Kornimate/medical-research-clean huggingface dataset:
a phase i study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ct-g20 in subjects with obstructive hypertrophic cardiomyopathy

Conditions: Cardiomyopathy, Hypertrophic Obstructive

Summary: this is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive hcm aged 18-70 years. the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ct-g20.


Eligibility criteria:
inclusion criteria: 1. men or women aged 18 to 70 years, inclusive at screening 2. has established diagnosis of hcm defined by standard criteria as a maximal left ventricular wall thickness ≥15 mm at initial diagnosis in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed or ≥13 mm if the subject has a family history of hcm 3. has lvot gradient ≥30 mmhg at rest or lvot gradient ≥50 mmhg with valsalva maneuver, due to sam exclusion criteria: 1. known infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics hcm, such as fabry disease, amyloidosis or noonan syndrome with lv hypertrophy 2. history of persistent atrial fibrillation prior to screening or baseline 3. history of paroxysmal atrial fibrillation requiring treatment (e.g., anti-coagulation and/or antiarrhythmic therapy) within 3 months prior to screening 4. recently treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to screening or plans to have either of these treatments during the study 5. systolic heart failure with ejection fraction \<55% or heart failure symptoms of nyha class iv 6. qtcf \>480 msec at screening or baseline 7. presence of diseases classified as significant by the investigator at screening or baseline, including the following but not limited to: 1. diabetes mellitus requiring treatment 2. moderate or severe renal insufficiency or renal insufficiency with estimated glomerular filtration rate \<70 ml/min/1.73m2 8. concomitant use of disopyramide or ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to screening
effect of hip adductors isometric contraction on knee extensors isokinetic torque in patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: the study will be done to investigate the effect of hip adduction isometric contraction on the pain level by vas and knee extensors peak torque by using the isokinetic dynamometer in patients with unilateral patellofemoral pain syndrome

the study will be done to investigate the effect of isometric hip adduction that will be measured by the hand held dynamometer (the manual muscle tester) to measure the produced adduction torque and its effect on the peak torque of knee extension by the knee extensors which will be measured by the isokinetic dynamometer in addition to measuring the pain intensity before and through the assessment by using the visual analogue scale

Eligibility criteria:
inclusion criteria: * anterior or retro-patellar knee pain from at least 2 of the following activities: (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping (tyler et al., 2006). * insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6 weeks (subacute or chronic pain). * they will be diagnosed as a pfps case by a physician * the patient's age will be ranged from 18-35 years to limit the possibility that pfps over age 35 may have been complicated by arthritic changes, and also the patients should have closed epiphyseal growth plates (robinson and nee, 2007). exclusion criteria: * a history of any of the following condition: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement. * a history of traumatic patellar subluxation or dislocation. * previous surgery in the knee and hip joints. * any lower limb bony/congenital deformity. * ankle, knee and hip joints osteoarthritis. * a history of any conditions affects muscle strength: diabetes mellitus, rheumatoid arthritis. * pregnancy.

Keywords: pfps
a study of the effect of oats on post prandial glucose response

Conditions: Normoglycemic; Normal Body Weight

Summary: the objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.

the trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. normoglycemic (\<5.6 mmol/l) males and females (12 of each) of age 18-45 y with a body mass index (bmi) of 18.5-29.9 kg/m2 will be recruited. each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. the participants will be asked to consume one of the breakfast foods during each visit. following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (vas). glucose measurements: capillary blood will be collected during each visit by finger prick. blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the clinical laboratory standard institute (clsi) guidelines. blood glucose will be measured in finger prick blood samples by glucose meters . males will be scheduled for three sessions over 3 weeks. women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week. during the wash-out days (5 - 7 days between each phase), participants can go about their daily activities unrestricted with the following exception: no strenuous activity or alcohol consumption on the days before the clinic visit. the investigators will ask that participants go to sleep at the same time on the days before the sessions.

Eligibility criteria:
inclusion criteria: * normoglycemic (\<5.6 mmol/l) * bmi= 18.5-29.9 kg/m² exclusion criteria: * a change in medication (dose or type) or medical event requiring hospitalization within the past month. * daily tobacco use. * eat meals at irregular or unusual times. * food allergy, aversion or unwillingness to eat study foods. * use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar. * presence of a gastrointestinal disorder. * currently pregnant or lactating.

Keywords: oatmeal beta glucan postprandial glycemic response blood glucose
phenotypic characterization of alveolar macrophages 2016 (caract-aires-2016)

Conditions: Lung Diseases

Summary: the aim of the study is to investigate by flow cytometry the phenotype of alveolar macrophages (ams) isolated from patients with non-infectious lung diseases.

although alveolar macrophages (ams) represent the main immune cell population in the human lungs, consensus on their phenotypic characterization is still missing. current translational protocols use human ams obtained by invasive methods (broncho-alveolar lavage and lung biopsy) or differentiate macrophages from blood monocytes cultured in the presence of growth factors such as macrophage colony-stimulating factor (m-csf) or granulocyte-macrophage colony-stimulating factor (gm-csf). the group has already published the phenotypic and functional comparison of human blood monocyte-derived macrophages differentiated with m-csf or gm-csf. aim of this study is to use a multi-staining flow cytometry (facs analysis) to better characterize the phenotype of ams isolated from broncho-alveolar lavage fluids of patients affected by non-infectious lung diseases. the facs profiles of ams will be further compared to the phenotypic profile of blood monocyte-derived macrophages differentiated in the presence of gm-csf or m-csf. the results of this study will allow to define the most valid in vitro model of ams in a non-infectious setting.

Eligibility criteria:
inclusion criteria: * patients affected by non-infectious lung diseases and for whom a broncho-alveolar lavage is scheduled for their medical care in the pulmonary division * patient information leaflet provided * written informed consent of the patient exclusion criteria: * a suspected respiratory infection

Keywords: alveolar macrophages blood monocyte-derived macrophages facs analysis broncho-alveolar lavage fluids non-infectious lung diseases
the effect of nicorandil on left ventricular myocardial strain in patients with coronary chronic total occlusion

Conditions: Coronary Artery Disease

Summary: background nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (rcts) to evaluate the benefit of nicorandil for patients with chronic total occlusion (cto) are still lack. objective to determine whether nicorandil can improve left ventricular myocardial strain in patients with cto. methods patients with cto were included and were randomized to the nicorandil group and the control group. nicorandil was given orally 15 mg/day for 3 months in the nicorandil group. 3-dimentional-speckle tracking echocardiography (3d-ste) and the seattle angina questionnaire (saq) survey were performed at baseline and at 3 months. participants were randomized according to an ibm spss23.0-generated randomization schedule, with a 1:1 allocation to the nicorandil group or the control group.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years;1 or more cto vessels (≥2mm in diameter) exclusion criteria: * successful pci for all cto lesions; st segment elevation myocardial infarction (stemi) during the past 3 months; planed coronary artery bypass grafting (cabg) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with nyha (new york heart association) class iii or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases
a study of cebranopadol for the treatment of acute pain after abdominoplasty

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of cebranopadol for acute pain after a abdominoplasty.

this study is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cebranopadol for the treatment of moderate to severe acute pain after full abdominoplasty. this study will be conducted in 3 phases: screening, treatment, and follow-up.

Eligibility criteria:
key inclusion criteria: * scheduled to undergo full abdominoplasty procedure without liposuction or other collateral procedures, using anesthesiologic and surgical procedures planned as described in this protocol. * must be able to adhere to the visit schedule, complete all study assessments, and protocol requirements including self-reported questionnaires. key exclusion criteria: * any clinically significant disease, medical condition or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity or compromise the safety of the subject. * subject has a current painful condition that could confound the interpretation of efficacy, safety or tolerability data in the study, in the opinion of the investigator. * history of allergy, hypersensitivity or intolerance to any opioid analgesics or anesthetics, including opioid-induced nausea or vomiting.

Keywords: abdominoplasty
nutritional support in pressure ulcer patients

Conditions: Pressure Ulcers

Summary: pressure ulcers are frequently associated with malnutrition. previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. moreover, other investigators have suggested the additional healing power of some nutrients. unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. the investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.


Eligibility criteria:
inclusion criteria: * patient or legal guardian or caregiver consent * stage ii, iii or iv pressure ulcers * malnutrition (as defined by low body mass index and/or unintentional weight loss and/or low serum albumin and/or reduced food intake \[\<60% of total daily estimated requirements\]) * patients who can drink supplements * home-care or long-term care exclusion criteria: * decompensated diabetes (hba1c \>7%) * renal failure * hepatic failure (child b and c) * current neoplastic disease * any organ-failure * immunosuppressive therapy * connective tissue disease * use of steroids * obesity * respiratory insufficiency (copd) * anemia (haemoglobin \<10g/dl) * previous neoplastic disease (\<1 year since last treatment ct or rt) * infected wounds * cellulitis, sepsis or osteomyelitis * poor tolerance to sip feeding

Keywords: pressure ulcers healing malnutrition nutritional support micronutrients
montelukast for patients with obstructive sleep apnea syndrome

Conditions: Sleep Apnea, Obstructive

Summary: this study compares the effect of montelukast vs placebo on flow mediated dilatation of the brachial artery (fmd) in patients with obstructive sleep apnea syndrome.

obstructive sleep apnea syndrome (osas) induces low-grade systemic and vascular inflammation, including activation of the leukotriene pathway. in apneic patients, the urinary excretion of lte4, a systemic marker of cyslt pathway activation, is increased in relation to the severity of osas and it's an independent predictor of cardiovascular risk event occurring at 10 years. montelukast is a cyslt1 receptor antagonist. by blocking cyslt1 receptors, montelukast prevents vasoconstriction, proliferation and migration of smooth muscle cells, adhesion molecule expression, and leukocyte recruitment induced by cyslts.montelukast may improve endothelial function and reduce vascular remodeling in apneic patients. a pharmacological blockade of cyslt pathway would be an interesting therapeutic strategy to limit the cardiovascular consequences of osas.

Eligibility criteria:
inclusion criteria: * with mild to moderate obstructive sleep apnea syndrome (apnea / hypopnea index\> 15 and \<30 events per hour) * little symptomatic (epworth sleepiness score \<10) * polysomnography within 3 months prior to inclusion * with a history of myocardial infarction or stroke * affiliation to social security or beneficiary of such a scheme * signed consent exclusion criteria: * osas support by ppc * cancer * chronic inflammatory disease * asthma previously treated with montelukast * chronic infectious disease * epworth sleepiness scale ≥10 * contraindication to montelukast: hypersensitivity to the active substance or to the excipients * contraindications to trinitrin: hypersensitivity to nitrates, state of shock, severe hypotension, association with sildenafil, obstructive cardiomyopathy, inferior right sided myocardial infarction with right ventricular extension, acute, except in case of signs left ventricular failure, intracranial hypertension, breastfeeding * treatment with phenobarbital, phenytoin, rifampicin: risk of montelukast metabolism increase and thus decrease of its effectiveness * persons referred in articles l1121-5 to l1121-8 of the csp (pregnant woman, parturient, nursing mothers, person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection, can not be included in clinical trials) * subject in exclusion period of another study * subject can not be contacted in case of emergency

Keywords: montelukast leukotriene pathway endothelial function flux-mediated dilation
smoking cessation intervention for women living with hiv

Conditions: AIDS/HIV

Summary: as people with hiv/aids live longer, the burden of non-aids-related health problems such as cardiovascular diseases and cancers on these people have consistently increased. smoking is one of the major contributing factors to these health problems and rates of cigarette smoking in this group are substantially higher than those of the general population: 40-70% vs. 17-10%. especially, women living with hiv/aids seem to be more susceptible to the negative consequence of smoking than their male counterparts. they are also less likely to see tobacco dependence treatment for dual stigma associated with both conditions: hiv infection and nicotine addiction. this is a pilot study to develop smoking cessation intervention for these women.

women are at high risk of becoming hiv positive due to biological vulnerabilities, low socioeconomic status, dominant sexual practices of males and epidemiological factors. for example, the risk of being infected with hiv during unprotected sex is two to four times greater for women than for men. with the use of combined antiretroviral therapies, these women now live longer than ever before which now faces the healthcare community with the need for evolving understanding of hiv and aging. however, the burden of non-aids related health problems such as cardiovascular diseases and cancers on people living with hiv/aids while aging has considerably increased. smoking is one of the major contributing factors to these health problems. rates of current cigarette smoking are substantially higher among people living with hiv/aids than the general population: 40-75% versus 19%. women smokers living with hiv have a 36% higher risk for developing aids and 53% higher mortality when compared to non-smoking women with hiv. this study is a pilot randomized controlled trial (rct) testing the feasibility and acceptability of a videoconferencing smoking cessation intervention (video arm) for women with hiv in comparison with a telephone-based smoking cessation intervention (telephone arm). both arms will receive 8, 30-minute weekly cessation counseling sessions plus 8-week nicotine replacement therapy. participants will be followed up at 1, 3 and 6 months from the target quit day. self-reported abstinence will be verified with a saliva cotinine test using an nicotine alert test strip and the testing process will be monitored via mobile-phone video call.

Eligibility criteria:
inclusion criteria: * english speaking * diagnosis of hiv infection * age 18 or older * smoking at least 5 cigarettes a day * having access to a mobile-phone with internet connection * willing to quit smoking within the next 4 weeks exclusion criteria: * inability to speak english * involvement in another cessation program * being pregnant or lactating * having an active skin disease * history of serious mental illnesses (e.g., schizophrenia and bipolar disorder) * serious alcohol use problem * use of any illegal substances excluding marijuana
hemodynamic parameters in euthyroid patients with thyroid nodules

Conditions: Thyroid Nodules

Summary: the purpose of this study is to determine the relationship of hemodynamic parameters with the level of thyroid hormones and the histological structure of thyroid nodules in euthyroid patients.

as opposed to widely investigated condition of cardiovascular system in patients with functional disorders of thyroid gland, the relationship between thyroid hormones and hemodynamic parameters in euthyroid patients remains not enough clear. we detect the parameters of blood pressure and thyroid hormones in euthyroid patients with thyroid nodules directly before planned operation on the thyroid gland. as the study is carries out directly before operation, that assumes presence of preoperative stress in patients, activity of the sympatho - adrenal system is estimated in addition. on the one hand, the design of our research will allow to estimate relationship of thyroid hormones with the parameters of blood pressure in conditions of euthyroidism, on the other hand - to investigate features of blood pressure in patients with thyroid nodules. the research of the patients in the preoperative period will enable to select the group of patients without pathology of cardiovascular system whose increased blood pressure is connected with preoperative stress, that in turn will allow to exclude influence of the pathology of the cardiovascular system on studied correlation.

Eligibility criteria:
inclusion criteria: * euthyroid patients with thyroid nodules before operation on the thyroid gland exclusion criteria: * hyperthyroidism * hypothyroidism

Keywords: thyroid nodules, blood pressure, thyroid hormones
normobaric hypoxic training and multiple sclerosis

Conditions: Multiple Sclerosis

Summary: to study the effects of normobaric hypoxic training on cardiorespiratory fitness, resting, postprandial and exercise activity energy expenditure, immunoregulatory functions and serum erythropoietin levels in relapsing-remitting multiple sclerosis patients.


Eligibility criteria:
inclusion criteria: * stable immunomodulatory therapy * expanded disability status scale score \< 4.5 * body mass index 18.5 - 29.9 kg/m2 exclusion criteria: * clinically relevant heart, lung, liver, and kidney diseases

Keywords: hypoxia training activity energy expenditure immunoregulation energy metabolism exercise
eliminating hepatitis c virus

Conditions: Hepatitis C; HIV; Type2 Diabetes

Summary: initially, hcv informatics (c-it) will be used to filter the emr data of the one million people who receive care at mount sinai and identify candidates for hcv testing (baby boomers, patients with hiv infection) and candidates for hcv treatment (patients with positive test results for hcv rna and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. hcv champions and patient navigators will be used to further lower barriers to the delivery of hcv care. they will be co-located at non-hepatology care sites and will help deliver open-label hcv treatment as part of standard medical care to 500 hiv/hcv co-infected patients and 200 patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: inclusion criteria for hcv treatment in patients with hiv/hcv co-infection * 18 years of age or older * hcv rna positive * any hcv genotype * documented infection with hiv, with the following additional criteria: - patients on haart should be on a stable regimen for 4 weeks, with a cd4 count \> 100, and an hiv viral load \ 350 * expected life expectancy sufficient to receive a benefit from hcv cure * no conditions that are contraindications for the use of hcv medications inclusion criteria for hcv treatment in patients with type 2 diabetes * 18 years of age or older * hcv rna positive * any hcv genotype * documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, dr. sherley abraham * expected life expectancy sufficient to receive a benefit from hcv cure exclusion criteria: * no conditions that are contraindications for the use of hcv medications