bioihbjkbjnl/mcl2 huggingface dataset:
Galantamine and CBT4CBT Pilot to Prevent Relapse.
Condition: Methadone or Buprenorphine Detoxoxification
MeSH terms: Recurrence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators are proposing a randomized pilot feasibility study to evaluate the effects
      of galantamine versus placebo on preventing relapse to opioid use following tapering from
      methadone or buprenorphine maintenance (Medication Assisted Treatment, or MAT) among adults
      with opioid use disorder, with additional behavioral therapy (web-based cognitive behavioral
      therapy) provided across all conditions to help individuals successfully transition from MAT
      to a drug-free state.
    

Detailed description: 
      This is a randomized pilot study to examine the potential use of galantamine as an adjunct to
      the standard buprenorphine or methadone taper in the context of behavioral support. Early
      abstinence from opioids is associated with high relapse rates and there is a great need to
      develop interventions that will prevent relapse to opioid use.

      In this randomized pilot, 30 adults enrolled in the methadone or buprenorphine maintenance
      programs at the APT Foundation and who have sought a medically supervised, voluntary taper
      from these medications will be offered participation in a double-blind, placebo controlled,
      randomized trial of galantamine as an adjunct to standard tapering procedures at this clinic
      along with the combined approach utilizing concurrent behavior therapy. Primary outcomes will
      be: (1) successful completion of taper (achieving a methadone/buprenorphine dose of 0), (2)
      opioid withdrawal symptoms, and (3) opioid use, assessed by self-report and urine samples
      during and up to 3 months after the end of opioid taper. The investigators will also closely
      monitor patient comfort and safety (assessed by opioid withdrawal symptoms, adverse events,
      with measures of stress, sleep and pain) as well as cognitive function (assessed by the
      CANTAB).
    

Intervention name(s): MAT taper with galantamine; MAT taper with placebo
Intervention type(s): Drug; Drug
Intervention description(s): Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program; Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program
Other intervention name(s): Razadyne ER, Razadyne
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men
Condition: Dehydration; Mood
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      Dehydration is defined as the state of water deficit due to excessive water losses and/or
      small water intake. Underhydration is the result of inadequate water intake leading to
      activation of water hormonal homeostasis, characterized by elevated vasopressin, lower
      urinary output, and concentrated urine without any measurable changes in total body water. It
      is well established that dehydration (water deficit) decreases exercise performance and
      worsens mood, mainly in women. However, the impact of increased water intake in underhydrated
      individuals on their exercise capacity and mood is not known.

      The aim of the proposed study is to investigate the impact of increased water intake in
      underhydrated individuals on aerobic exercise performance and mood in both women and men.
    


Intervention name(s): Increase water consumption; Maintain adequate water consumption
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The underhydrated individuals will be instructed to increase their water intake for one week in order to meet the following two criteria: a) urinate at least 7 times per day and b) have straw-like color urine. A 2-mile run will be completed before and after the 7-day intervention.; The subjects that are classified as euhydrated will be asked to maintain high water intake for one week to ensure proper hydration. A 2-mile run will be completed before and after the 7-day intervention.
Intervention MeSH terms: Benzocaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This is a randomized controlled study evaluating the impact of 2 months of oral appliance
      therapy on endothelial function in patients with severe obstructive sleep apnea syndrome
      intolerant to continuous positive airway pressure (CPAP) therapy.
    


Intervention name(s): AMO
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
Condition: Hepatitis A; Measles; Mumps; Rubella; Chickenpox
MeSH terms: Hepatitis A; Measles; Rubella; Chickenpox; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella
      [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data
      will be collected following each vaccination.
    


Intervention name(s): VAQTA®; ProQuad
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.; 0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
Other intervention name(s): V251
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Nitrous Oxide as Treatment for Major Depression - a Pilot Study
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Major depressive disorder (MDD) is a global medical problem with significant shortcomings in
      current therapy. Chief among these is the delay between initiation of pharmacologic therapy
      and clinical improvement in symptoms. Recently ketamine, an NDMA-receptor antagonist has been
      shown to rapidly and effectively reverse the symptoms of MDD. Nitrous oxide, another
      NMDA-receptor antagonist, may produce the same effect with a cleaner side-effect profile and
      perhaps without the need for intravenous access and anesthesia personnel. Therefore, we
      propose conducting a pilot randomized placebo controlled double-blind crossover study in
      which patients will receive up to 50% nitrous oxide in oxygen or up to 50% oxygen in air for
      a period of one hour in addition to standard medical therapy. Depression severity will be
      assessed by a blinded observer pre-treatment, 30 minutes and 2 hours post treatment using the
      Hamilton depression rating scale.
    

Detailed description: 
      We will study 20 patients with non-treatment resistant major depression and 20 patients with
      treatment-resistant major depression, defined as failure of at least 2 antidepressants in the
      current depressive episode and 3 lifetime medication failures.
    

Intervention name(s): Nitrous Oxide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or "placebo" (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.; 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
Other intervention name(s): Laughing Gas; 50% nitrogen [inert]/50% oxygen
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment
ALBION "Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis"
Condition: Ischemia
MeSH terms: Inflammation; Ischemia; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      -  To compare the Kinetics of inhibition of platelet aggregation (aggregometry) and
           platelet activation (flow cytometry) with different loading doses of clopidogrel

        -  To evaluate the effect on various parameters of inflammation and necrosis and the safety
           of these loading doses
    


Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational

Summary: 
      We will utilize a set of imaging modalities including computed tomography (CT), positron
      emission tomography (PET), and a suite of magnetic resonance imaging (MRI) tools, to
      investigate the changes in the human brain resulting from mild traumatic brain injury (mTBI).
    

Detailed description: 
      We will recruit mTBI subjects and control subjects. Each subject will undergo the set of
      imaging modalities, and the results will be analyzed for differences at the structural,
      physiological, and molecular levels. The long term goal of this research is the development
      of a method to diagnose mTBI based on physical markers. This is a phased project beginning
      with a pilot study followed by future studies with larger sample sizes.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients at Veteran's Administration Medical Center in Dayton, OH who have history of Mild
        Traumatic Brain Injury within 24 months prior to enrollment.
      
Keywords: Mild Traumatic Brain Injury; Concussion; Magnetic Resonance Imaging (MRI); Positron Emission Tomography(PET); Computed Tomography (CT)
Pharmacokinetic Properties of Nevirapine Extended Release Tablets When Administered Orally in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as
      4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence
      of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single
      dose
    


Intervention name(s): Nevirapine, low dose; Nevirapine, high dose
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg; 100 mg
Intervention MeSH terms: Nevirapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to determine whether noninvasive brain stimulation in form of active
      transcranial direct current stimulation (tDCS) combined with constraint induced movement
      therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in
      patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more
      than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.
    


Intervention name(s): active anodal transcranial Direct Current Stimulation (tDCS); sham transcranial Direct Current Stimulation; Constraint Induced Movement Therapy (CIMT)
Intervention type(s): Device; Device; Behavioral
Intervention description(s): Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT; sham transcranial Direct Current Stimulation 30 min with CIMT; 2 weeks of CIMT
Other intervention name(s): tDCS; Non invasive brain stimulation; transcranial stimulation; placebo stimulation; CIMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Mobile Food Record on Recall Effects
Condition: Healthy
Study type: Observational

Summary: 
      Human dietary habits remain challenging to measure. Even the "gold-standard"
      interviewer-administered 24 hour dietary recall has established underreporting issues
      especially in high-risk populations, such as patients with obesity. Performance of precision
      nutrition research requires state of the art tools to capture individual dietary patterns.
      Given the widespread availability of smart phones, mobile-phone based food records present a
      prime opportunity to capture "in the field" dietary intake. Mobile food records, however, are
      not yet widely used in nutrition research. Several reasons exist. First, the mobile food
      record needs to be validated relative to the "gold standard" of dietary intake, the 24-hour
      dietary recall. Second, many available mobile food records are commercially based, with
      caveats about data availability and meeting research-quality data security practices (HIPAA
      compliance).

      In response, this study includes using a freely available, research-focused, HIPAA compliant,
      mobile food record (mCC: my Circadian Clock app) actively used in research studies (including
      our own ongoing work) to test the hypothesis that a mobile food record can expand capture of
      dietary intake. The proposed aims include the following: Using a randomized, cross-over
      design, evaluation of augmenting interviewer-administered 24-hour dietary recalls by a mobile
      food record (Augmented Recall) results in less energy intake underreporting than a standard
      (un-augmented) interviewer administered 24-hour dietary recall (Standard Recall).
    


Intervention name(s): mCC app
Intervention type(s): Behavioral
Intervention description(s): Interviewer use of the mCC app during the 24-hour dietary recall interview.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adults
      
Keywords: Mobile food record; nutrition
A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of multiple
      ascending doses of MK-8189 in participants with schizophrenia.
    


Intervention name(s): MK-8189; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-8189 4 mg and/or 12 mg tablet(s) will be administered orally QD for a total daily dose of 48 mg, 60 mg, 80 mg.; MK-8189 dose-matching placebo tablets will be administered orally QD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the feasibility of a decentralized clinical trial in
      South Korea. The main questions it aims to answer are:

        -  Does decentralized elements feasible in Korea?

        -  Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients
           with functional dyspepsia?
    

Detailed description: 
      The trial aims to evaluate decentralized elements in South Korea, including clinical
      laboratory testing using local laboratories, medication adherence assessment using wearable
      devices, analysis of self-kit specimens, delivery and tracking of investigational medication,
      real-time remote interview of subjects and e-consent acquisition.

      Mastic gum is registered with the Ministry of Food and Drug Safety in South Korea as a
      dietary supplement for gastric health, and the study aims to explore the effect on the
      gastrointestinal symptoms and composition of the stool microbiome.
    

Intervention name(s): Mastic gum; Dietary modification
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Mastic gum 3g/pack daily for 21 days; Adhere to the dietary recommendations for Korean dyspepsia patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of a Food Frequency Questionnaire
Condition: Nutrition
Study type: Observational

Summary: 
      The purpose of this study is to collect nutritional information from young children aged
      15-36 months to validate a newly developed food frequency questionnaire.
    

Detailed description: 
      The primary purpose of this study is to validate a semi-quantitative food frequency
      questionnaire (FFQ) against a reference method (2-day weighed food records) in a sample of
      young children aged 15-36 months.

      In addition to dietary data, the investigators also collected information on parental
      demographics, toddler health with regards to allergies and intolerance, parental feeding
      practices, parent and child weight and height and lastly, saliva samples to study
      inflammatory markers.

      Therefore, in addition to the validation of the FFQ- the data will also be used to study
      associations between dietary patterns, food and nutrient intake and (i) parental feeding
      practices and (ii) inflammatory biomarkers from saliva
    

Intervention name(s): this study is observational, it is not an intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        children who are aged 15-36 months and of Chinese, Indian or Malay ethnicity
      
Biospecimen description: 
      saliva
A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depression and other psychiatric conditions are marked by exaggerated, preferential
      processing (or attention bias) of negative information relative to neutral or positive
      information. This depression-related attention bias can be measured using the Dot Probe task
      and Visual Search, that allow assessment of the degree to which one shows bias toward
      negative information in the presence of neutral or positive information. A clinically
      effective treatment for depression is noninvasive brain stimulation with transcranial direct
      current stimulation (tDCS), targeting the dorsolateral prefrontal cortex (DLPFC), delivered
      in repeated sessions across a period of time. The study will test the effect of a single
      session of DLPFC tDCS on attention bias in patients with mild to moderate depression.
    

Detailed description: 
      This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive),
      with mild to moderate depression (based on BDI-II score range 14-19 for mild and 20-28 for
      moderate) to determine if a single-session of tDCS can alter negative attention bias. The
      primary objective is to study if single-session tDCS will affect attention bias in depression
      and is not meant to treat depression. Subjects may or may not be receiving treatment for
      mild-moderate depression.
    

Intervention name(s): Transcranial direct current stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis
Condition: Acute Viral Bronchiolitis
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional

Summary: 
      The purpose of this study is to determine wether a single chest physiotherapy session with
      slow expiratory technique (SET) improves infants with viral bronchiolitis quality of life
      (food intake and sleep) on the next 24 hours.
    

Detailed description: 
      Bronchiolitis is the most common lower respiratory viral infection in infants. Nowadays
      bronchiolitis is the first reason of children hospitalisation worldwide. Symptoms are based
      on airway inflammation associated to an increased mucus production and cell necrosis leading
      to a multifactorial airway obstruction. Recommended treatments are supportive care based on
      oxygenation and rehydration. Airway clearance techniques represented by chest physiotherapy
      remain controversial.

      Considering that bronchiolitis impacts respiratory condition in young infants feeding and
      sleep may be reduced. Evaluating quality of life represented by feeding and sleep in
      hospitalized infants may be an important outcome in this population.

      The investigators hypothesized that chest physiotherapy with SET will improve children's
      quality of life, especially 24 hours food intake and sleep.
    

Intervention name(s): Chest physiotherapy with SET; Standard Treatment
Intervention type(s): Other; Other
Intervention description(s): Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice); Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Food intake; Chest physiotherapy; Sleep; Respiratory Distress