Kornimate/medical-research-clean huggingface dataset:
effect of recombinant human growth hormone (rhgh) on abdominal fat and cardiovascular risk in obese girls

Conditions: Obesity

Summary: teenagers and adults who are overweight or obese have an increase in fat in the abdomen, which increases their risk for diabetes and heart disease. reducing abdominal fat is important to reduce risk for diabetes and for heart disease. overweight teenagers also have low levels of growth hormone compared to normal weight teenagers, and teenagers with the lowest growth hormone levels also have the greatest abdominal fat. in children who are unable to make growth hormone for other reasons, giving back growth hormone leads to a decrease in abdominal fat. we are studying whether giving growth hormone in small doses to overweight teenagers can change body composition. we hypothesize that growth hormone will cause abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.


Eligibility criteria:
inclusion criteria: * adolescent girls 13-21 years old with bone age ≥ 14 years * overweight girls: body mass index (bmi) greater than the 95th percentile for age * waist/hip ratio ≥ 0.85 * insulin like growth factor -1 (igf-1) below -0.5 standard deviations (sd) for pubertal stage or age exclusion criteria: * pregnancy (positive pregnancy test) prior to enrollment in the study * significant weight gain or loss within 3 months of study (more than 5 kg) * use of medications that affect gh or cortisol levels (such as estrogen including oral contraceptive pills, oral glucocorticoids) * use of medications such as meridian and orlistat * presence of diabetes mellitus * uncontrolled thyroid disorders * chronic renal insufficiency * participation in another simultaneous medical investigation or trial * active neoplasm or history of cancer * prader-willi syndrome * history of scoliosis if bone age is \<15 years * hypersensitivity to rhgh or constituents of the injections

Keywords: obesity adolescent insulin resistance growth hormone visceral fat adolescent obesity
psma-pet to guide prostatectomy

Conditions: Prostate Cancer

Summary: in this study, 196 patients will be randomized 1:1 to either having only the standard of care mri prior to surgery versus having the standard of care mri and the psma pet scan. pet (and mri) findings will be validated against whole mount pathology. pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.


Eligibility criteria:
inclusion criteria: 1. significant prostate cancer: gleason 3+4 ≥1 core with pattern 4 ≥20% gleason 3+4 ≥1 core with ≥50% total involvement of core or ≥3 cores of gleason 3+4 or nccn unfavorable intermediate risk or any gleason 4+3, 4+4, 4+5, 5+4, or 5+5 and 2. baseline sexual function (iief-ef \> 17): no erectile dysfunction or mild-to- moderate erectile dysfunction (international index of erectile function domain ≥ 17) and 3. the patient desires to maintain erections following treatment 4. planned to undergo a standard of care mri or recently completed standard of care mri within 6 months of scheduled date of surgery. note: for subjects whose soc mri is not within 6 months or not 3tesla, they may be enrolled in the study and the mri will be repeated as a research study. the research mri will not be billed to the subject's insurance, but will be scheduled at iu ori, at no cost to study participant. 5. planned prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent. exclusion criteria: 1. participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days. 2. does not meet safety criteria for mri scan (e.g. metal implant that is not allowed, since mri is required for comparison). 3. significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
prevalence of orthostatic tremor in patients with unsteadiness

Conditions: Orthostatic Tremor; Neuropathy

Summary: clinical presentation of orthostatic tremor (ot) may be misleading and simply perceived by a postural instability such as in several peripheral neuropathies. in addition, peripheral neuropathies represent the leading cause of pathologies associated with ot. among patients referred for an electroneuromyogram (enmg) for peripheral neuropathy and presenting with postural unsteadiness, ot assessment will be systematically performed. demographic, clinical and polygraphy characteristics of these patients will be analyzed and prevalence of ot in the general population of peripheral neuropathies will be assessed.

among patients who will be referred for enmg and exploration of a neuropathy, orthostatic tremor will be investigated systematically. main objective and primary endpoint: * to estimate the prevalence of ot with its 95% confidence interval in the population of patients defined above * presence of ot confirmed by surface emg (polygraphy) in patients with standing instability referred for enmg. secondary objectives and end points * determine the demographic, clinical, electrophysiological characteristics of patients with ot; estimate the prevalence of peripheral neuropathy in patients with ot; duration of symptoms; correlation with quantitative neuropathy scores (iss, mrc, onls, r-ods) * age, sex, clinical parameters: symptoms reported by the patient (instability, tremor, weakness, pain, falls), duration, current medications, iss score, mrc score, onls score, r-ods score) and electrophysiological parameters (mean frequency of ot in hertz, munix score (number of motor units in the anterior tibialis, calculated by software on the enmg machine).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * all patients complaining of instability when standing up and referred for an enmg * patient informed and having expressed his non-opposition to participating in the research exclusion criteria: * patient's refusal to participate in the study * impossibility to stand * no affiliation to health insurance * patients under a legal protection measure or unable to express their will * patient under the state medical assistance (ame) * patient under 18 years old * pregnant women, parturients and breast-feeding mothers

Keywords: electroneuromyography polygraphy unsteadiness tremor anti-mag neuropathy chronic demyelinating inflammatory neuropathy
the effect of boceprevir in russian participants diagnosed with chronic hepatitis c genotype 1 (p08160)

Conditions: Chronic Hepatitis C Genotype 1

Summary: the purpose of this study is to determine whether boceprevir (boc, sch 503034, mk-3034) in combination with peginterferon alfa 2-b (peg) plus ribavirin (rbv) \[peg+rbv=pr\] is effective in the treatment of chronic hepatitis c (chc) genotype 1 among the russian population. the primary hypothesis is that the percentage of participants achieving sustained virologic response in the boc + pr group is superior to that in the placebo (pbo) + pr group.


Eligibility criteria:
inclusion criteria: * body weight ≥40 kg and ≤125 kg * previously documented chc genotype 1 infection; * must have a liver biopsy with histology consistent with chc and no other etiology * if cirrhosis present, must have an ultrasound within 6 months of the screening visit (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma (hcc) * agree to use acceptable methods of contraception with partner * previously untreated with pegylated-interferon (either alfa-2a or alfa-2b) plus rbv or failing prior treatment with pegylated-interferon (either alfa-2a or alfa-2b) plus rbv exclusion criteria: * co-infected with the human immunodeficiency virus (hiv) or hepatitis b virus (hepatitis b surface antigen \[hbsag\] positive). * required discontinuation of previous interferon or ribavirin regimen for an adverse event (possibly or probably related) * treatment with ribavirin within 90 days and any interferon-alpha, based on the amendment, should be within 1 month prior to screening * treatment with any investigational drug within 30 days of the screening visit in this trial * evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy * diabetic and/or hypertensive with clinically significant ocular examination findings * clinical diagnosis of substance abuse of specified drugs within specified timeframes * any known pre-existing medical condition that could interfere with the participant's participation in and completion of the trial
reproductive hormonal alterations in obesity

Conditions: Obesity

Summary: the purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. the proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (lh) and follicle stimulating hormone (fsh)). they will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. finally, the ovary's ability to produce progesterone after ovulation will be examined. --hypotheses: 1. obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (gnrh), but normal clearance of exogenous lh. (comparative study of obese compared to normal weight women) 2. obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)

aim 1: test the hypothesis that reduced pituitary sensitivity to gnrh-induced lh and fsh secretion causes the relative hypogonadotropic hypogonadism of obesity aim 2: test the hypothesis that the hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity

Eligibility criteria:
inclusion criteria: * aged 18-40 at study entry * bmi either 18-25 kg/m2 or ≥30 kg/m2 * prolactin (prl) and thyroid-stimulating hormone (tsh) within normal laboratory ranges at screening * baseline hemoglobin \>11 gm/dl * history of regular menstrual cycles every 25-35 days if bmi 18-25 kg/m2 * history of regular menstrual cycles every 25-40 days if bmi ≥30 kg/m2 exclusion criteria: * history of chronic disease affecting hormone production, metabolism or clearance * use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin) * use of hormones within three months of enrollment * excessive exercise (\>4 hours per week) * pregnancy, breast-feeding or current active attempts to conceive

Keywords: lh pulsatility obesity reproduction
optimized strategy for diabetic patients with critical limb ischemia(part i)

Conditions: Vascular Diseases; Diabetes

Summary: the purpose of this trial is to find out the appropriate way to treat dm patients with critical limb ischemia. this trial includes two parts. part i focuses on the treatment of femoral arterial lesion and part ii focuses on the treatment of below-knee arterial lesion.

the trial includes two parts and here is part i. this part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in dm patients. totally 70 patients will be entered into the study. the lesion of the femoral artery should be tasc b、c or d and the patients should suffered ischemic symptom with rutherford 3-6.the lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.

Eligibility criteria:
inclusion criteria: * the patients volunteer to join the trial and sign the formal consent. * the patients are ≥55 year-old and ≤75 year-old. * the patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. the presentation is severe intermittent claudication, rest pain, ulcer or gangrene. * the lesion of the femoral artery should be tasc b、c or d. * the femoral-popliteal artery has never received bypass or endovascular therapy before. * no obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured. * no obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot. * no surgical contraindications;no infection in operation region. * be diagnosed with dm for at least 1 year. exclusion criteria: * refuse random treatment. * previous operations on the superficial femoral artery. * acute lower extremity arterial thrombosis. * serious major organ failure. * allergic to the contrast agent or has contrast nephropathy. * no clinical compliance or unfit to join the trial

Keywords: critical limb ischemia diabetes femoropopliteal artery bypass stent
pre-approval access to golimumab subcutaneous for the treatment of stage 3 type-1 diabetes mellitus in children and young adults

Conditions: Diabetes Mellitus, Type 1

Summary: this is a single patient investigational new drug (ind) to golimumab subcutaneous (sc) for the treatment of recently diagnosed stage 3 type-1 diabetes mellitus (t1d) in children and young adults. the main purpose of a single patient ind is to provide treatment to participants with serious/life-threatening diseases or conditions prior to marketing authorization.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
pharmacokinetic (pk) and pharmacodynamic (pd) study of cd 2027 spray in adults with plaque-type psoriasis

Conditions: Plaque-type Psoriasis

Summary: this is a multicenter, open-label study to assess systemic plasma levels of calcitriol, calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of maximized use of cd 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of bsa for 3 weeks. there are a total of six visits: pre-treatment period (day -15, day -8 and day -1) and treatment period (day 1/ baseline, day 15 and day 22).


Eligibility criteria:
inclusion criteria: * diagnosis of plaque-type psoriasis involving 10% - 20% of body surface area (bsa), with a global severity score of at least 3 (moderate) exclusion criteria: * other type of psoriasis (other than plaque) * significant abnormal lab findings * secondary hyperparathyroidism * vit d deficiency * hypercalcemia

Keywords: psoriasis pk calcitriol
metabolic signatures of dairy products ingestion in humans: effect of age

Conditions: Nutrition

Summary: despite the fact that dairy products are greatly consumed, it remains today very difficult to determine with a classical blood biochemical test whether a person has ingested a fresh fermented dairy product or just milk, while their biological, metabolic and health impacts may be different. the metabolic footprint left by the consumption of these products could be modified by the age of the consumer. indeed, in the elderly, the processes of digestion, assimilation and metabolism are known to be altered /different compared to healthy adults. thus, different metabolic signatures in the elderly could appear as the result of a less effective use and metabolism of the nutrients ingested. this could further also result in different or altered biological effects on dairy products.

the two main objectives of this project are to: * determine precisely the plasma and urine metabolic signatures resulting from acute (postprandial) ingestion of yogurt or milk. * characterize the metabolic signature following the consumption of these dairy products in the elderly and compared with the signature of reference (adult). * understand the mechanisms and metabolic pathways involved if discriminating metabolites between age are detected.. the clinical study is open, monocentric, controlled and randomized, in a cross experimental design. the study is not performed in a double blind way. however, the measure bias will be limited because of the standardized and objective characteristic of the main criteria. moreover, biological samples will be analyzed by the same partners of the project. each subject will be its own control, so that confusion factors related to individual variability will be eliminated. a total of 28 volunteers (men) will participate in the study: 14 adults and 14 old people (\>65 yrs-old). after 3 weeks of controlled diet (without consumption of dairy products) the volunteers will ingest 600g of milk or yogurt. after 1 week of wash-out, the other product will be consumed. blood and urine will be collected during the postprandial period. the monocentric characteristic of the study, the low number of subjects and the expertise of the involved staff will enable to limit the number of missing data. the randomization (latin square) has been established by a bio-statistician of the project before the study started. a document describing the randomization proceeding is confidentially kept.

Eligibility criteria:
inclusion criteria: * no pathology and no medical treatment * bmi \>=21 and \<=30 kg/m² * normal biological status * no dislike for diary intake exclusion criteria: * smoking * no pathology and no medical treatment (no antibiotics in the last 3 months) * consumption of nutritional supplements several times at week

Keywords: dairy products milk yogurt metabolomics elderly
sonographic follow up in newborns diagnosed with prenatal hydronephrosis

Conditions: Pyelectasis of Newborns

Summary: in this retrospective study the investigators will enroll newborns that were born between 01.01.2010 and 31.12.2012 in hillel yaffe medical center with the prenatal diagnosis of pyelectasis according to prenatal sonographic screening test. these babies underwent renal sonography at the age of 2-5 days according to the protocol and were invited to an additional renal sonographic screening test at the age of 1 month. the investigators will compare the results of the 2 examinations and the investigators will try to reach conclusions whether there is correspondence between the severity of the pyelectasis in the first and second sonographic tests and the outcome of these newborn babies


Eligibility criteria:
inclusion criteria: * all newborns that were born at hillel yaffe medical center with prenatal diagnosis of hydronephrosis between 01.01.2010-31.12.2012 exclusion criteria: * none
an observational study to investigate the effects of rapid transmeridian travel

Conditions: Jet Lag Disorder

Summary: observational study to investigate circadian rhythm patterns


Eligibility criteria:
inclusion criteria: * ability and acceptance to provide written consent * men or women between 18-75 years * body mass index of ≥ 18 and ≤ 30 kg/m2 exclusion criteria: * history (within the 12 months prior to screening) of psychiatric disorders * major surgery, trauma, illness or immobile for 3 or more days within the past month * pregnancy or recent pregnancy (within 6 weeks) * a positive test for drugs of abuse at the screening visit * any other sound medical reason as determined by the clinical investigator
prophylaxis of hepatitis b virus recurrence after liver transplantation

Conditions: Liver Transplantation; Hepatitis B

Summary: entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. the investigators evaluated the effect of entecavir combined hepatitis b immune globulin (hbig) with lamivudine or adefovir or both combined hbig in chinese liver transplantation patients with hepatitis b virus (hbv) related diseases.


Eligibility criteria:
inclusion criteria: 1. patients into the transplant waiting list with hbv-related liver disease. 2. hbsag-positive. 3. serum hbv-dna negative. 4. no hcv, hdv and hiv co-infection. 5. without renal dysfunction. 6. no lamivudine, adefovir and entecavir drug allergy history. 7. no hbv-ymdd mutation for patients who have a long-term use of lamivudine. exclusion criteria: 1. patients with hbv-related hepatocellular carcinoma beyond milan criteria. 2. hbsag-negative. 3. serum hbv-dna positive. 4. hcv, hdv and hiv co-infection. 5. patients with severe renal dysfunction or failure. 6. lamivudine, adefovir and entecavir drug allergy history. 7. hbv-ymdd mutation for patients who have a long-term use of lamivudine.

Keywords: hbv recurrence entecavir
azithromycin in the prevention of lung injury in premature newborn

Conditions: Bronchopulmonary Dysplasia

Summary: the introduction of invasive mechanical ventilation in the treatment of preterm infants works as an adjuvant in the treatment of acute respiratory failure, which has resulted in significantly significant survival rates. in recent years there has been an increase in the number of evidence that mechanical factors can cause lung injury through inflammatory cells and soluble mediators. the alveolar and airway epithelium is an important source of cytokine release. cytokines are very low molecular weight proteins or glycoproteins with hormone-like actions. they contribute to the pathogenesis of various diseases through the ability to induce other inflammatory mediators mechanical ventilation strategies can increase pulmonary and systemic cytokines and lead to dysfunction of multiple organs and systems. azithromycin has a potent anti-inflammatory and immunomodulatory effect it suppresses the production of proinflammatory cytokines (il-6, il-1, and tnf-α), has effective antimicrobial properties against ureaplasma and, best of all, few side effects the hypothesis of this study is that azithromycin would reduce pulmonary inflammation induced by mechanical ventilation in premature infants, conferring a protective character.randomized clinical trial: use of azithromycin in preventing pulmonary damage newborn preterm undergoing mechanical ventilation

the nature of lung injury induced by mechanical ventilation is clearly established, including the release of immunoinflammatory mediators. however, safe drug therapy that decreases its severity is not available. azithromycin is a macrolide antibiotic with potent anti-inflammatory effects, but has been poorly studied in preterm infants except for very few studies in extreme preterms for the prevention of bronchopulmonary dysplasia. the aim of this study was to evaluate the effect of azithromycin on the prevention of cytokine-mediated mv-induced injury in cytokine plasma levels (il-1β, il-2, il-6, il-8, il-10 and tnf- α) in preterm newborns, submitted to mechanical ventilation in the first 72 hours of life. it is a double-blind placebo controlled clinical trial. when the use of azithromycin was considered, after signing the informed consent, a randomization was performed by the intravenous mixtures center of hospital de clinicas de porto alegre where a group of newborns will receive azithromycin ev at the dose of 10mg / kg / day and another group will receive placebo (sf 0.9%) in the same volume, a blood aliquot of 300μl will be collected in all etda for cytokine analysis and pcr for ureaplasma. after 5 days of starting azithromycin or placebo, a new sample will be collected for cytokines along with blood collection from the patient's routine. there will be no blood collection exclusively for the study.

Eligibility criteria:
inclusion criteria: * preterm infants of less than 37 weeks of gestational age who have undergone mechanical ventilation within the first 72 hours of life exclusion criteria: * major congenital malformations or chromosomal syndromes mothers carrying the hiv virus.