bioihbjkbjnl/mcl2 huggingface dataset:
Mobile Health Application for Adolescents With Asthma
Condition: Adolescent; Nursing Care; Asthma in Children; Self Efficacy
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Mobile health applications (mHealth apps) are an opportunity offered by developing technology
      which in widely used among youths. The evidence regarding mHealth apps suggests that the apps
      can be safer and more feasible if are developed by healthcare team. Healthcare professionals
      have a major role to play in developing mHealth apps of good interventions.
    

Detailed description: 
      This study aims at developing the mHealth application (YoungAsthma) and evaluating the
      effectiveness of YoungAsthma app on the mean score of the asthma control test and
      self-efficacy scale in adolescents with asthma. This study is a self-efficacy theory-based,
      4-week, randomized parallel group study. Participants will be randomized to either the
      intervention or control group in a 1:1 ratio. Adolescents will be randomly allocated to
      intervention (YoungAsthma which is a user-focused mHealth app) or control group (Usual care).
      The study protocol is conducted in accord with the Standard Protocol Items: Recommendations
      for Interventional Trials (SPIRIT 2013 Statement) (Chan et al., 2013), the RCT is perform by
      the Consolidated Standards of Reporting Trials (CONSORT) (Moher et al., 2010) and the mHealth
      app is identified according to the mERA guideline (Agarwal et al., 2016).
    

Intervention name(s): Mobile Health Application; Usual Care
Intervention type(s): Other; Other
Intervention description(s): YoungAsthma is a web-based mobile health app has been developing user-focused for adolescents with asthma and evidence-based by the research team. It is the integrated version of the knowledge content to software that enables effective management of asthma by strengthening the interaction between adolescents and healthcare professionals.; Adolescents in the control group, an asthma training covering also individualized specific conditions is provided by specialist training nurse for 15-30 minutes in the nursing room of the outpatient clinic for all children. In this nursing intervention that is only one-off and consist face-to-face training with adolescents video and visual materials included in the routine of the outpatient clinic for the use of devices and drugs are used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A self-efficacy theory based, randomized, 4-week, parallel group study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Asthma Control; Nursing care; Mobile Health; Self-Efficacy; Randomized Controlled Trial; Adolescent
Efficacy of an Intervention to Teach Zippering: A Two-Group Control Study
Condition: Typical Preschoolers Who Can Not Zipper
Study type: Interventional

Summary: 
      Preschoolers are assigned to a control group or a comparison group to examine the efficacy of
      a new intervention to teach the skill of engaging and pulling up a zipper.
    

Detailed description: 
      Purpose: This pilot study compares the efficacy of a standard teaching zippering vest
      presented with general verbal prompts to a modified teaching zippering vest presented with a
      related story and vocabulary in the acquisition of zippering skills among typically
      developing preschoolers. Institutional Review Board approval and parent consent was obtained.

      Design: An experimental two group pre-post test design was used. Setting: Research occurred
      in a local preschool. Participants: Participants were recruited from fifty 3.6-to
      4.11-year-old preschoolers.

      Intervention: Eligible children received 3 zippering practice sessions with either a standard
      zippering vest (control group) or a modified vest with added visual and language cues
      (comparison group).

      The treatment protocol for both cohorts of participants was administered over a three-week
      time period to minimize the impact of normal development.
    

Intervention name(s): Standard zippering vest; Modified zippering vest
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard zippering vest used to teach zippering; Modified zippering vest used to teach zippering, along with related story
Other intervention name(s): Control group; Comparison group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two cohort
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose
      Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy
      Adult Subjects
    

Detailed description: 
      The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and
      coadministered lesinurad and allopurinol tablets in the fed state.
    

Intervention name(s): lesinurad/allopurinol 200/300 FDC tablet; lesinurad 200 mg; allopurinol 300 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Allopurinol; Lesinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and tolerability profile of TAK-935
      in healthy participants when administered as a single dose of oral solution at escalating
      dose levels.
    

Detailed description: 
      The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and
      well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look
      at side effects and lab results in people who take TAK-935 and is designed as a randomized
      dose-rising study.

      The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6
      participants will receive a single dose of TAK-935 and 2 participants will receive placebo
      after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200,
      600, 900 and not to exceed 1350 mg in subsequent cohorts.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 51 days. Participants will make 2 visits to the clinic,
      including one 7-day period of confinement to the clinic. All participants will be contacted
      by telephone 14 days after the dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-935; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-935 oral solution; TAK-935 placebo-matching oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by
      measuring ALS-008112 plasma concentrations following administration of a single oral dose of
      JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to
      their respective current formulations under fasted conditions and to assess the effect of
      food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy
      adult participants.
    


Intervention name(s): JNJ-64041575 (oral suspension formulation); JNJ-64041575 (oral tablet formulation )
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 240 mg JNJ-64041575 under fasted and fed conditions in Panel 1 as current/new concept oral suspension formulation.; Participants will receive 250 mg JNJ-64041575 under fasted and fed conditions in Panel 2 as current/new concept oral tablet formulation.
Other intervention name(s): ALS-008176; ALS-008176
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Creatine Supplementation on Kidney Function in Resistance-trained Individuals
Condition: Healthy Persons
Study type: Interventional

Summary: 
      There is a claim that creatine supplementation might affect kidney function, especially in
      those consuming a high-protein diet. The aim of this study was to investigate the effects of
      creatine supplementation on kidney function in resistance-trained individuals ingesting a
      high-protein diet.
    


Intervention name(s): creatine; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20 g/d for 5 d followed by 5 g/d throughout the trial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries
Condition: Stress Disorders, Post-Traumatic; Mood Disorders; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Mood Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a newly developed, brief cognitive
      behavioral intervention, relative to supportive counseling, is effective in reducing acute
      stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression.
    

Detailed description: 
      Importance: Burns are painful, life threatening and disfiguring. Severe psychological
      distress, pain and sleep disturbance are among the most common, enduring and disabling of
      secondary complications, however, no evidence based treatments exists for these complex
      problems in the acute burn care setting.

      Design: Randomized, controlled effectiveness trial, group assignment blinded to baseline
      status, groups stratified by history of pre-existing psychiatric disorder.

      Objectives. To develop the Safety, Meaning, Activation and Resilience Training (SMART)
      protocol; To evaluate its short and long-term effectiveness, relative to viable placebo,
      Supportive Counseling (SC), in improving key dependent measures (e.g., ASD, PTSD), mediators,
      and, enhancing health and function outcomes.

      Setting: A leading edge, State-dedicated, regional burn center in a major, metropolitan
      teaching hospital serving diverse residents from large urban settings, small towns and remote
      rural areas.

      Interventions: SMART (focused cognitive-behavioral therapy with training in anxiety
      management, and treatment with prolonged exposure and cognitive restructuring) will be
      contrasted with SC (non-directive empathy, warmth, positive regard).

      Primary Outcome Measures: Health (psychological distress, sleep, pain), function (physical,
      psychological, social), costs (direct and indirect).
    

Intervention name(s): Cognitive Behavioral Therapy; Supportive Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT (4 sessions): 1) Cognitive therapy targeting key appraisals. 2) Prolonged exposure targeting trauma memories and reminders. 3) Active coping/Anxiety Management training mindfulness-based techniques.; Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)
Other intervention name(s): SMART; Usual Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Behavior Therapy; Randomized Controlled Trial
Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that this serious game (designed to provide a learning
      environment that maximizes opportunities for adolescents with autism to discover the
      functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to
      identify gazed-at objects, and will also lead to increased social attention to faces in
      adolescents with autism. The investigators will test this hypothesis in a small-scale
      exploratory randomized control trial that will include both behavioral and eye tracking
      outcome measures.
    


Intervention name(s): Computer Game
Intervention type(s): Behavioral
Intervention description(s): The game involves viewing subtle nonverbal behaviors of game characters for the purpose of executing their own goal-directed behavior in the game related to solving various crimes. The learning involves interpreting nonverbal cues on the animated characters, such as pointing, head turns, eye gaze cues.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized into intervention or standard care control conditions
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as
      leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal
      suppression and demonstrate increased bone turnover and consequent bone loss at the hip and
      spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.
    

Detailed description: 
      A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men
      aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate
      cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was
      measured every 6 months. In addition, bone turnover markers including N-telopeptide, serum
      C-telopeptide and procollagen peptide, and 25-OH vitamin D and intact parathyroid hormone
      were measured at baseline and at 6 months.
    

Intervention name(s): risedronate; Placebo risedronate oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): 35 mg/week by mouth; One tablet by mouth every week as directed
Other intervention name(s): Actonel
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo controlled trial.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Non-metastatic
Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis
Condition: Intracranial Atherosclerosis
MeSH terms: Intracranial Arteriosclerosis; Atherosclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of the Doctormate device, a specialized
      blood pressure cuff used to perform remote limb ischemic conditioning, on cerebral blood flow
      in subjects with intracranial atherosclerosis. Previous studies in patients with narrowing of
      the brain arteries have shown that this device is safe to use and suggested that if this
      device is inflated in both arms for 5 minutes, followed by deflation for 5 minutes and
      repeated 4 times in a row every day for 6-9 months, the risk of another stroke is lowered and
      the device may increase the blood flow to the brain.
    

Detailed description: 
      In this prospective randomized pilot study, 10 eligible high-risk subjects with ICAS will be
      randomized to RLIC (bilateral upper extremity daily for 30 days) plus medical management
      (n=5) or medical management alone (n=5). The medical management, which is the standard of
      care, will be started at study enrollment and continued until close-out in all subjects. It
      will consist of aspirin 325 mg per day, clopidogrel 75 mg per day, and risk factor management
      primarily targeting a systolic BP < 140 mmHg and LDL cholesterol < 70 mg /dl.

      All subjects will undergo baseline brain arterial spin labeling (ASL) and perfusion MRI to
      measure CBF and have blood drawn for biomarkers 3-5 days after randomization to allow for
      washout of any effect from the test RLIC treatment that will be done prior to randomization
      to determine the subjects' tolerability to RLIC treatment. The period of 3-5 days will
      provide flexibility for scheduling these tests. After the baseline MRI and biomarker tests
      are completed, the subjects randomized to RLIC will begin daily RLIC for 30 days. Each daily
      RLIC treatment will consist of 4 cycles of 5-minute inflations of both blood pressure cuffs
      simultaneously to a pressure of 200 mm Hg with 5 minutes of reperfusion between each
      inflation using the Doctormate device.

      All subjects will return for their close-out visits 33-35 days after enrolling in the study
      and will undergo brain ASL and perfusion MRI and have blood drawn for biomarkers at that
      visit. The study will be conducted at 4 sites (MUSC, MCG, UCLA, USC) to enable us to evaluate
      the consistency of CBF measurements across multiple sites and to ensure that the recruitment
      target of 10 subjects will be met in time to allow for the subsequent NIH grant submission in
      2017.
    

Intervention name(s): Doctormate; Usual Care
Intervention type(s): Device; Other
Intervention description(s): Ischemic conditioning device; Standard medical care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor
Condition: Tremor; Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR
      Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
    

Detailed description: 
      The non-invasive high-intensity focused ultrasound has been coupled with high resolution MRI
      to provide precise, consistent treatments that can be monitored in real-time. The development
      of phased array transducers allows for tightly focused treatment volumes and for the ability
      to compensate for distortions by tissue inhomogeneities. The landmark advance in MRgFUS for
      neurosurgeons occurred as the ability to sonicate through the intact cranium was achieved
      with phased array transducers and acoustic modeling using CT reconstructions of the skull. By
      coupling HIFU with MRI, detailed treatment plans can be generated and intra-procedure
      real-time monitoring is available. Standard MR sequences have been shown to reliably predict
      tissue damage during thermal lesioning with ultrasound. The precision of the technology has
      already been demonstrated in animal models and is currently being investigated in humans with
      brain tumors and neuropathic pain syndromes. Unlike stereotactic radiosurgery, the treatment
      can be monitored continuously in real time with MRI and MR-thermography. We anticipate that a
      MRgFUS non-invasive thermal lesioning is similarly as safe as DBS (or other current procedure
      and will provide several years of benefit through reduction of contralateral motor symptoms
      and potential medication side effects in ET, while still permitting subsequent treatment with
      DBS should that become clinically desirable.
    

Intervention name(s): ExAblate Transcranial System
Intervention type(s): Device
Intervention description(s): MR Guided Focused Ultrasound
Other intervention name(s): MRgFUS; FUS; Focused Ultrasound; MR Guided Focused Ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tremor; Essential Tremor; Medication-refractory Essential Tremor
Intraocular Pressure During Spine Surgery
Condition: Intraocular Pressure
Study type: Observational

Summary: 
      This study will compare the effect of two intravenous solutions on eye pressure during spine
      surgery in the following groups:

      Group A - Lactated Ringer's replacement for blood loss and placebo eye drops

      Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops

      Group C - Albumin replacement for blood loss and placebo eye drops

      Group D - Albumin replacement for blood loss and brimonidine eye drops
    

Detailed description: 
      Patients will be administered either brimonidine eye drops, or placebo eye drops,
      preoperatively, on the day of surgery and during surgery. Eye pressure will be measured
      before surgery, every 30 minutes throughout your surgery and every hour for 4 hours following
      surgery. Subjects will be evaluated before surgery and on days 5, 8, 15 after surgery. During
      these evaluations, the subject will be asked questions about recovery and his/her eyes will
      be checked by an ophthalmologist and vision will be tested.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing spinal surgery in the prone position for at least 5 hours.
      
Keywords: Spinal surgery; Prone spinal surgery