bioihbjkbjnl/mcl2 huggingface dataset:
Changes in Intestinal Permeability 4 Hours After Gluten Challenge
Condition: Celiac Disease; Wheat Hypersensitivity; Gluten Sensitivity; Gluten Enteropathy; Immune System and Related Disorders; Duodenal Diseases
MeSH terms: Celiac Disease; Duodenal Diseases; Hypersensitivity; Wheat Hypersensitivity
Study type: Interventional

Summary: 
      This study evaluates why people with celiac disease and non-celiac gluten/wheat sensitivity
      develop rapid onset symptoms within hours of gluten exposure. Half of subjects will be given
      gluten and half will not.
    

Detailed description: 
      When a person with celiac disease is exposed to gluten, their immune system attacks their
      bowel and causes abdominal pain, bloating, and diarrhea. This process takes 24-72 hours to
      occur. Some people without celiac disease develop similar symptoms when they eat gluten or
      wheat. Doctors and scientists do not know what causes this sensitivity to gluten. People with
      celiac disease and non-celiac gluten sensitivity report symptoms within hours of being
      exposed to gluten. This study evaluates why this occurs by looking at changes in blood,
      urine, stool, and the bowel after being given gluten.
    

Intervention name(s): Gluten; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Six grams of gluten will be mixed with water and Tang flavoring. Subjects will drink the mixture one time.; Subjects will drink a mixture of rice water and Tang flavoring one time.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blinded, placebo-controlled oral gluten challenge
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Randomized, double-blinded, placebo-controlled trial; Oral food challenge
Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
Condition: Preclinical Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to assess the safety and efficacy of gemfibrozil in modulating
      microRNA-107 levels for the prevention of Alzheimer's disease in subjects with intact
      cognition and mild cognitive impairment
    

Detailed description: 
      Double-blind, placebo controlled, parallel-design. 48 cognitively-intact subjects, and 24
      subjects with early cognitive decline (CDR 0.5) will be randomly assigned to treatment with
      gemfibrozil (600 mg orally twice a day) or placebo for 52 weeks. Safety assessments will
      include routine assessment of adverse events, safety labs, and brain magnetic resonance
      imaging.
    

Intervention name(s): Gemfibrozil; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemfibrozil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Alzheimer disease; mild cognitive impairment; normal cognition
A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction
Condition: Post-operational Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Post surgical pain associated with ligament reconstruction may persist for few days after the
      surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain
      through oral administration. This study will test the safety and efficacy of Arcoxia in the
      management of post-operational pain in patients receive the ligament reconstruction surgery.
    


Intervention name(s): Arcoxia(etoricoxib 90 mg/tablet)
Intervention type(s): Drug
Intervention description(s): Arcoxia(etoricoxib 90 mg/tablet) or placebo, #1, 3 days
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COX-2; post-operative ; sports injury; surgical pain
Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients
Condition: Cerebrovascular Accidents
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The findings of this study will advance movement reorganization mechanism underlying
      treatment approaches and clinical intervention techniques. These findings may inform
      rehabilitation professionals about which treatment approach is superior to another one in
      certain aspect of outcome and who can benefit most from certain treatment approach.
      Accordingly, the results of this project may help us move quickly to design and develop
      efficient and effective rehabilitation programs for individualized patients.
    

Detailed description: 
      The first purpose is to investigate the relative effects of modified constraint-induced
      therapy (mCIT) vs. bilateral isokinematic training (BIT) vs. traditional or therapist-based
      training (TR) on movement reorganization, motor performance, functional ability, and quality
      of life (QoL) immediately and six months later after treatment delivered at hospitals.
      Movement reorganization will be evaluated by kinematic instrument. Motor performance,
      functional ability, and QoL will be assessed using clinical assessment tools. By the same
      token, we also investigate the relative effects of these two approaches delivered at home.
      The second purpose is to study whether home-based mCIT is efficacious in various aspects of
      outcomes described above immediately and six months later following treatment, compared to
      home-based TR, and hospital-based mCIT and TR.We also study the same question regarding
      home-based BIT efficacy. The third purpose is to establish predictive models to predict
      functional and QoL outcomes immediately and six months later following mCIT and BIT.
    

Intervention name(s): Hospital-based mCIT; Hospital-based BIT; Hospital-based TR; Home-based mCIT; Home-based BAT; Home-based TR
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): restraint of the unaffected arm and practice of the affected arm; bilateral symmetric, repetitive arm training; hospital-based traditional rehabilitation : OT or PT or therapist-based training; restraint of the unaffected arm and practices of the affected arm; bilateral symmetric, repetitive arm training; home-based traditional rehabilitation:OT or PT or therapist-based training
Other intervention name(s): Hospital-based modified constraint-induced therapy(mCIT); Hospital-based bilateral isokinematic training (BIT); Hospital-based traditional rehabilitation (TR); Home-based modified constraint-induced therapy (mCIT); Home-based bilateral arm training (BAT); Home-based traditional rehabilitation (TR)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke rehabilitation; kinematic analysis; upper extremity training; predictors
The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora
Condition: Hyposalivation
MeSH terms: Xerostomia
Study type: Interventional
Phase: Phase 1

Summary: 
      The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥
      4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9
      used placebo tablets and gel. The salivary secretion rates were measured and microbial
      samples collected and analysed using cultivation technique twice both at baseline and at the
      3-month follow up (1-2 weeks between the appointments).
    

Detailed description: 
      The aim was to analyse the effect of daily intake of probiotic alpha-haemolytic facultative
      anaerobic streptococci (Streptococcus oralis), pH-rising components and Stevia on the oral
      microflora in hyposalivated subjects.

      Material and methods: Subjects with hyposalivation (unstimulated secretion rate of < 0.1
      ml/min and/or a stimulated secretion rate < 0.7 ml/min) and ≥ 10 000 cfu/ml of mutans
      streptococci and/or lactobacilli on the tongue or in the supragingival plaque were included.
      Eighteen subjects used probiotic tablets (≥ 4/day) and gel (once a week) for 3 months and 9
      used placebo tablets and gel. The salivary secretion rates were measured and microbial
      samples collected and analysed using cultivation technique twice both at baseline and at the
      3-month follow up (1-2 weeks between the appointments).
    

Intervention name(s): Test group, probiotic tablets and gel; Placebo group, placebo tablets and gel
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Effect of probiotic tablets and gel on acidogenic bacteria; Effect of placebo tablets and gel on acidogenic bacteria
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Microflora; Probiotics; Hyposalivation; Lactobacilli; Mutans streptococci; pH-rising components
The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
Condition: COPD; Exercise; Resistance Training
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of the present project is to investigate the physiological effects of two
      different types of exercise training in COPD patients. The patients will be examined before,
      during and after 8 weeks of training to evaluate the effect of different types of skeletal
      muscle stimulation on health related quality of life, 6 min walking distance, flow mediated
      dilation, and histological properties of skeletal muscle cells, regarding oxidative capacity,
      fiber type, purinergic receptor amounts and measures of systemic inflammation. The study will
      test the hypothesis that:

      Resistance training is superior to endurance training in patients with COPD
    


Intervention name(s): Resistance training; Endurance training
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Strength training, skeletal muscle, exercise, muscle training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
Condition: Gout; Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this 12-week randomized multicenter double-blind parallel group placebo-controlled
      dose finding study is to assess the efficacy and safety of three different doses of LC350189
      in subjects with hyperuricemia and a diagnosis of gout.
    


Intervention name(s): LC350189 formulated capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Xanthine Oxidase Inhibitor; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of
      both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in
      healthy adults 18 to 49 years of age.
    


Intervention name(s): Cell culture-derived influenza vaccine; Egg-derived influenza virus vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.; One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.; One dose (0.5 mL) of phosphate buffered solution.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; Flu; Cell Culture-Derived; Egg-Derived; Healthy Adults; Efficacy; Safety; Immunogenicity; Trivalent; Inactivated; Influenza-Like Illness; Vaccination
A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted in patients with erosive esophagitis due to gastro-esophageal
      reflux disease (GERD) Los Angeles (LA) grades C or D, and in patients with at least partial
      symptom response but still endoscopically unhealed (LA grades A or B) after 8 weeks history
      of standard treatment healing course with PPI, designed to support dose selection for Phase 3
      and to investigate safety, tolerability, and healing rates after 4 weeks treatment of X842 or
      Lansoprazole, and symptom pattern during subsequent 4 weeks treatment with Lansoprazole.
    

Detailed description: 
      This is a randomized, double-blind, active comparator-controlled study with a parallel-group
      design including four arms with X842 and one arm with Lansoprazole.

      Randomization to one of the treatments with X842 twice daily (BID) 25 mg, 50 mg, 75 mg, 100
      mg, or Lansoprazole 30 mg once daily (QD) will be based on a 1:1:1:1:1 scheme.

      The duration of each patient's participation in the study, including screening, blind
      treatment period, and open-label treatment period will be approximately 60 days. The patients
      will be randomized for 4 weeks of double-blind treatment and will be provided with
      investigational medicinal product for 35 days.

      All patients will have an endoscopic evaluation after 4 weeks of treatment. Following the
      endoscopic evaluation, all patients will receive subsequent 4 weeks of open-label treatment
      with Lansoprazole. Repeated symptom evaluation to detect symptom patterns will be assessed
      during this period.
    

Intervention name(s): X842; X842 Dummy; Lansoprazole; Lansoprazole Dummy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients will receive X842 tablets.; Patients will receive matching placebo tablets for X842.; Patients will receive Lansoprazole capsule.; Patients will receive matching placebo capsules for Lansoprazole.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lansoprazole; Los Angeles Grade; Double-blind; Active comparator-controlled; Proton-pump inhibitor; Dose selection
Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and
      50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects
      with schizophrenia or schizoaffective disorder.
    

Detailed description: 
      This is a Phase 2, open-label, dose titration study to assess the efficacy and safety of
      three once daily (q.d.) doses (12.5, 25, and 50 mg) of NBI-98854 administered once daily for
      up to 12 days consisting of three treatment periods of 4 days each (Periods 1, 2, and 3). The
      starting dose will be 12.5 mg q.d. (Period 1), and this dose will be escalated to 25 mg q.d.
      (Period 2) and then to 50 mg q.d. (Period 3) based upon each subject's ability to tolerate
      NBI-98854. Progression to the next dose level will be based upon the subject's ability to
      tolerate the previous dose and the Investigator's review of adverse events and safety data.
      For subjects who do not tolerate a dose increase, the dose may be decreased to the dose that
      was previously administered (i.e., 25 mg to 12.5 mg, 50 mg to 25 mg) and continued at that
      dose for the remainder of the study treatment. Up to 10 medically stable subjects with
      schizophrenia or schizoaffective disorder who have moderate or severe symptoms of TD will be
      enrolled as outpatients.
    

Intervention name(s): NBI-98854
Intervention type(s): Drug
Intervention description(s): powder in bottle, prepared doses at 12.5, 25, and 50 mg q.d. administered for up to 12 days consisting of three treatment periods of 4 days each
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      Researchers are trying to learn more about how individuals break down and process specific
      medications based on their genes. Pharmacogenomics (PGx) is a new, specialized field within
      individualized medicine. PGx is the study of how genes may affect the body's response to, and
      interaction with, some prescription medications. Genes carry information that determines
      things such as eye color and blood type. Genes can also influence how individuals process and
      respond to medications. Depending on genetic make-up, some medications may work faster or
      slower or produce fewer side effects.
    


Intervention name(s): Pharmacogenomics (PGx) genetic testing
Intervention type(s): Genetic
Intervention description(s): A buccal swab to collect cells from the inside the cheek
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Assessment of Efficacy of the Consumption of a Heat-treated Lactobacillus Paracasei (GM080) on Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The primary objective of this trial is to assess the efficacy of the consumption of
      heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo
      treatment.
    


Intervention name(s): GM080; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: All subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a SCORAD equal or above 20
Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD
      patients and to assess the influence of Px-104 on hepatic fat.
    


Intervention name(s): Px-104
Intervention type(s): Drug
Intervention description(s): 28 days treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor
      coordination and brain metabolic activity in regular users of marijuana. Subjects were tested
      twice, after smoking cigarettes with marijuana and after smoking cigarettes without
      marijuana.On both occasions they performed on a virtual reality maze task. They were
      afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG).
    

Detailed description: 
      This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor
      coordination and brain metabolic activity in regular users of marijuana. Subjects were tested
      twice, after smoking cigarettes with marijuana and after smoking cigarettes without
      marijuana. On both occasions they performed on a virtual reality maze task. They were
      afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG). 12
      subjects were tested so far on both conditions.
    

Intervention name(s): Tetra Hydro Cannabinol (THC)
Intervention type(s): Drug
Intervention description(s): Oral THC 13mg and 17mg smoked in low nicotine cigarettes
Other intervention name(s): Marijuana, cannabis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Marijuana, FDG, PET, maze, THC, motor coordination.
Diabetes-Specific Formula in Individuals With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will be conducted using a randomized, controlled, crossover design with three
      treatments. The purpose of the study is to determine the effects of diabetes-specific formula
      on glycemic control in individuals with type 2 diabetes.
    

Detailed description: 
      All study participants will be asked to attend a test session where their glycemic,
      insulinemic and satiety response to a test meal will be measured, followed by a seven-day
      washout period where they will not receive or consume any study meal during this period. This
      cycle will be repeated until all participants complete three test sessions.
    

Intervention name(s): Diabetes-Specific Formula; Bread with Spread; Rice Porridge
Intervention type(s): Other; Other; Other
Intervention description(s): Other: Diabetes Specific Formula; Other: White Bread with Spread; Other: Rice Porridge
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment