bioihbjkbjnl/mcl2 huggingface dataset:
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
Condition: Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis
MeSH terms: Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Intervention: Rosuvastatin (Crestor); Ezetimibe; Simvastatin
Intervention description: 10mg and 20 mg; 10 mg; 40mg and 80 mg
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1743.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypercholesterolaemia; Coronary Heart Disease (CHD); Atherosclerosis

Summary:

      The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or
      Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low
      Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary
      Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20%
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical
             evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20

          -  Patients will need to sign an informed consent before any visit procedures can be
             performed, including procedures for the optional genetic research and biomarker
             studies.

          -  Patients must be 18 years or older and will be asked to stop taking any current
             cholesterol-lowering medications. Dietary counselling will be provided which will
             include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will
             be asked to follow

        Exclusion Criteria:

          -  Use of lipid lowering drugs and other prohibited concomitant medications. History of
             statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA
             reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history
             of hypersensitivity to any components of ezetimibe.

          -  Patients considered to be unstable by their physician after the following events:

        a myocardial infarction, recent episode of unstable angina, myocardial revascularisation
        [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG)
        surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or
        stroke and patients awaiting a planned myocardial revascularisation
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165; Placebo
Intervention description: Specified dose on Specified Days; Specified dose on Specified days
Intervention MeSH terms: 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: 220.0
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 in participants with moderate to severe plaque psoriasis in mainland China,
      Taiwan, and South Korea
    

Eligibility criteria:

        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

        Other inclusion/exclusion criteria may apply.
Trial to Assess Chelation Therapy (TACT)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: EDTA; EDTA Placebo; High Dose Vitamin; High Dose Vitamin Placebo
Intervention description: Participants will receive 40 infusions of standard chelation solution.; Participants will receive 40 infusions of EDTA placebo.
Intervention MeSH terms: Vitamins; Edetic Acid; Pentetic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1708.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and effectiveness of ethylene diamine
      tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
    

Eligibility criteria:

        Inclusion Criteria for Participants:

          -  Heart attack at least 6 weeks prior to study start

        Exclusion Criteria for Participants:

          -  Serum creatinie level greater than 2.0 mg/dL

          -  Platelet count less than 100,000/µL

          -  Blood pressure greater than 160/100

          -  Chelation therapy within 5 years prior to study start

          -  History of allergic reactions to EDTA or any of the therapy's components

          -  Coronary or carotid revascularization procedures within 6 months prior to study start
             or a scheduled revascularization

          -  Cigarette smoking within 3 months prior to study start

          -  Childbearing potential

          -  History of liver disease

          -  Active heart failure or heart failure hospitalization within 6 months.

          -  Diagnoses of additional medical conditions that could otherwise limit patient survival

          -  Inability to tolerate 500-mL infusions weekly.
Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: CZP 200 mg Q2W; CZP 400 mg Q4W; Placebo
Intervention description: 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).; 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).; Matching Placebo to CZP injection.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 409.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia

Summary:

      Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to
      evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset
      active and progressive Psoriatic Arthritis (PsA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as
             defined by the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)

          -  Active Psoriatic Skin Lesions or a documented history of Psoriasis

          -  Active Arthritis with ≥ 3 tender joints at Screening and Baseline, ≥ 3 swollen joints
             at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during
             the Screening Period:

               1. Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour

               2. C-reactive protein (CRP) > Upper Limit Normal (ULN)

          -  Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

        Exclusion Criteria:

          -  Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia

          -  Exposure to more than 1 Tumor Necrosis Factor α (TNFα) antagonist or to more than 2
             previous biological response modifiers for PsA or Psoriasis

          -  Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents

          -  History of chronic or recurrent infections

          -  High risk of infection

          -  Live vaccination within the 8 weeks prior to Baseline

          -  Concurrent malignancy or a history of malignancy

          -  Class III or IV congestive Heart Failure - New York Heart Association (NYHA)

          -  Demyelinating disease of the central nervous system

          -  Clinically significant laboratory abnormalities
Mucosal Healing Study in Crohn's Disease (CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab pegol
Intervention description: Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab pegol; Crohn's disease; Mucosal healing

Summary:

      The aim of the study will be to investigate the effect of certolizumab pegol on the
      intestinal mucosa in active Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥
             220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with
             Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8

          -  Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

        Exclusion Criteria:

          -  Obstructive intestinal strictures, bowel resection, proctocolectomy or total
             colectomy, current total parenteral nutrition, short bowel syndrome

          -  History of tuberculosis or positive tests for tuberculosis at screening

          -  All the concomitant diseases or pathological conditions that could interfere with
             Crohn's disease assessment or to be harmful for the well being of the patient

          -  Previous clinical trials and previous biological therapy that could interfere with the
             results in the present clinical trial
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg; Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg; Lamivudine (LAM)
Intervention description: PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.; PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.; Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.
Intervention MeSH terms: Interferons; Lamivudine; Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy and safety of 2 different durations of treatment with
      pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen
      (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a
      treatment alone and in combination with lamivudine (LAM). The anticipated time on study
      treatment is 1-2 years, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults 18-70 years of age;

          -  HBeAg-negative chronic hepatitis B for >/=6 months;

          -  liver disease consistent with chronic hepatitis B.

        Exclusion Criteria:

          -  interferon-based, systemic anti-HBV, antiviral, anti-neoplastic, or immunomodulatory
             therapy </=12 months before first dose of study drug;

          -  non-responders to previous interferon therapy;

          -  co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);

          -  hepatocellular cancer;

          -  compensated (Child A, score 6) or decompensated liver disease (Child B or C).
Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor; Placebo
Intervention description: 150 mg tablet, oral use, administered twice a day (q12h); oral use, administered twice a day (q12h)
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects
      with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR)
      gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R,
      G1244E, S1251N, S1255P, or G1349D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with confirmed diagnosis of CF

          -  At least 1 allele of the following CFTR gating mutations: G178R, S549N, S549R, G551S,
             G970R, G1244E, S1251N, S1255P, G1349D

          -  Percent predicted forced expiratory volume in 1 second (FEV1) greater than or equal to
             (>=) 40 percent (%) predicted normal for age, sex, and height

          -  6 years of age or older

          -  Minimum weight of 15 kilogram (kg) at screening

          -  Females of childbearing potential must not be pregnant

          -  Willing to comply with contraception requirements

        Exclusion Criteria:

          -  G551D-CFTR mutation on at least 1 allele

          -  History of any illness or condition that might confound the results of the study or
             pose an additional risk in administering ivacaftor to the subject

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 4 weeks before the first
             dose of study drug

          -  History of solid organ or hematological transplantation

          -  History of alcohol, medication or illicit drug abuse within 1 year before the first
             dose of study drug

          -  Ongoing participation in another therapeutic clinical study or prior participation in
             an investigational drug study within 30 days before screening

          -  Use of inhaled hypertonic saline treatment

          -  Use of any inhibitors or inducers of cytochrome (CYP) P450 3A

          -  Evidence of cataract or lens opacity at screening
Phase 3 Papulopustular Rosacea Study
Condition: Papulopustular Rosacea (PPR)
MeSH terms: Rosacea
Intervention: CD5024; Azelaic acid 15% Gel
Intervention description: CD5024 1% Cream, once daily; Topical Gel applied twice daily
Intervention MeSH terms: Azelaic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 683.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its
      vehicle when applied once daily, at bed time, during a 12 week period in subjects with
      Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA)
             score rated 3 (moderate) or 4 (severe),

          2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and
             pustules) on the face.

        Exclusion Criteria:

          1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans,
             isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that
             may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial
             keratosis pilaris, seborrheic dermatitis, and acne,

          2. The subject has rosacea with more than two nodules on the face.
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
Condition: Upper Limb Spasticity
MeSH terms: Muscle Spasticity
Intervention: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
Intervention description: active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride [NaCl] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the
      treatment of arm tightness (upper limb spasticity) using two different dilutions of
      incobotulinumtoxinA (Xeomin).
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Female or male patients ≥ 18 years

          -  Stable upper limb spasticity of diverse etiology

          -  Focal spasticity with equal or more than 2 points on the Ashworth scale in the wrist
             flexors

          -  Disability Assessment Scale (DAS) ≥ 2 points for primary therapeutic target at both
             screening and baseline visits

        Main Exclusion Criteria:

          -  Fixed contracture

          -  Bilateral upper limb paresis/paralysis

          -  Previous treatment with BoNT of any serotype and for any body region within the 4
             months prior to screening

          -  Previous or planned treatment with phenol- or alcohol-injection in the target limb

          -  Other muscle hypertonia (e.g. rigidity)

          -  Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis,
             or any other significant neuromuscular disease which might interfere with the study

          -  Severe atrophy of the target limb muscles
A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
Condition: Contraception; Female Contraception
Intervention: DR-102
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2858.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pregnancy Prevention; Oral Contraceptives

Summary:

      This is an open-label, single treatment study. All subjects will receive 12 months of oral
      contraceptive therapy with DR-102. Study participants will receive physical and gynecological
      exams, including Pap smear. During the study, all participants will be required to complete a
      daily diary.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually active at risk for pregnancy

          -  Agreement to use study oral contraceptive therapy as their only method of birth
             control during the study

          -  History of regular spontaneous menstrual cycles or withdrawal bleeding episodes

          -  Others as dictated by protocol

        Exclusion Criteria:

          -  Any contraindication to the use of oral contraceptives

          -  Pregnancy or plans to become pregnant in the next 14 months

          -  Smoker and age greater than or equal to 35 years

          -  Others as dictated by protocol
Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Condition: Invasive Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 13-valent pneumococcal conjugate vaccine (13vPnC); Blood draw
Intervention description: 0.5 mL intramuscular injection; Collection of 10 mL of blood
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 5 Years
Maximum age: 7 Years
Healthy volunteers: No
Keywords: Immune response; pneumococcal conjugate vaccine; polysaccharide

Summary:

      The primary purpose of this study is to evaluate the immune response to 13-valent
      pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a
      complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine
      (PSV). This study is also intended to evaluate the safety of the 13vPnC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506)
             and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine
             (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that
             study.

          -  Subjects must be in good health as determined by medical history, physical examination
             and clinical judgment.

        Exclusion Criteria:

          -  Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC)
             or 13-valent pneumococcal conjugate vaccine (13vPnC).

          -  History of documented invasive pneumococcal disease (defined as a positive culture of
             S. pneumoniae from a normally sterile body site).

          -  Any known or suspected disease or dysfunction of the immune system, including: HIV
             infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell
             hemoglobinopathy.

          -  Receipt of immune-globulin within the past 3 months.

          -  Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.