Kornimate/medical-research-clean huggingface dataset:
evaluation of the effects of etifoxine 100 mg and lorazepam 2 mg on vigilance and cognitive functions in the elderly

Conditions: Healthy Volunteers

Summary: the purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.


Eligibility criteria:
inclusion criteria: * man or woman aged from 65 to 75 years * right-handed subject (edinburgh handedness inventory) * subject having signed the consent form * subject having agreed to be listed on the french national healthy volunteers database * subject affiliated or beneficiary to french social insurance exclusion criteria: * subject presenting a neurological or psychiatric disease notably cognitive, progressing * anxious subject (hamilton score \> 7 and/or spielberger score \> 51 for a man or \> 61 for a woman) * left-handed subject (edinburgh handedness inventory) * subject presenting a not corrected visual disease or a motor function disease that could interfere with tests realization * smoker * subject taking one or more psychotropics or apparent products * subject having taken, during the previous month, one or more drugs that could interfere with study drugs metabolism * subject drinking too much coffee or tea (\> 4 cups per day) or alcohol (\>½ liter of wine or equivalent per day) * subject presenting contra-indication to one of the drugs used in the study * subject with past history of intolerance to drugs used in the study * subject not capable to use the cantab cognitive evaluation system * subject which may not be able to participate to the whole study * subject under tutelage or guardianship * subject not able to well-understand french and so to understand cognitive tests * subject not capable to swallow capsules * subject participating to another study or in exclusion period (3 months after a previous trial).
the effect of direct antiviral therapy on hepatitis c virus-related thrombocytopenia

Conditions: Hepatitis C

Summary: autoimmune thrombocytopenic purpura is an immunological disorder characterized by increased platelet destruction due to presence of anti-platelet antibodies. hepatitis c virus infection, which is one of the most common chronic viral infections worldwide, may cause secondary chronic immune thrombocytopenic purpura. it seemed to play a pathogenic role in autoimmune thrombocytopenic purpura. moreover, the successful response (negative hepatitis c virus - ribonucleic acid) to tapered steroids and antiviral therapy was useful to revert thrombocytopenia


Eligibility criteria:
inclusion criteria: * hepatitis c virus infection and thrombocytopenia before treatment exclusion criteria: * infection hepatitis b virus * hypersplenism * diseases affecting bone marrow * major clotting factors abnormalities eg. disseminated intravascular coagulopathy, severe prothrombin deficiency
effectiveness study of community-based, peer-led education on weight loss and diabetes

Conditions: Pre-diabetes

Summary: the purpose of this study is to compare the effectiveness of a peer-led community-based lifestyle intervention, versus usual care, in achieving weight loss and prevention of diabetes among overweight adults with pre-diabetes in east harlem.

weight loss can prevent diabetes and eliminate racial and ethnic disparities in incident diabetes among overweight adults with pre-diabetes. however, proven effective interventions have not been sustained or disseminated in community settings. a community-academic partnership aims to employ community-based participatory research to conduct a randomized controlled trial to test the effectiveness of a culturally tailored, peer-led diabetes prevention intervention that promotes weight loss. people who develop diabetes go through a period when they have "pre-diabetes". in clinical settings, overweight adults with pre-diabetes who reduce their weight by 5-10% can reduce their risk of developing diabetes by 55-60%. to date, there are no studies testing the effectiveness of peer-led, community-based programs in achieving diabetes prevention through weight loss. we will identify and enroll 400 overweight (bmi \> 25) adults with pre-diabetes in east harlem and randomized half into a community-based, peer-led lifestyle education program that teaches simple ways to lose weight.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * residents of east harlem or members of an east harlem institution in zip codes 10029, 10035, or in the section of 10037 east of fifth avenue * bmi ≥ 25 and pre-diabetes glucose values, defined as fasting fingerstick glucose of 100-125mg/dl and/or glucose 2 hours after an oral glucose load of 140-199 mg/dl * able to communicate verbally to participate in a group education class * english or spanish speaking exclusion criteria: * \< 18 years * previous diagnosis of diabetes * bmi \<25 * fingerstick glucoses outside pre-diabetes level ranges * currently pregnant * on medications that may raise or lower blood glucose * cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak) * self-reported terminal illness with life expectancy of less than 1 year * plans to relocate from new york city within one year of enrollment

Keywords: pre-diabetes pre-diabetic state community-based participatory research overweight weight loss intervention, peer-led lifestyle education
study to evaluate the efficacy and safety of regn3918 in patients with paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: the primary objective of the study is to demonstrate a reduction in intravascular hemolysis by regn3918 over 26 weeks of treatment in patients with active pnh who are treatment-naive to complement inhibitor therapy or have not recently received complement inhibitor therapy. the secondary objectives of the study are: * to evaluate the safety and tolerability of regn3918. * to evaluate the effect of regn3918 on parameters of intravascular hemolysis * to assess the concentrations of total regn3918 in serum. * to evaluate the incidence of treatment-emergent anti-drug antibodies to regn3918 over time * to evaluate the effect of regn3918 on patient-reported outcomes (pros) measuring fatigue and health-related quality of life


Eligibility criteria:
key inclusion criteria: * diagnosis of paroxysmal nocturnal hemoglobinuria (pnh) confirmed by high-sensitivity flow cytometry * pnh granulocytes \> 10% at screening visit * active disease, as defined by the presence of 1 or more pnh-related signs or symptoms (eg, fatigue, hemoglobinuria, abdominal pain, shortness of breath \[dyspnea\], anemia \[hemoglobin \<10 g/dl\], history of a mave \[including thrombosis\], dysphagia, or erectile dysfunction) or history of red blood cell (rbc) transfusion due to pnh within 3 months of screening. * lactate dehydrogenase (ldh) level ≥ 2 × upper limit of normal (uln) at screening visit. key exclusion criteria: * prior treatment with a complement inhibitor either within 6 months prior to screening visit or at any time where the patient was refractory to complement inhibitor therapy, in the opinion of the investigator (with the exception of eculizumab refractory patients due to the c5 variant r885h/c) * history of bone marrow transplantation * body weight \< 40 kilograms at screening visit * peripheral blood absolute neutrophil count (anc) \<500/μl \[\<0.5 x 109/l\] or peripheral blood platelet count \<50,000/μl * documented history of systemic fungal disease or unresolved tuberculosis, or evidence of active or latent tuberculosis infection (ltbi) during screening period * any contraindication for receiving neisseria meningitidis vaccination and antibiotic prophylaxis therapy as recommended in the study * any active, ongoing infection within 2 weeks of screening or during the screening period * any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, or patients with short life expectancy * women who are pregnant, breastfeeding, or who have a positive pregnancy test at screening visit or day 1 note: other protocol defined inclusion/exclusion criteria apply.
a study of hs-20094 in patients with t2dm

Conditions: Type 2 Diabetes

Summary: this is a 32-week, phase 2, randomized study, hs-20094 and placebo were double-blind, dulaglutide was open-label. adults with t2d inadequately controlled with diet and exercise alone or with stable metformin, an hba1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg hs-20094, 10 mg hs-20094, 15 mg hs-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. the primary endpoint was change in hba1c from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.


Eligibility criteria:
inclusion criteria: 1. male or female patients 18 to 75 years of age, inclusive 2. patients were diagnosed with t2dm for at least 3 months before screening. 3. have an hba1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000mg/day and not more than the locally approved dose) for at least 2 months prior to screening 4. body mass index (bmi）≥ 22 kg/m2. exclusion criteria: 1. type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator 2. acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening 3. a history of grade 3 hypoglycemia (hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery) within 6 months before screening 4. occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening 5. occurrence of any of the following events within 6 months prior to screening: acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), transient ischemic attack, cerebrovascular accident, decompensated congestive heart failure, or class iii or iv heart failure (nyha classification) 6. significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)
interactive motivational media for perinatal drug abuse - 3

Conditions: Substance-Related Disorders

Summary: interactive motivational media for perinatal drug abuse

the goal of this exploratory/developmental proposal is to develop a low-cost, highly adaptable brief motivational intervention for perinatal drug abuse via embedding motivational principles in a self-contained interactive computer system. the motivation enhancement system (mes) will utilize a touch-screen, audio enhancement, and an interactive narrator to guide women in the immediate post-partum period through evaluation (thus facilitating self-report) and a one-time motivational intervention. a taxi voucher will be provided to further facilitate entry into treatment, and multiple tailored self-help mailings will be issued following discharge. if validated, this intervention could offer a highly cost-effective, replicable, and prescriptive method for increasing self-change and treatment involvement in drug abusers. following development of the mes, a preliminary pilot phase will study the use of the mes with post-partum drug-using women and make necessary modifications, using data from participant debriefings and a single-case research design. after optimization of the mes, a clinical trial will randomly assign 120 post-partum drug-using women into treatment or assessment only conditions, with a 3-month blinded follow up to evaluate intervention effects on drug use and treatment involvement. toxicological and self-report measures, as well as objective analysis of infant development, will be utilized. participants will be lower socioeconomic status urban women.

Eligibility criteria:
woman in immediate postpartum period inclusion criteria: screen positive for drug use (self-report) exclusion criteria: frank psychosis or other cognitive impairment, fatigue, grief over medically compromised infant, inability to communicate in english
effect of pentoxifylline on anemia in hemodialysis patients

Conditions: Hemodialysis Complication

Summary: the primary goal of this clinical trial is to evaluate the promoting effect of pentoxifylline on anemia correction in hemodialysis patients, and involvement of the hypoxia-inducible factor-2 alpha. while, the secondary aim is to evaluate the effect of pentoxifylline on inflammation, hepcidin and other markers of iron homeostasis in these patients. participants in this trial will be selected to be age and sex ratio matched and will be randomly assigned into two groups. patients in group i will receive their regular doses of erythropoietin stimulating agents and other routine treatments plus 400 mg pentoxifylline tablets twice daily with meals for 6 months. while, patients in group ii will receive their regular doses of erythropoietin stimulating agents and other routine treatments.


Eligibility criteria:
inclusion criteria: * both sexes of hd patients * age \>20 years * patients who have adequate hemodialysis for at least 6 months * hb level ≤ 10.5 g/dl exclusion criteria: * recently dialyzed patients (less than 6 months) * patients with known sensitivity to theophylline or other xanthine derivatives * severe iron deficiency with serum ferritin \< 100 µg/dl and/or tsat \< 20% * planning for pregnancy, pregnancy, or lactation * patients with severe liver disease or other organ failure * previous renal transplantation, noncompliance with medication or hd prescription, or inability to oral drug administration * malignancy within last 3 months
dv2-hbv-27: observational pregnancy registry

Conditions: Pregnant

Summary: purpose of the study is to evaluate pregnancy outcomes among women who received a dose of heplisav-b within 28 days prior to conception or at any time during pregnancy


Eligibility criteria:
inclusion criteria: * 18 years and older * heplisav-b exposure within 28 days prior to conception or at any time during pregnancy exclusion criteria: * less than 18 years of age * heplisav-b exposure greater than 28 days prior to conception

Keywords: pregnant conceived hbv vaccine hepatitis b hepatitis b vaccine hbv hepatitis registry prevention female volunteers
clinical utility of the 1-minute sit to stand test as a measure of submaximal exercise tolerance in patients with cystic fibrosis during acute pulmonary exacerbation

Conditions: Cystic Fibrosis

Summary: the aim of this study is to assess whether the 1 minute sit to stand (sts) test can be used as a measure of submaximal endurance during a pulmonary exacerbation of cystic fibrosis (cf) for patients in the acute care setting. we hypothesize that if the sts test is a valid measure of submaximal cardiovascular endurance, it will moderately correlate with 6 minute walk distance (6mwd).


Eligibility criteria:
inclusion criteria: * patients age 6-35 with cystic fibrosis who are admitted for a pulmonary exacerbation and receive ongoing physical therapy throughout their admission. exclusion criteria: * patients with cystic fibrosis who are under the age of 6, * patients with cystic fibrosis who are not admitted for a pulmonary exacerbation, * patients with cystic fibrosis who are not being followed regularly by physical therapy (\>5x/week) throughout their inpatient admission, * patients with cystic fibrosis who are unable to follow instructions for standardized testing, * patients with cystic fibrosis who are not medically stable to participate in submaximal exercise testing. * patients whose inpatient admission is anticipated to be \<1 week. * patients who are readmitted to the hospital within the year will not be included in the study more than once.

Keywords: cystic fibrosis walk test
effects of light emitting diode irradiation on the conduction parameters of the superficial radial nerve

Conditions: Peripheral Neuropathy

Summary: the introduction of light emitting diode (led) devices as a novel treatment for pain relief in place of low-level laser warrants fundamental research on the effect of led devices on one of the potential explanatory mechanisms: peripheral neurophysiology in vivo. a randomized controlled study will be conducted by measuring nerve conduction on the superficial radial nerve of healthy subjects (n=64). one baseline measurement and five post-irradiation recordings (2-min interval each) will be performed of the nerve conduction velocity (ncv) and peak latency (pl) and peak amplitude (pa). the experimental group (=32) will receive an irradiation of 2 j/cm2 with an infrared led device (dynatronics solaris model 705), while the placebo group will be treated by sham irradiation. the purpose of this study is to investigate the effects of led light on the conduction velocity and amplitude of the superficial radial nerve.


Eligibility criteria:
inclusion criteria: * no history of neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy exclusion criteria: * positive findings during the clinical screening examination suggestive of an underlying neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy. * a history of a neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.
a study to assess the safety of xospata in patients with relapsed or refractory acute myeloid leukemia (aml) with fms-like tyrosine kinase 3 (flt3) mutation

Conditions: Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation

Summary: the objective of this study is to describe the observed safety profile of xospata® 40 mg tablet when administered in patients with relapsed or refractory aml with flt3 mutation in routine clinical practice in korea.

this study is being mandated by ministry of food and drug safety (mfds) as a part of the korea-risk management plan (k-rmp) to assess safety in patients with relapsed or refractory aml with flt3 mutation in routine clinical practice in korea. this study collects data for 54 months according to the purpose of this study in routine clinical practice as an observational study.

Eligibility criteria:
inclusion criteria: * patients who receive xospata® 40 mg tablet according to the drug label approved at the time of marketing authorization in routine clinical practice. * patients who voluntarily signed the written informed consent form. exclusion criteria: * patients who meet the section 'do not administer to the following patients' in the precautions for use given at the time of marketing authorization. * patients who use the drug for an off-label purpose.

Keywords: gilteritinib xospata relapsed or refractory acute myeloid leukemia (aml)
a randomized, multicenter, double-blind, parallel-group, placebo-controlled trial of the efficacy and safety of bovine anti-cryptosporidium immunoglobulin (baci) in the treatment of cryptosporidium enteritis in aids patients

Conditions: Cryptosporidiosis; HIV Infections

Summary: primary: to assess the effect of bovine anti-cryptosporidium immunoglobulin (baci) on the volume of diarrhea due to cryptosporidium parvum in aids patients who have protracted cryptosporidium enteritis. secondary: to assess changes in stool consistency and frequency, body weight, and safety in this patient population.

forty patients are randomized to receive either baci or placebo (bovine colostrum from non-immunized cattle) for 1 week. the double-blind portion of the study will be followed by an open-label phase in which all 40 patients receive baci for 1 week.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antidiarrheal compounds (if dose remains stable). * zidovudine (azt), dideoxyinosine (ddi), dideoxycytidine (ddc), or alternative hiv therapy (provided dose was stable for at least 4 weeks prior to study entry). patients must have: * aids. * cryptosporidium parvum enteritis. * chronic diarrhea. * life expectancy of at least 4 weeks. * ability to tolerate food by mouth. * ability to take the histamine h2-receptor antagonist famotidine (pepcid). prior medication: allowed: * antidiarrheal compounds (provided dose has remained stable in the 7 days prior to study entry). * zidovudine (azt), dideoxyinosine (ddi), dideoxycytidine (ddc), or alternative hiv therapy (provided dose has remained stable for at least 4 weeks prior to study entry). exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * concurrent unresolved clinical infections with enteric pathogens other than c. parvum (e.g., rotavirus, salmonella, shigella, campylobacter, giardia, c. difficile toxin, yersinia, amebiasis, mai, cmv, microsporida) as determined by history or routine microbiology screening. * other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis. * grossly bloody diarrhea. * known allergy to milk or milk products (other than lactose intolerance). prior medication: excluded: * other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry.

Keywords: antidiarrheals cryptosporidiosis diarrhea acquired immunodeficiency syndrome cryptosporidium immunization, passive
effect of concord grape juice on endothelial function

Conditions: Obesity; Overweight

Summary: the study will compare concord grape juice to a beverage that contains no grape flavonoids, but has a similar appearance and taste (placebo juice). a total of 60 overweight and obese participants over age 50 will be enrolled. each participant will drink each beverage for 4 weeks with a 2-week rest period between two beverage consumption periods. the order of beverages (grape juice first or placebo juice first) will be randomized. the investigators will use ultrasound to measure brachial artery flow-mediated dilation, a measure of endothelial vasodilator function. the investigators will also collect blood samples to further assess the cardiovascular effects of grape juice. the aim of the study is to determine whether concord grape juice improves endothelial function in patients at risk who do not have cardiovascular disease and may provide information that would guide dietary recommendations. the results may also be used by the sponsor to substantiate claims and labeling of their product.


Eligibility criteria:
inclusion criteria: * body mass index ≥ 25 and \< 40 kg/m2 * age ≥ 50 years * otherwise healthy exclusion criteria: * clinical diagnosis of atherosclerotic vascular disease. * clinical history of diabetes mellitus or fasting glucose ≥126 mg/dl * uncontrolled hypertension * treatment with an investigational new drug within the last 30 days * clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, or other conditions that in the opinion of the principal investigator make the study inappropriate * psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study * use of vitamin e, vitamin c, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment. subjects taking multivitamins or other forms of vitamin e and c in doses that do not exceed two times the recommended daily allowance will not be excluded * extreme dietary habits (i.e. atkins, very high protein/low carbohydrate, or vegan diet

Keywords: grape juice