bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Lebrikizumab
Intervention description: Subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Eczema; Dermatitis; Dermatitis, Atopic; Skin Diseases

Summary:

      This is an open-label, single arm study of 52 weeks duration. The study will assess the
      safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40
      kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).

          2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has
             been present for ≥1 year before the screening visit.

          3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.

          4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit

          5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.

          6. History of inadequate response to treatment with topical medications; or determination
             that topical treatments are otherwise medically inadvisable.

        Exclusion Criteria:

          1. Participation in a prior lebrikizumab clinical study.

          2. Treatment with the following prior to the baseline visit:

               1. An investigational drug within 8 weeks or within 5 half-lives (if known),
                  whichever is longer.

               2. Dupilumab within 8 weeks.

               3. B-cell-depleting biologics, including to rituximab, within 6 months.

               4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.

          3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
             planned during the study.

          4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.

          5. Evidence of active acute or chronic hepatitis

          6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
             screening.

          7. History of malignancy, including mycosis fungoides, within 5 years before the
             screening visit, except completely treated in situ carcinoma of the cervix, completely
             treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

          8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
             during the study.
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Insulin Glargine
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine; Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 917.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T2DM

Summary:

      The main reason for this study is to compare the study drug tirzepatide to insulin glargine
      in participants with type 2 diabetes on metformin with or without a sulfonylurea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Treated with stable metformin with or without a sulfonylurea (metformin ≥1000
             milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2
             months

          -  Are insulin-naive (except for the use of insulin for treatment of gestational diabetes
             or short-term use [≤14 consecutive days] for acute conditions)

          -  HbA1c ≥7.5% to ≤11.0% at screening

          -  Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise
             program during the study with the intent of reducing body weight other than the
             lifestyle and dietary measures for diabetes treatment

          -  Body mass Index (BMI) ≥23 kilograms per meter squared

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Have history of chronic or acute pancreatitis

          -  Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or
             non-proliferative diabetic retinopathy that requires acute treatment

          -  Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months

          -  Have a history of ketoacidosis or hyperosmolar state/coma

          -  Have a known clinically significant gastric emptying abnormality, have undergone or
             plan to have during the course of the study, or chronically take drugs that directly
             affect GI motility

          -  Have acute myocardial infarction (MI), stroke or hospitalization due to congestive
             heart failure (CHF) within 2 months

          -  Have family or personal history of medullary thyroid carcinoma (MTC) or multiple
             endocrine neoplasia syndrome type 2 (MEN-2)

          -  Have been treated with prescription drugs that promote weight loss or similar other
             body weight loss medications including over the counter (OTC) within 3 months
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Intervention: RotaTeq™ experimental formulation; RotaTeq™ existing formulation
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1020.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™
      with the existing formulation in infants. The primary hypothesis of the study is that the new
      formulation will be noninferior to the existing formulation on the basis of immunogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent or legal guardian agrees to have infant participate by giving written informed
             consent

        Exclusion Criteria:

          -  History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic
             diarrhea, failure to thrive, or abdominal surgery

          -  History of intussusception

          -  Known or suspected impairment of immunological function, including Severe

        Combined Immunodeficiency (SCID)

          -  Prior administration of any rotavirus vaccine

          -  Clinical evidence of active gastrointestinal illness, with the exception of
             well-controlled gastroesophageal reflux disease (GERD)

          -  Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or
             equivalent) for 14 consecutive days or more since birth, or 2) systemic
             corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first
             dose of study vaccine. Participant using non-systemic corticosteroids will be eligible
             for vaccination.

          -  Residing in a household with an immunocompromised person

          -  Prior receipt of a blood transfusion or blood products, including immunoglobulins

          -  Participation in another interventional study within 14 days prior to the first study
             vaccination or expected anytime during the study

          -  Receipt of investigational inactivated vaccines within 14 days or investigational live
             vaccines within 28 days prior to the first study vaccination or expected anytime
             during the study
Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
Condition: Antiphospholipid Syndrome
MeSH terms: Thrombosis; Antiphospholipid Syndrome
Intervention: Hydroxychloroquine
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: antiphospholipid autoantibodies; antiphospholipid positive

Summary:

      In this multi-center international study, our aim is to determine the effectiveness of HCQ
      for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients
      without systemic autoimmune diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the
             screening defined as:

               -  aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th
                  percentile)and/or

               -  aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th
                  percentile)and/or

               -  Positive LA test based on the International Society of Thrombosis & Haematosis
                  Recommendations

        Selected Exclusion Criteria:

          -  History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis

          -  History of Transient Ischemic Attack Confirmed by a Neurologist

          -  SLE Diagnosis based on the ACR Classification Criteria > 4/11

          -  Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria

          -  Current Hydroxychloroquine or another antimalarial treatment (-3 months)

          -  Current warfarin treatment (-3 months)

          -  Current heparin therapy( -3 months)

          -  Current pregnancy

          -  History of Hydroxychloroquine eye toxicity

          -  History of Hydroxychloroquine allergy

          -  Known glucose-6-phosphate dehydrogenase deficiency
Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; exenatide
Intervention description: 1.8 mg once daily for s.c. (under the skin) injection.; 10 mcg twice daily for s.c. (under the skin) injection.
Intervention MeSH terms: Liraglutide; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to
      subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea
      or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week
      randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received
      liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both
      combined with OAD treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a
             combination of both) for at least 3 months at the discretion of the Investigator

          -  HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%

          -  Body Mass Index (BMI) equal to or lower than 45.0 kg/m2

        Exclusion Criteria:

          -  Previous treatment with insulin

          -  Treatment with any anti-diabetic drug other than metformin and sulphonylurea

          -  Any previous exposure to exenatide or liraglutide

          -  Impaired liver or/and renal function

          -  History of any significant cardiac events

          -  Known retinopathy or maculopathy requiring acute treatment

          -  Recurrent major hypoglycaemia or hypoglycaemic unawareness
Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
Condition: Bacterial Pneumonia; Community-Acquired Infections
MeSH terms: Pneumonia; Pneumonia, Bacterial; Community-Acquired Infections
Intervention: Omadacycline; Moxifloxacin
Intervention description: Injection for IV; Oral tablets; IV solution; Oral tablets
Intervention MeSH terms: Moxifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 774.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared
      to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, ages 18 years or older who have signed the informed consent

          -  Has qualifying bacterial pneumonia

          -  Female patients must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

        Exclusion Criteria:

          -  Known or suspected hospital-acquired pneumonia

          -  Evidence of significant immunological disease

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to any
             fluoroquinolone antibiotic

          -  Has received an investigational drug within past 30 days

          -  Women who are pregnant or nursing
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor; Placebo
Intervention description: 150-mg tablets given orally q12h for up to 48 weeks; Tablet given orally q12h for up to 48 weeks
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Fibrosis; Pancreatic Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Pathologic Processes

Summary:

      The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects
      with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic
      fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective
      CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein.
      Potentiators are pharmacological agents that increase the chloride ion transport properties
      of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of cystic fibrosis (CF) and G551D mutation in at least 1 allele

          -  Forced expiratory volume in 1 second (FEV1) of 40% to 90% (inclusive) of predicted
             normal for age, gender, and height at Screening.

          -  No clinically significant abnormalities that would have interfered with the study
             assessments, as judged by the investigator

          -  Willing to use highly effective birth control methods during the study

        Exclusion Criteria:

          -  History of any illness or condition that might confound the results of the study or
             pose an additional risk in administering study drug to the subject

          -  Acute respiratory infection, pulmonary exacerbation, or changes in therapy for
             pulmonary disease within 4 weeks of Day 1 of the study

          -  History of alcohol, medication or illicit drug abuse within one year prior to Day 1

          -  Abnormal liver function ≥ 3x the upper limit of normal

          -  Abnormal renal function at Screening

          -  History of solid organ or hematological transplantation

          -  Pregnant, planning a pregnancy, breast-feeding, or unwilling to follow contraception
             requirements

          -  Ongoing participation in another therapeutic clinical study or prior participation in
             an investigational drug study within 30 days prior to Screening

          -  Use of inhaled hypertonic saline treatment

          -  Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4)
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
Condition: Severe Hepatic Veno-Occlusive Disease
MeSH terms: Hepatic Veno-Occlusive Disease
Intervention: Defibrotide
Intervention description: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
Intervention MeSH terms: Defibrotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Healthy volunteers: No
Keywords: Defibrotide; Severe veno occlusive disease; Multi organ failure; Stem cell transplant; Liver; Regimen related toxicity; Day 100 survival

Summary:

      The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25
      mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2)
      evaluate serum and endothelial markers of veno-occlusive disease (VOD) through the analysis
      of blood samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of VOD, defined by jaundice (bilirubin >/= 2 mg/dL) and at least 2
             of the following clinical findings, by Day+21 post stem cell transplant: ascites;
             weight gain >/= 5% above baseline weight; hepatomegaly.

          -  Severe VOD, defined as VOD with multi-organ failure, i.e., presence of one or both of
             the following, by Day+28 post stem cell transplant: renal or pulmonary dysfunction.

          -  Provide voluntary written informed consent.

        Exclusion Criteria:

          -  Pre-existing (prior to SCT) cirrhosis

          -  An alternative diagnosis for weight gain, ascites and jaundice

          -  Graft-versus-host disease (GVHD) grade B or higher involving liver or gut or grade C
             or higher involving skin

          -  Prior solid organ transplant

          -  Dependent on dialysis prior to and/or at the time of SCT

          -  Dependent on oxygen supplementation prior to SCT

          -  Significant acute bleeding or hemodynamic instability

          -  Requirement for the use of any medications that increase risk of hemorrhage will be
             excluded from the treatment group
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Condition: Hemodialysis; Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: PA21; Sevelamer hydrochloride
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 213.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hyperphosphatemia

Summary:

      The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis
      patients with hyperphosphatemia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 20 or older, regardless of gender.

          -  Receiving stable maintenance hemodialysis 3 times a week.

          -  Patients not having changed their phosphate binder agent dose, for 4 weeks or more
             before their observation period start.

        Exclusion Criteria:

          -  Patients having history of a pronounced brain / cardiovascular disorder.

          -  Patients having severe gastrointestinal disorders.

          -  Patients having severe hepatic disorders.
A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
Condition: Chronic Kidney Disease; Hyperphosphatemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®); Placebo; Another phosphate binder (Sevelamer)
Intervention description: 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind; 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind; Current approved dosing recommendations for 12 weeks
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Phosphate binder

Summary:

      This is a phase III multi-centre study in three periods: the first period is a phosphate
      binder washout for 4 weeks, the second period is an open-label, randomised, parallel group,
      flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with
      placebo for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age or over

          -  Clinically stable haemodialysis or peritoneal dialysis

          -  Stable phosphate control

          -  On a stabilised phosphorus diet

          -  Female and of child-bearing potential have a negative serum pregnancy test.

          -  Male subjects must agree to use appropriate contraception.

        Exclusion Criteria:

          -  Current clinically significant medical comorbidities, which may substantially
             compromise subject safety, or expose them to undue risk, or interfere significantly
             with study procedures and which, in the opinion of the Investigator, makes the subject
             unsuitable for inclusion in the study.

          -  Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2

          -  A current or history of significant gastrointestinal motility problems

          -  A positive test for HIV 1 and 2 antibodies

          -  A history of substance or alcohol abuse within the last year.

          -  Seizure disorders

          -  A history of drug or other allergy

          -  A temporary catheter as a vascular access

          -  Participated in a clinical study with any experimental medication in the last 30 days
             or an experimental biological product within the last 90 days prior to signing of
             informed consent