bioihbjkbjnl/mcl2 huggingface dataset:
Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants
Condition: Pneumonia, Pneumococcal
MeSH terms: Pneumonia, Pneumococcal
Intervention: Pneumosil; Prevenar 13; Synflorix
Intervention description: One single dose contains 2 μg of polysaccharide for serotypes 1, 5, 6A, 7F, 9V, 14, 19A, 19F and 23F, and 4 μg for serotype 6B formulated with aluminium phosphate as an adjuvant in an appropriate buffer; One single dose contains 2.2 µg of the following pneumococcal polysaccharides serotypes - 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - and 4.4 µg of pneumococcal polysaccharide serotype 6B, all conjugated to CRM197 and absorbed onto aluminum phosphate; One single dose contains 1 μg of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14, and 23F, and 3μg of serotypes 4, 18C, and 19F formulated with aluminum phosphate as an adjuvant.
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: 660.0
Sex: All
Minimum age: 42 Days
Maximum age: 56 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objectives of this study are to evaluate the immunogenicity (antibody response)
      and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of
      Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants based on medical history and clinical assessment.

          -  Between 6 and 8 weeks (ie 42 to 56 days) old, inclusive.

          -  Subject's parent must provide voluntary written/thumb-printed informed consent and be
             willing to comply with study requirements and procedures.

          -  Subjects must have been born full-term, have a weight-to-height Z score of ≥ -2 at the
             time of enrollment (WHO child growth standard), and be ≥ 3.5 kg at randomization.

          -  Subject's parents must be available for the duration of trial participation

        Exclusion Criteria:

          -  Use of any investigational medicinal product prior to randomization.

          -  Previous vaccination against or infection with S. pneumoniae.

          -  History of anaphylactic shock or an allergic reaction to any prior vaccination.

          -  Any fever, illness (including malaria).

          -  Receipt of another study vaccine within 30 days of study start.

          -  Chronic administration of an immunosuppressant or administration of immunoglobulins

          -  History of blood disorder, primary immunodeficiency, or a sibling who has such a
             diagnosis or who died suddenly without apparent cause.

          -  History of meningitis, seizures or any neurological disorder.

          -  Exposure to human immunodeficiency virus (HIV) by history.
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
Condition: Opioid Dependence; Opioid Related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: SUBOXONE; RBP-6000; Placebo
Intervention description: SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.; Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose.; Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo controlled, multicenter study in male and female
      participants who are seeking treatment for opioid use disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
             (DSM-5) criteria for moderate or severe opioid use disorder

          -  By medical history has met DSM-5 criteria for moderate or severe opioid use disorder
             for the 3 months immediately prior to signing the informed consent form

          -  Is seeking medication-assisted treatment for opioid use disorder

          -  Is an appropriate candidate for opioid partial-agonist medication-assisted treatment
             in the opinion of the investigator or medically responsible physician

          -  Body mass index (BMI) of ≥ 18.0 to ≤ 35.0 kg/m^2

        Exclusion Criteria:

          -  Current diagnosis other than opioid use disorder requiring chronic opioid treatment

          -  Current substance use disorder as defined by DSM-5 criteria with regard to any
             substances other than opioids, cocaine, cannabis, tobacco, or alcohol.

          -  Positive urine drug screen (UDS) result at screening for cocaine or cannabis AND meets
             DSM-5 criteria for either moderate or severe cocaine or cannabis use disorder,
             respectively

          -  Meets DSM-5 criteria for moderate or severe alcohol use disorder

          -  Received medication-assisted treatment for opioid use disorder (e.g., methadone,
             buprenorphine) in the 90 days prior to providing written informed consent
A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: golimumab; Golimumab (CNTO 148); placebo; golimumab
Intervention description: 100 mg sc injections every 4 wks from wk 0 up to 5 yrs; SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg; 50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
Intervention MeSH terms: Golimumab; 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: 356.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spondylitis; subcutaneous injection; Bechterew's Disease; Spondyloarthritis; Spondyloarthropathy

Summary:

      The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections
      (under the skin) of golimumab for the treatment of active ankylosing spondylitis
      [AS(arthritis of the spine)]. Efficacy will be measured by reduction in the signs and
      symptoms of active AS, including effects on back pain and stiffness, physical function, range
      of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New
             York criteria, for at least 3 months prior to first dose of study drug

          -  Symptoms of active disease at screening and at baseline visits, as evidenced by both a
             Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4, and a Total
             Back Pain score of >= 4 (each on a scale of 0 to 10cm)

          -  Inadequate response to 3 months of continuous therapy with maximal recommended doses
             of NSAIDs, or else unable to receive a full 3 months of maximal NSAID therapy because
             of intolerance, toxicity, or contraindications to non-steroidal anti-inflammatory
             drugs (NSAIDs)

          -  Stable doses of methotrexate, sulfasalazine, hydroxychloroquine, low-dose
             corticosteroids, and NSAIDs are permitted.

        Exclusion Criteria:

          -  Patients cannot have complete ankylosis of the spine

          -  No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study
Condition: Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: DE-117 Ophthalmic Solution; Timolol Maleate Ophthalmic Solution 0.5%
Intervention description: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only; Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 426.0
Sex: All
Minimum age: 12 Months
Healthy volunteers: No

Summary:

      This is a Phase III, randomized, double-masked, active-controlled, parallel-group,
      multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at
      Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any.
      After completing the required washout period, subjects will return for Visit 2 (Baseline, Day
      1). Subjects who meet all eligibility criteria at baseline will be randomized to receive
      double-masked treatment for 3 months. Adult subjects will receive open-label DE-117
      Ophthalmic Solution for an additional 9 months.

      Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who
      meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

        -  DE-117 Ophthalmic Solution once daily and Vehicle once daily, or

        -  Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the
           efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate
           Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will
           provide additional safety data through Month 12 for subjects receiving DE-117.
    

Eligibility criteria:

        Inclusion Criteria:

        • glaucoma or ocular hypertension

        Exclusion Criteria:

          -  Females who are pregnant, nursing, or planning a pregnancy

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             tonometric measurements
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 hard gelatin capsules.; SAGE-217 matched placebo hard gelatin capsules.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 581.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study
      evaluating the efficacy of SAGE-217 in the treatment of adult participants with major
      depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant had a diagnosis of MDD with symptoms that had been present for at least a
             4-week period.

          2. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32
             and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at
             screening and Day 1 (prior to dosing).

        Exclusion Criteria:

          1. Participant had active psychosis.

          2. Participant had attempted suicide associated with the current episode of MDD.

          3. Participant had a medical history of bipolar disorder, schizophrenia, and/or
             schizoaffective disorder.
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Risankizumab; Placebo solution for risankizumab
Intervention description: Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously; Placebo solution in prefilled syringes, self-administered subcutaneously
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: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Risankizumab; Psoriasis; Plaque Psoriasis

Summary:

      The primary objective of this study was to evaluate the safety and efficacy of risankizumab
      (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants
      with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the
             baseline visit.

          -  Participant meets following disease activity criteria:

          -  Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal
             to 10% body surface area (BSA) psoriasis involvement, static physician global
             assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity
             Index (PASI) greater than or equal to 12 at Screening and baseline visit.

          -  Candidate for systemic therapy as assessed by the investigator.

        Exclusion Criteria:

          -  Participant has history of active skin disease other than psoriasis that could
             interfere with the assessment of psoriasis.

          -  Participant has history of erythrodermic psoriasis, generalized or localized pustular
             psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset
             guttate psoriasis.

          -  Participant has previous exposure to risankizumab.
A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide; Placebo
Intervention description: Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks; Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 843.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Lung function; Exacerbations; Quality of Life

Summary:

      To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with
      moderate to severe COPD during one year of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe
             stable COPD

        Exclusion Criteria:

          -  History or current diagnosis of asthma, recent respiratory tract infection or acute
             COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic
             hypertrophy, bladder neck obstruction or narrow-angle glaucoma
Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: Thymoglobulin; Daclizumab; Plasmapheresis; Mycophenolate mofetil; Tacrolimus; Dexamethasone; Prednisone; Cytogam
Intervention description: Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered; 2 gm/day. Standard of care; To achieve serum level of 8-10 ng/ml.; 100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses; Taper over three months to 5 mg daily; Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
Intervention MeSH terms: Mycophenolic Acid; Dexamethasone; Prednisone; Tacrolimus; Thymoglobulin; Daclizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: kidney; transplantation; positive crossmatch; antibody mediated rejection; rejection; induction; therapy; trial

Summary:

      The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is
      a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney
      transplant recipients who have a positive crossmatch with their live donor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (18 years or older)

          -  End-stage renal disease

          -  Identified to have positive lymphocytotoxic crossmatch or flow cytometric crossmatch
             with live donor

        Exclusion Criteria:

          -  Deceased donor recipients

          -  Pregnancy

          -  Active infection

          -  History of cancer within the past two years (with the exception of non-melanomatous
             skin cancer)

          -  History of heparin induced thrombocytopenia

          -  Medical contraindications to transplant procedure
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Intervention: turoctocog alfa; turoctocog alfa
Intervention description: The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.; Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: Male
Minimum age: 6 Months
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.

      The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in
      Haemophilia A patients.

      The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and
      NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600
      (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September
      2011) and NN7008-4015 (start: August 2012, stop: March 2013).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent obtained before any trial-related activities

          -  Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial
             NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015

        Exclusion Criteria:

          -  Previous participation in the current trial (defined as withdrawal) or withdrawn
             subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or
             NN7008-4015 after administration of trial product