bioihbjkbjnl/mcl2 huggingface dataset:
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults
Condition: Chronic Hepatitis C Virus (HCV Infection Genotype 1)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ombitasvir/paritaprevir/ritonavir, dasabuvir; sofosbuvir (SOF); ribavirin (RBV)
Intervention description: tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; tablet; tablet
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Treatment naive; Hepatitis C Genotype 1

Summary:

      This open-label study will evaluate the safety and efficacy of co-formulated
      ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or
      without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic
      HCV-genotype 1 infection without cirrhosis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 18 years of age at time of screening

          2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment

          3. Screening laboratory results from the central clinical laboratory indicating HCV
             genotype 1 infection only

          4. Absence of cirrhosis and advanced bridging fibrosis

        Exclusion Criteria:

          1. Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency
             virus (HIV) positive immunoassay

          2. Clinically significant abnormalities or co-morbidities, other than HCV infection, that
             make the subject an unsuitable candidate for this study or treatment with Ribavirin
             (RBV) in the opinion of the investigator

          3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal
             varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a
             Metavir score > 2 or an Ishak score > 3

          4. Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir,
             sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10
             half-lives whichever is longer, prior to study drug administration

          5. Current enrolment in another clinical study, previous enrolment in this study, or
             previous use of any investigational or commercially available anti-HCV agents
Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Montelukast; Placebo
Intervention description: Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days; Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 10 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of
      Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis
      of this study is that montelukast is superior to placebo in the treatment of nasal symptoms
      in SAR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weight: ≥ 25 kg

          -  Height: ≥ 125 cm

          -  Able to record symptoms in a diary

          -  Has had allergic rhinitis symptoms [Japanese Cedar (JC) pollinosis]

          -  Tested positive for JC pollen specific immunoglobulin E (IgE) antibody assay

        Exclusion Criteria:

          -  Has nasal findings that would interfere with evaluating nasal congestion symptoms

          -  Past or present medical history of bronchial asthma

          -  Medical history of allergies except allergic rhinitis and has possibility of
             dramatically worsening of these symptoms induced by JC pollen exposure
Long-Acting Growth Hormone in Children Compared to Daily rhGH
Condition: Growth Disorders
MeSH terms: Growth Disorders
Intervention: Somavaratan; rhGH
Intervention description: Somavaratan will be administered per dose and schedule specified in the arm description.; rhGH will be administered per dose and schedule specified in the arm description.
Intervention MeSH terms: Hormones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 3 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: VRS-317; Growth Hormone Deficiency; Long Acting Recombinant Growth Hormone; Long Acting Growth Hormone; Pediatric Growth Hormone Deficiency; Growth Hormone Replacement Therapy; Versartis; Xten; Human Growth Hormone; somavaratan; growth failure

Summary:

      The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of
      treatment effect against daily injections of rhGH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronological Age ≥ 3.0 years and ≤ 10.0 (girls) and ≤ 11.0 (boys).

          -  Pre-pubertal status: Absent breast development in girls, testicular volume < 4.0 mL in
             boys.

          -  Diagnosis of growth hormone deficiency (GHD) as documented by two or more growth
             hormone (GH) stimulation test results ≤ 10.0 ng/mL.

          -  Height standard deviation score (SDS) ≤ -2.0 at screening.

          -  Weight for Stature ≥ 10th percentile.

          -  Insulin-like growth factor-I (IGF-I) SDS ≤ -1.0 at screening.

          -  Delayed bone age (≥ 6 months).

        Exclusion Criteria:

          -  Prior treatment with any growth promoting agent

          -  History of, or concurrent significant disease (for example, diabetes, cystic fibrosis,
             renal insufficiency).

          -  Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD)
             or confirmed diagnosis of a named syndrome.

          -  A diagnosis of Attention Deficit Hyperactivity Disorder.

          -  Daily use of anti-inflammatory doses of glucocorticoid.

          -  Prior history of leukemia, lymphoma, sarcoma or cancer.

          -  Treatment with an investigational drug in the 30 days prior to screening.

          -  Known allergy to constituents of the study drug formulation.

          -  Ocular findings suggestive of increased intracranial pressure and/or retinopathy at
             screening.

          -  Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
             variants.

          -  Significant abnormality in screening laboratory studies
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mirikizumab SC; Mirikizumab IV; Placebo SC
Intervention description: Administered SC; Administered IV; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1177.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Interleukin-23 (IL-23); IL-23p19; Inflammatory Bowel Disease

Summary:

      The purpose of this study is to evaluate the efficacy and safety of mirikizumab as
      maintenance therapy in participants who completed as clinical responders in the prior 12-week
      induction study LUCENT-1 (NCT03518086).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and
             without early termination of study drug.

          -  Are willing and able to complete the scheduled study assessments, including endoscopy
             and daily diary entry.

          -  If female, must meet the contraception requirements.

        Exclusion Criteria:

          -  Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified
             (indeterminate colitis) during the induction study AMAN (NCT03518086).

          -  Participants with a bowel resection or other surgery for the treatment of UC during
             the previous induction study AMAN (NCT03518086), or are likely to require surgery for
             the treatment of UC during study AMBG.

          -  Participants with evidence of colonic dysplasia or have been diagnosed with cancer of
             the gastrointestinal tract during study AMAN (NCT03518086).

          -  Participants diagnosed with clinically important infection including, but not limited
             to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the
             induction study AMAN (NCT03518086).

          -  Participants who initiate a new prohibited medication during the induction study AMAN
             (NCT03518086).

          -  Participants with certain laboratory abnormalities prior to start of AMBG that would
             require permanent discontinuation from study drug.
Intranasal Dexmedetomidine Premedication in Children
Condition: Preoperative Sedation
Intervention: Midazolam; Dexmedetomidine
Intervention description: oral midazolam 0.5mg/kg upto maximum dose of 15mg; intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
Intervention MeSH terms: Midazolam; Dexmedetomidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Premedication

Summary:

      BACKGROUND INFORMATION AND RATIONALE

      Pediatric patients scheduled for dental procedures under general anesthesia can have
      significant anxiety before the procedure. They are commonly pre medicated to minimize
      distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose
      is more widely used for this purpose . However the commonly used maximum dose is up to 15mg.
      It also has many limitations such as paradoxical reaction, increased incidence of emergence
      delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been
      used an effective and safe alternative premedication to oral midazolam in children. At a dose
      of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation
      in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as
      providing analgesia and facilitating smooth emergence from anesthesia.

      The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative
      as premedication to oral midazolam in children weighing more than 20kg undergoing general
      anesthesia for dental rehabilitation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children older than 5yrs and weighing more than 20kg , who are scheduled for
             ambulatory dental rehabilitation at Batson operating rooms.

          -  ASA classification 1 or 2

        Exclusion Criteria

          -  Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and
             propofol.

          -  uncorrected congenital heart disease or history of cardiac arrhythmia,

          -  children at risk for airway obstruction (OSA or cranio facial syndrome),

          -  pregnant minors
Naproxen Sodium Extended-Release Actual Use Study
Condition: Pain
Intervention: Naproxen Sodium ER (BAYH6689)
Intervention description: Consumer use of Extended Release Naproxen Sodium
Intervention MeSH terms: Naproxen
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 497.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Non-prescription

Summary:

      The purpose of this Study is to assess how subjects will use the investigational product in
      an uncontrolled, naturalistic environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self report use of Over The Counter (OTC) analgesics

          -  Able to read and understand English

          -  Provide written informed consent (subjects 12- 17 years of age provide written as sent
             and/ or parent or legal guardian provide written consent)

          -  Purchase the investigational product

        Exclusion Criteria:

          -  Have participated in a study involving OTC analgesics in the last 12 months

          -  They or someone else in the household work for a market research company, an
             advertising agency, a public relations firm, pharmaceutical company, as a healthcare
             professional, or as part of a health care practice

          -  Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs)
             (i.e., Naproxen, Ibuprofen, etc) or Aspirin

          -  Have a history of heart surgery in the last 60 days or plans for heart surgery in the
             next 60 days

          -  (Female subjects) are pregnant or breastfeeding
Conversion to Monotherapy Study With Keppra XR for Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Intervention: Keppra XR; Keppra XR
Intervention description: Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks; Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 228.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Keppra XR; conversion to monotherapy; partial seizures

Summary:

      The primary objective of this study is to assess the efficacy of two doses of Keppra XR
      compared with a historical control as the placebo, in the monotherapy treatment of partial
      onset seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 12 to 75 years of age.

          -  Subjects must have inadequately controlled partial onset epilepsy.

          -  Subjects must be experiencing 2 to 40 seizures per 4-week period while being
             maintained on one or two standard AED(s)

        Exclusion Criteria:

          -  A history of status epilepticus in the 6 months preceding randomization.

          -  Significant medical, psychiatric or neurological illness.

          -  Intake of benzodiazepines on more than an occasional basis

          -  History of previous treatment with levetiracetam or sensitivity to levetiracetam.
A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo; Ixekizumab 80 mg Q4W; Ixekizumab 80 mg Q2W
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate how effective and safe the study drug known as
      ixekizumab is in participants with active psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6
             months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

          -  Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints

          -  Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)

          -  Men must agree to use a reliable method of birth control or remain abstinent during
             the study

          -  Women must agree to use reliable birth control or remain abstinent during the study
             and for at least 12 weeks after stopping treatment

          -  Have been treated with 1 or more conventional disease-modifying antirheumatic drugs
             (cDMARDs)

          -  Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor
             (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due
             to either an inadequate response (based on a minimum of 12 weeks on therapy) or
             documented intolerance.

        Exclusion Criteria:

          -  Current use of biologic agents for treatment of Ps or PsA

          -  Inadequate response to greater than 2 biologic DMARDs

          -  Current use of more than one cDMARDs

          -  Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other
             than PsA

          -  Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal
             antibody (MAb) therapy

          -  Serious disorder or illness other than psoriatic arthritis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
Condition: Erythema; Rosacea
MeSH terms: Rosacea; Erythema
Intervention: CD07805/47 gel 0.5%/CD07805/47 Vehicle; azelaic acid gel 15%
Intervention description: To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle.
During each treatment period (baseline to Day 15):
CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily; During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily
Intervention MeSH terms: Azelaic acid; Brimonidine Tartrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel
      0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily
      in subjects with moderate to severe facial erythema of rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is male or female aged 18 years or older.

          2. Subject has a clinical diagnosis of facial rosacea.

          3. Subject has a clinician's assessment score of moderate to severe erythema prior to
             enrollment.

          4. Subject has a self assessment score of moderate to severe redness prior to enrollment.

          5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

        Exclusion Criteria:

          1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.

          2. Subjects with a condition or who are in a situation, which in the Investigator's
             opinion may put a subject at risk, may confound study results, or may interfere with a
             subject's participation in the study.

          3. Subjects with conditions causing facial erythema which would confound the assessment
             of treatment.

          4. Subjects who are taking or have recently taken medications known to have interactions
             with α2-adrenergic agonists.

          5. Subjects with known allergies or sensitivities to one of the components of the
             investigational products.
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
Condition: Hyperlipidemia and Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Evolocumab; Standard of Care
Intervention description: Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen; Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3681.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: High cholesterol; Raised cholesterol; Cholesterol; Elevated Cholesterol

Summary:

      This study will contribute to the evaluation of long-term safety, tolerability and efficacy
      of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

        - Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114
        [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918],
        20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348
        [NCT01849497], or 20120356 [NCT01879319]).

        Exclusion Criteria:

          -  Experienced a treatment-related serious adverse event that led to study drug
             discontinuation in the parent study

          -  Have an unstable medical condition, in the judgment of the investigator

          -  Known sensitivity to any of the products to be administered during dosing

          -  Currently enrolled in another investigational device or drug study (excluding
             evolocumab (AMG 145) parent study), or less than 30 days since ending another
             investigational device or drug study(s),or receiving other investigational agent(s)