Kornimate/medical-research-clean huggingface dataset:
ipack nerve block for total knee arthroplasty

Conditions: Arthropathy of Knee; Anesthesia

Summary: double-blind, randomized controlled clinical trial to test the efficacy of ipack on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral tka. enrolled patients will be randomized to either continuous acb with ipack or to continuous acb with sham subcutaneous saline injection. outcomes assessors and patients will be blinded to the intervention.


Eligibility criteria:
inclusion criteria: * unilateral, primary tricompartment total knee arthroplasty * age 18 years or older * asa i-iii * eligible for spinal or combined spinal epidural anesthetic * able to speak, read, and understand english * willing to participate in the trial exclusion criteria: * contraindication to regional anesthesia or peripheral nerve blocks * allergy to local anesthetics * allergy to nsaids * chronic renal insufficiency with cr \> 1.4 or gfr \< 60 * have chronic pain that is not related to their knee joint * have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer) * have a pre-existing peripheral neuropathy involving the operative site * body mass index greater than or equal to 40
postpartum ultrasound evaluation to assess risk of hemorrhage

Conditions: Pregnancy Related; Post Partum Hemorrhage

Summary: up to 5% of patients in the united states have a postpartum hemorrhage. "postpartum hemorrhage" means excessive bleeding after delivery. the majority of these bleeds occur immediately with delivery. the current study focuses on hemorrhages that occur in the "medium-term" (1.5-24 hours after delivery). investigators are examining whether ultrasound exams performed at the beginning of this period 1.5 to 2 hours after birth can identify markers that predict a medium-term bleed. data collected for this study will include medical and obstetrical history, details about the course and outcomes of patients' labor and delivery, and particulars about postpartum bleeding. this information will be collected through the end of the patients' delivery admission and will allow correlation with the results of the ultrasound exam. if patients are re-admitted to the hospital after the delivery discharge, investigators may also collect relevant information about those admissions up to 6 weeks postpartum. all patients after term delivery (≥ 37 weeks' gestation) will be eligible to participate. patients will be approached to provide consent for participation as early as feasible during a prenatal visit (≥ 36 weeks' gestation) or during the delivery admission. no subjects will be consented while in significant pain, \>6cm dilated without an epidural, or \>8cm dilatated with an epidural.


Eligibility criteria:
inclusion criteria: * currently pregnant and planning to deliver at endeavor health \>37 weeks gestational age * english speaking * labor \<6cm dilated at time of consent without epidural * labor \<8cm dilated at time of consent with epidural exclusion criteria: * preterm delivery * non-english speaking * any conditions that impairs potential participants decision making
stool transplant in pediatric patients with recurring c. difficile infection

Conditions: Clostridium Difficile Colitis

Summary: the incidence of c. difficile infection (cdi) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children. the annual us financial burden associated with this infection is great and estimated to exceed $1.8 billion. c. difficile infection arises when the gut microbial ecology is disrupted during interventions notorious for perturbing the delicate microbial balance. a well known and common example is the use of antibiotics. fecal microbiota transplant (fmt) has been introduced several decades ago in an attempt to restore the gut microbial balance. to this date there have been a great number of reports of success in eliminating recurrent c. difficile infections and restoring the gut microbial profile to resemble that of the healthy donor. while over 300 cases have been described in the literature, there has been no pediatric controlled studies performed to compare its efficacy to placebo. therefore, there is a strong need to determine their safety and efficacy in pediatric randomized controlled studies. the investigators hypothesize that children with recurrent c. difficile infection will respond to fecal transplant therapy which will modify their gut microbial profile. the investigators propose a randomized, placebo controlled, pilot study of fecal microbial transplant in children with recurrent c. difficile infection to evaluate the safety and efficacy of fecal microbial transplant in children in preventing recurrent c. difficile infection. the investigators anticipate that fecal microbial transplant in children with recurrent c. difficile infection will be safe and efficacious and will provide these children with a great alternative to a disease that is difficult to treat. results of this study will establish the major role of the gut microbiome in this disease and demonstrate the viability of gut microbial transplant in recipients.

forty six children with recurrent c. difficle infection will be randomized 1:1 to receive either fecal microbial transplant or placebo. the safety and efficacy of this intervention will be monitored for one year.

Eligibility criteria:
inclusion criteria: 1. age: 1-21. 2. recurrent c. difficile infection defined as the occurrence of more than two infections exclusion criteria: 1. inflammatory bowel disease 2. immune-deficiency. 3. allergy to oral vancomycin. 4. children colonized with clostridium difficile without evidence of symptoms to suggest colitis such as diarrhea and/or rectal bleeding. 5. concurrent infections that require anti-microbial therapy. 6. unable to give informed consent/assent. 7. pregnancy.

Keywords: clostridium difficile children fecal transplant
financial navigation and peer support to improve diabetes outcomes

Conditions: Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Summary: the goal of this clinical trial pilot study is to test the feasibility, acceptability, and preliminary efficacy of a combined intervention strategy of 1) technology-supported financial navigation to address economic burden of disease and 2) peer support both to facilitate linkages to clinical care and community resources to address social risks and improve participants\&amp;#39; diabetes self-management. the main aims of this pilot study are: * to examine the feasibility and acceptability of technology-supported financial navigation and financial navigation with peer support * to examine trends in preliminary efficacy of technology-supported financial navigation and peer support versus financial navigation-alone on 1) a1c and blood pressure (primary outcomes), and 2) out-of-pocket costs, treatment-related financial stress, cost-related non-adherence behaviors, diabetes distress, diabetes self-care behaviors, and uptake of social care assistance (secondary outcomes). the investigators will assess whether a combined intervention of technology-supported financial navigation and peer support will produce trends in superior diabetes and social care outcomes to financial navigation alone via a 2-arm randomized controlled trial. participants will * complete 3 survey appointments at baseline, and 3 and 6 months. each appointment will consist of a survey assessment, an hba1c test, and two blood pressure readings over the phone. * be randomized to either financial navigation only or financial navigation and peer support.


Eligibility criteria:
inclusion criteria: participants: * 18-75 years of age * diagnosis of diabetes with prescribed anti-hyperglycemic medication * most recent (within the past 6 months) recorded hemoglobin a1c (hba1c) level of ≥7.5% for individuals ≤70 years and \&amp;gt;8.0% for individuals between 70-75 years in age * positive report of financial burden or cost-related non-adherence (crn) using screening questions developed and validated from prior work 20-22 * be willing to provide personal health information in order to effectively participate in the intervention peer supporters: * international classification of diseases (icd)-10 code for diabetes * in the past had a1cs\&#39; \&gt; 8.0% but whose most recent a1c in the prior 12 months is \&lt;8.0%. * past experience with economic burden or unmet social risk factors * adults 18-75 years exclusion criteria: participants: * a diagnosis of a serious psychiatric disorder (e.g., schizophrenia) * active alcohol or illicit drug use * current pregnancy or planning pregnancy * taking a medication that alters glucose metabolism (e.g., oral steroids) * report a comorbidity expected to limit life span to \&amp;lt; 3 years * participation in another diabetes study, but the investigators will ask them if they would like to be peer supporters peer supporters: * a diagnosis of a serious psychiatric disorder (e.g., schizophrenia) * active alcohol or illicit drug use * current pregnancy or planning pregnancy
bilberry as a dietary supplement after myocardial infarction (the bear smart trial)

Conditions: Myocardial Infarction

Summary: in a double blinded, randomized, clinical trial of patients suffering from stemi (st-segment elevation myocardial infarction) or non-stemi (non-st-segment elevation myocardial infarction)compare the effect of 3 months of dietary supplement with bilberry extract on a range of parameters with prognostic importance in cardiovascular disease: lipids, inflammation, oxidative stress and heart function. following inclusion of 8 individuals and as of february 12, 2014: due to intolerance to "bilberry placebo powder" we have amended to the protocoll that the trial design is changed from blinded to open and that the bilberry arm of the trial carries on in an open design and that the control group will receive no dietary supplement.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of stemi as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ecg with new st-segment elevation in two or more contiguous leads of ≥0.2 mv in leads v2-v3 and/or ≥0.1 mv in other leads or a probable new-onset left bundle branch block. * patients with a diagnosis of non-stemi as defined by a combination of; onset of symptoms such as central chest pain or an aggravated angina pectoris, with or without an ecg change with st-segment lowering or an inverted t-wave, and at least two values with levels of troponin-t or troponin-i above the established margin of an mi. exclusion criteria: * need for emergency coronary artery bypass grafting * inability to provide informed consent * age below 18 years * previous randomization in the bear smart trial * a daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc) exclusion criteria: * need for emergency coronary artery bypass grafting * inability to provide informed consent * age below 18 years * previous randomization in the bear smart trial * a daily intake, or the intent to start a daily intake of bilberries in some form (fresh berries, bilberry powder, bilberrysoup etc)
laparoscopic versus open pyeloplasty for treatment of upjo in children.

Conditions: Pyeloplasty

Summary: uretropelvic junction ( upj ) obstruction is a common congenital disorder , but not all cases require surgical intervention. uretropelvic junction ( upj ) obstruction is a common congenital disorder , but not all cases require surgical intervention. on the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay

uretropelvic junction ( upj ) obstruction is a common congenital disorder , but not all cases require surgical intervention. indications for surgical intervention include impaired split renal function (\ 10% in subsequent studies, poor drainage function after the administration of furosemide, increased anteroposterior diameter on us, and grade iii and iv dilatation as defined by the society for fetal urology. the open dismembered pyeloplasty was the historical gold standard repair of uretropelvic junction obstruction. schuessler et al. introduced the first laparoscopic pyeloplasty (lp) 1993 followed by peters et al, who performed the first pediatric laparoscopic pyeloplasty. since then, minimally invasive pyeloplasty (mip) -laparoscopic and robotic assisted- had an increasing interest among urologists and became widely adopted by many centers as a standard surgical intervention in upj obstruction; thanks to the decreased postoperative pain, short hospital stay, reduced postoperative recovery time, and comparable success rates. the high cost and long learning curve hindered generalization of mip in all centers. on the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay . tanaka et al. have reported that the benefits of laparoscopic pyeloplasty were evident only in older children . till now 85% of infants are still treated with open pyeloplasty . according to the eau guidelines 2023 "there does not seem to be any clear benefit of minimally invasive procedures in a very young child but current data are insufficient to defer a cut-off age " . most of the studies that compared open to lp didn't limit cases to mini-incision open pyeloplasty. to our knowledge there is no prospective randomized study comparing laparoscopic to open pyeloplasty with mini-incision in children to date.

Eligibility criteria:
inclusion criteria: * children between 1-18 years , males and females with upj obstruction in orthotopic kidney indicated for dismembered pyeloplasty and not else exclusion criteria: * recurrent upj obstruction. * cases that require technique other than dismembered pyeloplasty * patients that have contradiction to laparoscopy. * comorbidities that prevent surgery e.g: uncorrected coagulopathy and vertebro-spinal deformity * patient refusing participation in the study.
effect of cold application on patient's pain and vital signs during chest tube removal.

Conditions: Chest Tube Removal

Summary: in this study, the effect of cold application used during and after chest tube removal on pain and vital signs in infants and children in the 0-3 age group will be examined.

purpose of the research:in this study, the effect of cold application used during and after breast tube removal on pain and life signs in infants and children aged 0-3 years will be examined. hypotheses: h1: children who have cold application around the tube 15 minutes before chest tube removal have low pain scores during chest tube removal compared to other groups. h2: children whose skin temperature is lowered below 13.60 c before breast tube removal have lower pain scores compared to other groups. h3: the cold application technique in the group of children affects the crying time after the procedure. h4: the cold application technique in the group of children affects the signs of life before and after the procedure. the research is a study in randomized controlled, prospective and cross-sectional design. the data of the study will be collected using the patient identification information form, flacc pain scale, life signs follow-up form.

Eligibility criteria:
inclusion criteria: * between the ages of 0-3 years old, * the chest tube is located for at least 24 hours, * without mechanical ventilation support, * does not have any allergies to the drug * stable from the cardiovascular side exclusion criteria: * children with any neurological diseases, * children with anynephrological * children with any respiratory diseases

Keywords: chest tube removal, cold application, pain
study of the effectiveness and safety of shr-1314 for psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this study is a randomized, double-blind, multicenter, placebo-controlled phase ii clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. it is planned to include 111 adult subjects with psoriatic arthritis.


Eligibility criteria:
inclusion criteria: 1. the subject voluntarily signs an informed consent form before any procedures related to the research start; 2. age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender; 3. at the time of screening, it met the 2006 psoriatic arthritis classification standard (caspar); 4. there is active psa before randomization; 5. have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis; exclusion criteria: 1. existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc. 2. have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past. 3. those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents. 4. a history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
evaluation of the occurrence of acute complications caused by a central venous catheter placement

Conditions: Anesthesia

Summary: it is an observational, prospective, monocentric study. the purpose of the study is to assess the acute complications rate caused by a central venous catheter placement. all the patients who require a central venous placement could be enrolled in the study. the study will not change the usual practice. the placement will be on day 1 and patients will be contacted by phone on day 7 to identify potential complications and to assess pain. anaesthesia staff will keep patients under surveillance to control the absence of late complications.


Eligibility criteria:
inclusion criteria: * age \>= 18. * patient who requires the placement of a central venous catheter (a portacath (pac), a peripherally inserted central catheter (picc) or a tunnelled catheter). * patient able to understand, read and write french. * mandatory affiliation with a health insurance system. exclusion criteria: * active infection at placement of the central venous catheter. * patient who can't be contacted by phone. * patient who is likely to have a femoral venous catheter placement.

Keywords: catheterization, central venous
open-label study of levetiracetam intravenous infusion in children (1 month-4 years old) with epilepsy

Conditions: Epilepsy

Summary: keppra injection is approved in the us as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. the objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.

the primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment. the evaluation period was to be considered as one complete set of 4 pharmacokinetic (pk) samples for a maximum of 4 days; for children already taking levetiracetam oral solution prior to entering the study, the levetiracetam intravenous (lev iv) dose will be equivalent (mg-for-mg) to their oral dose (always in twice daily regimen) within the following dose range, calculated on the basis of their age and weight: * children ≥ 1 month to \< 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42 mg/kg/day (i.e 21 mg/kg/day twice daily); * children ≥ 6 months to \< 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60 mg/kg/day (i.e 30 mg/kg/day twice daily). the first intravenous (iv) infusion was to be administered 12 hours after the last oral dose of levetiracetam. for children not taking levetiracetam oral solution prior to entering the study, the intravenous (iv) dose will correspond to their age and weight as follows: * children ≥ 1 month to \< 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily). * children ≥ 6 months to \< 4 years: 20 mg/kg/day (i.e. 10 mg/kg twice daily). however, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (lev iv) dose could be modified after one day. subjects were hospitalized for the duration of the levetiracetam intravenous (lev iv) treatment.

Eligibility criteria:
inclusion criteria: * male or female between 1 month and 4 years of age, inclusive * the subject suffers from epilepsy (except status epilepticus) * the subject is requiring levetiracetam iv treatment in place of oral therapy for a short period of time exclusion criteria: * the subject has difficult venous accessibility * history of status epilepticus during the 3 months prior to screening * the subject is on felbamate with less than 18 months continuous exposure before screening. * the subject presents with current depressive symptoms, current suicidal ideation and/or behavior.

Keywords: epilepsy child levetiracetam keppra® infusion intravenous
postoperative outcomes in patients with hepato-biliary-pancreatic cancer according to inbody test

Conditions: Cancer

Summary: postoperative outcomes were evaluated by using inbody test

postoperative outcomes were evaluated by using inbody test

Eligibility criteria:
inclusion criteria: * surgically treated patients exclusion criteria: * a body weight loss of \>10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease