Kornimate/medical-research-clean huggingface dataset:
a study to evaluate fenofibrate combination with statin in chinese patients with dyslipidemic

Conditions: Dyslipidemias; Cardiovascular Diseases; Hypertriglyceridemia

Summary: atherogenic dyslipidemia includes patients who have coronary heart disease (chd) or chd risk equivalents, whose tg level is not adequately controlled after statin monotherapy. according to the published esc/eas consensus, fibrate is suggested to be added to this type of patient who has insufficient improvement. the purpose of the study is to evaluate the efficacy on lipid control and the safety of adding fenofibrate in patients on a background of statin treatment.

it is an open-label , single group, multi-center study. at around 30 investigate sites, 500 dyslipidemic chinese patients with coronary heart disease (chd) or chd risk equivalent, whose tg ≥1.70 mmol/l (150mg/dl) and \ 3uln, or ck \>10uln, or bun \>1.5uln or cr \>1.5uln. other arm type is a self comparator

Eligibility criteria:
inclusion criteria: 1. ≥18 years and \< 80 years, male or female 2. with at least one risk of coronary heart disease (chd) \[medical history of myocardial infarction (mi) or coronary angiography shows coronary stenosis ≥ 50% or post percutaneous coronary intervention (pci) or post coronary artery bypass grafting (cabg)\] or chd risk equivalents, which comprise, * other clinical forms of atherosclerotic disease (ischemic stroke, peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease) * type 2 diabetes * multiple risk factors that confer a 10-year risk for chd \>20%. 3. ≥ 2 months statin monotherapy with standard dose (atorvastatin ≤20mg q.d. or rosuvastatin ≤10mg q.d. or simvastatin ≤40mg q.d. or pravastatin ≤40mg q.d. or pitavastatin ≤4mg q.d or fluvastatin ≤80mg q.d. or lovastatin ≤40mg q.d.) and plan to continue the previous type and dose of statin 4. triglycerides (tg)≥1.70 mmol/l (150mg/dl) and tg\<5.65 mmol/l (500mg/dl) 5. subject must be able to provide informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), on his or her own behalf, prior to any study-specific procedures. exclusion criteria: 1. hypersensitive to fenofibrate or to any of its excipients 2. hepatic insufficiency \[alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2uln (upper limit of normal)\] 3. renal insufficiency \[creatinine clearance rate (ccr)\<60ml/min estimated from cockcroft-gault equation ccr=(140-age)\*weight(kg)\*0.85(if female)/\[0.818\*cr (µmol/l)\] 4. creatine kinase (ck) \> 2 uln 5. congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency 6. hypothyroidism 7. combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months 8. combination use of drug with similar structure as fenofibrate, especially ketoprofen 9. combination use of oral anticoagulants 10. pregnant or lactating woman 11. other conditions at investigator's discretion

Keywords: lipid regulating agents drug therapy cardiovascular diseases hypertriglyceridemia hydroxymethylglutaryl-coa reductase inhibitors fenofibrate dyslipidemias combination
prevalence of acute critical neurological disease in children: a global epidemiological assessment

Conditions: Cardiac Arrest; Stroke; Traumatic Brain Injury; Brain Mass; Status Epilepticus; Spinal Cord Disease; Hydrocephalus

Summary: pangea is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease.


Eligibility criteria:
inclusion criteria: 1. children aged 7 days to 17 years inclusively and admitted to an icu (icu can be classified as general, cardiac, trauma, etc). 2. children with acute or acute on chronic neurologic disease that occurred just prior to hospital admission or occurred during the hospital admission. 3. acute neurologic disease is secondary to tbi, stroke, brain mass, hydrocephalus, cardiac arrest, status epilepticus, cns infection/inflammation, or spinal cord injury. exclusion criteria: 1. children with acute perinatal neurologic disease. 2. children with isolated chronic brain injury and no acute neurologic disease.
bipolar disorder study for men and women

Conditions: Bipolar Disorder

Summary: a placebo controlled study evaluating efficacy and safety of medication in patients with bipolar disorder


Eligibility criteria:
inclusion criteria: * patients must provide written and informed consent * diagnosis of bipolar i disorder and currently depressed for minimum of the previous 8 weeks * patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior exclusion criteria: * patients must not be suicidal * patients must not have a history or non-response to antidepressant treatment * patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry * patients must not have had epilepsy or hypothyroidism
efficacy study of floseal in hemostasis after laparoscopic ovarian cystectomy

Conditions: Benign Ovarian Tumor

Summary: to compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between floseal and electrocauterization in laparoscopic ovarian cystectomy


Eligibility criteria:
inclusion criteria: * premenopausal women * patients who is planned to undergo laparoscopic ovarian cystectomy * american society of anesthesiologists physical status classification (asa ps) 1-2 * patients with adequate bone marrow, renal and hepatic function: wbc \> 3,000 cells/mcl platelets \>100,000/mcl creatinine \<2.0 mg/dl bilirubin \<1.5 x normal and sgot or sgpt \<3 x normal * patient must be suitable candidates for surgery * patients who have signed an approved informed consent exclusion criteria: * patients with a history of pelvic or abdominal radiotherapy; * patients who are pregnant or nursing * patients who is receiving or requires hormone replacement therapy after surgery * patients who is undergoing hysterectomy at this time * patients who is undergoing unilateral or bilateral oophorectomy * previous history of ovarian cystectomy or oophorectomy * patients with contraindications to surgery * unfit for surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * patient compliance and geographic proximity that do not allow adequate follow-up. * hormone therapy within 3 months before surgery
clinical characterisation of the vascular effects of cis-platinum based chemotherapy in patients with testicular cancer

Conditions: Testicular Cancer; Cardiovascular Diseases

Summary: incidence is increasing1,2. whilst the prognosis is very good with the vast majority of patients cured with orchidectomy alone, those with high risk stage one non seminomatous germ cell cancer (nscgt) or metastatic disease (nscgt or seminoma) are treated by surgery followed by chemotherapy. platinum based chemotherapy is associated with long-term cardiovascular sequelae. endothelial dysfunction is a key component of early atherogenesis and the later stages of obstructive atherosclerosis, plaque rupture and thrombus formation. whilst endothelial toxic effects of bep chemotherapy appear to be central in the pathophysiology of associated complications, abnormalities in endothelial function as assessed by measures of brachial artery flow-mediated dilatation (fmd) have not demonstrated a consistent effect over time. when assessed within ten weeks of platinum-based chemotherapy9, no change in fmd was observed whilst marked decreases are seen immediately following treatment11 and also one year following treatment12. therefore, the time-course of endothelial vasomotor impairment remains incompletely defined in a single prospective cohort.

there remains an unmet need to identify a preventive treatment for patients with testicular cancer treated with platinum based chemotherapy to diminish the substantial risk of subsequent cardiovascular events. a future randomised trial of statin therapy in these patients is under consideration and results from this pilot study will inform its design. before moving towards interventional studies the proposed pilot study will enable a better understanding of the nature, time-course and dose-dependent effects of the mechanisms contributing to increased cardiovascular risk. single-centre, prospective pilot study assessing the cardiovascular effects of treatment with orchidectomy or orchidectomy plus cisplatin based chemotherapy for testicular cancer.

Eligibility criteria:
inclusion criteria: * histological diagnosis of stage 1 or igcccg5good or intermediate prognosis metastatic testicular/retroperitoneal germ cell cancer with treatment plan that includes orchidectomy or orchidectomy plus cisplatin based chemotherapy * aged between 18 and 65 years inclusive exclusion criteria: * unable to provide written, informed consent * unable or unwilling to attend for investigations * current involvement in a clinical trial * anti-platelet therapy at time of enrolment * statin or other lipid-lowering therapy at time of enrolment * recreational drug use * ongoing inflammatory, infective or autoimmune disease * other malignant disease diagnosed in previous 5 years * previous venous or arterial thrombotic/thromboembolic event

Keywords: cisplatin flow mediated dilatation
aerobic exercises and postural stabilization exercises in fibromyalgia syndrome

Conditions: Fibromyalgia Syndrome; Physiotherapy; Rehabilitation

Summary: fibromyalgia syndrome (fms) is a chronic rheumatic disease characterized by a wide range of symptoms such as widespread muscle pain, fatigue, sleep disturbances, anxiety-depression, impaired balance, falling risk, poor physical condition, cognitive dysfunction, and irritable bowel syndrome. the aim of the study; it is a comparison of the effectiveness of aerobic exercises and postural stabilization exercises that are structured to reduce the pain severity, fatigue, sleep problems and anxiety-depression levels of patients who are being followed up with a diagnosis of fms, and to increase the duration of physical activity and quality of life.


Eligibility criteria:
inclusion criteria: * being in the age range of 25-60 according to the 2013 american college of rheumatology (acr) diagnostic criteria, the pain placement score (aes) is 17 and the symptomatic effect score (ses) is ≥21. * fms symptoms persist for more than 3 months * ability to adapt to exercise * having the ability to use the necessary devices for web-based training exclusion criteria: * any disease that may hinder exercise * finding cardiological problems for aerobic exercises * presence of loss of sense and sense of position * presence of an unhealed fracture or surgical wound patients with mental / psychotic disorders

Keywords: aerobic exercise postural control fibromyalgia
efficacy and safety of tenofovir df/atazanavir enhanced with low dose of ritonavir in hiv-infected patients

Conditions: HIV Infections

Summary: this trial is aimed at studying the antiviral activity, toxicity and pharmacokinetic (pk) interactions of tenofovir df and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to hiv patients with multiple failure, under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir.

when licensed, new drugs are widely used in patients failing antiretroviral therapy, including patients with multiple failures. in such patients, having multi-resistant virus, the introduction of one new drug only in the salvage regimen will infrequently result in undetectable virus load in the plasma. tenofovir df and atazanavir appear promising because of their pharmacokinetic profile, activity, safety and resistance properties. in addition, pharmacokinetic data in healthy volunteers suggest that atazanavir could be optimized by adding ritonavir at low dose. thus, one may speculate that atazanavir pharmacokinetic and antiviral activity could be optimized by adding ritonavir at low dose in patients exhibiting high rate of protease inhibitor mutations. this protocol is aimed at studying the antiviral activity, toxicity and pk interactions, of tenofovir df and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to patients with multiple failure, under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir. ekg abnormalities (increased pr and qtc intervals) were observed in normal volunteers treated with atazanavir, therefore ekg safety monitoring will be performed on all subjects during this study

Eligibility criteria:
inclusion criteria: * males and non pregnant females 18 years of age and older who have confirmed laboratory diagnosis of hiv infection and documented failure (plasma hiv rna level over 10,000 copies/ml) to at least two protease inhibitors (ritonavir \[rtv\] must have been given at a dose over 400 mg twice a day (bid), in order to qualify for a protease inhibitor in this study) and one non-nucleoside reverse transcriptase inhibitor (nnrti) * ongoing antiretroviral therapy at inclusion without change within the last month * no threshold of cd4 cell count * patients naive of atazanavir and tenofovir df exclusion criteria: * cardiomyopathy * qtc interval over 450 msec and pause length over 3 seconds on screening ekg * heart rate below 40 bpm * third degree heart block, and clinical symptoms potentially related to heart block * ongoing immunotherapy including il2, interferon or hiv specific vaccine * ongoing opportunistic infection

Keywords: hiv infections treatment failure tenofovir atazanavir
review of procedural factors and outcomes after atrial fibrillation ablation with active esophageal cooling: a sub-study of the real af registry

Conditions: Atrial Fibrillation

Summary: this is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation.

treatment of atrial fibrillation, using pulmonary vein isolation, involves some risks to collateral structure, including the esophagus. active esophageal cooling has shown benefits in multiple studies when used in the treatment of paroxysmal atrial fibrillation or persistent atrial fibrillation during left atrial ablation. the largest randomized, controlled trial to date, the impact study, found an 83% reduction in endoscopically identified esophageal lesions when using the active cooling, with a dedicated device, compared to standard esophageal monitoring, with no difference in atrial fibrillation recurrence rates at follow-up. recent analyses have suggested additional effects from active esophageal cooling during pulmonary vein isolation, including reductions in procedure time, reductions in fluoroscopy usage, reductions in post-ablation discomfort, and improvements in long-term freedom from arrhythmia. further investigation of these associations is important to better understand the magnitude of these findings in a variety of clinical settings.

Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal atrial fibrillation (af episode terminate spontaneously within 7 days) or persistent atrial fibrillation (af sustained beyond 7 days) who, in the opinion of the investigator, are scheduled for ablation for atrial fibrillation with active esophageal cooling. * \>18 years of age * index or redo ablation procedure and enrolled in the real af registry * willing and able to provide informed consent and complete gerd questionnaire. exclusion criteria: * for the purpose of this sub-study, candidates will be excluded if they meet any of the following criteria: * enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan. * in the opinion of the investigator, any known contraindication to an ablation procedure. * \<18 years of age
high-risk hpv infections in women aged 25 to 65

Conditions: Papillomavirus Infections

Summary: the purpose of this study is to determine risk factors for hpv infections in 25 to 65 year old women who report having used internet dating websites in the past year.

whether older women are susceptible to acquiring new, persistent high-risk (hr) hpv infections from new sex partners is largely unknown. this is a pilot study of predictors of hr hpv infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 400 women will be recruited and mailed kits for self-collecting vaginal specimens for hpv dna testing. women will self-collect two sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. if new hpv infections associated with recent new partners are detected in these women, this pilot data will be used to develop a larger longitudinal study of the acquisition and natural history of hr hpv infections in older women. this information is important for developing guidelines for hpv vaccine implementation and cervical cancer screening guidelines in populations of older women.

Eligibility criteria:
inclusion criteria: * have had sex with men * have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website) exclusion criteria: * pregnant, breastfeeding, or planning a pregnancy in the next 6 months * hysterectomy
a study of patients treated with erythropoietin receptor agonists for anemia who developed anti-erythropoietin antibodies

Conditions: Anemia

Summary: the purpose of this study is to assess the presence of anti erythropoietin antibodies (anti epo ab) in participants responding to any erythropoietin receptor agonist (era) therapy to treat or prevent anemia without loss of effectiveness to see if they will develop pure red cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the duration of effectiveness of era therapy.

this is an observational (study in which the investigators/physicians observe the participant's data and measure their outcomes), international, multicenter (study conducted at multiple sites), cohort (group of individuals with similar characteristics) study. the study consists of prestudy phase, observational phase (2 years), and follow-up phase (1 year). approximately 50 participants who already receiving era therapy for anemia will be observed in this study. in the observational phase, participants' erythropoietin antibody status (positive or negative), clinical progress, treatment for anemia or prevention of anemia, and outcome will be monitored. during this study, enrolled participants will continue to receive standard-of-care treatment for their disease from their individual investigators as before enrollment to this study. safety evaluations will include assessment of adverse events which will be monitored throughout the study. the total duration of the study will be 3 years.

Eligibility criteria:
inclusion criteria: * receiving any era therapy for any cause of anemia and having responded to the era therapy for at least 3 months * positive or borderline serum for antibodies to erythropoietin identified by serum radioimmunoprecipitation * maintained a stable hemoglobin within a 3-month period that has not decreased more than 2 g/dl in any 1-month period and with no increase in red blood cell transfusion requirement * an era maintenance dose that has not increased more than 50 percentages from initial effective dose * if blood count information is available, must have a count of reticulocytes (immature red blood cells) greater than or equal to 30 million/l exclusion criteria: * stem cell or bone marrow transplantation * treatment with medication that decreases the ability of the immune system to function normally, within the last 3 months * participants who have shown a loss of effectiveness to era therapy, defined as participants who initially responded to treatment for anemia \[a rise in hemoglobin which lasted for a minimum of 3 months\] followed by an unexplained decrease in hemoglobin (greater than or equal to 2 g/dl) within a 1-month period

Keywords: anemia erythropoietin epoetin alfa erythropoietin receptor agonist (era) therapy anti-erythropoietin antibodies (anti-epo ab) recombinant human erythropoietin pure red cell aplasia darbepoetin
prognostic value of the 6-minute stepper test in non-small cell lung cancer surgery

Conditions: Lung Neoplasm Malignant; Resectable Lung Non-Small Cell Carcinoma

Summary: the objective of this study is to evaluate the performances of the six-minute stepper test (6mst) and sit to stand test (stst) to predict post-operative complications after minimally invasive lung cancer resection.


Eligibility criteria:
inclusion criteria: * age \>18 * non-small cell lung cancer stage i to ii, justifying major resection by vats or rats (segmentectomy, lobectomy, pneumonectomy), with or without histological confirmation exclusion criteria: * partial or total amputation localized to the lower limb; * weight greater than 100 kg; * orthopedic, vascular or neurological disorders leading to the incapacity of realize the 6mst; * patient under tutorship or curatorship; * pregnant woman. * surgery canceled

Keywords: lung resection low technology six minutes stepper test sit to stand test physiotherapy lung surgery post-operative complications