Kornimate/medical-research-clean huggingface dataset:
couple-based motivational interviewing with mobile breathalyzers to reduce alcohol use in south africa

Conditions: HIV/AIDS; Alcohol Abuse

Summary: this project aims to develop and pilot test an intervention using couple-based motivational interviewing (mi) and mobile breathalyzers to reduce heavy alcohol use with couples living with hiv in south africa.

this project aims to develop and test an alcohol intervention using couple-based motivational interviewing (mi) and mobile breathalyzers to build dyadic support around drinking in hiv-affected couples in south africa. specifically, the study aims to: 1) to develop a couple-based mi intervention with mobile breathalyzer technology to deliver real-time feedback on bac levels. we will target heavy alcohol users with hiv and enroll their primary partner; 2) to develop and pilot test the study procedures for a future randomized controlled trial (rct) of the couple-based intervention; and 3) to determine the feasibility and acceptability (f\&a) of couple-based mi as a standalone intervention and when combined with mobile breathalyzers to provide real-time feedback and support to couples. we will also conduct qualitative interviews with a subset of 15 couples to contextualize f\&a data and refine our procedures. our goal is to demonstrate a proof-of-concept for the proposed intervention, which if shown to be feasible and acceptable, may provide a scalable intervention to reduce heavy alcohol consumption and improve hiv treatment outcomes for couples in south africa.

Eligibility criteria:
inclusion criteria: * in a primary relationship for at least 6 months * aged 18-49 * have at least one partner (the "index patient") with a positive audit-c screen score * has been on antiretroviral therapy (art) for at least 6 months * has disclosed hiv status to their partner exclusion criteria: * report severe intimate partner violence in the past 3 months and/or fear that their safety would be at risk (reported during screening)
prospective follow-up of the prevision hip stem with comparison of different implant variants

Conditions: Revision Total Hip Arthroplasty; Periprosthetic Fracture of Hip

Summary: the study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the prevision hip stem. the study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.

generally, the advantage of the prevision implant family is that all implant variants can be implanted with basically the same instrumentation, which makes it easier to switch to another variant. all implant variants will be available at the study sites and switching between the variants in the study will be encouraged. the aim of the study is to prove the non-inferiority of the ohs functional outcome after two years to the predecessor implant generation, and comparable revision hip stems. in addition, the patient groups treated with the different variants, and outcome of these subgroups will be descriptively compared.

Eligibility criteria:
inclusion criteria: * revision hip arthroplasty patients treated with a prevision hip stem * written patient informed consent * patients are able to attend at follow-up examinations exclusion criteria: * patients \< 18 years at surgery * pregnancy at implantation * patients held in a custodial setting * patients in a relationship of dependence on the sponsor, the clinic or the investigator

Keywords: patient-reported outcomes clinical performance and safety total hip arthroplasty implantation
the effect of hiit in handling obesity in children

Conditions: High Intensity Interval Training; Child Obesity

Summary: in this study the investigators wish to investigate whether a short duration high-intensity interval training(hit) is superior to a moderate activity training modus with regards to improving weight-loss, blood pressure and sleep quality in severely obese children and adolescents also receiving a multidisciplinary treatment regime.

prevalence of overweight and obesity among children and adolescents are rapidly rising worldwide. despite the alarming situation, great confusion of how to tackle obesity persists for two main reasons: the condition is much more complex than initially thought, and many aspects regarding pathophysiology remain unrevealed, leading to an insufficient understanding of the disorder. childhood obesity is, strongly associated with numerous disorders e.g. hypertension, insuline resistance, sleep apnea, depression and many more. high intensity interval training has proven beneficial in treating obesity and comorbidities in adults. the investigators wish to investigate whether twelve weeks of high-intensity interval training(hit) twice a week is superior to a moderate activity training modus for same period of time with regards to improving weight loss, blood pressure and sleep quality, in severely obese children and adolescents also receiving a multidisciplinary treatment regime. participants are severely obese children and adolescents referred to the outpatient clinic for treatment of obesity. participants are randomizid to either moderate training or hiit. antropometric measures, blood pressure and sleep quality as measured by sensewear armbands, are done at baseline, after the twelve weeks of training and again one year after inclusion. participants are monitored with pulse monitors during training sessions to register if training goals are obtained.

Eligibility criteria:
inclusion criteria: * iso-bmi \> 30 according to the iotf iso-bmi cut-off points * age 8-18 years of age exclusion criteria: * weight below iso-bmi 30, according to the iotf iso-bmi cut-off points * mental illness in the child or the parents that complicates attendance at activities. * physical limitations or illness that prevent the child from performing exercise * if participant is not able to perform all 12 weeks of exercise for other reasons.

Keywords: child obesity adolescents high intensity interval training moderate training
a study to evaluate the efficacy, safety and tolerability of bms-986368 in participants with multiple sclerosis spasticity

Conditions: Multiple Sclerosis Spasticity

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of bms-986368 in participants with multiple sclerosis spasticity


Eligibility criteria:
inclusion criteria * participants must have a multiple sclerosis (ms) diagnosis. * participants must have a history of spasticity due to ms for at least 6 months prior to visit 1. * participants must have a modified ashworth scale (mas) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at visit 1. * participants must have an expanded disability status scale (edss) score 3.0-6.5 at visit 1. exclusion criteria * participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity. * participants must not have an acute ms exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of visit 1 or visit 2. * participants must not have a history of any substance abuse disorder as defined in diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) diagnostic criteria for drug and alcohol abuse. * participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by visit 2. * participants must not have used faah/magl inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (cbd), or tetrahydrocannabinol (thc)) within 30 days prior to visit 1. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: spasticity multiple sclerosis bms-986368
safety evaluation and effect of food supplement containing dietary fiber from cassava on the alterations of physiological parameters in overweight female volunteers

Conditions: Overweight

Summary: this study is set up to determine the consumption safety and the effect of a food supplement containing dietary fiber from cassava on the alterations of physiological parameters including fasting blood sugar, hba1c, insulin resistance, lipid profiles, atherogenic index, blood pressure and gut microbes in overweight female volunteers.

cassava is one of the important industrial crops in thailand. the leftover fiber of cassava is still valuable and can be used as a dietary fiber. the previous study demonstrated that dietary fiber containing cassava fiber was safe for consumption without any contamination of the cyanide and heavy metals. moreover, the microbial contaminations were within the safety range. the toxicity study revealed that the ld50 of the cassava dietary fiber was more than 5 g/kg body weight (bw) and noael was 3 g/kg bw. the noael was used to calculate the human equivalent dose for determining the effect of cassava dietary fiber in a clinical study. cassava dietary fiber consists of water-insoluble fiber such as cellulose more than 50%. the previous study showed that insoluble fiber decreased the risk of type 2 diabetes and increased insulin release. moreover, a high fiber diet also decreased the fasting glucose and hba1c in type 2 diabetes volunteer. in addition, the effect of dietary fiber on the reduction of cholesterol was also reported. the previous study reported that the cassava dietary fiber could decrease the total cholesterol, triglyceride but increase high-density lipoprotein in a dyslipidemia rat model. therefore, the cassava fiber might be the potential food supplement for the control of blood sugar and lipid profiles in human. however, less scientific data support the effect of cassava dietary fiber in human.

Eligibility criteria:
inclusion criteria: * healthy women age between 35-60 years old * bmi 23-29.99 * blood pressure \<140/90 mmhg * fasting plasma glucose \< 100 mg/dl exclusion criteria: * presence of any chronic diseases * alcohol addict or consume more than 2 units/day * smoking more than 10 cigarettes per day * medication or herbal medicine usage within 1 month prior to the study * use any medication or food supplement which affect to outcomes * pregnant or breastfeeding women * athlete

Keywords: physiological parameters consumption safety cassava food supplement overweight female
timing for the medical treatment of patent ductus arteriosus in preterm infants

Conditions: Patent Ductus Arteriosus

Summary: this is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for pda closure for infants admitted into the nicu of the university of utah hospital from 1/2007-8/2008. the purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1.

this is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for pda closure for infants admitted into the nicu of the university of utah hospital from 1/2007-8/2008. the purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1. all infants born less than 1200 gms will be evaluated for whether or not an echocardiogram was done. if an echocardiogram was done that showed a pda, data will be collected as to what medical interventions were done, at what age, and what were the results of the medical intervention. infants will be stratified into birthweights \<800 gm and 800-1200 gm.

Eligibility criteria:
inclusion criteria: * birth weight less than 1200 gm exclusion criteria: * none

Keywords: efficacy of early vs late use of ibuprofen for pda closure
translation, cross cultural adaptation and validation of the italian version of the forgotten joint score in total knee arthroplasty

Conditions: Arthroplasty; Surveys and Questionnaires

Summary: this is an observational, prospective study that has the primary goal of validating the forgotten joint score (fjs)

this is an observational, prospective study that has the primary goal of validating the forgotten joint score (fjs) as described by behrend and giesinger in 2012. patients will be given two self-assessment questionnaires (womac and fjs) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery. comparison of data will be done for each patient by evaluating the evolution of the postoperative period, comparing the results obtained with a well known validated score (womac). questionnaires will be given pre-operatively, at 6 month ± 2 weeks, and 12 month ± 1 weeks after surgery.

Eligibility criteria:
inclusion criteria: * males and females * age range between 55 and 85 years * italian mother-tongue * patients with unilateral gonarthrosis who need total knee prosthesis exclusion criteria: * patients with orthopedic pathologies of other origin * patients with history of previous articular prosthetic replacement surgery on joints of the lower limb. * patients with history of previous major cardiovascular events * patients who need aids for walking * patients claiming that they can not submit to follow-up and therefore can not complete the study
effectiveness and process evaluation of the injury-preventive program #utviklingsklar

Conditions: Sports Injury

Summary: the majority of injuries among norwegian youth occur in sports. the purpose of the project is to conduct an effect and process evaluation of the intervention #utviklingsklar, an injury-preventive club-based intervention in youth handball and football. central to the evaluation is whether the intervention influences the occurrence of new and recurring injuries through changed coaching practices (injury prevention warm-up, strength training, and management of players with pain and injuries). over one season, participants from 30 clubs in youth handball and football respectively will participate in two cluster-randomized studies. coaches and club leaders implement #utviklingsklar and create plans and practices for injury prevention. the control clubs train as usual. players report injuries. an additional handball and football club are followed up with observation and interviews in a qualitative part of the process evaluation. the project provides knowledge about how injuries and health in the ¾ of norwegian youth who participate in organized sports are affected by interventions aimed at club and coaching practices.


Eligibility criteria:
inclusion criteria: -clubs are eligible for participation if they are able to participate with one club leader, 2-6 teams, and a minimum of one coach from each of the participating teams exclusion criteria: * players under the age of 12 * coaches under the age of 16
genetic epidemiology of blood pressure intervention

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to localize and identify new genes related to variation in blood pressure (bp) responses to a low dietary sodium intake, a high dietary sodium intake, oral potassium supplementation, and the cold pressor test.

background: systemic hypertension is a complex disease determined by both genetic and environmental factors and is of significant public health interest. in addition, identifying genes that interact significantly with dietary sodium and potassium intake, or even the cold pressure test may enable clinicians to target life style modification for prevention and treatment of hypertension. the study is conducted in response to a request for applications issued in october, 2001 on the interaction of genes and the environment in shaping risk factors for heart, lung, blood, and sleep disorders. design narrative: the study uses a family intervention study design. the investigators will recruit 750 sibships (n=1750 siblings) and their parents (n=1250) from 500 families, each family ascertained through a proband who has untreated high normal bp or stage-1 hypertension (systolic bp 130-160 mm hg and diastolic bp 85-100 mm hg) from rural china. they will collect baseline information on medical history, lifestyle risk factors, anthropometric measures, bp, and blood measures (renin activity, ace, angiotensin ii, natriuretic peptide, glucose, insulin, and lipids) in all participants, and dietary nutrient intake (three 24-hour recalls) and urinary sodium and potassium excretion (three 24-hour) in the siblings. they will conduct the following interventions in the siblings: a cold pressor test at baseline (day 2 or 3), a 1-week low sodium-feeding study (40 mmol sodium/day on days 4-10), a 1-week high sodium-feeding study (280 mmol sodium/day on days 11-17), and a 1-week oral potassium supplementation (90 mmol potassium/day on days 18-24). they will measure bp and 24-hour urinary sodium and potassium excretion during the last 3 days of each intervention period. they will also perform genotyping for genomewide linkage scans and for candidate genes in all siblings and their parents. bp responses to the interventions will be analyzed primarily as quantitative traits. the primary analyses include linkage analysis, transmission/disequilibrium test, and association analysis between genetic markers and bp responses to the interventions.

Eligibility criteria:
no eligibility criteria
understanding effects of folic acid on the methylosome and transcriptome of women with spina bifida affected pregnancies

Conditions: Pregnancy; Spina Bifida, Fetal; Environmental Exposure

Summary: folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. one hypothesis is that folic acid changes dna methylation and transcription of genes important in neural tube closure. in this study, the investigators will evaluate how dna methylation of genes associated with neural tube closure changes after a short course of standard-of-care folic acid supplementation. in addition, the investigators will assess whether environmental arsenic exposure modifies the effects of folic acid on the methylosome.

the investigators will encourage women who have recently had a pregnancy affected by spina bifida to take daily folic acid supplements for three months. folic acid supplementation is considered standard of care for primary and secondary prevention of spina bifida. the investigators will compare dna methylation in blood and folate levels before and after folic acid use.

Eligibility criteria:
inclusion criteria: * women (18+) with a prior pregnancy affected by spina bifida * available for required study visits exclusion criteria: * personal history of diabetes or gestational diabetes * current anticonvulsant medication use * history of pregnancy affected by identified genetic syndrome associated with neural tube defect such as trisomy 18 * current pregnancy * abnormal peripheral blood film results (suggestive of megaloblastic anemia/b12 deficiency.)

Keywords: spina bifida folic acid dna methylation arsenic
validation, reliability and pilot test of the personalized exercise questionnaire (peq)

Conditions: Osteoporosis, Postmenopausal; Osteopenia

Summary: the peq is the first tool to measure facilitators, barriers, and preferences to exercise in people with osteoporosis.

osteoporosis is a disease of the bones characterized by low bone mass and microarchitectural deterioration of bone tissue. this disease can increase the risk of bone fragility fractures and is indirectly associated with premature death. these fractures are more common than cancer or heart disease in north american women 50 years or older, with an osteoporotic fracture occurring every 3 seconds worldwide, and are a major issue to patients and the healthcare system. increased fracture rates, particularly in the hip and spine, may lead to hospitalization and subsequent immobility. some studies have shown fitness to be a better predictor of bone mineral density than age, yet adherence to exercise is poor. studies suggest that 50% of those registered in an exercise program drop out within the first 6 months, lack of time being the number one barrier in many populations. to increase adherence to an exercise program, a systematic review has identified a number of facilitators and barriers to exercise in adults with osteoporosis and osteopenia. hitherto, no measurement tool has been created to measure these facilitators and barriers in people with osteoporosis. the investigators have developed and validated the peq (personalized exercise questionnaire), a new tool that can measure the facilitators, barriers, and preferences to exercise. the next steps are to test the reliability, known-group validity, and pilot test this tool in the osteoporosis population. future physical activity or exercise interventions could benefit from using this tool to leveraging the facilitators and limiting the barriers to exercise to increase adherence to an exercise program.

Eligibility criteria:
inclusion criteria: 1. the participant is able and willing to provide informed consent 2. the participant is male or female, 18+ 3. the participant has received a diagnosis, from a physician, of primary osteopenia or osteoporosis (t \< - 1.0) 4. the participant can read and write english exclusion criteria: 1. the participant has been diagnosed with secondary osteopenia or osteoporosis 2. the participant has a history of smoking, alcoholism, gastrointestinal disease, hypercalciuria and/or steroid use. 3. the participant is diagnosed with a reading disability or dyslexia 4. the participant has a cognitive impairment of some severity as to adversely affect the validity of the data

Keywords: osteoporosis, osteopenia, test-retest, validity, peq, questionnaire, facilitators, barriers, exercise, physical activity