Kornimate/medical-research-clean huggingface dataset:
estimated physical activity of congestive heart failure patients by a physical activity questionnaire

Conditions: Congestive Heart Failure

Summary: the treatment and follow-up of congestive heart failure (chf) represents a major part of france's health expenses. the beneficial effects of cardiac rehabilitation is well established, especially regarding the reduction of dyspnea, exercise limitation and fatigue and leads ultimately to a better quality of life. maintaining these benefits in secondary prevention requires an improvement in daily physical activity, which is challenging and supposes a close follow-up difficult to perform on a daily living basis. however, a better knowledge of the type and dose of daily physical activity of this population would be very beneficial for the practitioner to prescribe or advise individually the type and the dose of physical activity required to maintain the benefits of cardiac rehabilitation. to date, only a physical activity questionnaire adapted to chf could provide information regarding both the type and dose of daily physical activity. such a questionnaire has been developed by our research team and allows an estimation of daily energy expenditure as well as the daily energy expended in its physical activity dimensions (rest, activities \ 5 met). during its first step of validation, daily and physical activity energy expenditure estimated by this questionnaire was correlated to various factors of physical condition and notably, to peak v'o2 (r=0.71), prognostic factor largely recognized in chf. a second step of validation was a pilot study comparing the estimation of daily energy expenditure by the questionnaire with a measurement of free-living daily energy expenditure with the doubly labelled water (dlw) method in 11 middle-aged males patients suffering chf (nyha i to iii). daily energy expenditure estimated from the questionnaire was very close to daily energy expenditure measured from the dlw method (r2 = 0.81; individual relative error \< 7%). however, the high cost of the dlw method reduced the population studied to a small sample, which is a major limitation of this study since the sample was somewhat different to general chf population in france.

therefore, the aim of the present study was to assess the validity of the questionnaire against the dlw method in a larger population of 30 patients with chf more representative of the general population with chf, including men and women, nyha i to iv, with a larger age panel. along with this concordance study, a measurement of the energy cost of specific physical activities of daily life is performed with an ambulatory gaz analyzer method to further validate the calculation method of daily energy expenditure from the questionnaire.

Eligibility criteria:
inclusion criteria: * congestive heart failure * stade ii, iii of nyha * between 20 to 80 years old * ef \< 45% * written informed consent * french language exclusion criteria: * corticotherapy * thyroid dysfunction * cachectic status

Keywords: heart failure
vitamin d supplementation in hiv

Conditions: HIV-infection/Aids

Summary: the purpose of this study is to evaluate safety and efficacy of vitamin d supplementation in children, adolescents and young adults with human immunodeficiency virus and acquired immunodeficiency syndrome (hiv/aids). the study is a 12-month randomized, double blind, placebo-controlled study of vitamin d3 (vit d) supplementation using 7000iu/day based on evidence from the vit d dose finding study-irb 09-007332.

optimal vitamin d (vit d) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with hiv/aids. the impact of vit d supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit d supplementation in research and clinical care. inexpensive and easy to administer, vit d supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with hiv/aids in the us and around the world. the study is a 12-month randomized, double blind, placebo-controlled study of vitamin d3 (vit d) supplementation using 7000iu/day based on evidence from the vit d dose finding study-irb 09-007332 in 58 subjects with both perinatally acquired (pa) and behaviorally acquired (ba) hiv/aids to assess the long-term safety in terms of serum calcium and 25ohd concentrations, and efficacy in terms of the effect of vit d supplementation on 25ohd, cathelicidin, growth (pre- and peripubertal participants), body composition, bone, muscle, immune and inflammatory status and hiv/aids disease severity and progression. primary hypotheses: h1: vit d supplementation is safe and does not result in an increased incidence of elevated serum calcium (above age-specific range) associated with elevated serum 25ohd (\>160 ng/ml) in treated subjects compared with the subjects receiving placebo. h2: vit d supplementation is significantly associated with both increased 25d and cathelicidin in treated subjects compared with subjects receiving placebo.

Eligibility criteria:
inclusion criteria: 1. hiv seropositive diagnosed with standard techniques 2. age for pa group: 5.0 to 24.9 y 3. age for ba group: 15.0 to 24.9 y 4. in usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment) 5. subject and/or family commitment to the 12-month study exclusion criteria: 1. other chronic health conditions that may affect growth, dietary intake, and/or nutritional status 2. pregnancy 3. participation in another hiv intervention study with impact on 25d serum concentrations 4. use of vit d3 supplementation for the purpose of treating vit d deficiency 5. use of vit d3 supplementation not part of a prescribed treatment plan for vit d deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period) 6. non-english speaking

Keywords: hiv/aids nutrition
assessment of the effect of restriction on alimentary age in progression of chronic kidney disease

Conditions: Kidney Failure, Chronic; Chronic Kidney Disease stage3; Chronic Kidney Disease Stage 3B; Chronic Kidney Disease Stage 3A (Disorder); Chronic Kidney Disease, Stage 3 (Moderate); Diet Habit

Summary: normal-protein and low-age through raw or rare proteins diet versus normal-protein and high-age diet in stage iiia-b renal failure patients


Eligibility criteria:
inclusion criteria: * patients with a grade iiia-b ckd (gfr with ckd-epi ≥ 30 ml/min and \< 60ml/min) * informed consent signed * aged 18 to 89 years exclusion criteria: * protected adult * acute renal failure * patient already on a low-age diet (\< 1ku age/day) following a dietetic consultation * current participation in another interventional research

Keywords: kidney failure advanced glycation products chronic kidney disease
comparing the pharmacokinetics, safety and tolerability of nva237 in renal impairment

Conditions: Renal Impairment

Summary: the purpose of this study is to see how the body processes and gets rid of nva237 in people who have impaired kidney function compared to people whose kidney function is normal.


Eligibility criteria:
inclusion criteria: * male and female subjects age 18 to 70 years of age inclusive. * female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion. * subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) within the range of 17 to 35 kg/m2. * able to communicate well with the investigator, to understand and comply with the requirements of the study. understand and sign the written informed consent * for renal insufficient subjects only - subjects must have stable renal disease without evidence of renal progressive disease (for the purpose of this study stable renal disease will be defined as no significant change for 12 weeks). * for health subjects only - a serum creatinine within the normal range and an egfr \>80 ml/min/1.73 m2. * for health subjects only - matched to at least one renal impaired subjects undergoing study by age (±5 years), sex and weight (±10% bmi). exclusion criteria: * smokers (use of tobacco products in the previous 3 months). smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/ml. if non-smoking subject are too difficult to recruit, smokers may be allowed to participate in the study provided they commit to smoke no more than 10 cigarettes/day during the days of pk-assessment * for healthy subjects, use of any prescription drugs, herbal and fitness/bodybuilding/athletic performance-enhancing supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (otc) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing * recent (within the last three \[3\] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting (unless related to water withdrawal during dialysis), palpitations, etc). * recent (within the last three \[3\] years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). * history of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study. * total wbc count which falls outside the range of 3000-12,000/μl, or platelets \<100,000/μl at screening. * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: renal impairment nva237 pharmacokinetics
effect of samsca on control of hyponatremia and extracellular fluid in cirrhotic patients with ascites

Conditions: Hyponatremia and Extracellular Fluid in Cirrhotic

Summary: this study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and hyponatremia


Eligibility criteria:
inclusion criteria: 1. subjects aged ≥ 20 years 2. subjects who have been diagnosed with hyponatremia \[serum sodium \< 125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction\] 3. subjects who have been diagnosed with an ascites on the abdominal ultrasound. 4. subjects who have diagnosed with cirrhosis. 5. subject or their legally acceptable representatives are able to provide informed consent/assent. exclusion criteria: 1. subject who has ascites by other causes (tbc, chf, malignancy, or renal disease) acute severe hyponatemia : serum na level \ 3.0 serum sodium ≥135 mmol/l serum potassium \> 5.5 mmol/l creatinine ≥ 2.0 mg/dl hepatorenal syndrome defined as 'new international ascites club's diagnostic criteria' systolic arterial pressure of \ grade1 known hepatocellular carcinoma intractable ascites 2. subject who requiring urgent intervention to raise serum sodium acutely 3. subject who are unable to sense or to respond appropriately to thirst 4. subject with hypovolemic hyponatremia 5. subject who should take strong cyp3a inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin) 6. subject who are anuric as no benefit is expected 7. subject who has genetic defects such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption 8. subject who has fluid depletion 9. female subjects who are pregnant or lactating 10. subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason
the blood pressure and metabolic effects of nebivolol in hypertensive patients with impaired glucose tolerance or impaired fasting glucose

Conditions: Hypertension

Summary: this study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (hctz) and placebo in hypertensive patients.

this study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide). all participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin receptor blocker. all medications are approved and marketed for the treatment of hypertension.this study is being conducted in about 500 patients at approximately 80 research centers in the united states. the study consists of approximately 9 study visits over a period of 5 months. during these visits, patients will undergo routine health exams and some special laboratory tests such as an oral glucose tolerance test.

Eligibility criteria:
inclusion criteria: * male or female, ambulatory outpatients 18-80 years old at screening. * have a history of hypertension and taking up to 2 medications for high blood pressure. * qualifying laboratory results confirming impaired fasting glucose or impaired glucose tolerance * vision and hearing (hearing aid permissible) sufficient for compliance with questionnaire completion exclusion criteria: * have clinically significant respiratory, liver or cardiovascular disease * presence of coronary artery disease requiring treatment with a beat blocker, calcium channel blocker or nitrates * use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study entry * have a history of hypersensitivity to nebivolol, other beta-blockers, hydrochlorothiazide, or other sulfonamide-derived drugs.

Keywords: nebivolol bystolic ™ hydrochlorothiazide lisinopril prinivil (tm) zestril (tm) losartan cozaar (tm) impaired fasting glucose impaired glucose tolerance hypertension
exploratory clinical study on the efficacy and safety of lactobacillus johnsonii in the treatment of patients with premature ovarian insufficiency

Conditions: Premature Ovarian Insufficiency

Summary: the goal of this clinical trial is to explore the effectiveness and safety of lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with premature ovarian insufficiency (poi). the main questions it aims to answer are: ① to explore the effectiveness and safety of lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with poi; ② to explore the potential mechanism of action of lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with poi. participants who meet all the inclusion criteria will be enrolled in the study and randomly assigned in a 1:1 ratio to either the lactobacillus johnsonii group or the placebo group.


Eligibility criteria:
inclusion criteria: 1. age between 20 and 39 years; 2. irregular menstruation or amenorrhea for \> 4 months; 3. at least two serum baseline follicle-stimulating hormone (fsh) levels \> 25 iu/l (with an interval of more than 4 weeks between measurements); 4. willing to voluntarily participate in this study, sign the informed consent form, and comply with the investigation and follow-up; 5. not having participated in other clinical trials within the past 3 months. exclusion criteria: 1. use of antibiotics or probiotics, prebiotics, and live bacterial preparations within the past month or during the intervention period; 2. received hormone replacement therapy within the past 2 months; 3. chromosomal abnormalities and genetic defects; 4. iatrogenic premature ovarian insufficiency; 5. stage iv endometriosis; 6. uncontrolled endocrine diseases or autoimmune diseases; 7. organic gastrointestinal diseases; 8. infectious diseases of the reproductive, urinary, or digestive systems; 9. severe cardiovascular, respiratory, renal, hematologic, endocrine, neurological, psychiatric, or other systemic diseases that the investigator believes may interfere with the study evaluation; 10. history of venous thromboembolism; 11. allergic or intolerant to the components of the investigational probiotic product; 12. allergic to two or more types of food/medications; 13. refusal to provide written informed consent; 14. other conditions deemed unsuitable for participation in the study by the investigator.
automatic prediction of edema after stroke

Conditions: Stroke, Acute; Brain Edema

Summary: to use machine learning for early detection of malignant brain edema in patients with mca ischemia

malignant cerebral edema following large ischemic strokes account for up to 10% of all ischemic strokes. mortality rates are high and most of the survivors are left severely disabled. although decompressive craniectomy has been shown to significantly decrease mortality, high morbidity rates among survivors are reported. the optimal timepoint when neurosurgical decompression should be performed in the individual patient varies and is a subject of debate. early prediction of malignant brain edema to identify those patients who benefit from surgical treatment is a clinical challenge. the aim of this study is to use machine learning for comprehensive analysis of ct images as well as clinical data from 1500 patients with large ischemic mca strokes in oder to develop a model for early prediction of malignant brain edema. in a first step algorithms automatically identify characteristic imaging features and clinical data of 1400 retrospective data sets to create a multistage model (learning phase). this is followed by a validation phase where the model is tested with 100 other retrospective data sets.

Eligibility criteria:
inclusion criteria: * acute ≥ subtotal mca infarct (m1-m2 occlusion) * with or without malignant brain swelling * with or without reperfusion therapy * with or without neurosurgical decompression * with or without death following malignant brain edema exclusion criteria: * non-acute mca infarct * \< subtotal mca infarct

Keywords: malignant brain edema stroke, acute prediction
wavefront guided scleral lenses for keratoconus and irregular astigmatism

Conditions: Keratoconus; Irregular Astigmatism; Corneal Ectasia; Aberration, Corneal Wavefront; Wavefront Aberration, Corneal; Pellucid Marginal Corneal Degeneration; Keratoglobus

Summary: aberrations are the spreading of light from a point focus. aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. patients with ectatic corneal disease, such as keratoconus, or irregular astigmatism cause by surgery, trauma or disease, experience vision that is unlikely to be adequately corrected with glasses or disposable soft contact lenses due to higher order aberrations (hoa). hoa's cause halos, flare, glare, starbursts, doubling, smearing or ghosting of vision. specialty contact lenses, such as scleral lenses, can be used to mask the irregularity of the cornea, reducing hoa's and improving vision. in many patients the resultant vision, though improved, still has some level of residual hoa's affecting the quality of vision. custom scleral lenses with customized wavefront guided optics can be used to reduce residual hoa's and improve vision further. these lenses have been referred to as higher order aberration correcting scleral lenses or hoa correcting sclerals and wavefront guided scleral lenses or wfg sclerals.

the purpose of this study is to investigate the effect of an advanced technique for designing custom scleral contact lenses to further improve vision in keratoconus or irregular astigmatism by reducing residual aberrations. the derived custom scleral lenses will include customized aberration correcting optics, guided by a wavefront aberrometer measurements. these lenses are custom made based on the individual measurements from an eye.the primary objective of this study is to evaluate the vision differences between traditional scleral lens optics and customized scleral lens optics. in particular, the investigators will compare efficacy in reducing aberrations and improvement in vision.

Eligibility criteria:
inclusion criteria: -a diagnosis of keratoconus or irregular astigmatism exclusion criteria: * patients with other visually significant ocular pathology. * inability to apply or remove a scleral lens.

Keywords: scleral lenses scleral lens wavefront guided scleral lenses higher order aberrations hoa scleral lenses sclerals higher order aberration correction custom scleral lenses wavefront guided keratoconus irregular astigmatism wfg scleral lenses
clinical trials to assess the efficacy and safety of hlim

Conditions: Acute Upper Respiratory Tract Infection; Acute Bronchitis

Summary: the purpose of this study is to assess the efficacy and safety of hlim

a randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Eligibility criteria:
inclusion criteria: * age between 2 and 75 * weight more than 11.5 kg exclusion criteria: * has a history of hypersensitivity to ip ingredients * hypertension or diabetes * smoking more than 20 pack-years
varus stem positioning of a cementless anatomical tha. (varabg)

Conditions: Osteoarthritis; Arthroplasty Complications

Summary: varus positioning is the most common femoral malposition in total hip arthroplasty (tha). the aim of this study was to compare the long-term results of an anatomical cementless femoral stem positioned in varus with those in neutral alignment.

data were prospectively collected and retrospectively reviewed for all patients who received a cementless anatomical femoral stem in tha between 1998 and 2008. after exclusion criteria applied, 127 stems had an varus axis deviated by more than 3 degrees (varus group) and 156 had an alignment between 0 and 2.9° from the femoral axis (neutral group). survivorship rates, complications, clinical scores, thigh pain, radiological score, cortical hypertrophy and filling rate were analyzed. mean follow-up was 10 years.

Eligibility criteria:
inclusion criteria: * all patients received by several senior surgeons, the same standardized posterolateral total hip arthroplasty, and the same rehabilitation protocol. exclusion criteria: * etiologies other than osteoarthritis (osteonecrosis, fracture, dysplasia, rheumatoïd arthritis), * complex cases with additional procedure, * dual-taper modular or cemented stem, * incomplete preoperative data or less than one-year postoperative data.

Keywords: total hip arthroplasty varus alignment anatomical stem survivorship