Kornimate/medical-research-clean huggingface dataset:
peptide gam immunoadsorption therapy in autoimmune membranous nephropathy

Conditions: Autoimmune Membranous Nephropathy

Summary: autoimmune membranous nephropathy is now understood to be a condition caused by the immune system although the exact mechanism is not completely known. this study aims to remove the offending part of the immune system using immunoadsorption to not only treat the disease but also use the opportunity to better understand the mechanism of disease. this will allow more targeted treatment in the future with less complications and side effects.

membranous nephropathy (mn) is among the most common causes of nephrotic syndrome in adults worldwide. the majority of patients will remain stable with either complete remission or partial remission but approximately 20% will progress slowly to end stage renal disease necessitating the need for renal replacement therapy (rrt). current standard therapy for primary (or autoimmune) membranous nephropathy is a regime of rotating high dose steroids and immunosuppression was first described in the mid-nineties and has been the mainstay of treatment since but comes with a high side effect burden. idiopathic membranous nephropathy is now understood to be an autoimmune disease characterised by the presence of igg autoantibodies to m-type phospholipase a2 receptor (anti-pla2r). immunoadsorption is a method of removing specific circulating immunoglobulins and has been shown to remove over 80% of circulating igg with a single session immunoadsorption of 2.5 plasma volumes, with albumin and antithrombin iii almost unaffected. with multiple sessions this can rise to over 98%. immunoadsorption therapy has been in use for a number of years and this study will use peptide gam immunoadsorption therapy developed by fresenius healthcare. this uses two systems, the art universal and adasorb. the art universal became commercially available in 2005 and the adasorb in 2002.

Eligibility criteria:
inclusion criteria: * biopsy confirmed primary membranous nephropathy within the last 3 years * active disease despite 6 months of supportive care including acei or arb (active disease defined as upcr \> 300mg/mmol or 24 hour urinary protein \>3.5g/1.73m2) * disease severity that in the physicians view warrants treatment prior to completion of 6 months supportive care * anti-pla2r titre \> 170 u/ml * haemophilus and pneumococcal vaccinations up to date * above the age of 18 * able to provide informed consent exclusion criteria: * evidence of causes of secondary membranous nephropathy * egfr \< 20ml/min * treatment with steroids or immunosuppression (including but not limited to cyclophosphamide, mmf or azathioprine) and biologics (including but limited to rituximab or belimumab) within 6 months of screening * therapeutic plasma exchange within 28 days of screening * previous renal transplantation * co-morbidity, which in physicians' view, would preclude patient from treatment with immunoadsorption. * pregnant at time of screening

Keywords: idiopathic membranous nephropathy primary membranous nephropathy immunoadsorption apharesis
prediction of postoperative pain by injection pain of propofol

Conditions: Cholecystitis, Acute

Summary: postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. however, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. therefore, it would be useful to find the way to predict the postoperative pain sensitivity. propofol, a popular anesthetic agent, induces pain during injection, which can not completely prevented by opioid or lidocaine in some patients. this is considered to be related to patient's pain sensitivity and it might be associated with postoperative pain sensitivity. therefore, the relation of propofol injection pain and postoperative pain intensity will be explored.


Eligibility criteria:
inclusion criteria: * america society of anesthesiologists class i-ii * laparoscopic cholecystectomy exclusion criteria: * pregnancy * illiteracy
the use of peanut ball in labor in obese women

Conditions: Labor Long

Summary: the purpose of this study is to assess the efficacy of peanut ball use on labor process and maternal, neonatal outcomes in obese pregnant women.

after being informed about the study, all participants giving written informed consent, on the active phase of labor (cervical dilatation = 5 cm), the pregnant women in the experimental group will be provided with a position change lasting at least 30 minutes every hour with a peanut ball. the peanut ball will be used with a sheath that is changed for each participant. pregnant women in the control group will be included in the study during the active phase of labor (cervical dilatation = 5 cm). no intervention will be made by the researcher. they will receive standard care by the service nurse.

Eligibility criteria:
inclusion criteria: * admitted for delivery * maternal bmi \> 30kg/m2 at admission * gestational age \> 37 weeks 0 days * singleton pregnancy * cephalic presentation * cervical dilatation less than 5 cm * turkish speaking exclusion criteria: * pre-pregnancy bmi \< 30kg/m2 * gestational age \< 37 weeks 0 days * multifetal gestation * intrauterine fetal demise * musculoskeletal problems * receiving magnesium sulfate * high risk pregnancies (preeclampsia/eclampsia, cholestasis, intrauterine growth retardation, fetal anomaly, polyhydramnios or oligohydramnios)

Keywords: peanut ball
efficacy and safety trial of flexible doses of oral ziprasidone in children and adolescents with bipolar i disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar i disorder (manic or mixed).


Eligibility criteria:
inclusion criteria: * dsm v criteria for bipolar i disorder (manic or mixed); age 10 - 17 years. exclusion criteria: * imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for qt prolongation.

Keywords: bipolar i disorder (current or most recent episode manic). children and adolescents aged 10 to 17 years.
validation of the gendolcat score for the prognosis of chronic postoperative pain in cesarean section

Conditions: Chronic Post Surgical Pain; Cesarean Section Complications; Chronic Pain

Summary: chronic post-surgical pain is a problem that has historically been underestimated. over the last few years there has been a search for strategies to both predict and prevent its occurrence in patients undergoing surgery. the gendolcat index is the only predictive model that uses only objective pre-surgical variables to assess the risk of suffering chronic post-surgical pain. however, it is only validated for the following surgeries: thoracotomy, hysterectomy and open inguinal hernia. our aim is to test whether the gendolcat model is also valid for cesarean section.


Eligibility criteria:
inclusion criteria: * patients who underwent elective caesarean section. * patients who have previously signed the informed consent form. exclusion criteria * urgent cesarean section. * patients with severe psychiatric pathology. * patients who require a different surgical approach than usual. * patients who refuse to take part in the study and/or to sign the informed consent form. informed consent. - patients with a high language barrier.
barriers to adherence to recommended follow-up in women with a history of gestational diabetes

Conditions: Gestational Diabetes Mellitus

Summary: the purpose of this study is to find out whether women who have had gestational diabetes mellitus (gdm) will make healthier lifestyle choices, achieve weight goals, and complete postpartum care assessments after receiving two online classes on healthy nutrition and exercise classes at 6 weeks - 3 months and at 9 months postpartum.

for this pilot study, we propose to conduct a 3-grouped randomized controlled trial to evaluate whether a 1 ½ to 2 hour on-line nutrition and physical activity intervention +/- block testing of blood glucoses fasting and 2 hours after each meal for 4 days/month from starting at 3 months postpartum and concluding at 9 months postpartum will: 1) improve adherence to the receipt of diabetes screening at 12 months postpartum through the recommended 75 gram 2 hour oral glucose tolerance test (ogtt) or fasting blood glucose test, 2) lower glucose values on the 75 gram 2 hour oral glucose tolerance test or fasting blood glucose test and 3) improve attainment of weight loss targets among women with a recent history of gdm. patients will participate in an online nutrition and physical activity class from 6 weeks to 3 months and 9 months for women assigned to both groups 2 and 3. for those women assigned to group 3, they will also do block testing using an assigned blood glucose meter and test strips 4 times a day for 4 consecutive days each month, starting at 3 months and ending at 9 months. women will have the option of submitting meter blood glucose data via e-mailed logs or downloading directly to the clinic using diasend software. once downloaded, the diasend software will create a pdf document with all recorded blood glucose values. for purposes of this study, we will obtain a diasend account specific to this study, which will allow women to download blood glucose information with an anonymous unique identifier that can be accessed by the study's principal investigator and the collaborative institutional training initiative (citi)-certified, international review board (irb)-approved research assistant. upon accessing the pdf document with the blood glucose meter information, both the pi and the research assistant can link blood glucose data with questionnaire and other health information collected in this study through the unique identifiers.

Eligibility criteria:
inclusion criteria: * gestational diabetes * age between 21 and 45 years * preconception bmi 19-40 * seen for at least 2 visits in the diabetes in pregnancy program during their pregnancy * singleton pregnancy exclusion criteria: * preexisting diabetes or diabetes diagnosed at the 6 week 75 gram 2 hour ogtt * bmi \>40 * multiple gestation (i.e., twins, triplets, etc.)

Keywords: gestational diabetes postpartum nutrition exercise
randomised controlled trial on pre-peritoneal drainage after totally extra-peritoneal hernioplasty for inguinal hernia

Conditions: Hernia, Inguinal

Summary: this is a rct on drain versus no drain after laparoscopic totally extra-peritoneal hernioplasty. we will assess the difference in seroma formation after surgery in 2 two groups by an independent assessor clinically and radiologist to document the size of seroma after surgery. other secondary outcomes will be measured including post-operative pain, discomfort, analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.

inguinal hernia is a common disease and causes significant morbidity if left untreated. with the advances of laparoscopic approach of extra-peritoneal hernioplasty, it significantly reduces the post-operative pain and lead to a better quality of life with higher acceptance to patients.however, similar to traditional litchenstein approach, post operative seroma formation is still a common problem encountered after surgery. numerous method has been described to reduce chance of seroma formation, however, none was proven to be effective except pre-peritoneal drainage. there are currently 2 large retrospective non-randomized cohort study to evaluate the effectiveness of preperitoneal drainage available for reference. we therefore study the feasibility and efficacy of preperitoneal drainage with large scale randomized trial. patient fulfill inclusion criteria and consent to surgery and study will be recruited. a standardized pre-peritoneal dissection and mesh placement will be adopted. immediately before deflation of pre-peritoneal space, randomization will be performed by calling research assistant for study group using computer generated code. drain will be placed for 23 hours after operation and ultrasonography will be performed immediately after removal of drain. usg will be repeated at post-operative 1 week, 1 month, 3 months, 6 months and 1 year after surgery. for non-drain group, a fake drain will be attach to the skin of the wound to achieve double blinding to patients and assessors. in addition to seroma, patient demographics and secondary outcome including post-operative pain score, discomfort, foreign body sensation, patient satisfaction, infection, recurrence, etc will be studied.

Eligibility criteria:
inclusion criteria: * age above 18 and below 80 * male or female patients * unilateral inguinal hernia * first occurrence hernia * consent to laparoscopic hernioplasty for inguinal hernia exclusion criteria: * inguino-scrotal hernia * recurrent inguinal hernia * incarcerated hernia * bilateral inguinal hernia * bleeding tendency * on anti-platelet agent or anti-coagulant * co-morbidies * decline or not consent to surgery

Keywords: hernia, inguinal extraperitoneal hernioplasty drain mesh repair laparoscopic
a post-marketing surveillance study to assess the safety of fedratinib in korean patients with myelofibrosis

Conditions: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

Summary: the purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (pmf), post polycythemia vera myelofibrosis (post-pv mf), or post essential thrombocythemia myelofibrosis (post-et mf) who were previously treated with ruxolitinib. participants will represent the overall patient population with pmf, post-pv mf or post-et mf who lost adequate response to and/or are intolerant to ruxolitinib. inadequate response definitions will follow ministry of food and drug safety-approved label and reimbursement criteria of the health insurance review \& assessment service.


Eligibility criteria:
inclusion criteria: * participants 19 years of age or older * participants who will receive fedratinib according to the approved label * for the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered * participants who signed the informed consent form exclusion criteria: * participants who have been prescribed fedratinib for an indication not approved in korea * participants who have been prescribed fedratinib at a dose not approved in korea * participants for whom fedratinib is contraindicated as clarified in korean prescribing information approved by the ministry of food and drug safety
cell based non invasive prenatal testing as an alternative to chorionic villus sampling following preimplantation genetic testing

Conditions: Prenatal Diagnoses; Preimplantation Genetic Diagnosis

Summary: the study aims to investigate whether cell-based non-invasive prenatal testing (cbnipt) can be used as an alternative to invasive chorionic villus sampling (cvs) in patients who achieve pregnancy following preimplantation genetic testing for monogenic disorders (pgt-m).


Eligibility criteria:
inclusion criteria: * achieved pregnancy following preimplantation genetic testing exclusion criteria: * none
biomarkers and preeclampsia outcomes

Conditions: Preeclampsia

Summary: prospective, observational, monocentric, non-interventional study.

in practice, patients with preeclampsia are referred to the hospital for medical management only clinical signs \& symptoms and standard biological tests are available for patient individualized care. hence, a new diagnostic tool to distinguish and stratify the different patients referred is in need of proper triage. reports study aims to determine the diagnostic utility of 2 preeclampsia biomarkers (sflt-1/plgf ratio) in clinical decision making in preeclamptic women. data are collected by dacima clinical suite, according to fda 21 cfr part 11 requirements (food and drug administration 21 code of federal regulations part 11), the hipaa specifications (health insurance portability and accountability act), and the ich standards (international conference on harmonisation)

Eligibility criteria:
inclusion criteria: * suspected or confirmed preeclampsia * singleton pregnancy * between 26 weeks of gestation and 37 weeks of gestation \& 6 days exclusion criteria: * multiple pregnancies
strength training and muscle lipids

Conditions: Healthy

Summary: the purpose of this study is examine the effects of 8 weeks (3 days/week) of resistance exercise training in children 8 to 10 years of age on muscle strength and power, motor unit activation, and lipid profiles of the vastus lateralis.


Eligibility criteria:
inclusion criteria: * healthy volunteer males and females ages 8 - 10 years. exclusion criteria: * no history or ongoing neuromuscular diseases. * no history or ongoing musculoskeletal injuries. * no history or ongoing disease that effects metabolism.

Keywords: exercise muscle cross-sectional area intramyocellular lipids extramyocellular lipids muscle power motor unit
efficacy study of diazoxide choline to treat hypertriglyceridemia

Conditions: Hypertriglyceridemia; Dyslipidemia

Summary: once a day oral administration with dccr helps lower triglycerides

the population will consist of statin-naive and statin-treated subjects, all without diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dl and \< 1500 mg/dl. subjects will be randomly assigned to 1 of 2 treatment groups: dccr and placebo approximately 44 subjects will be enrolled in the study and stratified by statin use at a 1:1 ratio in each treatment group,

Eligibility criteria:
inclusion criteria: fasting triglycerides * difference between visit 3 (7 days prior to baseline visit) and visit 4 (3 days prior to baseline visit) ≤ 60% (compared to the higher value of visit 3 or visit 4) * run-in triglycerides\* ≥ 500 mg/dl and \< 1500 mg/dl \*run-in triglyceride is defined as the average fasting triglycerides for visit 3 (7 days prior to baseline visit) and visit 4 (3 days prior to baseline visit). statin use • either statin-naive * must not be on statin at screening and remaining as such during the run-in/washout period and throughout the study • or statin-treated * must be on lipitor 20 mg initiated at the start of the run-in/washout period and continue throughout the study medication washout * all subjects must be willing to undergo washout of all other lipid-lowering medications glycemic status * fasting glucose \< 126 mg/dl at screening visit * hba1c \< 6.5% at screening visit exclusion criteria: medications: recent, current, anticipated * administration of investigational drugs within 1 month prior to screening visit * thyroid hormones or preparations within 1 month prior to screening visit (except in subjects on stable dose of replacement therapy for at least 1 month) * thiazide diuretics within 2 weeks prior to screening visit * discontinuation of beta-blockers within 1 month prior to screening visit or planned discontinuation of beta-blocker therapy * anticipated requirement for use of prohibited concomitant medications history of allergic reaction or significant intolerance to: * diazoxide * thiazides * sulfonamides * fenofibrate or fenofibric acid derivatives lifestyle changes • subjects intending to change exercise habits, quit smoking and/or quit alcohol use during the entire study specific diagnoses, medical conditions and history * known type i or iii hyperlipidemia * known type 1 dm * current diagnosis of type 2 dm * any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the study medications, according to the investigator specific laboratory test results • any relevant biochemical abnormality interfering with the assessments of the study medications

Keywords: triglycerides apo b non-hdl statin fenofibrate
application of cognitive combined sucking task training in dysphagia after stroke

Conditions: Prospective Study

Summary: this topic research, on the basis of traditional swallowing training to develop a set of scientific and advanced type of swallowing disorder in patients with stroke rehabilitation training of the new strategy, combined with cognitive training and sucking training for swallowing disorder in patients with cerebral apoplexy and to provide professional, systematic and comprehensive rehabilitation guidance, promote patients early recovery and return to society.

the incidence of dysphagia in stroke patients is as high as 30% \~ 65%. dysphagia caused by stroke is the primary cause of dysphagia and an independent risk factor for the prognosis of patients. the rehabilitation of cognitive function is the key to the assessment of swallowing and the recovery of rehabilitation function after stroke, and complete consciousness, sensorimotor consciousness and motivation are the prerequisites for the rehabilitation of swallowing function. traditional rehabilitation programs focus more on the single task training of patients' function and ignore the training of cognitive function. cognitive deglutition dual task training is a kind of cognitive rehabilitation training at the same time of deglutition rehabilitation treatment. in this study, the "dual task" training mode of cognitive combined sucking training was applied to the rehabilitation of patients with swallowing dysfunction after stroke, to evaluate the rehabilitation of patients with swallowing function and cognitive function, and to further guide the clinical development and implementation of early rehabilitation treatment and nursing. expected results: through this topic research, on the basis of traditional swallowing training to develop a set of scientific and advanced type of swallowing disorder in patients with stroke rehabilitation training of the new strategy, combined with cognitive training and sucking training for swallowing disorder in patients with cerebral apoplexy and to provide professional, systematic and comprehensive rehabilitation guidance, promote patients early recovery and return to society.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute stroke * clinical diagnosis of deglutition disorders * must be able to communicate through reading and writing exclusion criteria: * dysphagia not caused by stroke patients * with important organ failure or critical illness * severe mental illness or cognitive impairment * severe oropharyngeal organic disease