Kornimate/medical-research-clean huggingface dataset:
real-world safety and effectiveness of sotyktu (deucravacitinib) in patients with moderate-to-severe plaque psoriasis in korea

Conditions: Moderate-to-severe Plaque Psoriasis

Summary: the purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in korea that have been diagnosed with moderate-to-severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * adult participants ≥19 years of age * diagnosis of moderate-to-severe plaque psoriasis * candidate for phototherapy or systemic therapy * will begin deucravacitinib according to approved product label exclusion criteria: * participants prescribed deucravacitinib for therapeutic indications not approved in korea * participants for whom deucravacitinib is contraindicated as clarified in korean prescribing information by ministry of food and drug safety (mfds)
study of vx-770 and rifampin in healthy male subjects

Conditions: Cystic Fibrosis

Summary: the objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of vx 770.

this is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of vx 770 when administered alone or with rifampin. all enrolled subjects will receive the same treatments and undergo the same procedures. in period 1, subjects will receive a single dose of vx 770 on day 1. in period 2, subjects will receive a daily dose of rifampin on days 1 through 10 and a single dose of vx 770 on day 6.

Eligibility criteria:
inclusion criteria: * subject must be male and between 18 and 55 years of age * subject must have a body mass index (bmi) from 18 to 30 kg/m2 exclusion criteria: * history of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject * subjects who have active tuberculosis, human immunodeficiency virus, hepatitis c, or active hepatitis b
combination chemotherapy plus radiation therapy in treating patients with locally advanced unresectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. combining radiation therapy with chemotherapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

objectives: * determine the time to progression, local control, and survival of patients with locally advanced, unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy. outline: patients receive induction gemcitabine iv over 30 minutes and irinotecan iv over 90 minutes on days 1 and 8. treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. within 2 weeks of completing induction chemotherapy, patients receive gemcitabine iv over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks. patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years. projected accrual: approximately 60-120 patients will be accrued for this study within 1-2 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed locally advanced pancreatic cancer * regional (peri-pancreatic) lymph node involvement allowed * clinically or surgically staged and considered unresectable or inoperable patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * more than 6 months hematopoietic: * granulocyte count at least 1,500/mm3 * hemoglobin at least 10 g/dl * platelet count at least 100,000/mm3 hepatic: * not specified renal: * creatinine no greater than 2.0 mg/dl other: * not pregnant * fertile patients must use effective contraception * no other concurrent or prior malignancy within the past 2 years except nonmelanoma skin cancer or in situ carcinoma of the cervix or breast * no other serious medical or psychiatric illness that would preclude giving informed consent or limit survival to less than 2 years prior concurrent therapy: biologic therapy: * no concurrent anticancer immunotherapy chemotherapy: * no prior chemotherapy * no other concurrent anticancer chemotherapy endocrine therapy: * no concurrent anticancer hormonal therapy radiotherapy: * no prior abdominal-pelvic radiotherapy * no other concurrent anticancer radiotherapy surgery: * see disease characteristics * at least 3 weeks since prior open abdominal surgery * more than 10 days since prior laparoscopy other: * no other concurrent investigational drug * no concurrent participation in other clinical study

Keywords: stage iii pancreatic cancer
laser-excimer versus high-pressure dilation to treat under-expansion of the stent

Conditions: Cardiovascular Diseases; Arterial Disease

Summary: the laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. the laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.

the laser-excimer technology could be an essential tool to correct the under-expansion of the stent once it has been implanted unless severe calcification. the investigators propose a study that serves as proof of concept for this technology (laser excimer) used according to its intended use in this specific substrate of coronary lesions. (stent under-expansion without severe underlying calcification).the laser-excimer technology achieves a greater minimum luminal area when treating an infra-expanded stent, when compared with the results obtained with the simple dilatation at high or very high pressure.

Eligibility criteria:
inclusion criteria: patients with: * age ≥ 18 years. * consecutive real-world patients, referred for cardiac catheterization for any cause, who present in any main vessel, bypass or in the common trunk an under-expanded stent tributary of being treated (minimum luminal area \<4 mm2 or \<6 mm2 in the left main coronary artery measured by ivus (intravascular ultrasound) / oct(optical coherence tomography)) and that it is not possible to dilate with a nc balloon to a maximum of 20 atm. exclusion criteria: * refusal of the patient to participate in the study. * patients with life expectancy \<1 year. * patients with advanced kidney disease (grade iv) or liver failure (child c)

Keywords: laser expand
an efficacy and safety study of omacor® in taiwanese hypertriglyceridemic patients

Conditions: Hypertriglyceridemia

Summary: 1. evaluation of the efficacy of omacor® in taiwanese hypertriglyceridemia patients 2. evaluation of the safety of omacor® in taiwanese hypertriglyceridemia patients

the primary end point is to evaluate the efficacy and safety of omacor in taiwanese hypertriglyceridemia patients.

Eligibility criteria:
inclusion criteria: * patient has fasting serum tg ≥ 200 mg/dl but no more than 1000 mg/dl exclusion criteria: * patients had a history of pancreatitis or considered to be at risk of developing pancreatitis * patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization

Keywords: hypertriglyceridemia, omega-3-acid ethyl ester
the iris-resolute integrity (iris-integrity)

Conditions: Coronary Artery Disease

Summary: this is a prospective, observational, cohort study to evaluate the relative efficacy and safety of resolute integrity stent compared to other (drug eluting stents) des.

consecutive percutaneous coronary intervention patients receiving resolute integrity stent will be compared with other concurrent drug eluting stents.

Eligibility criteria:
inclusion criteria: * patients with significant coronary artery disease and receiving resolute integrity stent. * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethics committee of the respective clinical site. exclusion criteria: * patients with a mixture of other dess * terminal illness with life expectancy \<1 year * patients presented with cardiogenic shock

Keywords: coronary artery disease requiring drug eluting stents
effects of resistance strength training on functional capacity and well being of anorexic patients

Conditions: Anorexia

Summary: the purpose of the present randomized controlled trial was to determine the effects of a 3-month resistance training program (2 sessions/week) on the functional mobility and muscle function, muscular dynamic strength, body composition and quality of life of young anorexic outpatients (≤16 years). the investigators also assessed cardiorespiratory variables of clinical significance such as peak oxygen uptake.

a total of 22 outpatients \[20 female (tanner stage ii-iv), 2 male (tanner stage iv); age range: 12-16 years\] were finally eligible and thus participated in the study. participants in the intervention group were enrolled in two training sessions per week for 12 weeks. each session lasted 60-70 min and started at \~11:30 a.m., after the intra-hospital psychotherapy session. the program was individually supervised, i.e. one instructor for every three patients. each session started and ended with a low intensity 10-15min warm-up and cool-down period respectively, consisting of stretching exercises involving all major muscle groups. the core portion of the training session consisted of 11 strength exercises engaging the major muscle groups, i.e. bench press, shoulder press, leg extension, leg press, leg curl, abdominal crunch, low back extension, arm curl, elbow extension, seated row and lateral pull-down. for each exercise, the participants performed one set of 8-15 repetitions (total of \~ 20s duration) with resting periods of 1-2 min between exercises. the load was gradually increased as the strength of each child improved, i.e. from 20-30% of 6 repetition maximum (6rm) at the start of the program to 50-60% of 6rm at the end. stretching exercises of the muscles involved in the previous exercises were performed during the rest periods (21). participants also performed isometric contractions of large muscle groups (6 sets of 3 repetitions each, 20-30s duration per repetition) with their own body weight (for lower body exercises) or barbells (1-3kg) for upper body. outcome measures: * anthopometry * cardiorespiratory fitness * muscular strength * functional mobility * quality of life

Eligibility criteria:
inclusion criteria: * diagnosis of restrictive anorexia nervosa * age ≤ 16 years * undergoing intra-hospital psychotherapy and dietary counseling (two visits per week) in this hospital * body mass index \> 14.0 kg/m2 exclusion criteria: * none

Keywords: strength training anorexia girls quality of life functional mobility
68ga-ops202 study for diagnostic imaging of gep net

Conditions: Gastroenteropancreatic Neuroendocrine Tumors

Summary: the purpose of this study is to assess the safety and tolerability of 68ga-ops202 used for the diagnosis of gastroenteropancreatic neuroendocrine tumors (gep nets).


Eligibility criteria:
inclusion criteria: * a diagnostic ct or mri of the tumor region within the previous 6 months prior to dosing day is available. * a somatostatin receptor scan with results in the previous 6 months prior to dosing day. * at least 1 lesion detected by the previous somatostatin receptor scan. * not exceeding 30 lesions / organ detected by the previous somatostatin receptor scan. * blood test results as follows (wbc: ≥ 3\*109/l, hemoglobin: ≥ 8.0 g/dl, platelets: ≥ 50x109/l, alt, ast, ap: ≤ 5 times uln, bilirubin: ≤ 3 times uln) * ecg: any abnormalities have to be clarified by a cardiologist. * serum creatinine: within normal limits or \< 120 μmol/l for patients aged 60 years or older. * calculated gfr ≥ 45 ml/min. * negative pregnancy test in women capable of child-bearing. exclusion criteria: * known hypersensitivity to 68ga, to nodaga, to jr11 or to any of the excipients of 68ga-ops202. * history of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of corticosteroids. * presence of active infection at screening or history of serious infection within the previous 6 weeks. * known human immunodeficiency virus (hiv) or positive serology for hiv, hepatitis b and c. * any condition that precludes raised arms position for prolonged imaging purposes. * neuroendocrine tumor specific treatment between last somatostatin receptor imaging and start of this study. exception is the therapeutic use of any somatostatin analog (see below). * therapeutic use of any somatostatin analog, including sandostatin® lar (within 28 days) and sandostatin® (within 2 days) prior to study imaging. if a patient is on sandostatin® lar a wash-out phase of 28 days is required before the injection of the study drug. if a patient is on sandostatin® a wash-out phase of 2 days is required before the injection of the study drug. * administration of another investigational medicinal product within 30 days prior to entry. * prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study. * current \> grade 2 toxicity from previous standard or investigational therapies, per us-nci "common terminology criteria for adverse events v4.0". * pregnant or breast-feeding women. * history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. * clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product. * current history of malignancy; patients with a secondary tumor in remission of \> 5 years can be included.
chronic kidney disease prevention of an-lo district, keelung

Conditions: Chronic Kidney Disease; End Stage Renal Disease; Death

Summary: the prevalence and the incidence of the end-stage renal disease (esrd) are extremely high in taiwan (1, 2). more than 45,000 patients are under renal replacement therapy in the year 2004 (2). the disease had not only caused a significant impact in personal life, but also a great burden on social security and government-run health insurance. however, despite this high prevalence, the awareness of chronic kidney disease (ckd) in general population remains low (3, 4). the patients always come out too late for the intervention to slow down the progression of renal failure. furthermore, most of them are not well prepared for the renal replacement therapy. the facts result in high mortality and morbidity in this specific population (5). it is mandatory to screen out and treat these patients early enough. however, these patients are deep into the community as the asymptomatic nature of ckd. the major purpose of the study is to screen the community for the early ckd and provide the appropriate intervention at time. the study will collect the characteristic demographic epidemiological data and find out risk factors for ckd of this geographic area, provide multidisciplinary education of ckd and establish timely referral for appropriate nephrologist care for treatment and monitoring of complications.

the project will be last for 3 years. we will start to screen the patients within the community to identify the ckd population. this population will randomized into two group (one group with standard nephrologist care and another group with standard nephrologist care plus multidisciplinary ckd education) to evaluate the effectiveness of ckd education on the progression of renal function. the primary end-point will be the doubling tine estimated gfr, development of end-stage renal disease and all cause mortality. the non-ckd group of community will also follow up for urine and blood test for renal function, to determine the incidence and risk factors of new-onset renal disease. the accomplishment of this study will retard renal progression, improve community health and establish a model in preventing the chronic kidney disease.

Eligibility criteria:
inclusion criteria: * all ckd patients older than 18 y/o. exclusion criteria: * refusal to participate in the trial

Keywords: chronic kidney disease prevention cardiovascular disease
endothelin antagonism in anca vasculitis

Conditions: Vasculitis

Summary: patients with vasculitis commonly develop cardiovascular disease. the reasons for this are not clear and is not adequately treated with current drugs. it is thus understand the reasons why patients with vasculitis develop cardiovascular disease in order to develop new drugs to reduced this risk. endothelin is a chemical produced by blood vessels that contributes to the development of hypertension and cardiovascular disease higher than normal levels of endothelin are seen in patients with vasculitis but how this contributes to cardiovascular disease in patients with vasculitis is not clear. by using drugs that block the effects of endothelin ('endothelin receptor antagonists') the investigators can hopefully reduce the risk of cardiovascular disease in patients with vasculitis. the purpose of the study is to ascertain if endothelin receptor antagonists improve blood vessel function in patients with vasculitis.

vasculitis patients and healthy controls matched for age, sex will be enrolled into the study. patients will attend for 4 study days \>1 week apart, whereas controls will attend for single day. circulating mφ and other immune cells will be confirmed using facs prior each study. study 1 both patients and control will attend for visit 1: assessment of vascular function using forearm plethysmography as part of case control study. vasculitis patients will then attend for visits 2, 3 \& 4 as part of randomised three way crossover study (randomised \& infusions given in a double-blind method): comparison of the effects of selective eta receptor antagonism (bq123; 1000nmol/min for 15min iv), mixed eta/b antagonism (bq123/788; 1000 nmol/min \& 300 nmol/min for 15 min), and placebo on systemic haemodynamics.

Eligibility criteria:
inclusion criteria: * male or female * age 18 years and over * body mass index ≤35 * normal serum albumin exclusion criteria: * subject with diabetes or current smoking or chronic kidney disease (egfr \<60ml/min) * subject with pre-existing cardiovascular disease * subject is below the age of legal consent, or is mentally or legally incapacitated * history of multiple and/or severe allergic reactions to drugs (including study drugs) * the subject has donated blood (450 ml) within the last 4 weeks * past or present drug or alcohol abuse including intravenous drug abuse at any time * participation in another clinical trial within 1 month * considered to be at high risk of hiv or hepatitis b * women of child-bearing potential (only women who are post-menopausal or surgically-sterilised will be included in the study)

Keywords: endothelin; blood pressure; vasculitis
study of effectiveness and safety of azithromycin-based extended-spectrum prophylaxis to prevent post cesarean infection

Conditions: Endometritis; Wound Infection; Abscess; Surgical Site Infection

Summary: the cesarean section optimal antibiotic prophylaxis (c/soap) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection. hypothesis: compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.


Eligibility criteria:
inclusion criteria: - pregnant women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either: 1. labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of ≥1cm dilatation or ≥50% effacement), or 2. membrane rupture (standardized to duration of at least 4 hours prior to randomization). exclusion criteria: * patient unwilling or unable to provide consent * multiple pregnancy * known azithromycin (or other macrolide) allergy * vaginal delivery * elective or scheduled cesarean prior to labor or membrane rupture. * azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment. * clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization. * patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient) * fetal demise or major congenital anomaly * significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal * significant renal disease defined as serum creatinine known to be \>2.0 mg/dl or on dialysis. * active congestive heart failure (ef\<45%) or pulmonary edema * active diarrhea at time of delivery * any patient with significant electrolyte abnormalities such as hypokalemia or hypocalcemia * any patient with structural heart disease or arrhythmias, or taking any medications known to prolong the qt interval * patient currently being treated with efavirenz, nelfinavir or fluconazole

Keywords: pregnancy cesarean section antibiotic infections