Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of risperidone 1 mg tablets of torrent pharmaceuticals limited, india and risperdal® (risperidone) 1 mg tablets of janssen pharmaceutical products, lp, usa, in healthy human adult subjects, under fed conditions

Conditions: Healthy

Summary: objective: * to assess the bioequivalence of risperidone 1.0 mg tablets of torrent pharmaceuticals limited., india and risperdal® (risperidone) 1.0 mg tablets of janssen pharmaceutical products, lp, usa, in healthy human adult subjects, under fed conditions. study design: * a randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.


Eligibility criteria:
inclusion criteria: 1. healthy adult subjects of either sex between 18-55 years of age (inclusive) have a body mass index (bmi) between 18 and 27 kg/m2. 2. subjects who had no evidence of underlying disease during screening and whose physical examination was performed within 21 days prior to commencement of the study. 3. subjects whose screening laboratory values were within normal limits or considered by the investigator to be of no clinical significance. 4. informed consent given in written form according to section 11.3 of the protocol. 5. female subjects: * of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine contraceptive device, (iud) or abstinence. * postmenopausal for at least 1 year. * surgically sterile (bilateral tubal ligation, bilateral oophorectomy,or hysterectomy). exclusion criteria: 1. history or presence of significant: * cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. * alcohol dependence, alcohol abuse or drug abuse within past one year. * moderate to heavy smoking (\>10 cigarettes/day) or consumption of tobacco products. * history of difficulty in swallowing tablets. * clinically significant illness within 4 weeks before the start of the study. * asthma, urticaria or other allergic type reactions after taking any medication. * positive urine drug screening, hiv, hepatitis b \& c tests. * any history of hypersensitivity to risperidone. 2. participation in any clinical trial within the preceding 12 weeks of study start. 3. subjects who had: * systolic blood pressure less than 90 mm of hg or more than 150 mm of hg. * diastolic blood pressure less than 60 mm of hg or more than 94 mm of hg minor deviations (2-4 mm hg) at check-in, if any, were acceptable at the discretion of the physician /investigator. * pulse rate below 50 /min or above 105 /min. 4. female subjects demonstrating a positive pregnancy screen or currently breast-feeding or whose menstruation cycle coincides with the study dates.
ruxolitinib and chidamide intensified bu/cy conditioning regimen

Conditions: Peripheral Blood Stem Cell Transplantation

Summary: the purpose of this study is to determine the efficacy and safety of ruxolitinib and chidamide intensified conditioning regimen in patients with acute b cell lymphoblast leukemia underwenting haploidenticl peripheral blood stem cell transplantation.

haploidenticl peripheral blood stem cell transplantation should be offered to eligible patients with acute b cell lymphoblast leukemia whenever feasible. to further improve the outcome of transplantation patients with acute b cell lymphoblast leukemia, we developed a modified bu/cy conditioning regimen intensified by ruxolitinib and chidamide. in this study, we tested the efficacy and feasibility of the modified bu/cy conditioning regimen intensified by ruxolitinib and chidamide in patients with acute b cell lymphoblast leukemia undergoing allogeneic peripheral blood stem cell transplantation.

Eligibility criteria:
inclusion criteria: 1. high risk acute b cell lymphoblastic leukemia with the indications for allogeneic transplantation; 2. have matched sibling donors, ≥8/10 hla matched unrelated donors or haploidentical donors 3. all patients should aged 12 to 65 years; 4. liver function: alt and ast≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal; 5. renal function: creatinine ≤the upper limit of normal; 6. patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; 7. eastern cooperative oncology group (ecog) performance status ≤2; 8. have signed informed consent. exclusion criteria: 1. pregnant women; 2. patients with mental illness or other states unable to comply with the protocol; 3. all patients with ph positive;
clinical feasibility of new tracheoesophageal puncture set

Conditions: Larynx Cancer

Summary: during a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. with this voice prosthesis the patient learns to speak again. during this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.


Eligibility criteria:
inclusion criteria: * primary puncture during total laryngectomy * secondary puncture some time after total laryngectomy exclusion criteria: * anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture * not eligible to use a voice prosthesis for other reasons

Keywords: voice prosthesis, larynx cancer, laryngectomy
etanercept: single blind control study in ocular manifestations of behcet's disease

Conditions: Behcet Syndrome; Uveal Disease

Summary: the purpose of this study is to find if etanercept can improve the outcome of ocular lesions of behcet's disease treated with methotrexate and prednisolone

to test in a randomized single blind control trial the efficacy of etanercept in patients with posterior uveitis and/or retinal vasculitis of behcet's disease treated with methotrexate and prednisolone

Eligibility criteria:
inclusion criteria: * behcet's disease according to the international criteria for behcet's disease (icbd) * active posterior uveitis and/or retinal vasculitis exclusion criteria: * visual acuity inferior to 1/10 on snellen chart * being under cytotoxic drugs or having received them in the past 2 months * not being able to follow the one year treatment and the regular follow ups

Keywords: etanercept behcet's syndrome behcet's disease ocular lesions uveitis retinal vasculitis
sst2 biomarker level in acute/chronic coronary syndrome after revascularization

Conditions: Myocardial Ischemia; Heart Failure; Coronary Intervention

Summary: the role of soluble circulating suppression of tumorigenicity 2 biomarker (sst2) in the ischemic heart disease patient is a debatable point. therefore the aims of this study are to assess the plasma level of sst2 in ischemic heart disease patients versus non-ischemic ones, the acute changes in its level after percutaneous coronary intervention (pci) and its relation to the severity of ischemia.

a comparison of ischemic patients and non-ischemic controls will be done. the plasma level of sst2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group. then a study ischemic group will be divided into three subgroups; subgroup-1: single vessel disease, subgroup-2: two vessels disease and subgroup-3: multivessels disease. on admission, there will be a significant difference between the group of acute/chronic coronary syndrome cases and controls as regard sst2 plasma level or not. moreover, the differences between the three ischemic subgroups at the baseline st2 level will be assessed. the plasma sst2 level after pci and the correlation between the acute change in pot-pci sst2 level and the severity of ischemia by modified gensini score (mgs) will be evaluated. the final question that will be answered by this study does the rapid impact of pci on sst2 level will be mainly related to the severity of ischemia rather than left ventricular function or not.

Eligibility criteria:
inclusion criteria: * any patients aged 40 years or more and have the risk factors of ischemic heart disease (ihd) with coronary artery disease symptoms will be included. * for control subjects should be aged ≥ 40 years old with ihd risk factors including dm and htn and without any symptoms or signs of cardiac ischemia. exclusion criteria: * any patient with heart failure (ef \<50%), any patients with rhythm abnormalities including atrial fibrillation, obese patients, structural heart diseases, uncontrolled chronic diseases such as hypertension or diabetes mellitus, any pulmonary artery or parenchymal diseases up to respiratory failure, acute systemic infection or inflammation, and chronic/acute renal diseases.

Keywords: sst2 biomarker modified gensini score revascularization
evaluation of anatomic and visual outcomes of initially closed macular holes

Conditions: Macular Holes

Summary: to evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up.

in recent years, peeling of the internal limiting membrane (ilm) has been used as a supplementary treatment to reducing the tangential tractional forces and inducing hole closure in macular hole surgery, and thus the anatomic success rate has increased to over 90%. however, despite these high rates of surgical success, the reopening of initially closed macular holes has also been observed from the first month to several years following surgery. because about 45% to 95% of phakic patients frequently develop a progressive nuclear sclerosis cataract after macular hole surgery and require combined or subsequent cataract extraction to improve visual acuity, cataract extraction has become a potential factor in causing macular hole reopening, although this is still under debate. the purpose of this study is to describe the long-term anatomic and visual outcomes in patients who had initial anatomic success with macular hole surgery and who had postoperative follow-up of one or more years. all patient's charts were reviewed for age, macular hole stage (using the gass classification), macular hole duration, epiretinal membrane of macula presence, ilm peeling, preoperative and postoperative visual acuity, rate of macular hole reopening, cataract extraction, and length of follow-up after vitrectomy.

Eligibility criteria:
inclusion criteria: * successful closure of a macular hole after initial vitreoretinal surgery * a follow-up of at least one year exclusion criteria: * post-traumatic holes, * myopic macular holes, * macular holes associated with a rhegmatogenous retinal detachment, * eyes with silicone oil tamponade.

Keywords: reopening of macular hole; visual acuity; phacoemulsification cataract surgery; vitrectomy
donepezil, residual excessive daytime sleepiness, obstructive sleep apnea

Conditions: OSA; Sleepiness

Summary: it is a randomized, double-blind, single-center, 30-day study. patients aged 35-60 years, with apnea and hypopnea index and respiratory disturbance index normalized with cpap, and epworth sleepiness scale\> 11. patients undergo baseline and cpap titration polysomnography, liquor and blood collection, multiple sleep latency test, anxiety and depression and cognitive assessments.

obstructive sleep apnea (osa) is a sleep-disordered breathing characterized by recurrent episodes of total or partial obstruction of the upper airway during sleep, which can lead to cognitive, metabolic and cardiovascular consequences. more recently, osa has been associated with worsening alzheimer's disease symptoms. resolving respiratory events during sleep often has a beneficial impact on these consequences. however, even after adequate and optimized treatment with continuous positive airway pressure (cpap), about 6 to 10% of patients still remain sleepy. given the high prevalence of osa, this percentage represents a large number of under-treated and at-risk individuals. this residual excessive sleepiness (res) may be related to comorbidities and cognitive alterations. its physiopathology is still unknown. a few studies have tested modafinil as an adjunct treatment for res patients. since a) cpap is ineffective in patients with res; b) previous studies suggest some benefit with wake promoters; and c) cognitive impairment has also been reported associated with res; the hypothesis of the present study is that donepezil improves alertness and cognition in patients with osa and res, evidencing the role of the cholinergic system in the pathophysiology of res. objective: to evaluate the effects of donepezil on res in adult patients treated with cpap. thirty-six patients diagnosed with osa and res are estimated to be included. participants will be treated with cpap for more than 6 months with a mean use greater than 5 hours per day. after blood and cerebrospinal fluid collection, patients will be randomized into 2 groups of 30 days of treatment with donepezil or placebo. res will be evaluated by the vigilance test and the epworth sleepiness scale.

Eligibility criteria:
inclusion criteria: * both gender, age between 35 and 65 years; * confirmed diagnosis of moderate to severe osa; * treatment with cpap for at least six months; * persistent sleepiness with daily cpap use compliance \> 5 hours per night. exclusion criteria: * neurological or psychiatric diseases; * chronic use of psychoactive drugs, other sleep disorders than osa, visual defficiency, illiteracy.

Keywords: osa cpap sleepiness donepezil
line versus spot ablation in persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: in this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

this randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (pv), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior pv versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the pv and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation. both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation. the study endpoint is a combined efficacy/safety analysis. extensive follow-up with three-monthly 7 days holter ecg is provided.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * symptomatic persistent (\> 7 days lasting) atrial fibrillation * at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy * oral anticoagulation (\> 4 weeks prior to ablation) exclusion criteria: * moderate to severe valvular heart disease * congenital heart disease * lv-ef \< 35% * reversible cause for atrial fibrillation (e.g., hyperthyreosis) * prior left atrial ablation or maze operation * left atrial thrombus
multinational study to evaluate tadalafil in asian men with signs and symptoms of benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: this study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of tadalafil once-a-day dosing for 12 weeks in asian men with signs and symptoms of benign prostatic hyperplasia (bph).


Eligibility criteria:
inclusion criteria: * asian males, with benign prostatic hyperplasia (bph) for at least 6 months prior to initiation and ipss score greater than or equal to 13 at the beginning of the treatment * agree not to use any other approved or experimental pharmacologic bph, erectile dysfunction (ed) and overactive bladder (oab) treatments at any time during the study. * have not taken finasteride or dutasteride therapy, anti-androgenic hormone or any other bph therapy, ed or oab therapy for specified duration of time prior to the beginning of the treatment exclusion criteria: * prostate specific antigen (psa) score beyond acceptable range defined for study at initiation * history of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation * history of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation * clinical evidence of prostate cancer at initiation * clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation * history of cardiac conditions, including angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study * history of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation) * use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (lhrh)agonists/antagonists, or anabolic steroids at initiation
endothelial function in prostate cancer patients on degarelix vs. luteinizing hormone-releasing hormone agonists

Conditions: Prostatic Neoplasms; Cardiovascular Diseases

Summary: the purpose of this study is to test whether degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to lhrh agonists.

this is a national multicenter randomized open-label superiority study of the use of degarelix compared to lhrh agonists among men with advanced prostate cancer and pre-existing cardiovascular disease. patients will be stratified based on baseline endothelial function and presence prostate cancer metastasis. study population: subjects with pre-existing cardiovascular disease with locally advanced or metastatic prostate cancer and scheduled to start androgen deprivation therapy (adt). patients already on adt will be excluded. subjects will receive either two initial loading doses of 120mg degarelix for 1 month followed by 80mg monthly for eleven additional months or an lhrh agonist at the discretion of the treating urologist/oncologist for 1 year. follow-up visits will occur every 3 months. a blood sample for prostate-specific antigen (psa), cardiac biomarkers and rectal examination will be performed each visit. at baseline 6 and 12 months endopat2000 measurements will be taken.

Eligibility criteria:
inclusion criteria: * male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer. * scheduled to start adt for a period of at least one year. * subject has a history of one or more of the following: 1. myocardial infarction 2. ischaemic or haemorrhagic cerebrovascular conditions 3. arterial embolic and thrombotic events, 4. ischaemic heart disease 5. prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures) 6. peripheral vascular disease (e.g. significant stenosis (abpi\<0.9), claudication, prior vascular surgery/intervention) * life expectancy of over 12 months. * who performance status of 0-2 * subject is able and has agreed to sign a consent form. exclusion criteria: * prior use of adt. however, prior use of anti-androgens such as casodex, chimax, drogenil, and cyprostat will be allowed. * prior use of dutasteride/finasteride in past 6 months * known allergic reaction to degarelix. * any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.

Keywords: prostate cancer cardiovascular disease degarelix
epidemiology of venous thromboembolism

Conditions: Cardiovascular Diseases; Thromboembolism; Peripheral Vascular Diseases

Summary: to evaluate potentially modifiable lifestyle predictors of venous thromboembolism and their joint associations with biochemical and genetic determinants.

background: venous thromboembolism is a common condition with considerable morbidity and mortality. the disorder has diverse causes including trauma, stasis, drugs, cancer, and genetic factors that contribute to enhanced clotting and coagulation. the study uses existing large-scale population studies to unravel factors responsible for and contributing to venous thromboembolism. design narrative: the study design is a prospective cohort study of 77,118 persons based on pooling information from four large randomized trials of us health professionals that have collected detailed risk factor information and have used common strategies to prospectively identify and validate cases of venous thromboembolism (vte). these trials are: physicians' health studies i \& ii including 29,071 us male physicians, of whom 22,071 have been followed since the initiation of the first trial in 1982; the women's health study including 39,876 female health professionals who will have an average of 10 years of follow-up; and the women's antioxidant cardiovascular study including 8,171 female health professionals with prevalent cardiovascular disease or at high risk of cardiovascular disease who will have an average of 8 years of follow-up. archived blood samples were collected from approximately 75 percent of participants at baseline and will be used to assess biochemical and genetic markers of risk including factor v leiden, the g20210a mutation in the prothrombin gene, hyperhomocysteinemia, and anticardiolipin antibodies. the study will assess the joint association with risk of these markers and potentially modifiable factors including body mass index, hormone replacement therapy, physical activity, and aspirin use. the study population will include over 1,000 incident cases of vte, including 750 with blood samples.

Eligibility criteria:
no human subjects are involved. collected data are used.
expression of inflammatory proteins in pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: the purpose of this trial is to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue.

purpose: to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue * trial with surgical intervention

Eligibility criteria:
inclusion criteria: * patients with pancreatic cancer or chronic pancreatitis exclusion criteria: * patients with alpha 1-antitrypsin deficiency
perceived impact of art therapy in patients with cystic fibrosis and in professional interdisciplinary teams taking care of them.

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. the patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining high self-esteem that gives meaning to his life, allowing, among other things, a good grip of treatment. through this research we hope to encourage the integration of art therapy in the course of care of cystic fibrosis patients, from children to adults before and after transplantation, in connection with the patient education and counseling


Eligibility criteria:
inclusion criteria: * cystic fibrosis aged adolescents 13 to 18 years, as part of their monitoring at cystic fibrosis center of nantes * adults over 18 years nontransplanted in their follow at cystic fibrosis center/transplantation center of foch * more than 18 adult transplant as part of their monitoring at cystic fibrosis center/transplantation center foch * professional interdisciplinary teams taking care of the cystic fibrosis children center of nantes, cystic fibrosis center/transplantation center of foch * agreeing to participate in research non inclusion criteria: * patient refusal of adolescent parents to participate in the study * professional refusal of teams to participate in the study