Kornimate/medical-research-clean huggingface dataset:
whole body cooling using phase changing material

Conditions: Hypoxic Ischemic Encephalopathy

Summary: a prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 c using phase changing material in neonatal encephalopathy. effectiveness will be defined by examining the stability of rectal temperature during cooling. monitoring of vital signs, infection screen, blood counts, coagulation screen, liver and renal function tests, cranial us and mr imaging will be performed on recruited infants to evaluate safety of cooling. eeg will be performed on day 4 and hearing evaluation at discharge. neurodevelopmental evaluation will be performed at 1 year of age.

meta-analyses of these trials show that therapeutic hypothermia increases survival with normal neurological function (pooled risk ratio of 1.53) with a number needed to treat of 8 (95% confidence interval (ci) 5 - 17) and in survivors reduces the rates of severe disability and cerebral palsy. therapeutic hypothermia is now widely offered to moderately or severely asphyxiated infants in high-income countries. the global burden of disease estimates indicate that perinatal asphyxia is a very significant problem in low and mid resourced settings. there are, however, several compelling reasons why the efficacy and safety data on therapeutic hypothermia from high-income countries cannot be extrapolated to neonatal units in transitional countries, such as india; in particular there is a lack of effective low tech servo controlled cooling equipments that can be used in these settings. this pilot phase ii randomized control trial will examine the efficacy of phase changing material in providing satisfactory therapeutic hypothermia in neonatal encephalopathy, in a mid resource setting.

Eligibility criteria:
inclusion criteria: * apgar score of \<5 at 5 minutes or continued resuscitation at 5 minutes * neonatal encephalopathy exclusion criteria: * imminent death * major congenital malformations * gestation \<36 weeks * birthweight less than 1.8 kg

Keywords: neonatal encephalopathy therapeutic hypothermia phase changing material mr imaging
effect of an apple polyphenol extract on brachial artery flow-mediated vasodilatory function

Conditions: Borderline Hypertension

Summary: effect of apple polyphenols on fmd.

the aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (fmd) in volunteer subjects with borderline hypertension. fmd and endothelium-independent nitrate-mediated vasodilatation (nmd) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. diet diary data will be collected for the evaluation of the possible effects of diet on the study results. adverse events data will be collected throughout the study. safety laboratory determinations will be performed at the last visit of both treatment periods.

Eligibility criteria:
inclusion criteria: * borderline hypertension * otherwise healthy * aged 40-65 years (inclusive) * not consuming high amounts (over 20 mg daily) of flavonoids exclusion criteria: * bmi \>32 kg/m2 * total serum cholesterol ≥ 8 mmol/l * any abnormal safety laboratory parameter or abnormal finding in ecg evaluated to be clinically significant * coronary artery disease * pregnancy or lactating * alcohol abuse as evaluated by medical history * regular smoking/using nicotine products * diabetes mellitus * apple allergy * use of lipid lowering medications * regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction * any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject * high consumption of vitamin products, herbal remedies or products containing flavonoids

Keywords: fmd epicatechin apple polyphenol borderline hypertension
vascular interaction with age in myocardial infarction

Conditions: Myocardial Infarction

Summary: the body produces a natural compound, nitric oxide (no), which is known to improve the elasticity of blood vessels effect cardiac function and play a role in the remodeling process after a heart attack. the primary source of no is one of the amino acids that the body uses to form new proteins, l-arginine; although many individuals with heart disease also take medicines to increase the concentrations of no such as nitroglycerine. the vintage-mi trial is intended to investigate wether supplementation of the bodies supply of no with oral administration of l-arginine will improve the functional recovery of older patients who have recently suffered their first heart attack.

background: as we age, both our blood vessels and heart muscle naturally become stiff and loose their ability to flex as the heart beats and blood pressure changes. this is believed to worsen both blood vessel and cardiac function in older individuals. the stiffened tissue is likely to be less able to adapt to the stresses and remodeling that occur after a heart attack (myocardial infarction) because the loss of functional heart tissue predisposes the heart to poor function and the hearts blood vessels undergo various changes in order to increase the supply of blood to the damaged areas. design narrative: vintage-mi is a randomized, double blind study enrolling patients who have recently suffered their first heart attack. there are two recruitment clinics within the johns hopkins university network, the johns hopkins hospital and the hopkins bayview medical center. following preliminary testing to establish eligibility and baseline function of both the heart and blood vessels, study participants will be randomly assigned to receive either l-arginine or a placebo pill which is identical except that it does not contain l-arginine. these pills will be taken orally 3 times a day for 6 months. participants will return to the clinic 1, 3, and 6 months after they begin taking their medication to have the same functional testing repeated. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
patients will have suffered their first acute q-wave mi within 3 to 21 days with creatine kinase levels 3 times normal. all patients will have systolic blood pressure over 100 mmhg and the permission of their attending physician and the ability to give voluntary informed consent. patients will be excluded if they have had a prior q-wave infarction, present cardiogenic shock, unstable angina or non-cardiac disease limiting life expectancy to less than 1 year. other exclusion criteria include significant kidney or liver disease, uncontrolled diabetes, or symptomatic cerebrovascular disease (such as stroke). patients who have been previously shown to be non-compliant will be asked not to participate.
nature 3.2_new approach for the reduction of renal uremic toxins

Conditions: Hemodialysis

Summary: the objective of the pilot study is to validate a combined approach based on the use of an innovative symbiotic and an innovative dialysis cartridge in patients on hemodialysis (hd). the symbiotic consists of a mixture of probiotics (lactobacilli and bifidobacteria), prebiotics (fructoligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins). the cartridge is composed of a divinylbenzene (dvb) adsorbing resine, expected to have high affinity to protein-bound uremic toxins pcs and is, on the basis of its chemical structure. this combined approach will be aimed at achieving two main objectives: 1. reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications 2. reduction of inflammation markers and oxidative stress and reduction of intestinal permeability


Eligibility criteria:
inclusion criteria: * ckd patients on bicarbonate hemodialysis * aged between 30 to 65 * bmi between 18.5 and 29.9 * omnivore diet * informed consent signed exclusion criteria: * use of antibiotics or probiotics up to 30 days prior to recruitment * chronic gastrointestinal disorders * systemic inflammatory diseases * suspicion or clinical diagnosis of malignancy * chronic liver disease * treatment with corticosteroids or immunosuppressive drugs * psychiatric conditions reducing the compliance to treatment protocols

Keywords: uremic toxins gut microbiota dysbiosis symbiotic divinylbenzene cartridge
meal timing on glucose and hyperandrogenism in pcos women

Conditions: Polycystic Ovary Syndrome (PCOS) Women

Summary: the objective of this study is to investigate the effects of two isocaloric maintenance diets with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome p450c17 alpha activity in lean pcos women. the investigators hypothesis is that in lean pcos women a breakfast diet (bd) which consist in high calorie breakfast and reduced dinner, vs dinner diet (dd) which consist in high calorie dinner with reduced breakfast; the bd will improve glucose and insulin response to ogtt and would decrease the hyperandrogenism and cytochrome p450c17 alpha activity.

hyperinsulinemia plays a central role in the pathogenesis in obese as well as in lean pcos women. these women are insulin resistant and have compensatory hyperinsulinemia that stimulates ovarian cytochrome p450c17 alpha activity that in turn stimulates ovarian androgen concentrations. in obese pcos women, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. since lean pcos women do not have the option of weight loss, it is important to know if composition and meal timing distribution may influence glucose metabolism and hyperandrogenism and cytochrome p450c17 alpha activity. we hypothesized that a timing pattern of increased nutrient intake of protein and carbohydrates in the morning, with decreased caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women with pcos

Eligibility criteria:
inclusion criteria: lean women with polycystic ovary bmi below 25 kg/m2 testosterone above 1.0 ng/ml 17 oh progesterone below 200 ng/ml us of polycystic ovaries exclusion criteria: obesity bmi above 25 kg/m2 diabetes mellitus other endocrine disease like hypothyroidism, late onset adrenal hyperplasia pregnancy contraceptive or other hormonal treatment

Keywords: pcos bdiet ddiet ogtt
efficacy of fx06 in the prevention of myocardial reperfusion injury

Conditions: Myocardial Ischemia; Coronary Disease; Myocardial Infarction

Summary: the purpose of the study is to evaluate whether fx06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.


Eligibility criteria:
inclusion criteria: * patients who have given informed consent * patients after primary percutaneous coronary intervention (pci) for acute st-elevation myocardial infarction (stemi) * men or women with no child bearing potential * onset of symptoms to balloon time \< 6 hours * st-elevation of at least 2 mm in at least 3 leads on 12-lead electrocardiogram (ecg) * primary pci indicated per standard of care * first myocardial infarction (mi) * single index lesion with complete occlusion \[thrombolysis in myocardial infarction (timi) flow 0/i\] of one target vessel. exclusion criteria: * history of mi (from patient history, or from ecg) * chest pain or other angina symptoms in the 24 hours before the first recognized symptoms of the acute myocardial infarction (ami) * need for coronary artery bypass graft (cabg) * administration of any thrombolytic agent since onset of ami symptoms * serious procedural complications (e.g., procedural unintended occlusion of coronary artery branch, cardiac tamponade, emergency bypass operation, lm dissection, etc.) * presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents * contraindication to cardiovascular magnetic resonance (cmr): claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; frequent extrasystoles (\> 12/min) or atrial fibrillation (af). * known renal dysfunction defined as serum creatinine \> 250 µmol/l * previous cabg * history of congestive heart failure (chf) * body mass index (bmi) \> 35 * patients who cannot communicate reliably with the investigator * patients who are unlikely to cooperate with the requirements of the study * patients who are unwilling and/or unable to give informed consent * patients at increased risk of death from a pre-existing concurrent illness * patients participating in another clinical study * patients who have used any other investigational drugs within 1 month of first dosing * patients who have participated already in this study * patients who are employees at the investigational site; relatives or spouse of the investigator.

Keywords: angioplasty, transluminal, percutaneous coronary myocardial revascularization
a patient-centered strategy for improving diabetes prevention in urban american indians

Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome; Insulin Resistance

Summary: the goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. the investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced diabetes prevention program addressing psychosocial stressors to a standard version in a high-risk population of urban american indian and alaska native people within a primary care setting.

the goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. the investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced diabetes prevention program addressing psychosocial stressors to a standard version in a high-risk population of urban american indian and alaska native peoples within a primary care setting. diabetes is disproportionately prevalent among low-socioeconomic status and racial/ethnic minority populations in the us. the high prevalence of psychosocial stressors such as depression, discrimination, and exposure to trauma among these populations contributes to the high prevalence of diabetes and interferes with successful completion of lifestyle interventions. the investigators hypothesize that a dpp that directly addresses these psychosocial stressors will be superior to the standard dpp in addressing this disparity in diabetes.

Eligibility criteria:
inclusion criteria: * urban of indigenous ancestry from the americas (north, central and south america) * men and women * bmi between 30-55 * not diagnosed with type ii diabetes * at least one of the following criterion 1. triglycerides: 150mg/dl or higher 2. reduced hdl: \<40mg/dl (men); \<50mg/dl (women) 3. blood pressure: \>130/80 or current treatment with antihypertensives 4. fasting glucose: \>100mg/dl exclusion criteria: * significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse; * on greater than 10 prescription medications. * psychiatric disorders requiring atypical antipsychotics or multiple medications; * inappropriate for moderate exercise according to the revised physical activity readiness questionnaire; * pregnant, planning to become pregnant, or lactating; * family household member already enrolled in the study; * already enrolled or planning to enroll in a clinical trial that would limit full participation in the study; * resident of a long term care facility; * lack of spoken english by patient or a household member \> 18 y who can serve as interpreter; * plans to move during the study period (9 months post-randomization); * investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
the link between obesity and vitamin d in bariatric patients with omega-loop bypass surgery

Conditions: Bariatric Surgery Candidate

Summary: the aim of the study is to increase vitamin d concentrations or to keep it on high level, respectively, by supplementing with vitamin d3 in a different dose regime, and to improve the overall health status in bariatric patients. in this project, the vitamin d status, the parameters of inflammation, bone turnover, insulin resistance, liver and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.


Eligibility criteria:
inclusion criteria: * planned omega loop bypass surgery * 25-hydroxy vitamin d \< 75 nmol/l * bmi \>40 or ≥35 kg/m2 with co-morbidities e.g. diabetes mellitus, hypertension * body weight \<140 kg (due to limitation of dexa measurement) * capability to consent exclusion criteria: * another planned form of bariatric surgery * hypercalcemia (calcium \>2.63 mmol/l) or hypocalcemia (\<1.75 mmol/l) * renal insufficiency (creatinine \>133 μmol/l or gfr \<50 ml/min) * primary hyperparathyroidism * malignancy * infection e.g. human immunodeficiency virus * medical conditions requiring daily calcium supplements or antacid use * known hypersensitivity to cholecalciferol * no capability to consent * imprisoned persons

Keywords: bariatric surgery vitamin d supplementation
manual acupuncture (ma) for asymptomatic hyperuricemia (hua)

Conditions: Asymptomatic Hyperuricemia

Summary: assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.

this is a multicenter randomized, single-blind, sham-controlled trial. a total of 260 eligible patients with asymptomatic hyperuricemia will be randomly assigned in a 1:1 ratio to manual acupuncture group or sham acupuncture group.

Eligibility criteria:
inclusion criteria: * with serum uric acid (sua) level \>7 mg/dl after 1 month of a low-purine diet. * no history of gouty arthritis. * has not received uric acid-lowering drug treatment or stopped uric acid- lowering drug treatment ≥ 12 weeks. * 18.5kg/m2 ≤ body mass index (bmi) ≤ 30.0 kg/m2. * can write informed consent. exclusion criteria: * patients with poorly controlled hypertension: systolic blood pressure (sbp) ≥ 160mmhg, diastolic blood pressure (dbp) ≥ 100 mmhg. * patients with poorly controlled diabetes (hemoglobin a1c ≥ 8.4%). * patients with severe liver and kidney damage: chronic kidney disease (ckd) ≥ stage 2 or a serum creatinine, urea, alanine, or aspartate aminotransferase level more than twice of the upper limit. * patients with blood system diseases, such as acute and chronic leukemia, polycythemia, multiple myeloma, hemolytic anemia, lymphoma, or undergoing chemotherapy for multiple solid tumors. * patients with stroke, coronary heart disease, or severe neuropsychological diseases. * patients who are pregnant. * illiterate or unwilling to accept acupuncture treatment.

Keywords: ma hua sua deqi
san rocco study: implementation of the non-pharmacological therapies for people with dementia living in nursing home

Conditions: Nursing Home; Dementia; Staff

Summary: the goals of this clinical trial are 1) to estimate the number of professional caregivers and the time spent to carry out the non-pharmacological therapies for people with dementia and 2) to evaluate differences between professional caregivers trained and non-trained to non-pharmacological therapies for people with dementia in term of caregivers' burnout and well-being of people with dementia living in nursing home. the main questions it aims to answer are: * how long does it take professional caregivers to implement and carry out non-pharmacological therapies? * how many caregivers are needed to start and carry out non-pharmacological therapies? * do the non-pharmacological therapies improve the quality of life of people with dementia? * do the non-pharmacological therapies reduce behavioral and psychological symptoms of dementia? * do the non-pharmacological therapies improve professional caregiver burnout, sense of competence and ethical climate in nursing home? * do the non-pharmacological therapies reduce family caregivers' stress? participants will attend ten sessions: * five theoretical meetings on dementia and non-pharmacological therapies; * five supervision meetings on the methodology for implementing non-pharmacological therapies based on discussions of cases. the investigators will compare the experimental group with an usual care control group to see if there are improvements in term of the quality of life of the resident perceived by the team, professional caregivers burnout, sense of competence of the carers and the ethical climate at the workplace.

the san rocco study is a case-control study with two parallel arms aimed to estimate the number of professional caregivers and the time spent to carry out the non-pharmacological therapies for people with dementia and to evaluate the three- and six-months effectiveness of a training on non-pharmacological interventions, compared to usual care activities. investigators have planned to involve two convenience samples. experimental group: 18 professional caregivers and 18 people with dementia living in the san rocco special care unit for people with dementia (canton of ticino, switzerland). control group: 18 professional caregivers of the nursing homes attending the non-active group of the i-ace study (clinicaltrials.gov id: nct05710523). the nursing homes' responsibles will verify the presence of the inclusion and exclusion criteria. this information will be promptly transferred and kept in an electronic archive protected by a password. access to the personal computer containing the data will be protected by an access key.

Eligibility criteria:
inclusion criteria: * length of service more than six months exclusion criteria: * presence of psychiatric illness or other medical condition that prevents participation in the training

Keywords: nursing home staff behavioral symptoms burnout
melatonin in relapsing-remitting multiple sclerosis patients

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to determine whether melatonin is effective in the treatment of relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying drugs.

multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous system, and the major cause of disability in the youngsters all over the world, still with no definitely known etiology and treatment. melatonin is a hormone secreted by pineal gland famous for its role in circadian rhythm regulation, and with known antioxidant effects. it was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in comparison to other diseases and is correlated with the multiple sclerosis functional composite score of the patients. melatonin is also suggested to have an immunomodulatory role. therefore, we hypothesize that melatonin can be effective in the treatment of relapsing-remitting multiple sclerosis patients.

Eligibility criteria:
inclusion criteria: * definite diagnosis of relapsing-remitting multiple sclerosis * edss \<=5 * at least 6months consumption of interferon beta 1a exclusion criteria: * illiteracy * evidence of nystagmus or visual acuity lower than 5/10 in each of the eyes * relapse in the last 3 months * pregnancy or deciding to become pregnant during the following year * regulatory consumption of warfarin, nifedipine, nonsteroidal anti-inflammatory drugs (nsaids), beta-blockers, fluvoxamine, isoniazide, progestin * history of epilepsy, stroke, major depression, endocrine, hepatic, hematologic, and nephrologic diseases