bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Gastric Bypass on the Absorption of Metformin
Condition: Obesity; Gastric Bypass
MeSH terms: Obesity
Study type: Observational

Summary: 
      Background: Gastric bypass is the most commonly performed type of bariatric (obesity)
      surgery, has dramatically increased in popularity and is now considered to be preferred
      treatments in severely obese patients that fail non-surgical therapy - particularly in
      patients with type 2 diabetes. Drug malabsorption is a potential concern post-gastric bypass
      because intestinal length is reduced.

      Purpose: The purpose of this controlled, pharmacokinetic study is to determine whether the
      absorption of a single dose of metformin, the first line drug treatment in patients with type
      2 diabetes, is significantly reduced after gastric bypass.

      Methods: A single dose of standard release metformin 1000 mg will be administered to patients
      who have undergone gastric bypass and to patients who have not received surgery but are on
      the wait list (wait-listed controls). Blood sampling and urine sampling will occur in
      standardized fashion over the ensuing 24 hours to measure and compare the absorption of
      metformin between study arms. 34 patients total will be recruited.

      Significance: Following completion of this study, we will better understand how gastric
      bypass affects metformin absorption. Ultimately, this information will help to ensure that
      this patient population is receiving optimal doses of this important drug treatment.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Post gastric bypass and obese controls

          1. Male and Female

          2. 18 - 60 years old

          3. ≥ 3 months post-RYGB surgery or wait listed for bariatric surgery

          4. Able to provide written informed consent.
      
Keywords: obesity; gastric bypass; metformin; pharmacokinetics; absorption
Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine efficacy of preoperative IV dexamethasone for postoperative pain control after
      TKA.
    

Detailed description: 
      Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary
      TKA.
    

Intervention name(s): Dexamethasone; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes; NSS 50 mL IV slowly push over 5 minutes
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; pain control; dexamethasone; steroids
The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of AXERT when treating
      a migraine at the onset of headache pain, as compared to treating a migraine only after the
      headache pain has reached at least moderate intensity..
    

Detailed description: 
      AXERT has been approved by the FDA for the treatment of migraine headache with or without
      aura in adults. Early treatment of a migraine headache, independent of headache pain
      intensity symptoms, may provide the optimal therapeutic response. This is a multi-center,
      open label study to test the efficacy (effectiveness) and tolerability of AXERT when treating
      a migraine at the onset of headache pain versus treating a migraine only after the headache
      pain has reached at least moderate intensity. Patients will self-administer 12.5 milligrams
      of AXERT for the treatment of 2 migraine headaches. Centers will be randomly assigned to 1 of
      2 treatment interventions in which patients will sequentially treat both migraine headaches
      with 12.5 milligrams of AXERT using either the early treatment regimen (ET; ie, at the onset
      of pain) or conditional treatment regimen (CT; ie, after the headache has reached at least
      moderate intensity). Data will be collected regarding treatment response during and after
      each migraine headache. For each headache, patients will record study information and data
      during 3 telephone calls using Interactive Voice Response System (IVRS) technology. It is
      expected that patients who take 12.5 milligrams of AXERT at the first sign of pain of any
      intensity due to a migraine headache will experience an overall shorter duration of their
      migraine than patients who take AXERT 12.5 mg when their migraine pain has reached at least
      moderate pain intensity. In addition, it is expected that almotriptan malate (AXERT®) is
      generally well-tolerated.

      AXERT 12.5 milligram tablet orally either at the onset of migraine pain (within 1 hour of the
      start of a migraine-ET regimen) or when migraine pain reaches at least moderate intensity (CT
      regimen).
    

Intervention name(s): almotriptan malate
Intervention type(s): Drug
Intervention MeSH terms: Almotriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human
      rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately
      6-12 weeks at the time of first vaccination.
    


Intervention name(s): Rotarix ™; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two oral doses; Two oral doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gastroenteritis
The Effect of Fructose on Blood Fats in Dialysis Patients and Healthy Volunteers
Condition: End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      This study will evaluate how a common dietary sugar (fructose) raises blood fats
      (triglycerides). We will determine whether the production of fat from fructose is higher in
      dialysis patients compared to healthy volunteers. Dialysis patients have high levels of
      hormone-like substances called cytokines that may increase blood fats. The results will help
      set better guidelines for diets for the general population and patients with kidney disease
      who are at high risk for heart attack and stroke.

      There will be one or two outpatient screening visit(s) and a one-week (6 nights) stay at the
      Rockefeller University Hospital.
    

Detailed description: 
      Fifteen hemodialysis patients and 15 healthy volunteers will be studied.

      Outpatient screening visit(s): consent, fasting blood and urine analysis, a physical exam, an
      EKG and a 2-hour oral glucose tolerance test to screen for diabetes.

      Inpatient admission:

        -  Standardized diet that follows the guidelines for hemodialysis patients and healthy
           volunteers to maintain a stable weight.

        -  Blood and urine sampling. The total amount of blood drawn is less than 1 cup.

        -  To measure the production of fat from fructose, a trace amount of a non-radioactive
           labeled precursor of fat (13C-acetate) will be infused through a venous catheter for 22
           hours.

      At the end of the infusion, a sweet drink (fructose in 1 ounce of water) will be given orally
      every half hour for 6 hours.

      • Two small samples of fat taken right below the skin will be obtained after injection of a
      small amount of numbing medicine into the abdominal and gluteal regions.

      Dialysis patients will receive their usual dialysis at The Rogosin Institute Manhattan,
      Brooklyn or Queens Dialysis Units.
    

Intervention name(s): oral fructose and high fat diet
Intervention type(s): Procedure
Intervention description(s): High fat diet: The composition will be: 35% of energy as fat, 50% carbohydrate, 15% protein (~1.3 g/kg), sat:mono:poly 1:3:1, cholesterol 200 mg/d, 30% starch,15% sugar, 3% fructose, and 25 gm fiber/d. This relatively high fat diet, which falls within the recommendations by the National Kidney Foundation for hemodialysis patients, will suppress fatty acid synthesis in normal volunteers.
Fructose in 360 ml water will be orally administered as 1.4 g/kg (~100 g or 400 kcal for a 70 kg person), divided into 30 mL (1 ounce) doses given every 1/2h for 6 hours.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fructose; Lipogenesis; Triglycerides; Dialysis
The Effects of Using an Interactive Game With Virtual Reality for Children During Intravenous Placement
Condition: Pian; Fear
Study type: Interventional

Summary: 
      To develop the intervention strategies of hospitalized school-age children with IV placement,
      using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to
      further examine the effectiveness of reducing IV pain and fear.
    


Intervention name(s): Virtual reality; Photo book
Intervention type(s): Device; Device
Intervention description(s): To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.; To develop the intervention strategies of hospitalized school-age children with IV placement, using Photo book to further examine the effectiveness of reducing IV pain and fear.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Therapeutic play,virtual reality, intravenous placement, school-age, pain, fear
Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia
Condition: Diabetes, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with
      MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison
      sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1
      diabetic adults with an increased risk of hypoglycemia.

      The study should show:

        -  A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a
           reduction in the time spent in hypoglycemia six months in any group compared to
           Baseline.

        -  A complete prevention of severe and not severe hypoglycemia in the pump group Minimed
           640G + Enlite sensor with SmartGuard activation
    


Intervention name(s): Minimed 640G with smartguard activated; Minimed 640G with smartguard off
Intervention type(s): Device; Device
Intervention description(s): Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation; Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation
Other intervention name(s): Minimed 640G insulin Pump with Smartguard activation; Minimed 640G insulin Pump without activated Smartguard
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes, Type 1; Hypoglycemia; Insulin Infusion Systems
Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and tolerability of aripiprazole to
      olanzapine over 26 weeks for the treatment of schizophrenia
    


Intervention name(s): Aripiprazole; Olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 15-30 mg, once daily, 140 weeks; Capsule, Oral, 10-20 mg, once daily, 140 weeks
Other intervention name(s): Abilify
Intervention MeSH terms: Olanzapine; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy Subjects
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is the first-in-human study of BBT-877. The purpose of this phase 1 study
      is to assess the safety and tolerability of single and multiple ascending oral doses of
      BBT-877 in healthy adult subjects.
    


Intervention name(s): BBT-877, Single dose; Placebo group; BBT-877, Multiple doses
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of BBT-877, 5 dose levels, oral capsule; Placebo matched to BBT-877, oral capsule; Multiple doses of BBT-877, 14 days, 8 dose levels, oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autotaxin
Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.
Condition: Periapical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      To compare the dental survival in a period of one year of mature permanent teeth with apical
      lesion following the administration of encapsulated Mesenchymal Stem Cells under a
      regenerative endodontic procedure and a conventional root canal treatment.
    

Detailed description: 
      This is a controlled clinical trial designed to evaluate the survival of mature permanent
      teeth with apical lesion treated with regenerative endodontic procedure (REP) based on
      encapsulated Mesenchymal Stem Cells in a biological scaffold. The REP will be compared to the
      conventional endodontic therapy. The REP is based on the use of umbilical cord-derived
      mesenchymal stem cells encapsulated in a plasma-derived biomaterial . The study group will
      use the disinfection protocol, indicated in the clinical considerations for regenerative
      procedures as recommended by the American Association of Endodontics, using a paste of
      calcium hydroxide prepared with double-distilled water as intracanal medication, and will be
      operated with REP using allogeneic stem cells in a scaffold, while the control group will be
      operated with conventional endodontic therapy alone. This clinical trial pretends to
      determine the dental survival of the tooth with mature apex and apical lesion, over a period
      of one year.
    

Intervention name(s): Regenerative Endodontic Procedure; Conventional Root Canal Treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.; Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.
Other intervention name(s): REP; Tissue engineering procedure; Gold standard treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 interventions:
Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Endodontic treatment with inert product gutapercha.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mesenchymal stem cells; regenerative procedures; tissue engineering; regenerative endodontic; scaffold; cell encapsulation; dental pulp; pulp regeneration; plasma-derived biomaterial; allogenic stem cells; mesenchymal stromal cells; adult stem cells; umbilical cord stem cells
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
Condition: Cardiac Patients; ECG Monitoring
MeSH terms: Tissue Adhesions
Study type: Observational

Summary: 
      The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can
      serve the same purpose as standard monitoring systems. The new 7day patch is significantly
      smaller and lighter than previous ECG recorders.
    

Detailed description: 
      The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG
      Patch heart monitor after 7 full days of wear, establishing that the device is safe and
      effective to wear for up to 7 days.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        cardiac patients followed at the study site's location
Dose Comparison Study of Menactra® in US Children
Condition: Meningitis; Meningococcal Infection; Neisseria Meningitidis
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the potential benefit of the administration of Menactra vaccine as a two-dose
      regimen to children.

      Primary Objective:

      To assess, by age group, the immune response to Menactra vaccine after each vaccine
      injection.
    

Detailed description: 
      This is an open-label trial designed to explore the immune response to a two-dose schedule of
      Menactra vaccine compared with a standard one-dose schedule in children.
    

Intervention name(s): Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate; Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, 2 doses Intramuscular; 0.5 mL, 2 doses Intramuscular; 0.5 mL, 1 dose Intramuscular
Other intervention name(s): Menactra®; Menactra®; Menactra®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal infection, Neisseria meningitidis
Effect of a Physical-activity-promoting Environment on Motor Skills, Physical Activity and Quality of Life of Children in Childcare Settings
Condition: Obesity; Inactivity
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of a project promoting unstructured
      spontaneous physical activity (PA) through an adaptation of the built environment and the
      provision of a supportive social environment of childcare centers on motor skills, physical
      activity, desire to move around, body mass index (BMI), quality of life and PA and behavior
      of the family.
    

Detailed description: 
      The study will last one school year and includes 58 childcare centers in 3 provinces (JU, NE,
      VD) of the French part of Switzerland.
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Promoting unstructured spontaneous physical in childcare through an adaptation of the built environment and the provision of a supportive social environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Childhood obesity; Children; Inactivity; Physical activity; Motor skills; Motor fitness; Quality of life; Nutrition; Family
Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without
      water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under
      fasted conditions.
    


Intervention name(s): Viagra; sildenafil ODT; sildenafil ODT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg tablet on Day 1 of each period; 50 mg tablet on Day 1 of each period; 50 mg tablet on Day 1 of each period
Other intervention name(s): sildenafil citrate
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Viagra; ODT; bioquivalence
Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and tolerability of multiple intravenously
      administered doses of PD 0360324 in patients with rheumatoid arthritis receiving
      methotrexate.
    


Intervention name(s): PD 0360324; PD 0360324; PD 0360324; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 doses of PD 0360324 (Dose level 1) administered over 12 weeks; 3 doses of PD 0360324 (Dose level 2) administered over 12 weeks; 3 doses of PD 0360324 (Dose level 3) administered over 12 weeks; 3 doses of Placebo administered over 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.
    


Intervention name(s): Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR); placebo in addition to the standard treatment
Intervention type(s): Combination Product; Combination Product
Intervention description(s): 120 mg leaf extract , twice daily in addition to Diclofenac 100 mg Once daily + paracetamol 1g Twice daily; placebo in addition to the standard treatment
Other intervention name(s): Ginko Natrol company + Dolipran+Olfen 100 SR
Intervention MeSH terms: Acetaminophen; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment