Kornimate/medical-research-clean huggingface dataset:
phil evaluation in the endovascular treatment of intracranial cerebral arteriovenous malformation (cavm)

Conditions: Cerebral AV Malformation

Summary: the primary objective of this study is to assess the efficacy and safety of phil® liquid embolic agent in endovascular embolization of cerebral arteriovenous malformations.

this is an european multi-center observational study. treatments and follow-up visits will be done as per standard of care. the objective of this study is to evaluate the efficacy and safety of the phil® device in the treatment of intracranial cerebral arteriovenous malformation. the phil® device, a non-adhesive liquid embolic agent, has been ce marked since july 2014. it is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors. all patients with a cavm, ruptured or unruptured, eligible for endovascular treatment with a liquid embolic agent, phil®, based on multidisciplinary consensus are eligible for this study. a maximum of 108 patients will be enrolled in 18 european institutions. the expected approximate study duration is 39 months.

Eligibility criteria:
inclusion criteria: 1. all patients with a ruptured or unruptured and previously endovascularly untreated cavm that are eligible for endovascular treatment with phil® alone or in conjunction with n-butyl cyanoacrylate glue (nbca) and/or coils (e.g. if "pressure cooking" technique is needed or used). 2. all patients with a previously endovascularly treated cavm in which nbca and/or coils (but not another non-adhesive liquid embolic agent) have been used may be included.\*\* 3. all patients with a remaining cavm, ruptured or unruptured, that has previously been treated with ns and/or rt may be included. 4. patient or patient's legally authorized representative has received information about data collection and has signed and dated an informed consent form. (based on the country's regulation). exclusion criteria: 1. cavm not eligible for endovascular treatment 2. cavm previously treated with a non-adhesive liquid embolic agent other than phil® 3. treatment requiring the use of any other non-adhesive embolic liquid 4. patient is allergic to iodine 5. premature and newborn infant 6. patient with renal failure or significant liver impairment 7. patient is participating in another study evaluating other medical devices, other procedures or medications. 8. any other condition that might prevent patient participation in the study or follow up 9. patient does not want to and/or refuses to give consent to the collection and processing of data required for centralized monitoring
a multicenter treatment protocol of daclatasvir (bms-790052) in combination with sofosbuvir for the treatment of post-liver transplant subjects with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the primary objective of this program is to provide dcv for 24 weeks to be given in combination with sof to subjects with chronic hepatitis c with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis c recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to \<12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. however, safety data will be collected throughout the study as well as efficacy data


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * patients chronically infected with hepatitis c * subjects who received a liver transplant, have chronic hepatitis c virus (hcv) recurrence and advanced fibrosis (metavir f3-f4) or fibrosing cholestatic hepatitis * subjects with decompensated cirrhosis defined by child-pugh class c exclusion criteria: * patients who are \<18 years old * clinical or pathologic evidence of acute ongoing liver graft rejection * creatinine clearance (crcl) ≤30 ml/min (as estimated by cockcroft and gault formula) * patients who have contraindications to either daclatasvir (dcv) or sofosbuvir (sof) * patients who are pregnant or women of child bearing potential who are not using required contraception
evaluation of maridebart cafraglutide in adult participants without type 2 diabetes mellitus who have obesity or are overweight

Conditions: Obesity

Summary: the primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * body mass index ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (masld) or metabolic dysfunction-associated steatohepatitis (mash). * history of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. exclusion criteria: * type 1 or typ2 diabetes mellitus. * obesity induced by other endocrinologic disorders. * self-reported change in body weight \> 5 kg within 90 days before screening. * family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2. * history of chronic pancreatitis or history of acute pancreatitis within 180 days before screening. * history of unstable major depressive disorder (mdd) or other severe psychiatric disorder within 2 years before screening. * lifetime history of suicide attempt.

Keywords: overweight bmi body weight maridebart cafraglutide chronic weight management maritide
the effect of exercise on fatigue in white-collar workers

Conditions: Exercise; Fatigue

Summary: a survey will be conducted on the internet for desk workers. the questionnaire; international physical activity questionnaire will be filled out to evaluate the exercise level of the participants, the visual analog scale to question the general pain levels, and the fatigue severity questionnaire to investigate the fatigue levels. the patients will also be divided into the presence of osteoarthritis, the presence of fibromyalgia, and healthy group, and an evaluation will be made between the groups.

a survey will be conducted on the internet for desk workers. the questionnaire; international physical activity questionnaire will be filled out to evaluate the exercise level of the participants, the visual analog scale to question the general pain levels, and the fatigue severity questionnaire to investigate the fatigue levels. the patients will also be divided into the presence of osteoarthritis, the presence of fibromyalgia, and healthy group, and an evaluation will be made between the groups.

Eligibility criteria:
inclusion criteria: * 20-75 years old * white-collar worker * agree to participate in the study exclusion criteria: * history of musculoskeletal surgery * the presence of illness that will prevent him/her from exercising
surveillance study of acute gastroenteritis in hospitalized children

Conditions: Acute Gastroenteritis; Diarrhea; Dehydration

Summary: acute gastroenteritis is a common cause of hospital admission and health office visits and have a huge burden on the economy of developing countries. the investigators proposed this observational prospective study during summer period in a community and tertiary care hospital in a rural area of lebanon to investigate the etiologies and age distribution of admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.


Eligibility criteria:
inclusion criteria: * acute gastroenteritis exclusion criteria: * immunodeficiency * malnutrition

Keywords: diarrhea vomiting fever abdominal pain oliguria
the luteal phase after gnrha trigger - a proof of concept study

Conditions: Progesterone Levels; Infertility

Summary: the purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with gnrh antagonist protocol followed by gnrhagonist as induction of ovulation.

the purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with gnrh antagonist protocol followed by gnrhagonist as induction of ovulation. furthermore the aim is to explore whether the luteal phase can be supported with small daily boluses of hcg without the administration of exogenous p, while maintaining good reproductive outcome.

Eligibility criteria:
inclusion criteria: * women from the age of 25 up to 40 * serum-fsh and serum-lh levels under 12 iu/l * length of period between 25 and 34 days * bmi between 18 and 30 exclusion criteria: * less than 2 ovaries * uterine abnormalities * pcos or ul-pco (more than 11 follicles over 12 mm in 1 ovary
investigational study of psychological intervention in recipients of lung transplant (inspire)

Conditions: Lung Diseases; Depression

Summary: the purpose of this study is to examine the effectiveness of a telephone-based cognitive behavioral therapy intervention to alleviate psychological distress among lung transplant patients.

background: lung transplantation is a relatively new procedure developed to increase life expectancy in selected individuals with irreversible end-stage lung disease. in the brief period since its inception, it appears that lung transplantation has achieved its initial aim of extending life. despite these successes, lung transplantation remains fraught with difficult challenges for the patient and the medical community. the pre-surgical waiting period is a particularly stressful time. the long, uncertain wait for an organ, the marked decline in functional capacity, the tremendous financial burden, and the prospect of a complicated medical regimen after surgery, combine to exert a profound strain on patients' coping capacities. not surprisingly, the rate of clinically significant psychological distress during this period is quite high, with rates of clinical depression, panic, anxiety and adjustment disorders far exceeding those observed in the general population. although it is well established that brief, focused cognitive-behavioral therapy (cbt) can significantly improve psychological function in medically ill persons, the wide geographic distribution of transplant patients, along with their marked debilitation makes face-to-face delivery of such therapy extremely difficult. recent pilot data have demonstrated the feasibility and short-term efficacy of a telephone-based psychological intervention with patients awaiting transplant. design narrative: inspire was a collaborative study between duke university medical center and washington university medical school. participants first completed a baseline evaluation, including an interview with a staff member, tests of memory and concentration, and a questionnaire packet. they were then randomly assigned (by chance) to one of 2 groups: stress management (by phone) or usual care. stress management participants received a phone call from an inspire interventionist every week for 12 weeks; the phone sessions focused on helping to reduce stress and learning new skills to better cope with lung disease and the upcoming transplant. the inspire staff interventionists were all psychologists who had been trained to work with patients with lung disease. usual care participants continued their routine and usual treatments and did not receive the 12 telephone training sessions. participants completed follow-up evaluations three months after the initial (baseline) evaluation, after transplant surgery, and twelve months after the initial evaluation. the primary outcome measures were measures of health-related quality of life, general psychological well-being, and social support.

Eligibility criteria:
inclusion criteria: * potential lung-transplant candidates listed for lung transplantation at duke university medical center or washington university
study of igrp-specific t cell in peripheral blood of type 1 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: 10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (pbmc) were isolated. we implemented elispot(enzyme-linked immunospot assay) to detect the interferon-γ (ifn-γ）which secreted by igrp-specific t cell. results were compared between these groups.


Eligibility criteria:
inclusion criteria: * the criteria of type 1 and type 2 diabetes exclusion criteria: * no diabetes
crossover bioequivalence study of irbesartan hctz 300/25 mg tablets under fasted conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' irbesartan and hydrochlorothiazide 300 mg / 25 mg tablets under fasted conditions.


Eligibility criteria:
inclusion criteria: 1. male and female subjects between the ages of 18 and 45 years (inclusive). 2. voluntary consent to participate in the study. 3. body mass index (bmi) between 18 and 30 (inclusive). 4. female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), iud, or vasectomized partner (6 months minimum). 5. no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: 1. a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. a history of allergic or adverse responses to irbesartan and hydrochlorothiazide, or any comparable or similar product. 3. subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation. 4. subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation. 5. subjects must not have made a plasma donation within 14 days of study initiation. 6. participation in a clinical trial within 30 days prior to study initiation. 7. use of any over-the-counter (otc) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study. 8. use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy. 9. treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, maoi, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study. 10. smoking or use of tobacco products within 6 months prior to or during the study. 11. female subjects who are lactating. 12. positive serum pregnancy test for female subjects. 13. positive blood screen for hiv, hepatitis b or hepatitis c. 14. positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.
comparison of the biolimus a9-eluting stent with the zotarolimus -eluting stent in multi-vessel pci

Conditions: Multivessel Coronary Artery Disease

Summary: the risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of drug eluting stent. yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated. recently, pci in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics. however, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments. the primary purpose of this study is to evaluate the clinical progress of biolimus a9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.

the patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.each randomization of the enrolled subjects will be done 1:1 (biolimus a9-eluting stent : zotarolimus-eluting stent). randomization will be stratified by two factors: diabetes mellitus and acute coronary syndrome.clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.

Eligibility criteria:
inclusion criteria: * patients who need multi-vessel stenting with multi-vessel disease * patients with signed informed consent exclusion criteria: * known contraindication to any of the following medications: aspirin,clopidogrel, heparin, contrast agent, biolimus or zotarolimus group * cardiogenic shock * pregnant women or women with potential childbearing * end-stage diseases with life expectancy shorter than 2 years * patients with other drug eluting stents implanted * patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment.

Keywords: multivessel stenting
comparative study between the effect of diclofanic and ketorolac in post tonsillectomy pain management

Conditions: Pain, Acute

Summary: compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in post-tonsillectomy pain management.and compare between the effect of diclofenac sodium and ketorolac tromethamine on post-tonsillectomy bleeding

patients will be randomly allocated to two groups of 50 patients each group (a): will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously. group (b): will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously. then the two groups will continue postoperatively on the same drug received intra-operative i. intra-operative data: bleeding score will be assessed by the surgeon at the end of the operation using the following scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous). ii. early post-operative data: 1. post- tonsillectomy bleeding assessments; * bleeding score will be recorded immediately postoperative and 3, 6, 12 and 24h postoperatively. * hospital re-admission because of bleeding. * re-operation because of bleeding. 2. post- tonsillectomy pain assessments; pain intensity will be assessed postoperatively by the verbal rating scale (vrs; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). vrs assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively. analgesia will be given if requested or if the vrs≥3. patients in group a will receive diclofenac sodium 0.3 mg/kg iv, while patients in group b will receive ketorolac tromethamine 0.5 mg/kg. the total consumption of analgesics used in each group in the first 24 h postoperative will be calculated and the time of the first request for analgesia will be recorded. - time needed to restore normal dietary habits. iv. late post-operative data: as aweekly follow up for 2 weeks : 1. bleeding tendency 2. dysphagia. * time needed to restore normal dietary habits

Eligibility criteria:
inclusion criteria: * children scheduled for elective tonsillectomy\\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years exclusion criteria: * known hypersensitivity to medication drugs. * coagulation disorders, thrombocytopenia or active bleeding for any cause. * bronchial asthma. * significant cardiac, renal, pulmonary, hepatic disease or peptic ulcer. * the use of any analgesic medications within 24h preoperative or antiplatelet medication within the past 2 weeks.

Keywords: tonsillectomy post operative analgesia diklofanic ketorolac
pair (paracetamol and ibuprofen research) pilot trial

Conditions: Patent Ductus Arteriosus

Summary: presence of patent ductus arteriosus is detrimental to an infant born prematurely. the primary objective is to study the efficacy of paracetamol (proposed new treatment) in treating haemodynamic significant patent ductus arteriosus (hspda) in comparison to ibuprofen (current standard treatment) in preterm infants. outcome of such treatment will check on the conversion of hspda to non-hspda. all preterm infants (born at \<32 weeks gestational age or birth weight \< 1500 grams) with haemodynamically significant patent ductus arteriosus (hspda) who are ≤ 28 days old will be included over 2 years. sample size 32. secondary outcomes of this study will compare 1) bpd (broncho-pulmonary dysplasia) free survival at 36 weeks post menstrual age (pma), 2) incidence of complications of prematurity in each group and 3) to record any evidence of adverse effects with paracetamol or ibuprofen.

patent ductus arteriosus (pda) is present in 40-60 percent of preterm infants. a persistent pda with a large left to right ductal shunt may be 'haemodynamically significant' (hspda) resulting in pulmonary hyper-perfusion and systemic hypo-perfusion. the association of a pda with an increased incidence of pulmonary haemorrhage, bronchopulmonary dysplasia and prolonged need for ventilatory support is ascribed to pulmonary hyper-perfusion, whereas necrotising enterocolitis, renal failure, cerebral haemorrhage, and periventricular leukomalacia are consequences of systemic hypo-perfusion. in the united kingdom, ibuprofen (a non-steroidal anti-inflammatory drug, nsaid) is used to treat hspda in preterm babies. paracetamol has come up recently as a promising alternative with fewer side effects and has been used in the management of pda with promising results. however, the current available body of evidence is considered to be of moderate to low quality and hence its effectiveness and safety profile is not fully established in this patient population. the primary objective is to study the efficacy of iv paracetamol in treating hspda in comparison to iv ibuprofen in preterm infants born at less than 32 weeks' gestation or less than 1500 grams birth weight.

Eligibility criteria:
inclusion criteria: * gestational age - \<32 weeks or birth weight \< 1500 grams * postnatal age ≤ 28 days * meets criteria for hspda * clinician's decision to treat pda exclusion criteria: * contraindication for administration of ibuprofen (cyclooxygenase-inhibitors) or paracetamol, such as: active bleeding (e.g. intracranial or gastrointestinal haemorrhage), thrombocytopenia (\ 100 micromole/l) or oliguria (\ upper normal limit of the reference range, bilirubin \> national institute of clinical excellence exchange phototherapy level). * previous use of ibuprofen or paracetamol prior to randomisation. * persistent pulmonary hypertension (ductal right-to-left shunt ≧33% of cardiac cycle). * congenital heart defect, other than pda or patent foramen ovale (pfo). * life-threatening congenital birth defects. * chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopment.