Kornimate/medical-research-clean huggingface dataset:
the effect of time-restricted eating in cardiometabolic health

Conditions: Obesity; Pre-diabetes

Summary: time-restricted eating (tre) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. in rodents, tre improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. however, an understanding of the effect of tre on cardiometabolic health in people is not clear and few studies have evaluated this issue. accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h tre for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (cvd): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. the proposed studies will elucidate the cardiometabolic implications of tre in people with obesity and prediabetes.


Eligibility criteria:
inclusion criteria: * body mass index 30-39.9 kg/m2 * fasting plasma glucose 100-125 mg/dl, or 2h ogtt plasma glucose 140-199 mg/dl or hemoglobin a1c 5.7-6.4% * self-reported habitual eating period \> 15 h per day exclusion criteria: * shift worker, recent or expected travel crossing time zones * fasting \>12 h/day more than once a week or vegan * shift worker, recent or expected travel crossing time zones * fasting \>12 h/day more than once a week or vegan * \> once a week no food intake after 1800 h * habitually waking up before 0400 h and sleeping before 2230 h * ≥ 150 min per week of structured exercise * unstable weight (\>5% change the last 2 months) * type 2 diabetes or other major chronic disease * sleep disorder * cancer in last 5 years * conditions that render subject unable to complete all testing procedures * use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or beta adrenergic blockers or agonists, etc.) * smoking and illegal drug use * pregnant or lactating * menopause * individuals that have performed procedures involving substantial exposure to radiation in the last 12 months * gastrointestinal or bariatric surgery * unable to grant voluntary informed consent or comply with the study instructions * individuals who are not yet adults (infants, children, teenagers) * prisoners

Keywords: chrono-nutrition adipose tissue skeletal muscle insulin sensitivity diurnal rhythm
sleep, awake & move - part ii

Conditions: Idiopathic Parkinson's Disease

Summary: sleep benefit (sb) is a prominent spontaneous, apparently unpredictable, transitory improvement in motor function reported by around 50% of patients affected by parkinson's disease (pd) after sleep and before taking their first dose of dopaminergic medications. the aim of this study is to test the hypothesis that objective and/or subjective improvement of motor function might be due to a carry-over effect of rapid eye movements (rem) sleep at awakening from this sleep phase.

the "awake \& move" study is the second part of the sleep, awake \& move project. this study will be conducted in a subgroup of unselected, consecutive patients having completed the part i of the sleep, awake \& move project (i.e. the "sleep \& move" study). the investigators plan to explore the carry-over effect of rem sleep on motor function in a subgroup of pd subjects p. in this interventional study the investigators expect to induce sb by awakening the subjects from nocturnal rem sleep in a sleep laboratory setting, but not from non-rapid eye movements (nrem) sleep (control intervention).

Eligibility criteria:
inclusion criteria: * diagnostic criteria of idiopathic parkinson's disease (ukpdbb) * mild to moderate disease (hoehn \& yahr score ≥ 1 and \< 3) * mentally and physically capable to give informed consent * stable antiparkinsonian and psychotropic therapy for the last 30 days exclusion criteria: * atypical parkinsonian syndrome * cognitive impairment (mmse ≥ 26) * deep brain stimulation * history of cerebro-vascular disease, epilepsy, or other disabling neurological diseases * psychiatric disorders, excepting mild depression * alcohol abuse * other clinically significant severe concomitant disease states * inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, etc.) * participation in another study with investigational drug within the 60 days preceding and during the present project. * subjects with (a) sleep-disordered breathing \[respiratory disorder index (rdi)≥ 5\] and (b) with no clear-cut distinction of rem and nrem sleep, based on a video-polysomongraphical recording.

Keywords: parkinson's disease, sleep benefit
extension to qti571a2301 to evaluate the long-term safety, tolerability and efficacy of imatinib in severe pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: this is a multinational, multi center extension study. this study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: * patients who participated in cqti571a2301 clinical trial and completed the week 24 visit of the study protocol, including all study completion assessments * patients who withdrew from the cqti571a2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all study completion assessments exclusion criteria: * patients with a pulmonary capillary wedge pressure \> 15 mmhg at time of study completion assessments in core protocol cqti571a2301. if pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place. * lvef \< 45% * patients with thrombocytopenia, platelet count \< 50e9/l (50e3/µl) * patients with uncontrolled systemic arterial hypertension, systolic \> 160 mmhg or diastolic \> 90 mmhg * patients with a qtcf \> 450 ms for males and \> 470 ms for females in the absence of right branch bundle block (based on visit 1 ecg if required to be performed) other protocol-defined inclusion/exclusion criteria may apply

Keywords: pulmonary arterial hypertension, imatinib, 6mwd, pulmonary hypertension
ultrasound assessment of gastric content for semi emergency surgery

Conditions: Anesthesia; Surgical Procedure, Unspecified

Summary: aspiration of gastric content is a rare but serious complication of anesthesia. in this context, preoperative fasting for elective surgery is well defined. in an emergency situation, international guidelines recommend rapid sequence of anesthesia to reduce the risk of aspiration. in semi emergency situation, there is no consensus about the anesthetic procedure even if a preoperative fasting has been observed due to uncertainty of gastric emptying related to stress or painful condition. the choice of anesthesia induction technique depends mainly on the anesthetist. ultrasonography is a non invasive bedside tool that can provide reliable quantitative information about the volume of gastric content.


Eligibility criteria:
inclusion criteria: * undergoing a non-elective surgery * having a preoperative fasting period of six hours exclusion criteria: * patients with digestive diseases (gastroesophageal reflux disease, hiatal hernia, active peptic ulcer, upper gastrointestinal bleeding, vagal denervation, pyloric stenosis, extrinsic digestive compression, occlusive syndrome), neurologic diseases (spinal cord injury over t10, amylose, shy-drager syndrome) * patients with full stomach (preoperative fasting under 6 hours), * pregnant women (over 15 weeks of amenorrhea) * patients who received premedication.

Keywords: ultrasonography non-elective surgery anesthesia
alpha-lipoic acid in diabetic patients with ischemic cardiomyopathy

Conditions: Ischemic Cardiomyopathy; Diabetes Mellitus

Summary: the aim of this study is to investigate the effect of alpha-lipoic acid on inflammatory markers and cardiac fibrosis markers in diabetic patients with ischemic cardiomyopathy.

* a 3-month, prospective double blind interventional study, which will include 60 patients with type ii diabetes mellitus with ischemic cardiomyopathy on optimal standard medical therapy, who will be consecutively randomized into two groups, group on ala 600 mg once daily and the second group on placebo once daily. * approval will be obtained from research and ethics committee of faculty of pharmacy, damanhour university. a written informed consent will be obtained from patients before begining of the study. * all patients will undergo complete physical examination at baseline and after 3 months of treatment. * patients will be assessed using echocardiography before and after the study focusing on: left atrial diameter (lad), basic left ventricular dimensions (edd and esd) and both systolic and diastolic function. -measurements of inflammatory markers such as \[c-reactive protein (crp), tumor necrosis factor alpha (tnfα)\] and fibrosis markers such as \[transforming growth factor beta (tgfβ), matrix metalloproteinase 2 (mmp-2)\] at the beginning of the study and after 3 months of the study. study outcomes: all patients will be followed up for 3 months for: * 1ry outcomes: change in inflammatory and fibrosis markers levels. lv echocardiography improvements of any of basic echo parameters. * 2ry outcomes: major adverse cardiovascular events (mace) such as mi, stroke or death. any side effects of the drug. results the results of the study will be tabulated and statistical tests appropriate to the study will be conducted to evaluate significance of results. conclusion conclusion, and recommendations will be given.

Eligibility criteria:
inclusion criteria: * type 2 diabetes with a history of cad. * lv ejection fraction (lvef) ≤40%. * ischemic heart failure patients with nyha grade ii-iv. exclusion criteria: * type 1 diabetes. * severe ckd with gfr ≤ 15 ml/min/1.73m\^2. * severe liver disease. * thyroid disorders. * acute febrile illness. * autoimmune disorders or connective tissue disorders.
a study of ly3819253 (ly-cov555) and ly3832479 (ly-cov016) in preventing sars-cov-2 infection and covid-19 in nursing home residents and staff

Conditions: COVID-19; SARS-CoV2

Summary: the purpose of this study is to evaluate whether ly3819253 given alone and with ly3832479 prevent severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and coronavirus disease - 2019 (covid-19). facility staff and residents in contracted skilled nursing and assisted living facility networks with a high risk of sars-cov-2 exposure will receive ly3819253, ly3819253 and ly3832479, or placebo via an injection into a vein. samples will be taken from the nose. blood samples will be drawn. participation could last up to 25 weeks and may include up to 19 visits.


Eligibility criteria:
inclusion criteria: * part 1 and part 2: resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of sars-cov-2 detection less than or equal to (≤)7 days prior to randomization * are men or non-pregnant women who agree to contraceptive requirements * agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities * have venous access sufficient to allow intravenous infusions and blood sampling * the participant or legally authorized representative give signed informed consent * part 3 only: resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening * are greater than or equal to (≥) 65 years of age * have a body mass index (bmi) ≥ 35 * have chronic kidney disease * have type 1 or type 2 diabetes * have immunosuppressive disease * are currently receiving immunosuppressive treatment, or * are ≥ 55 years of age and have * cardiovascular disease, or * hypertension, or * chronic obstructive pulmonary disease or other chronic respiratory disease * positive sars-cov-2 test and infusion within 10 days of symptom onset, or positive sars-cov-2 test and infusion within 10 days of testing if asymptomatic exclusion criteria: * parts 1 and 2: * recovered from confirmed covid-19 disease or asymptomatic infection * prior history of a positive sars-cov-2 serology test * history of convalescent covid-19 plasma treatment * participation in a previous sars-cov-2 vaccine trial or received an approved sars-cov-2 vaccine * previous receipt of sar-cov-2-specific monoclonal antibodies * have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study

Keywords: prevention
effects of sofosbuvir/ledipasvir treatment on the pharmacokinetics and renal safety of tenofovir

Conditions: Hepatitis C and HIV Coinfection

Summary: this study evaluates the effect of sofosbuvir/ledipasvir (sof/ldv) treatment on the pharmacokinetics (pk) and renal safety of tenofovir. subjects receiving tenofovir-based antiretroviral therapy with human immunodeficiency virus (hiv) protease inhibitors (hiv pi/r) and initiating sof/ldv treatment for hepatitis c virus (hcv) will be invited to participate. the study consists of three visits: a screening visit and two abbreviated 4-hour pharmacokinetic visits (one before initiating sof/ldv and a second approximately 4 weeks after initiating sof/ldv).


Eligibility criteria:
inclusion criteria: * on tenofovir and a ritonavir-boosted pi for at least 30 days initiating hcv treatment with sof/ldv * hcv rna \<48 copies/ml at most recent clinic visit exclusion criteria: * egfr \< 60 ml/min * history of renal disease * pregnant or planning pregnancy * any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes
a european post-authorisation observational study (registry) of patients with chronic adrenal insufficiency (ai)

Conditions: Chronic Adrenal Insufficiency

Summary: as a post-approval requirement of the european medicines agency, this european patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).


Eligibility criteria:
inclusion criteria: * diagnosis of chronic adrenal insufficiency * written informed consent/assent in compliance with applicable country-specific and local regulations exclusion criteria: * participation in an interventional clinical trial

Keywords: adrenal insufficiency duocort congenital adrenal hyperplasia (cah) modified release hydrocortisone
yaz premenstrual dysphoric disorder (pmdd) in china

Conditions: Premenstrual Dysphoric Disorder ( PMDD)

Summary: the purpose of this study is to evaluate the efficacy and safety of yaz compared to placebo in the treatment of symptoms related to premenstrual dysphoric disorder (pmdd).


Eligibility criteria:
inclusion criteria: * chinese women of reproductive age 18-45 years (inclusive) with a diagnosis of premenstrual dysphoric disorder (pmdd) exclusion criteria: * any formal psychotherapeutic counselling within 1 month before the screening visit (visit 1) or used medication for premenstrual syndrome (pms) or premenstrual dysphoric disorder (pmdd) including, but not limited to hormones, bromocriptine, gnrh agonists, vitamin b6 (\>100 mg), calcium supplements (\> 1500 mg/day), anxiolytics and antidepressants during the 3 month period prior to visit 1 * use of sleeping medication (including melatonin) for more than 3 days per month. * pregnancy or less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment * obesity (body mass index or bmi \> 30 kg/m2) * hypersensitivity to any ingredient of the study drug

Keywords: premenstrual dysphoric disorder ( pmdd) oral contraceptive
iron, alpha-synuclein, and lymphocyte-activation gene-3 in ischemic stroke

Conditions: Brain Ischemia

Summary: this observational study aims to detect levels of iron, alpha-synuclein, and soluble lymphocyte activation gene 3 in acute ischemic stroke patients. and to see expressions of iron, alpha-synuclein, and lymphocyte activation gene 3 in the brain tissue of ischemic rats. the main questions it aims to answer are: * is there an association between iron and alpha-synuclein accumulation in ischemic stroke? * is there any change in soluble lymphocyte activation gene levels in ischemic stroke and if these levels are related to stroke severity and infarction size? . can soluble lymphocyte activation gene levels be used as an early biomarker to diagnose ischemic stroke?


Eligibility criteria:
inclusion criteria: 1. patients at the age between 50-70 years. 2. patients having neurological symptoms of acute ischemic stroke. exclusion criteria: 1. patients with acute hemorrhagic stroke. 2. patients with parkinson's disease (pd). 3. patients with dementia, and alzheimer's disease. 4. patients with any type of malignancy. 5. patients with central nervous system infection.
bla80 improve drinkers' gut microbiota

Conditions: Alcohol Drinking, Adult Disease

Summary: the goal of this clinical trial is to understand the effects of the probiotic bla80 on the gut health of people who drink alcohol regularly. we want to find out if this probiotic can help improve the health of the digestive system in those who consume alcohol. the main questions we aim to answer are: does bla80 positively change the composition of gut bacteria in alcohol consumers? participants in this study will: be randomly assigned to one of two groups. one group will receive the probiotic bla80, and the other group will receive a placebo (a substance with no active therapeutic effect). take their assigned treatment for a specified period, as directed by the study protocol. undergo regular health checks and provide feceal samples for analysis to see how their gut bacteria might have changed during the study. this study is important because it explores whether a specific type of probiotic can help protect or improve gut health in people who drink alcohol, potentially offering a new way to support digestive health.


Eligibility criteria:
inclusion criteria: aged 19-45 years, currently consuming alcohol (defined as having consumed alcohol on at least one day in the past 30 days); willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up; no symptoms of alcohol allergy, with a history of alcohol consumption; have not suffered from gastrointestinal diseases in the past month; have not taken antibiotics in the past month. exclusion criteria: individuals under 19 or over 45 years of age, with an allergic constitution or allergy to any component of the test substance, symptoms of alcohol allergy, and pregnant or breastfeeding women; those who experience discomfort such as diarrhea or bloating after taking the test substance; patients with serious diseases of the cardiovascular, liver, kidney, hematopoietic systems, autoimmune diseases, endocrine disorders, mental illnesses, existing high blood sugar, or unhealthy gastrointestinal conditions; those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data; recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results; individuals with a daily diet that is either too light or too greasy; those with special dietary structures due to weight loss or other reasons (such as a ketogenic diet); individuals with low body fat, bmi \< 23.
exploratory efficacy of n-acetylcysteine in patients with history of covid-19

Conditions: COVID-19

Summary: a randomized, double-blind, parallel-arm, phase ii, explorative study investigating the efficacy and safety of orally administered n-acetylcysteine (nac) versus placebo in patients with history of sars-cov-2 infection and residual respiratory impairment.


Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤90 years. 2. history of hospitalization for covid-19 pneumonia, as documented by positive rt/pcr testing for sars-cov-2 infection (nasopharyngeal swab) and suggestive radiological findings at the chest ct scan. 3. resolution of sars-cov-2 infection as defined by negative rt/pcr testing (nasopharyngeal swab). 4. evidence of residual interstitial lung abnormalities (including any of the following: ground glass, reticulation, or consolidation with overall extent ≥5% of total lung volume) on chest high resolution ct scan (performed during screening or within 30 days from screening visit) and one or more of the following: * dlco ≤ 70 % of predicted value at screening * oxygen desaturation at 6-minute walk test (6mwt) ≥4% from baseline value at screening. * total lung capacity ≤ 80 % of predicted value at spirometry performed at screening * exertional dyspnea at screening, as defined by mmrc ≥1 exclusion criteria: 1. evidence of resting respiratory failure, as defined by pao2 ≤60 mmhg (fio2 21%) at blood gas analysis at screening. 2. history of interstitial lung disease, or evidence of interstitial lung disease at screening that suggests any of the following: idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (other than sars-cov-2 infection) and connective tissue diseases. 3. history of other types of respiratory diseases, including disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study. 4. any other known disease, medical conditions or blood test abnormalities that in the opinion of the investigator may put the patient at risk because of participation, interfere with study procedures or cause concern regarding the patient inability to participate in the study. 5. concomitant treatment with oral corticosteroids and/or other immunosuppressive drugs. 6. pregnancy status. 7. incapacity of providing valid informed consent.
relationship between sensory processing and motor development

Conditions: Sensation Disorders

Summary: the aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants.

the aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants. a total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study. test of sensory function in infants was used to evaluate sensory processing, and alberta infant motor scale was used to evaluate motor development.spearman correlation test indicated strong positive relation between sensory processing and motor development in preterm infants. given the relationship between sensory processing and motor development in preterm group, for effective implementation of physiotherapy assessments and interventions, it was thought that it is necessary to evaluate the sensory processing as well as the motor development in preterm infants.

Eligibility criteria:
inclusion criteria: * gestational age lower than 37 month * corrected age within 10-12 months * without congenital anomaly or systemic disease * stay in neonatal intensive care unit (nicu) at least 2 weeks exclusion criteria: * taken physiotherapy or sensory integration therapy in any rehabilitation center * having newborn retinopathy

Keywords: preterm sensory processing motor development