bioihbjkbjnl/mcl2 huggingface dataset:
Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)
Condition: Cardiovascular Disease; Diabetes Mellitus, Type 2
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9901.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Cardiovascular disease; Diabetes Mellitus; Dulaglutide

Summary:

      The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular
      events and other serious outcomes in persons with type 2 diabetes, when added to their
      anti-hyperglycemic regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than
             81 mmol/mol)

          -  Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or
             without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone

          -  On stable antihyperglycemic regimen for at least 3 months

          -  Age equal to or greater than 50 years with established clinical vascular disease, or
             age equal to or greater than 55 years and subclinical vascular disease or age equal to
             or greater than 60 years and at least 2 or more cardiovascular risk factors

        Exclusion Criteria:

          -  Uncontrolled diabetes requiring immediate therapy

          -  History of severe hypoglycemia in past year

          -  Acute coronary or cerebrovascular event within past 2 months

          -  Planned or anticipated revascularization procedure

          -  History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell
             thyroid disorder

          -  Pregnancy or planned pregnancy during the trial period

          -  Completed or withdrawn from any study investigating dulaglutide
A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CTGel/ BPO Wash; Soap Free Cleanser and CTGel
Intervention description: Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days
Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days.; Soap Free Cleanser will be used once daily in the morning for 28 days
Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.
Intervention MeSH terms: Clindamycin, tretinoin drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acne Vulgaris

Summary:

      The purpose of this study is to evaluate the tolerability of a combined regimen of a topical
      antibiotic and retinoid and a benzoyl peroxide wash.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with mild to moderate facial acne vulgaris, with no history of known or
             suspected hypersensitivity or previous allergic reaction to any of the ingredients of
             the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable
             of understanding and willing to provide signed and dated written voluntary informed
             consent and able to complete the study and to comply with study instructions.

          -  Female subjects of childbearing potential must have a negative urine pregnancy test
             result at baseline and practice a reliable method of contraception throughout the
             study.

        Exclusion Criteria:

          -  Use of topical antibiotics on the face within the past 2 weeks or use of systemic
             antibiotics within the past 4 weeks.
A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1
Condition: Primary Hyperoxaluria; Primary Hyperoxaluria Type 1 (PH1)
MeSH terms: Hyperoxaluria, Primary
Intervention: Lumasiran
Intervention description: Lumasiran will be administered by subcutaneous (SC) injection.
Intervention MeSH terms: Lumasiran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 0 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: PH1; Primary Hyperoxaluria; Hyperoxaluria; RNAi Therapeutic; siRNA; AGT

Summary:

      The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and
      pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary
      hyperoxaluria type 1 (PH1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has genetic confirmation of primary hyperoxaluria type 1 (PH1)

          -  Meets urinary oxalate excretion requirements

          -  If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90
             days

        Exclusion Criteria:

          -  If <12 months old at screening, has an abnormally high serum creatinine

          -  If ≥12 months old at screening, has an estimated glomerular filtration rate (GFR) of
             ≤45 mL/min/1.73m^2

          -  Clinical evidence of systemic oxalosis

          -  History of kidney or liver transplant
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CT-P17 SC; Humira SC
Intervention description: Subcutaneous injection of Adalimumab 40mg every two weeks; Subcutaneous injection of Adalimumab 40mg every two weeks
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 648.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients
      With Active Rheumatoid Arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female aged 18 to 75 years old, both inclusive.

          -  Patient has had a diagnosis of rheumatoid arthritis according to the 2010 American
             College of Rheumatology(ACR)/EULAR classification criteria for at least 24 weeks prior
             to the first administration of the study drug .

        Exclusion Criteria:

          -  Patient who has previously received investigational or licensed product; biologic or
             targeted synthetic disease-modifying antirheumatic drugs for the treatment of
             rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any
             purposes.

          -  Patient who has allergies to any of the excipients of study drug or any other murine
             and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
Condition: Dyslipidemias; Coronary Heart Disease; Combined (Atherogenic) Dyslipidemia; Mixed Dyslipidemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Dyslipidemias
Intervention: ABT-335; placebo; atorvastatin; ezetimibe
Intervention description: 135 mg capsule, daily, 12 weeks; placebo capsule, daily, 12 weeks; 40 mg, tablet, daily, 12 weeks; 10 mg capsule, daily, 12 weeks
Intervention MeSH terms: Choline; Atorvastatin; Ezetimibe; Fenofibric acid; Fenofibrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 543.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to compare the safety and efficacy of ABT-335
      (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin
      coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with mixed dyslipidemia (trigylcerides, > or = to 150 mg/dL to < 400 mg/dL;
             HDL-C < 40 mg/dL for males, < 50 mg/dL for females; LDL-C, > or = to 130 mg/dL).

          -  Subjects must agree to use adequate birth control methods and to adhere to the
             American Heart Association (AHA) Diet.

        Exclusion Criteria:

          -  Subjects with unstable or uncontrolled medical conditions considered inappropriate in
             a clinical trial.

          -  Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous
             or intramuscular cyclosporine, statins, or certain other medications.

          -  Women who are pregnant or plan on becoming pregnant, or women who are lactating.
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium Bromide/Formoterol Fumarate; Formoterol Fumarate
Intervention description: Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day; Inhaled formoterol fumarate 12 μg, twice per day
Intervention MeSH terms: Bromides; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 590.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Summary:

      The purpose of this study is to assess the long-term safety and tolerability of inhaled
      aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive
      pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current or former cigarette smokers with a cigarette smoking history of at least 10
             pack-years

          -  A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined
             by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable
             airway obstruction.

        Exclusion Criteria:

          -  Patients who have been hospitalized for an acute COPD exacerbation within three months
             prior to Visit 1

          -  Any respiratory tract infection (including the upper respiratory tract) or COPD
             exacerbation in the six weeks before Visit 1.

          -  Patients with any clinically significant respiratory conditions other than COPD

          -  Clinical history that suggests that the patient has asthma as opposed to COPD

          -  Chronic use of oxygen therapy ≥ 15 hours/day

          -  Patients with clinically significant cardiovascular conditions

          -  Patients with uncontrolled infection that may place the patient at risk resulting from
             human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed
             active tuberculosis

          -  Patients with a history of hypersensitivity reaction to inhaled anticholinergics,

          -  Patients with Stage II hypertension, defined as systolic pressure of 160 and above,
             and/or diastolic pressure of 100 and above

          -  Current diagnosis of cancer other than basal or squamous cell skin cancer
Physical Activity in Women With Infants
Condition: Physical Activity
Intervention: physical activity tailored; physical activity standard
Intervention description: tailored telephone counseling, email feedback, and website resources over 12 months; standard print and website information on how to become more active
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 311.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: physical activity standard; exercise

Summary:

      This is a study testing ways to motivate new mothers to become more physically active over a
      one year period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  mother of infant aged 2-12 months

          -  sedentary

          -  healthy, able to do moderate intensity physical activity

          -  BMI = 18.5-40

          -  not planning to become pregnant in next year

          -  woman aged 18-45

          -  able speak and read English

        Exclusion Criteria:

          -  pregnant

          -  planning to leave Oahu, Hawaii in the next year (permanently move away)

          -  a diagnosis of cancer, coronary heart disease (including atrial fibrillation),
             insulin-dependent diabetes mellitus (IDDM), and other atherosclerotic cardiovascular
             diseases (e.g., stroke),
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferric Carboxymaltose (FCM); Ferrous Sulfate Tablets; IV Iron (standard of care); Ferric Carboxymaltose (FCM)
Intervention description: A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.; 325 mg Ferrous Sulfate tablets taken orally three times a day; IV standard of care (other IV iron) per the Investigator's discretion; A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
Intervention MeSH terms: Ferric Compounds
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 997.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IDA

Summary:

      The main objective of this study is to demonstrate the efficacy and safety of an
      investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in
      subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to
      oral iron.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects ≥ to 18 years of age and able to give informed consent.

          -  Diagnosis of Iron Deficiency Anemia (IDA).

          -  Hemoglobin (Hgb) ≤ to 11 g/dL.

          -  Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.

          -  Must demonstrate an unsatisfactory response or intolerance to oral iron.

        Exclusion Criteria:

          -  Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous
             sulfate.

          -  Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).

          -  Requires dialysis for treatment of chronic kidney disease.

          -  No evidence of iron deficiency.

          -  Any non-viral infection.

          -  AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the
             upper limit of normal.

          -  Known positive hepatitis with evidence of active disease.

          -  Received an investigational drug within 30 days of screening.

          -  Alcohol or drug abuse within the past 6 months.

          -  Hemochromatosis or other iron storage disorders.

          -  Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG
             Performance Status greater than 1.

          -  Any other laboratory abnormality, medical condition, or psychiatric disorders which in
             the opinion of the investigator would put the subject's disease management at risk or
             may result in the subject being unable to comply with study requirements.

          -  Pregnant or sexually-active females who are of childbearing potential and who are not
             willing to use an acceptable form of contraception.
Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis
Condition: Moderate to Severe Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: secukinumab low dose; secukinumab high dose
Intervention description: dose depends on the weight group; dose depends on the weight group
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: pediatric; secukinumab; plaque psoriasis; AIN457A; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching

Summary:

      This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged
      6 years to less than 18 years, at randomization, with moderate to severe chronic plaque
      psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified
      by weight and disease severity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed assent and parental permission (age as per local law) obtained at
             screening before any assessment is performed.

          2. Must be 6 to less than 18 years of age at the time of randomization

          3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011
             score of ≥ 3, and BSA involvement of ≥10%, at randomization.

          4. Subject being regarded by the investigator to be a candidate for systemic therapy.

        Exclusion Criteria:

          1. Forms of psoriasis other than chronic plaque-type active at randomization

          2. Drug-induced psoriasis

          3. Ongoing use of prohibited treatments

          4. Female subjects of childbearing potential defined as all women physiologically capable
             of becoming pregnant, unless they are using effective methods of contraception during
             dosing and for 16 weeks after stopping study treatment

          5. Pregnant or nursing (lactating) females

          6. Subjects with total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils
             <1,500/μL or hemoglobin <8.5 g/dL at screening

          7. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17
             or the IL-17 receptor
Lesinurad and Febuxostat Combination Extension Study in Gout
Condition: Gout
MeSH terms: Gout
Intervention: lesinurad; lesinurad; febuxostat
Intervention description: Tablets, 400 mg once daily (QD); Tablets, 200 mg QD; Tabletsm 80 mg QD
Intervention MeSH terms: Febuxostat; Lesinurad
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Gout

Summary:

      This study will assess the serum uric acid lowering effects and safety of lesinurad in
      combination with febuxostat over a long-term timeframe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is able to understand the study procedures and the risks involved and is
             willing to provide written informed consent before the first study related activity.

          -  Subject completed the double-blind treatment period in Study RDEA594-304 and was
             actively receiving and tolerating study medication (lesinurad or placebo) and
             febuxostat 80 mg at the Month 12 visit.

          -  Subject is male or female; female subjects of childbearing potential must agree to use
             an effective non-hormonal method of birth control during the study and for at least 14
             days after the last dose of study medication.

        Exclusion Criteria:

          -  Subject has any medical or psychological condition, which in the opinion of the
             Investigator and/or the Medical Monitor, might create undue risk to the subject or
             interfere with the subject's ability to comply with the protocol requirements, or to
             complete the study.
Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: voxelotor; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: This study is a double-blind study.
Enrollment: 449.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor
      Administered Orally to Patients With Sickle Cell Disease
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female study participants with sickle cell disease

          2. Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12
             months.

          3. Age 12 to 65 years

          4. Hemoglobin (Hb) ≥5.5 and ≤10.5 g/dL during screening

          5. For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at
             least 3 months prior to signing the ICF.

        Exclusion Criteria:

          1. More than 10 VOCs within the past 12 months that required a hospital, emergency room
             or clinic visit

          2. Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also
             termed chronic, prophylactic, or preventive transfusion) or have received a RBC
             transfusion for any reason within 60 days of signing the ICF

          3. Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of
             signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to
             signing the ICF)

          4. Hepatic dysfunction characterized by alanine aminotransferase (ALT) >4 × upper limit
             of normal

          5. Severe renal dysfunction (estimated glomerular filtration rate at the Screening visit;
             calculated by the central laboratory) <30 mL/min/1.73 m^2 or on chronic dialysis