bioihbjkbjnl/mcl2 huggingface dataset:
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
Condition: Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: DE-117 Ophthalmic Solution; Timolol Maleate Ophthalmic Solution 0.5%
Intervention description: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months; Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 417.0
Sex: All
Minimum age: 12 Months
Healthy volunteers: No

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

Eligibility criteria:

        Inclusion Criteria:

        • glaucoma or ocular hypertension

        Exclusion Criteria:

          -  Females who are pregnant, nursing, or planning a pregnancy

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             tonometric measurements
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; Dulaglutide
Intervention description: Administered subcutaneously (s.c., under the skin) once-weekly.; Administered subcutaneously (s.c., under the skin) once-weekly.
Intervention MeSH terms: Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
      the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on
      to metformin in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
        consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive)
        - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal
        tolerated dose documented in the patient medical record) for 90 days prior to screening
        Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant
        or is of child-bearing potential and not using an adequate contraceptive method (adequate
        contraceptive measures as required by local regulation or practice) - Any condition, which
        in the investigator's opinion might jeopardise subject's safety or compliance with the
        protocol - Treatment with any medication for the indication of diabetes or obesity other
        than stated in the inclusion criteria in a period of 90 days before screening. An exception
        is short-term insulin treatment for acute illness for a total of equal to or below 14 days
        - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50
        ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary
        Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60
        mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) -
        Subjects presently classified as being in New York Heart Association Class IV - Planned
        coronary, carotid or peripheral artery revascularisation on the day of screening -
        Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of
        malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and
        in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more
        than 14 consecutive days or on a frequent basis) known to affect weight or glucose
        metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20vPnC; Saline; 13vPnC; PPSV23
Intervention description: 20vPnC; Saline; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1425.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a
      20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age
      and older in Japan, Korea, and Taiwan
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female participants 60 years of age and older at the time of consent.

          -  Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease, defined as disease not requiring significant change in therapy in the
             previous 6 weeks or hospitalization for worsening disease within 12 weeks before
             receipt of study intervention. (For adults 60 through 64 years of age to be enrolled
             at Japan sites: Participants must have a preexisting chronic stable disease with an
             elevated risk for pneumococcal disease.)

        Exclusion criteria:

          -  History of microbiologically proven invasive disease caused by S pneumoniae.

          -  Serious chronic disorder, including metastatic malignancy, severe COPD requiring
             supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of
             the liver, clinically unstable cardiac disease, or any other disorder that, in the
             investigator's opinion, excludes the participant from participating in the study.

          -  Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant 60 mg; Placebo
Intervention description: Atogepant tablets.; Atogepant matching placebo tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Episodic migraine

Summary:

      This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared
      with placebo in participants with episodic migraine and who have previously failed 2 to 4
      classes of oral prophylactic treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis
             according to the ICHD-3, 2018.

          -  Age of the participant at the time of migraine onset < 50 years -History of 4 to 14
             migraine days per month on average in the 3 months prior to Visit 1 in the
             investigator's judgment

          -  Female participants willing to minimize the risk of inducing pregnancy for the
             duration of the clinical study and follow-up period. Male participants willing to
             minimize the risk of inducing pregnancy for the duration of the clinical study and
             follow-up period.

          -  4 to 14 migraine days in the 28-day baseline period per eDiary

          -  Failed oral migraine prophylaxis medications from 2 to 4 medication classes

        Exclusion Criteria:

          -  Any clinically significant hematologic, endocrine, pulmonary, hepatic,
             gastrointestinal, or neurologic disease

          -  Participant has any other concurrent pain condition that, in the opinion of the
             investigator, may significantly impact the current headache disorder

          -  In the opinion of the investigator, confounding psychiatric conditions, dementia,
             epilepsy, or significant neurological disorders other than migraine

          -  Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in
             the investigator's judgment

          -  Has ≥ 15 headache days in the 28-day baseline period per eDiary

          -  Clinically significant cardiovascular or cerebrovascular disease

          -  Has a history of migraine accompanied by diplopia or decreased level of consciousness
             or retinal migraine as defined by ICHD-3, 2018

          -  Has a current diagnosis of chronic migraine, new persistent daily headache, medication
             overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful
             cranial neuropathy as defined by ICHD-3, 2018
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
Condition: Neutropenic Complications; Breast Neoplasms; Chemotherapy-induced Neutropenia; Chemotherapeutic Toxicity
MeSH terms: Breast Neoplasms; Neutropenia
Intervention: LA-EP2006; Neulasta®
Intervention description: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.; Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 316.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: biosimilars; Pegfilgrastim,; G-CSF,; neutropenia,; breast cancer,; myelosuppressive chemotherapy,; supportive care; granulocyte-colony-stimulating factor

Summary:

      The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the
      mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in
      breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically proven breast cancer

          -  eligible for six cycles of neoadjuvant or adjuvant chemotherapy

        Exclusion Criteria:

          -  concurrent or prior chemotherapy for breast cancer

          -  concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy,
             immunotherapy, monoclonal antibodies, and/or biological therapy

          -  concurrent prophylactic antibiotics

          -  previous therapy with any G-CSF (granulocyte-colony stimulating factor) product

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: Glecaprevir/Pibrentasvir
Intervention description: Tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus (HCV); Glecaprevir; Pibrentasvir; Treatment Naïve; Cirrhosis; Compensated Cirrhosis; Genotype (GT) 1-6; Pangenotypic; Chronic Hepatitis C Virus (HCV)

Summary:

      A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic
      HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with
      glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response
      12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir
      compared to the historical SVR12 rates of 12 weeks of treatment with
      glecaprevir/pibrentasvir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6
             infection.

          -  Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000
             IU/mL at Screening.

          -  Treatment-naive to any approved or investigational anti-HCV medication.

          -  Participant must be documented as cirrhotic, with a Child-Pugh score of less than or
             equal to 6.

        Exclusion Criteria:

          -  Female participant who is pregnant, breastfeeding or is considering becoming pregnant
             during the study, or for approximately 30 days after the last dose of study drug.

          -  Any current or historical clinical evidence of decompensated cirrhosis.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV
             deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated
             positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and
             anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).

          -  HCV genotype performed by the central laboratory during screening indicating
             co-infection with more than one HCV genotype.

          -  History of suspected or confirmed hepatocellular carcinoma.
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: Interferon γ-1b
Intervention description: The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after Week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).
Intervention MeSH terms: Interferons; Interferon-gamma
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 10 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: Interferon gamma

Summary:

      The purpose of this phase 3 multi-center, open-label extension study is to evaluate the
      long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and child assent, if applicable.

          -  Completed 26 weeks of blinded treatment in Study HZNP-ACT-301 (NCT02415127).

          -  If female, the subject is not pregnant or lactating or intending to become pregnant
             during the study, or within 30 days after the last dose of study drug. Female subjects
             of child-bearing potential must have a negative urine pregnancy test result at
             Baseline/Day 1 (Week 26 of Study HZNP-ACT-301 [NCT02415127]), and agree to use a
             reliable method of contraception throughout the study and for 30 days after the last
             dose of study drug.

        Exclusion Criteria:

          -  Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely
             to comply with the study protocol or have a concomitant disease or condition that
             could interfere with the conduct of the study or potentially put the subject at
             unacceptable risk.

        NOTE: Additional inclusion/exclusion criteria may apply.
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
Condition: Contraception
Intervention: AG200-15; Levora
Intervention description: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.; One tablet of Levora will be taken each day for a 28 day cycle.
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Hormonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraceptive

Summary:

      The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal
      contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  sexually active women requesting contraception

          -  Regular menses every 24 - 35 days

          -  In good general health, confirmed by medical history, physical (including gynecologic
             examination adn screening laboratory values

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  Lactating women

          -  Significant skin reaction to transdermal preparations or sensitivity to surgical /
             medical tape

          -  Any disease that may worsen under hormonal treatment (cardiovascular, liver,
             metabolic)

          -  Use of other contraceptive methods than study medication
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Upadacitinib
Intervention description: Tablet; Oral; Tablet; Oral
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 661.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Musculoskeletal Disease; Arthritis; Joint Disease; Anti-inflammatory agents; Antirheumatic agents; Upadacitinib; ABT-494

Summary:

      The primary objectives of this study are to compare the efficacy, safety, and tolerability of
      upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and
      symptoms of adults with moderately to severely active rheumatoid arthritis who were on a
      stable dose of csDMARDs and had an inadequate response to csDMARDs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female, at least 18 years old.

          -  Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.

          -  Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for
             greater than or equal to 3 months and on a stable dose for greater than or equal to 4
             weeks prior to the first dose of study drug. The following csDMARDs are allowed:
             methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.

          -  Meets the following minimum disease activity criteria: greater than or equal to 6
             swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints
             (based on 68 joint counts) at Screening and Baseline Visits.

          -  Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled
             (up to 20% of study population) if they have documented evidence of intolerance to
             bDMARDs or limited exposure (less than 3 months) and have satisfied required washout
             periods.

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
             tofacitinib, baricitinib, and filgotinib).

          -  History of inflammatory joint disease other than RA. History of secondary Sjogren's
             Syndrome is permitted.

          -  Subjects who are considered inadequate responders to bDMARD therapy as determined by
             the Investigator.