bioihbjkbjnl/mcl2 huggingface dataset:
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone; Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Intervention description: Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day); Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Gemcitabine; Etoposide; Vincristine; Vinorelbine; Pixantrone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pixantrone; Non-Hodgkins lymphoma

Summary:

      BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows
      reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural
      similarities with mitoxantrone as well as general similarities with anthracyclines (such as
      the tricyclic central quinoid chromophore).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO
             classification.

          -  At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI
             and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be
             followed for response as target lesion.

          -  Relapse after 2 or more prior regimens of chemotherapy

          -  ECOG performance status of 0, 1, or 2

          -  Adequate hematologic, renal and hepatic function

          -  LVEF ≥50% determined by MUGA scan

        Exclusion Criteria:

          -  Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450
             mg/m²

          -  Prior allogenic stem cell transplant

          -  Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell
             lymphoma

          -  Active CNS lymphoma or HIV-related lymphoma.

          -  Any chemotherapy, radiotherapy, or other anticancer treatment (including
             corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks
             before randomization

          -  Pregnant women or nursing mothers
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Otelixizumab; Placebo
Intervention description: infusion; Infusion
Intervention MeSH terms: Muromonab-CD3
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: new onset type 1 diabetes; juvenile diabetes; T1DM; Type 1 diabetes

Summary:

      DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective
      is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in
      insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed
      meal-stimulated C-peptide.

      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3
      otelixizumab, 1/3 placebo). These study agents will be administered as an addition to
      insulin, diet, and other standard of care treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 12-17

          -  Diagnosis of diabetes mellitus, consistent with ADA criteria

          -  No more than 90 days between diagnosis and administration of study compounds

          -  Requires insulin for type 1 diabetes mellitus, or has required insulin at some time
             between diagnosis and administration of study compounds. In Canada, has to be using
             insulin at the time of dosing.

          -  Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50
             nmol/L

          -  Positive for one or more of the autoantibodies typically associated with T1DM:
             antibody to glutamic acid decarboxylase (anti-GAD); antibody to protein tyrosine
             phosphatase-like protein (anti-IA-2); zinc transporter autoantibodies (ZNT8); insulin
             autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and
             negative for the other autoantibodies will only be eligible if the subject has used
             insulin for less than 7 days total.

        Exclusion Criteria:

        •Other, significant medical conditions based on the study doctor's evaluation
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata
Intervention: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine; Matching Placebo
Intervention description: A 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.; A placebo 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12167.0
Sex: Female
Minimum age: 16 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent
      cervical cancer.
    

Eligibility criteria:

        Inclusion Criteria for the Base Study:

          -  Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

             --For Extension Phase:

          -  Participant received placebo or an incomplete vaccination series in the original study

             --For LTFU:

          -  Participant was randomized into the Base Study from Denmark, Iceland, Norway, or
             Sweden.

          -  Agreed to allow passive follow-up (retrospective review of registry data), analysis of
             biopsy specimens, future contact from National Registry Study Center and serum
             collection

        Exclusion Criteria for the Base Study:

          -  Prior Human Papilloma Virus (HPV) vaccination

          -  Prior abnormal Paps

          -  Prior history of genital warts

             --For Extension Phase:

          -  Prior complete HPV vaccination series

          -  Subject lives in a country in which Gardasil is approved and is within the age range
             of the local labeling for Gardasil

             --For LTFU Study:

          -  There were no exclusion criteria that did not overlap the inclusion criteria for this
             study.
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165; Placebo; Apremilast
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Apremilast; Deucravacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1020.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the experimental medication BMS-986165 compared
      to placebo and a currently available treatment in participants with moderate to severe plaque
      psoriasis.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Plaque psoriasis for at least 6 months

          -  Moderate to severe disease

          -  Candidate for phototherapy or systemic therapy

        Exclusion Criteria:

          -  Other forms of psoriasis

          -  History of recent infection

          -  Prior exposure to BMS-986165 or active comparator

        Other protocol defined inclusion/exclusion criteria could apply
Transfusion of Prematures Trial
Condition: Infant, Newborn, Diseases; Infant, Extremely Low Birth Weight; Infant, Small for Gestational Age; Bronchopulmonary Dysplasia (BPD); Anemia
MeSH terms: Bronchopulmonary Dysplasia; Infant, Newborn, Diseases; Birth Weight
Intervention: Liberal Cell Transfusion; Restricted red cell transfusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1824.0
Sex: All
Maximum age: 48 Hours
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Transfusions

Summary:

      The objective of the TOP trial is to determine whether higher hemoglobin thresholds for
      transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the
      primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months
      of age, using standardized assessments by Bayley.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Birth weight less than or equal to 1000 grams.

          -  Gestational age at least 22 weeks but less than 29 weeks

          -  Admitted to the NICU within 48 hours of life

        Exclusion Criteria:

          -  Considered nonviable by the attending neonatologist

          -  Cyanotic congenital heart disease

          -  Parents opposed to the transfusion of blood

          -  Parents with hemoglobinopathy or congenital anemia

          -  In-utero fetal transfusion

          -  Twin-to-twin transfusion syndrome

          -  Isoimmune hemolytic disease

          -  Lack of parental consent

          -  Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for
             perioperative transfusion.

          -  Prior blood transfusion on clinical grounds beyond the first 6 hours of life

          -  Infant has received erythropoietin prior to randomization, or is intended to receive
             erythropoietin through the neonatal course

          -  Congenital condition, other than premature birth, that adversely affects life
             expectancy or neurodevelopment.

          -  High probability that the family is socially disorganized to the point of being unable
             to attend follow-up at 22-26 months.
A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Mirikizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 530.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; IL-23

Summary:

      The purpose of this study is to evaluate the efficacy and safety of mirikizumab in
      participants with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of
             chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the
             following criteria:

               -  plaque psoriasis involving ≥10% BSA and absolute PASI score ≥12 in affected skin
                  at screening and baseline

               -  sPGA score of ≥3 at screening and baseline

          -  Candidate for systemic therapy and/or phototherapy for psoriasis.

        Exclusion Criteria:

          -  Have an unstable or uncontrolled illness, including but not limited to a
             cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
             hematologic, or neurologic disease or abnormal laboratory values at screening, that in
             the opinion of the investigator, would potentially affect participant safety within
             the study or of interfering with the interpretation of data.

          -  Breastfeeding or nursing women.

          -  Have had serious, opportunistic, or chronic/recurring infection within 3 months prior
             to screening.

          -  Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or
             received live vaccine(s) (including attenuated live vaccines) within 12 weeks of
             baseline or intend to receive either during the study.

          -  Have any other skin conditions (excluding psoriasis) that would affect interpretation
             of the results.

          -  Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days
             prior to baseline.

          -  Have received topical psoriasis treatment within 14 days prior to baseline.

          -  Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17
             targeting biologics within 12 weeks prior to baseline.

          -  Have previous exposure to any biologic therapy targeting IL-23 (including
             ustekinumab), either licensed or investigational.
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
Condition: Psoriatic Arthritis (PsA)
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo; Risankizumab
Intervention description: Placebo for risankizumab administered by subcutaneous (SC) injection; Risankizumab administered by subcutaneous (SC) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 444.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: KEEPsAKE 2; Risankizumab

Summary:

      The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults
      with moderately to severely active psoriatic arthritis (PsA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months
             prior to the Screening Visit and fulfillment of the Classification Criteria for PsA
             (CASPAR) at Screening Visit.

          -  Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts)
             and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and
             Baseline.

          -  Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm
             diameter or nail changes consistent with psoriasis at Screening Visit.

          -  Participant has demonstrated an inadequate response or intolerance to biologic
             therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs
             (csDMARD) therapy(ies).

        Exclusion Criteria:

          -  Participant is considered by investigator, for any reason, to be an unsuitable
             candidate for the study.

          -  Participant has a known hypersensitivity to risankizumab.
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose); Secukinumab placebo provided in 1 mL autoinjector
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: 414.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic arthritis; AIN457; PsA; ACR; CASPAR; PASDAS; secukinumab; autoinjector

Summary:

      The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,
      and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic
      Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),
      disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis
      factor alpha (TNFα) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for
             Psoriatic ARthritis (CASPAR) criteria.

          -  Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

          -  Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

          -  Inadequate control of symptoms with NSAID.

        Exclusion Criteria:

          -  Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
             infectious or malignant process.

          -  Subjects taking high potency opioid analgesics.

          -  Previous exposure to secukinumab or other biologic drug directly targeting
             interleukin-17 (IL-17) or IL-17 receptor.

          -  Ongoing use of prohibited psoriasis treatments / medications.

          -  Subjects who have ever received biologic immunomodulating agents except for those
             targeting TNFα.

          -  Previous treatment with any cell-depleting therapies.
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
Condition: Mycobacterium Infections, Nontuberculous
MeSH terms: Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous
Intervention: LAI (Liposomal Amikacin for Inhalation) 590 mg
Intervention description: LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes.
Intervention MeSH terms: Amikacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ALIS; ARIKAYCE

Summary:

      A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg
      administered once daily (QD) when added to multi-drug regimen (MDR) in participants with
      Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC)
      that were refractory to treatment.

      Participants were randomized 2:1 to LAI 590 mg administered QD + MDR or MDR alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be continually positive for MAC on sputum culture while adhering to a multi-drug
             treatment regimen for a minimum duration of 6 months which is either ongoing or was
             completed no more than 12 months before screening

          2. Be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis
             and/or fibrocavitary disease by chest CT

          3. Be willing to adhere to multi-drug treatment regimen during the course of the study

        Exclusion Criteria:

          1. Patients with cystic fibrosis

          2. Positive pregnancy test or lactation at screening. All women of child bearing
             potential will be tested. Women not of childbearing potential are defined as
             postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally
             sterile.

          3. Active pulmonary tuberculosis requiring treatment at screening

          4. History of lung transplantation

          5. Prior exposure to LAI (including clinical study).
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 3831
Intervention description: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Safety

Summary:

      The primary objective of this study is to evaluate the long-term safety and tolerability of
      ALKS 3831 in subjects with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Agrees to use an acceptable method of contraception for the duration of the study

          -  Subject has completed the 24-week treatment period in the antecedent study,
             ALK3831-A303, within 7 days

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Subject is currently taking medications that are contraindicated with olanzapine use
             or exhibit drug-interaction potential with olanzapine

          -  Subject has a positive test for drugs of abuse at study entry

          -  Subject is pregnant, planning to become pregnant, or breastfeeding during the study

          -  Additional criteria may apply
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Tofacitinib
Intervention description: Oral administration twice per day
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if tofacitinib is safe and effective in subjects
      with active ankylosing spondylitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria
             for AS (1984).

          -  Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.

          -  Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or
             intolerant to NSAIDs.

        Exclusion Criteria:

          -  History of known or suspected complete ankylosis of the spine.

          -  History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.

          -  History of any other rheumatic disease.

          -  Any subject with condition affecting oral drug absorption.