Kornimate/medical-research-clean huggingface dataset:
community care for croup (rct)

Conditions: Croup

Summary: this randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for 3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate croup. it was conducted in a practice-based research network of community pediatricians in the st. louis area. outcomes included additional health care for croup, duration of symptoms, nights of disturbed sleep, parental stress, missed work days, and adverse events. our hypothesis was that community-based treatment of children with mild or moderate croup with multiple doses of prednisone is superior to a single dose of dexamethasone.


Eligibility criteria:
inclusion criteria: * children aged 1 to 8 years old (not yet reached their 9th birthday), who have croup symptoms for less than or equal to 48 hours and have a physician diagnosis of mild or moderate croup. exclusion criteria: * severe croup or impending respiratory failure; * another reason to indicate the need for hospitalization; * symptoms or signs to suggest another cause of stridor; * active varicella infection; * diabetes; * known immunodeficiency disease; * chronic respiratory disease such as cf (cystic fibrosis); * prescribed a controller medication or oral steroids for asthma in the past 12 months; * a history of tb(tuberculosis) in a household member; * treatment for seizures; * treatment with epinephrine or oral corticosteroids for this croup episode before enrollment; * not accompanied by their legal guardian; * the accompanying adult will not be in the same household as the child for the next four days; * parent/legal guardian is unavailable for telephone follow-up or does not speak english.

Keywords: primary care treatment croup corticosteroids prednisone dexamethasone randomized trial
observational study of ibrutinib use in cll

Conditions: Chronic Lymphocytic Leukemia

Summary: ib-ru-scope is a "routine-clinical practice" oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the russian federation

ibrutinib is approved in russia for treatment of cll patients both in first line and in relapsed/refractory setting. there is a discrepancy in reported ibrutinib toxicity profile, efficacy and tolerability between registrational clinical trials and observational studies, which to some extent may be explained by patient selection in the former. ib-ru-scope is a first "routine-clinical practice" oriented cohort observational study of ibrutinib in cll in russia. the study is designed to include all previously untreated and relapsed/refractory cll patients older than 18 years with active disease, who have recently started or are about to start ibrutinib (both as monotherapy and in combination), and to follow them to a minimum of 18 and a maximum of 36 months. the study is being conducted in approx. 10 russian hematological centers and aims to include approx. 70 cll patients.

Eligibility criteria:
inclusion criteria: 1. age older than 18 years. 2. diagnosis of chronic lymphocytic leukemia, established according to iwcll criteria (hallek et al., 2018). 3. presence of indications for initiating treatment as listed in iwcll guidelines (hallek et al., 2018) before start of ibrutinib therapy. 4. treatment with ibrutinib per instructions for medical use of the drug, approved in the russian federation, is planned or this therapy has been started within 7 days before enrolment in the study (date of signing of informed consent). simultaneously, the patient has not received ibrutinib as one of the previous lines of treatment. 5. informed consent signed by the patient. exclusion criteria: 1. presence of contraindications for the use of ibrutinib in accordance with the instructions, approved in the russian federation for the medical use of the drug, namely: * known hypersensitivity to ibrutinib (e.g. with anaphylactic and anaphylactoid reactions); * pregnancy and the period of breastfeeding; * age under 18 years; * severe renal dysfunction (creatinine clearance \<30 ml/min), incl. need for hemodialysis; * severe liver dysfunction (child-pugh class c); * concomitant use with strong inducers of the isoenzyme cyp3a (e.g., carbamazepine, rifampicin, phenytoin and drugs, containing hypericum perforatum extract); * concomitant use with warfarin, other vitamin k antagonists, fish oil and vitamin e preparations.

Keywords: cll, chronic lymphocytic leukemia, ibrutinib
clinical evaluation of the safety and efficacy of fid 120947a

Conditions: Refractive Error

Summary: the purpose of this study is to evaluate the safety and efficacy of fid 120947a in soft contact lens wearers of japanese ethnicity.


Eligibility criteria:
inclusion criteria: * successful history of silicone hydrogel or other soft contact lens wear (except for daily disposable lenses) in both eyes during the past 3 months and history of at least 5 consecutive days of successful daily wear in both eyes at visit 1; * best spectacle corrected distance visual acuity greater than or equal to 0.8 (decimal visual acuity) in each eye; * other protocol-specified inclusion criteria may apply. exclusion criteria: * any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study; * need to wear contact lenses on an extended wear basis (ie, overnight) during the study; * monocular (only 1 eye with functional vision) or fit with only 1 lens; * use of a daily cleaner and/or enzyme cleaner to care for lenses at least 7 days prior to visit 1 (use of lens rewetting drops is acceptable); * history of intolerance or hypersensitivity to any component of the investigational products; * unwilling or unable to abstain from use of all over-the-counter (otc) or prescribed topical ocular medications (except for rewetting drops) within 7 days prior to visit 1 and for the duration of the study; * moderate (grade 3) or severe (grade 4) corneal edema, corneal staining, injection (limbal hyperemia, bulbar conjunctival hyperemia), tarsal abnormalities, or "other" findings; * corneal vascularization that is mild (grade 2) or higher; * conjunctival or structural lid abnormalities or abnormal corneal opacities at visit 1; * current or history of ocular infection, severe inflammation or disease within 6 months prior to visit 1; * any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions; * use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen for a minimum of 30 days prior to visit 1; * ocular or intra-ocular surgery and/or ocular trauma within the last 12 months (excluding placement of punctal plugs); * participation in any investigational clinical study within 30 days of visit 1; * other protocol-specified exclusion criteria may apply.
18 week study evaluating safety and efficacy of olmesartan, amlodipine, and hydrochlorothiazide, in type 2 diabetics

Conditions: Type 2 Diabetes; Hypertension

Summary: to determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

this is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (bp) goals were not met.

Eligibility criteria:
inclusion criteria: * males or females aged 18 to 80 years. * diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of byetta (exenatide); note: subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by american diabetes association criteria, including the specific plasma glucose results listed below: * fasting plasma glucose \>=126 mg/dl (7.0 mmol/l); or * symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose \>=200 mg/dl (11.1 mmol/l). the classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or * two-hour plasma glucose \>=200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test; * newly diagnosed hypertension or uncontrolled hypertension (defined as sbp \>130 mmhg and/or dbp \>80 mmhg) on current antihypertensive monotherapy or combination therapy. * subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (abpm) criteria. * females should not be pregnant or lactating and, if applicable, using adequate contraception. exclusion criteria: * subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator). * type 2 diabetes mellitus with a glycosylated hemoglobin a1c (hba1c) \>=9.0% at screening; * subjects with type 1 or type 2 diabetes mellitus requiring insulin. * subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.

Keywords: blood pressure reduction
propranolol for treating fibromyalgia pain

Conditions: Fibromyalgia Pain

Summary: the purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.

the main purpose of this study is to collect pilot feasibility study data for the use of low dose propranolol for helping treat fibromyalgia. the investigators plan to compare 20mg twice a day dosage of propranolol and 10mg twice a day dosage of propranolol to placebo. the design is a 3 arm, double blind randomized control trial. the investigators will also test ecg and respiratory assessment as a part of the safety screening and the feasible assessment of respiratory sinus arrhythmia. propranolol is not indicated to treat pain. however, the previous studies showed that low dose propranolol can re-regulate the adrenergic dysfunction and reduce pain in people with chronic musculoskeletal pain. however, the investigators are not aiming to develop a new indication of the drug.

Eligibility criteria:
inclusion criteria: * females with fibromyalgia (both meeting 1990 american college of rheumatology (acr) fms criteria and 2010 acr fms criteria) age 18-65 with at least 1 year of symptoms and sedentary (exercising less than 120 min per week). exclusion criteria: * general health criteria: * uncontrolled/unstable illnesses (physician diagnosed, self-report) * pregnancy or planning to be pregnant in the next year * having asthma requiring medication treatment including inhaler * type i diabetes or type ii diabetes requiring medical therapy that can lead to hypoglycemia * having acute pain or neuropathic pain * participation in exercise or psychological treatment studies in the past 2 years * having known serious psychopathology: psychosis, history of inpatient psychiatric admission in the past year, active suicidal intent, history of self-injurious behaviors in the past year, history of recreational iv drug use, substance abuse history in the past year) * cardiovascular criteria: * having known cardiovascular diseases (self-report, physician diagnosed) * pacemaker * bradycardia (resting heartrate of less than 55 bpm) * resting diastolic bp \< 55 mmhg or systolic bp\<100 mmhg * ecg showing prolonged pr interval \> .2 sec * ecg showing irregular pr interval * ecg showing incongruence between p wave and qrs * medication criteria * allergy or intolerance of beta blockers * current use of the following drugs: * antihypertensive drugs * neuroleptics * monoamine oxidase inhibitors * tizanidine * amphetamine-based medications * bupropion * mirtazapine * tricyclics: daily dose greater than 75mg amitriptyline or equivalent * benzodiazepine: daily dose greater than 5mg diazepam or equivalent * asthmatic medicine, including inhaler * participants may be included after minimum of 4 weeks of physician prescribed termination of these drugs
resection observatory

Conditions: Metastatic Colorectal Cancer; Colorectal Neoplasms

Summary: primary objective: -evaluate the resection rate (r0/r1) in current practice for aflibercept in combination with irinotecan plus 5-fluorouracil (folfiri) in patients treated for metastatic colorectal cancer (mcrc) after failure of an oxaliplatin-containing regimen secondary objectives: * evaluate overall survival, progression-free survival and relapse-free survival. * evaluate conversion rates (initially unresectable disease which became resectable after chemotherapy, with r0/r1 resection). * evaluate histological and radiological response rates. * evaluate rate of postoperative complications. * evaluate safety.

the estimated inclusion period is 45 months. patient follow-up is 24 months and the total study duration is 69 months. last patient status (alive or dead) collected before database lock.

Eligibility criteria:
inclusion criteria: * all patients treated with aflibercept in combination with folfiri for mcrc after failure of an oxaliplatin-containing regimen (including patients pretreated with bevacizumab or anti-egfr and patients treated with oxaliplatin in the adjuvant setting). * exclusively or predominantly hepatic metastases (≤ 5 pulmonary nodules \< 2 cm). * age \> 18 years. * signed consent for collection of personal and medical data. * eastern cooperative oncology group (ecog) performance status 0 or 1. exclusion criteria: * concomitant participation in a clinical trial. * patient receiving concomitant anti-vegf agents and/or receiving aflibercept as part of a clinical trial or in a compassionate use program. * patient receiving aflibercept in combination with chemotherapy other than folfiri. * patient with contra-indication to surgery. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
threshold inspiratory trainer versus trigger sensitivity adjustment on weaning from mechanical ventilation

Conditions: Respiratory Failure

Summary: ninety adult patients from both gender, with acute respiratory failure, intubated and mechanically ventilated. their ages ranged from 50 to 70 years. they were selected from intensive care unit (icu), department of chest diseases, cairo university hospitals. they have randomly assigned into three equal groups. group (a): trained by threshold imt device plus routine physical therapy. group (b): trained by adjusting mv trigger sensitivity plus routine physical therapy. group (c): only received routine physical therapy. (negative inspiratory force nif, arterial blood gases, p/f ration, respiratory rate rr, tidal volume vt, and rapid shallow breathing index rsbi) were measured before the study and at the end of the study (just before weaning for successfully weaned patients, or on the 10 day of intervention for failed weaning patients).


Eligibility criteria:
inclusion criteria: * their age ranged from 50-70 years. * the patients were diagnosed with acute respiratory failure duo to copd exacerbation and need mechanical ventilation support for more than 48 hours. * they were vitally stable and can tolerate pressure support * peep less than 8cm h2o , spo2 more than 90). * all patients were conscious and responded to verbal command. exclusion criteria: * unstable hemodynamics, * unstable neurological problems, * lack of attention and cooperation * skipping more than five training sessions.
low-dose evaluation of aspirin after stemi patients with pci: a multicenter, double-blind, randomized controlled clinical trial

Conditions: ST-elevation Myocardial Infarction (STEMI)

Summary: the study aims to optimize the dual antiplatelet therapy regimen for patients with stemi after pci, focusing on addressing the following key technical challenges: establishing an effectiveness evaluation system for a low-dose aspirin (50mg/day) antithrombotic treatment strategy based on ticagrelor, including the formulation of a scientific non-inferiority margin, assessment criteria, and composite endpoint determination standards; constructing a strict risk assessment system for major bleeding events, including bleeding event grading based on barc standards and a blind evaluation process by an independent endpoint event adjudication committee; and developing a quality control system for multicenter clinical research to ensure patient follow-up compliance and data reliability. by solving the above technical challenges, the study provides evidence-based medical support and technical support for optimizing the antithrombotic treatment regimen for stemi patients after pci.


Eligibility criteria:
inclusion criteria: stemi patients with clear diagnosis has received pci treatment (at least the culprit's blood vessels have been treated); 18 years old and above, regardless of gender; received dapt upon discharge: aspirin+ticagrelor; signed informed consent form approved by the ethics committee exclusion criteria: individuals with atrial fibrillation/dvt/valve surgery requiring anticoagulant medication; combined cardiomyopathy (hcm/dcm/rcm); combining severe ventricular arrhythmias requires icd; chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease); serious infectious diseases, including active hepatitis b, hepatitis c or aids patients; diseases of the blood system, such as thrombocytopenia, severe anemia, leukemia, etc; severe liver and kidney dysfunction; malignant tumors; cognitive impairment
european, multi-center, exploratory trial to assess web versus other endovascular treatment in ruptured aneurysms.

Conditions: Ruptured Aneurysm

Summary: comparison of efficacy and safety between web and other endovascular techniques


Eligibility criteria:
main inclusion criteria: * patient is above 18 years of age at the time of consent * patient has an identified acutely ruptured intracranial aneurysm requiring endovascular treatment (for the purposes of this study an acutely ruptured ia patient is defined as a patient with computed tomography (ct), magnetic resonance imaging (mri), or lumbar puncture (lp) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days) * aneurysm dome diameter must be ≤ 10mm and within the diameter (and parent vessel diameter, as appropriate) range treatable by commercially available web devices as well as at least one other alternative commercially available endovascular treatment device used per hospital standard practice * aneurysm is located on the anterior communicating artery complex segment (acom), internal carotid artery terminus (icat), anterior cerebral artery (aca), middle cerebral artery (mca), basilar apex, posterior communicating artery (pcom) or pericallosal artery * patient must be neurologically stable with a hunt \& hess score of i to iii * patient or patient's legally authorized representative (lar) has provided written informed consent main exclusion criteria: * aneurysm to be treated is unsuitable for endovascular treatment with commercially available web devices and/or all other available endovascular treatment techniques used per standard site practice * patient presenting as target aneurysm a blister like or dissecting aneurysm * patient has more than one aneurysm requiring treatment within 30 days of completion of treatment of the target aneurysm * patient with multiple aneurysms in whom ruptured aneurysm cannot be identified * patient has pre-morbid mrs \> 2
transdisciplinary oral/oropharyngeal cancer research & care in head and neck cancer (torch)

Conditions: Head and Neck Cancer

Summary: the purpose of this research study is to see if it is possible to collect tissue, saliva and blood samples from patients who are having surgery and send those samples to different labs across musc. the researchers in these labs will collect tissue, blood and saliva samples before surgery and during surgery to see if there are any changes in the samples. they will compare the changes in the samples to the clinical outcomes. patients will also be given surveys to evaluate patient preferences, anxiety/distress, symptom severity, support by hpv status.

the primary objective of this exploratory, proof of concept study is to facilitate translational science spanning clinicians and basic scientists to obtain tissue samples, pdx models, and clinical data in order to successfully analyze tissue linked to clinical outcomes in head and neck cancer, resulting in the methodological and statistical framework for a larger scale clinical trial in the future. while the incidence of hnscc has been steadily decreasing over the last thirty years, the incidence and prevalence of oropharyngeal cancer squamous cell carcinoma (opscc) and young patients with oral tongue cancer has increased in the face of an overall decline in smoking prevalence. over the past few years, evidence has emerged that oropharyngeal cancer is rising in incidence so rapidly that it has been described as an "epidemic" and that it has or soon will surpass cervical cancer in both incidence and mortality. in fact, over 30,000 patients will be diagnosed with oropharyngeal cancer in the us per year, making it the most rapidly rising head and neck cancer in incidence. despite this unique etiopathogenesis, treatment and toxicities related to treatment have not changed. this collaboration and interdisciplinary study will be the first of its kind to address these important issues of cancer site, hpv status, tobacco history, gender, age, and race using both patient tissue and pdx models to identify novel and unique biomarkers. also, innate to this project is the link between five separate laboratories each conducting unique biomarker analysis.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. ability to sign informed consent 3. newly diagnosed or recurrent oral cavity squamous cell carcinoma of the tongue (stage i-iva) or oropharyngeal squamous cell carcinoma confirmed by pathology report. patients with unknown primary of the neck that is hpv+ are eligible. 4. planning to undergo surgery as a part of definitive treatment exclusion criteria: 1. squamous cell carcinoma metastasis to node(s) of neck with unknown primary tumor site that is hpv negative. 2. already received some treatment, such as chemotherapy, radiation, or surgery for his/her disease at another institution when presenting to musc. an exception is neoadjuvant pd-1 blockade. 3. history of radiation therapy, for any indication, to the head and neck region