bioihbjkbjnl/mcl2 huggingface dataset:
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Rabeprazole ER; Ranitidine
Intervention description: 50 mg capsule, taken orally, once daily for 26 weeks.; 150 mg capsule, taken orally, twice daily for 26 weeks.
Intervention MeSH terms: Rabeprazole; Ranitidine; Ranitidine bismuth citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Gastroesophageal; Reflux; Disease; GERD

Summary:

      The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50
      mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing
      in subjects with healed erosive gastroesophageal reflux disease (eGERD).
    

Eligibility criteria:

        Inclusion Criteria:

        1. Prior completion of Study E3810-G000-301 or -303. Subjects will need to have healed
        erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and
        sustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-301 or -303.

        Exclusion Criteria:

          1. Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).

          2. Barrett's esophagus or esophageal stricture.

          3. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine
             receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs
             with significant anticholinergic effects throughout the study.

          4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs),
             oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).

          5. Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic,
             psychiatric, or cardiovascular system abnormalities that would be likely to interfere
             with the conduct of the study, the interpretation of study results, or the health of
             the subject during the study.

          6. Any condition that would make the subject, in the opinion of the investigator or
             sponsor, unsuitable for the study.
Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: tozadenant; placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Motor fluctuations; Off time; On time; Dyskinesia

Summary:

      Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,
      parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient understands study requirements and has given his/her written informed consent
             on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved
             consent form.

          -  Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain
             Bank Diagnostic criteria

          -  Minimum of 3 years since diagnosis.

          -  Meet Hoehn and Yahr PD stage

          -  Good response to levodopa

          -  Stable regimen of anti-PD medications

          -  Patients must have been taking a levodopa-containing anti-PD medication continuously
             for at least the previous 12 months

          -  Patient has documented a minimum amount of Off time.

          -  If of childbearing potential (male and female) must use an acceptable method of
             contraception

        Exclusion Criteria:

          -  Previous tozadenant study participation

          -  Current or recent participation in another study.

          -  Secondary or atypical parkinsonism

          -  Neurosurgical intervention for PD

          -  Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®

          -  Treatment with excluded medications

          -  Untreated or uncontrolled hyperthyroidism or hypothyroidism

          -  Clinically significant out-of-range laboratory

          -  MMSE out of range

          -  Current episode of major depression (stable treatment for depression is permitted).

          -  Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide
             Severity Rating Scale (C-SSRS)

          -  Women lactating or pregnant

          -  Hypersensitivity to any components of tozadenant or excipients

          -  Abnormal findings on the physical or neurological examination, or medical history that
             would make the patient unsuitable for the study

          -  History of hepatitis or cholangitis
Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections
Intervention: GSK1024805A; Prevenar; Infanrix hexa; Havrix; Varilrix
Intervention description: No vaccination in this trial; No vaccination in this trial; No vaccination in this trial; No vaccination in this trial; No vaccination in this trial
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 524.0
Sex: All
Minimum age: 28 Months
Maximum age: 32 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus pneumoniae; Haemophilus influenzae; Pneumococcal conjugate vaccine; Antibody persistence

Summary:

      This protocol posting deals with objectives & outcome measures of the extension phase up to
      48-50 months post booster vaccination, to assess long-term antibody persistence in children
      at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal
      conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a
      separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in
      order to comply with the FDA AA (Sep 2007).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between, and including, 28-30 months of age at the time of first blood
             sampling.

          -  Subjects who previously participated in the 105553 and 107046 studies and who received
             a full four dose regimen of pneumococcal conjugate vaccine during the primary and
             booster studies.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  Written informed consent, covering visits 1, 2 and 3, obtained from the parent or
             guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        Exclusion Criteria:

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within 6
             months prior to the blood sampling

          -  Administration of any additional pneumococcal vaccine since end of 107046 study.

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the blood sampling.

          -  Administration of immunoglobulins and/or any blood products less than 6 months prior
             to blood sampling.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition since the
             end of the 107046 study, based on medical history and physical examination.
A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Glucagon Nasal Powder; Glucagon Hydrochloride Solution
Intervention description: Administered intranasally; Administered IM
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of nasal glucagon compared
      to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese
      participants with diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)

          -  Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or
             18.5 to 35.0 kg/m2 for T2D

          -  Hemoglobin A1c (HbA1c) ≤10%

        Exclusion Criteria:

          -  Have significant changes in insulin regimen and/ or unstable blood sugar control
             within the past 3 month

          -  Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)
A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 438.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; ixekizumab; skin condition; skin disease; itching; psoriasis vulgaris; immune-mediated systemic disease; skin lesions; scaly patches; papules

Summary:

      The purpose of this study is to determine the efficacy and safety of the study drug
      ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris
             for at least 6 months prior to baseline.

          -  Have ≥10% BSA involvement at screening and baseline.

          -  Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline.

          -  Are candidates for phototherapy and/or systemic therapy.

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic
             and/or guttate psoriasis) at screening or baseline.

          -  Drug-induced psoriasis.

          -  Ongoing use of prohibited treatments.

          -  Have previously completed or withdrawn from this study, or have previously exposed to
             ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such
             as secukinumab) or the IL-17 receptor.

          -  Have concurrent or recent use of any biologic agent within washout periods or <5
             half-lives prior to baseline, whichever is longer.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test.
Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: voxelotor; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: This study is a double-blind study.
Enrollment: 449.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor
      Administered Orally to Patients With Sickle Cell Disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female study participants with sickle cell disease

          2. Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12
             months.

          3. Age 12 to 65 years

          4. Hemoglobin (Hb) ≥5.5 and ≤10.5 g/dL during screening

          5. For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at
             least 3 months prior to signing the ICF.

        Exclusion Criteria:

          1. More than 10 VOCs within the past 12 months that required a hospital, emergency room
             or clinic visit

          2. Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also
             termed chronic, prophylactic, or preventive transfusion) or have received a RBC
             transfusion for any reason within 60 days of signing the ICF

          3. Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of
             signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to
             signing the ICF)

          4. Hepatic dysfunction characterized by alanine aminotransferase (ALT) >4 × upper limit
             of normal

          5. Severe renal dysfunction (estimated glomerular filtration rate at the Screening visit;
             calculated by the central laboratory) <30 mL/min/1.73 m^2 or on chronic dialysis
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Investigational Medical Product (IMP) administered in parent study
Intervention description: IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A4091064 is a multicenter, long-term observational study of subjects from tanezumab
      interventional studies (regardless of treatment group) who undergo a total knee, hip or
      shoulder replacement during participation in the study. The study is designed with a total
      duration of subject follow-up of 24 weeks after the total joint replacement surgery. There
      will be two methods of data collection utilized in this study: interview by site staff via
      the telephone and interactive web-response system (or paper if the subject has no access to
      the internet).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Personally signed and dated informed consent document.

          -  Randomized and treated with subcutaneous investigational product in a tanezumab study
             and has completed the study or been withdrawn from the study.

          -  Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab
             study.

          -  Willing and able to comply with scheduled visits and other study procedures.

        Exclusion Criteria:

        - None.
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Condition: Partial Onset Seizures
MeSH terms: Seizures
Intervention: Pregabalin Dose Level 1; Pregabalin Dose Level 2; Placebo
Intervention description: Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase; Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase; Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 175.0
Sex: All
Minimum age: 1 Month
Maximum age: 3 Years
Healthy volunteers: No
Keywords: Partial Onset Seizures; Epilepsy; Safety; Efficacy; Tolerability; Pregabalin; Lyrica; Adjunctive treatment; Placebo controlled; blinded; Eligibility Criteria

Summary:

      This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce
      seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with
      refractory partial onset seizures. It is hypothesized that both doses of pregabalin will
      demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure
      frequency and that pregabalin will be safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have 3 partial onset seizures in the month prior to screening.

          -  Subject must have 2 partial onset seizures during the 48 hour baseline phase.

          -  Signed Informed Consent.

          -  On 1-3 stable anti-epileptic drugs at screening.

        Exclusion Criteria:

          -  Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile
             seizures, and infantile spasms.

          -  Lennox-Gasteau, BECTS, and Dravet's syndrome.

          -  Status epliepticus within 1 year of screening.

          -  Any change in AED regimen with 7 days of screening.

          -  Progressive structural central nervous system (CNS) lesion or a progressive
             encephalopathy.

          -  Progressive errors of metabolism.
Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)
Condition: Thrombosis, Venous
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Fondaparinux
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 114.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Fondaparinux; Hip Replacement Arthroplasty; VTE; THR; MOSLL; pentasaccharide; Xa factor

Summary:

      This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing either an elective primary THR (total hip replacement) surgery or
             a revision of a THR.

        Exclusion Criteria:

          -  Active, clinically significant bleeding (excluding drainage).
Glutamate for Metabolic Intervention in Coronary Surgery
Condition: Coronary Artery Bypass; Myocardial Ischemia; Myocardial Infarction; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction; Ischemia
Intervention: Intravenous infusion of saline; Intravenous glutamate infusion
Intervention description: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.; Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 865.0
Sex: All
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass; Myocardial Protection; Angina, Unstable; Myocardial Ischemia; Myocardial Infarction; Unstable Coronary Artery Disease; Glutamate

Summary:

      The main purpose of this study is to determine whether intravenous glutamate infusion given
      in association with surgery for unstable coronary artery disease can protect the heart from
      myocardial injury, postoperative heart failure and death.
    

Eligibility criteria:

        Inclusion Criteria:

          -  surgery for unstable coronary artery disease (unstable angina, non-STEMI)

          -  accepted for surgery < 2 weeks after STEMI

          -  coronary surgery for indications above performed with or without cardiopulmonary
             bypass

          -  coronary surgery for indications above with or without simultaneous valve procedure

        Exclusion Criteria:

          -  informed consent not possible because of critical condition or other reason

          -  preoperative use of inotropes or mechanical circulatory assist

          -  preoperative dialysis

          -  redo-procedure

          -  unexpected intraoperative finding / event that increased the dignity of the procedure
             to overshadow the originally planned operation

          -  body weight > 125 kg

          -  food allergy known to have caused flush, rash or asthma