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You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Genistein in Treating Patients With Prostate Cancer <BriefSummary:>RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer. <EligibilityCriteria:>Inclusion
* Participants must have a pathologic diagnosis of prostate cancer within the past 6 months, have clinical stage T1-3 disease, PSA \>= 10, Gleason score \>= 8, and have elected to undergo radical prostatectomy; those found to have detectable circulating prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to proceed onto the treatment phase of the protocol; pathology slides used for diagnosis will be submitted to the SPORE tissue pathology core for review
* ECOG performance status 0-1
* Hemoglobin \> 9.0gm/dl
* Platelets \>= 100 K/uL
* ANC \> 1000/uL
* AST (SGOT)/ALT (SGPT) \< 3X upper limit of normal
* Creatinine \< 2.0 mg/dl
* Total bilirubin \< 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
* Participants must agree not to take soy supplements
* Ability to understand and the willingness to sign a written informed consent document
* Willingness to take study agent for at least 2 weeks prior to radical prostatectomy
Exclusion
* History of venous thrombosis within past year
* Participants must not be receiving active therapy for neoplastic disorders (including hormone or radiation therapy for prostate cancer)
* Participants may not be receiving any other investigational agents
* Known soy intolerance
* Medical conditions that, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained <Conditions:>Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer <Interventions:>genistein, placebo, therapeutic conventional surgery | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study Comparing the MiStent SES Versus the XIENCE EES Stent <BriefSummary:>The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events. <EligibilityCriteria:>Inclusion Criteria:
All comers" patients:
* Male or female patients 18 years or older;
* Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
* The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
* The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.
Exclusion Criteria:
* Known pregnancy or breastfeeding at time of randomization;
* Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
* Concurrent medical condition with a life expectancy of less than 12 months.
* The patient is unwilling/ not able to return for outpatient clinic at 1 month and 12 months follow-up.
* Currently participating in another trial and not yet at its primary endpoint. <Conditions:>Coronary Stenosis <Interventions:>MiStent, XIENCE EES | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Efficacy Study in Adult Subjects With Acute Migraines <BriefSummary:>The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines <EligibilityCriteria:>Key Inclusion Criteria:
1. Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version\[1\] including the following:
* Not more than 8 attacks of moderate or severe intensity per month within last 3 months
* Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
2. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
3. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
4. Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Key Exclusion Criteria:
1. Patient history of HIV disease
2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption
6. The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit. <Conditions:>Migraine, With or Without Aura <Interventions:>Rimegepant, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Primary Migraine Type', 'Randomization Strata, Prophylactic Migraine Medication Use' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria <BriefSummary:>This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice. <EligibilityCriteria:>Inclusion Criteria:
* Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician
* HCV infection
Exclusion Criteria:
* None specified <Conditions:>Hepatitis C <Interventions:>Peginterferon alfa-2a, Ribavirin | 'Age, Continuous', 'Sex/Gender, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome <BriefSummary:>The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole <EligibilityCriteria:>Inclusion Criteria:
* Primary Restless Legs Syndrome (i.e. idiopathic RLS)
* Indication for treatment with pramipexole
* Male or female patients older than 18 years
Exclusion Criteria:
* Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
* Current treatment with pramipexole <Conditions:>Restless Legs Syndrome <Interventions:>Sifrol® (pramipexole dihydrochloride) | 'Age, Continuous', 'Sex/Gender, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging <BriefSummary:>Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively. <EligibilityCriteria:>Inclusion Criteria:
* Age 40-90
* Male or female
* Type 2 diabetes
Exclusion Criteria:
* Known pregnancy or nursing.
* Females of child bearing potential must have been surgically sterilized or be post menopausal.
* Smoking
* Known vascular disease
* Inability to complete MRI scan
* Symptoms of claudication
* Use of a nitrate medicine
* Use of any cholesterol-lowering agent
* LDL \< 70
* Acute illness
* Liver disease
* Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history). <Conditions:>Diabetes <Interventions:>lipitor | 'Age, Customized', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Molecular Guided Therapy for Refractory or Recurrent Neuroblastoma <BriefSummary:>The purpose of this study is to test the feasibility (ability to be done) of an experimental test to help plan your cancer treatment. This study plan is not studying the effectiveness of the proposed combinations of therapy for your cancer that you may receive after the experimental testing.
This study will look at an experimental technology to determine a tumor's molecular makeup (gene expression profile). This technology (called "OncInsights") is being used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future. The experimental technology has not been approved by the U.S. Food and Drug Administration. <EligibilityCriteria:>Inclusion Criteria:
* Patients must have histologically proven neuroblastoma and confirmation of refractory or recurrent disease with histologic confirmation at diagnosis or at the time of recurrence/progression
* Patients must be age \> 12 months and ≤ 21 at initial diagnosis.
* Life expectancy must be more than 3 months
* If measurable disease, this must be demonstrated by residual abnormal tissue at a primary or metastatic site measuring more than 1 cm in any dimension by standardized imaging (CT or MRI); tumor must be accessible for biopsy. Patients with bone marrow only disease expected to be \> 75% are eligible to enroll.
* Current disease state must be one for which there is currently no known curative therapy
* Lansky or KarnofskyScore must be more than 50
* Patients without bone marrow metastases must have an ANC \> 750/μl and platelet count \> 50,000/μl
* Adequate liver function must be demonstrated, defined as:
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND
* SGPT (ALT) \< 10 x upper limit of normal (ULN) for age
* No other significant organ toxicity defined as \> Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events NCI-CTCAE V4.0
* A negative serum pregnancy test is required for female participants of child bearing potential (≥ 13 years of age or after onset of menses)
* Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
* Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines. Voluntary consent for optional biology studies will be included.
Exclusion Criteria:
* Patients who have received any chemotherapy within the last 7 days prior to enrollment and 14 days prior to study treatment start date.
* Patients who have received any radiotherapy within the last 30 days must have another site of disease to follow.
* Patients receiving anti-tumor therapy for their disease or any investigational drug concurrently
* Patients with serious infection or a life-threatening illness (unrelated to tumor) that is \> Grade 2 (NCI CTCAE V4.0), or active, serious infections requiring parenteral antibiotic therapy.
* Patients with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a patient's ability to sign or the legal guardian's ability to sign the informed consent, and patient's ability to cooperate and participate in the study <Conditions:>Neuroblastoma <Interventions:>Guided Therapy | 'Age, Categorical', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot <BriefSummary:>20 parents with healthy preterm infants (born at \<37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment will be enrolled to obtain records of sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot. <EligibilityCriteria:>Inclusion Criteria:
Subjects (parent and infant) must meet the following criteria:
* Healthy infants (preterm and full-term) must be 0-6 months of age at time of enrollment
* Infants must be at home (discharged from the hospital) at time of enrollment
* Informed consent from parent whose age is ≥21 years
* Parent must be proficient in the English language
* Parent must be able to comply with the required study tasks, as per PI's judgment
* In-home access to reliable internet connections; a mobile device suitable for electronic communication
Exclusion Criteria:
Infant must not meet any of the following criteria:
* Known to have current or previous illnesses/conditions which could interfere with the study outcome (per PI's clinical judgment)
* Must not be currently participating in any other clinical study
Parent must not meet any of the following criteria:
* Must not be known to have a significant medical condition that might interfere with the study (per PI's clinical judgment) that meets one of the following criteria:
* Presence of current mental illness or history of mental illness
* Any acute or chronic illness that makes the parent unsuitable for the study based on the PI's judgment
* Must not be a single parent
* Inability of the parent to comply with the study protocol or PI's uncertainty about the willingness or ability of the parent to comply with the protocol requirements <Conditions:>Preterm Birth, Healthy <Interventions:>No Interventions | 'Age, Customized', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Internet-based CBT After Stroke Pilot <BriefSummary:>Mood disorders occur in 25-30% of stroke patients and are associated with lower quality of life, higher mortality, increased healthcare utilization, and higher costs. Cognitive behavioral therapy (CBT) interventions have been shown to both treat and prevent post-stroke mood disorders, thus having the ability to improve quality of life and reduce costs. This study aims to test the feasibility of internet-based CBT combined with a telephone/email based coaching service after stroke. <EligibilityCriteria:>Inclusion Criteria:
* Age ≥18 years of age
* Acute ischemic stroke within the past 3 months
* Regular access to the internet, sufficient to allow a minimum of interactions with the internet daily, either through a personal smartphone or web-based internet browser.
* Subject is willing and able to participate in internet-based cognitive behavioral therapy
* Can participate in the program in English
* Willingness and ability to sign informed consent by the patient
* Symptoms of mild to moderately depressed mood, defined as a score of 5-19 on the Patient Health Questionnaire-9 at the time of study enrollment.
Exclusion Criteria:
* Severely depressed patients, defined by a score of 20+ on the Patient Health Questionnare-9 are excluded
* Patients with an active bipolar disorder diagnosis are excluded
* Patients with personality disorder diagnoses are excluded
* Patients with active suicidality or past suicide attempts are excluded
* History of schizophrenia or schizoaffective disorder
* Active participation in face-to-face psychotherapy prior to stroke
* Patients with a history of dementia are excluded
* Patients with aphasia, defined as a score of 1 or greater on NIH Stroke Scale Item 9 are excluded.
* Patients without regular internet access through a computer, tablet or smartphone are excluded.
* Subjects requiring long-term inpatient nursing care are excluded. For patients enrolled as inpatients, individuals being discharged to both home and acute rehab are eligible. Individuals being discharged to a skilled nursing facility or hospice are excluded.
* Expected life expectancy less than 6 months or other inability to comply with study follow-up.
* Pregnant women and prisoners are excluded <Conditions:>Stroke, Depression <Interventions:>Cognitive behavioral therapy | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT <BriefSummary:>The purpose of this study is to see if applying parafilm as an external barrier on the central line in children having a bone marrow transplant helps to prevent central line associated bloodstream infection(s) and also to assess the ease of use of parafilm. <EligibilityCriteria:>Inclusion Criteria:
* Must be between the age of 0 and 21 years at the time of enrollment
* Must be undergoing allogeneic or autologous HCT for a malignant or non-malignant disorder
* Must have or be scheduled to have a tunneled CVC
Exclusion Criteria:
* Patients undergoing other interventions to prevent CLABSI (e.g. Children's Oncology Group (COG) study ACCL1034 with Chlorhexidine Gluconate (CHG); antimicrobial lock therapy, etc.)
* Patients who only have a port <Conditions:>Central Line Associated Bloodstream Infections (CLABSI), Bone Marrow Transplant <Interventions:>Parafilm | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Type of HCT', 'Underlying disease' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk <BriefSummary:>A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk. The investigators hypothesize that infants who receive primarily their own mother's milk will have better growth, a more diverse intestinal bacterial environment, and possibly some improved short term outcomes such as better feeding tolerance and lower rates of infection. <EligibilityCriteria:>Inclusion Criteria:
* Infants less than 72 hours old and less than 1500 g birth weight, who have reasonable expectation of survival and can adhere to a feeding protocol involving mother's own milk and/or donor milk that will include fortification using Prolacta and potentially human cream.
Exclusion Criteria:
* Exclusion criteria will include birth weight greater than 1500 g, age \> 72 hours old, major congenital anomalies, clinically significant heart disease, abdominal wall defects and/or intestinal atresias, severe perinatal hypoxia, or otherwise less than reasonable expectation of survival through the study period. <Conditions:>Infant, Very Low Birth Weight <Interventions:>Observational - no intervention | 'Age, Customized', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study) <BriefSummary:>HIV-infected individuals treated with antiretroviral medications are living longer, but have an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV population in association with with increased belly fat and altered glucose metabolism. Elevations in aldosterone hormone may also be associated with abnormal blood flow, inflammation, and coronary plaque in the heart. This study is being conducted to evaluate whether therapies to reduce the actions of aldosterone may decrease the burden and progression of heart disease in the HIV population. <EligibilityCriteria:>Inclusion Criteria:
1. Ages 40-65 years
2. Antiretroviral use (ART) \>12 months and HIV viral load \<100 copies/mL
3. VAT\> 110cm2
Exclusion Criteria:
1. Antihypertensive use including, ACE Inhibitor, ARB, MR blockade, diuretic, potassium (K) supplementation; or BP\>140/90 mmHg. Stable use (\>3 months) of beta-blockers or calcium channel blockers (CCB) (except verapamil) is allowed.
2. Unstable statin use \<12 months. Stable use (\>12 months) is allowed.
3. Use of full dose ritonavir, nelfinavir, clarithromycin, and other strong inhibitors of CYP3A4, as well as CYP3A4 inducers.
4. Continuous oral steroid use (equivalent to prednisone \> 5 mg daily) within the last 3 months.
5. Uncontrolled diabetes requiring insulin and/or HbA1c \> 7.5%.
6. Creatinine (Cr) \> 1.5 mg/dL or estimated GFR\<60 mL/min/1.73m2.
7. K \> 5.5 mEq/L.
8. Hemoglobin \< 10 g/dL.
9. Known liver disease or ALT \>3x ULN.
10. History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease.
11. Pregnant, actively seeking pregnancy or breastfeeding.
12. Estrogen, progestin derivative, or other sex steroid use within last 3 months. Stable physiologic testosterone replacement (\> 3 months) is acceptable.
13. Current bacterial or other infections.
14. Active substance abuse.
15. Significant radiation exposure over the course of the year prior to randomization (e.g., radiation therapy, PCI, catheter ablation of arrhythmia) within 12 months of randomization.
16. Previous reaction or contraindication to iodine-containing contrast media and gadolinium.
17. Coronary artery luminal narrowing \>70% on coronary CTA. <Conditions:>HIV <Interventions:>Eplerenone, Placebo, Lifestyle Modification | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Blood Level Study of Unit Dose Budesonide <BriefSummary:>The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers. <EligibilityCriteria:>Inclusion Criteria:
* Healthy adult volunteers, aged 18-50 years
* BMI less than 30 kg/m2
* Non smoker (currently and \<10 pack years total if ex-smoker)
Exclusion Criteria:
* Any use of corticosteroid in previous 4 weeks
* Pregnancy/lactation
* Significant blood donation (or testing) in previous 8 weeks <Conditions:>Asthma <Interventions:>Budesonide Inhalation Suspension, MAP0010 low dose, MAP0010 intermediate dose, MAP0010 high dose | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Dasatinib With Fludarabine and Rituximab in Relapsed and Refractory CLL and SLL <BriefSummary:>Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are similar diseases of the white blood cells and are typically treated the same way. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death of CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells. The purpose of this study is to see of the study drug dasatinib, in combination with fludarabine and rituximab, is safe and effective to use for people with relapsed or refractory CLL/SLL. <EligibilityCriteria:>Inclusion Criteria:
* CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23, and CD5. Patients may be CD23 negative as long as they are also cyclin D1 negative or t(11;14) negative.
* Participants must have received at least 1 prior regimen containing a purine analogue or have received at least 2 chemotherapy regimens not containing a purine analogue. Patients may be refractory to single-agent purine analogue treatment, but patients may not be refractory to a combination of purine analogue with rituximab. Patients may have received rituximab.
* 18 years of age or older
* Able to take oral medications
* ECOG Performance Status of 2 or better
* Adequate organ function to tolerate chemotherapy
* Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration and agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study is stopped.
* Require treatment based on 1996 NCI-WG criteria updated in 2008 by the IWCLL
* Patient agrees to discontinue St. John's Wort while receiving dasatinib therapy and stop at least 5 days before starting dasatinib.
* Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib
Exclusion Criteria:
* Pregnant or breastfeeding women
* Uncontrolled angina, congestive heart failure, or MI within 6 months
* Diagnosed or suspected congenital long QT syndrome
* Any history of clinically significant ventricular arrhythmias
* Prolonged QTc interval on pre-entry ECG
* Uncontrolled hypertension
* Hypokalemia or hypomagnesemia that is not corrected prior to dasatinib administration
* Patients should not be taking drugs that are generally accepted to have a risk of causing Torsades de Pointes
* Known HIV positive
* Known significant bleeding disorder unrelated to CLL
* Any significant pleural or pericardial effusion
* Patients may not have another malignancy that is uncontrolled or requires treatment within a year of starting this study. <Conditions:>Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma <Interventions:>dasatinib, Rituximab, fludarabine | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Open-Label Extension Study of Kuvan for Autism <BriefSummary:>This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism. <EligibilityCriteria:>Inclusion Criteria:
* All subjects must have completed earlier trial, CHC 0901 (NCT00850070)
* Parents must be willing and able to sign informed consent
Exclusion Criteria:
* Child failed to complete CHC 0901 (NCT00850070) <Conditions:>Autistic Disorder <Interventions:>Kuvan® | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients <BriefSummary:>The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health. <EligibilityCriteria:>Inclusion Criteria:
* Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification:
* T/natural killer (NK)-cell leukemia/lymphoma
* Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+)
* Angioimmunoblastic TCL
* Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy
* PTCL-unspecified
* Enteropathy-type intestinal lymphoma
* Hepatosplenic TCL
* Subcutaneous panniculitis TCL
* Transformed mycosis fungoides (tMF)
* Extranodal T/NK-cell lymphoma nasal or nasal type
* Primary cutaneous gamma-delta TCL
* Primary cutaneous CD8+ aggressive epidermic cytotoxic TCL
* Documented completion of at least 6 cycles of CHOP-based therapy:
* CHOP 21
* CHOP 14
* CHOP + etoposide
* Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization.
* Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization.
* Eastern Cooperative Oncology Group performance status less than or equal to 2.
* Adequate blood, liver, and kidney function as defined by laboratory tests.
* Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate.
* Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate.
* Has given written informed consent.
Exclusion Criteria:
* Patient has:
* Precursor T/NK neoplasms
* ALCL (ALK+) with IPI score less than 2 at initial diagnosis and CR after CHOP-based therapy
* T cell prolymphocytic leukemia
* T cell large granular lymphocytic leukemia
* Mycosis fungoides, except tMF
* Sézary syndrome
* Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis
* If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease.
* non-melanoma skin cancer
* carcinoma in situ of the cervix
* localized prostate cancer
* localized thyroid cancer
* Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except:
* Patients with nasal NK lymphoma who received local RT less than 4 weeks prior to randomization.
* Patients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation.
* Prior exposure to pralatrexate.
* Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of 10 mg/day or less of oral prednisone or equivalent for at least 4 weeks or as part of a CHOP prednisone taper.
* Planned use of any treatment for PTCL during the course of the study.
* Patient has:
* Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and receiving anti-retroviral therapy.
* Hepatitis B (HBV)-positive serology and is receiving interferon therapy or has liver function test results outside the parameters of study inclusion criteria. Other antiviral therapies are permitted if at a stable dose for at least 4 weeks.
* Hepatitis C (HCV) virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
* Symptomatic central nervous system metastases or lesions requiring treatment.
* Uncontrolled hypertension or congestive heart failure Class III/IV per the New York Heart Association's Heart Failure Guidelines
* Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability of the patient to receive protocol treatment.
* Major surgery within 2 weeks prior to study entry, except for line placement or biopsy procedure. <Conditions:>Peripheral T-cell Lymphoma <Interventions:>Pralatrexate Injection | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine <BriefSummary:>The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent A/H1N1 influenza vaccine (IVACFLU)--each dose with an HA content of 15 mcg from A/California/07/2009 (H1N1)-like virus--will be safe and immunogenic in healthy adults. <EligibilityCriteria:>Inclusion Criteria:
* Male or female adult 18 (age of legal consent in Vietnam) through 40 years of age at the enrollment visit.
* Literate and willing to provide written informed consent.
* Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
* Capable and willing to complete diary cards and willing to return for all follow-up visits
* For females, willing to utilize reliable birth control measures (intrauterine device, birth control pills, condoms) through the Day 42 visit.
Exclusion Criteria:
* Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
* Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 42 visit.
* Current or recent (within two weeks of enrollment) acute illness with or without fever.
* Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products prior to the Day 42 visit.
* Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, \>=0.5 mg per kg per day; topical steroids are allowed.)
* History of asthma.
* Hypersensitivity after previous administration of any vaccine.
* Other AE following immunization, at least possibly related to previous receipt of any vaccine.
* Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
* Known hypersensitivities (allergies) to food or the natural environment.
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives..
* History of leukemia or any other blood or solid organ cancer.
* History of thrombocytopenic purpura or known bleeding disorder.
* History of seizures.
* Known or suspected immunosuppressed or immunodeficient condition of any kind, including HIV infection.
* Known chronic HBV or HCV infection.
* Known active tuberculosis or symptoms of active tuberculosis, regardless of cause.
* History of chronic alcohol abuse and/or illegal drug use.
* Pregnancy or lactation. (A negative pregnancy test will be required before administration of study vaccine or placebo for all women of childbearing potential.)
* History of Guillain-Barre' Syndrome
* Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives. <Conditions:>Influenza <Interventions:>IVACFLU, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Handedness', 'Height', 'Weight' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes <BriefSummary:>The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied <EligibilityCriteria:>Inclusion Criteria:
* Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
* Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
* C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
* Body Mass Index ≤ 45 kg/m²
* Must be able to perform self monitoring of blood glucose
Exclusion Criteria:
* aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3\* upper limit of normal (ULN)
* Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
* Creatinine kinase \>3\* ULN
* Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases <Conditions:>Type 2 Diabetes Mellitus <Interventions:>Dapagliflozin, Placebo | 'Age, Continuous', 'Age, Customized', 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Body Mass Index in Kg/m^2', 'Hemoglobin A1c (HbA1c) %', 'Waist Circumference' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Pharmacokinetic Alterations During ECMO <BriefSummary:>In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide. However, in patients with severe lung failure, blood may not adequately be delivered to the lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may require assistance from a machine to help provide this oxygen. Extracorporeal membrane oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to recover from their illness. Patients receiving support from ECMO are often put in a medically induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the machine; therefore leading to decreased concentrations. Patients receiving ECMO often require high doses of both pain medications and sedatives in order to provide comfort. Low doses of a drug, ketamine, may help to provide additive effects to pain relief and allow lower doses of other pain medications. The hypothesis is that patients treated with continuous intravenous ketamine, will have lower requirements of other pain medications while receiving ECMO for acute respiratory failure while achieving the desired level of sedation. <EligibilityCriteria:>Inclusion Criteria:
* Receiving ECMO for acute respiratory failure
* Requiring deep sedation (RASS -5)
Exclusion Criteria:
* Allergy to ketamine <Conditions:>Acute Respiratory Failure <Interventions:>Ketamine, Sedative drug regimen | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD) <BriefSummary:>Critically ill patients with flu may receive a drug called oseltamivir. They may also receive medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO) and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD and ECMO may remove some oseltamivir from the bloodstream. The purpose of this study is to determine how much oseltamivir gets removed by CVVHD or ECMO in critically ill patients. <EligibilityCriteria:>Inclusion Criteria:
* receiving Continuous Venovenous Hemodialysis (CVVHD) or Extracorporeal Membrane Oxygenation (ECMO)
* require oseltamivir treatment
* informed consent granted
Exclusion Criteria:
* pregnant
* unable to complete 12 hours of CVVHD or ECMO
* \<6 kg body weight
* allergy to oseltamivir <Conditions:>Critically Ill Renal Failure Requiring CVVHD and Oseltamivir, Critically Ill Requiring ECMO and Oseltamivir <Interventions:>pharmacokinetic blood sampling, pharmacokinetic blood and dialysate sampling | 'Age, Categorical', 'Age Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL <BriefSummary:>This study is a Phase 1b, open-label, single arm dose escalation study of Betalutin followed by rituximab in patients with previously treated follicular lymphoma. The purpose of this study is to characterise the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of Betalutin in combination with rituximab. <EligibilityCriteria:>Inclusion Criteria:
* Patient must be ≥18 years at the time of signing the informed consent
* ECOG performance status of 0-2
* Histologically confirmed diagnosis (by 2008 World Health Organization \[WHO\] classification) of follicular lymphoma (grade 1, 2 or 3a)
* At least one (but not more than 3) prior regimens with an anti-CD20 antibody (alone or in combination with chemotherapy), with documented relapsed, refractory disease (must not be anti-CD20 antibody-refractory) or PD
* Presence of at least one bi-dimensionally measurable lesion by CT or MRI: longest diameter (LDi) \>1.5 cm for a nodal lesion; LDi \>1.0 cm for an extranodal lesion within 28 days prior to start of treatment
* Normal organ and bone marrow function defined as:
1. Absolute neutrophil count ≥1.5 x 109/L;
2. Platelet count ≥150 x 109/L;
3. Haemoglobin ≥9 g/dL;
4. Total bilirubin ≤1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome \[\<3.0 mg/dL\]);
5. Aspartate transaminase (AST); Alanine transaminase (ALT) or Alkaline phosphatase (ALP) ≤2.5 x ULN (or ≤5.0 x ULN if liver involvement by primary disease);
6. Adequate renal function as demonstrated by a serum creatinine within the upper limit of normal range
* Bone marrow involvement by lymphoma \<25%
* Life expectancy \>3 months
* Negative hepatitis B, hepatitis C and human immunodeficiency virus (HIV) screening tests
* Patients must agree to use effective contraception for 12 months following last study drug administration
Exclusion criteria:
* Previous haematopoietic stem cell transplantation (autologous and allogenic)
* Evidence of histological transformation from FL to DLBCL at time of screening.
* Previous total body irradiation
* Chemotherapy, immunotherapy or investigational therapy within 28 days before the start of study drug administration (corticosteroid treatment at doses of ≤20 mg/day, topical or inhaled corticosteroids, granulocyte colony-stimulating factor \[G-CSF\] or granulocyte-macrophage colony-stimulating factor \[GM CSF\] are permitted up to 2 weeks prior to start of study treatment) or failure to recover from AEs associated with prior treatment
* Previous treatment with radioimmunotherapy
* Patients who are receiving any other investigational medicinal products
* Known or suspected central nervous system (CNS) involvement of lymphoma
* History of a previous treated cancer except for the following:
1. adequately treated local basal cell or squamous cell carcinoma of the skin
2. cervical carcinoma in situ
3. superficial bladder cancer or localised prostate cancer undergoing surveillance or surgery
4. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy
5. other adequately treated Stage 1 or 2 cancer currently in CR
* Pregnant or lactating women
* Exposure to another CD37 targeting drug
* A known hypersensitivity to RTX, lilotomab, Betalutin or murine proteins or any excipient used in RTX, lilotomab or Betalutin
* Receipt of live, attenuated vaccine within 30 days prior to enrolment
* Evidence of severe or uncontrolled systemic diseases (e.g. ongoing infection, respiratory, cardiac, hepatic or psychiatric conditions) which in the Investigator's opinion would compromise the protocol objectives <Conditions:>Non Hodgkin Lymphoma, Follicular Lymphoma, Relapsed Follicular Lymphoma <Interventions:>10 MBq/kg Betalutin, 15 MBq/kg Betalutin | 'Age, Categorical', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Heart at Work Study <BriefSummary:>This is an observational study to examine the cardiovascular mechanisms of increased cardiovascular mortality in those with high activity occupations. <EligibilityCriteria:>Inclusion Criteria:
* middle age (35-59 years)
* male
* self-report working full-time in the food service industry (≥30 hours/week)
* self-report predominantly completing light intensity activity job responsibilities (≥75% work time walking, light movement, or standing)
Exclusion Criteria:
* Resting blood pressure of ≥150 mmHg systolic and/or ≥95 mmHg diastolic
* currently taking medications that are known to affect blood pressure or heart rate (e.g. Beta-blockers, ACE inhibitors, etc.)
* greater than low risk to participate in physical activity as determined by PAR-Q (answer of yes to any of the 7 physical activity readiness questionnaire questions)
* report working a second job in addition to their primary full-time job
* report working overnight shifts (10pm-6am)
* reported physical dysfunction (inability to walk 2 city blocks or climb 2 flights of stairs)
* inability to complete the sub-maximal exercise test to completion (80% age-predicted heart rate maximum)
* Currently being treated for a serious medical condition such as kidney disease, liver disease, cancer, or heart disease. <Conditions:>Occupational Diseases, Cardiovascular Diseases, Cardiovascular Risk Factor, Occupational Exposure <Interventions:>No Interventions | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Occupational Industry' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Efficacy Trial of Testosterone Undecanoate <BriefSummary:>The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men. <EligibilityCriteria:>Inclusion Criteria:
* Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)
Exclusion Criteria:
* Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression.
* Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event
* Untreated, severe obstructive sleep apnea
* Hematocrit \<35% or \>48%
* Serum transaminases \>2 times upper limit of normal, serum bilirubin \>2.0 mg/dL, and serum creatinine \>2.0 mg/dL
* BMI \> or equal to 38
* Stable doses of lipid-lowering medication for less than three months
* Stable doses of oral medication for diabetes for less than two months
* Abnormal prostate digital rectal examination \[palpable nodule(s)\], elevated PSA (serum PSA \>3.9 ng/mL), IPSS score \> or equal to 19 points, and /or history of prostate cancer.
* History of breast cancer
* Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks
* Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors
* Known history of abuse of alcohol or any drug substance with the previous 2 years
* Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics
* Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
* Blood donation within the 12 week period before initial dose administration in this study <Conditions:>Male Hypogonadism <Interventions:>Oral testosterone undecanoate | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes <BriefSummary:>RATIONALE: Combinations of biological substances in DT388IL3 fusion protein may be able to carry cancer killing substances directly to the cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of DT388IL3 fusion protein and to see how well it works in treating patients with acute myeloid leukemia or myelodysplastic syndromes. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Histologically or morphologically confirmed acute myeloid leukemia (AML), meeting 1 of the following criteria:
* Relapsed or refractory AML after treatment with ≥ 1 prior conventional induction therapy
* Patients in early first relapse must not have a matched donor available and/or be ineligible for allogeneic stem cell transplantation
* Poor-risk AML, as defined by any of the following criteria:
* Treatment-related AML, unless associated with favorable cytogenetics (e.g., inversion 16, t\[16;16\], t\[8;21\], t\[15;17\]), and ineligible for stem cell transplantation
* Antecedent hematological disease (e.g., myelodysplastic syndromes, myelofibrosis, or polycythemia vera) that evolved to AML (≥ 20% blasts) and ineligible for stem cell transplantation
* De novo AML (must be \> 70 years of age)
* AML with unfavorable cytogenetics (e.g., abnormalities of chromosomes -7, -5, 7q-, or 5q-; complex \[≥ 3\] abnormalities; or abnormalities of 11q23, excluding t\[9;11\], t\[9;22\], inversion 3, t\[3;3\], and t\[6;9\]), regardless of age, and ineligible for allogeneic stem cell transplantation
* High-risk myelodysplastic syndromes diagnosed by morphologic, histochemical, or cell surface marker criteria
* Resistant or intolerant to chemotherapy
* Ineligible for or unwilling to undergo immediate allogeneic stem cell transplantation
* Bone marrow index (i.e., percent cellularity × percent blasts) ≤ 40% at time of treatment
* No active CNS leukemia
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Bilirubin ≤ 1.5 mg/dL
* ALT and AST \< 2.5 times upper limit of normal
* Albumin ≥ 3 mg/dL
* Creatinine ≤ 1.5 mg/dL
* LVEF ≥ 50%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 weeks after completion of study treatment
* No complicated medical or psychiatric problems that would preclude study compliance
* No concurrent serious uncontrolled infection or disseminated intravascular coagulation
* No myocardial infarction within the past 6 months
* No allergies to diphtheria toxin
* No requirement for oxygen
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No other concurrent antineoplastic drugs
* No concurrent radiotherapy
* No concurrent corticosteroids as antiemetics
* No concurrent hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\])
* No concurrent intravenous immunoglobins <Conditions:>Leukemia, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasm <Interventions:>DT388IL3 | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Center of Research Translation (CORT) Project 2 <BriefSummary:>We propose a novel intervention for reducing BP that could have a preferential impact in patients with hyperuricemia and gout. There is a great need for new anti-hypertensives, particularly among those with gout. The proposed study is novel in its plans to investigate the physiologic mechanisms through which urate contributes to vascular disease and by which ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the described benefit of lowering serum urate extends beyond the adolescent population previously studied into young adults, 2) test whether a urate-lowering approach will benefit individuals that do not yet meet the current definition of hyperuricemia and do not have gout, and 3) begin to explore potential mechanisms for the higher prevalence of hypertension among African-Americans. If successful, this work could translate to the standard of clinical care and to health care recommendations for the population as a whole. <EligibilityCriteria:>Inclusion Criteria:
* Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
* Systolic blood pressure (SBP) ≥ 120 and \<160 or;
* Diastolic blood pressure (DBP) ≥ 80 and \< 100
* Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
* Age 18-40
Exclusion Criteria:
* Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed)
* Estimated glomerular filtration rate \< 60 mL/min/1.73m2
* Current use of any urate-lowering therapy or statins
* Prior diagnosis of gout or past use of urate-lowering therapy for gout
* Prior diagnosis of diabetes
* Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
* Active smokers
* Immune-suppressed individuals including transplant recipients or current use of azathioprine.
* Leucopenia with absolute white cell count \< 3000 /mL, anemia with hemoglobin \< 12 g/dL, or thrombocytopenia with platelet count \< 150,000/mL
* Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
* Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol <Conditions:>Pre-hypertension, JNC 7 Stage I Hypertension <Interventions:>Allopurinol, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Systolic Blood Pressure', 'Diastolic Blood Pressure', 'Body Mass Index', 'Serum urate (mg/dL)', 'Flow Mediated Dilation', 'high sensitivity C-reactive protein (hs-CRP)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia <BriefSummary:>The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability. <EligibilityCriteria:>Inclusion Criteria:
* Participants who meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (disorganized type \[295.10\], catatonic type \[295.20\], paranoid type \[295.30\], residual type \[295.60\], or undifferentiated type \[295.90\]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
* A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120, inclusive, at screening and baseline
* Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square (kg/m\^2)
* Female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study
* Be capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study Exclusion Criteria:
* A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
* A decrease of at least 25 percent in the total PANSS score between screening and baseline
* Participants who have previously participated in this study
* A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
* History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage) <Conditions:>Schizophrenia <Interventions:>Paliperidone palmitate (R092670), Risperidone | 'Age Continuous', 'Sex: Female, Male', 'Age Categorical' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet <BriefSummary:>• To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®). <EligibilityCriteria:>Inclusion Criteria:
* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).
Exclusion Criteria:
* 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 an investigational drug within 30 days or 5 half lives preceding the first dose of study medication. <Conditions:>Hypercholesterolemia <Interventions:>Atorvastatin, Atorvastatin | 'Age, Customized', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age <BriefSummary:>This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes. <EligibilityCriteria:>Key Inclusion Criteria:
* Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)
* Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex, and height.
Key Exclusion Criteria:
* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status.
* Solid organ or hematological transplantation.
Other protocol defined Inclusion/Exclusion criteria may apply. <Conditions:>Cystic Fibrosis <Interventions:>ELX/TEZ/IVA, IVA | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of Peginterferon Alfa-2a (Pegasys) When Administered in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) <BriefSummary:>This study will compare the efficacy and safety of 2 different treatment durations of peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is greater than (\>) 500 individuals. <EligibilityCriteria:>Inclusion Criteria:
* Male and female patients with chronic hepatitis C and genotype 1 (1a or 1b) or genotype 4
* Age between 18 and 70 years
* Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
* Present with at least one elevated serum alanine-aminotransferase (ALT) level higher than normal in the last 6 months before therapy start including the screening period
* Positive HCV-RNA level in serum
* Laboratory parameters (within 35 days prior to study start): -Hepatitis A anti - IgM negativity, HIV-Ab negativity, HBsAg negativity, Hemoglobin values \> 12 g/dl in women or \> 13 g/dl in men, Leukocyte count (WBC) \> 3 000 /mcl, Platelets count \> 100 000/mcl, Creatinine not 1.5 times higher than normal, normal TSH, normal uric acid with a maximum tolerance of 15 % in patients without history of gout
* Liver biopsy findings within 6 months prior to study therapy consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis. Biopsies older than 1 year are eligible only after direct communication with the principal investigator
* Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. If there is no laboratory report existing, the physician should make an entry in the medical history that the pregnancy test was negative.
* All fertile females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end. All fertile men with female partners must be using two forms of effective contraception during treatment and during the 7 months after treatment end.
* Written informed consent obtained
Exclusion Criteria:
* Any IFN and / or Pegylated IFN and ribavirin therapy at any previous time
* Class B or C cirrhosis as coded by Child Pugh classification
* Women with ongoing pregnancy or breast feeding
* Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
* Any investigational drug 6 weeks prior to the first dose of study drug
* Drug addiction within 1 year prior to study start (patients participating in an official methadone program are eligible)
* Diabetes mellitus in patients receiving an insulin therapy
* Hemophiliac patients (due to the increased risk of requested liver biopsy)
* History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
* History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease. Exception: if there is a current psychiatric report which certifies there is no contraindication to interferon therapy, patient may be included
* History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.)
* History or other evidence of chronic pulmonary disease associated with functional limitation
* History of a severe seizure disorder or current anticonvulsant use
* History of severe cardiac disease and severe coronary heart disease within the last 6 months (angina pectoris, congestive heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia). If there is clinical suspicion of coronary heart disease cardiologic workup of the patient prior to study entry is recommended.
* History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
* History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* History of major organ transplantation with an existing functional graft
* Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
* Inability or unwillingness to provide informed consent or abide by the requirements of the study
Additional exclusion criteria concerning ribavirin:
* Male partners of women who are pregnant
* Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
* Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL would not be well-tolerated <Conditions:>Hepatitis C, Chronic <Interventions:>Peginterferon alfa-2a, Ribavirin | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia <BriefSummary:>The aim of this study was to determine if the addition of ketamine reduces remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL(interleukin)-6 and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine). <EligibilityCriteria:>Inclusion Criteria:
* ≥ 18 years old
* both sexes
* ASA physical status I or II
* undergoing laparoscopic cholecystectomy
Exclusion Criteria:
* chronic users of analgesics or had used opioids within 12 h of surgery
* history of drug or alcohol abuse or psychiatric disorder
* contraindications to self-administration of opioids (ie, unable to understand the patient-controlled analgesia \[PCA\] device)
* contraindication for the use of ketamine, such as a psychiatric disorder, acute cardiovascular disorder, or unstable hypertension <Conditions:>Pain, Hyperalgesia, Inflammatory Response <Interventions:>Ketamine, Saline | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes <BriefSummary:>The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity <EligibilityCriteria:>Inclusion Criteria:
* Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit
* Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment
* C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
* BMI ≤ 45.0 kg/m2
Exclusion Criteria:
* Urine albumin to creatinine ratio (UACR) \> 1,800 mg/g (203.4 mg/mmol/Cr)
* Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 3X ULN
* Serum Total Bilirubin \> 2 mg/dL (34.2 μmol/l)
* Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases <Conditions:>Type 2 Diabetes Mellitus <Interventions:>Dapagliflozin, Placebo | 'Age, Continuous', 'Age, Customized', 'Sex/Gender, Customized', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Enhanced Medical Rehabilitation in Older Adults <BriefSummary:>The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events. <EligibilityCriteria:>Inclusion Criteria:
* 65 and older
* Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.
Exclusion Criteria:
* Language, visual or hearing barriers to participation
* Medical illness preventing study participation or accurate data collection
* Moderate-severe dementia (demonstrated by chart diagnosis and/or short blessed score greater than 13)
* Progressive neurological condition such that recovery of function is not feasible
* Patient did not have the ability to walk prior to hospitalization (e.g. paraplegic)
* Schizophrenia or other chronic or current psychotic disorder. <Conditions:>Disabling Medical Events, Disabled, Depression <Interventions:>Enhanced Medical Rehabilitation, Standard of Care Rehabilitation | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Impairment Type', 'MADRS Score', 'Short Blessed Test Score', 'Barthel Index Total Score (Premorbid)', 'Barthel Index Total Score (Admission)', 'CIRS-G Score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan <BriefSummary:>This is a survey among pharmacists who have instructed NINLARO therapy in ixazomib, lenalidomide and dexamethasone (IRD) dosing to patients with relapsed/refractory multiple myeloma (rrMM).
The main aims of the study are:
* To assess the frequency of pharmacists who have provided patients with the contents of the RMP material for patients.
* To assess the frequency of pharmacists who have obtained the RMP material for patients.
* To evaluate the depth of understanding of proper usage of NINLARO among pharmacists. <EligibilityCriteria:>Inclusion criteria:
1. Who belong to hospitals prescribing NINLARO.
2. Who have instructed the dosing of NINLARO in IRD therapy to patients.
Exclusion criteria:
None <Conditions:>Multiple Myeloma <Interventions:>No Intervention | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Developing and Testing a Comprehensive MS Spasticity Management Program <BriefSummary:>This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial. <EligibilityCriteria:>Inclusion Criteria:
Diagnosis of definite MS
* At least 18 years old
* Able to walk 25 feet independently with common assistive devices if needed
* Presence of spasticity by self-report interfering with usual daily activities
* Have an email account and be familiar with using it
* Willing to track daily exercise for 4 weeks
* Fluent in English
Exclusion Criteria:
Other medical or behavioral conditions that would limit participation or completion of the study. <Conditions:>Multiple Sclerosis, Spasticity <Interventions:>Spasticity: Take Control, Usual care | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Chronic Sildenafil for Severe Diaphragmatic Hernia <BriefSummary:>The purpose of this study is to test if sildenafil is effective in the treatment of infants with severe congenital diaphragmatic hernia (determined by the presence of prolonged pulmonary hypertension or prolonged oxygen supplementation on mechanical ventilation), as measured by the estimated pulmonary artery systolic pressure following treatment. <EligibilityCriteria:>Inclusion Criteria:
* Congenital diaphragmatic hernia
* 10-42 days (d) of age
* Significant illness severity as demonstrated by:
* Receiving assisted ventilation and
* FiO2 \>= 0.40 at 10-14d of age, or
* FiO2 \>= 0.40 for \>=48hours at 15-27d of age, or
* FiO2 \>= 0.35 at 28-42d of age
* Or, need for extracorporeal support at \>=10d of age
* Or, estimated pulmonary arterial or right ventricular systolic pressure of \>= 2/3 systemic pressure at 14-42d of age
Exclusion Criteria:
* Structural congenital heart disease (other than patent ductus arteriosus or patent foramen ovale/atrial septal defect \[ASD\] or non-hemodynamically significant ventricular septal defect \[VSD\])
* Sildenafil contraindicated (until condition resolves):
* Unable to absorb oral medication, or
* Unstable systemic blood pressure, or
* Receiving a drug that may interfere with sildenafil metabolism, or
* Renal insufficiency
* Hepatic insufficiency Previous use of sildenafil <Conditions:>Hernia, Diaphragmatic, Hypertension, Pulmonary, Hypoplasia, Pulmonary <Interventions:>sildenafil, Placebo | 'Age, Categorical', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The EMS Sleep Health Study: A Randomized Controlled Trial <BriefSummary:>The experiment seeks to determine the impact of a sleep health and fatigue education and training program on diverse indicators of sleep and fatigue among Emergency Medical Services (EMS) personnel. The overarching goals of this research study are to \[1\] enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and \[2\] determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue. The investigators will accomplish these goals by using a cluster-randomized trial study design with a wait-list control group. <EligibilityCriteria:>Inclusion Criteria:
* EMS Personnel:
1. 18 years of age or older
2. Currently working as an EMS clinician
3. Working a minimum of one shift a week
4. Working \& residing in the United States
5. Working at one of the EMS organizations that agreed to participate in this study
6. Have a cellular, mobile, or smart phone that can send and receive text messages
7. Willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months
Exclusion Criteria:
* EMS Personnel:
1. Individuals \<18 years of age
2. Not currently working as an EMS clinician
3. Does not work a minimum of one shift a week
4. Does not work and/reside in the United States
5. Does not work at one of the EMS organizations that agreed to participate in this study
6. Does not have a cellular, mobile, or smart phone that can send and receive text messages
7. Is not willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months. <Conditions:>Sleep Quality, Fatigue <Interventions:>Sleep Health Education | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Mean Pittsburgh Sleep Quality Index Score', 'Mean Chadler Fatigue Questionnaire Score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention <BriefSummary:>The goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question\[s\] it aims to answer are:
* What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination?
* What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine. <EligibilityCriteria:>Inclusion Criteria:
* Male/female patients \> 18 years who have indications for urodynamics
* Willing to participate in research
Exclusion Criteria:
* Allergy to levofloxacin
* Allergy to fosfomycin
* History of taking antibiotics in 1 month
* Pregnant
* Uncontrolled DM
* Use of urinary catheter
* Having a UTI before urodynamics, based on clinical symptoms and urine examination results
* Refuse to participate in research <Conditions:>Urological System Complication of Procedure, Urinary Tract Infections <Interventions:>Fosfomycin 3000 MG, Levofloxacin 500mg | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia <BriefSummary:>Background:
* Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma.
* LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding).
* Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in about 50 percent of patients with LGL leukemia.
Objectives:
* To identify what factors determine why cyclosporine works in some patients and not in others.
* To identify what causes low blood counts in LGL leukemia.
Eligibility: Patients 18 years of age and older with LGL leukemia.
Design:
* Patients have a medical history, physical examination blood tests, bone marrow biopsy and x-ray studies, including chest x-rays and computed tomography (CT) scans of the chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a node biopsy (removal of a small piece of tissue for microscopic examination).
* Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly to adjust the cyclosporine dosing to maintain therapeutic serum levels.
* Patients undergo apheresis (collection of white blood cells) at a number of different time points in the study (maximum 6 times) to look at the differences in the leukemia cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn through a needle in an arm vein and directed through a catheter (plastic tube) into a machine that separates it into its components. The white cells are extracted and the rest of the blood is returned through the same needle or through a second needle in the other arm. <EligibilityCriteria:>* INCLUSION CRITERIA:
1. All patients must have a histologic or cytologic diagnosis of T-cell LGL leukemia as determined by the Laboratory of Pathology or Hematology at the Clinical Center, National Institutes of Health
2. All patients must have hemocytopenias such as granulocyte count less than 1,200/ul, platelet count less than 100,000/ul or hemoglobin less than 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels.
3. Patients must have measurable or evaluable disease
4. Patients must have a creatinine of less than 2.0 mg/dl.
5. Omission of cytotoxic chemotherapy for 3 weeks prior to entry into the trial is required. However, patients receiving stable corticosteroids will be eligible.
6. Age greater than 18 years
7. Karnofsky performance greater than 70%
8. Patients must have a life expectancy of greater than 3 months.
9. Patients must be able to understand and sign an Informed Consent form.
10. All female patients must use adequate contraception during participation in this trial and for three months after completing therapy.
EXCLUSION CRITERIA:
1. Patients with uncontrolled hypertension
2. Pregnant and nursing patients are not eligible for the study as CSA crosses the placenta. Based on clinical use, premature births and low birth weight were consistently observed. Breast-feeding is contraindicated because CSA enters the blood milk and may possibly be administered to the child.
3. Underlying immunodeficiency state including human immunodeficiency virus (HIV) seropositivity.
4. Positive for antibodies to hepatitis C or positive for hepatitis B surface antigen,
5. Patients with serious intercurrent illnesses, concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease of such severity that it would preclude the patients' ability to tolerate cyclosporine.
6. Patients who received cyclosporine for LGL leukemia previously and failed to respond. <Conditions:>Large Granular Lymphocytic Leukemia, LGL Leukemia <Interventions:>Cyclosporine, Gene expression analysis, Microarray analysis, Laboratory biomarker analysis | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Multi-arm Optimization of Stroke Thrombolysis <BriefSummary:>The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with standard of care thrombolysis (0.9mg/kg IV rt-PA or 0.25mg/kg IV tenecteplase or TNK) within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well. <EligibilityCriteria:>Inclusion Criteria:
1. Acute ischemic stroke patients
2. Treated with 0.9mg/kg IV rt-PA or 0.25mg/kg IV TNK within 3 hours of stroke onset or time last known well
3. Age ≥ 18
4. NIHSS score ≥ 6 prior to IV thrombolysis
5. Able to receive assigned study drug within 60 minutes but no later than 75 minutes of initiation of IV thrombolysis
Exclusion Criteria:
1. Known allergy or hypersensitivity to argatroban or eptifibatide
2. Previous stroke in the past 90 days
3. Previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation
4. Clinical presentation suggested a subarachnoid hemorrhage, even if initial CT scan was normal
5. Any surgery, or biopsy of parenchymal organ in the past 30 days
6. Trauma with internal injuries or ulcerative wounds in the past 30 days
7. Severe head trauma in the past 90 days
8. Systolic blood pressure persistently \>180mmHg post-IV thrombolysis despite antihypertensive intervention
9. Diastolic blood pressure persistently \>105mmHg post-IV thrombolysis despite antihypertensive intervention
10. Serious systemic hemorrhage in the past 30 days
11. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>1.5
12. Positive urine or serum pregnancy test for women of child bearing potential
13. Glucose \<50 or \>400 mg/dl
14. Platelets \<100,000/mm3
15. Hematocrit \<25 %
16. Elevated pre-thrombolysis PTT above laboratory upper limit of normal
17. Creatinine \> 4 mg/dl
18. Ongoing renal dialysis, regardless of creatinine
19. Received Low Molecular Weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin) in full dose within the previous 24 hours
20. Abnormal PTT within 48 hours prior to randomization after receiving heparin or a direct thrombin inhibitor (such as bivalirudin, argatroban, dabigatran or lepirudin)
21. Received Factor Xa inhibitors (such as Fondaparinaux, apixaban or rivaroxaban) within the past 48 hours
22. Received glycoprotein IIb/IIIa inhibitors within the past 14 days
23. Pre-existing neurological or psychiatric disease which confounded the neurological or functional evaluations e.g., baseline modified Rankin score \>3
24. Other serious, advanced, or terminal illness or any other condition that the investigator felt would pose a significant hazard to the patient if rt-PA, TNK, eptifibatide or argatroban therapy was initiated
a. Example: known cirrhosis or clinically significant hepatic disease
25. Current participation in another research drug treatment or interventional device trial - Subjects could not start another experimental agent until after 90 days
26. Informed consent from the patient or the legally authorized representative was not or could not be obtained
27. High density lesion consistent with hemorrhage of any degree
28. Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT Scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment <Conditions:>Acute Ischemic Stroke <Interventions:>Argatroban, Eptifibatide, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'NIHSS', 'IV Thrombolytic', 'Stroke Onset to IV Thrombolytic Start', 'IV Thrombolytic Start to Study Drug Bolus', 'Endovascular Thrombectomy (EVT) received' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>What Makes People Better at Retrieving Proper Names? <BriefSummary:>This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce names of pictured people. Participants will perform a brief mental exercise, then see 83 celebrity photographs to produce the names of. Participants will also complete other surveys and measures. Collected data will give researchers a better understanding of how different variables relate to proper name production. <EligibilityCriteria:>Inclusion Criteria:
* fluent speaker of English
* ages 18-35 or 60-80
* lived in the United States for at least 5 years
Exclusion Criteria:
- <Conditions:>Healthy Aging <Interventions:>Mental Exercise | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment <BriefSummary:>Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with altered ripening capacity. Due to excessive proliferation, the blasts displace normal hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate extramedullary tissues.
Following the standard chemotherapy treatment, the CR rate achieved is around 65-75% for all patients and 15% lower when considering only patients over 65 years. Modifications to the standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of ara-C or adding a third drug.
Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a cytotoxic antitumor antibiotic, calicheamicin. Mylotarg ® antibody specifically binds to CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. Mylotarg ® selectively transports the cytotoxic agent calicheamicin into leukemic cells and hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of the antibody anti-CD33 and its internalization by the cell, after which binds to and damages the DNA.
Mylotarg ® is approved in the U.S. for the treatment of CD33 positive AML in first relapse, for patients older than 60 years non-candidates for other intensive treatment modalities.
Since the efficacy of Mylotarg ® is equivalent and its toxicity profile less than the conventional therapy, it is logical to conduct a phase II trial exploring the role of Mylotarg ® in the early stages of treatment of AML.
Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined with induction chemotherapy. The aim was to improve the CR rate reached with the latter and reduce relapse after achieving greater leukemic cytoreduction.
Recent data from the HOVON group support that the administration of G-CSF before and during induction chemotherapy decreases the incidence of relapse in patients with AML, particularly those considered to have intermediate risk.
Everything mentioned above justifies to investigate the combination of GO combined with chemotherapy with IDR and ara-C in standard 3x7 scheme and analyze the effect of sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is effective and presents an acceptable toxicity it should be investigated. <EligibilityCriteria:>Inclusion Criteria:
1. Patients with primary or "de novo" AML, different than promyelocytic or M3 subtype.
2. Age 18 to 70 years.
3. Written informed consent form
Exclusion Criteria:
1. Acute leukemia appeared after a myeloproliferative process or a myelodysplastic syndrome longer than 6 months, AML arising after another cured malignant disease (e.g. Hodgkin's disease), and secondary AML treated with alkylating agents or radiation.
2. Acute promyelocytic leukemia.
3. Relevant history of liver disease. Significant impaired liver function (bilirubin, AST or ALT ≥ 2.5 times the normal value) not attributable to leukemic infiltration.
4. Patients with prior heart failure.
5. Symptomatic chronic respiratory failure.
6. Positive serology for HIV, hepatitis C virus or its surface antigen.
7. Estimated life expectancy less than 3 months, despite treatment.
8. Pregnancy or breastfeeding at the time of inclusion in the study. <Conditions:>Novo Acute Myeloid Leukemia <Interventions:>Mylotarg | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment', 'Leucocites at diagnosis', 'Citogenetic' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab <BriefSummary:>The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer <EligibilityCriteria:>Key Inclusion criteria:
* Age \> 18 year old
* Confirmed HER2+ ve metastatic breast cancer
* Prior treatment and progression on trastuzumab
* Patients must have adequate laboratory values
* Eastern Cooperative Oncology Group (ECOG) performance status of \<2
Key Exclusion criteria:
* Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
* Impaired heart function or clinically significant heart disease
* Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
* Ongoing diarrhea
* Liver or renal disease with impaired hepatic or renal functions
* Concomitant use of any anti-cancer therapy or certain drugs
* Female patients who are pregnant or breast feeding
* Patients not willing to use an effective method of birth control <Conditions:>Breast Cancer <Interventions:>Panobinostat, Trastuzumab | 'Age, Continuous', 'Sex/Gender, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients <BriefSummary:>A two-period, two-treatment, crossover study to evaluate the safety, tolerability and efficacy of amifampridine phosphate in ambulatory patients diagnosed with spinal muscular atrophy (SMA) Type 3. <EligibilityCriteria:>Inclusion Criteria:
1. Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures.
2. Male or female between the ages of 6 and 50 years.
3. Genetically confirmed diagnosis of SMA Type 3.
4. Able to walk independently for at least 30 meters.
5. Not taking Nusinersen for the treatment of SMA (Nusinersen should be stopped at least 6 months before screening). Salbutamol is permitted only if the dose has been stable during the 6 months before screening.
6. Able to swallow oral medication.
7. Female patients of childbearing potential must have a negative pregnancy test (serum human chorionic gonadotropin \[HCG\] at Screening); and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment.
8. Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the Investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires.
Exclusion Criteria:
1. Epilepsy and currently on medication for epilepsy.
2. Concomitant use of medicinal products with a known potential to cause QTc prolongation.
3. Patients with long QT syndromes.
4. An electrocardiogram (ECG) within 6 months before starting treatment that shows clinically significant abnormalities, in the opinion of the Investigator.
5. Breastfeeding or pregnant at Screening or planning to become pregnant at any time during the study.
6. Treatment with an investigational drug (other than amifampridine), device, or biological agent within 6 months prior to Screening or while participating in this study.
7. Surgery for scoliosis or joint contractures within the previous 6 months.
8. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confound the assessment of the patient.
9. History of drug allergy to any pyridine-containing substances or any amifampridine excipient(s).
10. Less than a 3-point improvement in HFSME from start of the Open label Run -in period to end of Run-in (Day 0). <Conditions:>Muscular Atrophy, Spinal <Interventions:>Amifampridine Phosphate, Placebo Oral Tablet | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Weight', 'Height', 'BMI' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Health Effects of SLT, Cigarette Smoking, and New Tobacco Products <BriefSummary:>The use of smokeless tobacco (ST) as a substitute for cigarette smoking has been suggested since it is considered by some to be a less harmful tobacco product (Russell, Jarvis and Feyerabend, 1980; Russell et al, 1981; Rodu, 1994). ST does not have the volatile constituents and carbon monoxide (CO) that are found in cigarette smoke. Since ST is not smoked there would be less risk of cardiovascular and lung disease. In addition the harm associated with second hand smoke would be eliminated. Although the health risks are reduced in ST users, they still exist due to the presence of nitrosamines found in ST. A better approach would be to use nicotine replacement that did not contain carcinogens, however the cost of such NRT could be prohibitive especially in third world countries where the rate of smoking is continuing to rise and the per capita income is much lower than in the United States.
Purpose: The goal of this study is to evaluate the health effects of Camel Snus, the new oral tobacco product produced by RJ Reynolds and Taboka, produced by Phillip Morris. These products are pasteurized rather than fermented and contain less moisture to eliminate spitting. They are marketed as an alternative to cigarette smoking. <EligibilityCriteria:>Inclusion Criteria:
* Subjects between 18-70 years of age
* Smoking at least 10 cigarettes/day for at least one year
* Good physical and mental health as evidenced by a medical history with no unstable medical conditions.
Exclusion Criteria:
* Uncontrolled chronic disease or condition that requires medical attention during the course of the study
* Contraindications for nicotine replacement products: active ulcers, recent heart attack, heart disease or irregular heart beat, uncontrolled high blood pressure, or medication use that might affect tobacco use
* Current unstable psychiatric diagnoses or persons who currently are adjusting medication dose. (within the last 3 months)
* Subjects with current or recent (within 6 months) alcohol or drug abuse problem
* Other regular tobacco use such as regular cigar or pipe smoking
* Currently using other nicotine replacement products
* Chronic use of any drug that could interact with the study drugs. <Conditions:>Nicotine Dependence <Interventions:>Nicotine gum and lozenge, Taboka, Camel Snus | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment', 'Fagerstrom Test for Nicotine Dependence Score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV) <BriefSummary:>The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug. <EligibilityCriteria:>Inclusion Criteria:
* Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (\>) 1000 international units per milliliter (IU/mL)
* Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse
* Population B: Peg-IFN/RBV prior null or partial responder
* Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration
* Participant must have positive HIV antibody at Screening
* Participant must have a diagnosis of HIV-1 infection \>6 months before Screening
* Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening:
* Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine)
* Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components
* Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components
* Boosted atazanavir plus Epzicom®, or equivalent components
* Raltegravir plus Truvada®, or equivalent components
* Raltegravir plus Epzicom®, or equivalent components
* Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol
* Laboratory values within acceptable ranges at Screening as specified in the protocol
Exclusion Criteria:
* Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1
* Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides
* Contraindications to any planned HAART component as per the respective drug labeling information
* Contraindications to Peg-IFN or RBV
* Evidence of hepatic decompensation
* Clinical suspicion of acute hepatitis
* Any other cause of liver disease in addition to hepatitis C
* History of organ transplantation (except cornea and skin)
* Autoimmune-mediated disease
* Participated in any investigational drug study within 90 days before Day 1
* Previous treatment with an HCV protease inhibitor <Conditions:>Hepatitis C <Interventions:>Telaprevir, Ribavirin, Pegylated Interferon Alfa-2a, Highly Active Antiretroviral Therapy (HAART) | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI <BriefSummary:>One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with concurrent mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain injury influences how people think, act, and feel. This may include how people pay attention, keep information in memory, organize plans for achieving important goals, and manage stress. Another purpose of this research is to learn more about the effects of cognitive training on the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in the short- and long-term. With this research, the investigators hope to better understand and treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury. <EligibilityCriteria:>Inclusion Criteria:
* Diagnosis of PTSD
* History of mild TBI, including concussion \> 6 months ago
* Cognitive difficulties affecting daily functioning
* Age 18-75
* Veteran
* At least 12th grade education or equivalent
Exclusion Criteria:
* Amnesic/Severe memory problems
* Active Substance Abuse/Dependence
* Medical condition that may affect mental status/disrupt study participation
* Active psychotropic medication changes
* Participation in evidence-based PTSD treatment <Conditions:>Post Traumatic Stress Disorder, Mild Traumatic Brain Injury, Concussion <Interventions:>GOALS (Goal-Oriented Attentional Regulation), EDU (Brain Health Education) | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Attention/Executive Function Overall Z Score', 'Goal Processing Scale (GPS) Overall Performance Score', 'Profile of Mood States (POMS)-Total Mood Disturbance Score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients <BriefSummary:>The purpose of the study is to look at the biomarkers of inflammation and platelet activation in patients with drug eluting stents implanted approximately 12 months ago on aspirin and statin, for a 4-week period after the routine discontinuation of clopidogrel <EligibilityCriteria:>Inclusion Criteria:
* Subjects with one or more drug-eluting stents of any type who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment
* Subjects receiving low dose ASA
* Subjects receiving a statin
* Current medication regimen (including ASA and statins) must have been stable for three (3) months. i.e. no initiation of new prescription medication or change in dosage of any previously initiated medication within three (3) months of entering this study
* Subjects with no clinical history of diabetes mellitis
* Men and women, ages 18 years or older <Conditions:>Antiplatelet Aggregation <Interventions:>Blood Collection | 'Age Continuous', 'Age Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Mean Baseline High Sensitivity C-Reactive Protein (hs-CRP)', 'Mean Baseline Plasma Soluble P-Selectin', 'Mean Baseline Soluble CD40 Ligand' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Erlotinib Prevention of Oral Cancer (EPOC) <BriefSummary:>The goal of this clinical research study is to learn if erlotinib hydrochloride (Tarcevaâ (OSI-774 ) can prevent cancer in the mouth of people with a high risk of developing cancer in the mouth. The safety of this drug will also be studied, as well as the drug's effect on different cells in the body. <EligibilityCriteria:>Inclusion Criteria:
1. Male or female patients with one of the following: (a) loss of heterozygosity (LOH) at 3p14 and/or 9p21 in the oral IEN of patients with a history of curatively treated oral cancer or (b) LOH at 3p14 and/or 9p21 plus at one other chromosomal region in the IEN of patients with no oral cancer history.
2. Participants must have confirmed diagnosis of oral IEN lesion with LOH. (Note:The initial screening biopsy of oral IEN lesion with LOH must be obtained within 12 months of study enrollment. If initial diagnostic biopsy for LOH is \> 3 months prior to study enrollment, investigators may use clinical judgment to order an additional screening biopsy to assess histopathological changes).
3. Age \>/= 18 years
4. ECOG performance status \<2
5. Participants must have normal organ \& marrow function as defined below w/in 30 days of randomization:CBC w/ differential white cell count-acceptable results must include:WBC \>3,000ul, hemoglobin\>10 g/dl, platelet count \> 125,000ul, LFTs-total bilirubin \& alkaline phosphatase, AST (SGOT) \& ALT (SPGT) all w/in \<1.5xULN.Note:At the discretion of the attending physician,participants w/ Gilbert's disease may still be eligible to participate in the event the total bilirubin value is \>1.5xULN. Kidney function-serum creatinine\< 1.5xULN Chemistry-Sodium \& potassium all w/in normal institutional limits.
6. The effects of the study agent on the developing human fetus are unknown.For this reason,WOCBP \& men must agree to use adequate contraception (hormonal or barrier method of birth control;abstinence)prior to study entry\& for the duration of active treatment.Neg.serum pregnancy test in WOCBP.Childbearing potential will be defined as women who have had menses w/in the past 12 mths,who have not had tubal ligation or bilateral oophorectomy.Should a woman become pregnant or suspect she is pregnant while participating in this study,she should inform her study physician immediately
7. Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
1. Patients with active cancer or any cancer within the previous two years, excluding oral and non-melanoma skin cancer.
2. Patients with acute intercurrent illness or who have had surgery, radiation therapy, or chemotherapy within the preceding 4 weeks unless they have fully recovered.
3. Patients with a documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants
4. Women who are pregnant (confirmed by b-HCG if applicable) or breastfeeding
5. Any medical or psychological condition or any reason that, according to the investigator's judgment, makes the patient unsuitable for participation in the study
6. Patients who have participated in other experimental therapy studies within 3 months of enrollment to this trial
7. Patients with a history of inflammatory bowel disease
8. Patients with a documented history of interstitial lung disease <Conditions:>Oral Cancer <Interventions:>Erlotinib, Placebo | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates <BriefSummary:>Intestinal failure associated liver disease is a cholestatic liver disease associated with prolonged need for parenteral nutrition that can lead to such significant complications as liver failure. In the neonatal population, infants with history of intestinal resection and short bowel syndrome are at increased risk for this disease. The investigators plan to compare two possible lipid dosing preventative strategies including a composite, fish oil lipid and soy-based lipid reduction. <EligibilityCriteria:>Inclusion Criteria: Neonates with anticipated need for parenteral nutrition (based on primary physicians opinion) for greater than or equal to four weeks and one of the following diagnoses:
* Anatomic: Neonate with intestinal atresia, omphalocele, gastroschisis, or volvulus with or without intestinal resection.
* Ischemic/perforation: Neonates with spontaneous intestinal perforation or necrotizing enterocolitis requiring surgical intervention.
Exclusion Criteria:
* Current weight less than 750 grams
* AST or ALT greater than 5 times the upper limit of normal within 2 weeks of enrollment
* Direct bilirubin greater than 2 mg/dL on any consecutive measurements 5 - 7 days apart within 2 weeks of enrollment
* Severe coagulopathy with INR greater than 95th percentile for age (\>1.7 at less than 5 days of age, \> 1.5 older than five days of age)
* Culture confirmed sepsis with positive blood, urine, or CSF culture within 2 weeks of enrollment
* Renal failure requiring dialysis
* Cyanotic heart disease requiring prostaglandin therapy
* Hypertriglyceridemia (greater than 250mg/dL) at time of enrollment <Conditions:>Cholestasis of Parenteral Nutrition <Interventions:>Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion, Intralipid, 20% Intravenous Emulsion | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Yoga to Prevent Mobility Limitations in Older Adults <BriefSummary:>The loss of mobility during aging impacts independence and leads to further disability, morbidity, and reduced life expectancy. The study objective was to examine the feasibility and safety of conducting a randomized controlled trial of yoga for older adults at risk for mobility limitations. The investigators hypothesized that sedentary older adults could be recruited for the study, would attend either yoga or a health education control, would complete assessments, and that the interventions could be safely delivered. <EligibilityCriteria:>Inclusion Criteria:
* age 60-89 years
* self-reported sedentary lifestyle (not exercising in the past 3 months; included walking at a brisk pace or regular walking for exercise purposes)
* SPPB summary score \> 3 and ≤ 8
* willingness attend either yoga or health education for 10 weeks
* willing to complete two assessments
* residence in San Diego metropolitan area
* provided a physician-signed health clearance form.
Exclusion Criteria:
* practiced yoga \> 2x in the last year
* life expectancy \< 12 months. <Conditions:>Aging, Mobility Limitation, Sedentary Lifestyle <Interventions:>Yoga Intervention, Healthy Aging Education | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>EMPOWER Clinical Trial: Vagal Blocking for Obesity Control <BriefSummary:>This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese. <EligibilityCriteria:>Inclusion criteria
1. Informed consent.
2. Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more obesity related co-morbid condition. Co-morbid conditions may include one or more of the following:
* Type 2 diabetes mellitus (note: type 2 diabetics are allowed at selected centers only, see Inclusion criterion #5)
* Hypertension as defined by systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg a) treated or untreated with systolic ≥140 mmHg or diastolic ≥90 mmHg or b) treated with systolic \<140 mmHg and diastolic \<90 mmHg
* Dyslipidemia as defined by total cholesterol ≥200 or LDL ≥130 a) treated or untreated with total cholesterol ≥200 or LDL ≥130 or b) treated with total cholesterol \<200 or LDL \<130
* Sleep apnea syndrome (confirmed by overnight p02 studies)
* Obesity related cardiomyopathy
3. Females or males Note: females of child-bearing potential must have a negative urine pregnancy test at Screen and also within 14 days of implant procedure followed by physician-approved contraceptive regimen for the duration of the study period.
4. 18-65 years of age inclusive.
5. Type 2 diabetes mellitus subjects (at selected centers, limited to approximately 34 subjects) with:
* Glycosylated hemoglobin (Hb A1c) 6.5 - 9 % inclusive at screening visit.
* Onset: 10 years or less since initial diagnosis.
* Stable treatment regimen: no change in oral hypoglycemic treatment regimen within past 3 months.
* Currently not using insulin therapy, GLP-1 receptor agonists (e.g., exenatide), or DPP-4 inhibitors (e.g., sitagliptin) for diabetes treatment and have not been on these treatments in the past 6 months.
* Creatinine within normal reference range.
* No history of proliferative retinopathy.
* No history of peripheral neuropathy.
* No history of autonomic neuropathy.
* No history of coronary artery disease, with or without angina pectoris.
* No history of peripheral vascular disease.
6. Failure to respond to supervised diet/exercise program(s) in which the subject was engaged for at least 6 months within the last five years.
7. Ability to complete all study visits and procedures.
Exclusion criteria
1. Concurrent chronic pancreatic disease.
2. History of Crohn's disease and/or ulcerative colitis.
3. History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
4. History of pulmonary embolism or blood coagulation disorders.
5. Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant if they have not had one done during the previous 6 months that specifically reported on the presence or absence of hiatal hernia making reference to the Z-line and/or diaphragmatic notch, in order to rule out subjects with hiatal hernia that may require surgical repair (to support exclusion criterion #7).
6. Current portal hypertension and/or esophageal varices.
7. Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery.
8. Treatment with weight-loss prescription drug therapy within the prior three months and the use of prescription drug therapy or the use over-the-counter weight loss preparations for the duration of the trial.
9. Smoking cessation within the prior six months.
10. Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
11. Overall sustained reduction of more than 10% of body weight in the previous 12 months.
12. Physician-prescribed pre-operative diet with intent to lose weight prior to surgery (note: a) study subject may continue any personal diet they were on prior to study enrollment \[see exclusion criterion #24\] b) standardized EMPOWER weight management program to be initiated in all subjects at time of activation, approximately two weeks after implant)
13. Current type 1 diabetes mellitus (DM).
14. Current or recent history (within 12 months) of ongoing bulimia.
15. Current alterations in treatment for thyroid disorders (stable treatment regimen for prior three months acceptable).
16. Current alterations in treatment for epilepsy (stable treatment regimen for prior six months acceptable).
17. Current treatment for peptic ulcer disease (previous history acceptable).
18. Chronic (more than 4 weeks of daily use) treatment with narcotic analgesic drug regimens (treatment with non-steroidal anti-inflammatory drugs acceptable).
19. Current alterations in treatment regimens of anti-cholinergic drugs, including tricyclic antidepressants (stable treatment regimen for prior six months acceptable).
20. Current medical condition that, in the opinion of the investigator, would make subject unfit for surgery under general anesthesia or that would be exacerbated by intentional weight loss. Some examples include diagnosis of cancer, recent heart attack, recent stroke or recent serious trauma.
21. Presence of permanently implanted electrical powered medical device or implanted gastrointestinal device or prosthesis (e.g., pacemakers, implanted defibrillators, neurostimulators etc.).
22. Planned or contemplated use of Magnetic Resonance Imaging (MRI) or oncological radiation during the course of the trial.
23. Significant psychiatric disorders that, in the opinion of the investigator, may interfere with subject's ability to follow study procedures and/or instructions.
24. Current, active member of an organized weight loss program (e.g., Weight Watchers, TOPS).
25. Current participant in another weight loss study or other clinical trials.
26. Have a friend or family member who is currently participating or is planning to participate in this clinical trial.
27. Patient reported:
* inability to walk for about 10 minutes without stopping,
* feeling of pain in chest when doing physical activity,
* feeling of pain in chest when not doing physical activity. Note: unless pain in chest in known to be related to upper gastrointestinal disorders such as gastroesophageal reflux disease or heartburn.
28. Clinically significant cardiac rhythm disorder that requires either medical and/or surgical intervention (e.g., paroxysmal or chronic atrial fibrillation). <Conditions:>Obesity <Interventions:>Therapy ON, Therapy OFF | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1) <BriefSummary:>This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels \<100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels. <EligibilityCriteria:>Inclusion criteria:
* Participants in whom LDL-cholesterol target levels have not been achieved.
* Participants in whom a decision has been made by the physician to initiate treatment
with ezetimibe (longitudinal analyses). The treatment decision will be made prior to
and independent from inclusion of participants into this study.
- Participants with LDL cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.
Exclusion criteria:
* Any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe.
* In order not to interfere with data collection it is recommended not to include participants currently in a clinical trial.
* Previous and ongoing treatment with ezetimibe. <Conditions:>Hypercholesterolemia <Interventions:>Ezetimibe | 'Age, Continuous', 'Sex/Gender, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer <BriefSummary:>RATIONALE: A peripheral stem cell transplant or an umbilical cord blood transplant from a donor may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells can make an immune response against the body's normal cells. Methotrexate, cyclosporine, tacrolimus, or methylprednisolone may stop this from happening.
PURPOSE: This clinical trial is studying how well a donor stem cell transplant or donor white blood cell infusions work in treating patients with hematologic cancer. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following\*:
* Acute lymphoblastic leukemia in any disease phase
* Patients with any of the following high-risk features are encouraged to enroll:
* Philadelphia chromosome positive disease
* L3 morphology, especially in the presence of t(8;14), t(8;22), or t(2;8)
* Patients not in remission at day 28 of first induction
* High LDH (i.e., ≥ 300 IU/mL at presentation)
* Pre-B-cell, mixed lineage, or Burkitt's markers
* Relapsed in the marrow while receiving continuous chemotherapy
* Within 6 months after stopping chemotherapy
* Relapse in one organ or extramedullary relapses in more than one organ while still receiving chemotherapy
* Hodgkin's or non-Hodgkin's lymphoma beyond first complete remission (CR) or in first CR with features of high-risk disease, including, but not limited to:
* Lymphoma not in CR after 3 courses of primary therapy
* Patients with bulky disease at presentation, especially bulky mediastinal disease
* Patients with LDH ≥ 300 IU/mL at presentation
* Patients with extranodal disease
* Patients with first remission within less than 1 year
* Stage IV disease at presentation, especially with marrow involvement
* Patients with high-intermediate or high International Index Scores
* Acute myeloid leukemia (AML) meeting the following criteria:
* Beyond first remission or high-risk disease in first CR
* Required multiple courses of induction therapy to achieve a remission
* Had residual leukemia on day 14-28 bone marrow examination after initial induction
* Patients with any cytogenetic abnormality except inv 16 or t(8;21)
* Chronic myelogenous leukemia in the chronic or early accelerated phase of the disease
* Patients with blast crisis that can be induced back into chronic phase may be transplanted in second chronic phase
* Myelodysplastic syndromes (MDS) meeting the following requirements:
* Transfusion-dependent refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia (CMML)
* Patients with MDS that present with or evolve to AML must be re-induced back to remission prior to initiating a search for an unrelated donor NOTE: \*Patients with other hematologic malignancies not listed above, including diseases such as chronic lymphocytic leukemia (CLL), multiple myeloma, or rare pediatric malignancies, or patients who are felt to be at high-risk for relapse but who do not have features listed, may be allowed at the discretion of the investigator.
* Must have failed prior stem cell transplantation
* Must have a suitable unrelated allogeneic hematopoietic stem cell donor
* A 5/6 match degree is acceptable for unrelated bone marrow donors
* A 4/6 match degree is acceptable for unrelated cord blood units
PATIENT CHARACTERISTICS:
* SWOG performance status (PS) 0-2 OR
* Karnofsky PS 50-100% OR
* Lansky PS 50-100%
* Creatinine clearance ≥ 45 mL/min
* Creatinine ≤ 2.5 mg/dL
* Bilirubin ≤ 2 mg/dL (abnormally high liver function tests allowed if the only source for the elevation is due to lymphoma of the liver)
* AST or ALT ≤ 2 times normal (abnormally high liver function tests allowed if the only source for the elevation is due to lymphoma of the liver)
* No patients at high risk of veno-occlusive disease
* Not pregnant or nursing
* Negative serum pregnancy test
* Fertile patients must use an effective contraceptive method
* DLCO ≥ 50% of predicted
* FEV_1/FVC ≥ 65% of predicted
* No current congestive heart failure (CHF) and/or LVEF ≥ 45%
* No myocardial infarction within the past 6 months
* No unstable angina within the past 6 months
* HIV negative
* Life expectancy must not be limited by disease other than malignancy
* No allergy to any chemotherapeutic agent included in the regimen
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics <Conditions:>Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Unusual Cancers of Childhood <Interventions:>anti-thymocyte globulin, filgrastim, busulfan, carmustine, cyclophosphamide, cyclosporine, cytarabine, etoposide, fludarabine phosphate, melphalan, methotrexate, methylprednisolone, mycophenolate mofetil, tacrolimus, peripheral blood stem cell transplantation, umbilical cord blood transplantation, radiation therapy | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder. <BriefSummary:>This study aims to test the effect of a newly-approved stimulant medication, lisdexamfetamine dimesylate (Vyvanse), on specific residual symptoms of depression found in some patients who are undergoing treatment with, but have only partially responded to, a selective-serotonin reuptake inhibitor (SSRI) or selective-norepinephrine reuptake inhibitor (SNRI) antidepressant. Specifically, the investigators hypothesize that symptoms potentially related to deficient dopaminergic activity, such as lassitude, apathy, reduced positive affect and impaired executive function, in particular, will improve. This protocol is designed to test the hypothesis that this cluster of co-occurring residual symptoms sometimes found in treated depression will respond as a group to adjunctive psychostimulant therapy. The investigators propose to demonstrate this cluster of residual depressive symptoms and to measure the effect of stimulant therapy on it. The investigators hope to better understand the specific symptoms in this clinical population that are likely to improve with stimulant therapy. <EligibilityCriteria:>Inclusion Criteria:
1. Meeting diagnostic criteria for major depression during the present episode of illness, currently with at least mild improvement by report (CGI-I ≥3) but with continuing residual symptoms.
2. A score of ≥10 on MADRS items 1,2,6,7 and 8, (the MADRS Dysphoric Apathy/Retardation factor, Parker et al., 2003) at screening and randomization. These 5 items are: Apparent sadness, Reported sadness, Concentration difficulties, Lassitude, and Inability to feel. A score of ≥3 will be required for at least 2 of these items.
3. A score of 3 or 4 on the Clinical Global Impression of Severity (CGI-S) at screening and randomization.
4. At randomization subjects must have received therapeutic dosages of approved SSRI or SNRI agents for at least 8 weeks, with the last 4 weeks at a constant dosage.
5. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (B-hCG) pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit, and agree to use one of the following methods of birth control: oral contraceptives, contraceptive implants, injectable contraceptives, IUDs, double-barrier contraception, sexual abstinence or vasectomized partner(s).
Exclusion Criteria:
1. Treatment within 4 weeks of randomization with any non-SSRI/SNRI antidepressant (trazodone is permitted up to 100 mg at night for sleep); any antipsychotic agent; any mood stabilizer; any standing benzodiazepine regimen other than at low doses for sleep (≤ 1 mg lorazepam HS or the equivalent); or a standing regimen of any other agent that may affect cognitive function (e.g., psychostimulants, including modafinil or R-modafinil).
2. Any current or past psychotic disorder, Bipolar I or II disorder, Current panic disorder, History of ADHD, Antisocial Personality Disorder or Borderline Personality Disorder, Mental retardation or any dementing disorder.
3. Covi Anxiety Scale score greater than Raskin Depression Scale score at Screening, to exclude subjects with more prominent anxiety than depression
4. MADRS Sleep (item 4), or Appetite (item 5) \>3 at screening or randomization
5. Initial insomnia at screening that is not adequately controlled by sleep medication (trazodone up to 100 mg HS for sleep and/or ≤ 1 mg lorazepam HS or the equivalent).
6. Medical conditions that might be exacerbated by Vyvanse treatment, such as uncontrolled hypertension or angina; or conditions that would make study findings hard to interpret, such as hyperthyroidism
7. History of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
8. Known cardiac structural abnormality or any other condition that may affect cardiac performance
9. Any clinically significant ECG or laboratory abnormality at Screening
10. Current abnormal thyroid function, as defined by abnormal TSH at Screening (Treatment with a stable dose of thyroid medication for at least 3 months is permitted if TSH is normal at screening).
11. Suicide attempt within the past 2 years or a history of any homicidal behavior.
12. MADRS Suicidal thoughts (item 10) \>4 at any study visit, or if a patient is considered by the investigator to be at clinical risk of suicide at any time in the course of the study.
13. resting sitting systolic blood pressure \>149mmHg or diastolic blood pressure \> 95mmHg. Subjects may be on monotherapy with anti-hypertensive medication.
14. documented allergy, hypersensitivity, intolerance, or non-responsivity to methylphenidate or amphetamines.
15. Subject has a history of a substance use disorder (abuse or dependence, as defined by DSM-IV-TR™), with the exception of nicotine dependence, within 6 months prior to screening.
16. Subject has glaucoma
17. Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant <Conditions:>Major Depressive Disorder <Interventions:>Lisdexamfetamine Dimesylate (Vyvanse), Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Use of Stable Airway Management Device in Monitored Anesthesia Care <BriefSummary:>The aim of this study is to determine if the Stable Airway Management device (SAM) is safe in maintaining the airway in a stable, non-obstructing position during anesthetic cases requiring monitored anesthesia care (MAC). <EligibilityCriteria:>Inclusion Criteria:
1. Patients undergoing MAC anesthesia in the supine position
2. Patients able to give informed consent
Exclusion Criteria:
1. Age \< 18 years
2. Less than 88% oxygen saturation on room air
3. Non-elective procedures
4. Case duration \> 180 minutes
5. Presence of a cervical spine injury, instability, or cervical spine collar
6. Patients with airway, facial, or other anatomy deemed inappropriate for SAM use by anesthesiologist
7. General anesthesia as primary anesthetic
8. Prisoners
9. Pregnant women <Conditions:>Anesthesia <Interventions:>Stable airway management (SAM) device | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression <BriefSummary:>The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy. <EligibilityCriteria:>Inclusion Criteria:
* Males or females, aged 18-70 years
* If female, must state willingness to use medically accepted methods of birth control (if of reproductive age) and have negative pregnancy test
* Ability to understand study procedures and provide written informed consent
* A DSM-IV diagnosis of Major Depressive Disorder, with psychotic features, based on the Structured Clinical Interview for DSM-IV (SCID)
* Hamilton Depression Rating Scale score (21-item HDRS) greater than or equal to 22
Exclusion Criteria:
* A current or lifetime DSM-IV diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder
* A DSM-IV diagnosis of alcohol or substance abuse or dependence within 3 months of study entry
* A QTc greater than 460 msec or an abnormal EKG (except minor abnormalities considered by the site investigator to be clinically insignificant)
* A heart rate less than or equal to 50
* A personal or family history of QTc
* Any current or past history of syncope
* Concurrent treatment with medications associated with prolongation of the QTc
* Concurrent treatment with medications that may affect magnesium or potassium, such as diuretics
* Any acute, unstable or serious medical illness (eg, AIDS, history of seizures, history of CVAs).
* Baseline blood chemistries that are outside local reference ranges and which are felt clinically significant by the site investigator, or a potassium, magnesium or calcium level outside of local reference ranges or liver function tests that are greater than 20% above the upper limit of local reference ranges. If magnesium and/or potassium are below the lower limit of the local laboratory norm, they may be repeated and rechecked during the screening phase, and if within laboratory norms, the subjects may be included.
* History of unstable cardiovascular disease
* A significant risk of suicide in the judgement of the site investigator
* A history of allergy or hypersensitivity to haloperidol, sertraline or ziprasidone
* Any history of neuroleptic malignant syndrome
* Treatment with sertraline or ziprasidone within 30 days of study entry
* History of recent treatment with any long acting psychotropic medications
* Treatment with a MAO-inhibitor within 14 days of study entry
* Treatment with an investigational drug within 30 days of study entry
* Current use of carbamazepine, nefazodone, ketoconazole or erythromycin
* A positive pregnancy test
* A positive drug screen unless attributable to a prescribed medication (e.g. benzodiazepines) <Conditions:>Affective Disorders <Interventions:>Ziprasidone, Sertraline, Haloperidol | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Growth Hormone Therapy for Wasting in Cystic Fibrosis <BriefSummary:>Our hypothesis is that Growth Hormone (GH) will not only target the peripheral tissue to stimulate weight and muscle growth which will maximize nutritional potential and improve overall quality of life. We theorize that this will occur through a multitude of factors: increased appetite, more constructive utilization of caloric intake and decreased catabolic signaling. The first aim will address changes in weight and lean body mass following the institution of GH therapy in adults with Cystic Fibrosis (CF) related wasting. The second aim will measure impact on quality of life of these individuals. Additionally, the third aim will monitor effects of GH therapy on diabetes and insulin sensitivity. Finally, the fourth aim will observe changes in the subjects underlying diagnosis of CF, specifically lung function, muscle strength and inflammatory state. <EligibilityCriteria:>Inclusion Criteria:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Age \> 18 years
* Cystic fibrosis, diagnosed by either sweat chloride or genetic testing
* Less than 92% ideal body weight based on body mass index (BMI) of 22 for women and 23 for men
* Moderate or better pulmonary function (Forced Expiratory Volume (FEV1) \>40% of predicted).
* Agree to use an effective method of birth control to prevent pregnancy during the research study.
Women should not nurse (breast feed) a baby while on this study because Nutropin AQ may enter breast milk and possibly harm the child.
Exclusion Criteria:
* Pregnancy (positive pregnancy test) prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* Pediatric patients
* Active neoplasm
* History of organ transplantation
* Prader Willi Syndrome who are severely obese or have severe respiratory impairment
* Patients with hepatic impairment resulting in abnormal coagulation studies (\>1.5 times normal reference range)
* Poorly controlled diabetes as determined by a Hemoglobin A1c greater than or equal to 9.0%.
* Individuals with electrocardiogram abnormality or cardiac pacing. <Conditions:>Cystic Fibrosis <Interventions:>Nutropin AQ | 'Age, Categorical', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma <BriefSummary:>RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy also work in different ways to kill more cancer cells or stop them from growing. It is not yet known whether rituximab is more effective with combination chemotherapy or bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing peripheral blood stem cell transplantation.
PURPOSE: This randomized phase II trial studies how well giving rituximab together with combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy and peripheral blood stem cell transplantation works in treating older patients with previously untreated mantle cell lymphoma. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* All patients must have previously untreated stage III, IV, or bulky stage II mantle cell lymphoma (MCL)
* A diagnosis of MCL must be confirmed by histopathological diagnosis including immunohistochemistry and flow cytometry documenting both of the following phenotypes:
* CD19+ or CD20+
* Cyclin D1+ or evidence of the t(11;14) translocation by cytogenetics or FISH
* Adequate sections from the original diagnostic specimen must be available for submission for central review
* An adequate biopsy requires sufficient tissue to establish the architecture and a WHO histologic subtype with certainty
* Core biopsies, especially multiple core biopsies, MAY be adequate, but needle aspirations or cytologies are not adequate
* Bone marrow core biopsy or clot sections (not aspirates) may be used as diagnostic material if it is significantly involved and are the only diagnostic material available
* All patients must have bidimensional measurable disease documented on the Lymphoma Baseline Tumor Assessment Form (Form #48031)
* Patients who also have non-measurable disease in addition to measurable disease must have all nonmeasurable disease assessed within 28 days prior to registration
* Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma
* Any laboratory or radiographic tests performed prior to registration to assess CNS involvement must be negative
* Patients must have a unilateral/bilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration
* If the biopsy cannot be performed but the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes
* Patients must be eligible for stem cell transplantation by institutional guidelines with the plan that transplant will be conducted at a cooperative group-approved transplant center
* Patients must be planning to undergo stem cell transplantation within 84 days after day 1 of the last induction course
* Patients must have had at least 1.5 X 10\^6 CD34\^+ cells/kg collected and stored prior to second registration for stem cell transplantation
PATIENT CHARACTERISTICS:
* Zubrod performance status of 0-2
* Bilirubin ≤ 3 times upper limit of normal (ULN)
* Serum creatinine ≤ 2.0 times ULN
* Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Platelet count ≥ 100,000/mcL, unless due to bone marrow infiltration by lymphoma
* All patients ≥ 45 years of age must have an echocardiogram (ECHO) or Multi Gated Acquisition Scan (MUGA )scan within 42 days prior to registration (whichever method is used at baseline must be used at restaging)
* Patients \< 45 years of age should have ECHO/MUGA only if clinically indicated
* Patients with an ejection fraction \< institutional lower limit of normal (ILLN) are not eligible
* Serum Lactate dehydrogenase (LDH) and a Complete Blood Count (CBC with differential must be measured within 28 days prior to registration
* Patients known to be HIV positive, or who have a history of solid organ transplantation, are ineligible
* No active hepatitis
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated Stage I or II cancer from which the patient is currently in complete remission; or any other cancer from which the patient has been disease-free for 5 years
* Pregnant or nursing women may not participate
* Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics <Conditions:>Lymphoma <Interventions:>rituximab, bendamustine hydrochloride, cyclophosphamide, cytarabine, dexamethasone, doxorubicin hydrochloride, leucovorin calcium, methotrexate, vincristine sulfate | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>PRO 140 by IV Administration in Adults With HIV-1 Infection <BriefSummary:>The purpose of this study is:
1. To assess and characterize the PK and PD of PRO 140 administered IV
2. To assess the antiviral activity of PRO 140
3. To assess the safety and tolerability of PRO 140 <EligibilityCriteria:>Inclusion Criteria:
1. Males \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
3. CD4+ T-lymphocyte cell count ≥ 300 cells/mm3 and no documented count \< or = 250 cells/mm3
4. Has not taken any anti-retroviral therapy (ART) w/in 12 wks of Early Screening Visit
5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit \& a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, \& be non-lactating. Male \& female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.
Exclusion Criteria:
1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
3. History of active hepatitis within the previous 24 wks
4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, experimental or approved. <Conditions:>HIV Infections <Interventions:>PRO 140, PRO 140, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age <BriefSummary:>This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age <EligibilityCriteria:>Inclusion Criteria:
* Male or female children ≥15 months to \<18 years of age at the time of consent.
* Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
* For children \<5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered \>2 months before enrolment into the study
Exclusion Criteria:
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
* Major known congenital malformation or serious chronic disorder
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
* Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation
* Cohorts 3 and 4: Pregnant or breastfeeding female participants <Conditions:>Pneumococcal Disease <Interventions:>20vPnC | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Lucentis in Advanced Macular Degeneration <BriefSummary:>Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections.
Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails".
Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.
Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy. <EligibilityCriteria:>Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Age \> 50 years.
* Low vision AMD patients with a VA of 20/400 or worse.
* Evidence of active exudation as manifested by subretinal or intraretinal fluid on OCT or fresh appearing subretinal hemorrhage on fundus examination.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
* Pregnancy (positive pregnancy test) or lactation.
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* Participation in another simultaneous medical investigation or trial.
* Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma). <Conditions:>Macular Degeneration <Interventions:>ranibizumab | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Meloxicam 15 mg Tablets Under Non-Fasting Conditions <BriefSummary:>The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fed conditions. <EligibilityCriteria:>Inclusion Criteria:
* Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non tobacco user for at least 90 days prior to pre-study medical).
* Body mass Index (BMI = weight/height²) greater than or equal to 18.5 kg/m² and less than or equal to 29.9 kg/m².
* Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
* Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min, temperature between 35.8ºC and 37.5ºC).
* Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum ß-CG).
* No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
* Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.
Exclusion Criteria:
* Known history of hypersensitivity to meloxicam (for example Mobic®), or related drugs such as any other non-steroidal anti-inflammatory drugs (NSAID) such as acetylsalicyclic acid (e.g. Excedrin®, Aspirin®), ibuprofen (e.g. Motrin®), celecoxib (e.g. Celebrex®), Feldene®, Indocin®, Naprosyn®, Vioxx®, Toradol®, Clinoril®, Tolectin®, or Lodine®.
* Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, or liver disease, unless judged not clinically significant by the Principal Investigator, or medical designate.
* Any history or presence of peptic ulcer disease, gastrointestinal bleeding, or kidney disease.
* Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* Any clinically significant illness during the last four weeks prior to entry into this study.
* Presence of any significant physical or organ abnormality.
* Any subject with history of drug abuse.
* Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
* Use of any prescription medication within 14 days preceding entry into this study.
* Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
* Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
* Female subjects: presence of pregnancy or lactation.
* Female subjects at risk of becoming pregnant must consent to using two medically acceptable methods of contraception throughout the entire study, including the washout period and for one month after the completion of the study. Medically acceptable barrier methods of contraception that may be used by the subject and/or partner include diaphragm with spermicide, IUD, condom with foam, and vaginal spermicidal suppository. Complete abstinence can be used alone as a method of contraception.
* Any subject who has had blood drawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR or within the lockout period specified by a previous study conducted at BCR.
* Participation in a clinical trial with an investigational drug within 30 days preceding this study.
* Any subject who has donated blood within 56 days preceding this study.
* Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
* Any subject with a recent (less than one year) history of alcohol abuse.
* Significant or recent history of asthma (after 12 years of age), or familial history of asthma or aspirin-sensitive asthma, sever bronchospasm, nasal polyps or chronic sinusitis.
* Intolerance to venipuncture. <Conditions:>Healthy <Interventions:>Meloxicam 15 mg Tablets, Mobic® 15 mg Tablets | 'Age, Categorical', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>ACP-01 in Patients With Critical Limb Ischemia <BriefSummary:>The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options. <EligibilityCriteria:>Inclusion Criteria:
* Subject is diagnosed with critical limb ischemia.
* Subject has hemodynamic indicators of severe peripheral arterial occlusive disease.
* Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease.
* Subject must be on standard of care medical therapy for peripheral vascular disease.
* Male or female age 18 and above.
* Non-pregnant, non-lactating female.
* Subject is able to understand and provide voluntary signed informed consent.
Exclusion Criteria:
* Uncorrected aorto-iliac occlusive disease.
* Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo).
* Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene.
* Lower extremity non-treated active infection.
* Hypercoagulable state.
* Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
* Inability to communicate that may interfere with clinical evaluation.
* Recent major non-vascular operation.
* Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure.
* Severe aortic stenosis.
* Renal failure.
* Hepatic failure.
* Anemia.
* Major stroke.
* Diagnosis of malignancy.
* Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms.
* Severe concurrent disease (other than Peripheral Vascular Disease (PAD)).
* Bleeding diathesis.
* Participation at the same time in another investigational product or device study.
* Chronic cytotoxic drug treatment.
* Life expectancy of less than 6 months.
* Subject unlikely to be available for follow-up.
* Acute worsening of CLI. <Conditions:>Critical Limb Ischemia <Interventions:>ACP-01, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters <BriefSummary:>Arterial catheterization is frequently performed on critically ill patients for invasive blood pressure monitoring and/or frequent blood draws, especially arterial blood gas analysis. The distal part of the radial artery (wrist) is the preferred access site.
The potential complications of the procedure are mostly minor and comprise temporary occlusion of the radial artery (RA), hematoma, local infection or bleeding from the puncture site. Major complications including vessel aneurysm or occlusion with threat to hand viability are rare.
The standard approach to catheterization is "blind" puncture of the RA while locating its pulse by palpation, followed by threading a 20 Gauge (20G) angio-catheter into the vessel. Alternatively ultrasound can be used to locate the vessel and guide needle insertion.
To our knowledge, four prospective randomized trials (PRT)5-8 comparing palpation with ultrasound-guided RA catheterization have been conducted so far and one meta-analysis looked at the pooled data obtained from these. The results showed that ultrasound guidance increased the first-attempt success rate at RA catheterization by 71% compared to palpation. The use of ultrasound also significantly reduced the time to successful catheterization, the number of punctures as well as the amount of catheters required per procedure.
None of the prior randomized trials has been conducted in an ICU setting and in three out of the four studies the arterial lines were placed in patients undergoing elective surgery. The investigators hypothesized that ultrasound could improve first attempt success rate while placing arterial catheters in an ICU setting. Ultrasound may also reduce total time to successful insertion and reduce complications.
The investigators plan to randomize patients to either a palpation technique or ultrasound guided catheter insertion and record the above outcomes. <EligibilityCriteria:>Inclusion Criteria:
* All surgical intensive care unit patients at Yale New Haven Hospital in whom the indication for arterial catheterization has been established by the attending physician will be eligible for consented randomization to either the "Palpation" or the "Ultrasound" group.
Exclusion Criteria:
* The patient or his/her surrogate declines to participate or the patient lacks a radial artery into which a catheter can be place. <Conditions:>Severe Sepsis <Interventions:>Ultrasound guided radial artery catheterization., Blind insertion of radial artery catheterization | 'Age, Categorical', 'Sex/Gender, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Piloting +Connection is Medicine / The Healing Spirits Program <BriefSummary:>This study aims to assess what benefit, if any, an individualized coping plan and facilitating connections to care through referral coordination in conjunction with culturally tailored caring messages, (herein called the +Connection is Medicine intervention (Navajo Nation study name; +CiM)/The Healing Spirits Program (White Mountain Apache Tribe Study Name; HSP) have on the mental health of American Indian (AI) youth and caregivers who were previously identified as having high levels of anxiety and depression as part of their participation in a cohort study called Project SafeSchools (NIH Grant No.: OT2HD107543). <EligibilityCriteria:>Inclusion Criteria:
- All participants must be parents/caregivers or index youth enrolled in a cohort study called Project SafeSchools.
Adult participants
* Have elevated levels of mental distress as reported in a Project SafeSchools assessment.
* Agreement to be re-contacted for future research as part of their Project SafeSchools consent.
* Meeting symptom eligibility criteria at a screening assessment/baseline visit indicating mental distress.
Youth participants:
* Are 11-16 years old
* Agreement from parent/caregiver to be re-contacted for future research from their Project SafeSchools consent form.
* Meeting symptom eligibility criteria based on a self-report screening assessment/baseline visit indicating mental distress.
For the inclusion criteria, mental distress is defined as meeting eligibility cutoff scores on the following instruments:
Adult Participants
* General Distress (Kessler)
* Anxiety (PROMIS)
* Depression (CESDR-10)
* Recent Suicide Ideation (either CESDR-10 or Ideation Questionnaire)
Youth Participants:
* Depression (CESDR-10)
* Emotional Problems (SDQ Emotional Problems Subscale)
* Anxiety (SCARED)
* Recent Ideation (Ideation question on CESDR-10 or ideation questionnaire)
Exclusion Criteria:
* Inability to cognitively complete interventions and assessments <Conditions:>Mental Health Issue, Depressive Symptoms, Anxiety <Interventions:>Safety Planning Intervention, Caring Contacts | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Distress' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>TH-302 in Combination With Bevacizumab for Glioblastoma <BriefSummary:>Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease progression. <EligibilityCriteria:>Inclusion Criteria:
* 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 IRB/Ethics Committee
* Histologically confirmed glioblastoma
* Progression following both standard combined modality treatment with radiation and temozolomide chemotherapy, as well as bevacizumab
* Recovered from toxicities of prior therapy to grade 0 or 1
* ECOG performance status ≤ 2
* Life expectancy of at least 3 months
* Acceptable liver function:
1. Bilirubin ≤ 1.5 times upper limit of normal
2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN);
* Acceptable renal function:
a. Serum creatinine ≤ULN
* Acceptable hematologic status (without hematologic support):
1. ANC ≥1500 cells/uL
2. Platelet count ≥100,000/uL
3. Hemoglobin ≥9.0 g/dL
* All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose
Exclusion Criteria:
* The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
* The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage, punctate hemorrhage, or hemosiderin are eligible.
* The subject is unable to undergo MRI scan (eg, has pacemaker).
* The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
* The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.
* The subject has evidence of wound dehiscence
* Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation \<90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia
* The subject is pregnant or breast-feeding.
* The subject has serious intercurrent illness, such as:
1. hypertension (two or more blood pressure \[BP\] readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment
2. non-healing wound, ulcer, or bone fracture
3. significant cardiac arrhythmias
4. untreated hypothyroidism
5. uncontrolled active infection
6. symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
7. myocardial infarction, stroke, transient ischemic attack within 6 months
8. gastrointestinal perforation, abdominal fistula, intra- abdominal abscess within 1 year
9. history or clinical evidence of pancreatitis within 2 years
* The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.
* The subject has received any of the following prior anticancer therapy:
1. Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
2. Non-bevacizumab systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug
3. Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
4. Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
5. Prior treatment with carmustine wafers
6. Prior treatment with TH-302 <Conditions:>Glioblastoma <Interventions:>Bevacizumab, TH-302 | 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution <BriefSummary:>The patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. A flip of the coin will decide who gets and additive called buprenorphine in their block or not. They will both contain the same amount and type of numbing medicine. The goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block. <EligibilityCriteria:>Inclusion Criteria:
1. American Society of Anesthesiologists (ASA) physical status 1-3
2. Age 18-79, inclusive
3. BMI \<36 kg/m\^2
4. Patient consenting to single injection brachial plexus nerve block as primary anesthetic for a procedure
Exclusion Criteria:
1. Patients with coagulation disorders
2. Clinically significant pulmonary disease
3. Clinically significant cardiac disease
4. Neurologic deficit in surgical extremity
5. Allergy to bupivacaine or buprenorphine
6. Intolerance of narcotics
7. Local infection over intended area of needle insertion
8. Hepatic failure or renal failure
9. Significant psychiatric disease, including drug abuse
10. Seizure disorder
11. Possible pregnancy or lactation by patient report
12. Use of narcotic medication greater than 2 times a week for greater than 1 week.
13. Patients for whom the surgeon requests a shorter-acting block <Conditions:>Regional Block for Pain Control, Supraclavicular Block, Ultrasound Guided Block, Block Additive <Interventions:>Buprenorphine | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Comparison Study in Adult Surgical Patients of 5 Airway Devices <BriefSummary:>The placement of endotracheal tubes (intubation) is a physiologically stressful procedure for patients. Laryngoscopes are devices-typically composed of a blade attached to a handle with a light source-that allow examination of the upper airway through the mouth, often for the purposes of intubation. Recently some new laryngoscope devices (including the Airtraq® Optical Laryngoscope, the Storz DCI Video laryngoscope®, McGRATH® Video Laryngoscope, and the GlideScope®) have been developed, which may either decrease the stress related to intubation (reduce neck extension, reduce risk of complications or reduce time elapsed during intubation) or improve intubation success (reduce the number of attempts at intubating). Data are being collected in this study to determine which of these commonly-used devices may be better, particularly in comparison to the current hospital standard, the Macintosh laryngoscope. All of the devices to be used in this study are currently cleared or exempt by the Food and Drug Administration (FDA). <EligibilityCriteria:>Inclusion Criteria:
* Elective adult surgical patient requiring general endotracheal anesthesia.
* Males and Females.
* ASA Physical Status 1-3.
* Age 18 years of age and older
Exclusion Criteria:
* Body Mass Index (BMI) ≥35kg/m2.
* If subject is of childbearing potential, a positive pregnancy test at the time of study enrollment.
* Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
* Intubated prior to surgery.
* Severe cardiovascular, hepatic or renal disease.
* Need for nasal intubation.
* An investigator of this study.
* Inclusion in another clinical research study.
* Subject's refusal or inability to agree to and to sign the Informed Consent Form in English.
* Subject requiring awake airway management. <Conditions:>Laryngoscopy, Intubation <Interventions:>Macintosh laryngoscope, Airtraq® Optical Laryngoscope, Storz DCI Video Laryngoscope®, GlideScope® Video Laryngoscope, McGRATH® Video Laryngoscope | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study <BriefSummary:>This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU). <EligibilityCriteria:>Inclusion criteria:
* Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.
Exclusion criteria:
* Patient with serious cardiovascular disease or serious hepatic disease will not be eligible. <Conditions:>Diabetes Mellitus, Type 2 <Interventions:>Rosiglitazone (BRL49653C) | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis <BriefSummary:>This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis. <EligibilityCriteria:>Inclusion Criteria:
* Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
* Diagnosis of possible, probable, or proven invasive aspergillosis.
Exclusion Criteria:
* Patients with aspergilloma or chronic aspergillosis
* Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
* Anticipated survival of less than 5 days or Karnofsky score \<=20 <Conditions:>Aspergillosis <Interventions:>voriconazole, anidulafungin, voriconazole | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance <BriefSummary:>This phase II trial studies how well apalutamide works in treating patients with prostate cancer who are in active surveillance. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. <EligibilityCriteria:>Inclusion Criteria:
* Have signed an informed consent document
* Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
* Written authorization for use and release of health and research study information has been obtained
* Life expectancy \>= 10 years (as determined by the treating physician)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Histologically confirmed adenocarcinoma of the prostate as documented by a minimum 12 core prostate biopsy completed within 1-year of enrollment (note: most recent prostate biopsy must have demonstrated prostatic adenocarcinoma)
* Favorable risk prostate cancer as defined by:
* Very low-risk:
* Clinical stage T1c disease
* PSA density (PSAD) \< 0.15 ng/mL
* Gleason score 6
* =\< 2 core biopsies with =\< 50% involvement of any biopsy core with cancer, or unilateral disease =\< 2 core biopsies with any percentage involvement OR
* Low risk:
* Clinical stage =\< T2a
* PSA \< 15 ng/mL
* Gleason score 6 OR
* Low-intermediate risk:
* Clinical stage T1c
* PSA \< 15 ng/ml
* Gleason 3+4 present in =\< 50% of one core/site as detected by systematic biopsy or MRI/transrectal ultrasound (TRUS) fusion guided biopsy
* Gleason 6 disease in all other cores / sites
* Willing and qualified for active surveillance at Johns Hopkins or the University of Washington
* Serum testosterone \>= 150 ng/dL
* Able to swallow the study drugs whole as a tablet
* Hemoglobin \>= 9.0 g/dL, (at screening), independent of transfusion and/or growth factors within 3 months prior to registration
* Platelet count \>= 100,000 x 10\^9/uL (at screening) independent of transfusion and/or growth factors within 3 months prior to registration
* Serum albumin \>= 3.0 g/dL (at screening)
* Glomerular filtration rate (GFR) \>= 45 mL/min (at screening)
* Serum potassium \>= 3.5 mmol/L (at screening)
* Serum total bilirubin =\< 1.5 x upper limit of normal (ULN) (at screening) (note: in subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject may be eligible)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 × ULN (at screening)
* Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
* Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
Exclusion Criteria:
* Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
* Prior use of ARN-509 (apalutamide)
* Have known allergies, hypersensitivity, or intolerance to ARN-509 (apalutamide) or its excipients
* Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
* Hormonal therapy (e.g. leuprolide, goserelin, triptorelin)
* Cytochrome P450 (CYP)-17 inhibitors (e.g. abiraterone, ketoconazole)
* Antiandrogens (e.g. bicalutamide, nilutamide)
* Second generation antiandrogens (e.g. enzalutamide)
* Immunotherapy (e.g. sipuleucel-T, ipilimumab)
* Chemotherapy (e.g. docetaxel, cabazitaxel)
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
* History of any of the following:
* Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to registration, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration
* Any condition that in the opinion of the investigator, would preclude participation in this study
* Current evidence of any of the following:
* Uncontrolled hypertension
* Gastrointestinal disorder affecting absorption
* Active infection (e.g. human immunodeficiency virus \[HIV\] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
* Any condition that in the opinion of the investigator, would preclude participation in this study
* The use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
* The use of strong CYP3A4 inhibitors, including: itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice (or grapefruits)
* Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
* Strong CYP3A4 inducers, including: phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, efavirenz, tipranavir, St. John's wort
\*\*Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
* Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule <Conditions:>Prostate Adenocarcinoma <Interventions:>Apalutamide, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Patients with very low risk disease at baseline' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases <BriefSummary:>The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477. <EligibilityCriteria:>Inclusion Criteria:
* Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
* Measurable Central Nervous System (CNS) disease, as defined as at least one lesion \> or equal too 10mm in longest dimension
* New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both.
* Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option
* No increase in corticosteroid use in the week prior to study entry
* Any number prior lines of chemotherapy for metastatic breast cancer
* 18 years of age of older
* Life expectancy of greater than 12 weeks
* ECOG Performance Status 0-2
* Patients must have normal organ function as outlined in the protocol
Exclusion Criteria:
* Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
* Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT
* Patients may not be receiving any other investigational agent
* Patients may not be receiving any cancer-directed therapy
* Prior treatment with investigational chemotherapy for brain metastases
* Prior treatment with epothilone for metastatic breast cancer
* Leptomeningeal carcinomatosis as the only site of CNS involvement.
* Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine
* More than 2 seizures over the last four weeks prior to study entry
* Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel
* 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. <Conditions:>Breast Cancer, CNS Disease <Interventions:>ZK219477 | 'Age, Categorical', 'Age Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan <BriefSummary:>The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug. <EligibilityCriteria:>Inclusion Criteria:
Patients need to be administered Somavert (Pegvisomant) in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not administered Somavert (Pegvisomant). <Conditions:>Acromegaly <Interventions:>Somavert (Pegvisomant) | 'Age, Customized', 'Sex: Female, Male', 'Hepatic Function Disorder', 'Renal Impairment', 'Diabetes Mellitus (Concurrent Disease)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy <BriefSummary:>The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants. <EligibilityCriteria:>Inclusion Criteria:
Healthy adult participants and Healthy elderly participants:
• Participant weighs at least 50 kg (Healthy adults participants) / 40 kilogram (kg) (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive at Screening.
Narcolepsy participants:
* Participants weighs at least 40 kg inclusive at Screening (\>=50 kg is required for Cohort B4).
* A diagnosis of narcolepsy, as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3).
* At Day -1, Epworth sleepiness scale (ESS) score \>=10
Exclusion Criteria:
All Participants:
* Participants consume excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
* Participants have a moderate to severe substance use disorder.
* Participants have a risk of suicide according to endorsement of item 4 or 5 with Screening/Baseline visit C-SSRS (Columbia Suicide Severity Rating Scale) or has made a suicide attempt in the previous 6 months.
* Participants have a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia.
* Participants experienced sleep wake cycle disturbance with external factors such as irregular work hours. <Conditions:>Healthy Participants, Narcolepsy <Interventions:>TAK-925, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'Body Mass Index (BMI)', 'Height', 'Weight' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Antineoplaston Therapy in Treating Patients With Ependymoma <BriefSummary:>RATIONALE: Current therapies for patients with ependymoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of patients with ependymoma .
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with ependymoma. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Histologically confirmed ependymoma that is unlikely to respond to existing therapy and for which no curative therapy exists
* Evidence of residual tumor (\>= 5mm) by MRI scan performed within two weeks prior to study entry
* No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
* 6 months and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC at least 2,000/mm3
* Platelet count greater than 50,000/mm3
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure
Renal:
* Creatinine no greater than 2.5 mg/dL
* No renal failure
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No severe heart disease
* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
* No severe lung disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study
* No serious active infections or fever
* No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents
Chemotherapy:
* At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas)
* No concurrent antineoplastic agents
Endocrine therapy:
* Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study)
Radiotherapy:
* At least 8 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* No prior antineoplaston therapy <Conditions:>Ependymoma <Interventions:>Antineoplaston therapy (Atengenal + Astugenal) | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Inpatient Single Dose Interventions for Alcohol Use Disorder <BriefSummary:>Every year, alcohol use disorder (AUD) generates millions of emergency department (ED) visits and hospital admissions, costing the U.S. health sector over $90 billion. These hospital admissions are critical opportunities to start patients on addiction pharmacotherapy, but factors like medication non-adherence and post-discharge relapse contribute to frequent re-admissions. Two single-dose interventions are well suited to facilitate treatment retention and prevent re-admissions due to their prolonged, adherence-independent effects: extended-release (XR) naltrexone injection and intravenous (IV) ketamine infusion. These have not been thoroughly investigated in the hospital setting among high-utilizer, safety-net populations. Therefore, the investigators aim to:
1. Test the feasibility of randomizing hospitalized patients (n=45-60, age 18-65) with multiple AUD-related admissions to treatment with either extended-release (XR) naltrexone, intravenous (IV) ketamine, or no single-dose medication, all with enhanced linkage to care. Feasibility outcomes such as recruitment rate, patient acceptability, post-discharge follow-up rate, and adverse events will help to identify key lessons for a future comparative effectiveness study.
2. Estimate the 30-day re-admission rate for patients randomized to treatment with XR naltrexone, with IV ketamine, or no single-dose medication, all with enhanced linkage to care. The investigators hypothesize that the re-admission rate will be lower for each of the two single-dose medication groups than for the "linkage-alone" group. <EligibilityCriteria:>Inclusion Criteria:
* Age 18-65
* 1+ alcohol-related\* admission(s) or emergency department visit(s) in past 12 mo.
* Has insurance (public or private)
* Seen by inpatient addiction consult service
Exclusion Criteria:
* Known or suspected active COVID-19 infection
* Hepatic: AST/ALT \>5x upper-limit of normal, decompensated liver failure
* Renal: Glomerular filtration rate \<30ml/min
* Cardiovascular: History of acute coronary syndrome, cerebrovascular event, hypertensive crisis, known cardiomyopathy
* Known elevated intracranial pressure
* Thrombocytopenia (\<50/microliter)
* Active moderate/severe withdrawal (based on hospital withdrawal protocol)
* Active delirium (alcohol-related or otherwise)
* Already enrolled in study
* XR naltrexone or IV ketamine in last 30 days
* Known intolerance to naltrexone or ketamine
* Other active severe substance use disorder (tobacco, cannabis excluded)
* Pregnant or breast-feeding, or planning.
* Opioids: chronic, recent (\<24h), or anticipated
* Unstable psychiatric illness (active psychosis, active suicidality)
* Moving from region within 30-days of discharge
* Discharge to acute/residential treatment
* Involuntary hold <Conditions:>Alcohol Use Disorder, Severe <Interventions:>Naltrexone 380 MG, Ketamine Hydrochloride, Enhanced linkage | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Engaging Rural Men With Mobile Technologies for Weight Loss <BriefSummary:>Overweight and obese men in rural Northeast Nebraska are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care, and a rural milieu that contributes to their sedentary physical activity and unhealthy diet. This study proposes to use a pragmatic randomized controlled trial and community engaged research approaches to 1) determine the feasibility and acceptability of a commercially available, smart phone self-monitoring app (premium-version) plus text-based coaching and daily weighing via Wi-Fi scale intervention for achieving weight loss, 2) determine preliminary efficacy of this intervention group to a comparison group receiving only a self-monitoring app (basic-version) in achieving the outcomes of weight loss (kilogram) and improved dietary and physical activity behaviors (secondary) at 6 months post-baseline, and 3) determine quantitative and qualitative indicators of community capacity to support a contextually relevant weight loss intervention. Eighty men (ages 40-69) with body mass index of 28 or higher, randomly assigned (1:1 ratio) to intervention group or comparison group. Men will complete baseline assessments (weight, % body fat, body mass index height, blood pressure, health history, dietary intake, physical activity frequency/intensity) and receive orientation to the mobile technologies (app features, text messaging, Wi-Fi scale). Men will track their dietary intake, physical activity, and weight on the app for 12 weeks. After the 3-month intervention, post-measure assessments (weight, % body fat, BMI, dietary intake, PA frequency/intensity, technology usability surveys) will be collected at 3 and 6 months post-baseline. At 6 months post-baseline, two groups (n=8 each) of intervention completers will be purposively selected to share their perceptions of the intervention efficacy in an evaluative focus group. A community advisory board comprising local leaders within the men's social network, together with investigators and rural student nurses will guide community outreach efforts for study recruitment, implementation and evaluation. Study findings will be evaluated with the community to inform local dissemination, future intervention revision, and determination of community capacity for support of a larger clinical trial. <EligibilityCriteria:>Inclusion Criteria:
* Man age 40-69
* Reside in Northeast Nebraska
* BMI of 28 (kg/m2) or higher (BMI greater than 50 with clinician clearance, maximum weight 396 pounds)
* Smart phone owner with enabled text messaging
* Have an email account
* Answer "no" to all questions on the PAR-Q 17 health history assessment or are willing to get physician evaluation prior to enrolling
* Willing to share self-monitoring logs of eating, activity, and weight with investigative team.
Exclusion Criteria:
* Have recently lost 5% or more of body weight
* Are currently taking medications that cause or are influenced by weight loss
* Have used weight loss app in the past to lose weight
* Family member from same household is enrolled in this study
* Type I diabetes or Type II diabetes with insulin dependence <Conditions:>Weight Loss <Interventions:>Mobile Technology Plus, Mobile Technology | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The Effect of Growth Hormone Replacement on Liver Fat <BriefSummary:>We will examine a cohort of growth hormone deficient adults starting growth hormone (GH) replacement. The purpose of this study is to determine whether GH replacement reduces the fat content of the liver.
To compare the results we will include growth hormone deficient patients who do not start GH replacement as controls. <EligibilityCriteria:>Inclusion Criteria:
* 20-70 years of age
* Growth hormone deficiency, with (cohort 1) or without (cohort 2) planned growth hormone (GH) replacement
* clinically stable
Exclusion Criteria:
* known hepatic disease
* Acromegaly
* Diabetes mellitus
* growth hormone replacement within the last 12 months
* cushing's disease, if not cured for at least 12 months
* any contraindication to MR studies as set out in the MR safety questionnaire <Conditions:>Growth Hormone, Recombinant, Fatty Liver <Interventions:>No Interventions | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration. <BriefSummary:>To compare the dental survival in a period of one year of mature permanent teeth with apical lesion following the administration of encapsulated Mesenchymal Stem Cells under a regenerative endodontic procedure and a conventional root canal treatment. <EligibilityCriteria:>Inclusion Criteria:
Patient inclusion criteria:
* Age: 16 - 58 years old.
* Signed the informed consent.
* Non-smoking.
* Systemically healthy patients
Tooth inclusion criteria:
* Upper and lower incisors, upper and lower canines and lower premolars teeth with mature apex and apical lesion (greater than 2 PAI and 1 CBCTPAI).
* Teeth that do not response to both electrical and thermal pulp test
* Teeth that can be restored (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown.
Exclusion Criteria:
Patient exclusion criteria:
* Patients without a phone number for contact during the study.
* Subjects not available for follow up period (12 months).
* Patients who are or will undergo orthodontic treatment over the next 12 months.
* Patients with an allergy to any material or drug used in the study.
* Patients who are pregnant or lactating.
* Patients with a history of systemic diseases that alter immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's disease and Cushing.
* Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study.
Tooth exclusion criteria:
* Endodontically treated teeth
* Teeth with signs of severe root resorption.
* Teeth with mobility class III or Dens invaginatus.
* Teeth with avulsion history and conservation in a dry extraoral medium for more than 1 hour.
* Teeth with clinical and / or radiographic evidence of root fracture.
* Teeth that can not be absolutely isolated with rubber dam. . Teeth with more than one root or root canal. <Conditions:>Periapical Periodontitis <Interventions:>Regenerative Endodontic Procedure, Conventional Root Canal Treatment | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Safety and Efficacy Study in Patients With Gastric Cancer <BriefSummary:>This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm). Patients will be stratified by number of metastatic sites (one vs. more than one), locally advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or non-measurable disease, and center. <EligibilityCriteria:>Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
* Has given written informed consent
* Has histologically confirmed, unresectable, locally advanced (Stage IV) or metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction
* Has measurable or evaluable but non-measurable disease, defined as follows:
* Measurable Disease - Patients with measurable disease as defined by RECIST criteria, i.e., the presence of at least one measurable lesion. A measurable lesion is one that can be accurately measured in at least one dimension with the longest diameter \>_ 20 mm using conventional techniques or \>_ 10 mm using spiral Computed Tomography (CT)scan. Locally recurrent disease (other than primary) is accepted if there is at least one measurable lesion (i.e. peritoneal mass, lymph node, etc.)
* Evaluable but Non-measurable Disease - Patients with all lesions below the limits defined above for measureable disease (i.e., longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT) excluding those patients with only a primary lesion and/or with only non-evaluable cancer such as bone metastases, ascites, pleural or pericardia effusions, lymphangitic carcinomatosis of the skin or lung, previously irradiated lesions not in progression, or peritoneal carcinomatosis \< 10 mm in diameter with conventional imaging techniques.
* No prior palliative chemotherapy is permitted. Adjuvant and /or neo-adjuvant chemotherapy is permitted if more than 12 months have elapsed between the end of adjuvant or neo-adjuvant therapy and first recurrence. This does not qualify as 1st line therapy.
* Is able to take medications orally
* Is \>_ 18 years of age
* Is at least 3 weeks from prior major surgery
* Is at least 4 weeks from prior radiotherapy
* Has a ECOG performance status 0 to 1
* Has adequate organ function as defined by the following criteria:
* AST (SGOT) and ALT (SGPT) \<_ 2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) \<_ 5 x ULN
* Total serum bilirubin of \<_ 1.5 x ULN
* Absolute granulocyte count of \>_ 1,500/mm (i.e. \>_ 1.5 x 10/L by International Units (IU)
* Platelet count \>_ 100,000/mm (IU: \>_ 100 x 10/L
* Hemoglobin value of \>_ 9.0 g/dL
* Calculated creatinine clearance \>_ 60 mL/min (Cockcroft-Gault formula)
* Is willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
Exclusion Criteria:
Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed:
* Has had a treatment with any of the following within the specified timeframe prior to study drug administration:
* Any prior palliative chemotherapy or any previous therapy for malignancy, including any chemotherapy, immunotherapy, biologic or hormonal therapy, within the past 5 years.
* Adjuvant or neo-adjuvant therapy within the past 12 months
* Concurrent treatment with any investigational anti-cancer agent
* Prior cisplatin as neo-adjuvant and /or adjuvant chemotherapy with cumulative dose \> 300 mg/m
* \> 25% of marrow-bearing bone radiated
* Concurrent treatment with an investigational agent or within 30 days from randomization
* Concurrent enrollment in another clinical study
* Has a serious illness or medical condition(s) including, but not limited to the following:
* Known brain or leptomeningeal metastases
* Uncontrolled ascites requiring drainage at least twice a week
* Other malignancies within the past 5 years, except adequately treated carcinoma-in-situ of the cervix or non-melanoma skin cancer
* Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV
* Chronic nausea, vomiting or diarrhea
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS-related illness
* Psychiatric disorder that may interfere with consent and/or protocol compliance
* Known neuropathy, Grade 2 or higher
* 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 judgement of the Investigator would make the patient inappropriate for entry into this study
* Is receiving concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:
* Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1 activity)
* Allopurinol (may diminish S-1 activity
* Phenytoin (S-1 may enhance phenytoin activity)
* Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity)
* Is receiving concomitant treatment with drugs interacting with 5-FU:
* Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole(may enhance 5-FU activity)
* Allopurinol (may diminish 5-FU activity)
* Phenytoin (5-FU may enhance phenytoin activity)
* Is receiving concomitant treatment with drugs interacting with cisplatin:
* Phenytoin (cisplatin may diminish phenytoin activity)
* Aminoglycosides (should be avoided within 8 days after cisplatin administration)
* Ethyol (may diminish cisplatin activity
* Is a pregnant or lactating female
* Has known hypersensitivity to 5-FU or cisplatin
* Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients) <Conditions:>Gastric Cancer <Interventions:>S-1/Cisplatin, 5-FU/cisplatin | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Body surface area (BSA) Categories', 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'Tissue Type', 'Anatomical Location of Primary Lesion', 'Extent of Disease', 'Disease Measurability' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor <BriefSummary:>Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor <EligibilityCriteria:>Inclusion Criteria:
* Must be ≥22 years of age
* Competent and willing to provide written, informed consent to participate in the study
* Clinically significant postural tremor as defined by:
* Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score
* Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry
* Willing to comply with study protocol requirements including:
* Having the ability to do telemedicine or video calls for study visits
* remaining on a stable dosage of Parkinson's medications, if applicable, during the duration of the study
* no significant caffeine consumption within 8 hours of study visits
Exclusion Criteria:
* Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
* Suspected or diagnosed epilepsy or other seizure disorder
* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
* Peripheral neuropathy affecting the tested upper extremity
* Presence of any other neurodegenerative disease or dementia. These may include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
* Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
* Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
* Significant caffeine consumption within 8 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee).
* Subjects unable to communicate with the investigator and staff
* Any health condition that in the investigator's opinion should preclude participation in this study
* Pregnancy or anticipated pregnancy during the course of the study <Conditions:>Parkinson Disease <Interventions:>Cala Device | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa <BriefSummary:>This trial will create a skin graft, which the investigators call "LEAES," using the patient's own skin cells that have been genetically engineered in the lab to express a missing protein called type VII collagen. The corrected cells will be transplanted back to the patient. <EligibilityCriteria:>Inclusion Criteria:
1. Clinical diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)
2. 13 years old or older and willing and able to give assent/consent
3. Confirmation of RDEB diagnosis by immunofluorescence (IF) and electron microscopy (EM)
4. NC1\[+\] and mAb LH24 antibody staining negative
5. RDEB type VII collagen mutations in subject and carrier parents confirmed
6. At least 100 to 200 cm2 areas of open erosions on the trunk and/or extremities suitable for skin grafting
7. Able to undergo adequate anesthesia to allow grafting procedures to take place.
Exclusion Criteria:
1. Medical instability limiting ability to travel to Stanford University Medical Center
2. The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as active infection with HIV, hepatitis B or hepatitis C, as determined by hepatitis B surface antigen screening, detection of hepatitis C antibodies, or positive result of hepatitis C polymerase chain reaction (PCR) analysis.
3. Antibodies to type VII collagen associated antigens
4. Active infection in the area that will undergo grafting
5. Evidence of systemic infection
6. Current evidence or a history of squamous cell carcinoma in the area that will undergo grafting
7. Active drug or alcohol addiction
8. Hypersensitivity to vancomycin or amikacin
9. Receipt of chemical or biological study product for the specific treatment of RDEB in the past six months
10. Positive pregnancy test or breast-feeding
11. Clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute \[NCI\] toxicity scale) on laboratory tests performed prior to grafting, except for the following specific exclusionary laboratory threshold results, subject to approval or exemption by the EB physician:
* Albumin \< 2.5 g/dL
* Leukocytes \> 20K/uL
* Hemoglobin \< 7.5 g/dL. Low hemoglobin will be treated at the discretion of the investigators and the EB physician.
* Additional exceptions may be made at the discretion of the investigators and the EB physician.
12. Clinically significant abnormalities (Grade 2 or higher on the NCI toxicity scale) identified through medical history and physical examination on Day 0, with the following exceptions:
* Anorexia, can enroll up to Grade 4 (inclusive)
* Constipation, can enroll up to Grade 2 (inclusive)
* Dysphagia, can enroll up to Grade 4 (inclusive)
* Keratitis, can enroll up to Grade 4 (inclusive)
* Bone pain, can enroll up to Grade 2 (inclusive)
* Additional exceptions may be made at the discretion of the investigators and the EB physician. <Conditions:>Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa <Interventions:>LZRSE-Col7A1 Engineered Autologous Epidermal Sheets | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema <BriefSummary:>A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema <EligibilityCriteria:>Inclusion Criteria:
* Patients are required to have histologically or pathologically confirmed, metastatic or locally advanced adenocarcinoma of the pancreas or biliary tree
* No prior systemic chemotherapy for locally advanced or metastatic pancreaticobiliary cancer. No prior EGFR inhibitors.
* ECOG performance status 0-2 retain ability to swallow oral medications
* Age \> 18, non pregnant. Because no dosing or adverse event data are currently available on the use of GW572016 in patients \<18 years of age, children are excluded from this study.
* The effects of GW572016 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
A female is eligible to enter and participate in the study if she is of:
1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
* Has had a hysterectomy,
* Has had a bilateral oophorectomy (ovariectomy),
* Has had a bilateral tubal ligation, or
* Is post-menopausal(a demonstration of total cessation of menses for ³1 year).
2. Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following:
* Intrauterine Device (IUD),
* Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
* Complete abstinence from sexual intercourse for two weeks before exposure to investigational products, throughout the clinical trial, and for at least one week after the last dose of investigational product.
* Double barrier contraception (condom with spermicidal jelly, foam, suppository, or film; diaphragm with spermicide; or male condom and diaphragm)
* Adequate hematologic function: ANC≥1500/ul,platelets≥100,000/ul,hemoglobin 8
* Adequate hepatic function with total bilirubin ≤ 1.5mg/dL and ALT or AST ≤ 2x ULN. (Patients with liver metastases may have AST/ALT less than or equal to 5x upper limit of normal). Patients with elevated bilirubin secondary to biliary obstruction that have subsequently been stented may enter the protocol with a bilirubin of \< 2.0 as long as the bilirubin is falling.
* Adequate renal function: (creatinine ≤1.5mg/dL or estimated creatinine clearance greater than 60ml/min calculated by the Cockcroft Formula).
* Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan. Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution.
* No peripheral neuropathy for patients who receive oxaliplatin.
* Life expectancy of at least 12 weeks
* Signed informed consent
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
* Prior treatment with GW572016 or any EGFR targeting therapies.
* Prior treatment with systemic chemotherapy for metastatic pancreaticobiliary cancer.
* Evidence of brain metastases or leptomeningeal disease
* 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.
* Known contraindications to the use of oxaliplatin or gemcitabine.
* History of allergy to platinum compounds in patients receiving oxaliplatin. Amendment #2 4/28/05
* The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug.
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GW572016
* Participation in any investigational study within 28 days prior to study enrolment
* Any major surgery (insertion of a vascular access device is not considered a major surgery), hormonal therapy (other than replacement), chemotherapy or radiotherapy within the last 4 weeks and/or not recovered from prior therapy within the last 4 weeks and/or not recovered from prior therapy.
* Pregnant or lactating females are excluded from this study because GW572016 is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GW572016, breastfeeding should be discontinued if the mother is treated with GW572016.
* Malabsorption syndrome disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption of GW572016.
* Any unresolved bowel obstruction.
* The patient has inadequate venous access in the clinical judgment of the investigator or designated clinical staff.
* The patient is taking any medication on the prohibited medications list in Section 10.2 Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR. If medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with GW572016 is not expected.
* Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy. <Conditions:>Metastatic Pancreatic Cancer <Interventions:>cohort 1, cohort 2, cohort 3, cohort 4 | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>18F-DCFBC PET/CT in Prostate Cancer <BriefSummary:>Background:
- Prostate cancer is the second leading cause of cancer deaths in American men. A chemical called a radiotracer helps doctors get images of this type of cancer. Researchers want to test a radiotracer called N-\[N-\[(S)-1,3-dicarboxypropyl\]carbamoyl\]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC).
Objective:
- To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.
Eligibility:
- Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have relapsed, or has spread outside the prostate.
Design:
* Participants will be screened with physical exam and medical history. They will give a blood sample.
* Participants will be divided into three groups.
Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or biopsy at National Institutes of Health (NIH).
Group 2: people who had their prostate removed or had radiation therapy and now have a rising prostate-specific antigen (PSA) without other signs of disease.
Group 3: people whose cancer has spread to other areas of the body.
* Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on their back on the scanner table.
* Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a contrast agent injected through an intravenous line.
* Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21 days of the 18F-DCFBC scan to look for prostate cancer in the bone.
* Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.
* A few days after each scan, participants will be contacted for follow-up. <EligibilityCriteria:>* INCLUSION CRITERIA:
* Subject is greater than or equal to18 years old
* Platelet count \> 50,000/mm\^3
* Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
* Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.
* Categories
* ARM 1 only
---For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-\[N-\[(S)-1,3-dicarboxypropyl\]carbamoyl\]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging.
* ARM 2 only:
* For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir
* OR
* For patients status post prostatectomy, a PSA \>/=0.2 ng/ml
* Nonspecific or no evidence for disease on standard imaging modality
* ARM 3 only:
* Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality. If only soft tissue metastasis, one lesion must measure at least 6mm or greater. Patients must have confirmation of prostate cancer prior to 18FDCFBC imaging
Note: A patient who is eligible for one arm, subsequently may cross-over into a different arm.
EXCLUSION CRITERIA:
* Subjects for whom participating would significantly delay the scheduled standard of care therapy
* Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
* Subjects with severe claustrophobia unresponsive to oral anxiolytics
* Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
* Subjects weighing \> 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
* Serum creatinine \> 2 times the upper limit of normal
* Total bilirubin \> 2 times the upper limit of normal
* Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal <Conditions:>Prostatic Neoplasms, Prostate Cancer <Interventions:>18F DCFBC, Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT) | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Gleason Grade at Diagnosis', 'Prior Prostate Cancer Therapy', 'Baseline Imaging', 'Prostatic-Specific Antigen (PSA) at Baseline', 'Castration Status' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2) <BriefSummary:>This study will evaluate a combination of bedaquiline and rifampicin as post exposure prophylaxis (PEP) for leprosy in Comoros. It will be a follow-up to the PEOPLE trial on PEP with rifampicin, which is ending in 2022. This new trial will be called the 'Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy' or 'BE-PEOPLE' trial. There will be two main study arms, a comparator arm based on the current WHO recommendation of providing a single dose of rifampicin (10 mg/kg) to close contacts of leprosy patients and an intervention arm in which this regimen will be reinforced with bedaquiline, 400 or 800 mg depending on weight, to be repeated once after four weeks for household contacts. The main study will be preceded by a phase 2 safety study. <EligibilityCriteria:>Inclusion Criteria:
1. Being a permanent resident of the study village, in good state of health
2. Able and willing to provide informed consent
3. Age 5 years or above and weight of 20 kg or above
Exclusion Criteria:
1. Signs of active leprosy
2. Signs of active pulmonary tuberculosis (cough ≥2 weeks duration)
3. Signs of active extra-pulmonary tuberculosis (bluish-red nodules that cover the lymph nodes, bones or joints, or cervical glands with discharge)
4. History of liver- or kidney disease
5. Allergy to rifampicin or bedaquiline
6. Having received rifampicin or bedaquiline (if applicable) in the last 2-year period
7. Not able to swallow bedaquiline 100 mg tablets
8. Self-reported (suspected) pregnancy or breastfeeding
9. Concurrent (within the last three week period before D0) use of medications not included in the safe list (for bedaquiline only)
10. QT-prolongation of ≥450 msec in baseline ECG within the last week.
11. Jaundice or self-reported liver function abnormalities or hepatitis
12. Value of baseline ALT or AST \>3x ULN within the last week. In case only ALT is available, this would suffice for enrollment <Conditions:>Leprosy <Interventions:>BE-PEP (Bedaquiline), SDR-PEP, BE-PEP (Rifampicine) | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD) <BriefSummary:>The purpose of this study is to evaluate efficacy of ibrutinib in Japanese participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response \[CR\] and partial response \[PR\] defined by National Institutes of Health \[NIH\] consensus development project criteria \[2014\]). <EligibilityCriteria:>Inclusion Criteria:
* Steroid dependent/refractory chronic graft versus host disease (cGVHD) defined as modified National Institutes of Health (NIH) criteria (2014) below at any time post-hematopoietic cell transplant (post-HCT): a) Dependent disease, defined as, when glucocorticoid (prednisolone doses greater than or equal to \[\>=\] 0.25 milligram per kilogram per day (mg/kg/day)or \>=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks. In case of inability to taper the dose to less than or equal to (\<=)0.25 mg/kg/day or \<=0.5 mg/kg every other day (prednisolone doses) due to recurrence or progression of cGVHD manifestations, it is considered as steroid-dependent disease if the lowest tapering dose of the second occasion is equal or higher than the lowest tapering dose of the first occasion; b) Refractory disease, defined as, when cGVHD manifestations progress despite the use of a regimen containing glucocorticoid (prednisolone at \>=1 mg/kg/day for at least 1 week) or persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks
* Participants must be receiving baseline systemic glucocorticoid therapy for cGVHD at study entry. The dose of steroids must be stable for 14 days prior to starting ibrutinib
* At the time of trial enrollment, participants may be receiving other immunosuppressive therapies in addition to glucocorticoids. Immunosuppressant doses must be stable for 14 days prior to starting ibrutinib
* Clinically stable or worsening cGVHD for a minimum of 14 days between screening and Day 1 cGVHD response assessment
* Karnofsky or Lansky (participants less than \[\<\]16 years) performance status \>=60
Exclusion Criteria:
* Active acute graft versus host disease (GVHD)
* More than 3 previous systemic treatments for cGVHD. Treatment with glucocorticoids is considered a treatment for cGVHD and should be included in determining the number of previous treatments
* History of treatment with a tyrosine kinase inhibitor (example \[e.g.\] imatinib), purine analogs, or other cancer chemotherapy in the 4 weeks prior to starting ibrutinib. Participants may have received ibrutinib pre-transplant for other reasons besides cGVHD such as for the treatment of leukemia or lymphoma
* History of treatment with monoclonal T and B cell antibodies in the 8 weeks prior to starting ibrutinib
* Vaccinated with live, attenuated vaccines within 4 weeks of first dose of ibrutinib <Conditions:>Graft vs Host Disease <Interventions:>Ibrutinib | 'Age, Continuous', 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study <BriefSummary:>This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time. <EligibilityCriteria:>Inclusion Criteria:
* must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
* reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
* Teeth to be vital and asymptomatic prior to treatment
* No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
Exclusion Criteria:
* Devital or sensitive teeth
* Teeth with prior endodontic treatment of any kind
* Teeth with a history of direct or indirect pulp capping procedures
* Patients with significant untreated dental disease to include periodontitis and rampant caries
* Pregnant or lactating women
* Patients with a history of allergies to any of the materials to be used in the study
* Patients unable to return for the recall appointments <Conditions:>Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth <Interventions:>Celtra Duo | 'Age, Customized', 'Sex: Female, Male', 'Race and Ethnicity Not Collected' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Theta Burst Stimulation for Schizophrenia <BriefSummary:>Purpose and objective Schizophrenia is a chronic debilitating illness with cognitive deficits that cause serious impairment in psychosocial recovery and with few treatments to remediate these deficits. One area that holds great promise for the development of novel, effective therapies is noninvasive brain stimulation. The investigators have used one form of brain stimulation, transcranial magnetic stimulation (TMS), for some time to modulate and enhance cognitive function in the brain, especially working memory (WM) function, which has a central role in most executive processing that occurs in the brain. Theta burst stimulation (TBS) is a paradigm of TMS which has been shown to effectively modulate WM. Moreover, TBS can modulate gamma neural oscillations in the brain and neural activity, both of which have been implicated in the physiology of WM and pathophysiology of the disease process in schizophrenia, making these measures highly valuable for assessing physiological effects of TBS on cognition, quality of life and cortical inhibition. The purpose of this study is to evaluate the effect of TBS on WM in patients with schizophrenia, to develop evidence for potential brain stimulation techniques to treat cognitive deficits in schizophrenia.
Study activities and population group: Study subjects will be inpatient schizophrenic individuals with minimal positive symptoms and predominant cognitive deficits at Duke University Hospital. In an initial session they will be screened and taught a WM task. Following this, one TBS session will follow in which TBS will target dorsolateral prefrontal cortex. They will perform the WM task before, with and after the TBS, with an expected pre-post enhancement of WM performance.
Implications - There is a great need for treatments for cognitive deficits in schizophrenia. The results of this study will serve to generate pilot data for a much larger grant to develop a TBS therapy for remediating such cognitive deficits. <EligibilityCriteria:>Inclusion Criteria:
* Patients aged 18-65 years of age with schizophrenia or schizoaffective disorder
* No other mental health diagnoses
* Right handed males and females
* May have mild positive symptoms (score of \</= 21)
* May have negative symptoms
* Ability to provide informed consent
* No restriction on concomitant medications given
Exclusion Criteria:
* Intellectual disability
* Any organic brain illness Presence of dementia symptoms or traumatic brain injury Primary diagnosis of substance use Seizure disorder Actively symptomatic with PANSS positive symptom sub-scale \>21. Concurrently receiving electroconvulsive therapy (ECT) <Conditions:>Schizophrenia, Schizoaffective Disorder <Interventions:>Theta Burst Stimulation | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Brief Assessment of Cognition (BACS) Composite T Score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Adaptive COVID-19 Treatment Trial 2 (ACTT-2) <BriefSummary:>ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29. <EligibilityCriteria:>Inclusion Criteria:
1. Admitted to a hospital with symptoms suggestive of COVID-19.
2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
4. Male or non-pregnant female adult \> / = 18 years of age at time of enrollment.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either of the following:
* PCR positive in sample collected \< 72 hours prior to randomization; OR
* PCR positive in sample collected \>/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking \>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
6. Illness of any duration, and at least one of the following:
* Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
* SpO2 \< / = 94% on room air, OR
* Requiring supplemental oxygen, OR
* Requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
8. Agrees to not participate in another clinical trial for the treatment of COVID-19 through Day 29.
Exclusion Criteria:
1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
2. Estimated glomerular filtration rate (eGFR) \< 30 ml/min or patient is receiving hemodialysis or hemofiltration at time of screening.
3. Neutropenia (absolute neutrophil count \<1000 cells/microliter) (\<1.0 x 103/microliter or \<1.0 GI/L).
4. Lymphopenia (absolute lymphocyte count \<200 cells/microliter) (\<0.20 x 103/microliter or \<0.20 GI/L)
5. Pregnancy or breast feeding.
6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
7. Allergy to any study medication.
8. Received three or more doses of remdesivir, including the loading dose, outside of the study under the EUA (or similar mechanism) for COVID-19.
9. Received convalescent plasma or intravenous immunoglobulin \[IVIg\]) for COVID-19, the current illness for which they are being enrolled.
10. Received small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatibib, genfinitib), in the 1 week prior to screening
11. Received monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 \[IL-1\], anti-IL-6 \[tocilizumab or sarilumab\]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening.
12. Received monoclonal antibodies targeting B-cell (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening.
13. Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with baricitinib is larger than the risk of COVID-19.
14. Received \>/= 20 mg/day of prednisone or equivalent for \>/=14 consecutive days in the 4 weeks prior to screening.
15. Use of probenecid that cannot be discontinued at study enrollment.
16. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
17. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
18. Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects.
19. Have a history of VTE (deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) within 12 weeks prior to screening or have a history of recurrent (\>1) VTE (DVT/PE).
20. Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrollment, who, in the judgment of PI, are at increased risk for serious infections or other safety concerns given the study products. <Conditions:>COVID-19 <Interventions:>Placebo, Remdesivir, Baricitinib | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Disease severity' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia <BriefSummary:>This observational study will investigate suspected infectious diseases of unknown etiology prospectively during outbreaks and at healthcare facilities, and retrospectively through historical samples where no etiology was ever determined. The study is designed to rapidly, flexibly, and consistently respond to any potential scenario in Indonesia, and the data collected will provide needed insight into the landscape of infectious diseases in the country. By better understanding the infectious causes of outbreaks and difficult hospitalized cases, the Indonesian Ministry of Health will be able to more accurately and efficiently control infectious diseases and craft healthcare policies. <EligibilityCriteria:>Inclusion Criteria:
1. Adult or child of any age hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology
2. Negative for Dengue virus infection by an antigen-based and antibody-based diagnostic test (i.e. NS1 antigen test and Dengue-specific IgM test)
3. Negative for Salmonella Typhi infection by Standard of Care testing (i.e. blood culture, Widal test, or Tubex rapid test)
4. Able to provide a documented informed consent
5. Agrees to the collection and storage of specimens for laboratory testing and/or future research (participants may decline storage of specimens for future research)
6. For Ongoing patients in outbreak situations: Referral from the MoH as part of a suspected or identified outbreak of infectious disease
Exclusion Criteria:
* Investigators' discretion for patient safety and well being <Conditions:>Infectious Disease <Interventions:>No Interventions | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata <BriefSummary:>The purpose of the study is to see whether treating alopecia areata with injections of the corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal glands. <EligibilityCriteria:>Inclusion Criteria:
* Subject has clinical diagnosis of alopecia areata.
* Written informed consent and HIPAA authorization have been obtained.
* Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable method of birth control to prevent pregnancy.
* In the opinion of the investigator, subject is a candidate for intralesional therapy for alopecia areata.
* Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.
* Subject meets concomitant medication washout requirements.
* Subject is \>/= 18 years of age.
Exclusion Criteria:
* Subject has alopecia universalis.
* Subject has known adrenocortical insufficiency or Cushing's Syndrome.
* Subject is pregnant or lactating.
* Subject has current controlled or uncontrolled bacterial, viral, fungal, atypical, or opportunistic infections.
* Subject possesses hypersensitivity to cortrosyn or Triamcinolone Acetonide (Kenalog-10) or any component of their formulation.
* Subject is currently or has undergone therapy for malignancy within the past five years.
* Subject has history of substance abuse within the past five years.
* Subject has used oral corticosteroids within the past 12 months.
* Subject has concurrent use of phenytion rifampin, phenobarbital, mitotane, or other formulations of corticosteroid medications.
* Subject has any medical condition that, in the judgement of the investigator, would jeopardize the subject's safety following exposure to the administered medications. <Conditions:>Alopecia Areata <Interventions:>Triamcinolone Acetonide 10 mg/mL (Kenalog-10) | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities <BriefSummary:>The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight. <EligibilityCriteria:>Inclusion Criteria:
* Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²)
* Have a BMI ≥27 kg/m² and \<30 kg/m² with at least 1 of the following weight-related comorbidities eg; \[Have hypertension, or dyslipidemia, cardiovascular disease\]
* Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss)
Exclusion Criteria:
* Have any prior diagnosis of diabetes
* Have a prior or planned surgical treatment for obesity
* Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity
* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 milliliter (mL)/minute (min)/1.73 m²
* Have a history of acute chronic pancreatitis
* Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications.
Within 3 months prior to screening:
* Have poorly controlled hypertension
* Have history of acute myocardial infarction
* Have history of cerebrovascular accident (stroke)
* Had hospitalization due to congestive heart failure (CHF)
* Have cancer
* Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
* Have hepatitis B and/or positive hepatitis B surface antigen <Conditions:>Obesity, Overweight and Obesity <Interventions:>LY3502970, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Baseline Body Weight' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease <BriefSummary:>Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol. <EligibilityCriteria:>Key Inclusion Criteria include:
1. Participants who had completed participation in the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies within 4 weeks of screening
2. Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
3. Participant and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study
Key Exclusion Criteria include:
1. Experienced a serious adverse event related to IV iron therapy in the combined AMAG-FER-CKD-251 and AMAG-FER- CKD-252 studies
2. Hemoglobin level ≤7 g/dL <Conditions:>Iron Deficiency Anemia <Interventions:>Ferumoxytol | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction <BriefSummary:>The purpose of this study is to determine whether treatment with Ranolazine will improve exercise capacity in patients with Heart Failure with preserved left ventricular ejection fraction, or HFPEF. <EligibilityCriteria:>I. Inclusion Criteria
* Age \> 18 years old
* Diagnosis of Heart Failure (HF) with Preserved Ejection Fraction (PEF)
* Signs or symptoms of heart failure (breathlessness, pulmonary congestion, edema, fatigue), NYHA (New York Heart Association) Class II-III HF AND
* LVEF (Left Ventricular Ejection Fraction) \> 45% AND
* Evidence of elevated LV filling pressures
1. E/e-prime (E/e') mitral ratio \> 8. Mitral E/e' ratio has been proposed as a noninvasive measure of left ventricular filling pressure.
2. Brain natiuretic peptide (BNP) \> 80 pg/mL. BNP is biomarker of ventricular wall stress.
* Pulmonary Artery systolic pressure estimated at \> 35 mm Hg on echocardiography
* Stable medical management for at least 1 month
II. Exclusion Criteria
* Inability to perform 6 minute walk (6MW) test or 6 minute walk distance \> 550 meters at baseline
* Inability to perform the Naughton protocol exercise test, or an absolute contraindication to exercise testing
* Decompensated heart failure
* Clinically significant valvular disease or congenital cardiac defects
* Clinical diagnosis of Chronic obstructive pulmonary disease (COPD) or significant lung pathology
* Prior treatment with ranolazine
* Percutaneous coronary intervention within the past 6 months or planned intervention during the study period
* Acute coronary syndrome within the prior 2 months
* Presence of uncorrected perfusion defects on stress testing
* Presence of angina
* Any rhythm other than sinus
* Electrocardiogram measured QTc interval \> 500 msec
* Clinically significant hepatic impairment (ALT/AST \> 3x upper limit of normal)
* Participation in another investigational drug or device study within 1 month prior to screening
* Females of childbearing potential
* Current treatment with potent inhibitors of hepatic cytochrome P450 (CYP) enzyme complex pathways affecting drug metabolism (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
* Current treatment with CYP3A and/or P-Glycoprotein (Pgp) inducers (e.g. rifampin, rifampicin, carbamazepine, St. John's wort)
* Any other conditions that in the opinion of the investigators are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study. <Conditions:>Heart Failure With Preserved Ejection Fraction <Interventions:>Ranolazine, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Exercise Duration', 'Peak Oxygen Uptake (VO2)', '6MW test distance', 'BNP', 'Quality of Life (QOL) Score', 'Septal E/e' Doppler velocity ratio' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks <BriefSummary:>In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff. <EligibilityCriteria:>Inclusion Criteria:
* Women 18-50 years of age undergoing surgical termination of pregnancy
* English or Spanish speaking
* Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
* Eligible for a dilation and evacuation abortion with local anesthesia and sedation
* Ultrasound for dating purposes done within the last two weeks
Exclusion Criteria:
* Intrauterine infection
* Fetal demise
* Ruptured membranes
* Multiple gestation
* Uterine anomaly or significant distortion of the uterus with fibroids
* BMI greater than 45
* Inability to place osmotic dilators
* Active substance abuse or intoxication
* Adrenal failure, chronic corticosteroid use, anticoagulant usage
* Severe cervicitis, until treated and resolved
* Prior Cesarean section <Conditions:>Cervical Preparation <Interventions:>Mifepristone, osmotic dilators | 'Age, Categorical', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS <BriefSummary:>The purpose of this study is to find out if cannabis-based medicine compared to a dummy medicine (placebo that contains no active ingredient) can help the central neuropathic pain patients experience as a result of multiple sclerosis. This type of pain "central neuropathic pain" is described as shooting, stabbing, burning or searing like sensation, which is often worse at night. <EligibilityCriteria:>Inclusion Criteria:
* Any disease sub-type of MS of at least two years duration
* Central neuropathic pain (CNP) of at least three months and expected to remain stable for the study duration
* Moderate CNP defined by NRS pain score at baseline sum to at least 24
* Subject established on or previously tried and failed analgesic therapy for CNP
* If receiving disease modifying medications, stable dose for 3 months and maintained for study duration
Exclusion Criteria:
* Subjects whose identified pain is likely to be nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic in origin, or due to trigeminal neuralgia.
* Other non central neuropathic pain of a severity which is likely to interfere with the patients assessment of CNP
* medical history suggests subject is likely to relapse/remit during course of study
* history of schizophrenia (including family history), other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with MS
* known or suspected history of alcohol abuse, epilepsy or recurrent seizures or hypersensitivity to cannabinoids
* travel outside of the country of residence planned during the study
* significant cardiac, renal or hepatic impairment
* subjects with current recreational cannabis, medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration of the study <Conditions:>Multiple Sclerosis <Interventions:>Sativex, Placebo | 'Age Continuous', 'Sex: Female, Male', 'Duration of Multiple Sclerosis (MS)', 'Duration of Central Neuropathic Pain (CNP)', 'Baseline Pain Numerical Rating Scale (NRS) score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone <BriefSummary:>The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied. <EligibilityCriteria:>Key Inclusion Criteria
* Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
* Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
* C-peptide ≥1.0 ng/mL
* Body mass index ≤45.0 kg/m\^2
* Serum creatinine level \<1.50 mg/dL for men or \<1.40 mg/dL for women.
Key Exclusion Criteria
* Aspartate aminotransferase and/or alanine aminotransferase level \>3.0 times the upper limit of normal
* Serum total bilirubin level \>2 mg/dL
* Creatinine kinase level \>3 times upper limit of normal
* Symptoms of severely uncontrolled diabetes
* Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases <Conditions:>Type 2 Diabetes <Interventions:>Dapagliflozin, Placebo, Metformin | 'Age, Continuous', 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Female Age', 'Body Mass Index' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis <BriefSummary:>Specific Aim 1: To investigate whether, in Lymphangioleiomyomatosis (LAM) patients, the combination of sirolimus and hydroxychloroquine is safe and well tolerated
Specific Aim 2: To investigate whether, in LAM patients, 6 months of combination therapy with sirolimus and hydroxychloroquine results in improvement of indicators of disease, and whether the gains are sustained after stopping therapy.
Specific Aim 3: To investigate the potential role of a LAM-specific peripheral blood signature to predict rates of disease progression and determine responsiveness to combination therapy.
This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken orally daily. Up to 18 adult women with LAM will be enrolled. <EligibilityCriteria:>Inclusion Criteria:
* Female age 18 or older
* Ability to give informed consent
* Diagnosis of LAM as defined as typical cystic change on CT plus:
* biopsy or cytology of any tissue demonstrating LAM
* angiomyolipoma, chylothorax, lymphangioleiomyoma, or tuberous sclerosis
* serum VEGFD greater or equal to 800pg/ml
* Post-bronchodilator FEV1 equal or less than 80% of predicted or DLCO equal equal or less than 70% of predicted, or RV \> 120% of predicted at baseline
* Women of childbearing potential must agree to use 2 forms of barrier contraception during and for 8 weeks after the last dose of medication.
Exclusion Criteria:
* History of intolerance of mTOR inhibitors
* History of intolerance to hydroxychloroquine
* History of severe psoriasis
* History of porphyria cutanea tarda
* Uncontrolled intercurrent illness
* Pregnant, breast feeding, or plan to become pregnant in the next year
* Inadequate contraception
* Significant hematological or hepatic abnormalities
* Use of an investigational drug within 30 days of study start
* Inability to attend scheduled clinic visits
* Inability to perform PFTs
* Creatinine \> 2.5mg/dL
* Recent pneumothorax within 8 weeks of screening
* History of malignancy in the last 2 years other than basal cell skin cancer
* Use of estrogen containing medication within 30 days of screening
* Abnormal G6PD levels at baseline
* Preexisting maculopathy or retinopathy
* Preexisting myopathy
* Currently taking doxycycline, metformin, lupron, simvastatin
* Unable to undergo CT or MRI
* History of seizure within last year
* Hepatitis B, C, HIV positive serology
* Use of alternative medical therapies for LAM for at least 6 weeks prior to study participation
* History of myocardial infarct, angina, or stroke related to atherosclerosis
* History of cardiomyopathy
* Previous lung transplant
* Surgery (involving entry into a body cavity or requiring 3 or more stitches) within 2 months of initiation of study drug
* Uncontrolled cholesterol \> 350mg/dL, triglycerides \> 400mg/dL <Conditions:>Lymphangioleiomyomatosis <Interventions:>"Sirolimus" and "Hydroxychloroquine" 200 mg, "Sirolimus" and "Hydroxychloroquine" 400 mg | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Post-Menopause', 'Pneumothorax', 'Angiomyolipoma', 'Tuberous Sclerois (TSC)- Lymphangioleiomyomatosis (LAM)', 'Lung Biopsy', 'Chylothorax', '6 minute walk distance (6MWD) (m)', 'St. George's Respiratory Questionnaire (SGRQ)', 'Log VEGF-D (Veascular Endothelial Growth factor)', 'FEV1', 'FEV1 (%)', 'FVC (L)', 'FVC (%)', 'DLCO (ml/min/mmhg)', 'DLCO (%)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy <BriefSummary:>RATIONALE: Yoga and wellness classes may reduce fatigue and improve mood, sleep, and quality of life in women receiving chemotherapy for breast cancer. It is not yet known whether yoga is more effective than wellness education for women with breast cancer who are undergoing chemotherapy.
PURPOSE: This randomized phase II trial is studying a community-based yoga class to see how well it works compared with an educational wellness class for women with stage I, stage II, or stage III breast cancer undergoing chemotherapy. <EligibilityCriteria:>Inclusion Criteria:
Women will be eligible if they are:
* Scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start Yoga/Wellness sessions prior to second chemotherapy treatment.
* ≥18 years of age.
* Physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ECOG Performance Status rating 0-2; Zubrod et al., 1960).
* Diagnosed with breast cancer Stages I-III.
* Chemotherapy is anticipated to continue during the 10 weeks of the study intervention.
* 2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. Given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.
* Are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or Herceptin therapy only (no chemotherapy).
* Anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.
* Have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.
Pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. In fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. The anticipated number of pregnant women eligible to enroll is minimal. <Conditions:>Breast Cancer, Depression, Fatigue, Sleep Disorders <Interventions:>Yoga, Education | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Scalable Model for Promoting Functioning and Well-Being Among Older Adults With Mild Cognitive Impairment Via Meaningful Social Interactions: Project SPEAK! <BriefSummary:>The goal of this study is to refine and test a strategy for engaging older adults with symptoms of SCD/MCI (subjective cognitive decline/mild cognitive impairment) as volunteers to help English language learners (ELLs) who live in the US improve their speaking skills via structured conversations using videoconferencing. <EligibilityCriteria:>Mild Cognitive Impairment participant --
Inclusion Criteria:
* 55+ years of age, fluent speakers of English of any race/ethnicity, and be able to participate in a videoconference via a smartphone, tablet laptop, or desktop computer in their home or referring organization using a widely accessible, no cost videoconferencing platform.
Exclusion Criteria:
* Participants will be ineligible if they have a history of stroke or traumatic brain injury, bipolar disorder, schizophrenia, or current alcohol or drug abuse/dependence, that would affect their ability to participate in the study; MoCA score \<12. <Conditions:>Mild Cognitive Impairment <Interventions:>Intervention (videoconferencing) | 'Age, Continuous', 'Sex/Gender, Customized', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Highest Degree of Completed Education' |