bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA; TEZ/IVA
Intervention description: FDC tablet for oral administration.; Mono-tablet for oral administration.; Fixed-dose combination (FDC) tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 271.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX,
      VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with
      cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function
      mutation (F/G and F/RF genotypes).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subject has a confirmed diagnosis of CF and is heterozygous for F508del and either a
             gating or residual function mutation (F/G and F/RF genotypes)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Long-term Study of Cariprazine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine
Intervention description: Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 752.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Schizophrenia; Acute schizophrenia; Psychotropic drugs; Antipsychotic agents; Mental disorders; Dopamine agents; Central nervous system agents

Summary:

      The objective of this study is to evaluate the long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients and corresponding caregivers who have provided informed consents prior to any
             study specific procedures.

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,
             disorganized type, catatonic type, or undifferentiated type), as confirmed by the
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (SCID).

          -  Patients with normal physical examination, laboratory, vital signs, and
             electrocardiogram (ECG).

        Exclusion Criteria:

          -  Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform
             disorder, bipolar I or bipolar II disorder, or psychotic disorders other than
             schizophrenia.
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Condition: Infant, Newborn; Infant, Small for Gestational Age; Infant, Extremely Low Birth Weight
MeSH terms: Body Weight; Birth Weight
Intervention: Donor Milk; Preterm Formula
Intervention description: Donor milk provided by the Human Milk Banking Association of North America; Preterm Formula determined by center practice.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 483.0
Sex: All
Maximum age: 21 Days
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Prematurity; Neurodevelopmental Impairment; Donor Breast Milk; Preterm Formula

Summary:

      The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26
      months of donor human milk as compared to preterm infant formula as the in-hospital diet for
      infants whose mothers choose not to provide breast milk or are able to provide only a minimal
      amount. Infants will be randomized to receive donor breast milk or formula during their
      hospital stay. Infant's will be followed until they reach 22-26 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age less than 29 weeks.

          -  Admitted to the NICU at less than or equal to 72 hours of life

          -  Survived at least 12 hours

        Exclusion Criteria:

          -  Chromosomal anomalies

          -  Cyanotic congenital heart disease

          -  Diagnosed intrauterine infection

          -  Other congenital disorders known to impair neurodevelopment

          -  NEC or IP prior to seeking consent

          -  Decision documented to limit intensive care therapies

          -  Congenital disorders that may affect feeding

        Feeding Group Eligibility:

          -  Sole Diet Group: Infants will be eligible for the sole diet feeding protocol if the
             mother declines to provide breast milk for the baby.

          -  Supplemental Diet (minimal maternal milk) Group: Infants whose mothers initially
             choose to provide breast milk and begin pumping will be re-screened for eligibility at
             least weekly until the infant is 21 days old. If the mother stops expressing milk at
             any point prior to the infant's 21st day of life, her infant will be eligible for
             randomization. In addition, those whose mothers are providing less than 20% of the
             infant's dietary needs (averaged over past 5 days) when the infant reaches 21 days of
             age will be eligible for randomization at this point. No infant will be randomized
             after reaching 21 days.
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Condition: Stage IV or Recurrent Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence
Intervention: Nivolumab; Gemcitabine; Cisplatin; Carboplatin; Paclitaxel; Pemetrexed
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Nivolumab; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 541.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to show that Nivolumab will improve progression free survival in
      subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared
      to chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1

          -  Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic
             anticancer therapy

          -  Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per
             response evaluation criteria in solid tumors version (RECIST) 1.1 criteria

          -  PD-L1+ on immunohistochemistry testing performed by central lab

          -  Men and women, ages ≥ 18 years of age

        Exclusion Criteria:

          -  Known epidermal growth factor receptor (EGFR) mutations which are sensitive to
             available targeted inhibitor therapy

          -  Known anaplastic lymphoma kinase (ALK) translocations

          -  Untreated central nervous system (CNS) metastases

          -  Previous malignancies

          -  Active, known or suspected autoimmune disease
Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Glecaprevir/Pibrentasvir
Intervention description: Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic hepatitis C virus (HCV); Hepatitis; HCV genotype; aspartate aminotransferase; platelet; Aspartate aminotransferase to Platelet Ratio Index (APRI); glecaprevir; pibrentasvir; Sustained Virologic Response 12 weeks post dosing (SVR12)

Summary:

      A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in
      treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and
      with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and
             indeterminate GT may be acceptable.

          -  Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or
             equal to 1, at time of screening.

          -  Does not have current active hepatitis B virus infection defined as:

               -  positive hepatitis B surface antigen (HBsAg), OR

               -  hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of
                  quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core
                  (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])

          -  Platelets ≥ 150,000 cells/mm³

          -  Albumin ≥ lower limit of normal (LLN)

          -  Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥
             1,000 IU/mL at Screening and for at least 6 months before Screening.

          -  No past history/evidence of cirrhosis.

          -  No history of hepatocellular carcinoma.

          -  Hepatitis C virus treatment-naïve (had not received a single dose of any approved or
             investigational anti-HCV medication).

          -  If female, the subject must not be pregnant, breastfeeding, or considering becoming
             pregnant during the study and for 30 days after the last dose of study drug.
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Oliceridine; Placebo; Morphine
Intervention MeSH terms: Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine
      administered as needed (PRN) compared with placebo in patients with moderate to severe acute
      pain after abdominoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has undergone abdominoplasty with no additional collateral procedures.

          -  Experiences a pain intensity rating of moderate to severe acute pain.

          -  Able to provide written informed consent before any study procedure.

        Exclusion Criteria:

          -  ASA Physical Status Classification System classification of P3 or worse.

          -  Has surgical or post-surgical complications.

          -  Has clinically significant medical conditions or history of such conditions that may
             interfere with the interpretation of efficacy, safety, or tolerability data obtained
             in the trial, or may interfere with the absorption, distribution, metabolism, or
             excretion of drugs.

          -  Has previously participated in another TRV130 clinical study.
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Condition: Acute Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: Canakinumab 150mg in prefilled syringe
Intervention description: Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Uncontrolled
Masking: None (Open Label)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Gout; arthritis; gout flare; acute gout; gouty; rheumatic disease; uric acid; podagra

Summary:

      This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety
      and tolerability in patients who have frequent flares of acute gouty arthritis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Compliance and completion of the canakinumab PFS core study

          -  Unchanged significant clinical medical history from entry into core study

        Exclusion criteria:

          -  Physician judgment of unsuitability for the study

          -  Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may
             apply
Clinical Evaluation of Patient Preoperative Prep
Condition: Surgical Skin Preparation
Intervention: ZuraPrep; ChloraPrep; ZP Vehicle
Intervention description: Apply topically.; Apply topically.; Apply topically.
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 640.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to demonstrate the antimicrobial efficacy of the ZP
      Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race.

          -  Subjects in good health.

          -  Minimum skin flora baseline requirements on abdomen and groin.

          -  Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder
             near or on the applicable test area.

        Exclusion Criteria:

          -  Topical or systemic antimicrobial exposure within 14 days prior to screening and
             treatment days, including antibiotics.

          -  Subjects with a history of skin sensitivity, skin allergies, or skin cancer.

          -  Subjects who are pregnant, attempting pregnancy, or nursing.
A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Olumacostat Glasaretil Gel, 5.0%; Olumacostat Glasaretil Gel, Vehicle
Intervention description: Gel containing Olumacostat Glasaretil; Vehicle (placebo) gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 744.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil
      Gel compared to vehicle in patients with acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent and, for subjects under legal adult age, signed assent

          -  Age ≥ 9 years

          -  Clinical diagnosis of facial acne vulgaris defined as:

               -  At least 20 inflammatory lesions, and

               -  At least 20 non-inflammatory lesions, and

               -  Investigator Global Assessment of 3 or greater

        Exclusion Criteria:

          -  Active cystic acne or acne conglobata, acne fulminans, and secondary acne

          -  Two or more active nodulocystic lesions on the face

          -  Clinically significant abnormal laboratory or ECG result

          -  Subjects who are actively participating in an experimental therapy study or who have
             received experimental therapy within 30 days or 5 half-lives (whichever is longer) of
             the Baseline visit

          -  Treatment with over-the-counter topical medications for the treatment of acne vulgaris
             including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids,
             α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline

          -  Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid
             within 4 weeks prior to Baseline

          -  Treatment with a new hormonal therapy or dose change to existing hormonal therapy
             within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to,
             estrogenic and progestational agents such as birth control pills).

          -  Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks
             prior to Baseline.

          -  Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A
             supplements greater than 10,000 units/day within 6 months prior to Baseline

          -  Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8
             weeks
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
Condition: Influenza Virus
MeSH terms: Influenza, Human
Intervention: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
Intervention description: 1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months; 1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10644.0
Sex: All
Minimum age: 6 Months
Maximum age: 71 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; children

Summary:

      Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus
      Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months
      of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere
      influenza season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children, males and females, healthy or at high risk of complications from influenza,
             between ≥6 months to <72 months of age

          -  Documented consent provided by the subject's parent(s)/legal guardian(s)

          -  Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study
             procedures.

        Exclusion Criteria:

          -  Children with history of allergy to vaccine components.

          -  Additional eligibility criteria may be discussed by contacting the site
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive
Intervention: Placebo; Mirtazapine
Intervention description: Subjects randomized to placebo will receive placebo for duration of the study; Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg per week for subjects weighing less than 50 kg and up to 15 mg per week for subjects weighing more than 50 kg depending on efficacy and tolerability.
Intervention MeSH terms: Mirtazapine
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: 17 Years
Healthy volunteers: No
Keywords: Autistic Disorder; Asperger's Disorder; Pervasive Developmental Disorder

Summary:

      This study will determine the effectiveness of mirtazapine in reducing anxiety in children
      with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 5-17 years

          -  Diagnosis of autistic disorder, Asperger's disorder or Pervasive Developmental
             Disorder Not Otherwise Specified (PDD NOS)

          -  Clinically significant anxiety as evidenced by a Pediatric Anxiety Rating Scale (PARS)
             score of 10 or greater

          -  Abbreviated intelligence quotient (IQ) greater than 50 on the Stanford Binet 5th Ed.

        Exclusion Criteria:

          -  Diagnosis of Rett's disorder or childhood integrative disorder

          -  Diagnosis of obsessive-compulsive disorder (OCD), post-traumatic stress disorder,
             major mood disorder, psychotic disorder, or substance use disorder

          -  Presence of any past or present medical conditions that would make treatment with
             mirtazapine unsafe

          -  Use of other antidepressants or benzodiazepines

          -  Use of other psychotropic medications which are ineffective, poorly tolerated, or
             sub-optimal in terms of dose

          -  Previous adequate trial of mirtazapine