Kornimate/medical-research-clean huggingface dataset:
the effects of intermittent epidural bolus on fever during labor analgesia

Conditions: Labor Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Summary: epidural analgesia is associated with maternal intra-partum fever during labor. intermittent epidural injections appear to reduce the incidence of maternal intra-partum fever compared to continuous epidural infusion during labor analgesia. however, the optimal combination of bolus volume and administrating interval has not yet been compared. the purpose of this prospective, randomized, double-blind trial was to determine how intermittent epidural bolus reduced the incidence of maternal intra-partum fever compared with continuous epidural infusion during labor.


Eligibility criteria:
inclusion criteria: * nulliparous women * required labor analgesia * chinese * spontaneous labor exclusion criteria: * contraindications for epidural analgesia * allergic to opioids and/or local anesthetics * failed to performing epidural catheterization * organic dysfunction * those who were not willing to or could not finish the whole study at any time * using or used in the past 14 days of the monoamine oxidase inhibitors * alcohol addictive or narcotic dependent patients * subjects with a nonvertex presentation or scheduled induction of labor * twin gestation and breech presentation

Keywords: fever patient controlled epidural analgesia labor analgesia epidural analgesia combined spinal-epidural analgesia
sleep and quality of life among postmenopausal women

Conditions: Sleep Disturbance; Postmenopausal Symptoms

Summary: the purpose of this study is to assess the sleep quality and quality of life of the study population.

natural menopause can be defined as the cessation of menses for twelve sequential months without physiological or pathologic causes, referring to the end of a woman's reproductive capability. there is considerable variation in reporting of menopausal symptoms by women all over the world in different studies. the most common psychological symptoms was physical, mental exhaustion and sleep disturbances. sleep quality is affected poorly during the menopausal transition, and 40-60% of menopausal women are suffering from sleep disturbances. the causes for sleep disorders in postmenopausal women can be divided broadly into psychological and physical. however, changes in sleep patterns after menopause are frequently the result of physical factors. sleep quality and its effect on quality of life among postmenopausal women is vital topic and the previous literatures in this topic are deficient. so, there is a need to study sleep quality and quality of life particularly in our population where women are less aware about menopausal symptoms.

Eligibility criteria:
inclusion criteria: * postmenopausal women aged 45-70 years, married, who experienced natural menopause conﬁrmed by menstrual cessation for at least one year or a fsh level ≥40 iu/l . exclusion criteria: * women who 1. single, widow or divorced. 2. had an induced menopause 3. underwent simple hysterectomy . 4. receiving any kind of hormone therapy, antidepressants, or antipsychotics . 5. had medical conditions such as diabetes, hypertension, cardiac disease, and thyroid disorders . 6. had experienced any stressful events during the past year or had depressive disorders as they can mislead our results 7. patient refused to participate in this study.
magnetic resonance cholangio-pancreatography (mrcp) for suspected bilio-pancreatic disease

Conditions: Suspected Bilio-pancreatic Disease

Summary: the interpretation of magnetic resonance cholangio-pancreatography (mrcp)-findings is primarily performed by radiologists who only in some cases have experience with the interpretation of endoscopic retrograde cholangiopancreatography (ercp)-images. it is unclear if mrcp-interpretation by the radiologist is sufficient to decide which additional endoscopic procedures might be necessary in an individual case or if an additional mrcp-interpretation by the endoscopist renders any clinical impact.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older who were referred for pancreato-biliary endoscopy to our unit based on actual mrcp-findings. in all cases mrcp should have been performed within 4 weeks prior admittance and a written radiological report as well as the digital images must be available. exclusion criteria: * patients who had any endoscopic interventions in our institution before and also patients who underwent mrcp at our hospital were excluded.

Keywords: mrcp ercp eus image interpretation mrcp findings endoscopic intervention(s)
sequential intensive chemotherapy followed by ric for refractory and relapse all

Conditions: Lymphoblastic Leukemia, Acute, Adult

Summary: patients with refractory and relapse lymphoblastic leukemia had poor outcome even with marrow ablative conditioning mostly standard iv-bu-cy or cy-tbi. in this study, we focus on a new treatment strategy with high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+cyclophosphamide+etoposide followed by reduced intensity condiotning regimen consisting of fludarabine, busulfan and post-infusion cyclophophamide.

all patients with refractory and relapse lymphoblastic leukemia will receive a high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+ cyclophosphamide+etoposide. at day 7 after chemo, a bone marrow aspiration and mrd study by flow-cytometry is planned. for those patients with no residual blasts will undergo allogeneic stem cell transplantation with reduced intensity condiotning regimen consisting of 5-day fludarabine and 3-day busulfan and post-infusion cyclophophamide (d+3 and +4) as gvhd prophylaxis.

Eligibility criteria:
inclusion criteria: * adult patients with refractory or relapse acute lymphoblastic leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse * age 16-60 years with inform consent * no contraindication for allogeneic transplantation: active infection, allergy to flu/bu/ctx, liver and renal function damage * hla matched related (6/6), unrelated donors (8\~10/10) or haplo exclusion criteria: * liver function/renal function damage (over 2 x upper normal range) * mental disease
an observational study to evaluate the efficacy and safety of avelumab + axitinib combination in participants with arcc (avion)

Conditions: Carcinoma, Renal Cell

Summary: the main purpose of this study is to expand knowledge on the effectiveness of avelumab intravenous infusion in combination with axitinib as the first-line therapy in participants with advanced renal-cell carcinoma (arcc) in addition to the safety and tolerability under routine conditions of daily clinical practice.


Eligibility criteria:
inclusion criteria: * participants with the eastern cooperative oncology group (ecog) performance status 0, 1, or 2 * participants with a histologically confirmed diagnosis of rcc with any histological origin * participants with a locally advanced/metastatic disease (that is \[ie\], newly diagnosed stage 4 rcc per american joint committee on cancer) or has recurrent disease * participants has received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy according to the approved summary of product characteristics (smpc) * participants willing to sign the written informed consent form (icf) to participate in this study exclusion criteria: * participants with contraindications for avelumab or axitinib according to the approved smpc * participants who have participated in any interventional clinical study of a drug or device within 28 days prior to the start of avelumab plus axitinib

Keywords: axitinib renal cell carcinoma avelumab bavencio® inlyta®
an extension of istradefylline in parkinson's disease patients who have completed studies 6002-eu-007, 6002-us-013 or 6002-us-018

Conditions: Parkinson's Disease

Summary: this is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-eu-007, 6002-us-013 or 6002-us-018.

patients with parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-eu-007, 6002-us-013 or 6002-us-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.

Eligibility criteria:
inclusion criteria: * completion of study 6002-eu-007, 6002-us-013 or 6002-us-018 * non-pregnant and either not of childbearing potential or using specified contraception exclusion criteria: * history of psychotic illness * variant/atypical parkinson's disease * cancer within 5 years of enrollment * alt/ast levels \> 1.5 times uln * seizure disorder * neuroleptic malignant syndrome

Keywords: parkinson's disease levodopa end of dose wearing off off time
tram procedure in ambulatory surgical facility: quality of recovery outcomes

Conditions: Breast Diseases

Summary: specific aim: to assess the quality of recovery of patients following early discharge (18 hrs) after pedicled tram flap breast reconstruction. quality of recovery will be assessed using a 27-item validated questionnaire, qor-27 at discharge, and on post operative days (pod) 2, 4 and 7. in addition a 100 mm visual analog score (vas) for pain will be completed on discharge from the recovery room, discharge from hospital and on pod 2, 4 and 7. clinical relevance: postoperative recovery is a complex process related to various outcomes such as physiological endpoints, incidence of adverse events and change in psychological status. previous studies of recovery after surgery and anesthesia have focused primarily on the physiological endpoints and the incidence of adverse events. much of the work has occurred in specialties dealing with chronic disease states such as cancer, rheumatology and musculoskeletal disorders. there is clearly a need to focus on recovery outcome measures in the ambulatory population for postoperative recovery. here the investigators propose to measure postoperative recovery outcomes within the first week following a tram flap reconstructive procedure using a validated postoperative quality of recovery instrument (qor-27) and a 100 mm vas for pain.

women's college hospital is the first and only independent ambulatory care hospital in ontario, and the only hospital in ontario with a primary focus on women's health. patients undergoing breast reconstruction following breast cancer at our institution are now undergoing expedited discharge at 18 hrs postoperatively. to facilitate next day discharge, a multidisciplinary group was formed to determine the best evidence for perioperative care to ensure patient safety and excellent postoperative recovery. minimizing length of stay has obvious cost savings for hospitals, but for patients the advantages include minimizing exposure to hospital-acquired infections and an earlier return to their more familiar home environment. the need to balance the advantage of early discharge to patient complications, however, must be addressed. as other hospitals across the country face the same length of stay constraints as has been our experience, this study will provide important data on the quality of recovery of patients undergoing early discharge following breast reconstructive surgery.

Eligibility criteria:
inclusion criteria: * women undergoing any type of tram flap * age\<75 yrs * non-smoker exclusion criteria: * history of chronic pain or psychiatric disturbance * history of chronic use of opioid medications * allergy to local anesthesia or opioid medication * inability to communicate in english * bmi\>35
the specific elastance in acute lung injury/acute respiratory distress syndrome (ali/ards) patients

Conditions: Acute Lung Injury; ARDS

Summary: the investigators aim to study the specific elastance in ali/ards patients during invasive mechanical ventilation.

in sedated and paralyzed ali/ards patients, we studied the specific elastance and also, we compared the specific elastance to healthy subjects during invasive mechanical ventilation.

Eligibility criteria:
inclusion criteria: * stable ali/ards patients during invasive mechanical ventilation exclusion criteria: * hemodynamic failure, pneumothorax

Keywords: gas exchange respiratory mechanics
safety and efficacy evaluation of oxybutynin topical gel in children with neurogenic bladder

Conditions: Overactive Detrusor; Neurogenic Bladder

Summary: this study will evaluate the safety and efficacy of oxybutynin chloride 10% topical gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. children will be treated with 0.75 g of gel/day for two weeks. patients will then return to the clinic for a potential dose titration. at this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. the total treatment time is 14 weeks and total time on the study is 16 weeks.

this study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition

Eligibility criteria:
inclusion criteria: * 3 years to \< 17 years * neurogenic bladder * neurological condition * cic exclusion criteria: * have anatomical bladder abnormalities * sensitivity to anticholinergics * bladder augmentation
a trial of zinc and micronutrients in tanzanian children

Conditions: Diarrheal Illnesses; Respiratory Illness; Growth Faltering

Summary: a randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to hiv-negative tanzanian mothers.

we propose to study the efficacy of zinc or multiple micronutrient supplementation in reducing the risk of infectious diseases and growth faltering among infants and young children in tanzania. infants born to hiv-negative women will be recruited and randomly assigned in a factorial design to either zinc, micronutrients (vitamins c, e, b1, b2, niacin, b6, folate and b12), micronutrients plus zinc, or a placebo given daily. children will be followed at monthly clinic visits from age 6 weeks for 18 months. data obtained will include socioeconomic status, anthropometric data (weight, length, head circumference, and arm anthropometrics), dietary intake (including breastfeeding duration and frequency), hemoglobin, ferritin, and blood smear for malaria. the primary outcomes will be the incidence of diarrhea and respiratory tract infections. secondary outcomes will be weight and length gain. a subset of children will be tested for blood concentrations of vitamin a, e, zinc and c-reactive protein. all children will receive a large periodic dose of vitamin a every 6 months as per standard of care in tanzania.

Eligibility criteria:
inclusion criteria: * singleton, live born infants born to hiv- negative women * mothers will need to have registered for pre-natal care before 34 weeks gestation * intend to stay in dar es salaam for until delivery and 18 months thereafter. exclusion criteria: * infants born with multiple congenital abnormalities

Keywords: hiv tanzania micronutrients infants/children infectious disease growth faltering
strategies for kidney outcomes prevention and evaluation - the skope study

Conditions: Chronic Kidney Diseases

Summary: background: chronic kidney disease (ckd) is a major public health threat associated with significant morbidity, high mortality, and reduced quality of life. however, empirical evidence is limited on strategies to enhance the effectiveness of care for ckd. the objective of the trial is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies in preserving kidney function among patients with ckd at primary care clinics in singapore. methods: a pragmatic, randomized controlled trial, in 4 socioeconomically diverse primary care clinics (polyclinics) in singapore over 3 years. a total of 896 participants with ckd stage 3 or worse aged ≥40 and \<80 years will be enrolled, with 224 from each polyclinic. participants enrolled in each polyclinic will be randomly allocated to the intervention or usual care group in a 1:1 ratio. intervention includes four components 1) training nurses as health coaches for motivational conversation and ckd specific lifestyle counseling on diet and exercise, using hybrid follow-up approach of in-person, telephone, and secure whatsapp video meetings; 2)training physicians in algorithm-based standardized management of ckd and hybrid care delivery;3) subsidy on sodium-glucose transport protein-2 inhibitors (sglt-2i) for ckd; and 4) regular ckd case review meetings. patients in the usual care arm will be treated by physicians and nurses who and are not trained in skope treatment algorithms. study outcomes: the primary outcome will be the egfr total slope from randomization to final follow-up at 36 months. secondary effectiveness outcomes will be 1) change in cvd risk score as measured by the million hearts longitudinal ascvd risk assessment score 2) change in ckd quality of life measured by kdqol-36tm


Eligibility criteria:
4.3 inclusion criteria * patients with ckd stage 3 or stage 4 defined as persistent reduction in chronic kidney disease epidemiology collaboration (ckd-epi) formula egfr ≥15 and \< 60 ml/min/1.73m2 for at least 3 months based on two egfr readings at least 3 months apart and the last egfr should be measured at least 3 months ago. * receiving care at the polyclinics in singapore for at least one year at the time of recruitment * age \>=40 and \<80 years * singaporean or permanent resident 4.4 exclusion criteria * on kidney replacement therapy * pregnancy or breastfeeding * known terminal illness * recent hospitalization during last 3 months * history of leg or foot ulcers, severe mental illness, prior kidney transplant * inability to provide informed consent

Keywords: chronic kidney disease clinical trial primary care kidney function
healthcare costs among patients with cml receiving dasatinib or nilotinib in a commercial and medicare population

Conditions: Chronic Myeloid Leukemia (CML)

Summary: the purpose of this study is to examine the healthcare costs among patients with cml receiving dasatinib or nilotinib as first line therapy in a commercially or medicare insured population.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * age \>18 years * international classification of diseases, ninth revision, clinical modification (icd-9 cm) code for cml (205.1x) * at least 2 prescriptions for dasatinib or nilotinib from july 1, 2008 to june 31, 2013 * continuous eligibility for the 6 months pre- and post-index date (defined as the date of first fill for dasatinib or nilotinib) exclusion criteria: * history of bone marrow or stem cell transplant as identified in the 6 month pre-period
is kinesio taping more effective than medical adhesive tape in patients with chronic non-specific low back pain?

Conditions: Low Back Pain

Summary: sixty patients will be randomized into three groups to receive the kinesio taping, placebo kinesio taping (medical adhesive tape) and control group. the group kinesio taping receive the correct application of the method described. the placebo group will receive a medical adhesive tape. the control group will not receive any form of intervention.

the group kinesio taping receive the correct application of the method described with tension paper off (10-15%). the placebo group will receive a medical adhesive tape. the control group will not receive any form of intervention.

Eligibility criteria:
inclusion criteria: * patients with non-specific low back pain longer than 3 months * seeking care for low back pain exclusion criteria: * contra indications to any bandage * serious sinal pathologies (e.g. tumors, fractures and inflammatory diseases) * nerve roto compromise * pregnancy

Keywords: low back pain kinesio taping
dex combined with rtx, csa and ivig in the management of newly diagnosed itp patients

Conditions: Immune Thrombocytopenia

Summary: the project was undertaken by qilu hospital, shandong university in china. in order to report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous immunoglobulin in the management of newly diagnosed itp patients.

the investigators are undertaking a multicenter trial of 100 primary itp adult patients from 5 medical centers in china. all participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed itp patients.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. untreated hospitalized patients, may be male or female, between the ages of 18 -60 years. 3. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 4. eastern cooperative oncology group（ecog）performance status ≤ 2. 5. willing and able to sign written informed consent exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(ivig)in the 3 weeks prior to the start of the study. 3. current hiv infection or hepatitis b virus or hepatitis c virus infections. severe medical condition (lung, hepatic or renal disorder) other than itp. 4.unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5.female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6.have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 7.patients who are deemed unsuitable for the study by the investigator.

Keywords: dexamethasone rituximab cyclosporin intravenous immunoglobulin