bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Tolerability Study of GSK2982772, in Single (in Both Fed and Fasted States) and Repeat Oral Doses in Healthy Male Subjects
Condition: Inflammatory Bowel Diseases
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first administration of GSK2982772 in humans. The study will evaluate the
      safety, tolerability, pharmacokinetics (PK), and exploratory pharmacodynamics (PD) of single
      and repeat oral doses of up to 14 days with GSK2982772 in healthy male subjects.

      This study is planned to include approximately 52 subjects and will consist of 2 parts: Part
      A - single ascending dose, randomized, placebo controlled, 4 way crossover. In addition to
      the crossover treatment periods, up to 8 subjects in cohort 2 will participate in an
      additional treatment period and receive GSK2982772 with a high-fat meal. Part B - repeat
      dose, randomized, placebo controlled, sequential-group. In both cohorts of Part A (Cohorts 1
      and 2), subjects will be randomized equally (1:1:1:1) to one of 4 treatment sequences. Within
      each period, allocation of active to placebo treatment will be 3:1.

      In all cohorts in Part B (Cohorts 3, 4 and 5) subjects will be randomized to GSK2982772 or
      placebo in a 3:1 ratio. If required, subjects in the additional cohorts in Part A (Cohort 6)
      and Part B (Cohort 7) will be randomized to GSK2982772 or placebo in a 1:1:1:1 and 3:1 ratio,
      respectively. The study duration, including screening and follow-up, is not expected to
      exceed 105 days for any subject in the study.
    


Intervention name(s): GSK2982772 solution; GSK2982772 capsule; Placebo solution; Placebo capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Clear, colorless solution containing GSK2982772 in water with 5% ethanol (0.1mg/mL). Administered orally in required volumes for dosing less than 5mg; Size 00 White Opaque capsule containing GSK2982772 as white to almost white solid. Administered orally with water for dosing from 5 to 120 mg; Clear, colorless solution containing placebo in water with 5% ethanol (0.1mg/mL). Administered orally in required volumes for dosing less than 5mg; Size 00 White Opaque capsule containing Placebo as white to almost white solid
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FTIH; pharmacodynamics; pharmacokinetics; GSK2982772; safety; Repeat dose; tolerability
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of
      therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with
      stage 1 or stage 2 essential hypertension.
    


Intervention name(s): Nebivolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration; Dose-match placebo
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stage 1; Stage 2; Hypertension
High Flow Nasal Cannula and Diaphragmatic Function
Condition: Diaphragm Injury; Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Prospective randomized study investigating the effect of postoperative oxygen delivery on
      diaphragmatic function. Two different modalities of oxygen delivery will be compared: high
      flow nasal cannula versus standard oxygen therapy with facial mask
    


Intervention name(s): High flow nasal cannula; Facial mask
Intervention type(s): Device; Device
Intervention description(s): A device able to delivery high flow oxygen therapy; standard oxygen therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
Condition: Primary Insomnia; Secondary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare an investigational drug (LY2624803) with placebo and
      with zolpidem in the treatment of outpatients with chronic insomnia.
    

Detailed description: 
      Outpatients with chronic insomnia who participate in this study will be treated in each of
      four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg,
      or LY2624803 3 mg. Neither patients nor investigators will be told what treatments are being
      given in any treatment period. A patient who completes all four treatment periods will be
      treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the
      periods; and with LY2624803 in either 1 or 2 of the periods. No patient will receive placebo
      for all four of the 2-week treatment periods. All patients will receive LY2624803 for at
      least one of the four 2-week treatment periods. During each treatment period, patients will
      record information each morning about their sleep the night before, and each evening about
      their functioning since waking up. Patients will also wear wrist actigraphy devices to record
      their physical activity. At the conclusion of each treatment period, patients will answer
      questions about their sleep, functioning, health, and relative preference for treatments.
    

Intervention name(s): LY2624803; LY2624803; Placebo; zolpidem
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 mg, oral capsule, once nightly before bedtime; 3 mg, oral capsule, once nightly before bedtime; matching placebo (capsule or tablet), once nightly before bedtime; 5 or 10 mg, oral tablet, once nightly before bedtime
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24
      week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF)
      fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to
      Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in
      Patients with moderate to very severe COPD.
    


Intervention name(s): Glycopyrronium/Formoterol Fumarate; umeclidinium/vilanterol
Intervention type(s): Drug; Drug
Intervention description(s): Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation; Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD
Brain Stimulation and Cognitive Training in Healthy Older Adults
Condition: Aging
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive
      training of working memory leads to performance improvement in healthy older individuals.
    

Detailed description: 
      The goal of the present study is to assess behavioral (primary) and neural effects of a
      multi-session cognitive training combined with transcranial direct current stimulation
      (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various
      cognitive functions by modulating cortical excitability in young adults, but its behavioral
      impact and underlying mechanisms in aging still need to be elucidated. Healthy older adults
      will participate in a three-week cognitive training with concurrent online tDCS application.
      Cognitive performance (primary), as well as structural and functional imaging data will be
      examined before, during and after the intervention. In order to draw conclusions about the
      effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation
      during training, will be assessed. Furthermore, to assess neural correlates of performance
      improvement, functional and structural parameters will be measured with MRI before and after
      training. Follow-up sessions to assess long-term effects are planned four weeks and six
      months after the post assessment. The results of the study will offer valuable insights into
      efficacy of combined tDCS and cognitive training, as compared to training alone, in older
      adults. Moreover, improved understanding of tDCS effects on cognitive training performance
      and underlying neural correlates may help to develop novel approaches for cognitive decline
      in healthy and pathological aging.
    

Intervention name(s): Anodal tDCS; Intensive cognitive training
Intervention type(s): Device; Behavioral
Intervention description(s): Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA); Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: memory; brain stimulation
Safety of REPEVAX® Given One Month After REVAXIS®
Condition: Healthy Adult
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

        -  To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis
           vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus,
           Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of
           REPEVAX® administered one month after Placebo.

      Secondary objectives:

        -  To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy
           adults.

        -  To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after
           Td-IPV vaccine (REVAXIS®) or one month after Placebo.
    


Intervention name(s): REPEVAX® after REVAXIS®; REPEVAX® after Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated); Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this exploratory study is to compare the treatment effect on dentinal
      hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile
      sensitivity. This proof of concept study will compare the test dentifrice with three other
      treatment groups.
    

Detailed description: 
      This will be a single center, eight week, randomized, controlled, examiner blind, four
      treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of
      the two selected test teeth), exploratory study in participants with at least two sensitive
      teeth that meet all the criteria at the Screening and Baseline visit. Participants will be
      assessed at Baseline, four and eight weeks to monitor clinical efficacy and safety.
    

Intervention name(s): 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice; 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice; Sodium monofluorophosphate dentifrice; Sodium fluoride dentifrice
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate; Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate; Dentifrice containing 1000 ppmF as sodium monofluorophosphate; Dentifrice containing 1100 ppmF as sodium fluoride
Intervention MeSH terms: Calcium, Dietary; Listerine; Calcium; Fluorides; Sodium Fluoride; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Combined Transcranial and Peripheral Muscle Magnetic Stimulation in Chronic Tinnitus
Condition: Chronic Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Magnetic stimulation of the brain (repetitive transcranial magnetic stimulation) and of neck
      muscles (repetitive peripheral muscle stimulation) is used to alter tinnitus-related cortical
      activity and neck muscles tension.
    

Detailed description: 
      Chronic tinnitus is characterized by several comorbid disorders. One of them is neck and back
      pain. Here, we investigate the feasibility, safety and clinical efficacy of the combination
      of repetitive transcranial magnetic stimulation (rTMS) and peripheral muscle stimulation
      (rPMS) in chronic tinnitus in a pilot study. rTMS is considered to interact with neural
      tinnitus networks. rPMS is suggested to bring relief to muscle tension. This is an one arm
      study where explorative analyses will be done with special consideration on patients
      suffering from neck pain in the analysis.
    

Intervention name(s): rPMS and rTMS
Intervention type(s): Device
Intervention description(s): rPMS Stimulation of the neck muscles in five medial-lateral movements starting from the neck: left and right trapezius and deltoid muscle, trapezius and lattissimus dorsi muslce, and over the backbone. 20 stimuli per movement with 2s inter-train interval; four repetitions for each of the five movements; the first 20 trains with a frequency of 5Hz, the second 20 trains at 20Hz; stimulation at individual comfortable level (20-30% stimulator output); round coil.
rTMS 20Hz stimulation with 2000 stimuli over the left dorso-lateral prefrontal cortex at 110% motor threshold; followed by 1Hz stimulation with 2000 stimuli over the left temporo-parietal cortex; stimulation intensity 110% motor threshold; butterfly coil.
For stimulation we use MagPro X100 (Medtronic, Denmark).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex
Condition: Pulmonary MAC; Energy Metabolism; Emaciation
MeSH terms: Mycobacterium avium-intracellulare Infection; Emaciation
Study type: Observational

Summary: 
      We aim to examine energy metabolism in patients with pulmonary MAC and clarify the causes of
      emaciation. We will also investigate the following: the relation between energy metabolism
      and degree of pulmonary MAC progression; relations among hospitalization, mortality rate, and
      time-course of changes in energy metabolism; and factors that affect energy metabolism.
    

Detailed description: 
      Patients with pulmonary MAC with a lower BMI than healthy individuals also have a
      significantly poorer prognosis than those of normal weight. Emaciation in such patients is
      thought to be caused by destruction of lung structure from disease progression and an
      increased resting metabolic rate caused by the increased load from breathing; however, causes
      of emaciation and details of energy metabolism in these patients have not been studied.

      Elucidating details of energy metabolism and causes of emaciation in patients with pulmonary
      MAC could provide the basis for improvement in nutritional status and activities of daily
      living through early nutrition therapy and rehabilitation. We propose to clarify the
      following:

      Energy metabolism in patients with pulmonary MAC, including resting metabolic rate, calorie
      intake and consumption, and hormonal secretions.

      Relation between energy metabolism and degree of pulmonary MAC progression.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Petients with pulmonary MAC
      
Biospecimen description: 
      Blood samples (serum, plasma)
    
Keywords: pulmonary MAC; energy metabolism
Effects of Virtual Reality System in Children With Developmental Delays
Condition: Developmental Delays
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effects of virtual reality system on children
      with developmental delays.
    

Detailed description: 
      Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in
      addition to regular rehabilitation programs.
    

Intervention name(s): virtual reality system
Intervention type(s): Other
Intervention description(s): The participants were randomly assigned to either Group A or Group B. Group A received rehabilitation treatment and additional virtual reality system for 1 month, followed by rehabilitation treatment for 1 month; by contrast, the participants in Group B received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system for 1 month.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: virtual reality system, children, developmental delay
Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery
      experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with
      HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such
      as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is
      unknown. The aim of this study is to determine the effective dose of ramosetron for
      prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based
      patient-controlled analgesia after gynecological laparoscopic surgery.
    


Intervention name(s): ramosetron 0.3; ramosetron 0.45; ramosetron 0.6
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.; The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.; The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Exploring the Effect of an Intervention on Women's Physical Activity Behaviour
Condition: Physical Activity
Study type: Interventional

Summary: 
      Physical activity has been shown to reduce the risk of chronic diseases and promote physical
      and mental health and wellbeing, yet few women are active enough to see these benefits.
      Wearable activity trackers show promise for helping people increase their physical activity
      levels by supporting self-monitoring. However, few researchers have examined how providing
      people with these devices impacts physical activity levels, or motivation for physical
      activity which is a significant and robust predictor of physical activity. Based on previous
      research, it is possible that women's physical activity levels would be more likely to
      increase if they received an autonomy-supportive intervention to enhance motivation in
      addition to a wearable activity tracker. A pilot, three-armed randomized controlled trial was
      developed to test this hypothesis and to assess if changes in perceived autonomy-support,
      basic psychological need satisfaction/thwarting, motivational regulations, wellbeing
      indicators are associated with changes in physical activity over time.
    


Intervention name(s): Physical Activity Information; Physical Activity Monitoring; Autonomy-support
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive a copy of the Canadian Physical Activity Guidelines.; Participants will receive a wearable activity tracker (Polar A300).; Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: physical activity; obesity; pilot study; randomized controlled trial; women; eHealth