bioihbjkbjnl/mcl2 huggingface dataset:
Precedex Special Investigation (in Pediatric Patients)
Condition: Sedation
Study type: Observational

Summary: 
      Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual
      medical practice of Precedex in Japan.
    

Detailed description: 
      To assess the data, including safety profile, of Precedex Intravenous Solution administered
      for "sedation during and after mechanical ventilation in the intensive care setting" in
      pediatric patients under actual medical practice in Japan.

      Maruishi Pharmaceutical Co., Ltd. and Pfizer Japan Inc. will collect 50 subjects each.
    

Intervention name(s): Dexmedetomidine Hydrochloride
Intervention type(s): Drug
Intervention description(s): [Sedation during and after mechanical ventilation in the intensive care setting] For pediatric patients ages of 6 years and over, dexmedetomidine is usually administrated by continuous intravenous (IV) infusion of at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition.
For pediatric patients with corrected gestational ages (gestational age + postnatal age) of 45 weeks to under 6 years, dexmedetomidine is usually administrated by continuous IV infusion at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. The dosing rate could be decreased according to the patient's condition as appropriate.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients (45 weeks corrected gestational age to <18 years old) administered this
        drug for "sedation during and after mechanical ventilation in the intensive care setting"
      
Keywords: Precedex;; Dexmedetomidine Hydrochloride;; Sedation;; intensive care;; pediatric
Effects of Japanese Red Wines on Vascular Function in Adult Men
Condition: Vascular Function; Platelet Aggregation
Study type: Interventional

Summary: 
      The overall objective of this study is to investigate the effects of different types of red
      wine on markers of endothelial function and platelet aggregation.
    

Detailed description: 
      Potential participants are provided with information about the study and potential risks.
      Once participants decided to participate in the study, they will be scheduled for a health
      screening visit which determines eligibility to the study entry. If participants are
      eligible, they will be randomized in a three-way crossover study design to receive three
      interventions (control, red wine1, and red wine2) with the one-week washout period. On the
      study day, participants will be assessed for baseline measurements, provided with the
      designated beverage, and followed up for the measurements at 2 and 4 hours after the
      consumption.
    

Intervention name(s): Red wine A; Red wine B; Control
Intervention type(s): Other; Other; Other
Intervention description(s): 8 oz (237 ml) of red wine A and red wine B will be blinded and randomized between Japanese Zweigelt red wines from vintages 2015 or 2018.; 8 oz (237 ml) of red wine A and red wine B will be blinded and randomized between Japanese Zweigelt red wines from vintages 2015 or 2018.; 8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three-way crossover randomized controlled trial
Masking: Single (Participant)
Primary purpose: Other
Keywords: vascular function; platelet aggregation
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese
      adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1
      cohort of SC doses.
    


Intervention name(s): MEDI-545; MEDI-545; MEDI-545; MEDI-545; MEDI-545; MEDI-545 600
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses; Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses; Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Intervention MeSH terms: Sifalimumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; Japanese; phase 2; safety; tolerability; MEDI-545; Autoimmune Disease; Immune System Diseases
EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia
Condition: Brain Activity Under Sedation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how the commonly used anesthetic drug propofol
      works in the brain to produce loss of consciousness. While under general anesthesia your
      brain waves will be measured using electroencephalogram (EEG). On a separate day, the
      patient's brain will be imaged using magnetic resonance imaging (MRI).
    


Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women
Condition: Obesity
Study type: Interventional

Summary: 
      Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause,
      considering its high protein content and considerable amounts of essential amino acids, good
      fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled
      pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a
      day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary
      outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary
      outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less
      than daily energy requirements). Twenty-seven women were randomly assigned to the
      supplemented group (14) or placebo group (13). There was a significant interaction between
      time and group for body mass index (BMI) (p<0.0001), waist (p=0.002), and hip circumference
      (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index
      (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over
      time showed a clearly greater feeling of satiety for the supplemented compared to the placebo
      group. These findings indicate that RG supplementation in addition to a tailored diet
      counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body
      composition, insulin resistance, amino acid profiles and satiety.
    


Intervention name(s): Rice Germ; Placebo
Intervention type(s): Dietary Supplement; Combination Product
Intervention description(s): The rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks; An isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rice Germ; Body composition; Amino acids
A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in
      a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to
      sinus rhythm compared to placebo.
    

Detailed description: 
      Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed
      China as one of the countries participating in the study.
    

Intervention name(s): vernakalant hydrochloride; Placebo to vernakalent hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered.; Patients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered.
Other intervention name(s): MK-6621; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atrial Fibrillation
Effectiveness of an Adventure-based Training Programme
Condition: Healthy
Study type: Interventional

Summary: 
      This study tested the effectiveness of an adventure-based training programme in promoting the
      psychological well-being of primary schoolchildren. A randomised controlled trial was
      conducted, with 56 primary school pupils randomly assigned to the experimental group
      participating in the adventure-based training programme and 64 to the attention placebo
      control group.
    


Intervention name(s): an adventure-based training programme; a placebo control programme
Intervention type(s): Behavioral; Other
Intervention description(s): The programme consisted of five education sessions (around 75 minutes each) and a day's adventure-based training camp at the end of the academic year; Subjects in the control group were invited to attend five 75-minute sessions of leisure activities, organised by a community centre, which included a cartoon film show, handicraft workshops, a health talk on the prevention of influenza and age-appropriate physical leisure activities, such as table tennis, badminton, chess and Chinese billiards. Additionally, they were invited to join a day visit to Hong Kong Ocean Park at the end of the academic year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Subjects
A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.
      This study is designed to understand how the body handles the investigational drug, and to
      measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves
      intravenous (IV) infusion of the investigational drug and a procedure to measure
      concentrations in the fat tissue. Both parts of the study will be conducted in participants
      with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to
      complete.
    


Intervention name(s): Insulin Peglispro; Human Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Administered IV; Administered IV
Other intervention name(s): LY2605541
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Evaluation of a New Aspheric Intraocular Lens.
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the visual performance and occurrence of posterior capsular
      opacification after implantation of a new aspherical intraocular lens compared with a control
      spherical lens of otherwise identical design.
    


Intervention name(s): Advanced Akreos Adapt in one operated eye.; Akreos Adapt in fellow operated eye.
Intervention type(s): Device; Device
Intervention description(s): Cataract surgery to implant the assigned IOL according to randomized schedule.; Cataract surgery to implant the assigned IOL according to randomized schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fed condition in normal,
      healthy, adult, male and female human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India and the corresponding Reference
      Product: Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA, under fed
      condition in normal, healthy, adult, male and female human subjects in a randomized crossover
      study.

      The study was conducted with 40 healthy adult subjects. In each study period, a single 40 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 18 days including washout period of 14
      days between administrations of study drug in each study period.
    

Intervention name(s): Lisinopril Tablets 40 mg; Lisinopril
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg tablet once a day; 40 mg tablet once a day
Other intervention name(s): Test Product; Zestril® (Lisinopril) 40 mg Tablets
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy
      of GSK2586184 in patients with chronic plaque psoriasis.

      There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this
      part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects
      will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg
      GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of
      400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184
      concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will
      take 400 mg GSK2586184.

      In both Cohorts A and B, study medication will be administered orally (as tablets), twice
      daily, for up to 12 weeks.

      Each subject will have 7 out-patient visits: Screening; Baseline & Start of treatment; Week
      2; Week 4; Week 8; Week 12; and Follow-up (Week 16)
    


Intervention name(s): 100 mg GSK2586184; 200 mg GSK2586184; 400 mg GSK2586184; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.; 200 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.; 400 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.; Placebo tablets to be taken twice daily with food for up to 84 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PASI; DLQI; GSK2586184; plaque-type psoriasis; PGA; inflammatory gene transcription; JAK-1 inhibitor; serum neopterin; skin biopsy; ACR response criteria; VAS itch score
A Drug Interaction Study of Mosapride and Rebamipide
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators investigate the potential pharmacokinetic drug-drug interaction between
      Mosapride citrate 5 mg and Rebamipide 100 mg in healthy male volunteers who receive Mosapride
      citrate 5 mg, Rebamipide 100 mg, and both together in a 2 period repeatedly.
    

Detailed description: 
      To evaluate the safety, drug-tolerance, pharmacokinetics of Mosapride citrate 5 mg or
      Rebamipide 100 mg monotherapy or Mosapride citrate 5 mg and Rebamipide 100 mg combination in
      healthy male subjects.
    

Intervention name(s): Rebamipide; Mosapride citrate
Intervention type(s): Drug; Drug
Intervention description(s): oral administration, 3 times/day; oral administration, 3 times/day
Other intervention name(s): Mucosta® Tab.; Gasmotin® tab.
Intervention MeSH terms: Rebamipide; Mosapride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mosapride citrate; Rebamipide; pharmacokinetic drug drug interaction; oral administration; healthy male subjects
Efficacy and Safety of IBS Digital Behavioral Treatment
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the
      Efficacy and Safety of Two Self-administered behavioral treatments for Adult Subjects with
      Symptomatic Irritable Bowel Syndrome (IBS).
    

Detailed description: 
      EASITx is a pivotal study comparing two self-administered behavioral treatments for irritable
      bowel syndrome (IBS). The active treatment in EASITx is classified as Software as a Medical
      Device (SaaMD).
    

Intervention name(s): Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD); Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)
Intervention type(s): Device; Device
Intervention description(s): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment.; The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IBS - Irritable Bowel Syndrome; IBS; Irritable Bowel
The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation
Condition: Amputation
Study type: Observational

Summary: 
      Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is
      difficult since there are no generally established clinical guidelines based on objective
      data.

      Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle,
      NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional
      capacity, pain severity, satisfaction level and quality of life (QoL) in high activity
      patients with unilateral transtibial amputation.
    

Detailed description: 
      Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is
      difficult since there are no generally established clinical guidelines based on objective
      data.

      Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle,
      NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional
      capacity, pain severity, satisfaction level and quality of life (QoL) in high activity
      patients with unilateral transtibial amputation.

      Methods: Forty-two patients with unilateral transtibial traumatic amputation will be
      participated in this cross-sectional study. Functional capacity will be evaluated using the
      six-minute walking test (6MWT). The severity of residual limb pain, sound limb pain and low
      back pain will be evaluated with a 10-point Visual Analogue Scale (VAS). The socket system,
      prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS.
      The QoL of each patient will be assessed using the Short Form 36 (SF-36).
    

Intervention name(s): The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
Intervention type(s): Other
Intervention description(s): The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Fourty-two patients with unilateral transtibial traumatic amputation will be participated
        in this cross-sectional study. Only participants using active vacuum-assisted suspension
        system will be included in the study in order to prevent any bias from suspansion system on
        the results.
      
Keywords: Transtibial amputation; Prosthetic foot; Functional capacity; Satisfaction; Quality of life