bioihbjkbjnl/mcl2 huggingface dataset:
Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Comparator: Modified Process Hepatitis B Vaccine; Comparator: Comparator: ENGERIX-B
Intervention description: Single dose 5 µg/0.5ml modified process hepatitis B vaccine; Single dose 10 µg/0.5ml ENGERIX-B
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1478.0
Sex: All
Minimum age: 4 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children
      who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary
      vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed
      hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in
      this study will be either an investigational Merck product (Modified Process Hepatitis B
      Vaccine) or licensed ENGERIX-B vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Children 4 to 8 years of age

          -  Complete medical records documenting receiving a previous hepatitis B vaccination
             during the first year of life (for Cohort A and B only)

          -  Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary
             series of ENGERIX-B (for Cohort A and B only)

        Exclusion Criteria:

          -  Birth mother known to be a carrier of hepatitis B virus (Cohort C only)

          -  History of previous hepatitis B vaccine

          -  History of vaccination with any hepatitis B vaccine (Cohort C only)

          -  Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg
             aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum
             immune globulin, or any other blood-derived product

          -  Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or
             planned within study period

          -  Impairment of immunologic function or recent use of immunomodulatory medications

          -  A Combination of different hepatitis B vaccines used in the primary vaccination series
             (Cohort A and B only)
13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
Condition: Pneumococcal Vaccines
Intervention: 13-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.; Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 42 Days
Maximum age: 70 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevenar 13; 13vPnC; Healthy Subjects

Summary:

      This study will compare the immune responses of the infants who have been given 13vPnC in the
      mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in
      the single-dose syringe formulation.

      It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all
      infants who are vaccinated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 42 to 70 days at enrollment.

          -  Determined by medical history, physical examination, and clinical judgment to be
             eligible for the study

          -  Weight of 3.5 kg or greater at the time of enrollment

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal vaccine.

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Contraindication to vaccination with pneumococcal conjugate vaccine.

          -  Receipt of blood products or gamma-globulin since birth
The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis
Condition: Inflammatory Bowel Disease; Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer
Intervention: UC Home Automated Telemanagement; Best Available Care
Intervention description: Weekly assessment with UC Home Automated Telemanagement; Routine follow up visits and as needed telephone calls and clinic visits, written action plans, educational fact sheets from the CCFA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Inflammatory bowel disease; Ulcerative colitis; Telemedicine; Telemanagement; Chronic disease

Summary:

      The purpose of this study is to determine if home automated telemanagement improves bowel
      symptoms, quality of life, compliance with medications, and health care utilization compared
      to best available care in patients with ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ulcerative colitis confirmed by standard clinical, endoscopic, and
             histologic criteria

        Exclusion Criteria:

          -  Inability to comply with the study protocol

          -  Previous colectomy with ileostomy or colectomy with ileoanal anastomosis

          -  History of colonic dysplasia or colorectal cancer

          -  Uncontrolled medical or psychiatric disease

          -  Unable or unwilling to provide consent

          -  Age less than 18 years

          -  Other forms of colitis
Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
Condition: Arthritis
MeSH terms: Arthritis
Intervention: Theraworx; Placebo
Intervention description: Theraworx foam applied to skin and/or compression wrap; Placebo foam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40,
      which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are
      both conservative and surgical with surgical options including osteotomy, bone excision,
      ligament reconstruction, and various prosthetic implants. The conservative treatment options,
      however, are limited to NSAIDs and bracing or steroid injections.

      Advances in topical therapies have the potential to deliver focused treatment to the CMC
      joint. Novel treatment of inflammation can potentially reduce inflammation and pain
      associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that
      has theoretical impact on inflammation reduction in human subjects treated with the topical
      foam.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Thumb CMC arthritis

          2. greater than or equal to age 18

          3. Interested in non-operative treatment of thumb arthritis

        Exclusion Criteria:

          1. Recent corticosteroid injection into the thumb joint

          2. Non-English speaking

          3. skin lesions or rashes on the thumb

          4. current use of topical anti-inflammatory medications

          5. concomitant thumb/wrist diagnoses that would impact the results (as determined by the
             PI)

          6. known allergy to magnesium
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Asenapine; Placebo
Intervention description: Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks; Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety
      and tolerability of asenapine in bipolar I disorder subjects who had not completely responded
      to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute
      manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008
      (NCT00145470). The safety comparison was between the group receiving lithium or VPA and
      placebo against the group receiving lithium or VPA and asenapine, with the caveat that all
      subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have bipolar I disorder (current episode manic or mixed), be treated with lithium or
             valproic acid, and have completed the a 12-week lead-in trial

        Exclusion Criteria:

          -  Have an unstable medical condition or clinically significant laboratory abnormality.

          -  Have a primary diagnosis other than bipolar I disorder.
Intensive Glycemic Control and Skeletal Health Study
Condition: Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus; Coronary Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Coronary Disease; Diabetes Mellitus; Hypercholesterolemia
Intervention: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents
Intervention description: type 2 diabetes treatments, per standard of care
Intervention MeSH terms: Hypoglycemic Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Enrollment: 7287.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Fracture; Falls; Height Loss

Summary:

      The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic
      control for type 2 diabetes (in ACCORD participants) on factors related to bone health,
      including, fractures, falls, and bone mineral density.
    

Eligibility criteria:

        Inclusion criteria:

          -  Fulfills criteria for inclusion in the ACCORD main trial

          -  Must have been randomized into the ACCORD study and be a participant from the five
             CCNs in the ACCORD-BONE ancillary study.

        Exclusion criteria:

          -  Fulfills criteria for exclusion in the ACCORD main trial
A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Folate; Methotrexate; Methylprednisolone; Placebo; Rituximab
Intervention description: A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.; A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.; Intravenous infusion; Placebo to rituximab intravenous infusion; Intravenous infusion
Intervention MeSH terms: Methylprednisolone; Rituximab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: RA; Rituxan; SERENE

Summary:

      This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid
      arthritis (RA).
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult patients 18-80 years of age.

          -  Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987
             American College of Rheumatology (ACR) criteria for the classification of rheumatoid
             arthritis.

          -  Receiving outpatient treatment for RA.

          -  Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68
             joint count) at screening and baseline.

          -  At screening, either

               -  C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or

               -  Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour.

          -  Inadequate response to methotrexate, having received and tolerated at a dose of 10-25
             mg/week it for ≥ 12 weeks.

        Exclusion criteria:

          -  Rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA.

          -  Inflammatory joint disease other than RA, or other systemic autoimmune disorder.

          -  Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16.

          -  Surgery within 12 weeks of study or planned within 24 weeks of randomization.

          -  Previous treatment with any approved or investigational biological agent for RA, an
             anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.
SpaceOAR System Pivotal Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: SpaceOAR System
Intervention description: Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 222.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; Spacer

Summary:

      Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum
      and prostate in men undergoing radiation therapy (IG-IMRT)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects greater than 18 years old

          -  Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate
             and must be planning to undergo IMRT

          -  Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6
             months of the baseline/screening visit with Gleason Score less than or equal to 7

          -  Subjects Screening/Baseline laboratory testing must meet the following laboratory
             value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum
             creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of
             institution normal, and serum bilirubin less than 2.0 mg/dl

          -  Subject or authorized representative, has been informed of the nature of the study and
             has provided written informed consent, approved by the appropriate Institutional
             Review Board (IRB) of the respective clinical site

        Exclusion Criteria:

          -  Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline
             visit

          -  Subjects with extracapsular extension of the prostate cancer, with greater than 50% of
             the number of biopsy cores positive for cancer, metastatic disease, other ongoing
             cancers which will be treated during the study, or subjects for whom pelvic lymph node
             radiotherapy is planned

          -  Subjects with any prior invasive malignancy (except non-melanomatous skin cancer)
             unless the subject has been disease free for a minimum of 5 years.

          -  Subjects who are indicated for androgen deprivation therapy or who have been treated
             with androgen therapy within the prior 3 months.
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Intervention: Amoxicillin; Benzyl penicillin
Intervention description: Oral 45mg/kg 12 hourly; Intravenous 50,000IU/kg 6 hourly
Intervention MeSH terms: Amoxicillin; Penicillins; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 561.0
Sex: All
Minimum age: 2 Months
Maximum age: 59 Months
Healthy volunteers: No
Keywords: Severe pneumonia

Summary:

      This study seeks to determine whether clinical outcome following initial treatment of severe
      pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin.
      The study will also provide an estimate of the proportion of Kenyan children with severe
      pneumonia who fail treatment with a single antibiotic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical signs of WHO-defined severe pneumonia

          -  Age 2 months to 59 months

        Exclusion Criteria:

          -  Clinical signs of WHO-defined very severe pneumonia

          -  Clinical or laboratory diagnosis of meningitis

          -  Clinical diagnosis of severe malnutrition (marasmus/kwashiorkor)

          -  Clinical or laboratory diagnosis of severe anaemia requiring transfusion

          -  HIV-exposure on rapid HIV antibody test (only observational data will be collected
             from these patients)

          -  Elimination of signs of severe pneumonia in a child with wheeze after outpatient
             bronchodilator therapy

          -  Chronic condition that may underlie or contribute to a presentation with respiratory
             distress such as: known chronic renal or cardiac disease, presence of cerebral palsy
             predisposing child to aspiration/hypostatic pneumonia

          -  Established bronchiectasis or congenital abnormality of the lower respiratory tract

          -  Upper airway obstruction producing stridor

          -  Admission from outpatient clinic specifically for treatment of TB

          -  Referral from another inpatient facility following treatment with injectable
             antibiotics for more than 24 hours or because the initial regimen is considered to
             have failed

          -  Documented history of >48hours treatment with oral amoxicillin

          -  Failure to obtain informed consent

          -  Penicillin allergy
Vitamin D and Omega-3 Trial (VITAL)
Condition: Cancer; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: vitamin D3; omega-3 fatty acids (fish oil); Vitamin D3 placebo; Fish oil placebo
Intervention description: Vitamin D3 (cholecalciferol), 2000 IU per day.; Omacor, one 1-gram capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).; Vitamin D placebo; Fish oil placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25871.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vitamin D3; omega-3 fatty acids; fish oil; cardiovascular disease; cancer; primary prevention

Summary:

      The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and
      women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or
      omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart
      disease, and stroke in people who do not have a prior history of these illnesses. The 5-year
      intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention
      observational follow-up of study participants is ongoing.
    

Eligibility criteria:

        To be eligible for the study, respondents had to, at study entry,:

          1. be men aged 50 or older or women aged 55 or older;

          2. have no history of cancer (except non-melanoma skin cancer), heart attack, stroke,
             transient ischemic attack, angina pectoris, coronary-artery bypass grafting, or
             percutaneous coronary intervention;

          3. have none of the following safety exclusions: history of renal failure or dialysis,
             hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or
             sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or
             granulomatosis with polyangiitis (Wegener's);

          4. have no allergy to fish or soy;

          5. have no other serious illness that would preclude participation;

          6. be consuming no more than 800 IU of vitamin D from all supplemental sources combined
             (individual vitamin D supplements, calcium+vitamin D supplements, medications with
             vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to
             decrease or forego such use during the trial;

          7. be consuming no more than 1200 mg/d of calcium from all supplemental sources combined,
             or, if taking, willing to decrease or forego such use during the trial;

          8. not be taking fish oil supplements, or, if taking, willing to forego their use during
             the trial