bioihbjkbjnl/mcl2 huggingface dataset:
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Condition: Autoantibody Positive; Non-diabetic Relatives at Risk for Type 1 Diabetes; High Risk; Impaired Glucose Tolerance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to
      prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very
      high risk for developing the disease. Teplizumab has been studied in new onset type 1
      diabetes for testing of efficacy and safety in previous studies; other studies are currently
      in progress. The results of previous studies indicate that teplizumab reduces the loss of
      insulin production during the first year after diagnosis in individuals with type 1 diabetes.
      The purpose of this study is to determine if teplizumab can interdict the immune process that
      causes the destruction of insulin secreting beta cells in the pancreas during the
      "pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.
    

Detailed description: 
      The study plans to enroll approximately 71 subjects between the ages of 8-45 years, over 2-3
      years. The study is projected to last between 4-6 years, depending upon rate of enrollment
      and number of subjects who develop diabetes.

      The main study objective is to determine whether intervention with teplizumab will prevent or
      delay the development of type 1 diabetes in high risk autoantibody positive non-diabetic
      relatives of individuals with T1D. Secondary outcomes are to include analyses of C-peptide
      and other measures from Oral Glucose Tolerance Testing (OGTT), safety, tolerability, and
      other mechanistic outcomes will be assessed during the study.
    

Intervention name(s): Teplizumab; Placebo infusion
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusions; Placebo for Teplizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 1 diabetes; pre-diabetic; autoantibody positive; at risk for type 1 diabetes; glucose intolerance; relatives of people with type 1 diabetes
Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider
      Vinegar in newly diagnosed Type 2 Diabetic Patients
    

Detailed description: 
      Diabetes Mellitus is one of the oldest diseases known to men and has been treated with
      multiple agents,organic and with the current pharmacological advancement,with multiple
      synthetic drugs as well.

      Metformin has been considered first line for the treatment of Type 2 Diabetes, however
      presents itself with a side effect profile of GI distress, Vitamin B12 deficiency,to name a
      few.

      Vinegar has been used as therapeutic agent for centuries for multiple ailments including
      diabetes. This study aims to evaluate the combined effects of drug and natural therapy and
      compare it with conventional therapy.
    

Intervention name(s): Metformin Oral Tablet; Vinegar
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): A biguanide drug used as a first line therapy for Diabetes MellitusType 2; A common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses.
Intervention MeSH terms: Metformin; Acetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease
Condition: Patients Undergoing Coronary Angiography
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      In the present study the investigators will measure the extent of coronary artery disease via
      coronary angiography and the correlating risk factors.
    

Detailed description: 
      In the present study the investigators will examine the risk factors determining the
      development, extent and the manifestation of coronary artery disease. The study will recruit
      patients undergoing coronary angiography for clinical purposes.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Diabetics and non-diabetics who are admitted in the Cardiology Department in the University
        Hospital of Ioannina and undergo coronary angiography for clinical purposes will be
        studied. The study will include subjects who have suspected stable CAD or an acute coronary
        syndrome and undergo a diagnostic angiography. Patients revascularized in the past (either
        coronary artery bypass grafting or percutaneous coronary intervention) will be excluded
        from the study since it is not possible to describe the extent of CAD in these patients.

        We plan to recruit about 1,000 patients in about 2 years in order for valid conclusions to
        be drawn from association analysis between CV risk factors, gene polymorphisms and the
        presence and extent of CAD.
      
Biospecimen description: 
      Includes retaining blood samples for DNA analyses and biochemical markers.
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase IIb, randomized, double-blind, placebo-controlled study to determine the
      efficacy and safety of MM-II in subjects with symptomatic knee OA as compared to matching
      placebo.
    


Intervention name(s): MM-II dose I; MM-II dose II; MM-II dose III; Placebo; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intra-articular injection; Intra-articular injection; Intra-articular injection; Intra-articular injection; Intra-articular injection; Intra-articular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline)
      as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
    


Intervention name(s): Botulinum toxin type A Dose 1; Botulinum toxin type A Dose 2; Placebo (Normal Saline)
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.; Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.; Placebo (Normal Saline) intramuscular injections into specified muscles.
Other intervention name(s): onabotulinumtoxinA; BOTOX®; onabotulinumtoxinA; BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150,
      162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a
      2 dose vaccination schedule of hepatitis A vaccine.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      11 to 20.

      No additional subjects will be recruited during this long-term follow-up.
    

Detailed description: 
      This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after
      primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To
      evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years
      11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary
      vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations.

      If a subject has become seronegative for anti-HAV antibodies during any of the long-term
      blood sampling time point (i.e. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246),
      he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day
      of the additional vaccination 14 days and one month after additional vaccination to evaluate
      the immune response following this vaccination.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
      and to extend the follow up until Year 20.

      The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679,
      110680, 110681.
    

Intervention name(s): Havrix™
Intervention type(s): Biological
Intervention description(s): 2 doses at 12 months interval
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HAVRIX™; Hepatitis A
Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury
Condition: Spinal Cord Injury; Tetraplegia; Paresis; Plegia
MeSH terms: Spinal Cord Injuries; Quadriplegia; Paresis; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine if tetraplegic individuals with incomplete spinal
      cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are
      able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new
      robotic therapy device.

      The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects
      with incomplete SCI will result in improved strength, sensation, and functional movement in
      treated limb(s).
    

Detailed description: 
      Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several
      thousand new injuries each year. Most recovery, following SCI, occurs in the six months
      following surgery. Further recovery after 12 months is unusual.

      In this study 13 subjects, more than 1 year post injury, were enrolled to test the safety and
      efficacy of a new type of robotic therapy device known as the AMES device. The aim of this
      Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES)
      technology in hand rehabilitation of incomplete SCI subjects.
    

Intervention name(s): AMES treatment
Intervention type(s): Device
Intervention description(s): The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Incomplete Spinal Cord Injury; Rehabilitation; Upper Extremity; AMES device; Incomplete SCI; Quadriplegia
Heat Acclimation, Hand Cooling Efficacy, and Adaptation Maintenance.
Condition: Heat
Study type: Interventional

Summary: 
      This study had three aims:

        1. To determine the impact of consecutive days of exercise on thermoregulation and
           cardiovascular strain.

        2. To determine the efficacy of a hand cooling device to cool individuals throughout a heat
           acclimation period.

        3. To assess the maintenance of thermoregulatory and cardiovascular adaptations derived
           from heat acclimation during a 25-day intermittent exercise-heat exposure protocol.
    

Detailed description: 
      Participants completed 14 days of exercise heat acclimation in either a hot or cool
      environment, followed by a heat or cool exercise exposure every 5th day for 25 days.
      Cardiovascular, thermoregulatory, and perceptual strain were measured throughout exercise
      each day. Hydration assessment and stress response via blood biomarkers were measured before
      and after exercise. Aerobic capacity was measured before and after heat acclimation as well
      as after the intermittent exercise-heat exposure. Hand cooling was implemented periodically
      during exercise-heat stress visits to determine cooling efficacy before and after heat
      acclimation.
    

Intervention name(s): Heat acclimation; Exercise in a cool environment
Intervention type(s): Other; Other
Intervention description(s): 14 days of aerobic exercise in a hot environment; 14 days of aerobic exercise in a cool environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of a Vegan Diet Versus a Mediterranean Diet. Assessing Health Outcomes
Condition: Cardiometabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      This study aimed to evaluate the effect of a vegan diet (supplemented with vitamin B12) and
      an mediterranean diet on performance, cardiorespiratory fitness, metabolic health, immune
      status, and environmental impact in healthy adults.
    

Detailed description: 
      OMNIVEG is a controlled crossover trial. Initially, registered dietitians conducted an
      assessment of participants' lifestyles in a preliminary session. Qualified nutritionists then
      developed personalized diets for each participant in accordance with the recommendations of
      the International Society of Sports Nutrition (ISSN). These diets followed specific
      guidelines, including a daily intake of 3-5 g of carbohydrates per kilogram of body weight,
      1.4-2.0 g of protein per kilogram of body weight, and 0.5-1.5 g of fat per kilogram of body
      weight.

      Both the mediterranean diet and vegan diets prescribed to the participants were isocaloric,
      with similar distributions of macronutrients. The primary difference between the two
      interventions was the source of food: the vegan diet exclusively comprised plant-based foods,
      while the omnivorous diet included foods of both animal and plant sources. In the case of the
      omnivorous diet, 60% of the total protein intake was derived from animal sources (mainly from
      fish, white meat, low-fat dairy and eggs).

      As part of the vegan diet, participants were instructed to take 1000 µg of cyanocobalamin (a
      form of vitamin B12) twice a week from Harrison Sport Nutrition, Granada, Spain. This
      supplementation aimed to ensure adequate vitamin B12 intake, which is essential for
      individuals following a vegan diet.

      Throughout the study period, participants were advised to maintain their initial physical
      exercise frequency and volume to maintain consistency and avoid confounding variables. To
      ensure standardized measurements, all tests were conducted in the same laboratory, employing
      identical testing devices, and supervised by the same group of researchers. This approach
      aimed to minimize experimental variability and improve the reliability of the study's
      results.
    

Intervention name(s): Vegan diet; Mediterranean diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Normocaloric diet based solely on foods of plant sources.; Diet with a predominance of plant foods fruits, vegetables, whole grains, nuts and legumes); moderate to low consumption of fish, white meat, low-fat dairy and eggs; and very low consumption of red and processed meats, butter, full-fat dairy and sweets.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Plant-Based Diet; Environmental Impact; Cardiorespiratory Fitness; Performance; Metabolic Health; Mediterranean diet; Vegan diet
Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Recently, retrospective studies have shown that Down Syndrome children have a higher CO2
      (carbone dioxide) sleep pressure than the general pediatric population. This increase does
      not seem to be always related to sleep apnea. The Investigators wish to confirm these results
      prospectively. The investigators hypothesize that this alveolar hypoventilation may be due to
      ventilatory control disorders caused by dysautonomia, but also to a decrease in the strength
      of the respiratory muscles within the framework of the global muscular hypotonia described in
      children with Down syndrome. .
    

Detailed description: 
      47 Down syndrome patients age from 4 to 16 will be included. They will perform a medical
      visit at J0, then a measurement of gaz nocturnal exchanges at home within 1 month
    

Intervention name(s): Nocturnal gaz exchanges measurement
Intervention type(s): Other
Intervention description(s): Nocturnal gaz exchanges at patient's home BRIEF neuropsychological questionnaire VINELAND-II neuropsychological questionnaire Clinical OSA assessment Dysautonomia assessment
Intervention model: Single Group Assignment
Intervention model description: Down syndrome patients aged from 4 to 16 years
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Sleep Apnoa; Down Syndrome; Children; OSA
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg
      is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.
    


Intervention name(s): triazolam liquid oral drops; triazolam tablets
Intervention type(s): Drug; Drug
Intervention description(s): 0.25 mg single dose oral drops; 0.25 mg single oral dose
Intervention MeSH terms: Triazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence study; triazolam; liquid oral drops; tablet
Dynamic Measures of Neurochemistry in Mood Disorders
Condition: Depression
MeSH terms: Depression; Mood Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to understand changes in brain chemical signals when people take
      antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal
      fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought
      to be involved in depression. The study has potential to help understand and treat
      depression.
    

Detailed description: 
      The purpose of this study is to understand changes in brain chemical signals when people take
      antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal
      fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought
      to be involved in depression. The study has potential to help understand and treat
      depression.
    

Intervention name(s): sertraline; bupropion
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).; Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
Intervention MeSH terms: Bupropion; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; antidepressant; SSRI
Optimizing the Use of Entonox® During Screening Colonoscopy
Condition: Bowel Cancer Screening; Analgesia; Entonox; Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will randomise patients undergoing screening colonoscopy to receive Entonox either
      continuously or as required.

      Both these methods are used in the published studies of Entonox and in clinical practice.

      Null hypothesis There will be no difference in pain levels between these two methods of
      Entonox administration
    


Intervention name(s): Entonox
Intervention type(s): Drug
Intervention description(s): Entonox will be used according to the allocated method
Intervention MeSH terms: Entonox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bowel cancer screening; Analgesia; Entonox; Pain; Side effects; Colonoscopy
A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the influence of repeated oral doses of KW-6356 on
      the pharmacokinetics of index substrates for CYP3A4/5, CYP1A2 and BCRP.
    


Intervention name(s): Midazolam; Caffeine; Rosuvastatin; KW-6356
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.; In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.; In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.; In Period 2, Day 4-13(except Day11) a single dose of KW-6356 will be administered after breakfast, Day 11 a single dose of KW-6356 will be administered after fasting for at least 10 hours.
Intervention MeSH terms: Midazolam; Caffeine; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment