bioihbjkbjnl/mcl2 huggingface dataset:
A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of single rising oral
      doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg)
      in groups of 8 healthy male adult volunteers.
    

Detailed description: 
      Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate
      single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy
      male adult subjects. Within each group of eight subjects two subjects were randomised to
      receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No
      subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg,
      400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose
      occurred only after the previous dose level was deemed to be safe and well tolerated by the
      investigator and the sponsor.
    

Intervention name(s): BIA 2-093; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg; Identical placebo administered as oral tablets with 200 ml potable water.
Other intervention name(s): ESL, Eslicarbazepine acetate; PLC
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eslicarbazepine acetate; BIA 2-093; Epilepsy
A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Condition: Hyperphosphatemia Patients on Hemodialysis
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in
      hyperphosphatemia patients on hemodialysis
    


Intervention name(s): TS-172 10mg bid; TS-172 30mg bid; TS-172 60mg bid; TS-172 20mg tid; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral administration of TS-172 10 mg bid; oral administration of TS-172 30 mg bid; oral administration of TS-172 60 mg bid; oral administration of TS-172 20 mg tid; oral administration of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The aims of this pilot study are to determine the metabolic demand and exercise intensity
      level of E-Fit exercise intervention by evaluating the cardiovascular responses in AIS girls
      and whether the cardiovascular responses for AIS girls performing E-Fit will behave in the
      same way as compared to healthy controls. We hypothesise that 1) the metabolic demand and
      exercise intensity of E-Fit exercise intervention is equivalent to moderate-to-vigorous
      level; and 2) AIS girls have different cardiovascular responses as compared to healthy
      controls
    

Detailed description: 
      AIS girls and age- and gender-matched healthy controls will perform the E-Fit exercise
      intervention for two trials and gas exchange parameters including oxygen consumption (VO2)
      and carbon dioxide production (VCO2) will be taken continuously during the exercise.
      Comparison of VO2 and VCO2 between AIS and healthy controls when performing E-Fit exercise
      will be made.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Two trials of 7-min High Intensity Interval Training (HIIT) with 12 different exercises. Each exercise lasts for 30 seconds continuously with 10 seconds rest interval.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction andpREServed Lef venTricle Ejection Fraction (ARREST)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial will inform whether detection of ventricular arrhythmias by means of implantable
      loop recorder (ILR) can help to predict SCD in the large population of survivors of a
      myocardial infarction with preserved left ventricular function, EF>40%. This may improve risk
      stratification in these patients, and can inform on the clinical use of subcutaneous monitors
      to identify post-infarction populations in need for an intervention to prevent sudden death.
    


Intervention name(s): PCI; ILR implantation
Intervention type(s): Device; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Regulating Efficacy and Wellness in Diabetes
Condition: Diabetes Type 2; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The propose of the study is to test the hypothesis that an eight week program consisting of
      walking exercise and social cognitive theory based group workshops will increase physical
      activity adherence six months later in older adults with type 2 diabetes or metabolic
      syndrome.
    


Intervention name(s): Walking exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Rumination-focused CBT Training for the Prevention of Depression and Anxiety
Condition: Depression; Anxiety Disorders
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Depression and anxiety disorders are highly prevalent and associated with reduced quality of
      life for patients and enormous economic costs for society. Although effective treatments are
      available, a substantial number of patients fail to respond, and the time between disorder
      onset and treatment is typically long. The development of prevention programs therefore
      appears promising. The current project aims to prevent depression and anxiety by targeting
      excessive levels of worry and rumination, two important risk factors for emotional disorders.
      Participants will be selected on the basis of a high score on two validated questionnaires on
      worry and rumination. They will be randomly assigned to a rumination-focused
      cognitive-behavioral training delivered in a group format, a rumination-focused
      cognitive-behavioral training delivered via internet, or a no-training control condition. It
      is expected that both versions of the rumination-focused training will reduce symptoms of
      depression and anxiety, will reduce the incidence of major depressive episodes and
      generalized anxiety disorder, and will reduce symptom levels of other emotional disorders.
    

Detailed description: 
      see above
    

Intervention name(s): Rumination Focused CBT
Intervention type(s): Behavioral
Intervention description(s): see arms
Other intervention name(s): RFCBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of a Natural Source Supplementation on Muscle Mass
Condition: Muscle Disuse Atrophy; Nutrition, Healthy
MeSH terms: Muscular Disorders, Atrophic
Study type: Interventional

Summary: 
      Periods of muscle disuse are commonly experienced in young and elderly individuals as a
      result of short-term hospitalization or leg casting after injury. Periods of immobilization
      result in a profound loss of muscle mass and strength. This loss of muscle mass can have
      negative effects on health and the ability to carry out activities of daily living. Thus, it
      is very important to try to maintain muscle mass during muscle disuse. Recent research
      suggests that Fortetropin, which is an all-natural protein-fat complex made from fertilized
      hen egg yolks, can enhance muscle mass and strength with weightlifting in young men. In this
      study, we aim to investigate the safety and tolerability of Fortetropin and whether
      Fortetropin supplementation can reduce or prevent the loss of muscle mass during single-leg
      immobilization while you are wearing a knee brace. To make this decision, we require a study
      to compare Fortetropin to a placebo (something that contains the same amount of protein and
      energy as Fortetropin). The findings from this study will help us understand if Fortetropin
      supplementation is safe, tolerable, and can be used to slow muscle loss in people who undergo
      periods of muscle disuse (i.e. surgery, sickness).
    


Intervention name(s): Single leg immobilization
Intervention type(s): Other
Intervention description(s): 2 weeks of single-leg immobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Skeletal muscle; Supplementation; Disuse; Single-leg immobilization