Kornimate/medical-research-clean huggingface dataset:
access to pediatric rheumatology centers for jia patients: factors associated with time to access pediatric rheumatology centers

Conditions: Juvenile Idiopathic Arthritis

Summary: jia patients, their parents, and the health care professionals experience the complexity of the initial care pathway. the aim of the study is to explore the referral pathway to access pediatric rheumatology centers for jia patients. the exploration will aim to identify the barriers and facilitators of referral, based on the conceptual framework of the health literacy. the investigators will conduct a qualitative study using semi-structured interviews. the perspectives of parents/children/health care professionals will be crossed to enrich the data.


Eligibility criteria:
inclusion criteria: children: * age \> 11 years * jia diagnosed between 4 and 24 months prior to the start of the study parents: - parent of a child with jia diagnosed between 4 and 24 months prior to the start of the study health care professional: * physician with experience in the initial management of children with jia (between symptom onset and first visit with a pediatric rheumatologist). exclusion criteria: for all participants: * refusal to participate in interviews * presenting a health condition incompatible with an interview * participants with inadequate french to take part in semi-structured interviews

Keywords: qualitative research access to care time to referral health literacy
utility of [f-18] fluorodopa for neonatal hyperinsulinism

Conditions: Congenital Hyperinsulinism; Hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy; CHI; PHHI

Summary: children with congenital hyperinsulinism (chi) have low blood sugar, and some of these children may require surgery. in this study, researchers affiliated with the university of pennsylvania will test how well a radioactive drug (called f-dopa) can detect a form of hyperinsulinism that may be cured by surgery. eligible participants in this study will have positron emission tomography (pet) scans with f-dopa prior to surgery.

for children with congenital hyperinsulinism (chi), low blood sugar is caused by cells in the pancreas that release too much insulin. some children with chi have these cells throughout their pancreas; others have them located in specific areas of the pancreas. children who have them located in specific areas of the pancreas may be cured with surgery. f-dopa is a radioactive drug that may go to these very cells. f-dopa can also be used for positron emission tomography (or pet), an imaging technique used in nuclear medicine departments. in this study, researchers will test the possibility of using pet with f-dopa in the diagnosis of children with hyperinsulinism.

Eligibility criteria:
inclusion criteria: * any age, but primarily infants 0-6 months. * children with confirmed diagnosis of congenital hyperinsulinism. exclusion criteria: * cases in which surgery will not be considered by parents or guardians.

Keywords: congenital hyperinsulinism hyperinsulinism persistent hyperinsulinemic hypoglycemia of infancy chi phhi f-dopa l-fluoro-dihydroxyphenylalanine
ascending dose study to investigate the safety, tolerability and pharmacokinetics of bay1128688 after multiple oral administrations in healthy women

Conditions: Endometriosis

Summary: the objective of this trial is to investigate the safety and tolerability of bay1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. the investigational substance will be administered in tablet form to healthy women.


Eligibility criteria:
inclusion criteria: part a * postmenopausal state, revealed by 1. medical history. one of the following: * natural menopause at least 12 months prior to first study drug administration, * surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration) or * hysterectomy and 2. follicle-stimulating hormone (fsh) \> 40 iu/l * age 45 to 68 years part b * healthy female subjects * sterilized by tubal-ligation * pre-treatment menstrual cycle assessed as ovulatory * completion of more than 3 menstrual cycles after delivery, abortion or lactation * age 18 to 48 years exclusion criteria: * body mass index (kg/m2) greater or equal 32 (or less or equal 18) * smoking: part a: non-smoking; part b: less than 10 cigarettes per day * use of medicines including but not restricted to contraceptives and nsaids (details regarding previous use of medicines provided by the study center) * ability and willingness to adhere to restrictions regarding diet (part a and b) and to eat standardised meals (part a only) * significant diseases of the heart, gastrointestinal tract and/or liver and/or kidney and/or reproductive organs (present or in the past; details will be provided by the study center) * recent infectious diseases (details will be provided by the study center) * migraine or depression * thyroid disease which requires treatment * metabolic disorders, for example diabetes mellitus or hypertriglyceridemia * drug or alcohol abuse; regular consumption of more than 800 ml of beer per day (or other drinks resembling 40 g of alcohol)
community-based microalbuminuria screening in patients with hypertension

Conditions: Hypertension; Microalbuminuria

Summary: this study evaluates the effectiveness of different anti-hypertensive drugs on patients with hypertension and microalbuminuria.

this is a a real world registry study. all patients with hypertension in community hospitals in china will be eligible . patient demographics, medical history, clinical characteristics, physical examination, laboratory tests (including ucar, blood routine, urine routine, blood biochemistry, and ecg), antihypertensive drugs (including: acei/ arb, thiazide diuretics, ccb, beta-blockers, alpha-blockers, and other antihypertensive drugs used in real-life clinical practice in other communities.) will be recorded. all patients are anticipated to be followed up for 12-month. effectiveness of different antihypertensive medications on urine albumin-to-creatinine ratio (uacr) will be evaluted.

Eligibility criteria:
inclusion criteria: * patients with essential hypertension; * urinary albumin/creatinine ratio in random urine samples is 30-300 mg/g * age \>=18 * understand and sign informed consent exclusion criteria: * this is a real-world registry study and does not set exclusion criteria

Keywords: hypertension microalbuminuria effectiveness antihypertensive medications
sofosbuvir/velpatasvir fixed dose combination for 12 weeks in adults with chronic hcv infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (sof/vel) fixed dose combination (fdc) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * hcv rna ≥ 10\^4 iu/ml at screening * hcv genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory * chronic hcv infection (≥ 6 months) documented by prior medical history or liver biopsy * classification as treatment naive or treatment experienced * males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception exclusion criteria: * current or prior history of clinically-significant illness (other than hcv) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than hcv) are also excluded. * screening ecg with clinically significant abnormalities * laboratory results outside of acceptable ranges at screening * prior exposure to sof or other nucleotide analogue hcv ns5b inhibitor or any hcv ns5a inhibitor * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)

Keywords: sofosbuvir sof/vel velpatasvir hepatitis c hcv cirrhosis
single site thoracic surgery for pediatric pneumothorax

Conditions: Pediatric Disorder; Pneumothorax, Spontaneous; Thoracic Diseases; Thoracic Surgery

Summary: video-assisted thoracoscopic surgery (vats) has become a standard of care in adults, pediatric surgeons have been slower to undertake this approach. there are limitations for working in children. the site of a chest tube becomes the working site for thoracoscopic surgery and the only scar. we propose this study to do a retrospective review comparing the conventional multiport thoracic surgery with the newer single port site.

while video-assisted thoracoscopic surgery (vats) has become a standard of care in adults, pediatric surgeons have been slower to undertake this approach. the limitations for working in children are decreased working space, unknown thoracoscopic effects on body physiology, and instrument accommodation. especially as the field for minimally invasive surgery expands, using the single port approach has unique implications in children. the site of a chest tube becomes the working site for thoracoscopic surgery and the only scar. despite some learning curve, the preliminary outcomes are similar to the multiport surgeries with better cosmesis. the learning curves for single port site surgery have been well described and our group recently performed a similar study for appendectomies. we propose this study to do a retrospective review comparing the conventional multiport thoracic surgery with the newer single port site.

Eligibility criteria:
inclusion criteria: * age \< 19 years old * pneumothorax * underwent surgery for pneumothorax exclusion criteria: * age =/\> 19 years old * history of prior thoracic surgery * history of cancer
a phase ii study of the safety and efficacy of mpsk3169a in patients with coronary heart disease or high risk of coronary heart disease

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to evaluate the safety and cholesterol lowering effects of mpsk3169a when given as subcutaneous (sc) injections over a 24-week period to patients with a high risk of cardiovascular events and ldl-c levels well above goal.


Eligibility criteria:
inclusion criteria: * use of a standard-of-care statin at a stable dose, or intolerance of statins, without use of other lipid modifying therapies * fasting ldl cholesterol 90-250 mg/dl on the statin regimen above and at least one of the following: * coronary heart disease (chd) with a history of myocardial infarction (mi), percutaneous coronary intervention (pci), coronary artery bypass graft surgery (cabg), or prior coronary angiography demonstrating coronary atherosclerosis * a chd risk equivalent condition, including diabetes mellitus (type 1 or 2), chronic kidney disease, prior stroke, carotid disease, peripheral arterial disease, or abdominal aortic aneurism * \>/=2 chd risk factors (age \>/= 45 years for men or \>/= 55 years for women; smoking; hypertension; low hdl cholesterol; family history of premature chd) and a high risk of a cv event based on risk estimation systems exclusion criteria: * severe congestive heart failure (nyha class iii-iv) or left ventricular ejection fraction \</= 35% * recent (within 3 months) mi, unstable angina, stroke, transient ischemic attack, cabg, pci, hospital admission for heart failure, major surgery, uncontrolled cardiac arrhythmia (other than atrial fibrillation or flutter), or initiation of renal replacement therapy (dialysis) * fasting serum triglyceride level \>/= 400 mg/dl * homozygous familial hypercholesterolemia * poorly controlled diabetes mellitus, hypertension or thyroid disease * liver or muscle disease, including abnormal test results at screening * pregnant or lactating the above list is not intended to contain all factors relevant to a patient's eligibility for the study.

Keywords: hyperlipidemia dyslipidemia
efficacy of ece pedo (equipment for clever exercise) on abdominal obesity

Conditions: Obesity, Abdominal; Physical Activity

Summary: objective: to show the effectiveness of walking with ece pedo (equipment for clever exercise) comparing supervised treadmill walking corresponding moderate aerobic exercise intensity on abdominal obesity and cardiorespiratory capacity.

objective: to show the effectiveness of walking with ece pedo (equipment for clever exercise) comparing supervised treadmill walking corresponding moderate aerobic exercise intensity on abdominal obesity and cardiorespiratory capacity. methods: twenty-eight women with overweight and obesity were assigned to two groups: supervised treadmill walking (group i,n=14) or walking with ece pedo (group ii,n=14). target heart rate(hr) corresponding to values of 50-70% vo2max were determined by the submaximal treadmill test. group 1 was instructed walking at their target hr on a treadmill. the number of steps taken in a minute corresponding to target hr was determined by a criterion pedometer and group 2 was instructed walking in these step range recorded to ece pedo giving audible feedback. before and after a 12-week exercise program, participants were evaluated by bmi and waist circumference(wc); ultrasonographic visceral fat thickness(vft) and ergospirometric vo2max.

Eligibility criteria:
inclusion criteria: * eligible participants who meet the criteria for inclusion were women with overweight weight or obesity and were 26-60 years old with a bmi (in kg/m2) from 27.1 to 39.6 and, waist circumference \> 80 cm. exclusion criteria: * the exclusion criteria were bmi values less than 24.9 and higher than 40, presence of a atherosclerotic heart disease, musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, and participation in a calorie restricted diets.

Keywords: abdominal obesity walking aerobic exercise
blended unified protocol in chinese adolescents with non-suicidal self-injury

Conditions: Non-suicidal Self-injury (NSSI)

Summary: this study utilizes the unified protocol for transdiagnostic treatment of emotional disorders in adolescents (up-a) to address non-suicidal self-injury among chinese adolescents. this program is an annualized cognitive-behavioral therapy designed for adolescents aged 12-17 years who engage in non-suicidal self-injury behavior. its primary goal is to reduce the intensity and frequency of distressing emotional experiences by teaching adolescents how to confront and respond to these emotions in more adaptive ways. in turn, this helps reduce self-injury impulses and behaviors. the up-a is adapted to the chinese cultural context and delivered as a blended treatment, combining face-to-face and online sessions. the study will assess the feasibility, acceptability, and preliminary efficacy of this intervention through a single-arm design, which includes pretest, posttest, and follow-up assessments.

the blended up-a includes 8 weekly modules, 6 of which (module 2 - 7)are online self-guided sessions. the online self-guided sessions will last approximately 45 minutes each. over the course of these 6 weeks, participants will also have 6 therapist-guided online sessions via videoconference, each lasting 30 minutes. two face-to-face individual sessions are scheduled, one at the beginning of each (module 1) and one at the end (module 8), each with an expected duration of 90 minutes.

Eligibility criteria:
inclusion criteria: 1. aged between 12 and 17 years; 2. engaged in non-suicidal self-injury (nssi) at least 5 times in the past 12 months, with at least 1 episode in the past month; 3. minimum education level of primary school or above; 4. participant and guardian fully understand the research content and agree to participate, with signed informed consent provided. exclusion criteria: 1. suicide attempts in the past month or a score of ≥17 on the mini national neuropsychiatric interview for children (mini kid 5.0), indicating a high risk of suicide; 2. diagnosis of a psychotic disorder, manic or hypomanic episode, autism spectrum disorder, or other serious neurodevelopmental disorders according to the dsm-5; 3. presence of severe physical illness or other medical conditions that may affect the completion of treatment and evaluation; 4. currently receiving other professional psychotherapy or participating in another nssi intervention study; 5. received 5 or more sessions of cognitive behavioral therapy (cbt) in the past 5 years; 6. having received electroconvulsive therapy (ect) within the past 6 months.
absorption and safety with sustained use of relizorb evaluation (assure) study

Conditions: Cystic Fibrosis

Summary: protocol 0000498: multicenter, open label study to evaluate the effect of sustained relizorb (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained relizorb use, in patients with cystic fibrosis and exocrine pancreatic insufficiency.

study entry (day -14): baseline blood samples collected for plasma and erythrocyte concentrations of docosahexaenoic acid (dha) and eicosapentaenoic (epa). baseline characteristics collected included bmi and cystic fibrosis related diabetes. observation period (day -14 to day -8): subjects followed their usual enteral nutrition regimen with pancreatic enzyme replacement therapy (pert). run-in period (day -7 to day -1): subjects used peptamen 1.5 enteral formula at their normal volume of administration from 500 ml to 1,000 ml per feeding with usual pert regimen. treatment period (day 0 to day 90): subjects used impact peptide 1.5 up to a maximum volume of 1,000 ml per feeding with relizorb for the 90 day treatment period. blood screening measurements were repeated at start of treatment period (day 0), day 30, day 60 and day 90. pert use with enteral feedings was prohibited. safety and tolerability were assessed with gi symptom diaries and systematic assessments of adverse events and unanticipated adverse device effects.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of cystic fibrosis 2. documented history of exocrine pancreatic insufficiency 3. enteral formula use a minimum of 4x/week, using pert, consuming an unrestricted fat diet, and willing to use peptamen 1.5 and impact peptide 1.5 4. written informed consent or assent. exclusion criteria: 1. uncontrolled diabetes mellitus 2. signs and symptoms of liver cirrhosis or portal hypertension 3. lung or liver transplant 4. active cancer currently receiving cancer treatment 5. crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerance, inflammatory bowel disease

Keywords: cf, epi, diabetes, pert, lcpufa, dha, epa, omega-3 index
a study to evaluate safety and immunogenicity of topv in 1 to 5 years and at 6 weeks of age

Conditions: Poliomyelitis

Summary: the purpose of this study is to assess the safety (serious adverse events \[saes\]), and severe adverse events \[aes\] (grade 3 according to ctcae 4.03) after one dose of sabin topv in 1-5 year-old children and three doses of sabin topv in 6 week-old infants, and immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of sabin topv in vaccine-naïve infants.

this will be a single center, open study in children (aged 1 to 5 years) and vaccine-naïve infants, as follows: 50 opv-vaccinated children aged 1 to 5 years to receive 1 dose of topv (group 1); 104 vaccine-naïve infants to receive 3 doses of topv administered 28 days apart (group 2)

Eligibility criteria:
inclusion criteria: 1. age: group 1- children aged 1-5 years, previously vaccinated with ≥ 3 doses of opv. group 2- infants aged 6 weeks (-7 to +14 days) with no previous polio vaccinations. 2. healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination. 3. written informed consent obtained from 1 or 2 parents or legal guardians as per dominican republic regulations. exclusion criteria: 1. previous vaccinations: group 1: previous vaccination against poliovirus outside of the national immunization schedule and any vaccine in the previous 4 weeks. group 2: any vaccination against poliovirus 2. group 2: infants with birth weight (bw) \< 2,500 gm. 3. any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (hiv) infection. 4. family history of congenital or hereditary immunodeficiency. 5. major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). 6. known allergy to any component of the study vaccines or to any antibiotics. 7. uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections. 8. administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. 9. acute severe febrile illness at day of vaccination deemed by the investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met). 10. member of the subject's household (living in the same house or apartment unit) has received opv in the last 3 months, or is scheduled to receive opv during the study period. 11. subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
phaseⅲopen-label study of mra for rheumatoid arthritis(ra)

Conditions: Rheumatoid Arthritis

Summary: an open-label, phaseⅲ study to evaluate the efficacy and safety of mra in patients with ra


Eligibility criteria:
inclusion criteria: * diagnosed as having ra, on the basis of the criteria stipulated by the american conference on rheumatism(acr) in 1987 * active ra despite at least one dmards or immunosuppressants or infliximab or etanercept.active disease is defined as having at least 6 tender and 6 swollen joints among das28 (modified disease activity scores that include twenty eight joint counts) and esr at least 30 mm/hr or crp not less than 2.0mg/dl * active ra despite over 10mg adrenocortical steroids within 2 weeks before entry of this study exclusion criteria: * shown to have class-ⅳ steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug * treated with infliximab within 3 months before and with etanercept within 2 weeks before administration of the study drug * subjected to any of the following within 4 weeks before administration of the study drug: 1. surgical treatment (operations,etc.). 2. plasma exchange method