Kornimate/medical-research-clean huggingface dataset:
closed loop dbs implanted rc+s study

Conditions: Parkinson Disease

Summary: this study involves patients who are already planning to have deep brain stimulation (dbs) surgery to treat the symptoms of severe parkinson's disease (pd). the study has two goals: 1. to evaluate the effectiveness of implanting dbs electrodes in the two most common locations for dbs (subthalamic nucleus (stn), and globus pallidus interna (gpi)), instead of just one electrode, on each side of the brain; and 2. to develop an adaptive dbs system using brain signals measured from these two electrodes.

the purpose of this study is a small, first in man, clinical feasibility trial for patients with severe parkinson's disease (pd), who are already clinically eligible for deep brain stimulation (dbs) with two goals: 1. to compare efficacy from two common sites of dbs (subthalamic nucleus (stn), and globus pallidus interna (gpi)) through the implantation of dual dbs electrodes on each side of the brain; and 2. to develop a closed loop dbs system using evoked and spontaneous potentials derived from these two electrodes. the study will involve bilateral dual dbs electrode placement in clinically standard locations (ie, stn and gpi) unilaterally or (more often) bilaterally, the placement of the rc+s medtronic research implantable pulse generator (ipg), and a commitment to return for both extensive postoperative programming and testing to define clinical efficacy and separate research days to develop the closed loop approach. in addition, patients will undergo intraoperative research using temporary percutaneous extensions to the dbs electrode(s) and dbs lead cannula after implantation to confirm the electrode location and to identify what the signals will look like during later chronic recordings through the research ipg. the research rc+s ipg includes both ordinary dbs stimulation as well as a recording system that simultaneously measures the dbs local evoked potential (dlep) and/or local field potential (lfp) responses from either the same or a second dbs electrode.

Eligibility criteria:
inclusion criteria: * able to give informed consent * diagnosed with parkinson's disease and is considered a surgical candidate for dbs * has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations) * has off-on improvement with levodopa of at least 30% * is available for follow-up visits for length of study exclusion criteria: * is not safe surgical candidate for dbs * has severe neurological injury or disease other than parkinson's disease * has condition requiring repeated mri scans * has untreated, clinically significant depression * has an electrical or electromagnetic implant * had a prior thalamotomy or surgical ablation procedure * has dementia interfering with ability to comply with study requirements or give informed consent * abuses drugs or alcohol * has a history of seizures * has any metallic implants * is pregnant

Keywords: deep brain stimulation
exercise regulation of human adipose tissue

Conditions: Healthy; Obese; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether exercise training leads to changes in the white adipose tissue that are beneficial to the body's regulation of sugar and body weight.

the prevalence of obesity and type 2 diabetes in the united states and worldwide has risen dramatically over the last few decades, resulting in an enormous need for new therapies to treat these conditions. the discovery that beiging of subcutaneous white adipose tissue may increase energy expenditure has led to tremendous interest in beige cells as a potential treatment for diabetes and obesity. an established treatment for type 2 diabetes and obesity is endurance exercise training. exercise training can improve systemic homeostasis, and although adaptations to skeletal muscle play a critical role in these effects, the underlying mechanisms are not fully understood. moreover, the contributions of other tissues in these beneficial effects of exercise on metabolism have not been intensively investigated. the study team hypothesizes that exercise training results in fundamental changes to white adipose tissue, including beiging, and these adaptations play an important role in the effects of exercise training to improve metabolic homeostasis.

Eligibility criteria:
inclusion criteria: * age: 25-55 years old at the time of screening * body mass index (bmi) must be: * ≥20 and ≤ 27 kg/m2 for lean subjects * ≥25 and ≤ 37 kg/m2 for subjects with type 2 diabetes * ≥27 and ≤ 37 kg/m2 for obese/overweight subjects * hba1c values: * ≤5.7 ± 0.1% for lean and overweight/obese subjects * 6.5 ± 0.1% - 9.0 ± 0.1% for subjects with type 2 diabetes exclusion criteria: * age \ 55 years old * type 1 diabetes * hba1c ≥ 9.0% * heart or lung disease * basal-bolus insulin regimen * use of beta-blockers or thiazolidinediones * acute systemic infection accompanied by fever, body aches, or swollen lymph glands * bmi ≥ 37 kg/m2 * current dieting or weight loss efforts * current pregnant or breastfeeding * known history of hiv/aids or certain cancers * biochemical evidence of renal or hepatic dysfunction; renal or liver disease * demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis * recent blood donation * clinical history of stroke * severe hypertension (systolic \> 160 mmhg or diastolic \> 90 mmhg) * inability to exercise at 50% of predicted heart rate (hr) reserve at baseline * participants who screen positive for the american heart association's contraindications to exercise testing * history of keloid formation

Keywords: exercise training type 2 diabetes mellitus
treatment of supine hypertension in autonomic failure (cpap)

Conditions: Supine Hypertension; Autonomic Failure

Summary: supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. supine hypertension can be severe and complicates the treatment of orthostatic hypotension. the purpose of this study is to assess whether continuous positive airway pressure (cpap) decreases blood pressure in autonomic failure patients with supine hypertension.

supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. supine hypertension can be severe and complicates the treatment of orthostatic hypotension. drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. high blood pressure may also cause target organ damage in this group of patients. the pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. this study will test the hypothesis that continuous positive airway pressure (cpap) has an acute lowering-bp effect in autonomic failure patients with supine hypertension. cpap is a widely-used treatment for sleep-related breathing disorders including sleep apnea, that uses mild air pressure to keep the breathing airways open. it involves using a cpap machine that blows air into a tube connected to a mask placed over the nose, or nose and mouth. for these studies, a commercial cpap device will be used to apply pressure sequentially at 0, 4, 8, 12 and 16 cm h2o for 1-20 minute each. depending on the bp response and tolerability to cpap, cpap may be applied during the night using a cpap level that was tolerable and showed a bp-lowering effect during the acute test.

Eligibility criteria:
inclusion criteria: * patients with autonomic failure and with supine hypertension from all races exclusion criteria: * all medical students * pregnant women * high-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction) * history of serious allergies or asthma.

Keywords: hypertension supine hypertension autonomic failure pure autonomic failure multiple system atrophy cpap
titanium elastic nails in the treatment of pediatric femur fractures

Conditions: Femur Fracture

Summary: titanium elastic nails in the pediatric femoral fractures: a prospective randomized clinical trial of eliminating nail protrusion to decrease soft tissue complications

this study will be conducted as a prospective cohort study of children and adolescents treated with ten for a femoral shaft fracture. all children and adolescents presenting to the emergency department of a participating center with a femur fracture will be approached for inclusion in the study. the primary outcome for this study will be functional recovery, as measured using a pediatric specific generic qol measurement tool. the clinical outcome measure which will be used will be the performance version of the ask (ask-p) which has been previously tested and shown to be valid, reliable, and responsive in children and adolescents with acute and chronic orthopaedic disorders. the first time point for data collection will be at four months. clinical data which will be obtained over the course of follow-up will include clinical evaluation of hip and knee range of motion, limb rotation, clinical measurement of limb length, fracture union, and the presence of complications, including the need for nail removal in the group in which it was not planned. the second time point for data collection will be at one year. again, the ask-p will be mailed to all subjects in advance to allow completion at the desired time. the return of questionnaires and process for reminder notifications will proceed in a similar fashion to the four month time point. clinical and radiographic data will be collected in a similar fashion to the four month time point. no subjects will be excluded on the basis of failure to return questionnaires at the one year time point since this represents a secondary outcome.

Eligibility criteria:
inclusion criteria: open femoral physes; closed midshaft femur fracture; no concomitant injuries to either lower extremity; no history of injury to either femur; no history of asymmetric femoral malalignment; agree to participate in 2 years of follow up; informed consent/assent. exclusion criteria: open midshaft femur fractures; other injuries to either lower extremity; a history of injury to either femur; unable to comply with 2 years of follow-up

Keywords: femur fracture titanium elastic nails
the impact of probiotic bacteria on the efficacy of anti-retroviral therapy and recurrence of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: purpose of the proposed research is to determine the impact of probiotic yogurt supplemented with lactobacillus rhamnosus (fiti) compared to regular yogurt on the well-being of women living with hiv.


Eligibility criteria:
inclusion criteria: * confirmed hiv infection; * being treated with anti-retroviral medication for \> 6 months. exclusion criteria: * pregnancy; * hypersensitive to fermented milk; * intolerant for lactose; * complaints of bacterial vaginosis requiring treatment
distribution of trigger points in patient who have myofascial pain disorder

Conditions: Myofascial Pain

Summary: myofascial pain alone covers 45.3% of the diagnosis of tmj. it is defined as palpation sensitivity and regional muscle pain. clinically muscle pain connects to myofascial trigger points.these trigger points are hypersensitive points located in a tense band of the skeletal muscle, which can be described, causing provoked or spontaneous pain. they are divided into two as active and latent. those who cause spontaneous pain are active, and those who provoke pain are considered latent.spasm in the chewing muscles with myofascial pain reduces the patient's pain threshold and quality of life. therefore, patients with spasm and tmj pain in the masticatory muscles should be examined for head and neck muscles, the presence of myofascial trigger points should be determined and the head and neck muscles should be included in physical therapy. the aim of this study was to determine the presence of myofascial trigger points in patients presenting with pain in the masticatory muscles and tmj region, and to determine the relationship between the presence of trigger point and the degree of pain.


Eligibility criteria:
inclusion criteria: * will be conducted in volunteers who applied to our clinic with complaint of tmj exclusion criteria: * diagnosed rheumatoid diseases and fibromyalgia. * psychiatric drug users. * patients who use muscle relaxants. * tme pathology

Keywords: trigger point,myofacial pain
addition of azithromycin to cefazolin will reduce post cs infections more than cefazolin only.

Conditions: Randomized Controll Trial

Summary: the good standard antibiotic prophylaxis pre elective c s is cefazolin and this study will approve addition of azithromycin to cefazolin will reduce post cs infections more than cefazolin only.

patiants and methods randomization: patients fulfilling the inclusion criteria will be randomized to two groups. both two group will receive standard prophylaxis antibiotic cefazolin (zinol) (at a dose of 1 g) 2 hours preoperative. control group: this group will include 200women undergoing elective cs. in this group, patients will receive standard antibiotic prophylaxis cefazolin (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative. study group: this group will include 200women undergoing elective cs. in this group, patients will receive only standard prophylaxis antibiotic(cefazolin) inclusion criteria: * gestational age of 37 0/7 weeks and greater * elective cesarean section * medicaly free pregnant women exclusion criteria: * a known allergy to azithromycin * obstetric complications * azithromycin use within 7 days before randomization * chorioamnionitis or other infection requiring postpartum antibiotic therapy * pre-gestational diabetes

Eligibility criteria:
inclusion criteria: * gestational age of 37 0/7 weeks and greater * elective cesarean section * medicaly free pregnant women exclusion criteria: * a known allergy to azithromycin * obstetric complications * azithromycin use within 7 days before randomization * chorioamnionitis or other infection requiring postpartum antibiotic therapy * pre-gestational diabetes
niv versus hfo for acute exacerbations of interstitial lung diseases

Conditions: Interstitial Lung Disease; Acute Respiratory Failure

Summary: the objectives of this study are to compare the physiological consequences of high-flow oxygen therapy and noninvasive mechanical ventilation on ventilation, respiratory work and hemodynamics during acute respiratory failure in diffuse interstitial pneumonia.


Eligibility criteria:
inclusion criteria: * age \> 18 yrs * hospitalization in intensive care unit * acute exacerbation of a previously/presently documented diffuse (fibrotic) interstitial lung disease * dyspnea majoration since at least 1 month * alveolar or ground-glass opacities on ct-scan that are superposed to interstitial lung disease and not explained by left heart failure or volume overload * hypoxemia requiring oxygen flows \> 6 l/min exclusion criteria: * contraindication to noninvasive ventilation or high-flow oxygen therapy * immediate indication to endotracheal intubation or hemodynamic assistance * body mass index \> 40 * presence of a pacemaker or an implantable defibrillator * presence of cutaneous lesions where pulmovista® belt should be placed * moribund patient * pregnant or breastfeeding women or women of childbearing age without an effective method of contraception * protected adult patient (tutorship or curatorship) * patient deprived of liberty by court or administrative decision * no possibility to install nasogastric tube * endotracheal or tracheostomy tube requirement during the study * hemodynamic assistance requirement during the study

Keywords: noninvasive mechanical ventilation nasal high-flow oxygen therapy respiratory work hemodynamics diaphragm
characterization of new human models of non-histaminergic itch

Conditions: Papain; Itch; Skin Prick Test (SPT)

Summary: in this experiment the investigators would like to test a new new human itch model based on papain, and to characterize the sensory quality and temporary aspects of papain skin prick test (spt) in comparison to the inactivated-cowhage delivery system.

the most used model of non-histaminergic itch is cowhage but this models presents several problems, such us the impossibility of standardizing the amount of the spicules inserted in the skin and the difficulty of obtaining the substance. these aspects bring us the necessity to find a new and more standardized model of non-histaminergic itch. papain is a cysteine protease extracted from papaya plant that is known to cause itch if applied to the skin. for these reasons the investigators would like to test a new new human itch model based on papain, and to characterize the sensory quality and temporary aspects of papain skin prick test (spt) in comparison to the inactivated-cowhage delivery system.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids or other addictive drugs * previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.). * lack of ability to cooperate * current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers, as well as systemic or topical steroids. * skin diseases * moles, scars or tattoos in the area to be treated or tested. * hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
assess safety and efficacy of vilaprisan in subjects with uterine fibroids (asteroid 4)

Conditions: Uterine Fibroids

Summary: the primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (hmb) in subjects with uterine fibroids compared to placebo the secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids


Eligibility criteria:
inclusion criteria: * women, 18 years or older in good general health * diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm * heavy menstrual bleeding (hmb) in at least 2 bleeding periods during the screening period each with blood loss volume of \>80.00 ml documented by the alkaline hematin (ah) method * an endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology * use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at visit 1 until the end of the study exclusion criteria: * pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * hypersensitivity to any ingredient of the study drug * hemoglobin values ≤6 g/dl or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dl will be recommended to use iron supplementation) * any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug * any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results * abuse of alcohol, drugs or medicines (e.g. laxatives) * use of other treatments that might interfere with the conduct of the study or the interpretation of results * undiagnosed abnormal genital bleeding

Keywords: heavy menstrual bleeding
the effects of pelvic floor muscle training in women with overactive bladdder

Conditions: Overactive Bladder

Summary: the aim of our study is to investigate the effects of pelvic floor muscle training (pfmt) on pelvic floor muscle strength, sexual functions, bladder symptoms and quality of life in women with overactive bladder (oab).

overactive bladder (oab) is defined by the international continence association as an "urgency with or without urge urinary incontinence, often accompanied by frequency and nocturia." accordingly, pelvic floor muscle training (pfmt) plays an important role in the management of oab. however, a recent systematic review suggests that pfmt is insufficient against oab.

Eligibility criteria:
inclusion criteria: * having a diagnosis of overactive bladder * being volunteer exclusion criteria: * have a neurological disorder * only those with stress urinary incontinence * presence of advanced pelvic organ prolapse (stage 3-4) * having a mental problem that will prevent cooperation in evaluation and / or applications * women with the presence of malignant condition
modulating socially adaptive mirror system functioning in autism by oxytocin

Conditions: Autism Spectrum Disorder

Summary: this study investigates the efficacy of a single-dose of exogenous oxytocin administration on socially adaptive mirror-motor mapping in participants with autism spectrum disorders. a placebo-controlled cross-over trial will be conducted: each participant will receive both a single-dose of placebo and oxytocin in two sessions separated by one week. the order of nasal spray will be randomised across participants. mirror-motor mapping will be assessed by transcranial magnetic stimulation (tms), a standard technique to investigate mirror system activity.

the brain's action observation network or 'mirror system' supports a variety of socio-cognitive functions, as it enables us to internally simulate and understand others' actions, emotions and intentions. generally, mirror responses are larger upon the observation of actions accompanied by relevant information for the observer, such as direct eye contact from the actor. in other words, 'mirroring' is adaptively modulated according to the social salience of the observed actions (i.e. it is socially adaptive). individuals with autism spectrum disorders (asd) are known to endure difficulties with correctly recognizing eye contact as a communicative cue. instead, they tend to experience eye contact as stressful and arousing. it is therefore hypothesized that, upon the observation of actions combined with salient gaze cues from the actor, these mirroring processes will not be adaptively modulated in participants with asd. as appropriate processing of eye contact is a key aspect of (non-verbal) communicative behavior, the investigator will investigate the efficacy of a single dose of intranasal oxytocin administration for enhancing socially-adaptive mirroring in asd. oxytocin is a neuropeptide that acts as a regulator social brain areas. on a behavioral level, it is known to enhance the saliency of observed social cues and to improve prosocial behavior. as such, it is regarded a promising intervention for alleviating the social and communicative deficits in asd.

Eligibility criteria:
inclusion criteria: * male * young adults (between 18 - 35 y/o) * right-handed * official diagnosis of autism spectrum disorders (for asd participants) exclusion criteria: * female * left-handed * any neuro(psycho)logical / psychiatric illness (for healthy controls) * motor dysfunctions of the hands / arms * any contradiction to tms research as assessed with the tms screening list: no metal objects in the body (e.g. pacemaker, coronary bypass clips, implants, medication pumps, ...), history of brain trauma in the past (e.g. meningitis, epilepsy, surgery, ...) or history of drug and/or alcohol abuse.

Keywords: oxytocin eye contact mirror system transcranial magnetic stimulation