Kornimate/medical-research-clean huggingface dataset:
oxypurinol compared with placebo for class iii-iv nyha congestive heart failure

Conditions: Congestive Heart Failure

Summary: the opt-chf (oxypurinol therapy for chf) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. measures of clinical efficacy (nyha class and patient global assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.


Eligibility criteria:
inclusion criteria * 18-85 years old, * stable nyha class iii-iv * hospitalization or er visits in past 18 months for worsening heart failure (or addition of new heart failure medication added to regimen due to lack of stability on current regimen. * ef =\< 40% exclusion criteria * any condition (other than chf) that could limit exercise * any concurrent disease likely to limit life expectancy. * participation in another clinical trial * primary valvular disease, active myocarditis, or an obstructive or restrictive cardio-myopathy * heart attack, stroke, unstable angina or cardiac surgery within previous 3 months
blinded randomized controlled trial of artificial intelligence guided detection of intracardiac thrombus

Conditions: Atrial Fibrillation

Summary: to determine whether an integrated ai decision support can save time and improve the accuracy of detection of intracardiac thrombus, the investigators are conducting a blinded, randomized controlled study of ai-guided detection of intracardiac thrombus to electrophysiologist judgment in preliminary readings of echocardiograms.


Eligibility criteria:
inclusion criteria: 1. aged 18-80 years. 2. willing to sign informed consent. 3. patients diagnosed with atrial fibrillation paroxysmal af and persistent af according to the latest clinical guidelines exclusion criteria: 1. end-stage disease with a mean life expectancy less than 1 year 2. new york heart association (nyha) class iii or iv, or last known left ventricular ejection fraction less than 30% 3. previous surgical or catheter ablation for af 4. bradycardia and presence of implanted icd 5. uncontrolled hypertension: systolic blood pressure (sbp) \>180 mmhg or diastolic blood pressure (dbp) \> 110 mmhg 6. patients with cardiovascular events including acute myocardial infarction, any pci, valvular cardiac surgical, or percutaneous procedure within the past 3 months 7. women of childbearing potential who are, or plan to become, pregnant during the time of the study 8. have been enrolled in an investigational study evaluating devices or drugs.
8-week study to evaluate safety and efficacy of various combinations of valsartan, hctz, and amlodipine in patients with moderate to severe hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, hctz, and amlodipine in patients with moderate to severe hypertension.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe hypertension (msdbp ≥ 100 mmhg and \< 120 mmhg, mssbp ≥ 145 mmhg and \< 200 mmhg). exclusion criteria: * patients on two or more antihypertensive drugs with mssbp ≥ 180 mmhg and/or msdbp ≥ 110 mmhg at visit 1. * patients on three or more antihypertensive drugs with msdbp ≥ 90 mmhg and \< 110 mmhg, and/or mssbp ≥ 140 mmhg and \< 180 mmhg at visit 1. * patients on four or more antihypertensive drugs at visit 1. * arm circumference \> 42 cm for patients participating in abpm. other protocol-defined exclusion criteria may apply.

Keywords: hypertension valsartan amlodipine hctz
vr-pat and fnirs to identify cns biomarkers of pain

Conditions: Acute Pain; Pediatric ALL; Procedural Pain; Burns

Summary: this study aims to use functional near-infrared spectroscopy (fnirs) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (vr).

the objective of this study is to develop central nervous system (cns) biomarkers of pain experience during inpatient pediatric (age 6-17 years) burn dressing changes and pain relief induced by virtual reality (vr). we plan to use innovative functional near-infrared spectroscopy (fnirs) to identify and quantify the targeted cns biomarkers. the ultimate goal of this project is to optimize the cns biomarkers for predicting and/or monitoring response to vr-based pain reduction approaches for pain management in clinical trials. we will collaborate through a team science model to recruit n=4 pediatric burn injury subjects to address the following three specific aims: aim 1: to quantify the central nervous system (cns) responses associated with self-reported pain intensity during a standard clinical procedure (burn dressing changes). aim 2: to assess brain response patterns to virtual reality (vr)-based interventions for pain management. aim 3: to assess the degree to which objective brain measures and brain responses to vr intervention modulate objective brain markers of pain.

Eligibility criteria:
inclusion criteria: 1. being treated for acute burn injury 2. age 6-17 years, inclusive 3. admitted to nch burn unit for treatment 4. have a dressing that requires daily changes over 3 days 5. patient and family caregivers can communicate (read and write) using english exclusion criteria: 1. any wounds that may interfere with study procedures 2. vision, hearing, or cognitive/motor impairments preventing valid administration of study measures 3. history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras 4. minors in foster care, prisoners, or currently pregnant 5. suspected child abuse 6. unable to communicate in english

Keywords: virtual reality vr fnirs pain biomarker neuroimaging
efficacy of percussive ventilation therapy (metaneb ®) compared with mucolytic agents for atelectasis in the mechanically ventilated pediatric patient

Conditions: Atelectasis

Summary: the purpose of this study is to evaluate whether a therapy that uses a machine called a continuous high frequency oscillator (chfo) is more successful at removing mucus than medications that thin out the mucus.

both of these therapies (chfo and medication) are currently used in the pediatric intensive care unit and pediatric cardiac intensive care unit. this research study is being done because the investigator is trying to learn if the mechanical removal of mucus with chfo will effectively re-inflate the collapsed area of lung. specifically, the study team will determine if chfo can improve lung inflation with the same or improved vital signs (heart rate, blood pressure, and breathing rate), and the same or improved ability to help the lungs move oxygen into the blood. one of the problems with the medication approach is that while it thins out the mucus, actual removal from the lung requires a strong cough which is difficult for infants and children to produce when they are sedated and on a ventilator (breathing machine). thus, the aim of this research study is to test whether children with atelectasis on a ventilator are more likely to improve with mechanical removal of their mucus with the chfo as compared with medications that thin out the mucus. chfo and all the medications used in this study are part of the standard of care for atelectesis. however, there is no information on which combination works best and no one agrees that one approach is more effective than another. usually patients are evaluated for 48 hours after starting treatment, before adding or making any changes.

Eligibility criteria:
inclusion criteria: 1. informed consent from parent or legal guardian. 2. age \< 18 years and admitted to the picu or pcicu. 3. conventionally ventilated. 4. mucolytics are being initiated by clinical team for treatment of atelectasis. 5. endotracheal tube ≥ 3.5 mm internal diameter. exclusion criteria: 1. receiving chronic mucolytic or continuous high frequency oscillation therapy. 2. clinically significant pleural effusion. 3. status post cardiothoracic surgery with open chest. 4. pneumothorax. 5. pulmonary hemorrhage. 6. escalating doses of vasoactive agents (i.e. dopamine or epinephrine).

Keywords: atelectasis continuous high frequency oscillator acetylcysteine dornase alfa
a phase ii trial of calcitriol and naproxen in patients with recurrent prostate cancer

Conditions: Prostatic Neoplasms; Prostate Cancer

Summary: to determine whether, in this patient population, treatment with calcitriol and naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.

in summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown a promising role for both calcitriol and nsaids in the treatment of prostate cancer. moreover, calcitriol and nsaids both exert their antiproliferative effect by decreasing prostaglandin levels, but they do so by different mechanisms. thus, there is reason to believe that their combined effects on prostaglandins may be synergistic. preliminary in vitro assays in which calcitriol is given in combination with one of two different nsaids (naprosyn or sulindac) to lncap cell lines have indicated such synergy. this observation provides the rational for using them in combination for the treatment of prostate cancer. in addition, it is hoped that any synergy noted would allow for the use of lower doses of nsaids.

Eligibility criteria:
inclusion criteria: * must give written informed consent * histologically confirmed adenocarcinoma of the prostate * biochemical relapse after primary radiation therapy or surgery * normal testosterone levels * 3 rising psa after nadir, with interval between psa determinations \> 2 weeks exclusion criteria: * local recurrence by ct scan * distant metastases by bone scan * hypercalcemia * nephrolithiasis * renal insufficiency (serum creatinine \> 1.8 mg/dl) * pancreatitis * history of ulcer or gastrointestinal bleeding * more than 6 months of hormone ablation therapy * concurrent therapy for prostate cancer * uncontrolled htn * h/o mi, cva, tia * known coronary disease/cerebrovascular disease * platelet counts \<50 * patients on anticoagulants * patients on lithium
effects of lumbar pens and exercise in older adults with chronic low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to determine whether a form of electrical acupuncture, called percutaneous electrical nerve stimulation (pens), can reduce pain and disability in older adults with chronic low back pain (lbp). this study will also determine the effects of general conditioning and aerobic exercise (gcae) on chronic lbp.

each year, a significant number of elderly individuals experience at least one episode of lbp. when lbp becomes chronic, it can lead to functional and emotional impairment, increased health care utilization, and decreased quality of life. standard treatment for lbp typically consists of non-opioid analgesics and physical therapy; however, analgesic-associated morbidity in older adults often limits their utility. this study will determine the efficacy of pens treatment, a neuroanatomically guided form of electroacupuncture, and exercise in reducing pain in older adults with chronic lbp. participants will be randomly assigned to one of four treatment groups: pens alone, pens placebo, pens plus gcae, or pens placebo plus gcae. the treatments will be given twice weekly for 6 weeks. pain intensity, physical function, health care utilization, and psychosocial function will be assessed with self-report and performance-based measures. these assessments will be conducted at study start, immediately after the last treatment session, and 6 months after study completion.

Eligibility criteria:
inclusion criteria: * low back pain for at least 3 months * able to walk without an assistive device (e.g., cane or walker) exclusion criteria: * serious underlying illness causing back pain * nerve root compression * history of back surgery * has pacemaker * current use of blood thinners * major psychiatric disorder * chest pains or heart problems that interfere with daily activity * fibromyalgia

Keywords: aged acupuncture
inositol hexaphosphate: a novel treatment strategy for bipolar disorder?

Conditions: Bipolar Disorder; Manic Depression

Summary: inositol hexaphosphate (ip6, also called inositol hexakisphosphate, and phytic acid) is a naturally occurring phosphorylated derivative of myo-inositol. myo-inositol has shown preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in bipolar disorder in some studies, but failed to establish efficacy in subsequent meta-analyses. in the investigators proposed work, the investigators plan to orally administer the calcium/magnesium salt of ip6 (2,000-3,000 mg daily in two divided doses) to paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and who have failed an adequate course of treatment with lithium monotherapy. the investigators hypothesis is that ip6 may be similar to myo-inositol in terms of relieving depression, but more potent and effective. our aim is conduct a preliminary pilot study in 30 subjects (15 treated with ip6, 15 treated with lamotrigine, an active comparator) to assess the efficacy and tolerability of ip6 as an adjunctive treatment to lithium, the mood stabilizer most commonly used to treat bipolar disorder.


Eligibility criteria:
inclusion criteria: * must have bipolar disorder * must be currently depressed * must have failed adequate trial of lithium monotherapy * must have shown partial response of depression to lithium exclusion criteria: * diagnoses of schizophrenia, major depression, or other psychotic disorder * currently pregnant * unstable medical condition * active drug or alcohol dependence * concurrent use of antidepressant or mood stabilizer other than lithium * active suicidal or homicidal ideation * past adverse reaction to lamotrigine or current skin rash (lamotrigine arm only) * history of dietary malabsorption or nutritional deficiency (ip6 arm only)

Keywords: bipolar disorder depression inositol inositol hexaphosphate phytic acid ip6 lithium lamotrigine
to evaluate the safety and efficacy of 'avi' stent comparing with firebird2® for treating coronary revascularization

Conditions: Ischemic Heart Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome

Summary: to evaluate the safety and efficacy of 'avi' stent comparing with firebird2® for treating coronary revascularization.

the study is a prospective, open-lable, multi-center, randomized trial. 2000 primary coronary artery disease patients will be enrolled with a 1:1 randomization ratio(avi:1000,firebird 2:1000) at approximately 40 sites, subject follow-up be at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.

Eligibility criteria:
inclusion criteria: 1. patient must be at least 18 years of age. 2. ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(st elevated mi and non-st elevated mi) 3. at least one lesion diameter stenosis(ds) ≥70％, reference vessel diameter between ≥2.5mm, and ≤3.5mm. 4. if the subject has multiple vessel lesions, the implanted stents must be the same brand. the staged procedure only be allowed within 3 months after procedure, the implanted stent must be the same brand stent as the index procedure. 5. subject has no cabg contraindication. 6. subject or legal representative is informed the property of the study, understand the stipulations in the protocol, ensure the compliance and sign the icf. exclusion criteria: 1. pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure. 2. subject has a tendency to bleeding or coagulation disorders, or has contraindication of antiplatelet and/or anticoagulant therapy, or can't accept the continue dapt within 6 months. 3. poor compliance or expectation of life less than 1 year. 4. implanted any brand stent in the same target vessel within 1 year. 5. left ventricular ejection fraction (lvef) of \<30％ 6. cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support. 7. the subject is allergic to asprin, heparin, clopidogrel/ticlopidine, stainless steel alloy, arsenic trioxide, sirolimus, styrene-butene-styrene or polylactic acid(pla) polymer and contrast agent. 8. severe tortuous and/or heavy calcification lesion. 9. two or more proximal chronic total occlusion lesion. 10. bifurcation lesions with double stents. 11. the subject has multi vessel lesions but can not be implanted the same brand stents 12. the subject that the investigator considers he/she was unfit to implant the avi stents and firebird 2 stents. 13. the subject attended other drug/device study or in the follow-up period.
technology-enabled collaborative care for youth

Conditions: Psychosis; Metabolic Disease; Cardiovascular Risk Factor

Summary: the overall objective is to develop scalable interventions to address the physical health needs of patients affected by early psychosis. the objective of this project is to conduct a feasibility study of a high intensity technology-enabled collaborative care model (ccm) compared to lower intensity self-help modules and email support for early identification and treatment of cardio-metabolic risk factors in youth, ages 16-29, affected by early psychosis.


Eligibility criteria:
inclusion criteria: * ages 16 - 29 years * clinician diagnosis of early psychosis (diagnosed in last 5 years) * prescribed psychiatric medication, stable for 4 weeks * access to telephone or internet through computer or mobile exclusion criteria: * unable to provide consent * unable to understand english
dual chamber versus single chamber cardiac pacing in people 80 years of age and older

Conditions: Atrial Fibrillation; Cardiac Pacing, Artificial

Summary: of the 19,000 pacemakers implanted across canada in 2002, 1/3 of them were for patients 80 years and older. this is the fastest growing segment of our population, yet no study has specifically been done in this age group to determine the optimal pacing mode. we wish to determine whether dual chamber or single chamber pacing is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g., congestive heart failure (chf), atrial fibrillation (af)) resulting in improved quality of life.

many patients who are 80 years of age and older, develop af or chf. physiologic pacing has been shown to prevent af compared to ventricular pacing. whether prevention of af and chf by physiologic pacing reduces emergency room visits or hospitalizations for cardiovascular causes in this population in unknown. the investigators wish to determine the optimal pacing mode for this patient population that would enable optimal management of cardiovascular problems, resulting in improved quality of life and minimizing use of health care facilities. patients recruited to the study will be randomized to either dddr or vvir pacing, and followed in the clinic every 6 months for the 3 years of the study.

Eligibility criteria:
inclusion criteria: * 80 years of age and older * symptomatic bradycardia exclusion criteria: * permanent atrial fibrillation * previous pacemaker implant * life expectancy less than 1 year * geographic isolation * unable to give informed consent

Keywords: physiologic pacing ventricular pacing hospitalizations
short- and long-term outcomes of stenting for symptomatic intracranial arterial stenosis: a cohort study

Conditions: Intracranial Atherosclerosis

Summary: the purpose of this study is to assess short and long term outcomes of stenting for symptomatic intracranial arterial stenosis.


Eligibility criteria:
inclusion criteria: * participants had a symptomatic intracranial stenosis of 70-99 percentage (%) with a lesion length of ≤15 mm and target vessel diameter of ≥2.0 mm in the intracranial internal carotid, middle cerebral, intracranial vertebral or basilar arteries and the measurements of stenosis will be made on magnetic resonance angiography (mra) using the warfarin-aspirin symptomatic intracranial disease (wasid) trial method and confirmed by digital subtraction angiography (dsa). * presented with transient ischemic attack (tia) or stroke within the past 12 months attributed to the stenosis. exclusion criteria: * participants with acute infarctions within the past 3 weeks. * severe arterial tortuosity prevents the deployment of endovascular devices. * non-atherosclerotic lesion on magnetic resonance imaging (mri), embolic or perforator stroke on mri or computerized tomography (ct). * a baseline modified rankin scale (mrs) score of \>3. * massive cerebral infarction (\>1/2 middle cerebral artery (mca) territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on ct or mri scan.
effect of diaphragmatic release in sleep quality during pregnancy

Conditions: SLEEP APNEA PREGNANCY

Summary: sleep disordered breathing (sdb) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. maternal obesity, one of the major risk factors for sdb, together with physiological changes in pregnancy may predispose women to develop sdb. sdb has been associated with poor maternal and fetal outcomes. thus, early identification, diagnosis and treatment of sdb are important in pregnancy.

the present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will provide scientific basis for the clinical application of diaphragmatic release in sleep disordered breathing during pregnancy

Eligibility criteria:
inclusion criteria: * pregnant women (at third trimester), diagnosed with sleep disordered breathing by the gynaecologist. * their ages will range from 30- 40 years old . * their bmi will be 25 to 30kg/m2. * all are multipara. exclusion criteria: women will be excluded from the study if they have: * previous pulmonary surgery. * any pulmonary diseases. * asthma. * neurological disorders * musculoskeletal disorders (severe osteoarthritis, osteoporosis)