bioihbjkbjnl/mcl2 huggingface dataset:
Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD
Condition: Bronchopulmonary Dysplasia; Preterm Birth
MeSH terms: Lung Diseases; Bronchopulmonary Dysplasia; Premature Birth
Study type: Interventional

Summary: 
      The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance
      imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years
      born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term
      to characterize and probe the relationship between lung structure and function using imaging.
    

Detailed description: 
      This is a pilot, cross-sectional exploratory study to evaluate the relationship between
      imaging and other biomarkers in fifty patients born pre-term (with or without
      bronchopulmonary dysplasia [BPD]) and age-matched healthy controls. The term-born adults will
      serve as the controls.

      All subjects will visit the Clinical Imaging Research Laboratories at Robarts Research
      Institute or the University of Montreal University Health Centre Sainte-Justine in a single
      visit and undergo: vital signs, pulmonary function testing (more specifically: spirometry,
      body plethysmography, airwave oscillation, and lung clearance index), questionnaires, proton
      and 129Xe MRI. Preterm patients will also have a low-dose chest computed tomography (CT), and
      have blood and urine samples taken for biomarkers of inflammation and oxidative stress.

      MRI of the lungs will be performed using non-contrast enhanced methods (ultra-short echo time
      [UTE] MRI) and using an inhaled contrast agent: Hyperpolarized Xenon-129. Participants will
      inhale the hyperpolarized gas and perform a breathhold for up to 16 seconds. Four different
      types of images will be acquired in the coronal plain during each visit: 1) 1H thoracic
      cavity, 2) 129Xe static ventilation, 3) 129Xe diffusion weighted imaging, and, 4)
      multi-volume UTE MRI. Respiration and oxygen saturation will be monitored throughout the
      imaging session.
    

Intervention name(s): Hyperpolarized Xenon-129
Intervention type(s): Other
Intervention description(s): Hyperpolarized Xenon-129. Noble gas magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces.
Noble gas MRI provides a complimentary and alternative method for evaluating lung disease and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function.
Intervention MeSH terms: Xenon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Proton MRI; Noble Gas MRI; Pulmonary Function
Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,
      or coming back. The use of selenium may keep bladder cancer from growing or coming back. It
      is not yet known whether selenium is more effective than a placebo in preventing cancer
      recurrence in patients with bladder cancer.

      PURPOSE: This randomized phase III trial is studying selenium to see how well it works
      compared with a placebo in preventing cancer recurrence in patients with bladder cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the effect of selenium, when administered with standard care, in preventing
           the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell
           carcinoma of the bladder at risk for recurrence.

      Secondary

        -  To determine the effect of selenium on the recurrence of bladder cancer, in terms of
           histological type, number, and size.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral placebo daily in addition to standard care.

        -  Arm II: Patients receive oral selenium daily in addition to standard care.
    

Intervention name(s): selenium; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given orally; Given orally
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stage 0 bladder cancer; stage I bladder cancer; transitional cell carcinoma of the bladder
The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth
Condition: Digestive Irregularity; Digestive Discomfort; History of Straining During Bowel Movements; History of Hard or Lumpy Stools
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of probiotic supplemented yogurt in
      reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two
      yogurts will be administered, one containing a specific strain of probiotic in the
      Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that
      subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved
      gastrointestinal comfort and quality of life compared to those receiving the non-probiotic
      supplemented yogurt.
    


Intervention name(s): Probiotic strain of Bifidobacterium; No Bifidobacterium
Intervention type(s): Other; Other
Intervention description(s): 4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.; 4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability of GX-G6 in Healthy Male Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, double-blind, placebo-controlled, phase I study with healthy
      male subjects receiving ascending single s.c. doses of GX-G6
    

Detailed description: 
      A screening examination will be performed within 28 days prior to dosing. Eligible subjects
      will return to the study center in the morning of Day -1 and will remain in-patient until
      discharge about 98 hours after dosing (after oral glucose tolerance test in the morning of
      Day 5) if there are no safety issues. The s.c. injection will be administered in the morning
      of Day 1. Ambulatory visits will take place on Days 7, 9 and 12. A follow-up visit will take
      place on Day 15 and a final visit on Day 28.
    

Intervention name(s): Gx-G6; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.; Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants
Condition: Anemia of Prematurity
MeSH terms: Premature Birth; Birth Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on
      long-term neurodevelopmental outcome in extremely low birth weight infants.
    

Detailed description: 
      Extremely low birth weight (ELBW) infants uniformly develop anemia of prematurity and
      frequently require multiple red blood cell transfusions (RBCT) during neonatal intensive
      care. The criteria currently applied to indicate RBCT in this population are based on expert
      opinion rather than evidence and conclusive data of long-term effects of RBCT practices do
      not exist. Both, giving RBCT to improve oxygen carrying capacity and restricting RBCT to
      avoid RBCT associated risks and costs potentially impair long-term development. The proposed
      blinded randomized controlled trial was designed and will be powered to compare the effect of
      restrictive versus liberal red blood cell transfusion guidelines on long-term
      neurodevelopmental outcome in ELBW infants. ELBW infants will be randomized to receive RBCT
      according to liberal or restrictive RBCT guidelines, which both reflect current practice in
      Germany and aim for a clinically relevant difference in mean hemoglobin concentrations. The
      primary outcome measure is the incidence of death or major neurodevelopmental impairment
      determined at 24 months of age corrected for prematurity. Key secondary outcomes are the
      incidences of individual components of the composite primary outcome, the mental and physical
      developmental index scores of the Bayley Scales of Infant Development (II edition), and
      growth. Safety analyses will assess the incidences of all major diseases of prematurity. The
      results of this trial may help to improve the quality of life of these patients and reduce
      long-term health care costs.
    

Intervention name(s): red blood cell transfusion; red blood cell transfusion
Intervention type(s): Other; Other
Intervention description(s): Implementation of "liberal" guidelines for red blood cell transfusions in extremely low birth weight infants; Implementation of "restrictive" guidelines for red blood cell transfusions in extremely low birth weight infants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: prematurity; anemia; transfusion
Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain
Condition: Chronic Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a
      self-administered Virtual Reality program for the treatment of chronic lower back pain
      compared to a placebo VR program.
    

Detailed description: 
      A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a
      self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain.
      The primary objective of this study is to assess the impact of skills-based VR on changes in
      patient-reported pain and pain interference over the course of an 8-week intervention as well
      as compared to a placebo VR condition. The secondary objective is to assess the impact of
      skill-based VR on changes in patient-reported satisfaction over the course of an 8-week
      intervention and compared to a placebo VR condition. A tertiary objective is to assess the
      impact of skills-based VR on changes in patient-reported opioid use, physical function,
      behavioral skills development, and health outcomes immediately following the intervention
      relative to a pre-intervention baseline and compared to a placebo VR condition. An
      exploratory objective is to assess the impact of skills-based VR on changes in
      patient-reported pain levels, opioid use, physical function, behavioral skills development,
      health outcomes, and satisfaction at the 24-week post-intervention time point and compared to
      a placebo VR condition.
    

Intervention name(s): EaseVRx headset with active intervention; EaseVRx headset without active intervention
Intervention type(s): Device; Device
Intervention description(s): VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.; VR software developed by AppliedVR with neutral non-interactive content.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Virtual Reality; Chronic Lower Back Pain; Analgesia
Study to Compare the Immunogenicity and Safety of Two HIV Preventive Vaccinations in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the trial is to evaluate the effect upon immune system of two regimens of
      preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by
      DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the
      vaccines. Volunteers will be followed during 72 weeks.
    

Detailed description: 
      Methods: randomised phase I/II international trial with a parallel group design, open to
      participants and investigators but blind to laboratory personnel, in healthy volunteers.

      Vaccines strategies: 70 volunteers will receive 3 DNA-C vaccinations and 1 NYVAC-C
      vaccination; 70 volunteers will receive 2 DNA-C vaccinations and 2 NYVAC-C vaccination.

      DNA-C: 2x2ml intra muscular in right and left vastus lateralis; NYVAC-C: 1 ml intramuscular
      in non-dominant deltoid.

      Main outcome:

        1. the presence of CD8/CD4+ T cell responses defined according to internationally agreed
           criteria for evaluation of IFNgamma ELISPOT assays:

             -  in response to env plus at least one of the gag, pol, nef peptide pools,

             -  at weeks 26 or 28;

        2. the safety parameters.

      Secondary outcomes:

        -  cellular responses,

        -  antibody responses,

        -  all grade 1 and 2 adverse events,

        -  all events including those considered unrelated.

      Sample size: 140 volunteers

      Enrollment period: 9 months

      Patient's participation duration: 78 weeks

      Study duration: 27 months
    

Intervention name(s): DNA-C; NYVAC-C
Intervention type(s): Biological; Biological
Intervention description(s): 1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM; NYVAC-C 1 ml IM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: AIDS Vaccines; Vaccines, DNA; HIV Preventive Vaccine; HIV Seronegativity
Dual-task Training Using Virtual Reality
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of the study was to investigate the feasibility of using a virtual reality- based
      dual task training of upper extremity tracking while treadmill-walking, to improve walking
      and balance performance in post stroke survivors
    


Intervention name(s): Dual Task Walking (DTW); Single-task Treadmill Walking (TMW)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Each training session began with 8 min of general warm-up and 2 min walk around the gym. Then, for safety reasons, the participants were attached to a harness. The participants began walking slowly on the treadmill for 3 min. In the following phases the participants walked at the same speed, while training with 3 VR games. Each session lasted 3 min, and 3 min of single walking was performed between VR sessions. After the final VR session, 2 min of single-task walking was performed in order to allow for recovery. The time walked in each trial from the starting point to the destination was kept constant at 20 min.; this intervention, participants performed 8 min of general warm-up and 2 min walk around the gym, and then continued to walk for another 20 min on the treadmill at a speed that was equivalent to the intensity of 60%-70% of their heart rate reserve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CSD190102: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after
      using investigational snus products (A19010-R and B19010-O).
    

Detailed description: 
      This will be an unblinded, randomized, multi-site, two-way crossover study to assess nicotine
      pharmacokinetic parameters after use of two smokeless tobacco products A19010-R and B19010-O
      in healthy adult snus consumers. Eligible subjects will be confined to the site for 9 days
      and randomized to one of two investigational product (IP) (A: A19010-R and B: B19010-O) use
      sequences (AB/BA). Each subject will use a single product exclusively for 4 days prior to a
      PK assessment for plasma nicotine concentrations, and then subjects will use the other
      product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations.
    

Intervention name(s): A19010-R; B19010-O
Intervention type(s): Other; Other
Intervention description(s): A snus product; A snus product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia
Condition: Schizophrenia; Auditory Hallucinations
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is
      effective in the treatment of auditory hallucinations in schizophrenia.
    

Detailed description: 
      The project will investigate the use of a novel technique, transcranial direct current
      stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the
      application of an extremely weak continuous electrical current to the brain through an anode
      and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity
      whereas cathodal stimulation has the opposite effect.

      Using anodal & cathodal tDCS the investigators aimed to treat auditory hallucinations, a
      symptoms of schizophrenia. The investigators plan to apply tDCS such that it can
      simultaneously increased activity in the frontal brain areas and reduce activity over
      temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active
      stimulation will be compare to a sham condition in 60 patients (30 in each group). 30
      patients will be included in a French center (Hospital le Vinatier, sponsor of the study) and
      30 in Tunisia (laboratory "vulnerability to psychosis" (Pr Gaha) à Monastir).
    

Intervention name(s): active tDCS; sham tDCS
Intervention type(s): Procedure; Procedure
Intervention description(s): Intensity 2 mA during 20 minutes, 2 times per day; sham condition as delivered by the stimulator
Other intervention name(s): tDCS; transDirect Current Stimulation; Anodal tDCS; Cathodal tDCS; tDCS placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Study examining the effect of different diuretics on fluid retention in diabetics treated
      with rosiglitazone.
    

Detailed description: 
      A randomised, open-label, parallel group study to evaluate the management of
      rosiglitazone-related fluid retention by investigating the effect of diuretics on plasma
      volume in subjects with type 2 diabetes mellitus treated for twelve weeks with rosiglitazone
      4mg bd in addition to background anti-diabetic agents.
    

Intervention name(s): Rosiglitazone; spironolactone; hydrochlorothiazide; frusemide
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): spironolactone; hydrochlorothiazide; Rosiglitazone
Intervention MeSH terms: Rosiglitazone; Hydrochlorothiazide; Spironolactone; Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rosiglitazone; fluid retention; Type 2 diabetes; diuretics
Connectomics in Psychiatric Classification of Bipolar Disorder and Schizophrenia
Condition: Bipolar Disorder; Schizophrenia
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Observational

Summary: 
      Washington University Early Recognition Center is conducting a research study to examine
      brain functional connectivity and network patterns in participants with bipolar disorder and
      schizophrenia.
    

Detailed description: 
      This study extends the assessment of brain connectivity and function, being conducted in the
      Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has
      made significant improvements in MRI instrumentation, data acquisition, preprocessing, and
      analysis. These improvements are currently providing publicly available data on the
      structure, function, and connectivity of young adult human (age 22-35) brains at
      unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on
      individuals aged 18-40 years who have a diagnosis of either schizophrenia/schizoaffective
      disorder or bipolar disorder, or are healthy controls. Additionally, similar to the HCP, the
      investigator will study the effect of genetics on the patterns of brain connectivity in
      various psychiatric populations. DNA will be collected non-invasively from saliva.
      Furthermore, this investigator will study cortisol levels in hair samples as an additional
      assessment to help characterize brain imagining findings.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention is used
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals between the ages of 18-30 with a diagnosis of Bipolar Disorder or Schizophrenia
      
Biospecimen description: 
      saliva
    
Keywords: Bipolar; schizophrenia; schizoaffective