Kornimate/medical-research-clean huggingface dataset:
probiotic influence on obesity-related lipidemia

Conditions: Overweight or Obesity

Summary: this study aims to investigate the effects of bifidobacterium breve bbr60 on key health indicators in overweight and obese adults. specifically, it will assess the probiotic's impact on body composition metrics such as bmi, body fat percentage, whr, and bmr. the inclusion criteria for participants are a bmi of ≥28 kg/m\^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥ 28 kg/m2; 2. voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study; 3. those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan. 4. subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures; exclusion criteria: 1. taking items with similar functions to those tested in a short period of time will affect the judgment of the results; 2. patients with severe allergies and immune deficiency; 3. women who are pregnant, breastfeeding or planning to become pregnant; 4. severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases; 5. people who have used antibiotics in the past two weeks; 6. those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy; 7. have used laxatives or fiber supplements in the past 6 weeks; 8. subjects judged by other researchers to be unfit to participate. those who meet any of the above conditions will not be selected.

Keywords: probiotic obesity
efficacy and safety of m281 in adults with warm autoimmune hemolytic anemia

Conditions: Warm Autoimmune Hemolytic Anemia

Summary: the main purpose of this study is to evaluate the efficacy and safety of m281 in participants with warm autoimmune hemolytic anemia (waiha).

the study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.

Eligibility criteria:
inclusion criteria: * participants greater than or equal to (\>=)18 years of age * have been diagnosed with warm autoimmune hemolytic anemia (waiha) for at least 3 months, and are currently receiving treatment for waiha or have previously received treatment for waiha (treatment-naive participants are not eligible) * participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures exclusion criteria: * participants must not be pregnant or breastfeeding * participants must not have other clinically relevant abnormalities currently or in their history that the investigator would deem them ineligible to participate * have been diagnosed with cold antibody autoimmune hemolytic anemia (aiha), cold agglutinin syndrome, mixed type (that is, warm and cold) aiha, or paroxysmal cold hemoglobinuria

Keywords: warm autoimmune hemolytic anemia m281 (nipocalimab) waiha jnj-80202135
the study to describe symptom control and impact on daily life in gastroesophageal reflux disease (gerd) patients

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to evaluate symptoms control and impact on daily life from patients perspective using specific gerd impact scale(gis) questionnaire. the another objective is to obtain local epidemiological data for bosnia and herzegovina regarding gerd treatment in primary care.


Eligibility criteria:
inclusion criteria: * patients previously diagnosed with gerd (disease duration =3 years) or newly diagnosed patients that are currently not treated with proton pump inhibitor, for whom specialist or general practionaire (gp) have previously decided to initiate or change treatment for gerd; patients should be treated for gerd according to current practice exclusion criteria: * females of childbearing potential should not be pregnant or nursing

Keywords: gastroesophageal reflux disease gerd impact scale
the postprandial effects of a carob-containing meal

Conditions: Obesity

Summary: in an era where malnutrition and unhealthy eating patterns are salient contributors to global health deterioration, the urge for better access to nutritious alimentation is striking. native to the mediterranean region, the carob tree holds significant promise in this regard. with its rich nutritional profile, containing high levels of dietary fiber, polyphenols, and essential minerals, carob has been increasingly exploited by the food industry. carob flour, derived from the pod after seed removal, is widely used as a cocoa substitute. the carob tree's fruit comprises 10% seeds and 90% pulp, containing numerous bioactive components such as dietary fiber, cyclitols, phenolic compounds, amino acids, and minerals. these components have been associated with beneficial effects on the gastrointestinal system and glucose absorption, with small-scale clinical studies indicating a hypolipidemic effect in patients with hypolipidemia. nevertheless, comprehensive data from randomized controlled trials on the biological actions of carob remain restricted. this study explores the postprandial effects of incorporating carob into a western-style meal, focusing on regulating glucose, insulin, and appetite hormones. the hypothesis is that a carob-enriched breakfast meal could positively influence satiety and appetite regulation, potentially offering a nutritious and sustainable dietary option for improving metabolic health. the high fiber and polyphenol content in carob are expected to modulate these postprandial responses, contributing to a better understanding of carob's role in dietary interventions. this study supports international initiatives to combat malnutrition and encourage a healthy diet, especially in light of the growing world population and the requirement for sustainable food supplies. by investigating the impact of carob on postprandial metabolic responses, this study seeks to contribute valuable insights into its potential benefits as part of a healthy diet.


Eligibility criteria:
inclusion criteria: * healthy male adults * normal weight exclusion criteria: high body fat mass type 1 diabetes, cardiovascular diseases, hypertension thyroid disorder, liver disease, kidney disease gastrointestinal disease mental illness use of nutraceutical supplements or natural products for weight loss dietitians/nutritionists
multicenter prospective registry study of diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma; Neutropenia, Febrile

Summary: this study was designed to review clincal outcomes of diffuse large b cell lymphoma (dlbcl) treated with r-chop chemotherapy in the era of pegylated-filgrastim. the investigators will prospectively collect clinical data and treatment outcome of patients with dlbcl who use prophylactic pegylated-filgrastim.

* newly diagnosed dlbcl patients treated with r-chop chemotherapy * prphylactic peg-filgrastim on the day after chemotherapy

Eligibility criteria:
inclusion criteria: * 19 or older * newly diagnosed with dlbcl * r-chop chemotherapy * offer informed consent exclusion criteria: * other subtype of nhl * concomitant other cancer * previous chemotherapy or radiotherapy

Keywords: diffuse large b cell lymphoma peg-filgrastim febrile neutropenia
effect of moderate alcohol consumption to cognitive functioning after roux-en y gastric bypass

Conditions: Bariatric Surgery; Alcohol Consumption; Cognitive Function

Summary: objectives: alcohol metabolism is changed in gastric bypass patients, leading to faster resorption and higher alcohol peak concentrations in blood. because of stronger alcohol effects after gastric bypass we suggest that also general cognitive function is stronger impaired. materials and methods: we included 28 females (12 gastric bypass patients, 8 obese and 8 normal weight subjects) in the study. each participant had to drink 250 ml white wine. directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (tap) from zimmermann and fimm. during the whole examination breath-alcohol-contents (bacs) were measured every 5 minutes with breathalyser "dräger alcotest 7510".


Eligibility criteria:
inclusion criteria: gastric bypass group: * women * preop bmi \>35 kg/m² * time since bariatric surgery \> 1 year * age 18-60 years * moderate drinking habits obese group: * women * bmi \>35 kg/m² * age 18-60 years * moderate drinking habits normal weight group: * women * bmi 18.5 - 25 kg/m² * age 18-60 years * moderate drinking habits exclusion criteria: * men * patient does not drink wine * usage of psychotropic drugs * alcoholic * pregnancy
comparison of single trocar cholecystectomy to standard laparoscopic cholecystectomy

Conditions: Cholelithiasis

Summary: the purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * age 18-60 * symptomatic cholelithiasis * asa 1-2 exclusion criteria: * pregnancy * morbid obesity with bmi\>35 * other gallbladder pathology like polyps or tumor * history of upper abdomen laparotomy * suspected choledocholithiasis

Keywords: cholelithiasis cholecystitis
combined use of oxytocin and misoprostol versus oxytocin infusion and misoprostol alone to reduce blood loss at cesarean section

Conditions: Post Partum Haemorrhage

Summary: the purpose of this study is to demonstrate that the combined used of low dose of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol alone at cesarean sectionone hundred fifty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. the patients were randomly allocated to one of three groups of 50 each. the oxytocin group(group o) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 iu syntocinon dissolved in 1liter of lactated ringer's solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate ,the misoprostol group (groupm) received 400 µg sublingually and infusion of lactated ringer ( which one ampoule placebo dissolved it) and the combined misoprostol-oxytocin group(group mo) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate . the main outcome measures were blood loss at cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related side effects.the volume of blood in the suction bottle was measured, blood soaked sponges and added to volume from suction bottle. hemoglobin values were determined both before surgery and 24 h following surgery. hemodynamic variables were recorded every 5 minutes during surgery .the need for additional oxytocic therapy, operating time, infusion volume given intraoperatively, need for blood transfusion, side effects of study drug and any significant puerperal morbidity were also recorded.


Eligibility criteria:
inclusion criteria: * pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section exclusion criteria: * women with any risk factor * associated with an increased risk of postpartum * hemorrhage were excluded i.e. anemia (hb8 g%), multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus. * current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy

Keywords: post partum haemorrhage at cesarean section
porthos - portuguese heart failure observational study

Conditions: Heart Failure

Summary: this study aims to determine the prevalence of heart failure in the resident population in mainland portugal aged 50 years or above, using a contemporary, guideline-based diagnostic approach, to optimize patient management and improve strategic healthcare decision-making

the contemporary prevalence of heart failure in portugal is largely unknown and may differ from that reported in early studies, which were conducted in the late 1990s-early 2000s with the diagnostic techniques available at the time and did not include neither advanced echocardiographic parameters nor natriuretic peptides measurements. thus, a large and representative study is needed to address knowledge gaps on the epidemiology, characteristics and burden of heart failure in portugal. the study aims to determine the prevalence of global heart failure, as well as heart failure subtypes. it also aims to assess the distribution of comorbidities among patients with heart failure, as well as patients' health-related quality of life. the investigators will conduct a population-based study with a three-stage design approach, enrolling 5616 subjects aged 50 years or above, randomly selected through multi-stage sampling, using the national health service as reference: phase 0 - participant selection/enrollment through phone call; phase 1 - screening (nt-probnp levels determination), health-related quality of life evaluation and sociodemographic characterization; phase 2 - confirmatory assessment with a 12-lead electrocardiography, comprehensive transthoracic echocardiography, extended symptoms assessment and biomarkers assessment; phase 3 - heart failure with preserved ejection fraction exertion testing through a non-invasive echocardiographic diastolic stress test.

Eligibility criteria:
inclusion criteria: * community-dwelling citizens living in mainland portugal; * registration in a primary care centre; * age ≥50 years at recruitment; * voluntary signed informed consent. exclusion criteria: * living in institutions (e.g., nursing homes, prisons, military facilities, hospitals); * non-portuguese speakers; * reduced physical and/or cognitive ability hampering participation (e.g., blindness, deafness, or cognitive impairment).

Keywords: prevalence heart failure
open label extension study of stx209 (arbaclofen) in autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: this is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of stx209 among subjects with asd.

this is an open label extension study enrolling by invitation only to those subjects that have completed seaside protocols 209as208 and 22007. protocol 209as208, "a randomized,double-blind, placebo-controlled, study of the efficacy, safety, and tolerability of stx209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders." protocol 22007, "an open label extension study to evaluate the safety, tolerability and pharmacokinetics of stx209 in subjects with autism spectrum disorder." this open-label extension will provide data on the following: 1. evaluate the safety and tolerability of long term use of stx209 (arbaclofen) 2. provide supporting pharmacokinetic analyses 3. assess long term efficacy on social behaviors in subjects with asd.

Eligibility criteria:
inclusion criteria: * subject completed study 22007 or 209as208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study. * parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions. * treatment with no more than 2 psychoactive medications * subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol * for female subjects, negative pregnancy test exclusion criteria: * comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject. * current use of illicit drugs or alcohol abuse. * subjects with a serious adverse event or other adverse event in study 22007 or 209as208 that was related to stx209, and that endangers the subject, in the opinion of the investigator * current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole

Keywords: autism spectrum disorders autism asperger pervasive developmental disorder - not otherwise specified
sub-threshold exercise treatment for adolescents with sports related concussion

Conditions: Brain Injury; Concussion

Summary: adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. both groups will receive standard medical coverage with regular clinic visits. all participants will record symptoms daily on a dedicated web site. all participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. the primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. both groups will receive standard medical coverage with regular clinic visits. all participants will record symptoms daily on a dedicated web site. all participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. the primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

Eligibility criteria:
inclusion criteria: * adolescent with concussion injury from sports within first 10 days exclusion criteria: * evidence of focal neurologic deficit; adhd; history of moderate or severe tbi; greater than 3 prior concussions (or having history of long recovery from concussion, \>3 mths); inability to understand english
predictors of ovarian reserve in infertile women

Conditions: Ovarian Reserve

Summary: patients will be subjected to: a. clinical evaluation including history and examination b. ultrasonographic evaluation of ovarian morphometry: * patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by tvs scanning; using mindray dp-1100 plus digital machine, 7.5mhz, china, by only one examiner to avoid inter-observer variations. * ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. mean values of both ovaries will be used. ovarian volume will be calculated from ellipsoid volume formula, {ovarian volume = ovarian width (d1) × ovarian length (d2) ×ovarian height (d3) × 0 .523} * antral follicle count will be determined for each patient c. laboratory evaluation: blood samples will be collected in the early follicular phase. samples will be immediately centrifuged and serum saved at -20 degrees for measurement of: * anti mullerian hormone (amh) * follicle stimulating hormone (fsh) * estradiol (e2) using electro-chemiluminescence immunoassay (elica)

patients will be subjected to: a. clinical evaluation including history and examination b. ultrasonographic evaluation of ovarian morphometry: * patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by tvs scanning; using mindray dp-1100 plus digital machine, 7.5mhz, china, by only one examiner to avoid inter-observer variations. * ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. mean values of both ovaries will be used. ovarian volume will be calculated from ellipsoid volume formula, {ovarian volume = ovarian width (d1) × ovarian length (d2) ×ovarian height (d3) × 0 .523} * antral follicle count will be determined for each patient c. laboratory evaluation: blood samples will be collected in the early follicular phase. samples will be immediately centrifuged and serum saved at -20 degrees for measurement of: * anti mullerian hormone (amh) * follicle stimulating hormone (fsh) * estradiol (e2) using electro-chemiluminescence immunoassay (elica)

Eligibility criteria:
inclusion criteria: * less than 39 years old, * normal menstrual cycle with a range of 24 to 35 days * normal seum prolactin. * normal uterine cavity determined by previous hysterosalpingography or hysteroscopy exclusion criteria: * smokers * endometriosis * women with endometriosis; * abnormal endocrine functions such as diabetes mellitus, thyroid disorders, and adrenal abnormalities; general diseases, those with ovarian cysts, or those who have azospermia partners.

Keywords: predictors ovarian reserve infertile women
comparison of two dccv algorithms - rational versus maximum fixed energy

Conditions: Atrial Fibrillation

Summary: direct current cardioversion (dccv) is a widespread method to restore sinus rhythm in patients with atrial fibrillation. it is a safe and effective method of treating atrial fibrillation. in this study, the investigators want to compare two algorithms. the rational one, with lower initial energy and the second one with the maximum possible shock energy.


Eligibility criteria:
inclusion criteria: 1. patients must have atrial fibrillation or atrial tachycardia. 2. patients must be on therapeutic anticoagulation at least three weeks prior to dccv or undergo esophageal echocardiography to rule out intracardiac thrombus. 3. patients come on an empty stomach. 4. patients must be over 18 years of age. 5. patients must provide verbal and written informed consent to participate in the study. exclusion criteria: 1. omitting oral anticoagulant treatment in the last three weeks. 2. unclear time of onset of palpitations in acute patients without anticoagulation therapy. 3. a different type of arrhythmia than atrial fibrillation or atrial tachycardia.

Keywords: dccv atrial fibrillation