Kornimate/medical-research-clean huggingface dataset:
comparative pharmacokinetics study of clopidogrel and aspirin fixed-dose combination versus separate combination-2nd trial

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.


Eligibility criteria:
inclusion criteria: * a healthy male volunteer aged 20 to 55, and within 20% of ideal body weight. * have not any congenital or chronic diseases and medical symptom. * appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ecg, physical examination, blood, urinalysis result on screening. * able to participate in the entire trial. * signed the informed consent form prior to study participation. exclusion criteria: * take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first ip administration. * show evidence of acute disease within 28 days prior to the first ip administration. * have the medical history of bleeding symptom or bleeding disease * have the disease history(ex. inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug. * have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication. * have hypersensitivity reaction histories for clopidogrel or aspirin. * have abnormal laboratory result. ast or alt \> 1.25 times of upper limit/ total bilirubin \> 1.5 times of upper limit/ pt, aptt, bt over upper limit/ platelet count \ 350x10\^9/l * a drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first ip administration. * have a diet(especially, grapefruit juice-within 7days prior to the first ip administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s). * have donated whole blood within 60 days prior to the first ip administration. * participated in the other clinical trials within 90days prior to the first ip administration. * take medicine which affect to this trial within 10 days prior to the first ip administration. * appropriate subject for the trial judging from principal investigator.

Keywords: clopidogrel aspirin combination pharmacokinetics phase 1
effectiveness of internet delivered cognitive behavior therapy (cbt) for irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: the study will recruit 80 out-patients diagnosed with irritable bowel syndrome from a gastroenterological clinic. the recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. after recruitment and 3 week baseline measure of ibs symptoms they will be randomised to either 10 weeks of internet delivered cbt or waiting list. after treatment ibs-symptoms are measured again to assess treatment effectiveness. all patients on waiting list are offered the same treatment as patients randomised to treatment. all patients are assessed 12 months after completion of treatment. patients in treatment condition are hypothesized to experience significant reduction ibs symptoms and quality of life compared to patients on waiting list.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of irritable bowel syndrome according to rome iii criteria exclusion criteria: * history of inflammatory bowel disease (ibd) * symptom debut after age of 50 * ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease) * inability to participate in internet delivered treatment

Keywords: ibs cbt internet treatment cognitive behavior therapy
phase ii efficacy study of azd6244 in colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of the study is to assess if there is benefit when using azd6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. this study will also assess how safe and well tolerated azd6244 is.


Eligibility criteria:
inclusion criteria: * colorectal cancer * require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan * have world health organisation (who) performance status 0-2 and life expectancy \> 12 weeks exclusion criteria: * previous therapy with egfr inhibitor, mek inhibitor or capecitabine * any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study * nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption

Keywords: colorectal cancer azd6244
first-line treatment for atrial fibrillation in cardiology and geriatric departments

Conditions: Atrial Fibrillation

Summary: in order to evaluate the implementation for the recommendations about the patient care for atrial fibrillation in aged patients, a non-interventional study is performed retrospectively by comparing two approach of the focus in cardiology department and in geriatric unit.


Eligibility criteria:
inclusion criteria: * having an atrial fibrillation * cared in cardiology department or in geriatric unit exclusion criteria: * having a mitral valvulopathy, or a valvular disease with a surgery indication * having a valvular prosthesis * history of valve reconstruction
pk study of tacrolimus and cyclosporine when co-administered with adefovir dipivoxil in post-liver transplant patients

Conditions: Hepatitis B

Summary: open-label pharmacokinetic drug interaction study.

multi-center, phase 2, open-label, sequential-cohort, drug interaction study. cohort 1 subjects (tacrolimus and adefovir dipivoxil) were enrolled first. based on the findings in cohort 1, a decision was made on whether to enroll subjects in cohort 2 (cyclosporine and adefovir dipivoxil)(i.e., if no interaction was observed in cohort 1, cohort 2 subjects would not be enrolled). since no pharmacokinetic interaction was observed in cohort 1, cohort 2 was not enrolled.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * greater than or equal to 6 months post-liver transplantation * must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months. * must have calculated creatinine clearance greater than or equal 50 ml/min (cockcroft-gault method).

Keywords: hepatitis b post-liver transplantation adefovir dipivoxil tacrolimus cyclosporine
onlay mesh hernioplasty vs sublay mesh hernioplasty for paraumbilical hernia repair

Conditions: Paraumbilical Hernia

Summary: it is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.


Eligibility criteria:
inclusion criteria: * patients of both sexes and age 20 years and above with paraumblical hernia defect size 3 to 6cm in greatest diameter exclusion criteria: * defect size less than 3cm or greater than 6 cm in greatest diameter obstructed or strangulated hernia uncontrolled diabetes
trial in extensive-disease small cell lung cancer (ed-sclc) subjects comparing ipilimumab plus etoposide and platinum therapy to etoposide and platinum therapy alone

Conditions: Small Cell Lung Carcinoma

Summary: the purpose of the study is to determine whether the addition of ipilimumab to etoposide and platinum therapy will extend the lives of patients with extensive-stage disease small cell lung cancer (ed-sclc) more than etoposide and platinum therapy alone.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * extensive-stage disease small cell lung cancer (ed-sclc) * eastern cooperative oncology group (ecog) of 0 or 1 exclusion criteria: * prior systemic therapy for lung cancer * symptomatic central nervous system (cns) metastases * history of autoimmune disease
intractable self-harm-what support is effective?

Conditions: Self-harm

Summary: the aim of this project is to evaluate a novel treatment program for individuals with intractable and lethal self-harm. the main questions are: 1: is there, in individuals with intractable self-harm, a relevant improvement in daily functioning and is this improvement related to the provided interventions? the secondary research questions are: 2. is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm? 3. is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions? 4. is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions? 5. is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata? 6. is there, in individuals with intractable self-harm, a relevant improvement in cost-effectiveness related to the provided interventions?

individuals with intractable, imminent and lethal self-harm often have multifaceted psychiatric symptoms, pervasive suffering, high mortality and a reduced level of daily functioning. severe self-harm can lead to long periods of psychiatric inpatient care which can lead to reduced autonomy and aggravated self-harm. effects of this care remain uncertain. the swedish national board of welfare has provided national specialized medical care units for severe self-harm behaviour to three swedish hospitals. in one of this hospitals, region skåne, the intervention will be consultation-based. individuals with intractable self-harm will be offered an assessment and review of all medical records which will result in a individualized intervention plan. interventions include further assessments and supporting the existing treatment providers, families or caregivers. recurring network-meetings will occur every three months as well as at he end of the intervention. data collection will include self-report measures as well as information from charts and national och regional registries.

Eligibility criteria:
inclusion criteria: * having tried or made serious attempt to try at least two different interventions with evidence to reduce self-harm, without sufficient reduction in suffering or self-harm exclusion criteria: * need for translation services to complete measures or interviews * not able to complete measures or interviews

Keywords: deliberate self-harm suicide
genomics-based target therapy for children with relapsed or refractory malignancy

Conditions: Relapsed Pediatric Solid Tumor; Refractory Pediatric Solid Tumor; Relapsed Pediatric AML; Refractory Pediatric AML

Summary: the purpose of this study is to evaluate the efficacy and feasibility of combination chemotherapy with target agents according to the result of targeted deep sequencing in pediatric patients with relapsed/refractory solid tumor or aml.

outcome of pediatric cancer has been improved substantially over the past few decades, but the prognosis of relapsed/refractory pediatric cancer still remains poor. advances in genomic technologies have improved the ability to detect diverse somatic and germline genomic aberrations of cancer patients, and it has been incorporated in the clinical management of cancer. samsung genomic institute developed a targeted next-generation sequencing (ngs) platform, cancerscan™, which can detect clinically significant genomic aberrations of tumors. in this study, tumor samples of refractory/relapsed pediatric cancer patients will be tested with cancerscan™ and the patients will receive combination chemotherapy with matched single-targeted agent or multi-targeted receptor tyrosine kinase inhibitor according to the result of cancerscan™. i. relapsed/refractory solid tumor * perform cancerscan™ at enrollment * conventional chemotherapy (ifosfamide, carboplatin, etoposide) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of cancerscan™ ii. relapsed/refractory aml * perform cancerscan™ at enrollment * conventional chemotherapy (fludarabine, cytarabine) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of cancerscan™

Eligibility criteria:
inclusion criteria: * under 18 years of age at initial diagnosis * patients with refractory/relapsed solid tumor or aml (solid tumor: stable or progressive disease after 1st-line treatment or relapse; aml: persistence after 2 cycles of induction chemotherapy or relapse) * patient with tumor sample which is adequate for targeted deep sequencing exclusion criteria: * patients who had salvage chemotherapy previously * patients with organ dysfunction as follows (creatinine elevation ≥ 3 x upper limit of normal (uln), ejection fraction \<40%, significant arrhythmia or conduction disturbance) * patients who are not eligible to have scheduled treatment due to the other significant impaired organ function * patients whose tumor samples are not sufficient for targeted deep sequencing * pregnant or nursing women
the mri-based evaluation of safety and efficacy of evt and smt: a retrospective, multicenter study

Conditions: Stroke; Acute Ischemic Stroke; Ischemic Stroke

Summary: acute basilar artery occlusion (abao), a condition with a high risk of mortality or disability (up to 80%). the safety and efficacy of endovascular thrombectomy (evt) in abao remains uncertain due to inconsistent evidence from random controlled trials (rcts). recent studies have explored the use of mri in abao, this study aims to assess the efficacy and safety of evt and standard medical therapy (smt) in the treatment of abao within 24 hours of onset. it also aims to explore the feasibility and prognostic value of mri-based assessment of abao infarction using ai image analysis software.


Eligibility criteria:
inclusion criteria: 1. preliminary diagnosis of posterior circulation ischemic stroke based on clinical symptoms or imaging examinations. 2. confirmation through cta/mra/dsa that there is occlusion of the basilar artery or the v4 segment of the vertebral artery leading to functional occlusion of the basilar artery. 3. age 18 years and older. 4. symptom onset within 24 hours. 5. having a baseline mri evaluation, including at least dwi and t2 flair sequences (baseline mri for the evt group before the operation; baseline mri for the smt group within the treatment window (within 4.5 hours of onset) for thrombolytic patients before or during the thrombolysis process should initiate as early as possible; baseline mri for the smt group for extended treatment window patients (between 4.5 hours to 12 hours of onset) should initiate as early as possible). exclusion criteria: 1. mrs score ≥ 3 before onset; 2. significant neuroimaging changes such as cerebral hemorrhage, cerebellar mass lesion, acute hydrocephalus, etc., are present; 3. lack of follow-up results within 90 days after operation; 4. life expectancy \< 3 months; 5. baseline imaging and crucial clinical data are missing; 6. special cases involving pregnancy and lactation; 7. severe systemic diseases or advanced cancer that may potentially interfere with the prognosis; 8. allergic reactions to contrast agents or nickel-titanium alloys; 9. currently participating in other clinical trials; 10. pre-existing neurological disorders or psychiatric conditions that could affect the assessment of the disease.

Keywords: mri endovascular thrombectomy standard medical therapy large vessel occlusion acute basilar artery occlusion
bariatric surgery and modulation of perceived satiety

Conditions: Obesity, Morbid

Summary: bariatric surgery is the ideal therapeutic strategy for patients with severe obesity when lifestyle interventions have failed. unfortunately, weight recovery after surgery affects one third of patients and is due to several factors, such as recovery of incorrect eating behaviour, reduction of physical activity or hormonal factors. dilation of gastro-jejunal anastomosis is one of the main causes as it determines reduction of satiety in the patient and consequent increase of the portions of food consumed. in these cases it is necessary to make a review of gastro-jejunal anastomosis and to reduce surgical complications in recent years has been developed a method that allows the execution of sutures through a totally endoscopic way (overstitch™ endoscopic suturing system). literature studies to assess hunger-satiety in patients undergoing bariatric surgery, suggest that surgery results in weight loss due to a series of changes in gastrointestinal physiology which impact on the feeling of hunger-satiety, and on the modification of the secretion of hormones involved in the regulation of gastric emptying such as the reduction of ghrelin secretion and the increase in postprandial cholecystokinin and glp-1. there are no data in the literature on satiety in patients in previous bariatric surgery with weight recovery secondary to dilation of the gastro-jejunal anastomosis. there are various methods to assess satiety, most of which are invasive and difficult to perform in routine clinical settings. a recently proposed method to evaluate the perception of satiety and validated on healthy adults, is the water load tests (wlts). the test consists in making the subject drink a quantity of water until he feels "pleasantly" full. the volume of water ingested is a valid indicator of the subjective feeling of satiety. the aim of yhe study is to assess perceived satiety (measured by water load test) after intervention of sleeve gastrectomy or a revision surgery with overstitch™ endoscopic suturing system in obese individuals suitable for bariatric surgery


Eligibility criteria:
inclusion criteria: * subjects who are eligible for sleeve gastrectomy according to the sicob criteria * subjects, previously undergoing sleeve gastrectomy or gastric bypass, who, for weight regain, have been scheduled for revision surgery with the overstitch™ endoscopic suturing system exclusion criteria: * none

Keywords: obesity, satiety, sleeve gastrectomy ,overstitch
suicide in people aged 45-60: a case-control psychological autopsy study

Conditions: Suicide

Summary: the purpose of this study is to learn about the possible causes of the negative trend in suicide rates in both males and females aged 45-60 in flanders, belgium. this will be carried out using a psychological autopsy study.

a case-control psychological autopsy study will be carried out to identify what risk factors are related to suicide in people aged 45-60. people close to the person who died by suicide (next of kin or close friends) will be interviewed. to increase the validity of our findings, a control group will also be interviewed. the control group will be someone who is very close to someone with mental health problems.

Eligibility criteria:
inclusion criteria: * close to suicide victim or person who has mental health problems * suicide victim or person with mental health problems was/is 45-60 years old * the suicide happened more than 3 months and less than 5 years ago exclusion criteria: * not dutch-speaking

Keywords: psychological autopsy prevention
antiplatelet therapy for patients undergoing transcatheter aortic valve implantation

Conditions: Aortic Valve Disease; Myocardial Infarction; Stroke; Bleeding

Summary: at present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (tavi). dual antiplatelet therapy (dapt) using aspirin and a thienopyridine in the initial period after tavi is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. in patients with atrial fibrillation (af) or another indication for oral anticoagulation (oac), no recommendations on best treatment regimen currently exist although triple therapy (oac + dapt) is best avoided due to increased bleeding risk. we hypothesise that the omission of clopidogrel in the first 3 months after tavi is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort a) or oac (cohort b).

the trial consists of two cohorts: * cohort a, patients without an indication for oac prior to tavi. * cohort b, patients with an indication for oac prior to tavi (eg. atrial fibrillation, mechanic mitral valve prosthesis).

Eligibility criteria:
inclusion criteria: * cohort a 1. patient has provided written informed consent. * cohort b 1. need for long-term oral anticoagulation; 2. patient has provided written informed consent. exclusion criteria: * cohort a 1. need for long-term oral anticoagulation; 2. drug-eluting stent implantation within 3 months prior to tavi procedure; 3. bare-metal stent implantation within 1 month prior to tavi procedure; 4. allergy or intolerance to aspirin or clopidogrel. * cohort b 1. drug-eluting stent implantation within 3 months prior to tavi procedure; 2. bare-metal stent implantation within 1 month prior to tavi procedure; 3. allergy or intolerance to (n)oac or clopidogrel.

Keywords: transcatheter aortic valve implantation (tavi) transcatheter aortic valve replacement (tavr) aortic valve disease aortic stenosis myocardial infarction ischemic stroke bleeding thrombosis myocardial ischemia heart diseases cardiovascular diseases vascular diseases embolism and thrombosis aspirin clopidogrel prasugrel ticagrelor antithrombotic treatment oral anticoagulation warfarin platelet aggregation inhibitors genetic testing cytochrome p450 2c19 (cyp2c19) prostaglandin-endoperoxide synthase 2(ptgs2)
bioglass wound dressing in treatment of chronic wound in different stage：a randomized controlled trial

Conditions: Chronic Wound

Summary: the goal of this randomized control trial is to test the efficacy and safety of a bioglass wound dressing in patients with chronic wound in different stages. the main question it aims to answer are: * whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in necrosis stable stage？ * whether the bioglass wound dressing have better efficacy and safety than blank control in treatment of chronic wound in granulation growth stage？ participants will be assigned with a 1:1 ratio into intervention group and control group. participants of intervention group will receive bioglass wound dressing in addition with clinical optimal treatment plan. participants of control group will only receive clinical optimal treatment plan.


Eligibility criteria:
inclusion criteria: 1. the patient is aged 18-80 years old; 2. ulcerative wounds; 3. in the stage of stable necrosis or granulation growth; 4. voluntarily participate in this study and sign an informed consent form exclusion criteria: 1. severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; 2. uncontrolled blood glucose, glucose test#fasting blood sugar\>15mmol/l, glycated hemoglobin\>12%; 3. there is active bleeding inside the wound, and routine basic treatment plans cannot be implemented; 4. serum albumin \< 20 g/l; hemoglobin\<60 g/l; platelets\<50 × 10\^9/l; 5. spreading infection status, currently or about to be treated with antibiotics; 6. patients with advanced malignant tumors; 7. active period of autoimmune diseases; 8. previous allergies to bioactive glass ointment dressings (self originating); 9. the patient is unable to cooperate or has mental disorders; 10. according to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.

Keywords: chronic wound bioactive glass