Kornimate/medical-research-clean huggingface dataset:
masitinib in treatment of patients with severe persistent asthma treated with oral corticosteroids

Conditions: Asthma

Summary: the study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with severe persistent asthma treated with oral corticosteroids.

masitinib is a selective tyrosine kinase inhibitor. it is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-kit, lyn and pdgfr kinase signaling pathways; all key targets of masitinib. the objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. the primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.

Eligibility criteria:
main inclusion criteria: 1. patient with severe asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit 2. patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening 3. patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit 4. non-smoker patient for at least 1 year and with a prior tobacco consumption \< 10 packs/year main exclusion criteria: 1. patient with active lung disease other than asthma (e.g. chronic bronchitis) 2. female patient who is pregnant or lactating 3. asthmatic patient still exposed to allergens or to triggering factors influencing asthma control 4. patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit

Keywords: severe persistent asthma tyrosine kinase inhibitor
efficacy and safety of risperidone compared with placebo in the treatment of psychotic symptoms in patients with alzheimer's disease

Conditions: Dementia; Alzheimer Disease; Mental Disorders

Summary: the purpose of this study is to evaluate the efficacy and safety of risperidone compared with placebo in the treatment of psychotic symptoms in patients with alzheimer's disease

dementia is frequently observed in the elderly, often associated with psychotic symptoms such as delusion or hallucinations, or with behavioral disturbances such as aggressive behavior, wandering, and aimless behavior induced by the psychotic symptoms. this is a double-blind, placebo-controlled study of the effectiveness and safety of risperidone (taken twice daily over 8 weeks) in the treatment of psychotic symptoms in patients with alzheimer's disease. assessments of effectiveness include: behavioral pathology in alzheimer's disease (behave-ad), a scale used for global assessment of symptoms associated with dementia; the psychosis cluster scale of behave-ad, a subscale that assesses paranoid and delusional ideation as well as hallucination; and clinical global impression-change (cgi-c), a measure of an improved or aggravated condition. safety evaluations include the incidence of adverse events throughout the study; physical examinations, electrocardiograms (ecgs), laboratory tests (hematology, biochemistry, urinalysis), and assessment of extrapyramidal symptoms at specified intervals. the study hypothesis is that treatment with risperidone shows greater improvement in psychotic symptoms, as measured by the behave-ad psychotic cluster score, in patients with alzheimer's disease, as compared to placebo. in addition, it is hypothesized that risperidone is well tolerated. risperidone tablets (0.25 mg or 0.50 mg) or placebo tablets taken orally twice daily. total daily dosage of 0.5mg on day 1, 1.0mg on days 3-5, and 1.5mg (maximum dose) on days 5-13. optimum dose maintained during weeks 3-8 of treatment.dose may be increased or decreased at investigator's discretion.

Eligibility criteria:
inclusion criteria: * a diagnosis of dementia of the alzheimer's type with or without a vascular component, a score of 2 or more on any item of the behave-ad psychosis subscale at screening, and a mini-mental state examination (mmse) score of 5 to 23 * residents of nursing homes or long-term care facilities and deemed in need of treatment with an atypical antipsychotic medication. exclusion criteria: * disease that could significantly diminish cognitive function * history of neuroleptic malignant syndrome * hypersensitivity to risperidone.

Keywords: alzheimer's disease psychosis elderly dementia risperidone antipsychotic agents
solace european confirmatory trial

Conditions: Stress Urinary Incontinence

Summary: the solace european confirmatory (solect) trial is designed to determine whether the solace bladder control system is safe and effective for the treatment of stress urinary incontinence (sui) in adult females.

subject will undergo treatment with the solace bladder control system or a sham procedure, with the results being compared at 3 months. all patients undergoing sham treatment are treated at 3 months.

Eligibility criteria:
inclusion criteria: * female 18 years of age or older with stress urinary incontinence (sui) * experienced sui for at least 12 months and attempted and failed prior noninvasive treatment * willing to undergo cystoscopic procedures required and 36 month follow-up * on stable medication for a minimum of 3 months * free of local genital skin infection * positive pad weight test * free of impassable urethral strictures, trauma or necrosis exclusion criteria (must answer no): * pregnant or planning to become pregnant during the study period * non-ambulatory or bedridden or physically unable to complete test exercises * morbidly obese (defined as bmi ≥ 40 kg/m2) * bladder infection (including bladder inflammation or edema) or uti within 3 months * history of recurrent urinary tract infections * prior surgical procedure for incontinence within the past 6 months * is taking medications for urinary incontinence other than anticholinergics * history of kidney stones * has a prosthetic heart valve * unable to tolerate any form of antibiotic * taking anticoagulation therapy, other than aspirin * has urinary incontinence due to intrinsic sphincter deficiency (isd)

Keywords: urinary incontinence urinary incontinence, stress urination disorders urologic diseases urological manifestations signs and symptoms
magnetic resonance imaging for the study of patients with neurological disorders

Conditions: Amnesia; Dementia; Healthy; Nervous System Disease

Summary: this study is divided into two parts. the first part of the study will use mri technology to view the brain structure of patients with neurological disorders and normal volunteers. this portion of the study will attempt to detect specific areas of damage in the brains of patients with amnesia and dementia. it will also try to correlate the amount of brain damage with performance on tests used to measure memory. in the second part of the study, researchers plan to use mri technology to study brain function of patients with neurological disorders and normal volunteers when they perform tasks. mri signals during task performance will be used to record areas of the brain receiving more blood flow indicating increased activity. researchers believe this study will help improve existing methods of evaluating patients with neurological disorders. in addition, this study may contribute information about areas of the brain involved in thought processing and motor and sensory function.

we wish to use mri technology to study brain structure (part 1) and function (part 2) in several neurological disorders and in normal controls. in part 1 of this protocol, we describe our interest in using detailed mri brain structure analysis to identify predicted specific neural structure atrophy in patients with selective amnesia and dementia and to attempt to associate the magnitude of atrophy in these neural structures with performance on selected memory tests. in part 2 of this protocol, we outline our interest in utilizing newly developed mri techniques to identify selective changes in local brain blood volume, blood flow, and other physiological parameters during functional stimulation. recent developments permit recording of mri signals that are indicative of regional cerebral blood volume and blood flow changes. local changes in these physiological measures appear to topographically overlap with expected areas of functional brain activation. the advantage of this method over positron emission tomography is the exquisite spatial resolution of mri. this mri technique is new and has had only limited use so far. the studies in part 2 of this protocol should help develop the method and begin to answer fundamental biological and functional questions about the representation and activation of cognitive, motor, and sensory functions.

Eligibility criteria:
inclusion criteria: subjects between the ages of 18 and 80. exclusion criteria: patient must be able to give informed consent. patients with ferromagnetic objects in their bodies which might be adversely affected by mri (surgical clips or metal fragments in or near brain, eye or blood vessels, cardiac or neurological pacemaker, cochlear impairments) will be excluded. pregnant or lactating women will be excluded. a pregnancy test will be administered to women of childbearing age.

Keywords: magnetic resonance imaging contrast enhancement neuroanatomic morphometry neurobehavioral deficits neurological disorders blood flow blood volume normal volunteer
a pragmatic initiative for ldl-c management by a clinical pharmacist-led team among atherosclerotic cardiovascular disease patients

Conditions: Atherosclerotic Cardiovascular Disease

Summary: patients who had an ascvd event at an intermountain hospital will be screened for eligibility to be randomized. subjects who meet eligibility criteria will be randomized 1:1 to receive targeted care of their ldl-c through a pharmacist-driven management program or not. patients may opt-out of receiving ldl-c management by the pharmacy team at any time. the purpose of this program is to increase the proportion of patients who achieve guideline-based recommendations of ldl-c levels of \<70 mg/dl by increasing statin and/or llt adherence and ldl-c testing. data collection as part of the study will continue until the last person randomized has had 1-year of follow-up.


Eligibility criteria:
inclusion criteria: 1. male or female \>18 years of age 2. receive follow-up care with intermountain health 3. value-based patient (as defined in the edw) 4. documentation of an ascvd diagnosis, by 1 of the following: * coronary artery disease (primary inpatient cad diagnosis during index encounter; primary inpatient mi diagnosis during index encounter; pci during index encounter; or cabg during index encounter * cerebrovascular accident (primary inpatient ischemic stroke diagnosis during index encounter; carotid endarterectomy during index encounter; or carotid stent during index encounter) * peripheral arterial disease (bypass or percutaneous intervention during index encounter) exclusion criteria: 1. patient age \<18 years. 2. receipt of or expected receipt of palliative care, expected discharge to hospice, or long-term care facility (i.e., skilled nursing facility). 3. pregnant or lactating women
pharmacokinetics of cp-690,550 in patients with impaired renal function

Conditions: Renal Impairment

Summary: a study to evaluate the pharmacokinetics of cp-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.


Eligibility criteria:
inclusion criteria: * subjects with normal renal function: subjects must be healthy with estimated creatinine clearance \>80 ml/min * subjects with renal impairment: subjects should be in good general health commensurate with the population with chronic kidney disease exclusion criteria: * kidney transplant patients * subjects with any condition possibly affecting drug absorption * subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin

Keywords: cp-690 550 pharmacokinetics renal impairment
open label pharmacokinetic study of sar302503 in subjects with hepatic impairment

Conditions: Hepatic Impairment

Summary: primary objective: to study the effect of mild and moderate hepatic impairment on the pharmacokinetics of sar302503. secondary objective: to assess the tolerability of sar302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects with normal hepatic function.

study duration=17-35 days

Eligibility criteria:
inclusion criteria : * male or female subjects, between 18 and 75 years of age, inclusive. * body weight between 50.0 and 115.0 kg, inclusive if male, and between 40.0 and 100.0 kg, inclusive if female, body mass index between 18.0 and 34.9 kg/m2, inclusive. * stable chronic liver disease with child-pugh classification score between 5 and 9 assessed by medical history, physical examination, laboratory values * 12-lead ecg without clinically significant abnormality * laboratory parameters within the acceptable range for subjects with hepatic impairment * using a double contraception method exclusion criteria: * uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. * hepatocarcinoma. * acute hepatitis * any significant change in chronic treatment medication within 14 days before inclusion * concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers cyp3a4 sensitive or narrow therapeutic index substrate of cyp3a4 * concomitant treatment gastric ph modifying agent * positive result on any of the following tests: anti-human immunodeficiency virus 1 and 2 antibodies (anti-hiv1 and anti hiv2 ab). * positive result on urine drug screen * positive alcohol test. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
extracorporeal support for respiratory insufficiency (ecmo)

Conditions: Acute Respiratory Failure; Lung Diseases

Summary: to evaluate indications for the use and efficacy of extracorporeal membrane oxygenators (ecmo's) for the support of patients with potentially reversible acute respiratory failure.

background: the report of the task force on respiratory diseases identified a clinical syndrome of acute respiratory insufficiency (ari) and estimated that approximately 60,000 americans die of ari yearly. ari was not precisely defined; indeed, the task force realized that pathologists do not recognize ari. the task force pointed out that no diagnostic tests for early detection of ari exist, that the incidence and prevalence of the disease are not known, and that existing therapy is supportive and nonspecific (diuretics, corticosteroids, etc.). the pathogenesis of the syndrome, the mechanism of interstitial edema, the defenses of the lung against agents causing ari, and the ultrastructural pathology and natural history of the disease were virtually unknown. the task force indicated a need for respiratory care centers with highly trained personnel that could reduce mortality from ari. this clinical trial grew out of the task force report. nine participating centers defined ari in clinical and physiological terms and agreed to a prospective randomized study for 3 years to compare treatment of severe ari by conventional means with treatment by extracorporeal membrane oxygenators. animal studies have shown that ecmo's can provide one to two weeks' support for the lungs without serious blood damage, in contrast to bubble oxygenators, which allow complete pulmonary bypass for approximately 6 hours, after which severe blood damage occurs at the direct blood-gas interface. if patients with hypoxia secondary to acute reversible lung injury can be supported with ecmo's until the lung lesion heals, improvement in survival rates and avoidance of the hazards of conventional therapy may result. the trial, now completed, was conducted at nine clinical centers in the united states. design narrative: randomized, non-blind, fixed sample; 90 eligible patients were randomly assigned to a group receiving extracorporeal membrane oxygenation plus conventional therapy or to a group receiving conventional therapy. the study completion date listed in this record was obtained from the query/view/report (qvr) system.

Eligibility criteria:
men and women, ages 12 to 65, not stratified as to ethnic group, who had potentially reversible acute respiratory failure.
use of hand-held dynamometry to obtain objective measures of lower extremity force production with chronic stroke

Conditions: Chronic Stroke; Weakness, Muscle

Summary: this study wants to know if using handheld dynamometry (hhd) to test leg strength in persons who have had a stroke, will reduce mistakes and give therapists better information to use for therapy. this study will collect normal values of leg muscle peak force production, cumulative peak force production, and sustained peak force production in patients with chronic stroke.

the activbody activ5 device will be used for data collection with all information logged and stored through the device's app and transferred to secure files. assessment of isometric muscle strength and power will be performed as follows: * hip flexors with the participant seated and hips and knees flexed at 90 degrees * knee extensors with the participant seated and hips and knees flexed at 90 degrees * knee flexors with the participant seated and hips and knees flexed at 90 degrees * ankle plantarflexors with the participant lying supine with the ankle in plantargrade and hips and knees extended * ankle dorsiflexors with the participant lying supine with the ankle relaxed and hips and knees extended * hip abductors with the participant lying supine and hips and knees extended * hip adductors with the participant lying supine and hips and knees extended * hip extensors with the participant lying prone and hips and knees extended 1 session, two trials per side

Eligibility criteria:
inclusion criteria: * age 18 years or older * stroke \> 3 months * ability to follow two-step commands * ability to assume all test positions and maintain for duration of testing (i.e. upright seated, prone, side lying, supine) exclusion criteria: * lower extremity contractures preventing full passive range of motion (rom) * vital signs contraindicated for exercise (i.e. resting heart rate \> 100 bpm \ 200 mmhg or \ 110 mmhg, oxygen saturation \< 90%) * symptoms contraindicated for testing (i.e. shortness of breath, angina, dizziness, severe headache, sudden onset of numbness or weakness, painful calf suggestive of deep vein thrombosis) * active infection and/or injury at location of testing site * other diagnosed co-morbidities that would impact physical participation
a validation study of selfie technology for assessment of vital signs

Conditions: Healthy; Hypertension

Summary: the aim of this study is to compare accuracy of docme, a video technology developed by docme health technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.

photoplethysmography (ppg) makes uses of low-intensity infrared (ir) light. when light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. however, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by ppg sensors as changes in the intensity of light. the signal from ppg is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. ppg is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits. recently, it has been shown that ppg data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this. docme health technologies has developed a system of obtaining these data using a video selfie. at this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. however, to make the technology more widely useful, the results obtained by video selfies need to be formally validated. the aim of the study therefore is to compare measurements obtained from video selfies with measurements taken using already validated machines in the same patients.

Eligibility criteria:
inclusion criteria: * adults (18 - 100 years old). participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse. exclusion criteria: * none

Keywords: photoplethysmography video selfie vital signs blood pressure oxygen saturation smartphone docme heart rate respiratory rate
effects of pomegranate seed oil and mediterranean diet on mci

Conditions: Mild Cognitive Impairment

Summary: a double-blind clinical trial of pomegranate oil and mediterranean diet that will be carried out on 60 patients with mild cognitive impairment (mci) and apoe ε3 and ε4 allele. the aim of the research is to examine if the mediterranean diet with pomegranate oil and without it can bring positive changes in patients with mci in terms of motor and cognitive skills.

objectives of the trial the objectives of this study are: to investigate the efficacy of mediterranean diet and pomegranate oil as a disease course modifying treatment for mci. study design this is a greek, controlled double-blind trial of two compared groups, one with mediterranean diet and one with mediterranean diet and pomegranate oil. qualifying patients will be assigned to receive 0.15 ml of pomegranate oil every day with mediterranean diet at one group and at the other group will not. a mediterranean dietary protocol will be given on a daily basis for 12 months at both groups. duration the total study duration will be 12 months. the recruitment will be about 6 months and the statistics and the preparation of the paper other 6 months. number of subjects: sixty (60) subjects total will be enrolled.; thirty (30) in the a group (pomegranate oil + mediterranean diet); thirty (30) in the b group (mediterranean diet). patient identification: initials (first initial of first name and first initial of surname), date of birth and patient identification number from database empedocles. eligibility screening form (esf) : checklist of inclusion and exclusion criteria eligibility statement: for patients found to be ineligible, the reason for ineligibility must be stated and written informed consent will be obtained from the subjects which are eligible. the informed consent form must be co-signed by the physician. the nature of the study and the potential risks associated with the trial will be explained to all subjects- candidates and their responsible informants. signature and date: the esf may be completed by a research assistant but it is required that the principal investigator/study clinician sign and date the esf to verify eligibility of the patient for inclusion.

Eligibility criteria:
inclusion criteria: * diagnosis of mild cognitive impairment * carry apoe ε3 or ε4 genes exclusion criteria: * diagnosis of dementia * patients who receive medication for memory or depression * patients who do not carry apoe ε3 or ε4 genes

Keywords: mild cognitive impairment cognition mental health apoe ε3/ε3 ε3/ε2 ε3/ε4 ε2/ε4 ε4/ε4 pomegranate oil