Kornimate/medical-research-clean huggingface dataset:
study to evaluate elexacaftor/tezacaftor/ivacaftor (elx/tez/iva) long-term safety and efficacy in subjects without f508del

Conditions: Cystic Fibrosis

Summary: this study will evaluate the long-term safety, efficacy and pharmacodynamics of elx/tez/iva in participants with cystic fibrosis (cf) with at least 1 non-f508del elx/tez/iva-responsive cf transmembrane conductance regulator (cftr) gene mutation.


Eligibility criteria:
key inclusion criteria: part a: completed study drug treatment in parent study or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study part b: completed study drug treatment in part a or had study drug interruption(s) in part a but completed study visits up to the last scheduled visit of the treatment period of part a key exclusion criteria: history of study drug intolerance in the parent study other protocol defined inclusion/exclusion criteria may apply.
the molecular mechanism and the role of nramp 1gene on tuberculosis in taiwan aboriginal tribes population

Conditions: Tuberculosis

Summary: the human homologue of mice natural-resistance-associated macrophage protein 1 (nramp 1) gene, nramp 1, has been reported to play a role in the susceptibility to tuberculosis in humans. the aboriginal population in taiwan has a 5-fold higher prevalence of tuberculosis than the han chinese. whether genetic factors such as nramp 1 polymorphisms play a role in the prevalence of tuberculosis in taiwanese aboriginals should be clarified.


Eligibility criteria:
inclusion criteria: * the nramp 1 polymorphism of tuberculous patients in taiwan. exclusion criteria: -
human vasodilatory effect of glp-1

Conditions: Coronary Stenosis; Type2 Diabetes; Angina, Stable

Summary: comprehensive assessment of human vasodilatory effect of glp-1 in forearm and coronary arteries


Eligibility criteria:
inclusion criteria: * waiting list for elective pci to lad able to give informed consent over 18 exclusion criteria: * glp-1 based therapy insulin calcium channel blockers nicorandil nitrates
the safety and efficacy of cerebrolysin in patients with acute ischemic stroke

Conditions: Ischemic Stroke

Summary: the study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30ml cerebrolysin based on a comparison with placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving cerebrolysin, the control group receiving placebo. study drug will be given once daily by intravenous infusion for 10 consecutive days. acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. the clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at baseline (day 1) and on study days 2, 5, 10, 30 and 90.


Eligibility criteria:
inclusion criteria: * age between 18 and 85 years * focal neurological deficit * clinical diagnosis of acute hemispheric ischemic stroke * ct or mri results compatible with clinical diagnosis of acute hemispheric stroke * nih stroke scale score between 6 and 22, both inclusive * functionally independent prior to stroke with a pre-stroke rankin score of 0 or 1 * randomization and first treatment with the trial medication within 12h after stroke onset * informed consent given by the patient and/or the patient's legally acceptable representative exclusion criteria: * evidence on ct/mri of acute or chronic intracerebral hemorrhage, sah, avm, cerebral aneurysm, or neoplasm * signs of herniation, increased intracranial pressure or likely etiology other than brain ischemia at baseline ct scan * patients with a substantial decrease of consciousness or alertness at the time of randomization, defined as score of 2 or more one of the nih stroke scale questions 1a. * neurological signs and symptoms that improve rapidly during screening and are likely to resolve completely within 24h * severe coexisting systemic disease that significantly limits life expectancy * systolic blood pressure over 220 mmhg or diastolic blood pressure over 120 mmhg on repeated measurement (interval of 30 min) prior to study entry * severe congestive heart failure or presentation with acute myocardial infarction at study entry * epilepsy or epileptic seizures at onset of stroke * pre-existing disorders or conditions that would impair interpretation of neurological assessment (eg. severe dementia, severe psychiatric illnesses, etc). * concomitant treatment with other neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational neuroprotective substances) * patients which cannot tolerate or have contraindication to aspirin or cerebrolysin treatment * concomitant treatment with substances that have a dilative effect on blood vessels like naftidrofuryl, cinnarizine, flunarizine or nimodipine * pregnancy and lactation period; for women with child-bearing potential a negative pregnancy test is required * participation in a clinical trial with an investigational drug in the past 4 weeks
pharmacodynamic and clinical outcome study of mongersen in patients with crohn's disease

Conditions: Crohn's Disease

Summary: this study is designed to explore mechanism of action of mongersen (ged-0301) 160 mg once daily in patients with active crohn's disease

subjects will be screened to provide 20 enrolled subjects who complete 12 weeks of mongersen (ged-0301) 160 mg qd treatment as open-label therapy. the study will consist of 4 periods: * screening period - up to 4 weeks * induction period - 12 weeks (week 0 visit through week 12 visit) * maintenance period - 88 weeks (after week 12 visit through week 100 visit) * follow-up period - 4 weeks (ie, no ip taken) subjects who prematurely discontinue treatment from this study prior to week 100 will have an early termination visit and also enter the 4-week follow-up period. at the screening visit, all subjects who meet the entrance criteria will be eligible to enter the study. the number of subjects with previous exposure to tumor necrosis factor-alpha (tnf-α) blockers is targeted to be approximately 40% (ie, approximately 8 subjects).

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age. * active crohn's disease (cd) disease as determined by the crohn's disease activity index (cdai) score and the simple endoscopic score for crohn's disease (ses-cd) * subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of cd. * subject must use protocol approved contraception exclusion criteria: * diagnosis of ulcerative colitis (uc), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis * crohn's disease (cd) manifestations such as abscesses, short bowel syndrome; or intestinal strictures with prestenotic dilatation, requiring procedural intervention or not passable with an adult colonoscope. * intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the screening visit * ileostomy or a colostomy * prior treatment with more than 2 tnf-α blockers (eg, infliximab or adalimumab). * prior treatment with any integrin antagonists (eg, natalizumab or vedolizumab). * subject is pregnant or breastfeeding. * subject has received prior treatment with mongersen (ged-0301), or participation in a clinical study involving mongersen (ged-0301).

Keywords: crohn's disease ged-0301 open-label pharmacodynamic mongersen
study looking at the effect of silverlon on post operative wound infections

Conditions: Infections; Surgery

Summary: this clinical study is a prospective, randomized, controlled trial of patients undergoing elective colorectal surgical procedures that receive an abdominal skin incision of at least 6 cm. treatment with silverlon® will be compared to standard postoperative dressings of 4x4 gauze and paper tape. patients will be randomized with a 1:1 treatment allocation ratio to receive either 1) silverlon® or 2) standard postsurgical dressing. neither the investigators nor the participants will be blinded to the treatment modality after randomization. silver has long been known to have antimicrobial properties. it interacts with structural proteins and dna, inhibiting bacterial replication and causing fatal structural changes within the cell wall. it has broad antimicrobial activities and unlike antibiotics, it is rarely associated with microbial resistance. silverlon® is a silver-nylon dressing specifically designed for surgical wounds to prevent the development of surgical site infections. it is an easy to use product with no known microbial resistance or adverse effects. the efficacy of silverlon® in preventing surgical site infections has been shown in several retrospective studies but as of yet has not been tested in a prospective fashion. the objective of this study is to perform a prospective, randomized, clinical trial directly comparing the incidence of surgical site infections in patients treated with silverlon® to standard postoperative dressing following elective colorectal surgery


Eligibility criteria:
inclusion criteria: 1. all patients undergoing elective colorectal surgery by a trained colorectal surgeon with an abdominal skin incision of at least 3 cm 2. patients that are willing and able to comply with the requirements of the protocol including follow-up requirements 3. patients willing and able to sign a study specific informed consent exclusion criteria: 1. patients that fail to meet the skin incision size criteria 2. patients with a known allergy to silver 3. patients less than 18 years of age 4. any contraindication to undergoing a surgical procedure under general anesthesia 5. patients with preoperative evidence of a current abdominal wall infection/surgical site infection from a previous laparotomy/laparoscopy 6. patients that have received antibiotic therapy within the week prior to surgery 7. patients with preoperative evaluation suggestive of an intra-abdominal process that would preclude full closure of the skin 8. patients with a previously placed anterior abdominal wall mesh that is not planned to be completely removed during the planned procedure 9. women who are pregnant or breast feeding or are considering becoming pregnant during the follow-up period 10. mental incompetence as determined by the investigator which would affect participation in the study 11. concurrently participating in any other investigational study

Keywords: all patients undergoing a colorectal resection surgical site infections
effectiveness of tcc followed by mbct and predictive factors (genetic, clinical and cognitive) response

Conditions: Bipolar Disorder; Anxious Disorder; Alcohol Dependence

Summary: the purpose of this study is to determine whether a cognitive and behavioral group therapy (cbt) + mindfulness based cognitive therapy (mbct) decreased relapses and hospitalizations and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a large sample of refractory bipolar i patients on mood stabilizers.

in recent years, various controlled studies showed that psychoeducational interventions have been effective in decreasing relapse and improving outcomes for bipolar disorders. however, samples were often small, compromising statistical power, and with a large variety of patients. the investigators therefore tested if a cbt group psychoeducation program + mbct decreased relapses and improved outcomes in a large sample of refractory bipolar i patients on mood stabilizers. patients were tested at recruitment, at 6-month follow-up cbt and at 2-month follow-up mbct using clinical interviews and self-report questionnaires. the primary outcome measure of efficacy was relapse during the follow-up requiring either hospitalization, modification of treatment or hdrs ≥ 16 or mrs ≥ 6. the secondary outcome measure was symptomatic and functional improvement.

Eligibility criteria:
inclusion criteria: * patients aged 18-65 years * men and women * addressed to the cbt unit of the clinique des maladies mentales et de l'encéphale - cmme- (sainte anne hospital) * having a bipolar i or ii disorder (224 patients) or eating disorder (224 patients) : bulimia or discorder of use alcohol or gambling (224 patients) * mood stabilizer treatment for more than six months, for bipolar patients * understanding and speaking french fluently * patient agreeing to participate and signing the consent form exclusion criteria: * age \ 65 * current manic, hypomanic, or depressive episode for bipolar patients * score on the hamilton depression rating scale - hdrs greater than or equal to 16 * score on the mania rating scale - mrs higher or equal to 6 for bipolar patients * schizophrenic disorder * severe somatic pathology (cancer, heart, kidney or respiratory failure, central neurological disorder), scalable, or are likely to be life-threatening in a period of less than one year * refusal of a mood stabilizer treatment for bipolar patients * inability to respond to assessment (eg failure or deterioration of mental ability.) * no affiliation to a social security scheme * private topics of liberty by judicial or administrative decision * pregnant women for bipolar patients, the presence of rapid cycling, family history of bipolar disorder, comorbid axis i and ii disorders, protective measures (curatorship or guardianship) are not exclusion criteria.
adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection

Conditions: Thymus Neoplasms

Summary: the purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.

adjuvant radiotherapy(postoperative radiotherapy) is proposed in stage ii and iii thymic carcinoma，stage iii thymoma，stage iib b2/b3 thymomas. hypofractionation radiotherapy is used in this study. the purpose of this study is to evaluate the efficiency and toxicity of adjuvant hypofractionation radiotherapy for thymic epithelial tumours after complete resection.

Eligibility criteria:
inclusion criteria: * thymoma and thymic carcinoma confirmed by histology or cytology * r0 resection (complete resection) * stage ii and iii thymic carcinoma，stage iii thymoma，stage iib b2/b3 thymomas. * karnofsky performance status(kps) 80, 90 or 100. * having sufficient pulmonary function, renal function and liver function. neutrophile granulocyte count\>1.5×109 /l, platelet count\>80×109 /l, hemoglobin ≥10g/dl. exclusion criteria: * prior thoracic radiotherapy. * uncontrolled comorbidities. * pregnant or nursing mother. * pneumonia

Keywords: thymus neoplasms adjuvant radiotherapy
coronary artery disease mortality in turkiye

Conditions: Coronary Artery Disease (CAD) Mortality

Summary: this study aims to analyze the geographical variations and identify key environmental and behavioral predictors of coronary artery disease (cad) mortality in turkiye.

a 10-year longitudinal province-level data was used to identify change trajectories of cad mortality. . environmental determinants (such as air quality and climatic conditions) and behavioral factors of alcohol consumption and smoking were examined for their association with cad mortality change trajectories using ordinal logistic regression models.

Eligibility criteria:
inclusion criteria: * all citizens in a given province exclusion criteria: * none
double-j plus postmarket registry

Conditions: Ureter Obstruction

Summary: a multi-center global registry to obtain post-market safety and efficacy data on boston scientific ureteral and urinary diversion stents


Eligibility criteria:
inclusion criteria (for all ureteral stent types except urinary diversion stents): * subject is undergoing placement of a boston scientific ureteral stent * subject anatomy is appropriate to accommodate a stent size available in the study * subject is able to accurately detect and report bladder function and pain * subject is willing and able to: * complete patient qol questionnaire at specified time points (for subjects aged ≥ 18 years) * return for all follow-up visits inclusion criteria (for urinary diversion stents): * subject is undergoing placement of a boston scientific urinary diversion stent(s) * the anatomical features of the involved renal collecting system are known by either prior or concurrent urography or axial ct imaging * subject is willing and able to return for all follow-up visits exclusion criteria (for ureteral stents and urinary diversion stents): * subjects who meet any of the contraindications per individual stent dfu * subjects receiving different stent type in case of bilateral/multiple stenting * subjects with an indwelling ureteral stent(s) not planned to be removed prior to/or concurrently with the study stent implant
monitoring the early follicular phase with androstenedione in low-dose step-up ovulation induction in high responders

Conditions: Infertility; Ovarian Hyperstimulation Syndrome

Summary: this study aims to predefine the threshold fsh doses during the early follicular phases in low- dose step-up ovulation induction cycles used to treat anticipated high responders by monitoring total testosterone and androstenedione blood levels. the blood levels of total testosterone and androstenedione levels will be measured in patients at the starting day and at every control day when vaginal sonographic folliculometries and blood estradiol measurements are made. hence, we are aiming to define an early monitoring parameter by which we will be able to define a follicular response to treatment before estradiol rise or apparently selected follicular growth.

50 patients with anticipated high ovarian response, who are being planned to be conventionally treated with low-dose step-up ovulation induction and intrauterine insemination will be analysed in this study. at every control day including the start day, blood samples taken for blood estradiol (and if required progesterone) measurements will be used to measure blood androstenedione and total testosterone levels, as well. hence, we will have defined an early parameter for defining follicular response in the first 5-7 days of low-dose step-up ovulation induction. low-dose step-up ovulation induction will be started at 50-75units/day of rhfsh and the dose will be increased at not earlier than the 7th day at an increment of +37,5units/day unless a response is observed ( which is at least a 10mm follicle, selected for growth). if more than 3 dominant follicles are selected, the cycle will be cancelled. otherwise, when at least one follicle \>16mm is obtained, a 150microgram sc. injection will be administered for ovulation trigger and intrauterine insemination made at the 34th-36th hours.

Eligibility criteria:
inclusion criteria: * primary/secondary infertile women; aged 20-35 years of age * high ovarian response to ovulation induction anticipated.(antral follicle count on the 3rd day of cycle\>10) * mild male factor or normal sperm parameters * normal anatomic findings with the hsg * eugonadotropic * normal blood prolactin and tsh levels exclusion criteria: * amenorrheic women * women with diabetes mellitus * body mass index: \ 30 * age\ 35 years old * hormonal abnormalities: regarding prolactin, tsh * hypo- or hypergonadotropic women * additional medical or surgical disease * ovarian cysts * previous ovarian surgery

Keywords: infertility ovulation induction low-dose step-up protocol ovarian high responder androgens androstenedione testosterone rhfsh
cohort study on associations between purinergic receptor snps and osteoporosis risk

Conditions: Osteoporosis

Summary: background: osteoporosis is a high-prevalence disease with a strong genetic component. nucleotides, including atp (adenosine 5'-triphosphate) and its purinergic receptors, play a role in bone physiology. single nucleotide polymorphisms (snps) in the p2x7 receptor gene were recently found to be associated with fracture risk in a cohort of postmenopausal women. objective: to investigate associations between purinergic receptor snps and osteoporosis risk in humans. genetic data from a fracture cohort in the netherlands with high prevalence of osteoporosis will be analyzed. furthermore, effects of aberrant purinergic receptor signalling on bone turnover markers will be assessed ex vivo. design: the cohort will include app. 1,000 fracture patients of 50 years and older, who will be recruited at the maastricht university medical center during standard medical follow-up after a clinical fracture. the standard medical follow-up includes assessment of bone mineral density (bmd) by dual-energy x-ray absorptiometry (dxa), if necessary followed by medication for osteoporosis. prior to medication, blood samples will be collected from fracture patients to be genotyped for purinergic receptor snps and analyzed for biochemical markers of bone turnover. systemic correlates of osteoporosis will be compared between osteoporotic subjects (i.e. low bmd) and non-osteoporotic controls (i.e. normal to high bmd). subsequently, whole blood assays in patient subgroups (n=20 per subgroup), based on bmd and purinergic receptor snps, will be performed to evaluate ex vivo effects of atp and related nucleotides bone markers. study population: patients of 50 years and older attending an outpatient osteoporosis clinic at the maastricht university medical center for standard medical follow-up after a clinical, non-pathological fracture. primary outcome parameters: bmd and purinergic receptor snps. secondary outcome parameters: bone markers.


Eligibility criteria:
inclusion criteria: * age 50 years and older; * clinical fracture; * attending osteoporosis outpatient clinic for standard medical care. exclusion criteria: * disease of bone metabolism (e.g. bone tumours, hyperparathyroidism); * unwillingness to donate blood for dna analyses; * failure of bone densitometry (dxa-scan).

Keywords: osteoporosis atp purinergic receptors bone mineral density single nucleotide polymorphism
phase 3 study to evaluate anecortave acetate vs. visudyne for the treatment of the wet form of amd

Conditions: Macular Degeneration

Summary: the purpose of this study is to demonstrate that anecortave acetate is as effective after twelve months of treatment as photodynamic therapy (pdt) with visudyne in patients eligible for initial pdt treatment for wet age-related macular degeneration.


Eligibility criteria:
patients of any race, either gender, aged 50 years and above, diagnosed with subfoveal cnv due to amd with best corrected logmar visual acuity of 20/40 (snellen equivalent) to 20/400 (snellen equivalent) in the study eye. clinically relevant concomitant diseases will be excluded.

Keywords: amd age-related macular degeneration anecortave acetate wet form of age-related macular degeneration