Kornimate/medical-research-clean huggingface dataset:
effects of dutasteride on risk reduction of acute urinary retention relapse following trial without catheter

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study is to evaluate the efficacy and safety of dutasteride at reducing relapse rates of acute urinary retention (aur), including reduction in surgical intervention for benign prostatic hyperplasia (bph), in patients who receive a 6 month treatment of dutasteride (0.5mg once daily) following a single episode of aur followed by successful trial without catheter compared with placebo.


Eligibility criteria:
inclusion criteria: * able to read, write and understand instructions related to study procedures and able to give written informed consent * able to swallow and retain oral medication * had a single, spontaneous episode of aur related to bph with a drained volume of between 500 and 1500ml * had a successful twoc (defined as successful if the patient returns to satisfactory voiding within the first 24 hours after catheter removal without re-catheterisation) following 2 - 3 days treatment with alpha blocker (preferably alfuzosin 10mg od) pre twoc followed by up to seven days treatment with alpha blocker (preferably alfuzosin 10mg od) post twoc. * able to be randomised within 7 days of successful twoc exclusion criteria: * prostate volume (pv) of less than 30cc and greater than 80cc measured via trans rectal ultrasound (trus) either at time of hospitalisation or as part of the screening / randomisation visit * previous episode of aur prior to the current episode * aur not related to bph i.e. postoperative retention following major abdominal / pelvis surgery * previous prostate or urethral surgery * previous positive prostate biopsy * any cause other than bph that may result in urinary symptoms or changes in flow rates. * any unstable co-existing medical condition * previous 5-ari use * previous alpha blocker treatment other than the study mandated 2 - 3 days pre and up to 7 days post twoc period with alpha blocker (preferably alfuzosin 10mg od) * use of prohibited meds (e.g. 5ari's, anabolic steroids including testosterone, drugs with antiandrogenic properties) * liver enzymes (alt, ast, alp) at time of hospitalisation / screening visit greater than 2 x uln or bilirubin at time of hospitalisation / screening visit greater than 1.5 x uln. * serum creatinine at time of hospitalisation / screening visit greater than 1.5 x uln * treatment with any other investigational product within 30 days prior to the first dose of study medication * history or current evidence of alcohol or drug abuse within the last 12 months * prostate specific antigen (psa) greater than 20ng/ml * use of suprapubic catheterisation after failed urethral catheterisation * neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology * isolated bladder neck disease * acute or chronic prostatitis * confirmed or suspected urethral stricture * known bladder stones * clot retention secondary to haematuria of any cause * patient unwilling to use a condom during sexual intercourse

Keywords: acute urinary retention benign prostatic hyperplasia trial without catheter
the esvs® mesh randomized post-market study

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Summary: the purpose of this study is to evaluate patency rates of the external saphenous vein support (esvs) mesh saphenous vein grafts (svg) and control svg at 3-6 months and 24 months.

the study will enroll up to 200 patients at up to 6 sites. patients will be enrolled upon meeting entrance criteria, including obtaining written informed consent. eligible patients must be clinically indicated for coronary artery bypass grafting (cabg) using autologous saphenous vein grafts (svg). the study is a prospective, randomized, repeated measure controlled trial based on each patient receiving one control svg and one external saphenous vein support (esvs) mesh treated svg. each patient will be their own control.

Eligibility criteria:
inclusion criteria: * patient has been diagnosed with multi-vessel coronary artery disease * requires saphenous vein graft (svg) coronary artery bypass graft (cabg) surgery of the right coronary artery (rca) and the circumflex artery (cx) systems due to atherosclerotic coronary artery disease * svgs (esvs mesh and control) meet size requirements as outlined in esvs mesh instructions for use * esvs mesh implant procedure can be performed as outlined in the esvs mesh instructions for use * are able to give their informed consent exclusion criteria: * not able to give informed consent * no appropriate target coronary vessels * svgs (esvs mesh or control) do not meet size requirements as outlined in esvs mesh instructions for use * esvs mesh implant procedure cannot be performed as outlined in the esvs mesh instructions for use * inability to tolerate or comply with normal post-surgical drug regimen * inability to comply with required follow-up coronary angiography/ct
effect of oral glutamine on muscle mass and function in duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne

Summary: the purpose of this study is to determine whether long-term oral glutamine supplementation is effective in improving muscle mass and function in children with duchenne muscular dystrophy (dmd).

glutamine inhibits whole body protein degradation in children with duchenne muscular dystrophy (dmd). the effect is observed after 5 h oral glutamine administration and is also found when glutamine is given over a 10-day period. this multi-site national study aims to evaluate the functional benefit of long-term oral glutamine administration in 30 dmd children using a randomized double-blind placebo-controlled cross-over design. the study includes two 4-month periods: 1) a treatment period in which the subject receives oral glutamine (0.5 g/kg/d) and 2) a control period in which the subject receives a placebo. the order of treatment allocation is randomized. the two 4-month periods are separated by a 1 month wash-out period. the children are monitored every 2 months during period 1 (m0, m2, m4) and period 2 (m5, m7, m9) in the clinical investigation centres of hospital robert debré in paris and the chr\&u de lille, as well as the clinical research centre of the chu de poitiers. evidence of a functional benefit would involve evaluating the administration of glutamine over longer periods (as early as possible following diagnosis) among severely handicapped children and in other chronic pathologies associated with increased muscle protein catabolism. in dmd, such evidence would enable children to undergo gene therapy under improved physical condition. comparisons: glutamine administration compared to placebo on the following outcome measures: walking speed on a standard course, work (kcal) and power (kcal/s) in relation to effort, body composition (bioelectrical impedance analysis and biphotonic absorptiometry), muscle mass (24-h urinary creatinine excretion), indices of protein degradation (cpk and 3-methyl histidine excretion) and biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, igfi, igf-bpi).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of duchenne muscular dystrophy * able to walk \>170 m * absence of hepatic insufficiency * absence of renal insufficiency exclusion criteria: * dependent upon wheelchair * body weight \>60kg * liver failure * kidney failure * surgery scheduled during the year following the first visit

Keywords: glutamine nutrition children pediatrics randomized controlled clinical trial therapy supplement oral administration handicap
study of subcutaneous immune globulin in patients requiring igg replacement therapy (eu extension study)

Conditions: Primary Immunodeficiency (PID)

Summary: this study is a continuation of the study zlb06_001cr with the objective of assessing efficacy, tolerability, safety of igpro, as well as long-term health-related quality of life in patients with pid.


Eligibility criteria:
inclusion criteria: * subjects with primary humoral immunodeficiency, namely with a diagnosis of common variable immunodeficiency (cvid) as defined by the pan-american group for immunodeficiency (pagid) and the european society for immunodeficiencies (esid), or x-linked agammaglobulinemia (xla) as defined by pagid and esid, or autosomal recessive agammaglobulinemia who have participated in the study zlb06_001cr and who have tolerated igpro well * written informed consent exclusion criteria: * hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total urine protein concentration \> 0.2g/l) * other significant medical conditions that could increase the risk to the subject * females who are pregnant, breast feeding or planning a pregnancy during the course of the study * participation in a study with an investigational medicinal product within three months prior to enrollment, except for zlb06_001cr * evidence of uncooperative attitude * any condition that is likely to interfere with evaluation of the imp or satisfactory conduct of the study * subjects who are employees at the investigational site, relatives or spouse of the investigator

Keywords: immune globulin subcutaneous scig primary immunodeficiency pid
piloting getcare: a remote goal-based education and skills training program for caregivers poststroke

Conditions: Stroke

Summary: the purpose of this study was to evaluate the getcare program, a goal-based education and skills training program for caregivers poststroke.

the purpose of this study was to utilize a single-arm mixed method pilot trial to evaluate the5-week getcare program with the following study aims: (1) explore feasibility and acceptability, (2) assess knowledge acquisition and goal attainment, and (3) test preliminary effects on key caregiver outcomes. this remote program included guided goal setting, individualized resource recommendations, and education modules.

Eligibility criteria:
inclusion criteria: * self-identification as a primary caregiver (direct care involvement) of someone who had a stroke (no restriction on stroke duration) * ≥ 18 years old * access to internet/telephone throughout the study * able to speak, read, and understand english * person with stroke expected to discharge within 1 month if still in the hospital exclusion criteria: * unable to read and follow basic instructions * indicated the individual with stroke had no deficits poststroke

Keywords: caregiver intervention pilot education goals skills
patients' long-term survival of obstructive hypertrophic cardiomyopathy (hcm)

Conditions: Cardiomyopathy; Obstructive Hypertrophic Cardiomyopathy

Summary: background: hcm is a genetic heart disease. it can cause fatigue, chest pain, or even death. for more than 50 years, a surgery called septal myectomy has been used to help people with this disease. dr. andrew g. morrow originated the surgery and performed it more than 200 times at nih starting in 1960. researchers want to learn the long-term success of this surgery. objective: to determine long-term survival at least 35 years after surgical myectomy at nih and examine data for people who are confirmed to be deceased or alive. eligibility: people who had surgical myectomy by dr. morrow from 1960 to 1983. design: this study uses images and data that were obtained in the past. many of the participants are deceased. most of the others are no longer being followed at the nih. the medical records of people treated by dr. morrow were microfiched. these records can be accessed at the nih. the records will be searched for keywords to find participants for this study. participants clinical data, such as lab testing and imaging, will be used. other data collected as part of the original study will also be used. researchers will use participants name, date of birth, and social security number to learn if they are alive or deceased. if they are deceased, researchers will try to find the age of death. online databases and search engines will also be used. survival data will be compared to data from the general u.s. population for the same time period. data will be stored in a database that is password protected. the study will last about 1 year.

hypertrophic cardiomyopathy (hcm) is a relatively common autosomal dominant genetic heart disease which may produce lifestyle limiting symptoms or even death. medication can sometimes be of benefit, but surgical intervention with septal myectomy has been an alternative intervention. the experience with this surgery at nih provides a unique opportunity to evaluate the long-term success of this operation.dr. andrew g. morrow was the originator of this operation and performed over 200 septal myectomies at nih starting in 1960. reviewing the results of his experience will provide important information regarding the benefits of this intervention in these patients.

Eligibility criteria:
* eligibility: patients operated on 1960-1983 with surgical myectomy by dr. andrew g. morrow at the nih.

Keywords: hcm septal myectomy surgical intervention genetic heart disease natural history
relationship between academic achievement, musculoskeletal system, quality of life and technology addiction

Conditions: Technology Addiction; Musculoskeletal System; Quality of Life; Youth

Summary: the increasing use of technological devices such as mobile phones and computers has become indispensable elements of daily life. especially students are one of the groups that use communication tools most with the developing technology. this study was conducted to investigate the effect of technology addiction on academic achievement, musculoskeletal system and quality of life in young people.


Eligibility criteria:
inclusion criteria: * individuals between the ages of 20-30, using smartphones and/or computers were included in the study. exclusion criteria: * individuals who did not meet the inclusion criteria and had a physical-psycho-social condition that could affect the study were excluded from the study.
prospective evaluation of fortified eggs related to improvement in the biomarker profile for your health

Conditions: Hypercholesterolemia; Hyperlipidemia; Vitamin Deficiency; Obesity

Summary: the objective of the study is to assess the effect of fortified eggs (compared to a non-egg supplemented diet) and intermittent fasting (if) (compared to a usual care diet) on biomarker profile at 4 months. this will be a 140-participant, 2x2 factorial, randomized clinical trial comparing fortified eggs vs. a non-egg supplemented diet and if vs. usual care diet through 4 months. participants will be randomized 1:1:1:1 to the four treatment groups. participants will have in-person follow-up visits at 1- and 4- months (inclusive of laboratory assessments) in addition to telephone calls at months 2 and 3. a subset of patients (\~24 in each egg randomized strata) will undergo microbiome assessment at baseline and at 4 months.


Eligibility criteria:
inclusion criteria: * ≥ 50 years of age and * at least one of the following two criteria: * prior cardiovascular event (myocardial infarction, coronary revascularization or ischemic stroke) or * 2 cardiovascular risk factors including: 1) diabetes mellitus (defined as taking a medication for diabetes or hgba1c ≥6.5% within the prior 18 months; patients with diabetes may be treated with medications that are not associated with hypoglycemia such as metformin, thiazolidinediones (tzds), glucagon-like peptide-1 receptor agonists (glp-1 ras), sodium glucose co-transporter 2 (sglt2) inhibitors and/or dipeptidyl peptidase-4 (dpp-4) inhibitors, 2) body mass index (bmi) ≥ 30 kg/m2, 3) hypertension (defined as taking blood pressure lowering medications or systolic bp \> 140mmhg at screening or diastolic bp \> 90mmhg at screening), 4) dyslipidemia (defined as taking lipid lowering medication or ldl ≥130 or hdl \<50 for women or hdl \<40 for men or triglycerides ≥150), or 5) chronic kidney disease (defined as egfr \<60 on most recent laboratory assessment within prior 18 months) * signed informed consent exclusion criteria: * known allergy or intolerance to eggs * patients with diabetes who are on insulin or insulin secretagogues (e.g., sulfonylureas and meglitinides) * recent cardiovascular event (mi, stroke, hf hospitalization) within the past 30 days * planned initiation/change in lipid therapy within the next 4 months * current daily use of any supplements or multivitamins containing vitamin b2 (riboflavin), vitamin b12, vitamin d, vitamin e, or selenium or planned initiation within the next 4 months (current users need a 1-month washout period off supplement prior to eligibility) * inability or unwillingness to comply with the study requirements * history of heart transplant or left ventricular assist device * pregnant or nursing women * malignancy or other non-cardiac condition limiting life expectancy to \<4 months * consumption of \> 2 eggs per week (this does not include eggs contained within other foods) * ongoing or recent (prior 30 days) participation in another interventional study

Keywords: fortified eggs high cholesterol
real-world study of inetetamab in her2-positive metastatic breast cancer

Conditions: HER2-positive Metastatic Breast Cancer

Summary: a multicenter real-world study was conducted to gather clinicopathological data from patients with her2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. the study aimed to estimate the progression-free survival (pfs), objective response rate (orr), disease control rate (dcr), and adverse events (aes) associated with inetetamab therapy.


Eligibility criteria:
inclusion criteria: 1. an age of at least 18 years or older 2. pathologically diagnosed with her2-positive recurrent or metastatic breast cancer 3. having at least one measurable lesion as defined 4. receiving inetetamab-based therapy in the recurrent or metastatic stage 5. having traceable medical history records exclusion criteria: 1. pregnant or lactating women 2. patients with other conditions deemed unsuitable for participating in this study by the researcher
metabolic syndrome and degenerative meniscus lesions related knee function

Conditions: Metabolic Syndrome; Meniscus Lesion; Obesity, Abdominal; Knee Arthritis

Summary: studies have suggested that obese patients with metabolic syndrome(mets)were correlated with knee joint degeneration and osteoarthritis. however, no studies demonstrate the relationship between obese patients with metabolic syndrome and degenerate meniscus lesions and its knee function.the aim is to detect the correlation between obese patients with metabolic syndrome and degenerate meniscus injuries.

obese patients with metabolic syndrome(mets)were correlated with knee joint degeneration and osteoarthritis. however, no studies demonstrate the relationship between patients with metabolic syndrome and degenerate meniscus lesions or knee function. participants were recruited from first affiliated hospital of jinzhou medical university. 100 bmi\ 27 were included in the study. obese patients with mets were assessed knee function and degenerate meniscus tears verified by magnetic resonance imaging. and patients with a mild or no osteoarthritis with kellgren and lawrence grade\<2 verified by x ray. we tested the relationship between metabolic syndrome and degenerate meniscus lesions. obese patients with mets and volunteers were detected by mcmurry's test and mri image to measure degeneration grade of meniscus tears. number of mets components were accounted and the knee function koos, ikdc score or degenerate meniscus tears were analyzed.

Eligibility criteria:
inclusion criteria: * must be age between 35 and 70 years old; * clinical diagnosis of metabolic syndrome; * bmi score more than 27 or less than 24 * clinical diagnosis of 3 grade degneration meniscus leisons; exclusion criteria: * must be able to have no acute knee injury such as car crash or acute sports injury; * must be able to have no knee surgeries history; * must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity; * must be able to have no contraindications to mri; * must be able to have no severe cardiopulmonary disease; * must be able to have no musculoskeletal or neuromuscular impairments ; * must be able to have good visual, hearing, or cognitive;

Keywords: metabolic syndrome degenerate meniscus lesions obesity knee function
risk factors associated with the global burden of disease in reunion island and comparison with mainland france and indian ocean countries

Conditions: Disability or Chronic Disease Leading to Disablement

Summary: the question posed by this project is that of the regional estimate of the relative importance of the risk factors of the main pathologies. our hypothesis is that these risk factors are of different relative importance in reunion island compared to metropolitan france.

the definition of health priorities in a given territory is a major field of public health research. the world health organization has been conducting the global burden of disease study since the 1990s. this study, which has been the subject of numerous publications, aims at estimating the burden for a given population of different causes of mortality and morbidity. it defines a standardized measure allowing comparisons between different countries. the measure developed internationally is the "disability-adjusted life year" (daly). this also allows the monitoring of the relative importance of each pathology. this standardized classification of the relative importance of the pathologies and risk factors involved is a major public health tool. this measure was developed at the international level initially and then recently applied locally (london neighborhoods, us states). for the indian ocean zone, daly values are available for madagascar, seychelles and mauritius. the estimate of this measure for reunion island is based on data from metropolitan france. it therefore uses for reunion mortality, morbidity, income per capita and social indicators of metropolitan france. it does not take into account the specificities of reunion. in order to better understand reunion's public health priorities, it seems important to decline this measure at the regional level. the implementation of this measure at the regional level corresponds to the research project aviron which aimed at collecting all the data for the calculation of the daly in reunion island. the aviron-2 study, which extends aviron's focus on morbidity and mortality, will aim at determining the attributable part of the various disease risk factors and to classify these risk factors according to their importance in a given population for all diseases.

Eligibility criteria:
inclusion criteria: the whole population living in reunion island exclusion criteria: people not living in reunion island