Kornimate/medical-research-clean huggingface dataset:
effect of vitamin d on ovulation rate in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome; Anovulation

Summary: this is a randomized double-blind controlled trial on the effect of vitamin d supplementation to assess the ovulation rate of women with polycystic ovary syndrome (pcos) and other reproductive, endocrine and metabolic outcomes after one year of treatment.

the hypothesis is that vitamin d supplementation results in significant improvement in the ovulation rate of women with pcos either spontaneously or with oral ovulation induction agent. anovulatory women with pcos diagnosed by the rotterdam criteria will be recruited. participants will be randomized to the (1) vitamin d group or (2) placebo group. those in the vitamin d group will take vitamin d 50,000 iu/ week for 4 weeks, followed by 50,000iu once every 2 weeks for 52 weeks, whereas those in the placebo group will take placebo tablets with the same external appearance. those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction. the primary outcome is the ovulation rate and will be compared between the 2 groups.

Eligibility criteria:
inclusion criteria: * premenopausal * aged 18-40 years * irregular long menstrual cycles (\>35 days) * pcos according to the rotterdam criteria * agree for transvaginal ultrasound exclusion criteria: * use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months * history of any medical condition or medications that may predispose to vitamin d sensitivity, altered vitamin d metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants * use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive * anticipated to use the above medications in the coming one year * known type 2 diabetes mellitus * refusal to join the study * abnormal blood calcium level for those on supplements, we asked them to stop their own supplements.
individualizing hemophilia bypassing agent therapy utilizing thromboelastography

Conditions: Hemophilia a with Inhibitors

Summary: this pilot study will investigate the use of thromboelastograph (teg) to determine the primary bypassing agent for the management of bleeding in children and adults severe hemophilia a patients with inhibitors. the study will evaluate the teg profile for each of the available bypassing agents (feiba and rfviia) in each participating patient, which will then determine which agent provides the most robust clot formation as measured by the teg. this study will consist of screening visit and 2-4 pharmacokinetic studies to determine the "best" bypassing agent based on the teg results. patients will then be assigned that bypassing agent and dose for the treatment of their bleeding episodes (prophylaxis or on-demand). each patient will be then followed for a period of 6 months to monitor short-term safety of those patients whose bypassing agent was modified.

currently, there are no laboratory assays that can assess the pharmaceutical activity of the available agents known collectively as bypassing agents, which negatively impacts the treating physician's ability to manage these patients, leaving decisions on the dosing regimen to trial and error. both agents, feiba and recombinant activated factor vii (rfviia), are approved for the treatment of bleeding in inhibitor patients with recommended dosing regimens that are based on clinical trials. however, a significant amount of "experimenting" with other dosing regimens is used by physicians and patients. the goal of this project is to demonstrate that teg is an excellent biomarker for predicting, managing and individualizing the treatment with feiba and rfviia of this rare and difficult to treat patient population.

Eligibility criteria:
inclusion criteria: 1. males, 4-60 years old, inclusive on prophylaxis or on-demand treatment 2. diagnosis of hemophilia with active titer inhibitors (\> 0.6 bu) 3. willing to alter their treatment regimen per study protocol exclusion criteria: 1. bleeding disorder(s) other than hemophilia a with inhibitors 2. thrombocytopenia (platelet count \<100,000k/µl) 3. any concurrent clinically significant major disease that, in the opinion of the investigator, would make the subject unsuitable for enrollment 4. participation within the past 30 days in a clinical study involving investigational drugs 5. planned major surgery within 30 days prior to screening or during the study period
normalcy of food intake in head and neck cancer patients

Conditions: Neoplasms, Head and Neck

Summary: * background: oral nutrition appears to be a challenge for patients with head and neck cancer after radiotherapy. many patients desire to (their) 'normal food intake' and return to oral nutrition with normal consistency without modifications and diet formulas. due to the dysphagia experienced post treatment this seems tremendously difficult. referral to a speech-language therapist for swallowing therapy is no standard procedure. * study design: a prospective randomized study in patients with a tumor in oral cavity, nasopharynx, oropharynx, hypopharynx or larynx with stage ii-iv (uicc tnm-tumor classification), ≥ 18 years, eligible for primary treatment with (chemo)radiation or adjuvant radiotherapy with curative intent. * intervention: individually tailored swallowing therapy by an experienced speech-language therapist in cooperation with individual dietary counselling (by an experienced dietician, 'usual care') pre-, per- and post treatment (until 6 months after treatment). this might improve 'normalcy of food intake', quality (no food modifications) and quantity of food intake and besides decrease the use of tube feeding and/or nutritional supplements. also patients quality of life and nutritional status may be influenced positively. * study hypothesis: the purpose of this study is to determine whether combined individual swallowing therapy and individual dietary counselling in patients with head and neck cancer receiving (chemo)radiotherapy can improve 'normal food intake'. food intake without modifications and tube feeding and/or nutritional supplements.


Eligibility criteria:
inclusion criteria: * patients with tumor in oral cavity, nasopharynx, hypopharynx or larynx with stage ii-iv (uicc tnm-tumor classification) * eligible for primary curative treatment intentions with (chemo)radiation or adjuvant (chemo)radiotherapy * a signed informed consent exclusion criteria: * historical swallowing problems (neurological or not tumor related) * unable to comprehend and carry out the swallowing rehabilitation * unable to answer study questions * radiation or surgery for head and neck cancer in history.

Keywords: head and neck neoplasms radiotherapy diet counselling swallow therapy food intake
glucocorticoids in covid-19 (cortivid)

Conditions: Covid-19 Pneumonia

Summary: around 30% of admitted patients with covid-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (arsd) could be prevented by the early initiation of immune-modulatory agents. the role of glucocorticoids (gc) in this setting remains controversial. this study aims to assess the safety and effectiveness of gc pulses to improve the clinical outcomes of patients with covid-19 pneumonia with risen inflammatory biomarkers.


Eligibility criteria:
inclusion criteria: * age ≥18 years old. * diagnosis of sars-cov-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (rt-pcr) on nasopharyngeal swab or sputum according to the recommendations of the spanish ministry of health. * length of symptoms consistent with covid-19 ≥7 days. * hospital admission. * at least one of the following: crp \>60 mg/l, il-6 \>40 pg/ml, ferritin \>1000 μg/l. * acceptation of informed consent exclusion criteria: * allergy or contraindication to any of the drugs under study. * spo2 \<90% (in air ambient) or pao2 \<60 mmhg (in ambient air) or pao2/fio2 \<300 mmhg. * ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication. * decompensated diabetes mellitus. * uncontrolled hypertension. * psychotic or manic disorder. * active cancer. * pregnancy or lactation. * clinical or biochemical suspicion (procalcitonin \>0.5 ng/ml) of active infection other than sars-cov-2. * out-of-hospital management patient. * conservative or palliative management patient. * participation in another clinical trial. * any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.

Keywords: covid-19 pneumonia inflammatory phase glucocorticoids
prospective multicenter study to characterize the real-world evidence regarding safety and performance of the ptca nc catheters family

Conditions: Coronary Artery Stenosis

Summary: the purpose of this post market study is to collect clinical data of the arthesys ptca nc catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support mdr submission.


Eligibility criteria:
inclusion criteria: patients will be included as per instructions for use (ifu), hospital standard of care and good clinical practice (gcp): * patient with a percutaneous intervention to a native coronary or coronary bypass graft indication * patient \>18 years * patient who understands the trial requirements and the treatment procedures and provides written informed consent exclusion criteria: patients will be excluded as per ifu, hospital standard of care and gcp. patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
alcohol & men's sexual risk behaviors

Conditions: Sexual Behavior; Alcohol Drinking; Sexual Aggression; Emotions

Summary: this project extends the investigators' previous research regarding the intersecting risks of alcohol, sexual risk behavior (srb), and sexual aggression (sa) in male drinkers who have sex with women by examining the mediating and moderating roles of both intrapersonal and interpersonal emotional factors. while independent streams of research consistently document alcohol's role in srb and sa, the investigators' work has demonstrated that these behaviors are related, and that alcohol exacerbates their likelihood both independently and synergistically. the researchers' investigations focus on a particular type of srb: men's resistance to condom use with female partners who want to have protected sex. condom use resistance (cur) is common and normative among young male drinkers, with up to 80% of men reporting engaging in cur. of particular concern, research demonstrates that up to 42% of men report using coercive cur tactics such as emotional manipulation, deception, condom sabotage, and force to obtain unprotected sex. investigators will evaluate hypotheses that distal and proximal emotional and alcohol factors influence in-the-moment srb/cur intentions as well as daily alcohol use and srb/cur. the investigators will also examine whether the relationships among assessed variables are similar across experimental and naturalistic settings. that is, investigate the extent to which men's responses in the lab parallel their real-world drinking and srb/cur behaviors, particularly regarding self and partner emotions, empathy, and interpersonal stress.


Eligibility criteria:
inclusion criteria: * single * male * ages 21-30 * engagement in unprotected intercourse with a woman at least once in the past year * consumed alcohol at least 2 times per week in the past 30 days * had sex with a woman at least 2 times in the past 30 days exclusion criteria: * a history of alcohol problems * a medical condition and/or medications which contraindicate alcohol consumption * in a relationship that is monogamous and has lasted longer than 6 months

Keywords: condom use resistance emotion dysregulation
stress among final year bams students in relation with covid lockdown through cssq-a cross sectional survey

Conditions: Covid Related Psychological Stress

Summary: we were randomly selected the ayurveda colleges in kerala.selected final year bams students as participants.we have also selected a group of 5 members for data colle tion.we have selected a validated covid stress questionnaire and circulated through what's app and gmail.we were received responses from each college with .we analyzed and interpreted data.

we were randomly selected the ayurveda colleges in kerala.selected final year bams students as participants.we have also selected a group of 5 members for data colle tion.we have selected a validated covid stress questionnaire and circulated through what's app and gmail.we were received responses from each college with .we analyzed and interpreted data.

Eligibility criteria:
inclusion criteria 1.final year bams 2.irrespective of gender - exclusion criteria: * age group other than 20-22 yrs

Keywords: stress,covid,lock down days
pegylated somatropin (peg somatropin) in the treatment of children with growth hormone deficiency

Conditions: Growth Hormone Deficiency

Summary: to evaluate the safety and efficacy of peg somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of peg somatropin.


Eligibility criteria:
inclusion criteria: * diagnosed as ghd before starting treatment, according to medical history, clinical symptoms and signs, gh provocation tests and imaging and other examinations: 1. according to statistical height data of physical development of chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children; 2. height velocity (hv) ≤5.0 cm / yr; 3. gh provocative tests (with two drugs of different mechanism of action) confirmed plasma gh peak \<10.0 ng / ml; 4. bone age for girl≤9 years old, for boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year; * before puberty (tanner i stage), age≥3 years old, male or female; * have not received hormone therapy within 6 months; * subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent. exclusion criteria: * dysfunction of liver and kidney (alt\> 2 times the upper limit of normal, cr\> upper limit of normal); * patients positive for hepatitis b c-antibody (hbcab), hepatitis b surface antigen (hbsag) or hepatitis b e antigen (hbeag); * patients with known hypersensitivity to peg somatropin or somatropin or any other components of the study product; * patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases; * potential cancer patients (family history); * patients with diabetics; * patients with other growth disorders, such as turner's syndrome, sexual physical delayed puberty, laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities; * patients with congenital bone dysplasia or scoliosis; * subjects took part in other clinical trial study during 3 months; * other conditions in which the investigator preclude enrollment into the study.
effect of 6r-bh4 treatment in coronary artery disease (oxbio study)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the effect of 6r-bh4 on vascular function in patients with coronary artery disease. we hypothesize that 6r-bh4 will improve vascular function in these patients.

decreased production of nitric oxide (no) from the endothelium (the layer of cells that forms the lining of all blood vessels) has been shown to contribute to atherosclerosis. no has multiple beneficial effects on vascular function. endothelial function can be measured in humans via a number of methods, and endothelial dysfunction has been shown to be a strong adverse predictor of cardiovascular events and mortality. tetrahydrobiopterin (bh4) is essential for the production of no in endothelial cells. 6r-bh4 is a synthetic version of naturally occurring bh4. we aim to investigate the effects of oral 6r-bh4 supplementation on endothelial function in patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * multi-vessel coronary artery disease scheduled for coronary artery bypass surgery (cabg) exclusion criteria: * inability to provide informed consent * female subject who is pregnant, lactating or planning pregnancy during course of study * prior clinical diagnosis of heart failure requiring diuretic therapy with evidence of severe left ventricular dysfunction * recent acute coronary event (\<4 weeks) * emergency cabg * newly diagnosed diabetes mellitus (\<1 month) * body weight \>130kg * impaired renal function (creatinine \>180umol/l) * elevated liver function tests (alt \>50umol/l or ast \>2x normal) * pacemakers, icds or metallic implants not compatible with mri scanning * subjects receiving experimental medications or participating in another study * terminally ill subjects * known hypersensitivity to 6r-bh4 * concomitant treatment with methotrexate, levodopa, pde-3 or pde-5 inhibitors

Keywords: endothelium nitric oxide magnetic resonance imaging tetrahydrobiopterin
stress management program for world trade center (wtc) responders

Conditions: PTSD; Signs and Symptoms, Respiratory

Summary: many responders to the world trade center (wtc) disaster continue to experience significant mental and physical health problems. two of the most common health problems, post-traumatic stress disorder (ptsd) symptoms and respiratory illness, often occur together. mental health conditions, such as ptsd, make physical illnesses worse and interfere with treatment. the primary goal of this study is to test a mind-body treatment designed to reduce both ptsd and respiratory symptoms.

mind-body interventions including relaxation training and other coping skills are effective for patients with both mental and physical health problems. a leading mind-body treatment is the relaxation response resiliency program (3rp) developed at harvard. this treatment has been shown to reduce both mental and physical health symptoms. the objective of this study is to adapt the 3rp to wtc responders and test its ability to reduce both ptsd and respiratory symptoms. this treatment will be compared to a health enhancement program that addresses negative health behaviors. the investigators will randomly assign 175 patients with ongoing wtc-related ptsd and respiratory illness to the 3rp or health enhancement program and will assess outcomes immediately after the treatment and at 3 and 6 month follow-ups.

Eligibility criteria:
inclusion criteria: * pcl score equal to or greater than 35 * 2 or more lower respiratory symptoms exclusion criteria: * regular elicitation of the relaxation response * history of psychosis * current unmanaged bipolar disorder * history of suicide attempt --or-- current ideation with plan or intent

Keywords: ptsd trauma world trade center respiratory mind-body
bi 2536 second line monotherapy in sclc

Conditions: Carcinoma, Small Cell

Summary: open label, uncontrolled phase ii trial to assess the efficacy and safety of bi 2536 in second line treatment in sensitive-relapse sclc patients.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed, -sensitive-relapse- sclc defined by a relapse 60 days or more after cessation of prior first-line chemotherapy. * patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater. * life expectancy of at least three months and ecog performance score of 2 or less and written informed consent that must be consistent with ich-gcp guidelines. exclusion criteria: * more than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology. * symptomatic brain metastases or leptomeningeal disease * patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer) * absolute neutrophil count (anc) \<1,500/µl, platelet count \<100,000/µl, or hemoglobin \<9 mg/dl * total bilirubin \>1.5 x uln, aspartame amino transferase (ast) and/or alanine amino transferase (alt) \>2.5 x uln, or aspartate amino transferase (ast) and/or alanine amino transferase (alt) \>5 x uln in case of known liver metastases, serum creatinine \>2.0 mg/dl (\>176 µmol/l, si unit equivalent) * chemo-, hormone- (other than megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug * radiation therapy within the past 2 weeks prior to or during treatment with the trial drug * patients with any serious active infection (i.e., requiring an iv antibiotic, antifungal, or antiviral agents), patients with known hiv, hepatitis-b or -c infection * known or suspected active drug or alcohol abuse * treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug * patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (coumadin ®) * patients with neuropathy (sensory or motor) ctcae 3
can ct enteroclysis predict the outcome of crohn's disease

Conditions: Crohn's Disease

Summary: specific ct enteroclysis findings with or without other clinical and laboratory variables, can identify crohn's disease patients who will response to medical therapy versus those who will either fail and require surgery or have uncontrolled disease.


Eligibility criteria:
inclusion criteria: * crohn's disease with ct enteroclysis during symptomatic treatment exclusion criteria: * crohn's disease subjects who have had a follow-up less than 1 year, without surgery * crohn's disease subjects that were later diagnosed with a bowel malignancy

Keywords: crohn's disease ct enteroclysis