bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
Condition: Enthesitis Related Arthritis (ERA)
MeSH terms: Arthritis; Enthesopathy; Arthritis, Juvenile
Intervention: adalimumab; placebo for adalimumab
Intervention description: Adalimumab solution for subcutaneous injection.; Placebo for adalimumab solution for subcutaneous injection.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: inflammatory back pain; ankylosing spondylitis; sacroiliitis; Juvenile Idiopathic Arthritis; enthesitis; arthritis

Summary:

      The purpose of this study is to evaluate the efficacy and safety of adalimumab given
      subcutaneously every other week (eow) as compared to placebo in pediatric subjects with
      Enthesitis Related Arthritis (ERA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Enthesitis Related Arthritis (ERA) as defined by International League of
             Associations for Rheumatology (ILAR);

          -  Disease activity defined as at least 3 active joints and evidence of enthesitis in at
             least one location;

          -  Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug
             and at least one disease modifying anti-rheumatic drug, either sulfasalazine or
             methotrexate.

        Exclusion Criteria:

          -  Any ILAR Juvenile Idiopathic Arthritis (JIA) subtype other than ERA;

          -  Psoriasis or a history of psoriasis in the patient or first-degree relative;

          -  Presence of Immunoglobulin M (IgM) rheumatoid factor;

          -  Presence of systemic JIA;

          -  History of inflammatory bowel disease;

          -  previous biologic therapy including anti-tumor necrosis factor (anti-TNF) therapy with
             a potential impact on pediatric ERA;

          -  Infection(s) requiring treatment with IV anti-infectives within 30 days prior to
             Baseline or oral anti-infectives within 14 days prior to Baseline.
Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: adalimumab
Intervention description: Adalimumab pre-filled syringe, administered by subcutaneous injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 508.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hidradenitis suppurativa; open-label; acne inversa; PIONEER (OPEN-LABEL EXTENSION); adalimumab; HS; acne; tumor necrosis factor; abscess; inflammatory nodule

Summary:

      The purpose of this study to evaluate the long term safety, tolerability and efficacy of
      adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who previously participated in a prior Phase 3 AbbVie hidradenitis
             suppurativa (HS) study (M11-313 or M11-810) and:

               1. Completed the study; or

               2. Experienced a loss of response (LOR); or

               3. Experienced worsening or absence of improvement

                  Exclusion Criteria:

          -  Prior treatment with any other anti-tumour necrosis factor (anti-TNF) therapy (e.g.,
             infliximab, etanercept), or participation in an adalimumab trial other than a prior
             Phase 3 AbbVie HS study.

          -  Subject received any oral antibiotic treatment for HS within 28 days prior to the
             Baseline visit, except for antibiotics permitted in a prior Phase 3 AbbVie HS study.

          -  Subject received prescription topical therapies for the treatment of HS within 14 days
             prior to the Baseline visit of Study M12-555.
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Condition: Epilepsies, Partial
MeSH terms: Seizures; Epilepsies, Partial
Intervention: gabapentin
Intervention description: Orally administered gabapentin
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 3 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in
      Japanese pediatric patients with partial seizures
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15
             years old or less at the baseline visit

          -  Seizures are classified as simple partial, complex partial or partial becoming
             secondarily generalized (defined according to the International League Against
             Epilepsy)

          -  Have not been able to achieve adequate seizure control with antiepileptic drugs

        Exclusion Criteria:

          -  Seizures related to drugs or acute medical illness

          -  History of any serious medical or psychiatric disorder

          -  Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be
             progressive
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Condition: Relapsed/Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Plitidepsin; Dexamethasone
Intervention description: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.; 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Aplidin; plitidepsin; dexamethasone

Summary:

      Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients
      with relapsed/refractory multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2

          -  Life expectancy ≥ 3 months.

          -  Patients previously diagnosed with multiple myeloma

          -  Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at
             least three but not more than six prior therapeutic regimens for MM, including
             induction therapy and stem cell transplant in candidate patients, which will be
             considered as only one regimen.

          -  Patients must have received previous bortezomib-containing and lenalidomide-containing
             regimens (or thalidomide where lenalidomide is not available)

          -  Women must have a negative serum pregnancy test

          -  Voluntarily signed and dated written informed consent

        Exclusion Criteria:

          -  Concomitant diseases/conditions

          -  Women who are pregnant or breast feeding.

          -  Concomitant medications that include corticosteroids, chemotherapy, or other therapy
             that is or may be active against MM

          -  Known hypersensitivity to any involved study drug or any of its formulation components
A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: Tocilizumab will be administered at 8 mg/kg intravenous infusion every 4 weeks, up to 104 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, open-label, single arm long-term extension of study WA19926 will evaluate
      the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with early,
      moderate to severe rheumatoid arthritis who have completed the WA19926 core study. Eligible
      participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who complete WA19926 core study (visit at Week 104 and two follow-up
             telephone visits) and who may benefit from study drug treatment according to the
             Investigator's assessment

          -  No current or recent adverse event or laboratory finding preventing the use of the
             study drug dose of tocilizumab 8 mg/kg at baseline visit

          -  Receiving treatment on an outpatient basis

          -  Females of child-bearing potential must agree to use at least one adequate method of
             contraception as defined by protocol during the treatment period

        Exclusion Criteria:

          -  Pregnant women

          -  Participants who have prematurely withdrawn from the WA19926 study for any reason

          -  Treatment with any investigational agent or cell depleting therapies since last
             administration of study drug in the WA19926 core study

          -  Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL)1 agent, or
             a T-cell co-stimulation modulator since the last administration of the study drug in
             the WA19926 core study

          -  Immunization with a live/attenuated vaccine since the last administration of study
             drug in the WA19926 core study

          -  Diagnosis since visit at Week 104 of the core WA19926 study of rheumatic autoimmune
             disease other than rheumatoid arthritis

          -  Diagnosis since visit at Week 104 of the core WA19926 study of inflammatory joint
             disease other than rheumatoid arthritis

          -  Evidence of serious uncontrolled concomitant disease or disorder

          -  Known active or history of recurrent infection

          -  Current liver disease as determined by Investigator
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
Condition: Bipolar I Disorder; Acute Mania
MeSH terms: Mania
Intervention: Brexpiprazole
Intervention description: Brexpiprazole tablets
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Intervention model description: Group composed of eligible rollover participants who completed one of the double-blind, phase 3 efficacy trials (331-201-00080 (NCT03259555) or 331-201-00081 (NCT03257865)).
Masking: None (Open Label)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar; Mania; Brexpiprazole

Summary:

      This study evaluated the safety and evaluate the safety and tolerability of open-label
      brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult
      subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
    

Eligibility criteria:

        Inclusion Criteria (rollover participants from 331-201-00080 & 331-201-00081 trials)

          -  Participants remaining in hospital at the Day 21 visit of trial 331-201-00080 or
             331-201-00081 were permitted to enroll in the 331-201-00083 trial at the week 3 visit
             of the double-blind trial if they were planned to be discharged from the hospital
             before the week 1 visit of trial 331-201-0083. Participants not discharged by the week
             1 visit of trial 331-201-0083 were withdrawn.

          -  Participants who, in the opinion of the investigator, could potentially benefit from
             administration of oral brexpiprazole for the treatment of bipolar I disorder and who
             completed 3 weeks of post-randomization treatment in Trial 331-201-00080 & Trial
             331-201-00081.

        Exclusion Criteria (rollover participants from 331-201-00080 & 331-201-00081 trials)

          -  Participants with a major protocol violation during the course of their participation
             in the double-blind phase 3 trials (331-201-00080 or 331-201-00081).
Effect of Omega-3 Fatty Acid on Cortical Function in ADHD
Condition: Attention Deficit Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: DHA Omega-3; Placebo
Intervention description: Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks; corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 5 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      The study hypothesis is that DHA is more effective than placebo in increasing brain
      activation and reducing symptoms in psychostimulant-free children with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent/assent

          -  Ages 5-15 years old

          -  Meets DSM-IV-TR criteria for ADHD as determined by the KSADS

        Exclusion Criteria:

          -  Contraindication to an MRI scan (i.e., braces, claustrophobia)

          -  A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy)

          -  Greater than 1 year outside appropriate age/grade level

          -  A history of intolerance or hypersensitivity to omega-3 fatty acids

          -  Currently taking omega-3 supplements

          -  Not proficient in English language

          -  Any history of a hematological disorder or concomitant use of anticoagulant
             medications

          -  Personal history of an Axis I psychiatric disorder other than ADHD

          -  Inability to swallow capsules
A Pharmacokinetic Substudy of the TDE-PH-304 Protocol
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Intervention: UT-15C SR; treprostinil diethanolamine
Intervention description: Open label study drug.
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients
      transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily
      dosing regimen.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Only subjects who are eligible for and have entered into Protocol TDE-PH-304 may
        participate in this substudy.

        Exclusion Criteria:

          1. The subject must voluntarily give informed consent to participate in the substudy.

          2. No dose changes to study drug are made within 5 days of the pharmacokinetic
             (PK)substudy visits.

          3. No additions or deletions to concurrent medications are made within 7 days of the
             pharmacokinetic substudy visit. Note: changes to diuretics and/or anticoagulants are
             permitted.

          4. The preceding evening dose of study drug should have been taken 9 to 13 hours prior to
             the BID dose and 6-10 hours prior to the TID morning dose of study drug to ensure a
             trough level of study drug for PK sampling.

          5. Subject dosing of study drug on the day of PK sampling must be observed in the clinic
             by study personnel.

          6. Subject has not experienced a significant loss of blood (> 450 mL) within the last 6
             weeks of the pharmacokinetic substudy visit.

          7. The subject must not be receiving any CYP 2C8 inducers or inhibitors
Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion
Condition: Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion
Intervention: ranibizumab; Peripheral Laser
Intervention description: Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.; Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RVO; CRVO; BRVO; Horizon; Bravo; Cruise

Summary:

      This study evaluates long-term safety in patients with macular edema due to Retinal Vein
      Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in
      the HORIZON extension trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent and authorization of use and disclosure of protected health
             information

          -  Age greater than or equal to 18 years

          -  Completion of 12 months in BRAVO or CRUISE trials, with subsequent follow-up in the
             HORIZON extension study. Exit from HORIZON should be within 90 days of enrollment

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) or lactation

          -  Premenopausal women not using adequate contraception. The following are considered
             effective means of contraception: surgical sterilization or use of oral
             contraceptives, barrier contraception with either a condom or diaphragm in conjunction
             with spermicidal gel, an IUD, or contraceptive hormone implant or patch.

          -  Any condition that the investigator believes would pose a significant hazard to the
             subject if investigational therapy were initiated.

          -  Inability to comply with study or follow up procedures

          -  Participation in another simultaneous medical investigation or trial
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Condition: Iron Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol; Oral Iron
Intervention description: Experimental: Ferumoxytol; Active Comparator: Oral iron
Intervention MeSH terms: Ferrous fumarate; Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; ferumoxytol; CKD; pediatric; dialysis-dependent; nondialysis-dependent

Summary:

      Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral
      iron for the treatment of pediatric participants with chronic kidney disease (CKD).
    

Eligibility criteria:

        Key Inclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies
        include:

          1. Males or females 6 months to <18 years of age

          2. CKD non-dialysis participants or dialysis-dependent participants who were on
             peritoneal dialysis or stable hemodialysis prior to Screening

          3. Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter
             (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level <100
             nanograms/milliliter (ng/mL)

          4. Female participants of childbearing potential who were sexually active must have been
             on an effective method of birth control for at least 1 month prior to Screening and
             agreed to remain on birth control until completion of participation in the study

        Key Exclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies
        include:

          1. History of allergy to either oral or IV iron

          2. Hemoglobin level ≤7.0 g/dL

          3. Serum ferritin level >600 ng/mL

          4. Female participants who were pregnant or intended to become pregnant, or were
             breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test