Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability of multiple doses of valsartan in children with hypertension with or without ckd

Conditions: Pediatric Hypertension With or Without CKD

Summary: to assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without ckd.


Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study have to fulfill all of the following criteria: have the ability to provide written informed consent; have at baseline , a documented diagnosis of hypertension (as defined in the national high blood pressure education program 2004); msbp (mean of 3 measurements) must be ≥95th percentile, and ≤25% above the 95th percentile, for age, gender and height, at baseline; ckd patients must be defined as any of the following criteria: kidney damage for ≥3 months, as defined by structural or functional abnormalities of the kidney, with or without decreased gfr, manifested by one or more of the following features: abnormalities in the composition of urine, abnormalities in imaging tests, abnormalities on kidney biopsy, estimated egfr \ 3 times the upper limit of the reference range; estimated glomerular filtration rate \[egfr\] \ 5.3 mmol/l; uncontrolled diabetes mellitus, as defined by the investigator; unilateral, bilateral and graft renal artery stenosis; current diagnosis of heart failure (nyha class ii-iv); patients taking any of the following concomitant medications following screening: raas blockers other than study drug, lithium, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; non-steroidal anti-inflammatory drugs (nsaids), including selective cox-2 inhibitors, acetylsalicylic acid \>3g/day, and non-selective nsaids (paracetamol/acetaminophen is permitted); antidepressant drugs in the class of mao inhibitors (e.g. phenelzine); chronic use of stimulant therapy for add/adhd; patients who have coarctation of the aorta with a gradient of ≥30 mmhg; previous solid organ transplantation except renal transplantation. renal transplant must have occurred at least 1 year prior to enrollment; patient must be on stable doses of immunosuppressive therapy and deemed clinically stable by the investigator; patients known to be positive for the human immunodeficiency virus (hiv) other protocol defined inclusion/exclusion criteria may apply.

Keywords: hypertension; ckd; pediatric
obalon navigation/touch system post-approval study

Conditions: Obesity

Summary: post-approval study for the obalon navigation/touch system (nts)

the obalon nts pas is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the obalon nts in a commercial setting and confirm results observed in the supplemental pma ide study.

Eligibility criteria:
inclusion criteria: 1. ages 22 years and older 2. starting or current therapy bmi of 30.0-40.0 kg/m2 3. commercially purchased the obalon balloon device exclusion criteria: 1. known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation or any other disorder of the esophagus. 2. known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms. 3. known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (\> 2 cm), cancer or any other disorder of the stomach. 4. active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.
women's health trial: feasibility study in minority populations

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia; Postmenopause

Summary: to evaluate the feasibility of recruiting women of different socioeconomic status and minority groups and to determine whether these women could achieve and maintain a modified fat-eating pattern. the full-scale trial sought to determine whether a low-fat diet could decrease the incidence of cancer and coronary heart disease in postmenopausal women. the national heart, lung, and blood institute contributed funds over a three-year period to measure lipids, lipoproteins, and other cardiovascular disease risk factors.

background: the request for proposal for the women's health trial: feasibility study in minority populations was developed and released by the national cancer institute with assistance from the national heart, lung, and blood institute. design narrative: randomized. recruitment began in august 1992 and ended in february 1994. forty percent of the subjects were randomized to a control group and 60 percent to the dietary intervention group. dietary counseling aimed to reduce total fat to 20 percent of calories, reduce saturated fat and dietary cholesterol intakes, and to increase the intake of fruits, vegetables, and grain products. recruitment and randomization were conducted over an 18-month period at three clinical centers. other objectives of the trial included: development and evaluation of strategies for recruiting and retaining women of different racial and ses groups into a dietary intervention study; identification of factors affecting compliance; assessment of the effects of a modified fat eating pattern on cardiovascular disease risk factors, including fasting blood lipids and lipoproteins, glucose and insulin, body weight and blood pressure; identification and assessment of potential biochemical and/or biological markers for dietary adherence. close-out visits began in may 1994 and ended in september 1994. these visits included six, twelve, and eighteen-month follow-up. nci extended the coordinating center contract through january 1996 to support data analysis and publication of research results.

Eligibility criteria:
postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total calories as fat at baseline.
baby nutrition and physical activity self-assessment for child care (nap sacc) intervention study

Conditions: Obesity

Summary: this study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. the focus of the intervention will be on center policies, provider and parent practices, and children's home environments that influence dietary intake and physical activity. outcomes for this study include child dietary intake, physical activity, and two adiposity measures: weight-for-length and skinfold thicknesses. child care centers and children's home environments will also be measured to evaluate how well they support healthy behaviors.


Eligibility criteria:
inclusion criteria: * licensed child care centers in north carolina (nc) serving children birth - 2 * within 120 mile radius of duke university * children must be from participating center and 3-18 months of age at baseline * read/speak english * adult teachers from infant/toddler classrooms within participating centers * adult parents of infant/toddlers within participating centers exclusion criteria: * child care centers outside of 120 mile radius of duke university * children younger than 3 months or over 18 months of age * parents with children who intend to leave the participating center in \< 12 months

Keywords: childhood obesity child care infant toddler
highlife™ transcatheter mitral valve replacement system study

Conditions: Mitral Valve Regurgitation; Mitral Valve Insufficiency

Summary: multicenter feasibility study of the highlife™ tmvr system.

this is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the highlife tmvr system in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the heart team. the data gathered in this study will allow to evaluate the feasibility of mitral replacement using the highlife™ tmvr system and characterize the safety and performance profile of the highlife™ tmvr system. all patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 years.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * severe mitral regurgitation * new york heart association (nyha) functional class ii, iii or ambulatory iv. * patient is under maximally tolerated gdmt (incl. crt) for at least 3 months * multidisciplinary heart team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions * multidisciplinary heart team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions * patient meets the anatomical criteria for highlife valve sizing as determined by ct and tee main exclusion criteria: * mitral stenosis * rheumatic valve disease * severe calcifications of the mitral annulus and/or mitral leaflets * prior surgical or interventional treatment of the mitral valve * unsuitable anatomy for the transapical access * unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access * untreated clinically significant coronary artery disease requiring revascularization * lvef \< 30% * lvedd \> 70mm * echocardiographic evidence of intracardiac mass, thrombus or vegetation * hypertrophic obstructive cardiomyopathy (hocm) * any surgical or interventional procedure (including pci) done in the past 30 days prior to procedure
to evaluate the safety and efficacy of stsg-0002 injection in patients with chronic hepatitis b

Conditions: Chronic Hepatitis b

Summary: this trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of stsg-0002 injection in patients with chronic hepatitis b treated with oral antiviral therapy.


Eligibility criteria:
inclusion criteria: * patients with chronic hbv； * receiving anti-hb viral therapy; * 10 iu/ml≤hbsag≤3000 iu/ml. exclusion criteria: * patients co-infected with hepatitis c virus, hiv, hav, hdv, hev; * liver cirrhosis; * hepatocellular carcinoma; * autoimmune liver disease; * clinical hepatic decompensation; * fibroscan\>12 kpa; * a. hemoglobin\ 1.5 ×uln，alt\>2 × uln，serum albumin\ 1.5；d. serum creatinine \>1.5×uln.
evaluation of quality of life and survival with ms-20 in patient with advanced hepatocellular carcinoma (fda ind 74572)

Conditions: Hepatocellular Carcinoma

Summary: to evaluate quality of life (qol) score of ms-20 versus placebo in advanced hcc patients using european organization for research and treatment of cancer (eortc) qlq c-30 questionnaire.


Eligibility criteria:
inclusion criteria: subjects may be included in the study only if they meet all of the following criteria: 1. subject aged ≧ 20; 2. histologically documented, unresectable advanced hcc. for patients with difficulty in obtaining histological diagnosis, a "clinical diagnosis" of hcc is acceptable if all the following criteria are met: * chronic hepatitis b or c with evidence of liver cirrhosis; * presence of hepatic tumor(s) with image findings (sonography, ct scan) compatible with hcc and no evidence of gastrointestinal tumors; * elevated serum α-fetoprotein level ≧ 400 ng/ml; 3. cancer of the liver italian program (clip) score of 3-4; 4. liver transaminase ≦ 5 times upper normal limits (unl); 5. patient fulfilling any of the follow conditions: * refuse to receive aggressive cancer therapy after explained to the subjects the benefits and risks; * progressive malignant disease after previous radiotherapy, percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, transarterial chemoembolization, systemic chemotherapy, immunotherapy, or any experimental therapy, or unable to tolerate such therapy; * no treatment of high priority is available; 6. ecog performance status of 0 - 2; 7. patients are willing and able to comply with study procedures and sign informed consent. exclusion criteria subjects will be excluded from the study for any of the following reasons: 1. patient with history of hcc rupture; 2. medical condition requiring anticoagulant or anti-platelet drugs; 3. patients with brain metastases; 4. patient unable to receive oral medication; 5. patients with significant renal function impairment (creatinine\>1.5mg/dl), severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (new york heart association functional classification iii and iv) or physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that might render the subject at high risk from treatment; 6. female subjects of childbearing potential who: * are lactating; or * have positive pregnancy test (urine) at v2; 7. active infection or on antiretroviral therapy for hiv disease; 8. patient with known hypersensitivity to any component of the study medication (soy bean or soy product).

Keywords: microbio, ms-20, hepatoma, advanced hepatocellular carcinoma
oxidative stress, inflammation, and lipoprotein in metabolic syndrome

Conditions: Metabolic Syndrome; Obesity, Metabolically Benign

Summary: obesity is associated with general low grade inflammation and, consequently, of oxidative stress that affects properties and functionality of lipoproteins. metabolic syndrome exacerbate low grade inflammation. the intentional weight loss of at least 5% of the initial weight can modulate the pro-inflammatory state and reduce the oxidative stress related to the metabolic syndrome, thus diminishing the cardiovascular risk.

metabolic syndrome is a clustering of risk factors for the development of cardiovascular disease and type 2 diabetes mellitus. patients with metabolic syndrome have an increased general low grade inflammation and, consequently, of oxidative stress that affects properties and functions of lipoproteins (dandona et al 2005). intentional weight loss can improve or prevent many of the metabolic syndrome-related risk factors and these benefits are often found after weight loss of at least 5% of initial weigh. aim: i) to investigate the structure and functionality of plasma lipoproteins, oxidative stress and the inflammatory condition in subjects with bmi between 25kg/mq and 35 kg/mq and with or without metabolic syndrome; and ii) to test the effects of weight loss of at least 5% of initial weigh promoted by an hypo-caloric balanced diet on these parameters. methods: eighty overweight and moderately obese subjects (bmi: 25 - 35 kg/m2) with or without metabolic syndrome were recruited for the study. fasting blood samples were taken and analyzed for routine laboratory analysis, lipoprotein isolation and analysis, and oxidative stress and inflammation markers measurements. the subjects received an hypo-caloric balanced diet. fasting blood samples were taken from subjects who had lost at least 5% of their initial weight at the end of the intervention period and analyzed for same markers determined at baseline.

Eligibility criteria:
1. inclusion criteria. 1.a group "obese with ms": * bmi between 25 e 35 kg/m2 * presence at least three of the following:1) waist circumference \>102 cm for males or \> 88 cm for females; 2) triglycerides: ≥ 150 mg/dl;3) hdl-cholesterol \< 40 mg/dl in males or \< 50 mg/dl in females; 4) hypertension (systolic blood pressure ≥ 130 mm hg or diastolic blood pressure ≥ 85 mm hg or antihypertensive intake); 5) glycemia: ≥ 110 mg/dl * alcohol consumption \< 25 g/die * no smoking or smoking less that 5 cigarettes/die * no use of antioxidant based supplements * absence of hormonal treatments * informed consent signature 1.b group "obese without ms": * bmi between 25 e 35 kg/m2 * alcohol consumption \< 25 g/die * no smoking or smoking less that 5 cigarettes/die * no use of antioxidant based supplements * absence of hormonal treatments * informed consent signature 2. exclusion criteria * presence of major disease * receiving hypoglycemic treatment * receiving treatments that alter lipoprotein metabolism * receiving hormonal treatments * use of antioxidant supplement * alcohol consumption \> 25 g/die * smoking \> 5 cigarettes/die. * for women:pregnancy
investigation on burnout of physicians

Conditions: Burnout

Summary: this study proposes to analyze the burnout, emotional states, and sleep conditions of internal medicine doctors at the second affiliated hospital of zhejiang university school of medicine through a questionnaire survey. the findings aim to provide reference for implementing measures to address burnout among medical staff, improve their physical and mental health, and enhance the quality of healthcare.

burnout, proposed by american psychologist herbert freudenberger in 1974, is defined as a syndrome resulting from chronic exposure to workplace stressors and the inability to successfully manage them. subsequently, maslach et al. considered burnout as the state of emotional exhaustion, depersonalization, and reduced personal accomplishment resulting from prolonged exposure to work-related stressors. in january 2022, the world health organization (who) included "burn-out" in the 11th revision of the international classification of diseases (icd-11) for the first time, officially recognizing it as a disease. burnout is considered a syndrome resulting from chronic workplace stress that has not been successfully managed. compared to other professions, doctors are at a higher risk of experiencing burnout. burnout among medical professionals is closely related to job quality, doctor-patient relationships, and overall health. in 2022, 47% of 13,000 physicians in the united states reported experiencing burnout. investigating whether burnout affects physical and mental health, thereby impacting the quality of healthcare, is essential.

Eligibility criteria:
inclusion criteria: 1. currently employed or non-employed internists, including those in gastroenterology, cardiology, pulmonology, hematology, rheumatology, endocrinology, general medicine, infectious diseases, oncology, neurology, psychiatry, nutrition, and other related specialties. 2. ability to complete the questionnaire. 3. no history of mental illness. exclusion criteria: 1. individuals who are not part of the internal medicine system, such as those in surgery, medical technology departments, or administrative roles. 2. inability to effectively complete all sections of the questionnaire.
visual outcomes and patient satisfaction with implantation of the clareon monofocal iol with the new clareon manual monarch iv iol delivery system

Conditions: Cataract

Summary: to evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either clareon monofocal or clareon monofocal toric iols with the monarch iv inserter and targeted for emmetropia.

this study is a single-arm clinical evaluation study of visual performance and patient satisfaction, after successful bilateral cataract surgery. subjects will be assessed pre- operatively, operatively and at 1 month and 3 months post-operatively. clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and iolsat questionnaire.

Eligibility criteria:
inclusion criteria: subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * adult cataract surgical patients over the age of 45 with visually significant bilateral cataracts (glare visual acuity 20/40 or worse with bcva testing), with planned cataract extraction using phacoemulsification, clear corneal incision and clareon monofocal or clareon toric with monarch iv. * able to provide written informed consent for participation in the study. * all eyes will be in the range of availability for clareon monofocal and clareon toric with monarch iv. * expected visual potential of 20/25 snellen (0.10 logmar) or better in each eye. exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery. * history of neovascular amd, diabetic macular edema, unstable proliferative diabetic retinopathy, geographic atrophy, branch retinal artery or branch retinal vein occlusion, central retinal artery or central retinal vein occlusion, moderate to severe epiretinal membrane, severe dry eye. * history of intraocular infection including hsv keratitis, vzv keratitis, endophthalmitis. * history of previous ocular surgery, including corneal refractive surgery, eye trauma or retinal detachment surgery. * history of rheumatoid arthritis, ocular cicatricial pemphigoid, or steven's johnson syndrome. * history of glaucoma. the principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
1 year post discharge prognostic model from the national heart failure audit (nhfa)

Conditions: Heart Failure

Summary: the aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in england and wales.

there is a need for a prognostic model for 1 year survival of patients discharged alive after an unscheduled hospital admission for heart failure. this study aims to develop and validate a prognostic model that will enable management planning and facilitate the identification of therapeutic needs or targets. also, it will assist care providers to predict or quantify patients' survival based on their baseline characteristics. the national heart failure audit (nhfa) held by national institute for cardiovascular outcomes research (nicor) is one of the largest available national heart failure registry. it includes data from unscheduled heart failure admissions in england and wales. in the audit, heart failure diagnosis is defined as a diagnosis that has been confirmed by imaging or brain natriuretic peptide (bnp) measurement. this study will use nhfa data to develop and validate the proposed model.

Eligibility criteria:
inclusion criteria: * aged 18 and above * survived to discharge * have mortality status at 1 year post-discharge exclusion criteria: non-index heart failure admissions during the study period will be excluded from the study sample.