Kornimate/medical-research-clean huggingface dataset:
sleep disordered breathing and diabetes

Conditions: Type 2 Diabetes; Obstructive Sleep Apnea

Summary: the hypothesis of this study is: sleep disordered breathing (sdb), specifically, obstructive sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition. in an exploration of this hypothesis, the investigators hope to provide evidence linking sdb to increased severity of disease in the type 2 diabetic patient. by doing so, the investigators ultimately seek to support investigating the use of sdb interventions as an additional method of care in the treatment of type 2 diabetes.


Eligibility criteria:
inclusion criteria: * adult female and male patients with type 2 diabetes who are followed by university of chicago physicians exclusion criteria: * patients with the diagnosis of type 1 diabetes (dm); newly diagnosed type 2 dm patients * patients with the diagnosis of osa using cpap for either 4 or more hours per night or 5 nights per week

Keywords: type 2 diabetes, obstructive sleep apnea
evaluation of auditory mirror-therapy for tinnitus

Conditions: Tinnitus

Summary: the investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.the auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. this procedure is called auditory mirror therapy (amt).

the goal of this study is to determine efficacy of a 21 day, 3 hours per day intervention of auditory mirror therapy (amt) for chronic tinnitus. hypothesis: amt, as contrasted to a sham device, will significantly reduce symptom ratings on the tinnitus functional index (tfi) scale. along with tfi, additional measures will be collected every two days throughout the intervention; tinnitus handicap index, visual analogue scale, minimum masking level (mml) and residual inhibition (ri), and auditory mirror therapy questionnaire.

Eligibility criteria:
inclusion criteria: * male or female * ages 18-80 years old * chronic tinnitus (\> 3months) exclusion criteria: * use of hearing aids * no history of significant drug or alcohol use * no history of debilitating neurological or psychiatric illnesses * no current or past history of balance-, vertigo- and/or vestibular- symptoms including ménières disease
learning strategies for improving dual task performance in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study is a randomized controlled study in which we aim to include 60 persons with multiple sclerosis and 30 healthy controls. two different learning strategies, an explicit and an implicit one, will be compared on effects on dual task performance. further, clinical profile associated with these effects, and brain activity measured by functional near-infrared spectroscopy during dual tasking will be investigated. to this end, the study will cover 4 days: day 1: examine clinical profile; day 2: baseline dual task measures; day 3: experimental learning paradigm with subjects randomly assigned to either the implicit or the explicit learning condition. day 4: delayed retention dual task and fnirs measures.


Eligibility criteria:
inclusion criteria: * all participants: minimal cognitive function (moca ≥ 26) * persons with ms: * diagnosis of ms * edss 2.0 - 5.5 * no relapse within the past 30 days. * able to walk minimally 6 minutes consecutively and to step over the stepping platform without aid. exclusion criteria: * other medical conditions interfering with mobility. * other neurological conditions. * not able to understand instructions. * major (unresolvable) problems with hearing or vision.
in utero surgery for fetal myelomeningocele: decision-making mechanisms and psychological impact of prenatal therapy

Conditions: Myelomeningocele

Summary: myelomeningocele is a malformation of the spine and spinal cord, generally diagnosed prenatally, and responsible for a complex disability for the unborn child. in the event of continued pregnancy, in utero surgery can be performed to improve the prognosis of the children. this fetal therapy does not allow a cure and induces risks for the fetus, and for the mother, both during surgery and for her obstetric future. currently, few studies have focused on the factors influencing the choice to resort to in utero surgery and the experience of patients and co-parents before and after this intervention. no qualitative study on the subject has been published to date.

the study population corresponds to all couples who have chosen to continue the pregnancy in the face of a prenatal diagnosis of myelomeningocele in their fetus as well as to resort to in utero surgery to repair this malformation. in order to obtain the largest possible sample, the study will be offered to both couples who have had open surgery and those who have had fetoscopy. this study aims to investigate, a posteriori, the experience of couples who have chosen fetal surgery to repair a myelomeningocele. this is a study in clinical psychology, cross-sectional observational with an approach that will be mixed, qualitative and quantitative. in practice, the only procedures added by the research will consist of: * an interview between the mother of the child operated on in utero and a psychologist researcher-student pair in master 2 of psychology * an interview between the father of the child operated on in utero and a psychologist researcher-student pair in master 2 of psychology * the completion of a decision scale by each of the parents the presence of the interview with a psychologist not planned as part of the care may lead to the modification of the usual care of the parents.

Eligibility criteria:
inclusion criteria: * mothers and adult co-parents of the child with mmc operated in utero, having signed informed consent. if both members of the couple have agreed to participate, they will be received separately. * mother who had fetal surgery for in utero repair of a fetal myelomeningocele by laparotomy and hysterotomy aged 18 years or older at the time of surgery, and whose child affected by the surgery is at least 6 months old * speaking french * not presenting a severe psychiatric disorder altering the relationship with reality * patient affiliated to a social security system exclusion criteria: * patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study * patient under state medical aid

Keywords: psychology fetal myelomeningocele parents
the effect of terlipressin on recovery of liver function after hepatectomy

Conditions: Terlipressin Adverse Reaction; Ascites Hepatic; Liver Failure; Acute Kidney Injury

Summary: portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. in this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension.

portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. in this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension. the primary outcome is the total abdominal drain on postoperative day (pod) 1 to 3. the secondary outcomes are: (1) the incidence of post-hepatectomy liver failure; (2) post-operative acute kidney injury; (3) the side effects of terlipressin.

Eligibility criteria:
inclusion criteria: * subjects signed informed consent. * an open liver resection is planned. * hepatitis b virus infection background. * pre-operative liver function is child-pugh a. * subjects with clinical significance portal vein hypertension or the liver stiffness \> 12 kpa before surgery. * portal vein pressure \> 12 mmhg at 5 min after liver resection. exclusion criteria: * age \ 75 y. * subjects received anti-cancer therapy within 3 months before surgery, or with a history of open or laparoscopic surgery. * portal vein tumor thrombus was confirmed by preoperative imaging study. * obstruction of biliary tract. * pre-operative alt or ast \> 2×uln. * a history of myocardial infarction or chronic kidney disease. * severe arrhythmia. * intraoperative portal vein pressure could not be measured technically. * any other contraindications of the terlipressin.

Keywords: hepatectomy terlipressin liver failure acute kidney injury
comparison between cisatracurium and rocuronium in terms of recovery of the muscular strength in the postoperative phase after surgery and general anaesthesia

Conditions: Postoperative Residual Curarization; Residual Neuromuscular Block

Summary: the purpose of this study is to determine the incidence of post-operative residual curarization in our patients and to determine if cisatracurium and rocuronium behave differently from each other in terms of residual curarization.


Eligibility criteria:
inclusion criteria: * general anaesthesia with need to use of neuromuscular-blocking agents * awakening and extubation of the patient in the operating room and permanence in the pacu for at least 60 minutes * age 18-80 * surgical operations lasting at least 1 hour * asa class i-iii * possibility to apply tof-monitoring with thumb-acceleromyography * women of childbearing age not using contraceptives * women of childbearing age using contraceptives exclusion criteria: * subjects unable to give a valid consent * patients in emergency situations * patients not awakened and not extubated in the operating room * age above 80 years or under 18 years * surgical operations lasting less than an hour * asa class iv * impossibility to apply and/or perform tof-monitoring * neuromuscular diseases * intake of therapies interfering with the neuromuscular function * patients having contraindications for either studied drug * pregnant women * women who are breast-feeding

Keywords: postoperative residual curarization residual neuromuscular block complications postoperative neuromuscular function neuromuscular block
real-world data study to evaluate the effectiveness of oca on hepatic outcomes in pbc patients

Conditions: Primary Biliary Cholangitis

Summary: this is an observational, retrospective cohort study of patients with primary biliary cholangitis (pbc) who failed ursodeoxycholic acid (udca) treatment, using a real-world data source, the komodo health united states (us) claims database. the study is designed to evaluate the effectiveness of obeticholic acid (oca). all patients who meet diagnostic criteria for pbc in the database between 01 jun 2015 and 31 dec 2021 and who meet all eligibility criteria were considered for this study.


Eligibility criteria:
key inclusion criteria: 1. definite or probable pbc diagnosis 2. inadequate response or intolerance to udca 3. age ≥18 years at the index date 4. continuous enrollment and evaluable data for at least 12 months before the index date (inclusive) key exclusion criteria: 1. history or presence of other concomitant liver diseases 2. history of non-skin malignancy or melanoma 3. history of hiv 4. medical conditions that may cause non-hepatic increases in alp 5. patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury 6. history of liver transplant 7. evidence of fenofibrate, or bezafibrate use 8. history or presence of hepatic decompensating events

Keywords: primary biliary cholangitis primary biliary cirrhosis pbc hepatic impairment liver
preventing diabetes in the deep south: extending partnerships and adapting interventions to reach rural communities at high risk.

Conditions: Pre-diabetes

Summary: diabetes is responsible for a huge and growing burden of patient suffering and social costs, and the impact of this disease is shared disproportionately by minorities and in rural resource-challenged communities, particularly in the deep south. to address this problem, the university of alabama (uab) diabetes research center (drc) will establish a primary care clinical network in rural counties of alabama and in the mississippi delta that will provide the (drc) and its members with opportunities for partnership and the infrastructure to conduct translational and clinical research in those patients with the greatest need. a pilot trial will be conducted within the coalition to assess feasibility for a larger trial to evaluate a novel and sustainable approach for diabetes prevention that involves an innovative lifestyle intervention combined with metformin.

the pilot trial in aim three will include enrolling four primary care practices. each of the participating practices will be randomized to one of two arms and accordingly enrolled participants from each clinic will be assigned to one of two conditions: condition 1. receive lifestyle modification alone (diabetes prevention program (dpp). condition 2. receive lifestyle modification (dpp) with metformin therapy recommendation. twenty five participants will be enrolled from each participating practice. participants will be followed up for 12-14 months after recruitment.

Eligibility criteria:
inclusion criteria: * age 19 to 65 years * body mass index (bmi) ≥30 * receives care at one of the participating primary care clinics * hba1c 6.0% to 6.4% * resides in one location at least 5 days each week * willing to attend group-based classes * willing to work with a peer advisor in-person and over the phone * has regular access to telephone or cellular phone * willing and able to use telemonitoring body weight to conduct daily self-weighing * estimated glomerular filtration rate (egfr) of ≥60 in their medical record within 6 months exclusion criteria: * diabetes diagnosis or hba1c \>6.4% or fasting glucose ≥126 * hba1c \<6.0% * pregnancy or anticipating pregnancy * unwilling or unable to do any of the following: give informed consent, accept random assignment, allow study staff to visit them at their primary care clinic for two follow-up visits * likely to relocate within next 6 months and no longer be seen at clinic within the next 12 months * weight loss ≥5% of body weight in past 6 months (other than postpartum) * past bariatric surgery * prescription weight loss medications within the past 6 months * egfr \< 60 within past 6 months * unable to ambulate * have end-stage medical conditions with limited life expectancy

Keywords: obesity metformin therapy
operative vs non-operative management of posterior-medial meniscal root tears: a randomized multicenter trial (rct)

Conditions: Meniscus Tear, Tibial

Summary: the purpose of this study is to determine differences in pain, functional patient reported outcomes, and objective imaging parameters following non-operative and meniscus root repair treatment. furthermore, the long-term goal of this research proposal is to understand the natural history of meniscal root tears and their subsequent repair, in order to better determine risk factors for inferior outcomes and progression to osteoarthritis (oa).

this study is a pragmatic design, parallel group, randomized clinical trial in which 140 subjects with a diagnosed medial meniscus root tear based on mri and confirmed intra-operatively will be randomized to one of two treatment arms. the first group (arm 1) will be treated non-operatively with analgesics, physical therapy, and will be kept non-weight bearing for 6 weeks (to match the postoperative protocol). if no subjective improvement is seen at 3 months, crossover will be allowed to a transtibial medial meniscal root repair (acute operative pathway (arm 2) (consort flow diagram)) as determined by 3 month patient reported outcomes (pros and operating study physician approval. the second group (arm 2) will be treated acutely with a transtibial medial meniscus root repair and will be non-weight bearing for 6 weeks as well. a previously published protocol will be used to standardize the rehabilitation. (14) subjects will be followed with patient reported outcomes, serial radiographs (3 views), and a magnetic resonance imaging (mri) scan at 12 months to determine repair status, meniscal extrusion, and presence of degenerative changes. subjects who crossover at 3 months will be evaluated using additional mri imaging prior to assignment to the acute operative meniscal root repair pathway (arm 2). these subjects will crossover from arm 1 to arm 2 without first performing the arm 1, 3 month radiograph (x-rays-3 views). the 3-month radiograph (x-rays-3 views) will be performed 3 months post-operative.

Eligibility criteria:
inclusion criteria: * mri-verified isolated tibial medial meniscus root tear * subject must be 18 years of age or older exclusion criteria: * concurrent ligamentous knee pathology requiring surgical intervention (i.e. anterior cruciate ligament tear, posterior cruciate ligament tear, posterolateral corner injury, high-grade medial collateral ligament tear), * preoperative kellgren-lawrence grade of 3 or 4 * inability to complete outcome questionnaires or comply with required postoperative imaging or mri requirements, or medical contraindications to surgery or physical therapy. * there will be no exclusion criteria regarding body mass index (bmi) or mechanical alignment, however subjects will be stratified in groups for further analysis (bmi less and over 35 and varus alignment below and over 3º of varus). * pregnancy * subjects \< 18 years of age
repetitive transcranial magnetic stimulation for tinnitus treatment

Conditions: Tinnitus

Summary: in this study, we perform an open-label rtms over the left ac on patients with tinnitus. outcome measures will be evaluated statistically. the results will be instrumental in deciding the efficacy of this technique in a local patient group.

tinnitus is a subjective auditory perception of sounds or noise not triggered by external auditory stimuli, affecting millions of people worldwide. to date, pharmacological and physical/ behavioural treatments in severe cases are generally unsatisfactory. functional brain imaging changes associated with tinnitus include hyperactivity of discrete temporoparietal regions, including both the primary auditory cortex (ac) and the secondary, or associative cortex. high-frequency rtms (10 hz or more) applied on the scalp overlying the hyperactive left ac produced an intense tinnitus attenuation. repetitive tms consists of 1000 stimulations/ day at 1 hz and 110% of the motor threshold, for five consecutive days over the left ac. a high number of stimuli/day were applied because of the previously suggested dose dependency of tinnitus alleviation by rtms. furthermore, the use of such relatively high intensity assured the stimulation of most of the target region, even in the case of mismatch between the scalp position and the underlying anatomy, which can be expected using the international eeg system as anatomical reference for tms stimulation. upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rtms sessions. tinnitus rating will be performed weekly. tinnitus is rated by a 0-100 visual analogue scale (vas), where 0 is wellness and 100 the worst possible tinnitus related discomfort. in addition, our validated tinnitus inventory scoring will be administered. audiometry and otoscopy will be performed at enrolment and at the end of the study. tinnitus, and acoustic evaluations are then collected by experimenters blind to the type of rtms applied. standard statistical methods (spss for windows) will be used to perform comparisons.

Eligibility criteria:
inclusion criteria: * all patients with tinnitus exclusion criteria: * patients with contraindications to tms: pacemaker, intracranial surgery, implants and seizures
short-term renal hemodynamic effects of tolvaptan in subjects with autosomal dominant polycystic kidney disease (adpkd)

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: the purpose of the trial was to determine the short-term effects of tolvaptan in patients with autosomal dominant polycystic kidney disease (adpkd) at various levels of renal function.

renal function was assessed during screening with the estimated glomerular filtration rate (egfr), which was calculated with the 4-variable modification of diet in renal disease (mdrd) equation using a minimum of 2 creatinine measurements. the egfr values were used to categorize participants into 1 of 3 mutually exclusive strata (\> 60 \[group a\], 30 to 60 \[group b\], and \< 30 \[group c\] ml/min/1.73 m\^2). each of the 3 groups received the same tolvaptan treatment. during the 3-week treatment period, participants were up-titrated on a weekly basis from 45/15 mg to 60/30 mg to 90/30 mg (am and pm \[8 hours later\] split-dose) to the maximally tolerated dose. the 3-week treatment period was followed by a 3-week post-treatment period during which no study medication was administered. the effects of the highest tolerated split-dose of tolvaptan on renal hemodynamics and pharmacokinetic and pharmacodynamic parameters were assessed throughout the 6 weeks of the study. the reversibility of changes during the post-treatment period after withdrawal of the drug was determined and the acute transitory effects on kidney volume were also explored.

Eligibility criteria:
inclusion criteria: * diagnosis of autosomal dominant polycystic kidney disease (adpkd) by ravine criteria. exclusion criteria: * renal replacement therapy. * use of therapies for the purpose of affecting polycystic kidney disease (pkd) cysts. * evidence of significant renal disease, eg, active glomerular nephritides, renal cancer, single kidney. * significant risk-factors for renal impairment, eg, chronic use of diuretics, advanced diabetes, use of nephrotoxic drugs. * history of significant coagulation defects or hemorrhagic diathesis.
clinical pilates training for persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic-progressive and neurodegenerative disease. thus, exercise programs are needed to maintain and increase functional status of persons with ms (pwms). pilates exercises designed by physiotherapist can enhance participation and functionality in pwms. the aim is to investigate the effects of a clinical pilates training on balance, walking, fall risk, respiratory and cognitive functions in pwms. forty-two pwms will be included in this randomized controlled trial. participants will be divided into two groups with stratified randomization. pilates exercises group (n=21) will receive therapy once a week for 8 weeks plus home exercise programme. the home exercise program group (n = 21) will be given written exercises that matched the aims of the pilates exercises and the program compliance will be monitored by telephone calls once a week. the assessments will be done twice at the beginning and at the end of the treatment. the outcome measures include the timed 25-foot walk (t25fw), six-minute walk test (6mwt), timed up and go (tug), tug cognitive and manual forms, 12-item multiple sclerosis walking scale (msws-12), curl-up test (cut), falls efficacy scale-international (fes-i), activities-specific balance confidence (abc) scale, respiratory muscle strength assessment, brief international cognitive assessment for ms (bicams).


Eligibility criteria:
inclusion criteria: * a diagnosis of definite ms * an age over than 18 years * walking independently 100 meters * willingness to participate in the study exclusion criteria: * any neurological disease other than multiple sclerosis * relapse within 3 months * having orthopaedic disorders that could negatively affect gait and balance * having cardiopulmonary disorders * diagnosed cognitive and psychiatric problems * current and recent (within the last 6 months) participation in a core stability based exercise program