Kornimate/medical-research-clean huggingface dataset:
a study of multiple-ascending doses of gsbr-1290 in healthy overweight/obese participants

Conditions: Healthy Volunteers

Summary: the purpose of this study is to compare the safety, tolerability, pharmacokinetic (pk), and comparative bioavailability of repeated administration of gsbr-1290 in healthy overweight/obese participants.

this is a 2-part study in which part 1 will compare the pk of gsbr-1290, administered as tablet and capsule, using a 2-period, 2-sequence, crossover design in approximately 16 healthy overweight/obese participants. part 2 will evaluate multiple-ascending doses of gsbr-1290 tablet in 3 cohorts, using 3 different titration regimens. secondly in part 2, the study will evaluate the comparative bioavailability of gsbr-1290 tablet versus capsule at a potentially clinically efficacious dose at steady state in cohort 3.

Eligibility criteria:
inclusion criteria: 1. provided evidence of a signed informed consent before any study-related activities are initiated and be willing to comply with all study procedures. 2. healthy overweight or obese adult men and women. 3. age greater then or equal to (\>=)18 and less than or equal to (\<=) 75 years. 4. body mass index (bmi) \>=27.0 kilogram per square meter (kg/m\^2). exclusion criteria: 1. history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease.
correlation between lr-act and anti xa activity during endovascular surgery procedures. axaes (anti xa vs act-lr in endovascular surgery)

Conditions: Aortic Diseases; Arterial Disease; Thrombosis

Summary: activated clotting time (act) is currently recommended to monitor high concentrations heparin anticoagulation. act-lr was specifically designed to measure the activity of low dose of heparin used during endovascular surgery. the correlation between act-lr and anti xa activity which is considered as the gold standard seems to be debated. few studies in literature had shown controversial results. these studies were conducted in patients who underwent open as endovascular surgery. however, the act monitoring is not recommended in open surgery. in addition, heparin administration protocols are not described and specific to each centre. in this study investigators want to study the correlation between lr-act and anti xa after introducing a heparin protocol during complex endovascular procedures.


Eligibility criteria:
inclusion criteria: * age ≥ 18 ans * weight ≥ 37,5 kg * patients operated for * complex endovascular aortic aneurysm repair * deep vein recanalization * complex arterial revascularization (tasc d lesions) * patient informed of the study details and who didn't opposed to participate in this research exclusion criteria: * known allergy to heparin * known hepatic insufficiency with repercussion on coagulation * thrombocytopenia * known hemostasis disorders * anemia defined hb\<8 g/l * pregnant women * persons deprived of their liberty by a judicial or administrative decision * persons subject to psychiatric care * persons admitted to a health or social establishment for purposes other than research * adults subject to a legal protection measure (guardianship, curatorship)

Keywords: complex aortic endovascular repair arterial recanalization deep veinous recanalization anti xa lr-act heparin endovascular procedures
carboplatin plus topotecan in treating patients with relapsed acute myelogenous leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining carboplatin and topotecan in treating patients with relapsed acute myelogenous leukemia.

objectives: i. determine the efficacy of a 5-day continuous infusion of carboplatin and topotecan in patients with relapsed and refractory acute myelogenous leukemia (aml). ii. assess the toxic effects of this treatment in these patients. outline: patients receive continuous intravenous infusions of topotecan and carboplatin for 5 days. treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks during consolidation. no more than four courses of treatment are given. patients are followed every 6 months for 5 years.

Eligibility criteria:
disease characteristics: previously established diagnosis of acute myelogenous leukemia: failure to achieve a complete remission with initial induction regimen first relapse within 1 year of initial complete remission failure to achieve complete remission with one or two courses of reinduction therapy at first relapse second relapse after no more than two different induction regimens chemotherapy-related leukemia with unfavorable cytogenetics no active cns leukemia not eligible for allogeneic bone marrow transplant from related donor patient characteristics: age: 18 to 74 performance status: ecog 0-2 life expectancy: at least 4 weeks hematopoietic: not specified hepatic: bilirubin no greater than upper limit of normal (uln) (unless elevation due to aml) renal: creatinine no greater than 0.3 mg/dl above uln cardiovascular: no myocardial infarction within the past 3 months no congestive heart failure no poorly controlled cardiac arrhythmia other: not pregnant or nursing fertile patients must use adequate contraception no psychosis no active systemic infections prior concurrent therapy: biologic therapy: not specified chemotherapy: recovered from the toxic effects of previous chemotherapy at least 3 days since hydroxyurea endocrine therapy: not specified radiotherapy: not specified surgery: not specified other: no prior or concurrent aminoglycosides or amphotericin b within past 7 days

Keywords: recurrent adult acute myeloid leukemia secondary acute myeloid leukemia
early diagnosis of acute renal failure by urine trehalase levels.

Conditions: Trehalase Levels; Acute Kidney Injury

Summary: we think that in surgical patients requiring hypotensive anesthesia, acute kidney injury, which may occur due to intraoperative renal hypoperfusion, can be diagnosed early by evaluating the urine trehalase value using the elisa method, and thus, early diagnosed acute renal failure can be treated quickly and patients can be protected from subsequent complications in the postoperative period.


Eligibility criteria:
inclusion criteria: * being over the age of 18 and under the age of 65 * having signed the bgof form to be included in the study, * being in asa 1 or asa 2 classification * not having kidney failure or kidney disease * no history of single kidney or renal transplantation * not using nephrotoxic drugs or agents before surgery * renal function tests taken preoperatively should be within normal ranges. * no urinary tract infection or urinary problems (such as polyuria, oliguria or anuria) exclusion criteria: * those under the age of 18 or over the age of 65 * those who do not want to participate in the study * asa 3 and above * having previously received treatment for kidney disease - including kidney stones - * having been previously diagnosed with acute or chronic renal failure * having a single kidney or a history of renal transplantation * using nephrotoxic drugs or agents (such as contrast material) before surgery * kidney function tests taken preoperatively are not within normal ranges * having a urinary tract infection or urinary problem (such as polyuria, oliguria or anuria) * having a history of kidney stones, acute renal failure or chronic renal failure * those with active infection or disease before surgery * they were determined as patients for whom consent was not obtained for the study.
sleep quality among children and adolescents with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: sleep is an important health behavior for children and adolescents due to the impact it has on both mental and physical development. although sleep is considered a resting period, it is also a period when the brain work to encode and consolidate memories into more stable representations for long term recall . unfortunately, pediatric sleep disorders affect 25 - 40% of youth and several studies showed that children with chronic illness experience more problems with initiating and maintaining sleep than their non- chronically ill children . type 1 diabetes mellitus (t1dm) affects the quality of sleep in children and adolescents as well as their caregivers. sleep disturbances in patients with t1dm may negatively impact their ability to manage their diabetes .


Eligibility criteria:
inclusion criteria: * children and adolescents aged 6 to 15 years . * diagnosed with t1dm for at least 6 months * attending the pediatric diabetes outpatient clinic at sohag university hospital. * age and sex matched control group for acute non-serious illnesses exclusion criteria: * children and adolescents with associated neurological or psychiatric disorders .
the effect of covid-19 on diabetes mellitus

Conditions: Diabetes Mellitus; Covid19

Summary: the study aimed to evaluate the effect of sars-cov-2 infection on metabolic status in patients with diabetes mellitus. patients' hba1c levels before and after sars-cov-2 infection will be evaluated.

in this time pediods, all patients with rt-pcr positive for sars-cov-2 will be analysed for the presence of diabetes mellitus. previous hba1c levels will be obtained from hospital records. in these patients, previous a1c levels and a1c levels 3 months after the sars-cov-2 infection will be compared.

Eligibility criteria:
inclusion criteria: - all hospitalised diabetic patients with rt-pcr- positive for sars-cov-2 will be enrolled. exclusion criteria: - the absence of diabetes mellitus rt-pcr- negative for sars-cov-2 non-hospitalised patients
verbal autopsy to assess early neonatal death and stillbirth

Conditions: Perinatal Mortality; Cause of Neonatal Death; Cause of Stilbirth

Summary: the nichd global network (gn) for women's and children's health research, a multi-site, international research network, provides a unique infrastructure to implement an expanded perinatal verbal autopsy study using the first breath trial as its platform. the first breath trial is an ongoing study of neonatal resuscitation training in rural community settings within global network sites in central africa, asia and latin america. this study uses a validated va questionnaire to determine cod of stillbirths and early neonatal deaths among participants in the first breath study. we propose to expand the usefulness of perinatal verbal autopsy methodology in two ways. first by assessing whether the community coordinator (a non-physician health worker) can assign cod with a high level of concordance comparable to a physician panel, and second, whether the first breath birth attendant can provide as reliable perinatal information as the mother during the va interview. our primary hypothesis is that the cod assigned by the first breath community coordinator will be the same as the cod assigned by the physician panel in greater than 70% of early neonatal deaths (ends), when both use the same va and first breath data.


Eligibility criteria:
inclusion criteria: * neonatal death with 7-days or stillbirth * lives in study cluster exclusion criteria: * mother died * delivery in hospital setting

Keywords: verbal autopsy stillbirth neonatal death
effects of oral nicotine and caffeine pouches on anaerobic performance, autonomic function, cognition, and behavior

Conditions: Fatigue; Muscle, Heart; Fatigue, Mental

Summary: the goal of this randomized placebo controlled crossover trial is to determine effects of oral nicotine and caffeine pouches on anaerobic performance, autonomic function, cognition, and behavior in adult non-obese adult male volunteers between ages 21 and 40. accordingly, the primary aims of the study are to determine the effects of acute oral nicotine pouches, oral caffeine pouches, or both, on measures of * anaerobic performance * cognition * cardiovascular and autonomic function * appetite and food intake. researchers will compare oral nicotine pouches, oral caffeine pouches, both oral nicotine and caffeine pouches, and a flavor and color matched placebo to see if how they differentially affect measurements of * physical performance, * cognition, * cardiovascular and autonomic function * appetite and food intake. on four separate occasions, participants will be asked to place the oral pouches in their mouth and complete several anerobic cycling, cognitive, and balance tests while blood and salivary biomarkers, subjective appetite ratings, and cardiovascular and autonomic function measurements are collected. after each trial, participants will complete a 24-hr food record.


Eligibility criteria:
inclusion criteria: * being 21 to 40 years of age * being biologically male * having a body mass index (bmi) of \< 30 kilograms/meter-squared * participating in moderate/vigorous exercise for at least 150 minutes/week over the last month exclusion criteria: * individuals who are younger than 21 or older than 40 * missing any limbs or part of a limb * having any neuromuscular/musculoskeletal injury or impairment that would prevent performing any exercise/functional measures for this study * having a pacemaker or any other electrical implant * a diagnosis (defined as the presence of disease of or using medication to treat the disease) of heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease, type i or type ii diabetes * taking insulin injections * any history of severe or mild traumatic brain injury within the last two years * kidney, liver, thyroid, or heart disease * treated or untreated american heart association stage 2 hypertension (\>140 millimeters of mercury / \> 90 millimeters of mercury) * any diagnosed neurological or neurodegenerative diseases * having donated blood or plasma in the last 20 days prior to blood collection procedures * taking any supplements/medications that may interfere with the results of the study * any surgeries that would impact swallowing and/or digestion * currently smoking, vaping, using e-cigarettes, or using any other combustible/smokeless tobacco products * using smokeless tobacco-free nicotine products on more than 2 days/week * daily caffeine use of more than 250 milligrams/day or use of any oral caffeine pouches * have allergies or are regularly taking medications that would impact this study and/or negatively interact with caffeine or nicotine.
paediatric ards neuromuscular blockade study

Conditions: ARDS

Summary: paediatric acute respiratory distress syndrome (ards) is a manifestation of severe, life-threatening lung injury. care for paediatric patient is mainly supportive and based on what works in adults and personal experiences, including the use of mechanical ventilation. however, differences in lung physiology and immunology between (young) children and adults suggests that adaptation of adult practices into paediatrics may not be justified. a study in adults with severe ards showed that early use of neuromuscular blocking agents (nmba) improved 90-day survival and increased time off the ventilator without increasing muscle weakness. it is unknown if this is also true for paediatric ards


Eligibility criteria:
inclusion criteria * informed consent * age younger than 5 years * need for mechanical ventilation with tidal volume 5 - 8 ml/kg ideal bodyweight and peep equal to or greater than 5 cmh2o * early moderate - to - severe paediatric acute respiratory distress syndrome originating from any cause, i.e. acute onset of disease, and oxygenation index greater than 12, and one or more (bilateral) infiltrates on chest radiograph, and no evidence of left ventricular failure or fluid overload, and within the first 48 hours of picu admission * sedation defined by comfort - b scale between 9 - 12 exclusion criteria * no informed consent * known allergy or intolerance to rocuronium * continuous administration of neuromuscular blockade prior at the time of meeting the criteria for pards * chronic respiratory failure on home ventilation * intracranial hypertension * bone marrow transplantation * immunocompromised patients (congenital or acquired) * pre-existing pulmonary hypertension * congenital heart disease with left - to - right shunting * cyanotic congenital heart disease * expected duration of mechanical ventilation less than 48 hours * withdrawal of life - sustaining treatment
safety and efficacy challenge study of live oral cholera vaccine candidate,pxvx0200, to prevent cholera

Conditions: Cholera

Summary: the purpose of the study is to determine if pxvx0200 is safe and effective in preventing cholera infection

a phase 3 randomized, double-blind, placebo-controlled, efficacy trial of a single dose of live oral cholera vaccine candidate, pxvx0200 cvd 103-hgr strain, in preventing cholera following challenge with vibrio cholerae o1 el tor inaba 10 days or 3 months after vaccination in volunteers aged 18-45 years

Eligibility criteria:
inclusion criteria: * healthy men or women, * age 18 to 45 years inclusive; * normal medical history and physical examination; and * no clinically significant abnormalities from: * urine dipstick for glucose, protein, and blood * complete blood count, * serum hepatic transaminases, * total bilirubin (direct if abnormal), * creatinine, * electrolytes, * albumin, or * electrocardiogram. * women must have a negative pregnancy test. exclusion criteria: * travel to a cholera endemic area in the previous 5 years; * abnormal stool pattern or regular use of laxatives; * history of eating disorders (such as bulimia), anal or rectal disorders, allergy to tetracycline and/or ciprofloxacin; * history of cholera or enterotoxigenic e. coli challenge or infection; * current or recent antibiotic use; * pregnancy or nursing; * positive serology for hiv, hepatitis b antigen, or hepatitis c; * any immunosuppressive medical condition; * history of hospitalization for psychiatric illness or use of specific psychiatric drugs.
prostatectomy adaptive radiation therapy (art)

Conditions: Prostate Cancer

Summary: this study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. these patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. these results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy and * clinical stage pt3, pt4, or pt2 with positive margin or * any p-stage with a persistently elevated post-operative psa \> 0.05 ng/ml or * a delayed rise in psa post-operatively exclusion criteria: * inflammatory bowel disease or other contraindications to radiotherapy * prior pelvic radiotherapy * previous cytotoxic chemotherapy * radiological or pathologic evidence of nodal metastases. * planned radiotherapy to pelvic lymph nodes * evidence of systemic metastases on imaging. * prosthetic hip replacement * no signed informed consent

Keywords: prostate cancer adaptive radiotherapy prostatectomy patients who had a prostatectomy
nonverbal synchrony, therapeutic alliance and treatment engagement in first episode schizophrenia

Conditions: Schizophrenics

Summary: the quality of the therapeutic intervention in a first psychotic episode is a major challenge for quality and effectiveness of treatment. this project aims to better understand the mechanisms underlying the quality of communication between patient and psychiatrist, especially those related to non-verbal communication. psychiatrist/patient interpersonal motor synchronization is a reliable index of therapeutic alliance and a predictor of psychotherapy effectiveness. this project aims to show a link between psychiatrist and patient motor synchrony and treatment adherence. this link could be explained by an association between therapeutic alliance and motor synchronization.

several studies have highlighted the utmost importance of initial medical and psychosocial support during a first psychotic episode. recent research has shown that non-verbal communication and particularly interpersonal motor synchronization between the patient and his psychiatrist is a key factor in therapeutic alliance. however, such hypothesis have never been tested in terms of treatment adherence neither in a first psychotic episode, nor during a 6-month follow-up. by measuring the interpersonal motor synchronization between the patient and psychiatrist during a video recorded interview at inclusion, month-3 and month-6, the project aims to validate the hypothesis that a high level of interpersonal synchronization should be associated with a high level of therapeutic alliance. this therapeutic alliance being hypothesized as a mediator between synchronization and treatment adherence, the project should show for the first time in a first psychotic episode that the use of reliable and objective variables extracted from the analysis of the synchronization between psychiatrist and patient allows to predict the outcome of therapeutic and treatment alliance.

Eligibility criteria:
inclusion criteria: * patients after hospitalisation for a first psychotic episode (oms criteria 1992) * patients fluent in french (spoken and written) * age ≥ 18 years and \< 50 years * signed informed consent * participation noted in medical files. exclusion criteria: * inpatients * history of brain trauma * history of neurological disease * current electro-convulsive-treatment * drug abuse and dependence (except for tabacco and cannabis) * pregnant/breast feeding woman
study of a prebiotic supplement to mitigate excessive weight gain among physicians in residency

Conditions: Weight Gain Trajectory; Metabolic Syndrome

Summary: a randomized placebo controlled trial to determine if increased dietary fiber will prevent weight gain, inhibit adiposity and reduce perceived stress levels in residents at the waco family health center as the result of changes in distal gut microbiota composition and function.

this study will utilize a single blind, placebo controlled, parallel design to assess the effect of dietary fiber \[prebiotin\] on the gut microbiome, perceived stress, anthropometric variables, and clinical biomarkers of metabolism. all participants in this study will be resident physicians at the family health center in waco, tx. this population was selected based on pilot data indicating they are at a greater risk for weight gain and have higher levels of stress than the average population. the goal is to recruit 40 participants for a 12 week intervention trial.

Eligibility criteria:
inclusion criteria: * currently a resident in training at the family health center in their first year. exclusion criteria: * pregnancy * currently on prescribed metformin or nsaids * a diagnosed gastro-intestinal disease (i.e. irritable bowel syndrome or crohn's disease) * known allergy to the supplement, placebo, or provided meal replacements * antibiotic use within the last 3 months.

Keywords: fiber microbiome metabolism