bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Efavirenz 600mg; Efavirenz 400mg
Intervention description: 3 x EFV 200 milligram (mg) tablets once daily; 2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily
Intervention MeSH terms: Efavirenz
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 636.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: HIV; Antiretroviral Therapy (ART); Efavirenz (EFV); Dose reduction

Summary:

      Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV),
      could be reduced without compromising its effectiveness. Lower drug doses could have fewer
      side effects and would make EFV more affordable. The purpose of this study is to compare the
      safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV
      in controlling HIV as part of initial combination antiretroviral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 positive by licensed diagnostic test

          -  aged >16 years of age (or minimum age as determined by local regulations or as legal
             requirements dictate)

          -  50 < cluster of differentiation (CD)4 <500 cells/µL

          -  No prior AIDS-defining illness, using the Center for Diseases Control 1993 Case
             Definition (except pulmonary tuberculosis)

          -  HIV RNA ≥1000 copies/mL

          -  no prior exposure to antiretroviral therapy (ART) (including short course ART for
             preventing MTCT)

          -  calculated creatinine clearance (CLCr) more than or equal to 50 mL/min
             (Cockcroft-Gault formula)

          -  provision of written informed consent.

        Exclusion Criteria:

          -  the following laboratory values:

               -  absolute neutrophil count (ANC) <500 cells/μL

               -  hemoglobin <7.0 g/dL

               -  platelet count <50,000 cells/μL

               -  alanine aminotransferase and/or aspartate aminotransferase >5 x upper limit of
                  normal

          -  pregnant women or nursing mothers

          -  active opportunistic or malignant disease not under adequate control

          -  use of immunomodulators within 30 days prior to screening

          -  use of any prohibited medications

          -  current alcohol or illicit substance use that might adversely affect study
             participation
Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-120 Gel; IDp-120 Vehicle Gel
Intervention description: IDP-120 Gel, once-daily application; IDP-120 Vehicle Gel, once-daily application
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
Enrollment: 608.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120
      Vehicle Gel
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older;

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit);

          3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
             Severity Score (EGSS) assessment at the baseline visit;

          4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20 but no more than 50;

          5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
             less than 25 but no more than 100;

          6. Subjects with two or fewer facial nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
             eczema;

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive;

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments;

          5. Subjects with more than two (2) facial nodules;

          6. Evidence or history of cosmetic-related acne
A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Dalcetrapib; Placebo
Intervention description: Dalcetrapib 600 mg orally once daily; Placebo orally once daily
Intervention MeSH terms: Dalcetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 936.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect
      of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker
      profile and long-term safety profile of dalcetrapib in patients with coronary artery disease.
      Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound
      (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial
      Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have
      coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg
      orally once a day or placebo. The anticipated time on study treatment will be 24 months. The
      target sample size is 800-1000 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients over the age of 18 years

          -  Angiographic evidence of coronary artery disease

          -  Ultrasound evidence of carotid artery disease

          -  Treated appropriately for dyslipidemia

        Exclusion Criteria:

          -  Previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or
             CETP-vaccine within the last 3 months before study start

          -  Previous coronary artery bypass graft surgery (CABG) or probable need for CABG in the
             next 24 months

          -  Myocardial infarction in the target coronary artery for IVUS between the initial IVUS
             examination and randomization

          -  Patients who have symptomatic congestive heart failure at baseline (New York Heart
             Association class III or IV)

          -  Severe anemia

          -  Uncontrolled hypertension

          -  Poorly controlled diabetes
Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABP 501
Intervention description: Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Maximum age: 81 Years
Healthy volunteers: No
Keywords: arthritis; rheumatoid

Summary:

      The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP
      501 in adults with moderate to severe rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26
             visit

        Exclusion Criteria:

          -  Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the
             20120262 study that could cause extension treatment to be detrimental

          -  Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26
             visit of study 20120262

          -  Current infection requiring the use of oral or intravenous antibiotics

        Other Inclusion/Exclusion criteria may apply
Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Placebo
Intervention description: Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.; Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14671.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment
      with sitagliptin used as part of usual care compared to usual care without sitagliptin in
      participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV)
      disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.

      Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to
      usual care without sitagliptin with regard to the risk of developing a confirmed event in the
      primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If
      hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care,
      is superior to usual care without sitagliptin with regard to the risk of developing a
      confirmed event in the primary CV composite endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has T2DM

          -  Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of
             antihyperglycemic agent(s), including insulin

          -  Has pre-existing cardiovascular disease

        Exclusion Criteria:

          -  Has a history of type 1 diabetes mellitus or ketoacidosis.

          -  Is not able to take sitagliptin
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab; Placebo
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: 514.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      This study will evaluate higher versus standard adalimumab dosing regimens for induction and
      maintenance therapy in subjects with moderately to severely active Crohn's Disease and
      evidence of mucosal ulceration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during
             the Screening Period.

          -  Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral
             corticosteroids and/or immunosuppressants.

          -  Mucosal ulceration on endoscopy.

        Exclusion Criteria:

          -  Subject with ulcerative colitis or indeterminate colitis.

          -  Subject who has had surgical bowel resections in the past 6 months or is planning
             resection.

          -  Subjects with an ostomy or ileoanal pouch.

          -  Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

          -  Subject who has short bowel syndrome.

          -  Chronic recurring infections or active Tuberculosis (TB).
Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: Rotigotine transdermal patches:
10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neupro®; Rotigotine; Parkinson's Disease

Summary:

      The objective of this open-label extension is to assess the long-term effect of the 24-hour
      transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and
      non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the
      rotigotine transdermal patch will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of trial SP889

        Exclusion Criteria:

          -  Ongoing serious adverse event assessed as related to trial medication
Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis; Hay Fever
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Beclomethasone dipropionate; Placebo Nasal Aerosol
Intervention description: Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.; Placebo nasal aerosol administered each morning for two weeks.
Intervention MeSH terms: Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 340.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the efficacy and safety of an investigational nasal
      aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent

          -  Male or female subjects 12 years of age or older

          -  Documented history of season allergic rhinitis to mountain cedar pollen

          -  General good health

          -  Other criteria apply

        Exclusion Criteria:

          -  History of physical findings of nasal pathology (within 60 days prior to screening
             visit)

          -  Participation in any investigational drug study 30 days preceding screening visit

          -  History of respiratory infection/disorder with 14 days preceding screening visit

          -  Use of any prohibited concomitant medications

          -  Other criteria apply
Growth Retardation In Children With Special Pathological Conditions Or Disease
Condition: Endocrine System Diseases
MeSH terms: Endocrine System Diseases
Intervention: Somatropin
Intervention description: Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 11 Years
Maximum age: 13 Years
Healthy volunteers: No

Summary:

      To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in
      standard deviation (SD) after 3 years will be compared to growth rate before the start of GH
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bone age < 13 years for a boy and < 11 years for a girl

          -  Naive child: Measured Height < -2.5 SD for CA

          -  Child currently treated by GH

        Exclusion Criteria:

          -  Idiopathic short stature

          -  Syndrome known to be associated with an increased risk of cancer e.g. family history
             of adenomatous polyposis
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
Condition: Amblyopia
MeSH terms: Amblyopia
Intervention: Atropine; Plano Lens
Intervention description: Atropine 1% once each weekend day; Plano lens for the sound eye
Intervention MeSH terms: Atropine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 3 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Amblyopia; Atropine; Plano lens

Summary:

      The purpose of the study is:

        -  To compare the effectiveness and safety of weekend atropine augmented with a plano lens
           for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100)
           in children 3 to less than 7 years old.

        -  To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine
           treatment with and without a plano lens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be 3 to less than 7 years old with amblyopia associated with strabismus,
             anisometropia, or both.

          -  Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual
             acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR
             lines.

          -  Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity
             documented to be stable.

        Exclusion Criteria:

          -  Atropine treatment within 6 months of enrollment and other amblyopia treatment of any
             type (other than normal spectacle lenses) used within one month of enrollment

          -  No myopia in amblyopic eye
A Study of LY900014 in Participants With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug LY900014
      compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in
      adults with type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T1D for at least 1 year prior to screening and continuously using insulin for at
             least 1 year.

          -  HbA1c of ≥7.0 and ≤9.5%.

          -  Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.

          -  Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn
             (NPH) insulin as basal insulin.

        Exclusion Criteria:

          -  Have used other antihyperglycemic medications or therapies (inhaled, oral or
             injectable) within 90-days of screening.

          -  Have had more than 1 severe hypoglycemic episode within 6 months of screening.

          -  Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis
             within 6 months of screening.

          -  Have clinically significant gastrointestinal disease.
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Condition: Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Metformin; Vitamin E; Matching placebo
Intervention description: 500 mg, twice daily; 400 IU, twice daily; Twice daily
Intervention MeSH terms: Vitamin E; Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 173.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Non alcoholic fatty liver disease

Summary:

      The purpose of this study is to determine if therapeutic modification of insulin resistance
      or oxidative stress leads to improvement in serum or histologic indicators of liver injury or
      quality of life.
    

Eligibility criteria:

        -  Age 8-17 years at first screening visit

          -  Histologic evidence of Nonalcoholic Fatty Liver Disease (NAFLD) - biopsy cannot be
             older than 6 months as of randomization

          -  ALT level >60 U/L at time of screening and on one previous occasion determined at
             least one month but no greater than 6 months prior to screening ALT

          -  Consent