Kornimate/medical-research-clean huggingface dataset:
growth evaluation, health promotion, and clinical management in children and adolescents with thalassemia

Conditions: Thalassemia Intermedia; Thalassemia Major; Growth Delay; Puberty, Delayed

Summary: there are nearly 300,000 patients with severe or intermediate thalassemia in china. growth retardation is the most significant health issue for children and adolescents with transfusion-dependent thalassemia (tdt), placing a substantial economic burden on their families and a serious social strain on the labor force. investigating the growth and development of these children and adolescents, and establishing targeted intervention plans, holds significant social value for public health practice. 1. to screen and identify pediatric patients with growth problems by conducting growth and development assessments in high-incidence areas of china, including physical development, endocrine function, nutritional status, brain function and lifestyle behaviors. 2. implement the menbs clinical interventions for pediatric patients with growth problems, concentrating on the following areas: * monitor: continuously monitor health-related indicators through regular follow-up. * education: provide health education to improve the cognition of patients and their families. * nutrition: assess patients' nutritional risks and develop personalized diet plans. * behavior: recommend appropriate exercise plans to promote physical development. * support: conduct home visits, offer free clinics and establish a support network. 3. repeat growth assessment for pediatric patients with growth problems after 1-year clinical interventions. 4. evaluate the effectiveness of menbs interventions by comparing changes in growth and development indicators.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with transfusion-dependent thalassemia (tdt) * male or female age ≤18 years * subjects who are willing and able to provide written informed consent exclusion criteria: * not applicable

Keywords: thalassemia children and adolescents growth development health promotion clinical management
pulsta transcatheter pulmonary valve pre-approval study

Conditions: Heart Diseases; Pulmonary Valve Regurgitation; Pulmonary Valve Stenosis; Tetralogy of Fallot

Summary: the purpose of the study is to evaluate the safety and effectiveness of the pulsta transcatheter pulmonary valve (tpv) system for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.

the pulsta tpv is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (rvot) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post pulsta tpv implantation.

Eligibility criteria:
inclusion criteria: * body weight greater than or equal to 30 kilograms * pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient \>35mmhg by echocardiography * main pulmonary artery trunk of ≥16 mm and ≤30 mm * patients willing to provide written informed consent and comply with follow-up evaluations. exclusion criteria: * females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after tpv implantation * pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves * obstruction of the central veins to be approached for the tpv implantation * coronary artery compression confirmed by angiography * a known severe allergy to nickel * a known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease * suspected active infectious disease (e.g. endocarditis, meningitis) * life expectancy of less than 6 months
women with minor degrees of glucose intolerance and the postpartum glucose tolerance test

Conditions: Glucose Tolerance Impaired in Pregnancy

Summary: the aim of this study is to offer a 75g postpartum glucose tolerance test to women with minor degrees of glucose intolerance and to assess if these women are significantly different from women who were diagnosed as gdm (gestational diabetes mellitus)


Eligibility criteria:
inclusion criteria: * healthy women (without pre-existing diabetes) who underwent an ogtt during pregnancy exclusion criteria: * pre-existing diabetes, or failed to perform the ogtt
treatment duration of ipa

Conditions: Invasive Aspergillosis; Antifungal Therapy

Summary: the goal of this observational study is to identify the duration of posaconazole-initiated antifungal treatment for ipa in patients with hematological malignancies and to explore the value of monitoring immune factors and cells in ipa treatment in order to assess practices in ipa management in chinese hematology patients including tools to evaluate duration and discontinuation. the main question it aims to answer is: does any indicators that could be used to guide the duration of ipa treatment? does immune factors have value in monitoring ipa treatment? we will not do any interventions to participants. participants will be monitored routinely for their clinical characteristics, microbiological test( including g/gm test, blood culture), imaging examination, blood routine, the number and function of immune cells, cytokines(il-1β/il-2/il-4/il-8/il-10/il-12/il-17/ifn-α/ifn-γ/tnf-α)， and we will collect these datas for analysing.

1. a total of 15 patients will be involved in the study. 2. for each patient, the investigator will first evaluate the patient to determine if the patient meets the enrollment criteria and does not meet any of the exclusion criteria. 3. for the patients included in the study, the investigators will collect their blood rt, immune cell count and function, and cytokine levels (including il-1β/il-2/il-4/il-5/il-6/il-8/il-10/il-12/il-17/inf-γ/inf-α/tnf-α et al). 4. closely monitor the patient's status and discontinue antifungal therapy if the patient meet the 4 critera: ①pmns recovery\>500；②previous signs/symptoms of active ipa (such as fever) has been resolved; ③nagative mycological evidence; ④ct: the reduction in the size of the lesion must exceed 90% or stable cave. if the patient does not meet any of these criteria, antifungal therapy is continued until the 4 critera are met. 5. blood rt, neutrophil count and function, and cytokine levels (il-1β/il-2/il-4/il-5/il-6/il-8/il-10/il-12/il-17/inf-γ/inf-α/tnf-α) were collected at the time of stopping antifungal therapy and at 2, 4, 8, and 12 weeks after stopping treatment. at the same time, the patient's symptoms (cough, hemoptysis, fever, etc. )and signs (chest pain, etc. ) were observed and the patient's microbiology examination results (blood g/gm text, fungal culture, etc. ) and imaging examination results (ct, etc.) were collected at the follow-up. 6. follow-up will be conducted instantly if any symptom, sign, or text result suspected ipa after discontinuation.

Eligibility criteria:
inclusion criteria: 1. informed consent form signed 2. patient with hematological malignancies 3. patients with posaconazole-initiated antifungal therapy 4. treatment duration ≥12w exclusion criteria: 1. refuse to enroll 2. pregnancy or breastfeeding women 3. are expected to survive no more than 72 h 4. fungal or mycobacterial lung co infection at time of ipa diagnosis 5. hematological malignancy with lung location 6. disseminated aspergillosis (lung and sinus aspergillosis can be included)
the effect of a contingency management intervention on substance use

Conditions: Substance Use Disorders

Summary: contingency management interventions involve providing a tangible reward for progress toward treatment goals. the purpose of this study is to determine whether a contingency management intervention added to usual care leads to improved attendance and decreased substance use in patients attending outpatient substance use disorders treatment.

design: this will be a randomized, controlled trial. 360 veterans presenting for specialty substance use disorders treatment at the minneapolis vamc and the va puget sound health care system will be randomly assigned to 8 weeks of usual care or usual care plus contingency management. minimal exclusion criteria include primary cannabis dependence, primary opioid dependence, screening positive for pathological gambling, serious psychiatric symptoms or suicide risk. randomization will be stratified by site and primary substance use disorder (alcohol or stimulant). all participants will meet with a research assistant twice per week to submit urine drug and breath alcohol samples. participants randomized to the contingency management interventions will have the opportunity to draw tokens (with replacement) from a bowl each time they submit negative urine drug and breath alcohol screens. the number of drawings allowed escalates with continuous weeks of negative screens or returns to baseline if screens are positive or missed. half of the 500 tokens will result in social reinforcement ("good job!"). the remainder will earn a va canteen voucher worth monetary value. follow-up assessments occur 2, 6, and 12 months after enrollment into the study. primary outcomes measures include number of days with negative urine drug and breath alcohol screens during the intervention phase, days of treatment attendance during the intervention phase, and percent days abstinent on the timeline follow-back interview at follow-up assessments. secondary outcomes include a brief assessment of employment, housing, legal, and psychiatric status, and administrative data on va service utilization. a process evaluation and an economic analysis are included.

Eligibility criteria:
inclusion criteria: * veterans presenting for outpatient substance use disorders treatment with a diagnosis of alcohol, cocaine, amphetamine, or methamphetamine dependence exclusion criteria: * primary cannabis dependence * primary opioid dependence * severe psychiatric symptoms * suicide risk * positive history or screen for pathological gambling * lacking transportation or living too far away to attend twice per week research appointments

Keywords: contingency management interventions substance use disorders treatment treatment effectiveness randomized clinical trial behavioral research
the use of medical-expulsive therapy with alfuzocine xl 10mg x1/d for distal ureterolithiasis.a randomized prospective study

Conditions: Distal Ureterolithiasis

Summary: we will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. a total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group a (n=30) who will receive only analgetic therapy(dipyrone)and diclofenac i.m. 75mg and group b (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.no significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. potential side effects and complications of the drugs were discussed. the expulsion rate will the primary end-point of this study.


Eligibility criteria:
inclusion criteria: * stone in the distal ureter until 1 cm of diameter exclusion criteria: * evidence of urinary tract infection or sepsis * moderate or severe hydronephrosis * acute renal failure * ureteral stricture * stone with \>1cm of diameter * previuos use of alpha blocker * pregnancy * previuos ureteral endoscopic or open surgery
influence of positive margins on tumour recurrence and overall survival after gastrectomy for gastric cancer

Conditions: Stomach Neoplasms

Summary: incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. it has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (os). however, the management of these patients remains unclear.


Eligibility criteria:
inclusion criteria: * all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between january 2010 and december 2018 at ramon y cajal university hospital. exclusion criteria: * distant disease (including patients with positive cytology), early postoperative mortality (within 30 days after surgery) and follow-up data not available. resections in patients with palliative intent were also excluded.

Keywords: gastric cancer gastrectomy r1 positive margins recurrence overall survival prognosis
efficacy of local anesthetic through continuous infusion

Conditions: Pain Control

Summary: efficacy of using continuous infusion of local anesthetic for post operative pain control following laparotomy.

this study will evaluate the benefits of placing an analgesic pain pump in laparotomy incisions with the addition of intravenous/oral pain medications as needed versus using solely intravenous and oral pain medications as needed for post-operative pain management. the goal of this study will be to decrease the usage of narcotics in post-operative laparotomy patients by providing local incision pain relief. this will be a double blinded randomized control study with placebo with two groups of patients: one with a local anesthetic infusion pump filled with bupivacaine, a local anesthetic, after laparotomy and the other group with an infusion pump filled with normal saline. the pain pumps will be placed in the or. post-operatively, all patients will have the standard pain regimen available to them during their stay. surgeons will monitor the patient for 4 days post-operatively and the infusion pain pump will be removed on post-operative day 4. investigator will then look back through each patient's records and gather the amount of pain medications that they requested during their stay. both groups will then have their data collected in the same manner and placed for data analysis. - the standard pain regimen will include a morphine iv 4mg every 4 hours and hydrocodone-acetominophen 5/325 q6h prn. if a patient controlled analgesia infusion pump is needed this will be considered a need for increase in pain management. every patient will be started on this pain regimen post operatively. during their stay, if the patient requires an increase in their pain medication, the supervising attending will determine which drug will be added in improve their pain. at the end of the patients stay, the amount of narcotic usage will be compiled and turned into morphine equivalents in order to compare them with the control group.

Eligibility criteria:
inclusion criteria: - patients scheduled for elective laparotomy exclusion criteria: * emergency laparotomy * pregnancy * patients on chronic pain medication

Keywords: local anesthetic continuous infusion pain control
tolerance and effectiveness of cell therapy by autologous apoptotic cells in the treatment of rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of rheumatoid arthritis * therapy failure with at least one biological agent from anti-tnf-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-il6 (tocilizumab; 3 months); t-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-cd20 (rituximab; 6 months at optimal dose); anti il-1 (anakinra; 3 months) * disease activity score (das) das28 ≥ 3.2 * subject has provided written informed consent exclusion criteria: * pregnant or lactating women * inflammatory arthritis other than rheumatoid arthritis * history of invasive cancer * immunodeficiency (hiv infection, immunosuppressive therapy) * active bacterial or viral infections, in particular hcv or hbv. * surgery not older than 4 weeks. * unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment. * contraindication to an apheresis

Keywords: apoptotic cells
recover clinical pathway for pediatric concussion

Conditions: Concussion, Brain; Pediatric Disorder; Mild Traumatic Brain Injury

Summary: the project encompasses the development and implementation of an acute care, pediatric concussion clinical pathway at 5 pediatric emergency departments in the province of alberta (canada).

clinical pathways (cps) do not currently guide the care of children with concussions presenting to acute care settings in alberta. the alberta health services maternal newborn child \& youth (mncy) strategic clinical network established a work group to develop best-practice, evidence-based clinical practice guidelines for the management of concussion that are being translated into specific cps for different clinical settings. the research has three key objectives: 1. design an evidence-based, knowledge-user informed, and theory-driven approach to implementation of a clinical pathway for acute care of pediatric concussion. guided by the theoretical domains framework (tdf), the investigators will assess barriers and facilitators likely to influence uptake of the cp in acute care settings. the results of that assessment will inform implementation strategy design, again guided by the tdf. 2. evaluate the impact of the implementation of the cp on patient-centered outcomes using a stepped wedge cluster randomised trial. within the context of a stepped wedge cluster randomised trial, the investigators will assess relevant process and clinical outcomes to determine whether implementation of the cp results in significant uptake of the pathway, as well as higher patient satisfaction and better health outcomes following concussion. 3. determine whether the implementation and use of a cp for acute care of pediatric concussion is associated with changes in health care utilization and associated costs. health care utilization and costs associated with care of concussion will be compared before and after the implementation of the cp. utilization and costs are expected to remain stable or decline following implementation of the cp.

Eligibility criteria:
inclusion criteria: * children evaluated for concussion (including their parents) january 30 - november 30, 2019 at the 5 participating emergency departments exclusion criteria: * moderate to severe brain injury
optimise-ckd study_current clinical landscape in spain

Conditions: Renal Disease

Summary: optimise-ckd is a retrospective, observational study, using secondary data. the incidence of renal disease, including ckd, using egfr or uacr laboratory measurements and diagnostic codes will be assessed in the study population. the study will also assess the incidence of selected cardiovascular and renal events and the current use of kidney-protective treatments


Eligibility criteria:
inclusion criteria: age ≥18 years as of study index date * with renal function measured as either of the following: * at least 1 uacr measure of ≥30 mg/g; or * at least 2 egfr measures taken ≥90 days apart, of which both egfr is ≤75 ml/min/1.73m2 ; or * registered with chronic kidney disease (ckd) diagnosis in the medical history (without biochemical confirmation) exclusion criteria: * history of stage 5 ckd, dialysis, organ transplant, type 1 diabetes, or gestational diabetes on or before the start date of the observation period
transdermal clonidine in the treatment of severe hyperemesis gravidarum

Conditions: Hyperemesis Gravidarum

Summary: clonemesi is an academic, independent, randomized placebo-controlled trial to assess the effect of transdermal (td) clonidine in improving the symptoms of severe hyperemesis gravidarum(hg) affecting women in their 6th-12th week of pregnancy. the study has a crossover design.

setting. the trial is performed at a single hospital setting after admission of patients. ethics. the study has been approved by our local ethics committee and women are requested to sign an informed consent. no pharmaceutical company is involved in any phases of the trial including protocol design, study conduction, coordination and monitoring, data handling and analysis. randomization. the patients are allocated to a random list to receive first placebo and then td clonidine or the other way round. blinding. neither the patients nor their attending caregivers know the order of administration . the outcome assessors are blinded as well. treatment.the patients are randomly treated with and without td clonidine for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, metoclopramide, ondansetron) and anti- reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis. all patients receive intravenous hydration and supplementation with thiamine. assessment. physical condition of patients are assessed daily: blood pressure (lying and standing), body weight, morning ketonuria. two different clinical self administered scores as puqe (pregnancy unique quantification of emesis) and vas (visual analogue scale) are employed to check daily the intensity of symptoms and the sense of wellbeing. the consumption of antiemetic and anti-reflux drugs administered in the two periods is monitored .

Eligibility criteria:
inclusion criteria: * gestational age 6-12 weeks and a major grade of hg clinical severity defined as follows: * a puqe score index ≥ 13 associated to one or more of the following conditions: * weight loss \> 5% of pregravidic weight, * electrolyte disturbances, * dehydration, * duration of symptoms \> 10 days , * inadequate food and drink intake exclusion criteria: * language barrier.

Keywords: hyperemesis gravidarum treatment transdermal clonidine
mobile health intervention to support healthful diet

Conditions: Frailty

Summary: this will be a pilot clinical trial to evaluate preliminary efficacy of a newly designed mobile intervention designed to support healthy eating in old people. the main scientific premise of this project is that mobile approaches are feasible for behavioral and metabolic improvements in the population of people 65+ with mild-to-moderate frailty. specific aim of this project is to describe feasibility, acceptability and initial efficacy of the newly designed mobile intervention in a pilot rct. the pilot rct, comparing usual care to usual care plus mobile intervention, will provide data on the sensitivity of outcome measures and estimated effect size to inform a larger rct. primary outcomes for the pilot rct will include change in adherence to mediterranean diet (medd) score, change in insulin sensitivity measures, feasibility and acceptability. secondary outcomes include medd knowledge, self-efficacy, outcome expectation, self-regulation, social support, platform use and anthropometric and functional measures.


Eligibility criteria:
inclusion criteria: age 65+ mild to moderate frailty suboptimal diet - exclusion criteria: 1. dependence in activities of daily living 2. memory impairment 3. hearing or visual impairment 4. unusual dietary restrictions