bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: AzaSite; Vehicle
Intervention description: 1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected
eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.; Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
Intervention MeSH terms: Azithromycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 685.0
Sex: All
Minimum age: 12 Months
Healthy volunteers: No
Keywords: Bacterial Conjunctivitis; Pink Eye; Conjunctivitis; Eye Infection; Eye Discharge

Summary:

      The purpose of this study is to evaluate the clinical and microbial efficacy and safety of
      AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age
      and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be
      randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required
      for this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject, of any race, who is at least 1 year of age.

          -  Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit
             mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular
             and yellow discharge) and redness in at least one eye.

          -  The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72
             hours) or less.

          -  Must be willing to discontinue contact lens wear for the duration of the study.

        Exclusion Criteria:

          -  Any uncontrolled, systemic, debilitating disease.

          -  Use of topical ophthalmic solutions including tear substitutes within 2 hours before
             and during the study.

          -  Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and
             during the study.

          -  Any active upper respiratory tract infection.

          -  Pregnant or nursing females.

          -  Use of any antibiotic (topical or systemic) within 72 hours of enrollment
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Condition: Glioblastoma; Gliosarcoma
MeSH terms: Glioblastoma; Gliosarcoma
Intervention: Temozolomide; Depatuxizumab mafodotin; Radiation; Placebo for ABT-414
Intervention description: Oral Capsule; Intravenous (IV) Infusion; IV Infusion (IV)
Intervention MeSH terms: Temozolomide; ABT-414
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Sub-study was open-label.
Enrollment: 691.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Newly Diagnosed Glioblastoma; Epithelial Growth Factor Receptor (EGFR); Temozolomide; ABT-414; Radiology Therapy Oncology Group; Antibody Drug Conjugate; Brain Tumor; Brain Tumor Group; EGFRvIII; EGFR Amplified; First Line Therapy; Brain Cancer

Summary:

      This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and
      temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall
      survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal
      growth factor receptor (EGFR) amplification.

      In addition, there is a Phase 1, open-label, multicenter sub-study to assess the
      pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed
      EGFR-amplified GBM who have mild or moderate hepatic impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a clinical diagnosis of glioblastoma (GBM).

          -  Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.

          -  Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to
             randomization (N/A to the sub-study).

          -  Must have recovered from effects of surgery, postoperative infection and other
             complications of surgery.

          -  Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the
             participant must have adequate bone marrow and renal function and have
             mild-to-moderate hepatic impairment).

        Exclusion Criteria:

          -  Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the
             participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or
             metastatic GBM).

          -  Prior chemo therapy or radiosensitizer for head and neck cancer.

          -  Prior radiotherapy to the head or neck in overlap of radiation fields.

          -  Prior therapy for glioblastoma or other invasive malignancy.

          -  Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF),
             EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or
             intracavity anti-neoplastic therapy.
Effectiveness of Telephone Versus Face-to-Face CBT in Treating People With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Telephone-administered cognitive behavioral therapy (T-CBT); Face-to-face administered CBT (FtF-CBT)
Intervention description: Over 18 weeks, participants will receive eighteen 45-minute sessions of T-CBT administered by a therapist. Participants will undergo telephone-administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.; Over 18 weeks, participants will receive eighteen 45-minute sessions of FtF-CBT administered by a therapist. Participants will undergo face-to-face administered sessions twice a week for 2 weeks, once a week for 12 weeks, and once every 2 weeks for the last 4 weeks. Participants will be taught ways to modify thoughts and behaviors that contribute to their depression and ways to maintain the lifestyle changes that they have made.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Depressive Disorder, Major; Cognitive Behavioral Therapy; Psychotherapy; Telemedicine; Primary Care

Summary:

      This study will compare the effectiveness of telephone versus face-to-face administration of
      cognitive behavioral therapy in treating people with depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a current diagnosis of major depressive disorder

          -  Has a primary care physician at Northwestern University in Illinois, or one of a
             number of approved community clinics in Chicago.

          -  Resides in Illinois

          -  Has a telephone

          -  Speaks and reads English

        Exclusion Criteria:

          -  Hearing, voice, or visual impairment

          -  Meets criteria for dementia

          -  Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current
             substance abuse, or other condition for which participation in a clinical trial of
             psychotherapy may be either inappropriate or dangerous

          -  Currently receiving individual psychotherapy or planning to receive psychotherapy
             during the treatment phase of the study

          -  Planning to be out of town or unavailable for treatment for 4 weeks or more during the
             scheduled treatment time

          -  Recent history of suicide attempts or is severely suicidal

          -  Initiated treatment with an antidepressant in the 2 months before study entry
             (antidepressant medication is not exclusionary)

          -  Depression determined to be primarily of an organic etiology
Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: Tablets, Oral, Once Daily, Up to 24 weeks; Tablets, Oral, Once Daily, Up to 24 weeks
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 497.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases

Summary:

      The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can
      help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well
      controlled on diet and exercise alone. The safety of this treatment will also be studied
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus

          -  Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%

          -  C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)

          -  Body Mass Index ≤ 45 kg/m²

          -  Must be able to perform self monitoring of blood glucose

        Exclusion Criteria:

          -  aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit
             of normal (ULN)

          -  Serum Total bilirubin >2 mg/dL (34.2 µmol/L)

          -  Creatinine kinase >3* ULN

          -  Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L)
             for female subjects

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematological,
             oncological, endocrine, psychiatric, or rheumatic diseases
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
Condition: Chronic Obstructive Pulmonary Disorder
MeSH terms: Lung Diseases
Intervention: BFF MDI 320/9.6 μg; BFF MDI 160/9.6 μg; FF MDI 9.6 μg; BD MDI 320 μg; Symbicort® TBH 400/12 μg BID
Intervention description: Blinded Treatment; Blinded Treatment; Blinded Treatment; Blinded Treatment; Open Label
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2389.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung
      function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320
      μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Give their signed written informed consent to participate

          2. Are at least 40 years of age and no older than 80 years

          3. COPD patients who are symptomatic

          4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

        Exclusion Criteria:

          1. Current diagnosis of asthma,

          2. COPD due to α1-Antitrypsin Deficiency

          3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis,
             Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months

          4. Long-term-oxygen therapy (≥ 12 hours a day).
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis
Condition: Moderate to Severe Nail Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab; Placebo
Intervention description: Study treatment was provided in pre-filled 1 mL syringes.; Placebo was provided in pre-filled 1 mL syringes.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate nail psoriasis; Severe nail psoriasis; psoriasis; Secukinumab

Summary:

      This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on
      nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with chronic moderate to severe plaque type psoriasis for at least 6 months
             prior to randomization, including significant nail involvement, defined as Nail
             Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND
             Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score
             ≥10%

          -  Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical
             treatment (including super potent topical corticosteroids) and/or phototherapy and/or
             previous systemic therapy

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis,
             palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate
             psoriasis)

          -  Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers,
             calcium channel inhibitors or lithium)

          -  Ongoing inflammatory skin diseases other than psoriasis or any other disease affecting
             the fingernails which may potentially confound the evaluation of study treatment
             effects

          -  Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS),
             UV therapy). Washout periods do apply

          -  Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting
             IL-17 or the IL-17 receptor

          -  Exposure to any investigational drugs within 4 weeks prior to study treatment
             initiation or within a period of 5 half-lives of the investigational treatment,
             whichever is longer

          -  History of hypersensitivity to constituents of the study treatment

          -  Other protocol-defined inclusion/exclusion criteria do apply
Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Ubrogepant; Placebo-matching Ubrogepant
Intervention description: Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1686.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25
      and 50 mg) compared to placebo for the acute treatment of a single migraine attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis
             according to the International Classification of Headache Disorders, 3rd edition, beta
             version

          -  Migraine onset before age 50

          -  History of migraines typically lasting between 4 and 72 hours if untreated or treated
             unsuccessfully and migraine episodes are separated by at least 48 hours of headache
             pain freedom

          -  History of 2 to 8 migraine attacks per month with moderate to severe headache pain in
             each of the previous 3 months.

        Exclusion Criteria:

          -  Difficulty distinguishing migraine headache from tension-type other headaches

          -  Has taken medication for acute treatment of headache (including acetaminophen,
             nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or
             combination analgesics) on 10 or more days per month in the previous 3 months

          -  Has a history of migraine aura with diplopia or impairment of level of consciousness,
             hemiplegic migraine, or retinal migraine

          -  Has a current diagnosis of new persistent daily headache, trigeminal autonomic
             cephalgia (eg, cluster headache), or painful cranial neuropathy

          -  Required hospital treatment of a migraine attack 3 or more times in the previous 6
             months

          -  Has a chronic non-headache pain condition requiring daily pain medication

          -  Has a history of malignancy in the prior 5 years, except for adequately treated basal
             cell or squamous cell skin cancer, or in situ cervical cancer

          -  Has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes,
             inflammatory bowel disease) that may affect the absorption or metabolism of
             investigational product; participants with prior gastric bariatric interventions which
             have been reversed are not excluded

          -  Has a history of hepatitis within previous 6 months.
Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Etoricoxib 90 mg; Etoricoxib 120 mg; Ibuprofen 600 mg; Matching Placebo for Etoricoxib 120 mg; Matching Placebo for Etoricoxib 90 mg; Matching Placebo for Ibuprofen; Morphine; Oxycodone
Intervention description: One 90 mg tablet once daily; Two 60 mg tablets once daily; One tablet three times daily; Two tablets once daily; One tablet once daily; One tablet three times daily; As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection; 5 mg as needed
Intervention MeSH terms: Ibuprofen; Etoricoxib; Morphine; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 776.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to
      placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total
      knee replacement surgery. The hypotheses for this study were that the average pain intensity
      difference (at rest) in participants treated with Etoricoxib (120 mg, 90 mg) is superior to
      placebo, the average total daily dose of morphine in participants treated with Etoricoxib
      (120 mg, 90 mg) is less than in participants treated with placebo, and that Etoricoxib (120
      mg, 90 mg) will be generally safe and well tolerated by participants treated for pain
      following total knee replacement orthopedic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        - Is in generally good health and is scheduled to have a total knee replacement

        Exclusion Criteria:

          -  Is allergic, intolerant to, or has a history of a significant clinical or laboratory
             adverse experience associated with etoricoxib or other cyclooxygenase-2 (COX-2)
             inhibitors/non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen, morphine, or
             oxycodone, or has hypersensitivity to aspirin, or other NSAIDs

          -  Has uncontrolled hypertension

          -  Is currently a user of any illicit drugs, or has a history of drug or alcohol abuse
             within the past 5 years
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Intervention: MenHibrix (Hib-MenCY-TT); Hib conjugate vaccine (ActHIB)
Intervention description: First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose; First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 22 Months
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Humans; Meningococcal vaccines; Immunogenicity; Vaccines; H. influenzae type b vaccine; Conjugate; Toddlers; Comparative study; Neisseria meningitidis

Summary:

      This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2,
      4 & 6 years of age, respectively) in subjects vaccinated in a previous study.

      This protocol posting deals with objectives & outcome measures of the extension phase at
      years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in
      a separate protocol posting (NCT00129129).

      This protocol posting has been amended in order to comply with the FDA Amendment Act of
      September 26, 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female children who completed the previous four dose vaccination
             series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines
             are as follows:

               -  Year 1: 22 to 36 months of age.

               -  Year 3: 44 to 60 months of age.

               -  Year 5: 5 years post-dose 4 +/- 8 weeks

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study

          -  Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006

        Exclusion Criteria:

        Children should not have:

          -  received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine

          -  had a history of H. influenzae type b, meningococcal serogroup C and Y diseases