bioihbjkbjnl/mcl2 huggingface dataset:
Standing Cognition and Co-morbidities of POTS Evaluation
Condition: Postural Tachycardia Syndrome; Ehlers-Danlos Syndrome
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Ehlers-Danlos Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate cognition in patients with postural tachycardia
      syndrome (POTS) while lying down and standing and to assess the prevalence of hypermobile
      Ehlers-Danlos Syndrome in POTS.
    


Intervention name(s): Standing; Supine
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will stand and complete cognitive tests.; Participants will complete cognitive tests while supine.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: postural tachycardia syndrome; cognition
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The primary objectives of this proposal are to develop objective pre-deployment predictors of
      PTSD and test two pre-deployment resiliency interventions.
    

Detailed description: 
      The primary objectives of this proposal are to develop objective pre-deployment predictors of
      PTSD and test two pre-deployment resiliency interventions. The objective predictors will be
      based on: 1) physiologic reactivity (heart rate, heart rate variability, eye blink startle,
      skin conductance) to virtual reality (VR) environments depicting common Operation Iraqi
      Freedom (OIF) or Operation Enduring Freedom (OEF) combat scenarios and 2) cognitive bias
      assessment using a recognition memory paradigm. We hypothesize that a model combining
      physiologic reactivity and cognitive bias predictors will be superior to either the
      physiologic reactivity or cognitive bias model alone for predicting post-deployment PTSD. We
      also will test two pre-deployment resiliency interventions: heart rate variability
      biofeedback and cognitive bias modification training that we have designed to target
      physiologic and cognitive responses to stress, respectively. We will compare the prevention
      interventions to a no intervention control group. We hypothesize that the prevalence of
      post-deployment PTSD will be lower in the intervention groups compared to the control group.
    

Intervention name(s): heart rate variability biofeedback; Cognitive bias modification training; Sham Comparator
Intervention type(s): Device; Device; Device
Intervention description(s): Heart rate variability biofeedback, 3 session plus handheld device; Cognitive bias modification training - 3 session plus handheld device; Subjects received iPod without a study app and no additional resilience training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: post-traumatic stress disorder; post-deployment; prediction; prevention
Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This project proposes to investigate the role of brain connectivity in the mechanism of
      treatment response to dopaminergic medications in cocaine dependence.
    

Detailed description: 
      This project will use stochastic DCM, which is a recent DCM extension that takes into account
      hidden fluctuations in neuronal and vascular responses, and thus is especially suited for
      investigating effects of disease or drugs. In addition, this project will use nonlinear DCM,
      a DCM extension that can measure gating effects by striatum on cortico-cortical pathways. The
      overall aims of this project are: (1) To conduct functional magnetic resonance imaging-based
      DCM studies of working memory and impulsivity in order to determine the effective
      (directional) connectivity between PFC and striatum in treatment-seeking Cocaine Dependent
      (CD) subjects compared to non-drug using controls. We hypothesize that DLPFC causally affects
      ventral striatum in CDs, and that the strength of this connection is lower in CDs compared to
      controls. (2) To determine whether the pretreatment gating effect by the dorsal striatum, as
      a reflection of pretreatment hypodopaminergic state associated with chronic compulsive drug
      use, predicts the treatment response to dopaminergic pharmacotherapy in CDs. We hypothesize
      that lower pretreatment gating by the dorsal striatum on prefrontal-parietal effective
      connectivity predicts greater 8-week improvement from treatment of CDs with DA enhancing
      medications (combined with cognitive behavioral therapy [CBT]), but not from treatment with
      placebo (combined with CBT).
    

Intervention name(s): levodopa/carbidopa 400/100 BID
Intervention type(s): Drug
Intervention description(s): Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
Other intervention name(s): Sinemet; Parcopa
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: drug abuse; cocaine; impulsivity; dopamine
Inter-relationship Between Vitamin D Requirements and Calcium Intake in Older Adults
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This winter-based placebo-controlled, single-dose vitamin D randomized controlled trial (RCT)
      aims to examine the impact of various levels of habitual calcium intake on dietary vitamin D
      requirements in older adults stratified by calcium intake. This will provide new data on the
      impact of different levels of calcium intake, ranging from low/moderate to high, on winter
      serum 25(OH)D levels, and their utilization and catabolism in adults.
    

Detailed description: 
      The aim of this study is to perform a randomised controlled vitamin D3 intervention study in
      apparently healthy, free-living adults (aged 50+ y) to investigate whether different levels
      of habitual calcium intake, ranging from low-moderate to high, influence serum 25(OH)D
      concentrations and indices of vitamin D activation and catabolism during winter, when vitamin
      D intake is adequate versus inadequate.

      This research will provide new data and scientific understanding in relation to the impact of
      different levels of dietary calcium intake on vitamin D requirements in the older adult
      population. As such, this new data will inform dietary reference values for vitamin D.
    

Intervention name(s): Vitamin D3 (20 micrograms/day); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin D3 (20 micrograms/day); Placebo (0 micrograms vitamin D3/day)
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D status; 25-hydroxyvitamin D; Vitamin D3; RCT; Calcium intake; Dietary requirement
Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS)
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      The current trial is designed to assess the safety and efficacy of sustained oral
      administration of inorganic nitrate in patients with severe aortic stenosis and to assess the
      mechanisms by which inorganic nitrate enhances oxygen uptake and exercise capacity in this
      population.
    

Detailed description: 
      This is a randomized double-blind crossover clinical trial, in which 22 subjects who
      underwent transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) three
      or more months prior to enrollment will receive the following 2 interventions, in randomized
      order: (1) Potassium nitrate (KNO3), at a dose of 12-18 mmol/d by mouth for 4 weeks, or; (2)
      Potassium chloride (KCl), at a dose of 12-18 mmol/d by mouth for 4 weeks. A 1-week washout
      period will be introduced between the 2 interventions. The purpose of the trial is to test
      the safety of KNO3 and its efficacy on a number of clinical and physiologic endpoints in
      subjects who underwent TAVR for severe AS.
    

Intervention name(s): Potassium Nitrate; Potassium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Potassium nitrate capsules will consist of potassium nitrate (KNO3-) crystals [610 mg, corresponding to 6.03 mmoles of NO3-] with 190mg of lactose monohydrate, spray dried, NF. The dose for this trial will be 18 mmoles of NO3-per day, given as one capsule (6 mmoles) three times a day.; Potassium chloride capsules will consist of potassium chloride (KCl), granular, USP (450mg) plus lactose monohydrate, spray dried, NF (300mg). The dose for this trial will be 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In this phase IIb, double-blind, cross-over trial, we will assign 22 subjects who are post-TAVR for severe AS to: (A) Potassium nitrate administered by mouth at a dose of 6 mEq three times daily for 4 weeks, or (B) Potassium chloride (KCl) at identical doses. The order of the interventions (AB-BA design) will be randomized, with a 1-week washout period separating each intervention. A crossover design will enable each subject to receive both treatments.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aortic stenosis, aortic valve replacement
Mobile Technology for Reducing and Preventing Adolescent Suicide
Condition: Suicide, Attempted; Suicidal Ideation
MeSH terms: Suicide; Suicidal Ideation; Suicide, Attempted
Study type: Interventional

Summary: 
      This single-group open-label trial will evaluate the feasibility and preliminary efficacy of
      a suicide prevention mobile application when used as an adjunct to usual care in adolescents.
    

Detailed description: 
      This study will enroll 20 adolescent (age 13-17) inpatients at elevated risk for suicide.
      Participants will download the app onto their phones during their inpatient stay and will
      complete a single therapy session involving psychoeducation and crisis response planning.
      Participants will be encouraged to use the app on their own in addition to their usual
      outpatient services to learn and practice suicide prevention skills. Participants and their
      parents will be interviewed 1, 4, 8, 12, and 16 weeks after discharge.
    

Intervention name(s): Smartphone App
Intervention type(s): Behavioral
Intervention description(s): Smartphone app teaching suicide prevention skills.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation
      Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating
      fibromyalgia syndrome.
    

Detailed description: 
      Background: Fibromyalgia syndrome (FMS) is a chronic pain disorder that frequently leads to
      poor quality of life. The need for more effective FMS treatments has prompted empirical
      investigations into the applications of mindfulness for treating the condition. However,
      studies have predominantly focused on first-generation mindfulness-based interventions
      (FG-MBIs). To date, a randomised controlled trial (RCT) assessing the effectiveness of a
      second-generation mindfulness-based intervention (SG-MBI) for treating FMS has not been
      undertaken. SG-MBIs are distinct from FG-MBIs because they are overtly spiritual in nature
      and employ (i) a greater range of (normally secularised) meditative/spiritual techniques,
      (ii) ethics as a key component of the taught programme, and (iii) an instructor training
      programme that typically requires several years of supervised mindfulness practice.

      Aims: To evaluate the effectiveness of Meditation Awareness Training (MAT) - an SG-MBI - for
      treating FMS.

      Method: Adults with FMS will receive MAT or an active control intervention known as
      Cognitive-Behavioural Therapy for Groups. Assessments will be performed at pre-intervention,
      post-intervention, and follow-up phases.
    

Intervention name(s): Meditation Awareness Training; Cognitive Behavioral Therapy for Groups
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 Week Meditation Intervention; 8 week intervention based on Cognitive Behavioral Theory
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia Syndromey
Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine
Condition: HIV Seropositivity
MeSH terms: HIV Seropositivity
Study type: Observational

Summary: 
      HIV+ patients are considered at risk for excessive bone fragility. Several factors could
      contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D
      deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is
      used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as
      TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine
      (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone
      formation by stimulating osteoblasts, of often impaired bone quality.

      The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal,
      bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than
      60 months. The patients will be randomly selected, then matched according to age, ethnic
      origin, BMI.
    

Detailed description: 
      Fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine,
      bone remodelling by measurement of P1NP. Dual X-ray absorptiometry (DXA) will be used to
      determine the areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal
      radius. Volumetric BMD (v-BMD) and micro-architecture of distal radius and tibia will be
      studied using a HR-pQCT scan (Xtreme, Scanco).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months.
      
Keywords: male patients; treated by TRUVADA® or VIREAD® for more than 60 months
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
Condition: Bladder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic
Study type: Interventional
Phase: Phase 2

Summary: 
      Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and
      evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in
      children with a neuropathic bladder, over the course of 12 months of active treatment.
    


Intervention name(s): tamsulosin hydrochloride
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tamsulosin; pediatric; neurogenic bladder
Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment
Condition: Scarring; Skin Aging
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      Open-label, Prospective, Study to Evaluate the Cutera excel V laser at 532 nm in a low
      fluence, high repetition rate mode and the Micro-Lens Array attachment used with excel V
      laser at 1064 nm and 532 nm for the improvement of skin quality.
    

Detailed description: 
      This is an open-label, prospective, study in approximately 60 male or female subjects, age 18
      to 65 years who desire laser treatment for the improvement of rhytides, lentigines,
      pigmentation, erythema, telangiectasia, pore size and skin texture. Subjects may undergo a
      2mm punch biopsy a treatment area up to 72 hours post treatment and at a designated follow-up
      period per Investigator discretion. Subjects will receive laser treatments. Subjects will
      return to the site after final study treatment for two follow-up visits: 6 and 12 weeks.
    

Intervention name(s): Excel V™ Laser & Micro-Lens Array Attach
Intervention type(s): Device
Intervention description(s): Subjects will receive laser treatments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Lifestyle Modification for Type 2 Diabetes Involving Reduction of After-meal Blood Glucose Elevations
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a lifestyle modification program (GEM) that
      focuses on reducing after-meal blood glucose elevations can improve blood glucose control in
      people with type 2 diabetes. Half of the participants will continue their routine medical
      care, and half will receive five sessions of GEM in addition to their routine care. The two
      groups will be assessed using diabetes-relevant medical, behavioral and psychological
      measures.
    


Intervention name(s): GEM
Intervention type(s): Behavioral
Intervention description(s): GEM is an integrated lifestyle modification program that focuses on reducing postprandial blood glucose through replacing high with low glycemic load foods and increasing routine physical activity guided by systematic blood glucose monitoring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diet and Exercise in Pompe Disease
Condition: Pompe Disease; Glycogen Storage Disease Type II; Lysosomal Storage Diseases
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease; Lysosomal Storage Diseases; Metabolic Diseases
Study type: Interventional

Summary: 
      This study examines the effects of individualized diet and exercise plans on muscle strength,
      quality of life and respiratory function in Pompe disease. Subjects will be given a diet and
      exercise plan based on their individual needs, which will be followed for 16 weeks.
      Participants will also be provided with an activity tracker in order to track their exercise
      activities, access to an app that will allow them to input their daily food intake, and they
      will also come to the University of Florida for exercise tests, respiratory tests and
      questionnaires.
    

Detailed description: 
      Pompe is a rare disease, which occurs in approximately 1 in 40,000 births. It is a
      progressive and often fatal neuromuscular disorder resulting from a mutation in the gene for
      acid alpha- glucosidase (GAA), an enzyme necessary for the degradation of glycogen. Common
      symptoms include skeletal and smooth muscle myopathy, resulting in respiratory insufficiency,
      peripheral muscle weakness and generalized fatigue.

      The progressive myopathy in Pompe disease seems to be influenced by increased muscle protein
      breakdown. The increased muscle protein breakdown leads to muscle wasting, weakness,
      increased resting energy expenditure and, consequently, increased fatigue. Our hypothesis is
      that a high protein, low carbohydrate diet associated with regular physical exercise will
      improve respiratory and peripheral muscle functions in Pompe disease.

      In this study, we will investigate the effects of 16 weeks of planned diet and exercise in
      adolescent and young adult (15-55 years old) individuals with Pompe disease using an activity
      tracker.

      The participant will be asked to come to the University of Florida 4 times throughout the
      study (screening, baseline, +/- 15 days of completing the diet and exercise plan and a follow
      up three months later) for exercise testing, quality of life questionnaires, respiratory
      function testing and blood draws.
    

Intervention name(s): Diet and Exercise
Intervention type(s): Other
Intervention description(s): Exercise will consist of 2x/week aerobic exercise, 2x/week strength training and 1x/week core-stabilizing exercise.
Diet will be constructed so that 30% of the daily caloric goal will be protein, 35% fat, and 35% carbohydrates.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment