabolism may be affected in these children Children who are visually impaired (partially or completely blind) as light suppresses melatonin synthesis and these children may have altered diurnal melatonin rhythms Children with known genetic syndromes co-morbid with autism including fragile X, Down syndrome, neurofibromatosis, or tuberous sclerosis Children who have outside normal limits on blood work for complete blood count, liver and renal function and hormone levels of ACTH, cortisol, LH, FSH, prolactin, testosterone and estradiol Tanner staging beyond level 1 at any time point in the study Children whose assessment score does not place them on the autism spectrum", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 8.0-18.0, All Brain Tumors Age \u22658 to \u2264 18 years of age Brain tumor survivor \u22655 years post diagnosis \u22652 years post active cancer-directed therapy or observation only Parents speak and read English fluently Potential participant reads English fluently Potential participant/guardian willing to sign consent Survivor of any cancer other than a brain tumor", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Apnea Adults more than 18 years old Subjects Unwilling to Complete the Questionnaire", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 5.0-7.25, All Sleep Healthy child age 5-6 years old School enrollment for a minimum of 5 hours/day Positive Children's Sleep Habits Questionnaire (score \u2265 41) Permanent housing for the previous 12 months Permission for research staff to complete 5-9 home over 1 year Have telephone access or a contact with telephone access Fluent in either English or Spanish Serious co-morbid condition that may impact sleep including genetic syndromes neuromuscular disorders seizure disorder mental retardation autism severe learning disabilities psychiatric disorders attention-deficit/hyperactivity disorder", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Apnea, Obstructive diagnosis of obstructive sleep apnea syndrome other causes of dysphagia pharyngeal surgery prior treatment for obstructive sleep apnea", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-80.0, All Obstructive Sleep Apnoea Hypopnoea Syndrome Biomarkers of Fibrin Clot Structure Biomarkers of Vascular Endothelial Injury 80 year old with h/o daytime sleepiness, snoring and apnoeas Refusal to give written informed consent Personal or family history of pro thrombotic or bleeding disorders, severe liver disease (clotting problems) and those prescribed warfarin or heparin Those with borderline sleep studies (4% Diprate or AHI 10-14 per hour) Aged less than 18 years or greater than 80 years", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 5.0-12.0, All Sleep Apnea, Obstructive Sleep Apnea Syndromes Child Behavior Disorders Attention Deficit Disorder With Hyperactivity Disorders of Excessive Somnolence Children ages 5-12 years old Scheduled for an adenotonsillectomy for treatment of sleep apnea Child must provide assent, and Parent or legal guardian must be able to speak and read English, and agree to the study No siblings of children already enrolled in the study Children who expect to have another surgery (in addition to AT) during the period of participation in this study Neurological, psychiatric, or medical conditions, or social factors that may affect test results, prevent children from returning for required study visits, or interfere with the study treatment, or Certain medications that affect sleepiness or alertness, for example Stimulants (such as Ritalin, Adderall, or Concerta) Sleep aides (such as Melatonin, Ambien, or Ativan), or Sedating medicines (such as Benadryl, Klonopin, Xanax, or Valerian)", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 40.0-52.0, All Menopausal and Other Perimenopausal Disorders Age 40-52 History of regular menstrual cycles every 20-35 days in mid-reproductive life (20-35 years of age) At least 1 period within the past 3 months BMI less than 35 kg/m2 Presence of at least one of the following perimenopausal symptoms Hot flashes (vasomotor symptoms) Cyclical headache, bloating or adverse mood Self-reported poor quality of sleep Age < 40 years Hysterectomy or bilateral oophorectomy Cigarette smoking Signs or symptoms of restless leg syndrome or sleep apnea Any chronic renal or hepatic disease that might interfere with excretion of gonadotropins or sex steroids Moderate/vigorous aerobic exercise > 4 hours per week Inability to read/write English Pregnant Women Prisoners Decisionally challenged subjects", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-75.0, All Obstructive Sleep Apnoea males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI \u226515/h or sleep apnoea with an ODI \u22655/h plus an Epworth sleepiness score >10 morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with SpO2<90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants)", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-90.0, All Sleep Apnoea Syndrome patients with supected sleep apnoea syndrome and scheduled diagnosis at a sleep laboratory male and female patients aged at least 18 years persons who understand and follow the instructions of the study staff singed informed consent persons being housed in an institution by court or governmental order pregnancy or breastfeeding patients who are not able to consent acute or chronic inflammations of the external and middle auditory canal abnormal anatomic proportionsof the external and middle auditory canal which are pathological or congenital, for example limitation of the auditory canal persons in a dependence or in an employment contract to the investigator participation in another study at the same time", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-75.0, All Obstructive Sleep Apnea Syndrome Patients with low or medium suspicion of Sleep Apnea Patients with notorious comorbidity Age between 18 and 75 years Capability to fill in written questionnaires Patients with high suspicion of sleep apnea Serious heart disease, resistant systemic hypertension, Suspicion of non-apneic sleep disorders, such as narcolepsy, REM behavior disorders and restless leg syndrome Patients with diagnosis of SAHS Lack of informed consent", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-65.0, All Obstructive Sleep Apnoea (OSA) BMI > 35 attending bariatric surgery retrognathia micrognathia acromegaly downs syndrome", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 20.0-85.0, All Obstructive Sleep Apnea Central Sleep Apnea Mixed Sleep Apnea Cheyne-Stokes Respiration Able to understand and sign the informed consent Able to comply with visits and follow ups included in this protocol Ages 20-85 years An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection Skin rash on the nose or on the maxillary area A history of skin allergy to medical tape, and hypoallergenic tapes A history of skin cancer on the nose or on the maxillary area A history of the base of skull fractures, facial fractures", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 6.0-18.0, All Snoring Ability to understand how to perform reaction time test and complete without assistance Children who are unable to understand or perform test or parents refusal", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-999.0, All Obstructive Sleep Apnea End Stage Renal Disease end stage renal disease on renal replacement therapy age \u2265 18 years unstable congestive heart failure active psychiatric disease", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 2.5-5.917, All Sleep Initiation and Maintenance Disorders Age 30-71 months Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night English speaking parent or guardian Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5 Currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids Serious medical conditions likely to affect sleep, including diabetes or cancer Major cognitive or developmental disorder, including autism spectrum disorder", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 16.0-999.0, All Acromegaly Adults aged 16 and above Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea Have capacity to given informed consent Patients under 16 years of age Not referred to the Sleep Apnoea Clinic Unable to give informed consent", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-35.0, All PCOS Sleep Apnea Females 18 years old Receiving care at University of South Florida Reproductive Endocrinology Offices Polycystic ovarian syndrome defined by the modified Rotterdam Able to speak and understand as well as give informed consent in English Late onset congenital adrenal hyperplasia Cushings disease Androgen-secreting tumors Previous diagnosis of obstructive sleep apnea Current use of over the counter or prescribed sleep medications Examples of medications that a patient from this study but are not limited to Unisom, Ambien or Lunesta Patients who are taking non-prescribed herbal medications for sleep will not be excluded from the study. Examples of these but are not limited to melatonin, chamomile, or valerian Untreated thyroid disease Prolactin excess Patients with the following medical conditions will be excluded from the study as portable sleep apnea monitors are not indicated in patients with severe pulmonary disease, neuromuscular disease, or congestive heart failure", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 3.0-12.0, All Obstructive Sleep Apnea Syndrome Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram Children who are suffered from any chronic medical or psychiatric condition Children with acute respiratory infection Children with severe craniofacial deformities Children with cardiopulmonary diseases Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-18.0, All Sleep Apnea Sudden Cardiac Death Heart Failure Ischemic Cardiomyopathy Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death Previously diagnosed sleep apnea CPAP, BiPAP or ASV treatment Patients with previously implanted ICD/CRT-D device indicated for device replacement Uncontrolled hypertension Severe valvular heart disease/dysfunction with exception of ischemic and functional mitral regurgitation Acute coronary syndrome or acute cardiac decompensation in 4 weeks before ICD/CRT-D implant Expected indication of heart transplant in period of 12 months or less after ICD/CRT-D implant Expected cardiac surgery or percutaneous coronary intervention in period of 12 months or less after ICD/CRT-D implant Severe pulmonary diseases Rejection of participation in the study Pregnancy", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Apnea Syndrome Men and Women over 18 years old Diagnosed as OSA and requiring CPAP treatment Written informed consent form signed Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders) Severe heart failure Severe chronic pathology associated Psychiatric disorder Periodic leg movements Pregnancy Other dyssomnias or parasomnias Patients already treated with CPAP", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-90.0, All Obstructive Sleep Apnoea Obesity Hypoxia men with or without obstructive sleep apnoea weight loss interventions steroid use active smoking", "label": "0"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 3.0-10.0, All Sleep-Disordered Breathing Diagnosis of mild sleep-disordered breathing (MSDB) defined by an obstructive apnea index (OAI) <1/hr and an apnea-hypopnea index (AHI) <2/hr confirmed by nocturnal polysomnography Parental report of habitual snoring defined as occurring on average >3 nights per week Tonsillar hypertrophy \u22652+ Deemed to be a surgical candidate for adenotonsillectomy by otolaryngologist evaluation Previous tonsillectomy Recurrent tonsillitis that merits prompt adenotonsillectomy (AT) per the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines (i.e., \u22657 episodes/yr in the past year; \u22655 episodes/year over the past 2 years or \u22653 episodes/yr over the past 3 years.) Severe obesity (body mass index (BMI) z-score \u22653) Severe chronic health conditions that might hamper participation or confound key variables under study Current use of psychotropic medication (other than medications for attention deficit hyperactivity disorder(ADHD)), hypnotics, antihypertensives or growth hormone History of severe developmental disability or Adaptive Behavior Assessment System (ABAS) score <60 Parent/guardian unable to accompany the children on the night of polysomnography (PSG) Family planning to move out of the area within the year Family does not speak English", "label": "1"} +{"topic": "A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.", "doc": "eligible ages (years): 18.0-999.0, All Sleep Apnea/Hypopnea Syndrome Age 18 years or older No previous diagnosis of sleep apnea Fulfilling at least one of the following Pacemaker indication ICD or CRTD therapy indication Heart failure and preserved LVEF (40-50%) Heart failure and reduced LVEF (<40%) Signed informed consent Age younger than 18 years Renal hemodialysis Cardiac transplant indication Women who are pregnant Advanced cancer Enrollment in another investigational study Able and willing to comply with all testing and requirements Patient not suitable for due to psychiatric conditions or short life expectancy", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Cysticercosis Cysts Seizures years of age or older. If children are evaluated they can be seen under the general protocol and they may be entered into the present protocol under an exception Likely diagnosis of inactive cysticercosis and present or past seizure activity. Requires \"a\" and \"b\" plus any one of the remaining History of seizures or present seizure activity Previously treated or has inactive disease and declines treatment Single calcified lesions and positive serology Multiple calcified lesions Multiple small enhancing nodular lesions History of cystic lesions responding to specific chemotherapy If female, not pregnant and using effective birth control methods Less than 18 years of age Pregnant or unwilling to use effective birth control measures Refuse blood tests Unwilling or unable to undergo testing according to the schedule Unable to undergo MRI or CT examinations Patients who require anesthesia to undergo imaging studies", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease ", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 50.0-80.0, All Osteoporosis 80 years of age, inclusive years since last menses Dx femoral neck osteoporosis No vertebral fractures Poor candidate for study drugs Hx of diseases affecting bone metabolism Hx of breast/estrogen-dependent cancer Current use of osteoporosis drug therapy Hx/high risk of VTE", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Small Cell Lung Cancer Written informed consent (patient's written understanding of and agreement to participate in this study) Patients with confirmed extensive small cell lung cancer (SCLC) No prior chemotherapy within 5 years of the diagnosis of SCLC Presence of either measurable or non-measurable SCLC by X-ray or physical examination At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient) At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting Laboratory Patients must have adequate bone marrow reserve and adequate kidney and liver function Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids Any active infection Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC Use of an investigational drug within 30 days before the first dose of study medication Women who are pregnant or lactating Patients of child-bearing potential who refuse to practice an adequate form of birth control Patients with clinical evidence of any stomach or intestinal (GI) condition Patients requiring treatment with the drug cyclosporin A", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Sepsis Adult patients with severe sepsis Presence of a suspected or proven infection One or more sepsis-associated organ failure Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country Platelet count <30,000/mm3 Are receiving therapeutic heparin", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Severe Acute Respiratory Syndrome Healthy adults, children and cord blood ", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Colon Mucinous Adenocarcinoma Colon Signet Ring Cell Adenocarcinoma Lynch Syndrome Stage IIA Colon Cancer Stage IIB Colon Cancer Stage IIC Colon Cancer STEP 1 The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if this distance was not confirmed on endoscopy pre-operatively, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination; colonoscopy should be performed postoperatively for those unable to have a preoperative colonoscopy to guarantee there are no synchronous lesions; (if tumor is located beyond sigmoid colon and centimeter distance unavailable, anatomic region of colon, e.g. right colon, transverse colon, hepatic flexure descending colon, cecum etc.) Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk High-risk patients will be randomized to treatment Arms A or B Low-risk patients will be registered to Arm C for observation NOTE: Every effort should be made to submit blocks (tumor and normal mucosa) to the Principal Coordinates Analysis (PCO) immediately; blocks be accepted after day 50 (post surgery) in order to allow for molecular assessment Specific laboratory requirements for Step 2 must be obtained within 2 weeks prior to Step 2 randomization Patients must not have synchronous tumors Patients must not have appendiceal tumors Patients must not have a history of inflammatory bowel disease (IBD) ", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 8.0-17.0, All Asthma Allergy Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97) Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6 Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2) Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16) Positive house dust mite skin prick test, with a more than 3 mm infiltrate Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial Active smoking Dogs or cats in the home Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-90.0, All Abscess Cysts Female or male, aged between 18 and 90 years Written informed consent Abscess formation or abdominal cyst scheduled to drainage Plasma creatinine <1.5 mg/dL Pregnancy or lactation Hemodialysis or hemofiltration Allergy or hypersensitivity against study drugs Massive edemata or hypernatremia Reduced liver function (Child-Pugh A, B, C) Relevant prolongation of QT-interval CNS-diseases which predispose for cramps", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-65.0, All West Nile Fever A participant must meet all of the following 18 to 65 years old Available for clinical follow-up through Week 32 and contact (correspondence, telephone or e-mail) or clinical visit through Week 52 of the study Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly Able and willing to complete the informed consent process Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results Willing to donate blood for sample storage to be used for future research and genetic testing, including HLA analysis In good general health without clinically significant medical history and has satisfactorily completed screening Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment A volunteer will be excluded if one or more of the following conditions apply Women Breast-feeding or planning to become pregnant during the 32 weeks of study participation Volunteer has received any of the following substances Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded) Blood products within 120 days prior to HIV screening Immunoglobulin within 60 days prior to HIV screening Investigational research agents within 30 days prior to initial study vaccine administration Live attenuated vaccines within 30 days prior to initial study vaccine administration Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-50.0, All Ebola Hemorrhagic Fever Ebola Virus Disease Ebola Virus Vaccines Envelope Glycoprotein, Ebola Virus Filovirus A subject must meet all of the following 18 to 50 years old Available for clinical follow-up through Week 48 Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly Able and willing to complete the informed consent process Willing to donate blood for sample storage to be used for future research In good general health without clinically significant medical history Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment Laboratory within 28 days prior to enrollment A subject will be excluded if one or more of the following conditions apply Women Breast-feeding or planning to become pregnant during the first 24 weeks after enrollment Subject has received any of the following substances Ebola vaccines or any recombinant adenoviral vector vaccine in a prior clinical trial Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. [Note: that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded.] Blood products within 120 days prior to HIV screening Immunoglobulin within 60 days prior to HIV screening Live attenuated vaccines within 30 days prior to initial study vaccine administration Investigational research agents within 30 days prior to initial study vaccine administration", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-26.0, All Behavioral Disorders Being less than 26 years old Being pregnant for less than 27 weeks Being primiparous Living in the study area Being socially vulnerable: less than 12 years of education AND/OR socially isolated AND/OR eligible for a public health insurance for people with low resources Refusal to participate Not able to speak French Having a medical follow-up which necessitates regular contact with health professional Not having health insurance Persons for whom follow up at 27 months is impossible (evaluation at baseline)", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Influenza For pediatric population: Age of patient: 30 days years; for adult population: any age Illness onset within past 5 days Symptoms of fever (>=38\u00b0) plus one or more of the following: cough, runny nose, congestion, or sneezing (twice or more within one day). These symptoms must be present at the time of presentation to the emergency department (ED) or admission to the hospital Patient or parent/guardian is able to give informed consent Pediatric patient or non-verbal adult is not accompanied by a caregiver Participant/caregiver cannot be reached by phone in 7-10 days Patient has a condition that can compromise respiratory function or the handling of respiratory secretions (e.g., severe cognitive dysfunction, spinal cord injuries, or other neuromuscular disorders)", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Hypertension Obesity patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus according to SPC", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Scrub Typhus were Adults aged 18 years or older A fever of higher than 37.5\u00b0C The concurrent presence of eschar or a maculopapular skin rash; and the clear presence of more than two symptoms such as headache, malaise, myalgia, coughing, nausea and abdominal discomfort Patients were hospitalized at Chosun University Hospital in Kwangju, Korea or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009 The were An inability to take oral medications Pregnancy Hypersensitivity to the trial drugs Previous drug therapy with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, fluoroquinolones or tetracyclines) within 48 h prior to admission Severe scrub typhus (shock requiring vasopressor therapy for more than one hour A stuporous or comatose level of consciousness Respiratory failure requiring mechanical ventilation or renal failure requiring immediate dialysis) (4, 10) For the differential diagnosis of scrub typhus from other diseases with similar symptoms (e.g., murine typhus, leptospirosis, hemorrhagic fever with renal syndrome and systemic lupus erythematosus), patients underwent diagnostic tests. We thus excluded patients with concurrent infections who had the risk of causing different outcomes", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Child Abuse resident of Durham, NC a child between the ages of 0-7 was the focus of the Department of Social Services report child's caregiver was the focus of the report Child Protective Services report occurred on or after June 1, 2004 family is English speaking Sexual abuse was not \"confirmed\" or \"highly suspicious\" during an evaluation Child Protective Services report of sexual abuse that was \"confirmed\" or \"highly suspicious\"", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 15.0-90.0, All Leptospirosis adult patients (> 14 years) with suspected severe leptospirosis patients who presented with acute fever (oral temperature more than 38.00 C for <15 days) in the absence of an obvious focus of infection In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration) pregnant or breastfeeding those with history of bleeding disorder those who had underlying diseases such as chronic liver disease, diabetes mellitus those who received diuretic or glucocorticoid", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-45.0, All Familial Mediterranean Fever Fulfilling the Tel Hashomer for the diagnosis of FMF [5] Suffering from episodes of exertional leg pain and or exertional ankle edema 18-45 years old On a stable (\u2265 2 weeks) dose of oral colchicine therapy Non-smokers with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) Suffering from muscular or neurological diseases not related to FMF With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Leishmaniasis DoD healthcare beneficiary of any age and gender Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection Able to provide informed consent or assent (children) All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period History of hypersensitivity to pentavalent antimonials Any of the following on screening examination QTc interval greater or equal to 0.5 sec Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias) History of recurrent pancreatitis Liver failure or active hepatitis with transaminases > 3x upper limit of normal Renal failure or creatinine > 2.5 mg/dL Thrombocytopenia (platelets <100,000/mm3) White blood cell count < 2000 / mm3", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-70.0, All Acute Viral Hepatitis Diabetes Mellitus All patients between the ages of 18 to 70 years Recent intake of drugs known to cause acute hepatitis History of alcohol ingestion >40mg/day Suspected ischemic hepatitis Illness causing acute hepatitis such as Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia HIV Associated co morbidities, which can affect survival such as cardiovascular disease and diabetic nephropathy Recent intake of drugs known to cause acute hepatitis History of alcohol ingestion >40mg/day Suspected ischemic hepatitis Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 21.0-999.0, All Headache All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED patients who need immediate oxygen after triage: Recent fire or carbon monoxide exposure_______ O2 saturation 94% or less on room air on triage vitals ______ patient arrives on supplemental oxygen_______ patient reports shortness of breath_______ patients in whom 100% oxygen is contraindicated, potentially undesirable, or controversial: history of COPD_______ possible cardiac ischemia (mouth / jaw / neck / shoulder / chest / abdomen pain or pressure)_______ possible stroke (new focal weakness or numbness, speech, hearing or vision deficit, bowel or bladder incontinence or retention)_____ patients unable to tolerate the gas treatment: patient not able to tolerate a face mask_______ patient requests immediate treatment with another preferred therapeutic agent_______ treating physician or nurse request to discontinue the study at any point_______ patients who have diminished decision-making capacity history of mental retardation or pervasive developmental disorder_______ patient not awake and alert_______ patient not oriented to self, month and year, and current location_______ patient unwilling or unable to fully participate in the research associate interview and consent process_______ patients who are at risk for intracranial hemorrhage history of intracranial aneurythm, hemorrhage, surgery, or tumor_______ current headache began after trauma_______ current headache began after using elicit drugs_______ patients who are at high risk for intracranial infection fever > 100.4 F on triage vitals_______ complaining of recent onset neck stiffness_______ patients who are at high risk for extracranial head pathology ear pain or drainage_______ tooth or gum pain_______ headache localized to a skin lesion on the head______ patient is potentially critically ill active bleeding from any source_______ heart rate <60 or >130 on triage vitals_______ systolic blood pressure <90 or >180 on triage vitals_______ respiratory rate < 10 or >30 on triage vitals_______ patient is younger than 21_______", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Recurrent Large Cell Lung Carcinoma Recurrent Lung Adenocarcinoma Recurrent Squamous Cell Lung Carcinoma Stage IV Large Cell Lung Carcinoma Stage IV Lung Adenocarcinoma Stage IV Squamous Cell Lung Carcinoma Patients must have histologically or cytologically proven primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified); disease must be stage IV; disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation; patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease will not be considered to have stage IV disease and are not eligible Patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day Patients may have measurable or non-measurable disease documented by CT or MRI; the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form Patients must have tumor tissue available for submission that is sufficient for EGFR FISH testing and must agree to submission of these specimens; patients must also agree to submission of specimens for other translational medicine studies; patient must be offered participation in banking for future research Patients must not have received prior chemotherapy for any stage non-small cell lung cancer; patients must not have received prior platinum-based chemotherapy for any purpose; patient must not have received any cetuximab, gefitinib, erlotinib, or other investigational agents that target the EGFR pathway; patients must not have received for any purpose prior bevacizumab or other vascular endothelial growth factor (VEGF)-related agents; patients must not have received for any purpose prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA) Prior radiation is permitted; however, patients must have recovered from all associated toxicities at time of registration; in order to qualify as measurable, measurable disease must be outside the previous radiation field or must have progressed Time from surgical or biopsy procedures is dependent on whether it is planned for the patient to receive bevacizumab For patients who are bevacizumab-appropriate AND bevacizumab is planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or video-assisted thoracoscopic surgery [VATS] resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 14 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), thoracentesis or central venous access device implanted within 7 days prior to registration; for other surgical procedures not listed here, please contact the study coordinators For patients who are bevacizumab-inappropriate or bevacizumab is not planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or VATS resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 7 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), or thoracentesis within 1 day prior to registration; patients may have had a central venous access device placed at any time prior to registration; for other surgical procedures not listed here, please contact the study coordinators Absolute neutrophil count (ANC) >= 1,500/mcl ", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 17.0-65.0, All Crimean-Congo Hemorrhagic Fever Lassa Fever An individual will be enrolled in this study if the patient Meets the case definition for a probable or a suspected case of CCHF or LF (see below) Has read and signed the Informed Consent Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Agrees to collection of required specimens Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (\u00b12 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy Has known intolerance to Ribavirin Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission) Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major) Has history of autoimmune hepatitis Has a calculated serum creatinine clearance of < 30 mL/min History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome A sinus bradycardia of less than 40 beats per minute Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin Relative", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-80.0, All Septic Shock Sepsis all patients aged between 18 and 80 years old with the diagnostic of septic shock or severe sepsis pregnants previous diagnosis of any cancer diagnosis of leptospirosis diagnosis of aids", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Flavivirus Infection Alphavirus Infections Malaria Parasitic Disease Leptospirosis Hypertension Metabolic Syndromes For community participants: Health volunteers who are willing to join this study (including the stool and blood testing) after explanation and sign the informed consents For hospital cases: The patients ,who were suspicious of malaria, leptospirosis, Alpha-viral(Chikungunya virus, Ross river virus), and flavivirus infections (dengue fever, Japanese encephalitis..ect) by the attending physicians, will be informed about this study by drawing blood samples if they agree to participate The participants whose stool or blood samples were in-adequate or missing will be excluded from this study The participants whose documented personal information is fake or cannot be identifiable will also be excluded from this study", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection Age > 18 years Transplanted by a functional kidney affected by a hepatitis E chronic Benefiting from a follow-up in the Center of Nephrology and renal Transplantation or in the service of H\u00e9pato-gastro-ent\u00e9rologie of the CHU The Conception in Marseille Having signed a consent informed about participation in the study Affected by another sharp or chronic viral infection", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-85.0, All Japanese Encephalitis Living in the specific 2 villages in Hualien county Aged 18-85 Difficulty to have blood test due to coagulopathy or small blood vessels", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All QIAGEN ResPlex II Advanced Panel Influenza A Influenza B Respiratory Syncytial Virus Infections Infection Due to Human Parainfluenza Virus 1 Parainfluenza Type 2 Parainfluenza Type 3 Parainfluenza Type 4 Human Metapneumovirus A/B Rhinovirus Coxsackie Virus/Echovirus Adenovirus Types B/C/E Coronavirus Subtypes 229E Coronavirus Subtype NL63 Coronavirus Subtype OC43 Coronavirus Subtype HKU1 Human Bocavirus Artus Influenza A/B RT-PCR Test Influenza A, Influenza B, Subjects that sign the Informed Consent form required for prospectively enrolling patients into the study Subjects that present at a hospital, clinic, or physician's office with the signs and symptoms of a respiratory tract infection Subjects with an acute respiratory infection where said acute respiratory infection is suspected of being caused by an Influenza virus Subjects where the duration of the symptoms of such an acute respiratory infection is greater than or equal to 5 days (i.e., \u22655)", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 40.0-80.0, All Pulmonary Disease, Chronic Obstructive Type of subject: outpatient Informed consent: Subjects must give their signed and dated written informed consent to participate Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to or women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception Age: >=40 and <=80 years of age at Screening (Visit 1) Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 Airflow Obstruction Subjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of <=0.70 at Screening (Visit 1) Subjects with a measured post-albuterol/salbutamol FEV1 >=50 and <=70% of predicted normal values calculated using III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1) Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1) Pregnancy: Women who are pregnant or lactating Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD) alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable) Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD) Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal) Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.5-100.0, All Staphylococcus Aureus Infection Cohort A: Participant or child of participant in the Agricultural Health Study Cohort B: Resident of Iowa Cohort A: Age < 8 months Cohort B: Age < 8 months", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 4.0-18.0, All Ascaris Lumbricoides Ascaris Suum Trichuris Trichiura Trichuris Vulpis Ancylostoma Duodenal Ancylostoma Caninum Ancylostoma Ceylanicum Necator Americanus Subjects who are unable to provide a stool sample at follow-up Subjects who are experiencing a severe concurrent medical condition Subjects with diarrhea at first sampling", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Cough Myalgia Nasal Obstruction Sore Throat Headache Fatigue Fever Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study ", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 6.0-16.0, All Serious Emotional Disturbance child has a Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis child at risk of psychiatric hospitalization due to serious out-of-control behaviors child resides in home of legal guardian, who is primary caregiver child insured by Medicaid score in the borderline clinical or clinical range on the Externalizing Scale of the Child Behavior Checklist (CBCL) referred to by a probation officer suffers from an unstable, chronic medical comorbidity prior receipt of", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-4.0, All Pneumococcal Infections Infants Child has birth weight \u2265 2500g Child was born at \u2265 37 weeks of pregnancy or judged to be full-term by midwife or birth attendant Mother has resided in Burkina Faso for at least 2 years Mother has African nationality Child will reside in Bobo-Dioulasso urban area for the duration of the study Parent or guardian has given informed consent for child's participation Infants Child was born with a congenital abnormality Child has chronic or acute severe illness requiring specialized medical care Child has a blood coagulation disorder Mother has known HIV infection Child is enrolled in another clinical trial Child has known allergy to a component of the vaccine Child received a pneumococcal vaccine outside the context of the trial Child is 53 days of age or older at 6 week visit Child weighs <3500g at the 6 week visit Blood draw at 6 week visit was unsuccessful after 3 attempts", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.167-2.0, All Bronchiolitis, Viral Home Nursing Age: 2-24 months, but age postconception of over 44 weeks Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest X-ray confirms a viral diagnosis of bronchiolitis First attack of wheezing O2 Saturation < 91% room air while arrival to the ER The baby and his family have a way to return to the ER after discharge The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine The baby lives in an environment with no smoking The baby's family is available by phone The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of < 4 (see definitions) Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem Age since conception is less than -44 weeks History of apneas Bacterial pneumonia suggested by a localized-focal finding on X-ray Previous wheezing attack O2 Saturation > 92% on room air Family has no transportation available follow-up visits The family lives at a distance greater than 30 minutes drive from the medical facility The baby was treated with steroids for this attack There is no continuous monitoring of the baby at home", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 2.0-4.917, All Influenza Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area and who intends to be present in the area for the duration of the trial A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination Has any serious chronic disease including progressive neurologic disease, tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system Is receiving immunosuppressive agents including systemic corticosteroids during the two weeks prior to study vaccination Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before Lives in household with somebody currently participating in a respiratory vaccination or antiviral study Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 3.0-4.0, All Children Under-nutrition Child is between 36 and 48 months of age Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile Child is capable of oral feeding Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period Child whose either parent has BMI greater than or equal to 27.5 kg/m2 Child allergic or intolerant to any ingredient found in the study product Child who was delivered pre-term Child was born small for gestational Child had birth weight < 2500 g or > 4000 g Child has current acute or chronic infections Child demonstrates presence of severe gastrointestinal disorders Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases Child has a diagnosis of hormonal or metabolic disorders Child has a congenital disease or genetic disorder", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.25-4.0, All Cystic Fibrosis Cystic Fibrosis participants laboratory diagnosis of Cystic Fibrosis Major organ system disease other than Cystic Fibrosis History of prematurity Non Cystic Fibrosis control participants Proof of a negative newborn CF screening test Major organ system disease History of prematurity", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 40.0-999.0, All Acute Coronary Syndrome Recently (< 52 weeks) hospitalized for ACS Age < 40 years ACS event occurring more than 52 weeks prior to randomization visit LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Atrial Fibrillation patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention patients with mild or moderate renal impairment age >= 18 years at enrollment severe renal impairment (Creatinine Clearance < 30 ml/min)", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 5.0-999.0, All Visceral Leishmaniasis Human African Trypanosomiasis Enteric Fever Melioidosis Brucellosis Leptospirosis Relapsing Fever Rickettsial Diseases HIV Tuberculosis Malaria Amoebic Liver Abscess fever for \u2265 1 week \u2265 5 years old (18 years onward in Cambodia) unwilling or unable to give written informed consent unable in the study physician's opinion to comply with the study requirements existing laboratory confirmed diagnosis need of immediate intensive care due to shock or respiratory distress", "label": "1"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-30.0, All Influenza Adults aged between 18-30 Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature \u226537.8\u00b0C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) within 48 hours of illness onset being tested positive with a QuickVue rapid influenza test Allergic to paracetamol or any other antipyretics Have any underlying immunocompromized condition or be receiving immunosuppressive agents Have any history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 2.0-5.0, All Overweight Obesity In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy If the randomly selected child care center has an open case of child abuse or neglect", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 50.0-999.0, All Diabetes Diabetes Mellitus, Type 2 Type 2 diabetes Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day One or more oral or injectable antidiabetic agent(s) An acute coronary or cerebrovascular event in the previous 60 days Planned coronary, carotid or peripheral artery revascularisation Chronic heart failure NYHA (New York Heart Association) class IV Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.25-16.0, All Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 40.0-999.0, All Pulmonary Disease, Chronic Obstructive Informed Consent: A signed and dated written informed consent prior to study participation Type of subject: Outpatient Age: Subjects 40 years of age or older at Visit 1 Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, \"documented\" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening (visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history Severity of COPD symptoms: A score of >=10 on the COPD Assessment Test (CAT) at screening Severity of COPD Disease: A post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of <0.70 at Screening Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only Pro re nata (PRN) COPD medications are not eligible Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD) Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening Risk Factors for Pneumonia: immune suppression (e.g. human immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded Other Respiratory tract infections that have not resolved at least 7 days prior to screening Abnormal Chest x-ray(CXR): Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (Bundesamt f\u00fcr Strahlenschutz [BfS]) Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.25-4.917, All Pneumonia Children admitted with severe pneumonia as defined by the presence of all the following as defined as below months to 59 months old History of cough and/or shortness of breath Unwell for <= 7 days -Increased respiratory rate ( \u2265 50/min if \u226412 months old, \u2265 40/min) or retractions,- Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy Documented fever (axillary /central temp \u2265 38/38.5\u00b0C) within 24 hrs of admission Abnormal CXR with presence of alveolar infiltrates Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 2.0-999.0, All Influenza Poultry-exposed individuals with poultry in the household willing to participate by signing a consent or assent form as appropriate for age, completing the study questionnaire, and permitting the withdrawal of blood, nasal washes, nasal swabs, and throat swabs Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample.) Terminally ill individuals Children who are less than 2 years old when baseline enrollment is performed", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Infant Behavior Child Behavior Parenting Child Rearing Depression Personal Satisfaction Behavioral Symptoms Social Control, Informal Baby is getting pediatric care at Bellevue Hospital Center or Pittsburgh Children's Hospital Caregiver primary language is English or Spanish Family can be contacted (has a working phone) Family attended second (follow-up) meeting with study team Birth weight <2500gm Gestational age < 37 weeks Not singleton birth (twin, triplet, etc.) Known or suspected significant genetic abnormality Known neurodevelopmental/neuromuscular disorder likely to affect development, movement, e.g., seizure disorder, microcephaly (low head circumference) Known sensory defect Known significant malformation likely to affect development or likely to require significant therapy Meets for Early Intervention at birth Significant postnatal complication requiring level II or III nursery stay. Examples: sepsis, significant hypoglycemia, seizures Mother with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia)", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 0.0-999.0, All Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 5.0-999.0, All Tenia Solium Infection Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets (the latter specific for the elimination arm) Willing and able to provide informed consent (signature or thumb print with impartial witness; assent for minors with parental consent) Living in, attending school in, or regularly visiting the bore holes present in, the study communities Aged five years of age or older People without epilepsy Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets (the latter specific for the elimination arm) Unwilling or unable to provide written (signature or thumb print with impartial witness) informed consent (or assent for minors) Living outside of, and not regularly visiting, or attending school in, the study communities Children aged four years or younger People with epilepsy (identified cases by the Rural Health Centre, questions included in the registration procedure) Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses)", "label": "0"} +{"topic": "A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis.", "doc": "eligible ages (years): 18.0-999.0, All Child Abuse Parenting for villages (n = 8) Situated within 1 hour driving distance from Shinyanga, Tanzania Provide community consent via community local leader and approval from local authorities Contain registered farmer groups for participating farmer groups (n = 16, 2 per village) Situated within participating village Registered with Tanzanian Ministry of Agriculture within the previous 3 years Registered to participate in ICS's Agribusiness and Skilful Parenting programme Provide consent via farmer group leader for adults caregivers (n = 240, 30 per village) for adult participants Any adult exhibiting severe mental health problems or acute mental disabilities Any adult that has been referred to social services or child protection services during the course of baseline data collection as a result of reported or observed indications of significant potential psychological harm towards a child for child respondents (n = 240, 30 per village) Age 10 to 17 years at initial assessment Lives in the house at least 4 nights per week Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study Provides assent to participate in the full study for child respondents Any child who is either experiencing severe mental health problems, has acute developmental disabilities", "label": "0"}