Kornimate/medical-research-clean huggingface dataset:
dose escalation study of the safety, tolerability and pharmacokinetics of bilr 355 bs plus low dose ritonavir in hiv-uninfected male volunteers

Conditions: Healthy

Summary: study to determine the safety, tolerability and pharmacokinetics of bilr 355 bs plus low dose ritonavir in healthy male volunteers.


Eligibility criteria:
inclusion criteria: 1. males who meet the following criteria: based upon a complete medical history, including the physical examination, vital signs (bp, pr), 12-lead ecg, clinical laboratory tests * no finding deviating from normal (except as noted below) and of clinical relevance * no evidence of a clinically relevant concomitant disease 2. age ≥18 years and \<60 3. bmi ≥18.5 and bmi ≤29.9 kg/m2 (body mass index) 4. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation exclusion criteria: 1. current and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 2. surgery of gastrointestinal tract (except appendectomy) 3. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 4. history of relevant orthostatic hypotension, fainting spells or blackouts 5. chronic or relevant acute infections 6. history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator 7. intake of drugs with a long half-life (\>24 hours) within one month prior to administration of study drug or during the trial 8. use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation 9. participation in another trial with an investigational drug within one month prior to administration or during the trial 10. smoker 11. inability to refrain from smoking on trial days 12. alcohol abuse (more than 60 g/day) 13. drug abuse 14. recent blood donation (more than 100 ml within 4 weeks prior to administration or during the trial) 15. excessive physical activities (within 1 week prior to administration or during the trial) 16. any laboratory value outside the normal reference range that is of clinical relevance 17. inability to comply with dietary regimen of study centre 18. infected with hepatitis b or hepatitis c viruses (defined as either being hepatitis b surface antigen, hepatitis b core antibody, or hepatitis c antibody positive) 19. hiv-1 infected as defined by a positive hiv elisa test
screening for fabry disease in renal transplantation

Conditions: Fabry Disease; Nephropathy

Summary: single centre, prospective pilot study examining the relevance to screen for fabry disease in a cohort of patients who have undergone renal transplantation for nephropathy of indeterminate cause, vascular nephropathy, diabetic nephropathy or secondary focal segmental hyalinosis with no established cause.

exploration whether fabry disease cases can be identified among patients who are followed at the montpellier university hospital after renal transplantation, with indeterminate cause of renal failure or diabetic nephropathy (due to its high frequency) or secondary focal segmental hyalinosis (fsh). at the population level, the identification of cases at the montpellier centre could then justify to expand this screening to other french centres. the goal is to contribute to adapt current guidelines of renal failure assessment, by systematically including fabry among the diagnostic tests. whether all patients with renal failure are concerned, or only those with indeterminate cause, is an important question this study will address.

Eligibility criteria:
inclusion criteria: * nephropathy of indeterminate cause, or secondary fsh or diabetic nephropathy * patients with kidney transplanted * patients still followed at the montpellier university hospital * obtaining written informed consent * age \> 18 years old, no upper age limit exclusion criteria: * n/a

Keywords: fabry disease renal transplantation diabetic nephropathy focal segmental hyalinosis (fsh) undetermined nephropathy
preclinical imaging biomarkers of alzheimer's disease neuropathology in young adults with youth-onset diabetes: a proof-of-concept study

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Youth Onset

Summary: the goal of the study is to characterize preclinical alzheimer's disease and related dementias (ad/adrd) neuropathology in a selected group of young adults with youth-onset diabetes, and an age-similar group of young adults without diabetes.

the goal of the current proof-of-concept study is to characterize brain structural, functional, and molecular imaging biomarkers of preclinical alzheimer's disease and related dementias (ad/adrd) neuropathology in a selected group of young adults with youth-onset diabetes (y-dm; type 1 diabetes \[t1d\], n=5; type 2 diabetes \[t2d\], n=5) from the search for diabetes in youth study cohort, and an age-similar group of young adults without diabetes (n=5). this study will quantify structural and functional imaging biomarkers of ad/adrd neuropathology via magnetic resonance imaging by assessing gray matter (gm) volume/cortical thickness, as well as gm and white matter (wm) microstructure, resting state functional network connectivity (rsfmri), and cerebral blood flow (cbf) and wm hyperintensity volume. this study will additionally quantify brain tau density via positron emission tomography as the gold-standard measure of preclinical ad/adrd neuropathology.

Eligibility criteria:
inclusion criteria: * part of the search for diabetes in youth study cohort or * age 18-40 * without diabetes exclusion criteria: * head trauma with loss of consciousness \>30 minutes * claustrophobia * metal in the body * major psychiatric disorder (eg. schizophrenia, bipolar, and major depression) * neurological conditions affecting cognition (eg. epilepsy) * stroke * if female, breastfeeding, plan to become pregnant or are pregnant

Keywords: diabetes mellitus, type 1 diabetes mellitus, type 2 diabetes, youth onset magnetic resonance imaging positron emission tomography imaging
a family based intervention to reduce the risk of type 2 diabetes in children

Conditions: Pediatric Obesity; Type 2 Diabetes; Metabolic Syndrome

Summary: the purpose of this study was to determine if a family-focused lifestyle intervention helps to improve the health status, behaviors, and adjustment of overweight children.

type 2 diabetes (dm2), and obesity is increasing dramatically in the united states and worldwide among children. even before children are diagnosed with dm2, they often show signs such as being overweight, having high blood pressure, abnormal lipid metabolism, and impaired glucose tolerance that put them at risk for other diseases, such as heart disease. in addition, children who are at risk for dm2 also face elevated risks of other major medical complications along with psychological and social consequences (e.g., depression, teasing, discrimination, school problems), which can often be just as damaging as the medical problems. since obesity plays an important role in the progression to dm2, the need to prevent children from progressing to a diagnosis of dm2 is critical. the proposed study was a randomized controlled trial comparing an education group for families of children at high risk for progression to metabolic syndrome and type 2 diabetes with a family-focused multi-component lifestyle intervention. the study addressed these specific aims: 1. evaluated the effects of a family-focused lifestyle intervention on the health status of children at risk of metabolic syndrome (bmi, blood pressure, cholesterol, impaired glucose tolerance, waist circumference). 2. evaluated the effects of a family focused psychosocial treatment on the health behaviors of children at risk for developing metabolic syndrome (eating behaviors, physical activity). 3. evaluated the effects of a family focused psychosocial treatment on psychological outcomes of children at risk of developing metabolic syndrome (overall behavioral functioning, perception, self esteem, depression, quality of life). 4. analyzed variables that are predictive of maintenance or termination of engagement in the family-focused lifestyle intervention. it was hypothesized that this intervention approach will result in: a) improved health status and a reduction of risk for developing metabolic syndrome (bmi, waist circumference, blood pressure, cholesterol, and glucose levels), b) improved health behaviors (physical activity, diet), and c) generalize to more optimal psychosocial functioning (depression, self-perception, quality of life, school attendance) at short and long-term follow-up of the children in the intervention group compared with children in the education group.

Eligibility criteria:
inclusion criteria: * bmi 85th percentile and above, otherwise healthy * age between 8-11 years old exclusion criteria: * diagnosis of metabolic syndrome * diagnosis of type 2 diabetes * diagnosis of mental retardation

Keywords: family-focused intervention pediatric obesity diabetes prevention
a single ascending dose of hrs-4029 in healthy subjects

Conditions: Acute Ischemic Stroke

Summary: the study is being conducted to evaluate the safety, tolerability and pharmacokinetics of hrs-4029 following a single intravenous dose administration in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. age between 18 to 55 years. 2. body mass index (bmi) of 19.0 to 28.0 kg/m2 (inclusive). 3. agreed to take effective contraceptive measures during and 3 months after the last dose of the study period. 4. understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (icf). exclusion criteria: 1. diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded. 2. vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator . 3. subjects with positive tests for infectious diseases. 4. female who are pregnant or breastfeeding. 5. unable to tolerate venipunctures or have a history of fainting needles and blood. 6. historic abuse of alcoholic beverages 7. smoke ≥5 cigarettes per day within 3 months prior to the study 8. history of drug abuse. 9. other reasons that the investigator consider it inappropriate to participate in the trial.
are nsaids effective enough for postoperative pain control after functional endoscopic sinus surgery and septoplasty

Conditions: Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Summary: the purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (nsaids) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ess) and/or septoplasty.


Eligibility criteria:
inclusion criteria: * english speaking * candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist * scheduled for surgery at texas sinus institute exclusion criteria: * allergy to either nsaids or opioids * contraindication to nsaids (ex. gastritis, chronic kidney disease) * surgical plan exceeding basic endoscopic sinus surgery * use of anticoagulation * the presence of any pain disorder * the current usage of any analgesic medication * history of opioid addiction * pregnancy * history of chronic pain or fibromyalgia * current daily use of nsaids, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)
efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening

Conditions: Laxity; Skin

Summary: the goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. the main questions it aims to answer are: * efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and skin elasticity * the changes in texture and pore volume using antera * the changes in bioengineering assessment: melanin index, erythema index, sebum level * adverse events participants will be treated with 3 sessions of fractional 1064-nm picosecond laser (full face 4 passes, vector lines 4 passes), spaced 4 weeks apart. follow-up visits 1, 3, and 6 months after the last treatments.

the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, bmi \< 25 kg/m2, and have mild to moderate facial laxity.

Eligibility criteria:
inclusion criteria: * aged 40-55 years * bmi \< 25 kg/m2 * asian * mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5) exclusion criteria: * pregnant or lactation * subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion * subjects who have been injected with botulinum toxin, filler, or platelet-rich plasma on their faces 6 months prior to the inclusion * active skin infections * history of hypertrophic scars or keloids
mindfulness based stress reduction for metabolic syndrome

Conditions: Metabolic Syndrome

Summary: mindfulness based stress reduction offered to couples where one has metabolic syndrome to see if their stress is reduced as measured by bio markers and surveys

this is a pilot study being designed to pilot a mbsr program for the purposes of future research.the investigators will be using two cohorts. one who will get the intervention and the other who will be wait listed and receive the intervention at a later date. eight week mindfulness class offered to couples, who also attend an orientation session and a half day retreat with other couples to learn how to control stress through mindfulness meditation practices. participants will come for lab work before intervention, eight weeks after initial class and at the end of entire program. bio- markers to be measured are waist circumference, fbs and cholesterol.

Eligibility criteria:
inclusion criteria: * participant has 3 of the following: a abdominal obesity; b. hypertriglyceridemia; c. low high density lipoproteins (hdl); d. high blood pressure; e. high fasting blood sugar (fbs) * participant must be married or co- habituating * both partners are over sixty exclusion criteria: * either partner is non- english speaking * either partner practices mind- body therapies more than once a week/ * either partner taking psychiatric medicine
comparing blood loss and visualization after the preoperative use of topical 0.05% oxymetazoline versus 1:1000 epinephrine prior to endoscopic sinus surgery

Conditions: Endoscopic Sinus Surgery; Nasal Polyps

Summary: the purpose of this study is to compare the effects of oxymetazoline and epinephrine (which are 2 different nasal decongestants both of which are routinely used before sinus surgery) on blood loss and the surgeon's view of the surgical field during sinus surgery.


Eligibility criteria:
inclusion criteria: * the inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ess) in which the same sinuses and procedures on both sides are the same for crs with or without nasal polyposis. exclusion criteria: * pregnancy * known coagulopathy * an international normalized ratio greater than 1.3 * a partial thromboplastin time greater than 50 seconds * use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses) * use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta) * poorly controlled hypertension with a preoperative systolic blood pressure of 160mm hg or greater or a diastolic blood pressure of 90mm hg or greater * having any adverse reaction to topical epinephrine or oxymetazoline.
pharmaco-magnetic resonance spectroscopy (mrs) study of clavulanic acid

Conditions: Cocaine Dependence

Summary: a dose-escalation study to determine the optimum dose of clavulanic acid (clav) for effects on craving and efficacy.

this is a randomized, double-blind, placebo-controlled, parallel group inpatient study of clavulanic acid for 10 days in adults (18-65) seeking treatment for cocaine use disorder. for those subjects who can tolerate 500 mg/day for 3 days (or matched placebo), there will be a forced dose escalation to 750 mg/day for 3 days. subjects who can tolerate 750 mg/day for three days will have a forced dose escalation to 1000 mg/day for 4 days until the study ends. thus, there are 3 periods for each participant: period 1: 500 mg clav per day for days 1-3; period 2: 750 mg per day for days 4-6; period 3: 1000 mg/day for days 7-10. subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed daily. structural mri, resting state mri (rs-fmri), functional mri (fmri) and magnetic resonance spectroscopy (mrs) scans will be done at baseline and on days 3, 6 and 10 of the study. at the time of each scan, safety of the subject to complete the scan will be re-assessed. fmri was not done at baseline.

Eligibility criteria:
inclusion criteria: 1. be able to verbalize understanding of consent form 2. be male or female adult volunteers ages 18-65 inclusive. 3. have a diagnostic and statistical manual-5 (dsm-5) diagnosis of cocaine use disorder, moderate to severe in early remission 4. have a body mass index (bmi) of 17.5 to 39.9 kg/m2; and a total body weight of at least 45 kg (99 lbs.) 5. have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness. exclusion criteria: 1. have a current dsm-5 substance use disorder, mild, moderate, or severe, on any drug of abuse other than nicotine, caffeine, and cocaine use disorder in early remission verified by urine drug screen (uds). alcohol use disorder and marijuana use disorder, mild without withdrawal symptoms, will be permitted. 2. have any previous medically adverse reaction to clav, augmentin, penicillin, ticarcillin, cephalosporin, or any beta-lactam drug. 3. have any illness, condition, and use of medications, in the opinion of the principal investigator, sub-investigators which would preclude safe and/or successful completion of the study. 4. report having human immunodeficiency virus (hiv) infection or test positive for hiv during screening 5. be pregnant (females). 6. unable to tolerate mri scan for duration of 60 minutes for physical or psychological reasons.
enteral feeding composition and acute respiratory failure

Conditions: Acute Respiratory Failure

Summary: this study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in intensive care unit (icu) patients with acute respiratory failure. in this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in icu that receive enteral feeding, will be randomly assigned to three groups of 14 each. first intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. intravenous levels of uric acid, high sensitive c-reactive protein (hs-crp), interleukin 6 (il-6) and total antioxidant capacity (tac) measured at days 0 and 10. as well as, organ failure, duration of ventilation, length of icu stay and mortality rates will be evaluated.


Eligibility criteria:
inclusion criteria: * enrolled in icu * age older than 18 years old * need to be mechanically ventilation * have enteral feeding * no previous diabetes * no previous hiv infection * no previous nervous system * no previous liver failure * no previous nephrotic syndrome * not passed more than 48 hours from diagnose of acute respiratory failure exclusion criteria: * death at less than three days of enteral feeding administration * extubation at less than three days of enteral feeding administration

Keywords: acute respiratory failure lung enteral feeding feeding composition olive high fat
medical and surgical hybrid treatment of atrial fibrillation.

Conditions: Atrial Fibrillation (AF)

Summary: the objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation. this is a single procedure for both surgical epicardial by minimally invasive route (thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time. this faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.


Eligibility criteria:
inclusion criteria: patients with complex af defined by the following criteria : * af\> 1 week or long term persistent\> 1 year * and symptomatic * and after failure of treatment of anti-arrhythmic or against-indication for anti-arrhythmic exclusion criteria: the exclusion criteria are relevant contraindications thoracoscopy or the non-complex nature of the af: * paroxysmal af or af cardioverted anti-arrhythmic test (unless against indicated) * recent af for which a simple gesture is intracavitary considered sufficient * permanent af * asymptomatic af * very old af (\> 5 years) or atrial major ectasia (\> 60 mm) * need another surgery (valve bypass coronary) * previous history of sternotomy or thoracotomy * high-risk surgical or anesthetic patient * bmi\> 35 * sleep apnea * ejection fraction \<35% * thoracic trauma history * veins pulmonary stenosis\> 50% * hyperthyroidism * thrombus in laa

Keywords: epicardial surgical removal closure of the left atrial left atrial appendage (laa)
effectiveness of the use of a mobile tool in improving lifestyles

Conditions: Healthy Subjects Without Cardiovascular Disease

Summary: objectives: to develop and validate a mobile tool for use in smartphone supports as a first step, and to evaluate the effect of adding this new tool of information and communication technologies (ict), to a standardized intervention to increase adherence to nutritional recommendations of the mediterranean diet and increase physical activity as primary endpoint. analyze adherence and intervention results from a gender perspective. methodology: multicenter, randomized double-blind, clinical trial with two parallel group, aimed at assessing the effects of adding an tic tool, developed for the smartphone application (intervention), in support of behavioral and educational recommendations (control) in the increased physical activity and adaptation to the mediterranean dietary pattern. population: 1215 included subjects younger than 70 years from the project evident who agree to participate. measurement and interventions: physical activity will be assessed with the accelerometer and the 7-par day and adaptation to the mediterranean diet with a questionnaire of adherence and a food frequency survey. it will also assess vascular structure and function, central blood pressure, augmentation index, pulse rate and of carotid intima-media thickness. the counsel to adaptation the mediterranean diet (based on the project predimed) and exercise (based on pepaf project), will be common to both groups. the intervention group will be added training and use of an application on a smartphone designed to promote healthy eating and increased physical activity.


Eligibility criteria:
inclusion criteria: * healthy subjects since 20 to 70 years exclusion criteria: older than 70 years are excluded, due to difficulties in the use of icts and those who can not exercise or follow a diet mediterranean diet

Keywords: physical activity alimentation information and communication technology arterial aging