bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Condition: Lymphoma; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone; Dexamethasone (Oral); Dexamethasone (IV); Elotuzumab (BMS-901608; HuLuc63)
Intervention description: Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug; On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug.
On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug; On weeks without Elotuzumab dosing: Not Applicable (N/A)
On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Elotuzumab; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 646.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether the addition of Elotuzumab to
      Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Documented progression from most recent line of therapy

          -  1-3 prior lines of therapy

          -  Measurable disease

          -  Life expectancy ≥3 months

          -  Prior treatment with Lenalidomide permitted if:

               1. Best response achieved was ≥Partial Response (PR)

               2. Patient was not refractory

               3. Patient did not discontinue due to a Grade ≥3 related adverse event

               4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9
                  months between the last dose of Lenalidomide and progression

        Exclusion Criteria:

          -  Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma

          -  Active plasma cell leukemia

          -  Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
Condition: Analgesia After ED Discharge for Extremity Injuries
MeSH terms: Acute Pain
Intervention: Hydrocodone (first trial); Codeine (first trial); Oxycodone (for second trial); Codeine (for second trial); Oxycodone (third trial); Hydrocodone (third trial)
Intervention description: Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain; Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain; Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain; Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain; Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain; Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
Intervention MeSH terms: Acetaminophen; Oxycodone; Hydrocodone; Codeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 720.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Pain Management; Emergency Medicine; Extremity Injuries

Summary:

      There will be 3 randomized, double-blinded clinical trials to help determine which of
      commonly prescribed oral opioid combination is most effective in managing acute extremity
      pain after discharge from the adult emergency department. The first trial compares
      hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg. The second trial
      compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg. The third
      trial compares oxycodone 5mg/acetaminophen 325 mg to hydrocodone 5mg/acetaminophen 325 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patient has complaint of acute extremity pain (less than 7 days duration)

          -  clinician plans to discharge on oral pain medication

        Exclusion Criteria:

          -  patients on methadone

          -  chronic pain condition such as sickle cell anemia or fibromyalgia

          -  history of adverse reaction to one of the study medications

          -  taken prescribed opioids in the past 24 hrs

          -  have a medical condition that might alter the metabolism of one of the study
             medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)

          -  Take a medication that might interact with one of the study medications
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: SM-13496
Intervention description: 40 or 80 mg once daily orally
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the long term safety and efficacy of SM-13496 in patients with
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are considered by the investigator eligible for the present study with no
             significant safety concerns

          -  Patients who are fully informed of and understand the objectives, procedures, and
             possible benefits and risks of the study and who provide written voluntarily consent
             to participate in the study

        Exclusion Criteria:

          -  Patients who are planning pregnancy for the expected duration of the study

          -  Patients who are otherwise considered ineligible for the study by the investigator
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Condition: Meningococcal Vaccine
Intervention: MenABCWY; Saline; rLP2086; MenACWY-CRM
Intervention description: N meningitidis group A, B, C, W, and Y vaccine; Placebo; Bivalent recombinant lipoprotein 2086 vaccine; meningococcal group A, C, W-135, and Y 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: 1610.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a
      0-,6- month schedule. This trial is also studying safety and immunogenicity of a
      meningococcal pentavalent vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject aged >=10 and <26 years at the time of enrollment.

          -  Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          -  Negative urine pregnancy test for all female subjects.

          -  Subjects who have not received, or who have received no more than 1 prior dose within
             the past 4 years, of a vaccine containing 1 or more ACWY serogroup

        Exclusion Criteria:

          -  Previous vaccination with any meningococcal serogroup B or purely polysaccharide
             (nonconjugate) meningococcal vaccine.

          -  Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
             allergen immunotherapy with a licensed product and are not on stable maintenance
             doses.

          -  A known or suspected defect of the immune system that would prevent an immune response
             to the vaccine, such as subjects with congenital or acquired defects in B cell
             function, those receiving chronic systemic (oral, intravenous, or intramuscular)
             corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the
             United States with terminal complement deficiency are excluded from participation in
             this study.

          -  Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          -  Current chronic use of systemic antibiotics.

          -  Received any investigational vaccines, drugs, or devices within 28 days before
             administration of the first study vaccination.

          -  Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
Condition: Hypercholesterolemia; Mixed Dyslipidemia; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Hypercholesterolemia; Dyslipidemias
Intervention: Evolocumab; Placebo to Evolocumab
Intervention description: Administered by subcutaneous injection with an automated mini doser; Administered by subcutaneous injection with an automated mini doser
Intervention MeSH terms: Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; type 2 diabetes; high blood cholesterol; hypercholesterolemia; mixed dyslipidemia; high cholesterol; statin intolerant

Summary:

      The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab
      taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein
      cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a
      maximally tolerated oral dose of statin of at least moderate-intensity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 years

          -  Type 2 Diabetes Mellitus

          -  Hemoglobin A1c < 10%

          -  Stable diabetes therapy

          -  Must be on maximally tolerated dose of statin of at least moderate Intensity

          -  Fasting triglycerides ≤ 600 mg/dL

          -  Not at LDL-C or Non-HDL-C goal.

        Exclusion Criteria:

          -  Moderate to severe renal dysfunction

          -  Uncontrolled hypertension

          -  Persistent active liver disease or hepatic dysfunction

          -  Has taken a cholesterylester transfer protein inhibitor in the last 12 months,

          -  Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary
             artery bypass graft or stroke within 3 months prior to randomization
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
Condition: Autism Spectrum Disorder (ASD)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: BUMETANIDE (S95008) for week 0 - 26; PLACEBO for week 0 - 26; Open-Label BUMETANIDE (S95008) for weeks 26 - 52
Intervention description: Oral solution dosed at 0.5 mg/mL Taken twice daily.; Oral solution Taken twice daily.; Oral solution dosed at 0.5 mg/mL Taken twice daily.
Intervention MeSH terms: Bumetanide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 6-month, randomized, double-blind, placebo-controlled, parallel groups followed by an open label active 6-month treatment period with bumetanide.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 211.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008
      in the improvement of Autism Spectrum Disorder core symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients from 2 to less than 7

          -  Primary diagnosis of ASD as per Diagnostic and Statistical Manual of Mental Disorders
             - Fifth Edition (DSM-5) criteria

          -  Criteria met for ASD on Autism Diagnostic Observation Schedule-Generic (ADOS-2) and
             Autism Diagnosis Interview Revised (ADI-R)

          -  CGI (Clinical Global Impression) - Severity rating Score ≥ 4

          -  Childhood Autism Rating Scale second edition (CARS2-ST or HF) total raw score ≥ 34

          -  Social responsiveness Scale second edition (SRS-2) total score ≥ 66 T-Score

          -  Absence of diagnosis of Fragile X or Rett Syndrome

          -  Absence of any clinically significant abnormality likely to interfere with the conduct
             of the study according to the judgment of the investigator.

        Exclusion Criteria:

          -  Patients not able to follow the study assessments defined by the protocol, with the
             exception of self-rating questionnaires which will be assessed by parent/legal
             representative/caregiver for those patients unable to complete them

          -  Patients having a high suicidal risk according to the investigator judgement

          -  Chronic renal dysfunction

          -  Chronic cardiac dysfunction

          -  Patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural
             therapy

          -  Severe electrolyte imbalance that is likely to interfere with the study conduct or
             evaluation
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Dabrafenib; Vemurafenib; Trametinib
Intervention description: Dabrafenib 150 mg twice daily orally; Vemurafenib 960 mg twice daily orally; Trametinib 2 mg once daily orally
Intervention MeSH terms: Trametinib; Dabrafenib; Vemurafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 704.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BRAF inhibitor; Metastatic Melanoma; Cancer; MEK inhibitor

Summary:

      This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436)
      and trametinib (GSK1120212) combination therapy with vemurafenib.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  >= 18 years of age

          -  Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma

          -  Measurable disease according to RECIST 1.1

          -  Women of childbearing potential with negative serum pregnancy test prior to
             randomisation

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Adequate baseline organ function

        Key Exclusion Criteria:

          -  Any prior use of a BRAF or MEK inhibitor

          -  Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior
             systemic treatment in the adjuvant setting is allowed

          -  History of another malignancy (except subjects who have been disease free for 3 years
             or with a history of completely resected non-melanoma skin cancer)

          -  Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which
             will be allowed)

          -  Brain metastases (except if all known lesions were previously treated with surgery or
             stereotactic radiosurgery and lesions, if still present, are confirmed stable for >=
             12 weeks prior to randomisation or if no longer present are confirmed no evidence of
             disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for
             >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4
             weeks prior to randomisation

          -  History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood
             pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by
             anti-hypertensive therapy)

          -  History or current evidence/risk of retinal vein occlusion (RVO) or central serous
             retinopathy (CSR)
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Intervention: Lubiprostone
Intervention description: 12 or 24 mcg soft capsules for oral administration.
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years
      diagnosed with functional constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic
             Criteria for Childhood Functional Constipation

          -  At least 6 years of age but less than 18 years of age at the time of randomisation

          -  Only stable dose of selective serotonin re-uptake inhibitors (SSRIs),
             serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO)
             inhibitors are allowed if participant is taking antidepressants

        Exclusion Criteria:

          -  Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or
             defecation

          -  Untreated faecal impaction at the time of screening

          -  Medical/surgical condition that might interfere with the absorption, distribution,
             metabolism, or excretion of the study medication
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia
Intervention: Inhaled Nitric Oxide; Placebo
Intervention description: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.; Nitrogen gas will be administered in the same manner as the experimental drug.
Intervention MeSH terms: Nitric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 451.0
Sex: All
Minimum age: 5 Days
Maximum age: 14 Days
Healthy volunteers: No
Keywords: Bronchopulmonary Dysplasia, BPD

Summary:

      This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will
      attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive
      pressure support at any point during days 5 to 14 after birth may benefit from treatment with
      iNO.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Preterm infants who are:

               1. 500 to 1250 grams at birth

               2. < 30 weeks gestational age

               3. 5 to 14 days of age (inclusive) at the time of entry

               4. Requiring mechanical ventilation or for those infants ≤ 800 grams, positive
                  pressure support (including CPAP) for respiratory insufficiency on days 5 to 14
                  days of age (inclusive)

        Exclusion Criteria:

          1. Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic,
             chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject
             who will not receive complete intensive care

          2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)

          3. Subjects who are dependent on right to left shunting to maintain the systemic
             circulation

          4. Preterm infants who received prior iNO therapy

          5. Use of another investigational agent
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib; Ofatumumab
Intervention description: 150 mg tablets administered orally twice daily; Administered intravenously
Intervention MeSH terms: Ofatumumab; Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLL; Chronic Lymphocytic Leukemia; GS-1101; CAL-101; Ofatumumab

Summary:

      The primary objective of this study is to evaluate the effect of the addition of idelalisib
      to ofatumumab on progression-free survival (PFS) in participants with previously treated
      chronic lymphocytic leukemia (CLL).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adults with previously treated recurrent CLL who have measurable lymphadenopathy

          -  Require therapy for CLL

          -  Have experienced CLL progression < 24 months since the completion of the last prior
             therapy

          -  Have disease that is not refractory to ofatumumab

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.