bioihbjkbjnl/mcl2 huggingface dataset:
Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Divalproex Sodium; risperidone
Intervention description: Divalproex sodium is a mood stabilizer; Risperidone is a second generation antipsychotic and antimanic drug
Intervention MeSH terms: Valproic Acid; Anticonvulsants; Risperidone; Antipsychotic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 10 Years
Maximum age: 20 Years
Healthy volunteers: No

Summary:

      The study is to examine the null hypothesis that risperidone and divalproex sodium are
      equally effective in treating/stabilizing pediatric bipolar disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with Bipolar Disorder

          -  Must be able to swallow tablets

        Exclusion Criteria:

          -  Children with general medical condition such as head injury, epilepsy, endocrine
             disorders

          -  Those who are on mood altering medications such as steroids, and those diagnosed with
             mental retardation are excluded to avoid confounding and contributing factors to mood
             swings.

          -  If we discover during the interview that the parent and/or child does not understand
             the consent/assent procedures, we will exclude them.

        We expect only a small number of children to be excluded from the study due to exclusionary
        criteria. Selection of the subjects is not based on sex, race, or ethnic group.
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
Condition: Renal Transplantation
Intervention: Sirolimus; tacrolimus; Cyclosporine A
Intervention description: Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
Intervention MeSH terms: Cyclosporine; Sirolimus; Tacrolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 830.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Renal; Allograft; Recipients

Summary:

      The purpose of this study is to determine the effect of conversion from calcineurin inhibitor
      to sirolimus based therapy on renal function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 13 years.

          -  Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks
             thereafter

          -  Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20
             mL/min, within 2 weeks before randomization

        Exclusion Criteria:

          -  Biopsy-confirmed acute rejection within 12 weeks before randomization, that was
             determined to require antirejection treatment

          -  Patients in whom kidney-pancreas or other multiple organ transplants have been
             performed
Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
Condition: Coronary Computed Tomographic Angiography
Intervention: Isovue 370; Visipaque 320
Intervention description: Isovue 370 is a contrast agent with increased iodine concentration.; Visipaque 320 is standard protocol.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coronary computed tomographic angiography; contrast

Summary:

      Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in
      the body as an alternative to directly injecting contrast into the vessels and taking
      pictures. Different types of intravenous (into the vein, IV) contrast are available to fill
      the vessels and make them easier to see. The purpose of the study is to determine the best
      type of contrast for this scan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients who are referred for coronary CTA for suspected or known coronary
             artery disease

        Exclusion Criteria:

          -  creatinine greater than 2.0

          -  allergy to contrast media

          -  patients under the age of 18

          -  women who are pregnant or breast feeding

          -  patients with cardiac arrhythmia will also be excluded
16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
Condition: Anklyosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab (75 mg); Placebo; Secukinumab (150 mg)
Intervention description: Secukinumab 75 mg s.c.; Placebo; Secukinumab 150 mg s.c.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing spondylitis; AS; Chronic inflammatory disease; Inflammatory back pain; Secukinumab; Prefilled syringe; PFS; Subcutaneous injection; AIN457; AIN457F; AIN457F2310; adult

Summary:

      This study assessed the efficacy and safety of secukinumab in patients with active ankylosing
      spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or
      TNFα inhibitor
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female patients

          -  Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray)
             fulfilling the Modified New York criteria for AS (1984)

          -  Patients should have been on NSAIDs with an inadequate response

          -  Patients who were regularly taking NSAIDs as part of their AS therapy are required to
             be on a stable dose

          -  Patients who had been on an anti-TNFα agent (not more than one) must have experienced
             an inadequate response

        Exclusion Criteria:

          -  Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process

          -  Patients with total ankylosis of the spine

          -  Patients previously treated with any biological immunomodulating agents except for
             those targeting TNFα

          -  Previous treatment with any cell-depleting therapies
A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; Ocrelizumab; Placebo
Intervention description: Oral repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Methotrexate; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 613.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FILM; RA; anti-CD20; CD20

Summary:

      This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in
      combination with methotrexate in patients with active rheumatoid arthritis who are naive to
      methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or
      ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be
      administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5
      mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and
      the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age ≥ 18

          -  Rheumatoid arthritis for 3 months-5 years

          -  Naive to methotrexate

          -  If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to
             baseline

        Exclusion criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease other than RA

          -  Prior receipt of any biologic therapy for RA

          -  Concurrent treatment with any DMARD
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex; Proellex
Intervention description: 2, 25 mg capsules once per day; 1, 25 mg capsule once per day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Uterine Fibroids

Summary:

      Safety and efficacy study of 25 and 50 mg doses of Proellex
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 1 uterine fibroid must be identifiable and measurable by Transvaginal
             Ultrasound (TVU)

          -  Subject has a menstrual cycle lasting from 20 to 40 days.

          -  Subject must have satisfactorily completed all study visits from the previous study in
             which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

        Exclusion Criteria:

          -  Subjects who have not participated in 1 of the previous Repros studies: ZPU-301,
             ZPU-302, ZPU-303, or ZPU-304.

          -  Subjects who met treatment stopping rules as per the DILI Guidance requirements while
             participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol; Placebo
Intervention description: Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/mL
Route of Administration: Subcutaneous use; Active Substance: Placebo
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 0.9 % saline
Route of Administration: Subcutaneous use
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia; Psoriasis

Summary:

      The purpose of this study is to investigate the efficacy and safety of two dose levels of
      certolizumab pegol in adults with moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided informed consent

          -  Adult men or women >= 18 years

          -  Chronic plaque psoriasis for at least 6 months

          -  Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and
             Physician's Global Assessments score >= 3

          -  Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Erythrodermic, guttate, generalized pustular form of psoriasis

          -  History of current, chronic, or recurrent infections of viral, bacterial, or fungal
             origin as described in the protocol

          -  Congestive heart failure

          -  History of a lymphoproliferative disorder including lymphoma or current signs and
             symptoms suggestive of lymphoproliferative disease

          -  Concurrent malignancy or a history of malignancy as described in the protocol

          -  History of, or suspected, demyelinating disease of the central nervous system (e.g.,
             multiple sclerosis or optic neuritis)

          -  Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
             study or within 3 months following last dose of study drug. Male subjects who are
             planning a partner pregnancy during the study or within 10 weeks following the last
             dose

          -  Any other condition which, in the Investigator's judgment, would make the subject
             unsuitable for participation in the study

          -  Other protocol-defined exclusion criteria may apply
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
Condition: Vaccines, Pneumococcal
Intervention: 13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine
Intervention description: 1 dose at 2,4,6 and 15 months of age; 1 dose at 2,4,6 and 15 months of age
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 449.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine paediatric vaccinations in Spain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month-old infants

          -  Available for the entire study period

        Exclusion criteria:

          -  Previous vaccination with any vaccine before the start of the study

          -  Known contraindication to vaccination
China Registration Study in Patients With Skin Infections
Condition: Skin Diseases; Infectious
MeSH terms: Skin Diseases
Intervention: Daptomycin; Vancomycin
Intervention description: 4mg/kg IV ; Q 24 hr (once every 24 hours); Vancomycin - 1g per 12 hrs, for 7-14 days
Or switch to
Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin:
- 1 g every 6 hours or 2 g every 8 hours
Intervention MeSH terms: Vancomycin; Daptomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Skin Infections; Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens

Summary:

      The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin
      (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by
      Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated
      Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of inform consent

          -  A diagnosis of of complicated skin and skin structure infection known or suspected to
             be due to Gram-positive bacteria

          -  Diagnosis of bacterial skin and skin structure infection in the presence of some
             complicating factor, including infections involving deeper soft tissue or requiring
             surgical intervention, a pre-existing lesion or underlying condition affect healing

        Exclusion Criteria:

          -  Subjects known to have any bloodstream infection (including bloodstream infection
             caused by S. aureus). Subjects whose baseline blood cultures are positive for any
             clinically pathogenic organism ( including S. aureus ) should be discontinued from
             study

          -  Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess,
             Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites,
             Infected burn wounds of a large area,

          -  Conditions requiring surgery that in and of itself would cure the infection or remove
             the infected site (eg, amputation)

          -  Conditions requiring emergent surgical intervention at the site of infection (eg,
             progressive necrotizing infections)
Efficacy Study of Travoprost APS Versus TRAVATAN
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution; Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
Intervention description: One drop once daily in the evening for 3 months; One drop once daily in the evening for 3 months
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OAG; OHT

Summary:

      A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to
      TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older, either gender and any race.

          -  Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).

          -  Not currently on any IOP-lowering medication or currently on a stable treatment (i.e,
             at least 30 days) with and IOP-lowering monotherapy.

          -  All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits):

             ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Females of childbearing potential not meeting conditions set in the protocol.

          -  Severe central visual field loss.

          -  Angle Shaffer grade < 2.

          -  Cup/disc ratio > 0.8 (horizontal or vertical measurement).

          -  Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent
             to approximately 20/80 Snellen or 0.25 decimal).

          -  Intraocular surgery or trauma within last 6 months.

          -  Any abnormality preventing reliable applanation tonometry.

          -  History of or current ocular pathology (including severe dry eye) that would affect
             the conduct of the study.

          -  Allergy/hypersensitivity to study medications.

          -  Unable to discontinue use of all IOP-lowering medications for a minimum wash-out
             period of 5 to 28 days prior to the Eligibility Visit.

          -  Less than 30 days stable dosing regimen of medications used on a chronic basis that
             may affect IOP.

          -  Use of any additional topical or systemic ocular hypotensive medication during the
             study.

          -  Therapy with another investigational agent within 30 days prior to the Screening
             visit.

          -  Other protocol-defined exclusion criteria may apply.
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Condition: Facial Rhytides; Crow's Feet Lines; Glabellar Lines
Intervention: onabotulinumtoxinA 24 U; onabotulinumtoxinA 44 U; normal saline
Intervention description: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.; 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart; Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 917.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of botulinum toxin Type A compared to
      placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe Crow's Feet Lines and Frown Lines

          -  Have adequate vision without the use of eyeglasses to assess facial wrinkles in the
             mirror (contact lenses OK)

        Exclusion Criteria:

          -  Current or previous botulinum toxin treatment of any serotype

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis

          -  Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow
             lift, eyelid lift or eyebrow surgery)

          -  Facial laser or light treatment, microdermabrasion, or superficial peels within 3
             months

          -  Oral retinoid therapy within one year
A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)
Intervention description: 8mg/kg iv every 4 weeks for 6 months; As prescribed
Intervention MeSH terms: Antirheumatic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying
      Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe
      active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs
      will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6
      months. The anticipated time on study treatment is 3-12 months, and the target sample size is
      100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  rheumatoid arthritis >=6 months duration;

          -  DAS28>=3.2;

          -  inadequate response to prior treatment with a stable dose (>=8 weeks) of DMARD
             therapy.

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than rheumatoid arthritis;

          -  history of or current inflammatory joint disease other than rheumatoid arthritis;

          -  unsuccessful treatment with an anti-TNF agent;

          -  previous/concurrent treatment with any cell-depleting therapies.