bioihbjkbjnl/mcl2 huggingface dataset:
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide ophthalmic suspension; Azopt®
Intervention description: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks; dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Intervention MeSH terms: Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic
      equivalence study with clinical endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or
             ocular hypertension in both eyes.

          -  Provide signed and dated informed consent in accordance with good clinical practice
             and local legislation prior to any study procedure.

          -  Be able and willing to follow study instructions and complete all required visits.

          -  Subject requires treatment of both eyes and is able to discontinue use of all ocular
             hypotensive medication(s) or switch ocular hypotensive medications and undergo
             appropriate washout period.

        Exclusion Criteria:

          -  Subjects with angle closure glaucoma

          -  Females who are pregnant, breast feeding, or planning a pregnancy.

          -  Females of childbearing potential who do not agree to utilize an adequate form of
             contraception.

          -  Current, or past history of, severe hepatic or renal impairment

          -  Current, or history within 2 months prior to baseline of, significant ocular disease

          -  Functionally significant visual field loss

          -  Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to
             any component of brinzolamide or sulfonamide therapy

          -  Subjects currently in another clinical trial
Lesinurad and Febuxostat Combination Extension Study in Gout
Condition: Gout
MeSH terms: Gout
Intervention: lesinurad; lesinurad; febuxostat
Intervention description: Tablets, 400 mg once daily (QD); Tablets, 200 mg QD; Tabletsm 80 mg QD
Intervention MeSH terms: Febuxostat; Lesinurad
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Gout

Summary:

      This study will assess the serum uric acid lowering effects and safety of lesinurad in
      combination with febuxostat over a long-term timeframe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is able to understand the study procedures and the risks involved and is
             willing to provide written informed consent before the first study related activity.

          -  Subject completed the double-blind treatment period in Study RDEA594-304 and was
             actively receiving and tolerating study medication (lesinurad or placebo) and
             febuxostat 80 mg at the Month 12 visit.

          -  Subject is male or female; female subjects of childbearing potential must agree to use
             an effective non-hormonal method of birth control during the study and for at least 14
             days after the last dose of study medication.

        Exclusion Criteria:

          -  Subject has any medical or psychological condition, which in the opinion of the
             Investigator and/or the Medical Monitor, might create undue risk to the subject or
             interfere with the subject's ability to comply with the protocol requirements, or to
             complete the study.
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
Condition: Hereditary Periodic Fevers
MeSH terms: Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Amyloidosis; Fever
Intervention: Canakinumab; Placebo
Intervention description: Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution.; Matching placebo to canakinumab solution for subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 1 Month
Healthy volunteers: No
Keywords: Canakinumab, interleukin-1, Hereditary Periodic Fevers, auto-inflammatory diseases

Summary:

      This study is to determine whether canakinumab is able to induce and maintain a clinically
      meaningful reduction of disease activity in participants with Hereditary Periodic Fevers
      (HPF) compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria: - Patient's written informed consent (or parent's written informed
        consent in case of pediatric patient) at screening - Male and female patients at least 2
        years of age at the time of the screening visit. Male and female patients >28 days but <2
        years eligible for open label treatment only. - Confirmed diagnosis and active flare at
        randomization - CRP >10mg/L at randomization

        Exclusion Criteria: - Use of the following therapies (within varying protocol defined
        timeframes): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF
        inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine,
        intravenous immunoglobulin, 6-Merceptopurine, azathioprine, cyclophosphamide, or
        chlorambucil, any other investigational biologics - History of malignancy of any organ
        system (other than localized basal cell carcinoma of the skin or in - situ cervical
        cancer), treated or untreated - Significant medical diseases, including but not limited to
        the following: a. History of organ transplantation b. Elevated liver enzymes ≥3x ULN d.
        Increase in total bilirubin e. Serious hepatic disorder (Child-Pugh scores B or C) f.
        Chronic Kidney Disease g. Thyroid disease h. Diagnosis of active peptic ulcer disease i.
        Coagulopathy j. Significant CNS effects including vertigo and dizziness - Any conditions or
        significant medical problems which immunecompromise the patient and/or places the patient
        at unacceptable risk for immunomodulatory therapy - Live vaccinations within 3 months prior
        to the start of the trial, during the trial, and up to 3 months following the last dose
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Levetiracetam
Intervention description: Pharmaceutical form: Oral tablets and oral solution
Route of administration: Oral use
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 223.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Pediatric; Partial onset epilepsy; Levetiracetam; Keppra

Summary:

      Open-label study to allow pediatric patients who have participated in prior Levetiracetam
      (Keppra®) studies to continue their treatment with adequate monitoring and standardized
      follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the
      completion of the development program for pediatrics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed Study N151, or any other applicable pediatric trials of Levetiracetam
             (Keppra®)

          -  Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential
             benefit such that the patient/parent(s)/legal guardian and the Investigator agree to
             continue treatment.

        Exclusion Criteria:

          -  Not be on a ketogenic diet (during the course of this study).

          -  Not have seizures too close together to accurately count (i.e., the patient's seizures
             must be countable).
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: N1539; Placebo
Intervention description: Once Daily; Once Daily
Intervention MeSH terms: Meloxicam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Total Knee Arthroplasty; Pain; Analgesia; N1539; Phase 3b; Knee Replacement

Summary:

      The primary objective of this study is to assess the effect of preoperative administration of
      N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty
      compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily provide written informed consent.

          -  Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral
             total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an
             inpatient setting for ≥24 hours, and receive at least two doses of study drug.

          -  ASA physical status category 1, 2, or 3.

          -  Female subjects not pregnant or planning/attempting to become pregnant, not lactating;
             or commits to the use of an acceptable form of birth control for the duration of the
             study.

          -  Have a body mass index <40 kg/m^2

        Exclusion Criteria:

          -  Have a known allergy or hypersensitivity to any study treatment.

          -  Have a history of previous TKA.

          -  Has plans for a concurrent surgical procedure (eg, bilateral TKA).

          -  Has TKA planned to be performed under general anesthesia.

          -  Have a history of myocardial infarction within the preceding 12 months.

          -  Have, as determined by the investigator or the sponsor's medical monitor, a history or
             clinical manifestations of significant condition that would preclude participation.

          -  Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.

          -  Have a known bleeding disorder which may be worsened with the administration of an
             NSAID.

          -  Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within
             48 hours prior to surgery.

          -  Have previously received N1539/IV meloxicam or received any investigational product
             within 30 days before dosing with study medication.

          -  Have undergone or be expected to undergo radiation therapy, chemotherapy, or other
             biological therapy for cancer treatment, within 60 days prior to screening through
             last follow-up.
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Daily oral doses administered until disease progression or unacceptable toxicity or death.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center study will evaluate the progression-free survival and safety of
      erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with
      activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor
      (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or
      unacceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating
             mutations in the tyrosine kinase domain of the EGFR

          -  Measurable disease according to RECIST

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy greater than or equal to (>/=) 12 weeks

          -  Adequate hematological, liver and renal function

          -  Participants with asymptomatic and stable cerebral metastases receiving medical
             treatment

        Exclusion Criteria:

          -  Previous chemotherapy or treatment against EGFR for metastatic disease

          -  Treatment with an investigational agent less than 3 weeks before enrollment

          -  History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of
             the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)

          -  Participants with symptomatic cerebral metastases

          -  Any significant ophthalmologic abnormality

          -  Unstable systemic disease

          -  Coumarins use

          -  Evidence of any other disease, neurological or metabolic dysfunction, physical
             examination or laboratory finding contraindicating the use of an investigational drug

          -  Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis,
             lymphangiosis carcinomatosis

          -  Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B
             (HBV), Hepatitis C (HCV)
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Condition: Candidemia
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Intervention: Anidulafungin; Fluconazole
Intervention description: Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day).
Maximum treatment duration with anidulafungin is 35 days.; Subjects may be switched to oral fluconazole [6-12 mg/kg/day (not to exceed 800mg/day] provided they meet specified criteria. Maximum total treatment duration is 49 days.
Intervention MeSH terms: Fluconazole; Anidulafungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 1 Month
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Anidulafungin; pediatrics; candidemia; invasive candidiasis; safety

Summary:

      Prospective, open label study to assess the pharmacokinetics, safety & efficacy of
      anidulafungin when used to treat children (aged 1 month - <18 years) with invasive
      candidiasis, including candidemia (ICC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be either (1) at high risk for candidiasis (1 month - < 2 years ONLY) or
             (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age
             groups)

          -  Male and female patients from 1 month to less than 18 years of age.

        Exclusion Criteria:

          -  Any patients with allergy to the drug; and any pregnant female or lactating.

          -  Failed previous antifungal therapy or expected to live < 3 days.

          -  Patients with documented or suspected Candida meningitis.
Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset
Condition: Stroke
MeSH terms: Stroke
Intervention: alteplase
Intervention MeSH terms: Tissue Plasminogen Activator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours
      after onset of stroke symptoms in Chinese patients with acute ischemic stroke
    

Eligibility criteria:

        Inclusion criteria:

        Age >= 18 years at screening(visit 1A) but <= 80 years Signed and dated written informed
        consent in accordance with good clinical practice and local legislation prior to admission
        to the trial Diagnosis of ischemic stroke with a measureable neurological deficit on
        National Institute of Health Stroke Scale (NIHSS) Thrombolytic therapy can be initiated
        within 3 to 4.5 hours of stroke onset Further inclusion criteria apply

        Exclusion criteria:

        Evidence of intracranial haemorrhage (ICH) on the (Computer Tomography) CT/(Magnetic
        Resonance Imaging)MRI-scan or symptoms suggestive of subarachnoid haemorrhage, even if the
        CT/MRI-scan is normal Acute bleeding diathesis Severe stroke as assessed clinically( e.g.
        National Institute of Health Stroke Scale>25) and/ or imaging demonstrates multi-lobar
        infarction (hypodensity >1/3 cerebral hemisphere) Severe uncontrolled arterial
        hypertension, e.g. systolic blood pressure>185 mmHg or diastolic blood pressure>110mmHg, or
        aggressive management (intravenous medication) necessary to reduce blood pressure to these
        limits Blood glucose <50mg/ dL or >400 mg/dL Any history of prior stroke in previous 3
        months, or any history of prior stroke with concomitant diabetes Seizure at stroke onset
        Further exclusion criteria apply
Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics
Condition: Helicobacter Pylori Infection
Intervention: BreathID® Hp System; BreathID® Hp Lab System; Stool Test
Intervention description: Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea; Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea; Each subject was asked to perform a stool test in parallel to the breath test.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: A 13C labeled substrate is used as part of a combination product; a diagnostic breath test.
Masking: None (Open Label)
Masking description: The investigator and treating physician will remain blinded to the breath test results until the end of the study. There is only one arm.
Enrollment: 54.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Clinical Study to Confirm Safety and Accuracy in Detection of H. pylori with 13C-Urea Breath
      Test using the BreathID® Hp and BreathID® Hp Lab Systems in the Pediatric Population
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be older than 3 and younger than 18 years of age

          -  Present with a clinical indication compatible with H. pylori based on the judgement of
             the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic
             ulcer, dyspepsia, etc., or following treatment for H.pylori)

          -  Subject/Legal guardian (and subject whenever relevant) is willing to sign the Informed
             Consent/Assent Form

          -  Naïve to H. pylori treatment in the past 6 weeks

        Exclusion Criteria:

          -  Participation in other interventional trials

          -  PPI or H2 blockers within two (2) weeks prior to breath test/stool antigen test

          -  Pregnant or breastfeeding female

          -  Allergy to test substrates

          -  Antibiotics (not related to H. pylori eradication) and/or Bismuth preparations within
             four (4) weeks prior to breath test

          -  Exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the
             breath test.

          -  Exposure to any 13C-enriched substance 24 hours prior to the breath test.

          -  Children 12 years and older - to be excluded after a written notification from the
             sponsor is received at the site that the limit of 1/3 of the sample size was achieved
             for this group

          -  Subjects outside US - to be excluded after a written notification from the sponsor is
             received at the site that the limit of 1/3 of the sample size was achieved for this
             group
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Intervention: ABBV-951
Intervention description: Solution for continuous subcutaneous infusion (CSCI)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's Disease (PD); ABBV-951; Levodopa/Carbidopa

Summary:

      The purpose of this study was to assess the safety and tolerability of ABBV-951
      (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).

      This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or
      High Dose) based on the modal total daily dose (most frequent dose) over the treatment
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is
             levodopa-responsive

          -  Participants must be judged by the investigator to be inadequately controlled by
             current therapy, have recognizable/identifiable "Off" and "On" states (motor
             fluctuations), and have a minimum of 2.5 hours of "Off" time per day

        Exclusion Criteria:

          -  Participant is cognitively impaired and is not able to safely and effectively manage
             the drug delivery system and the diaries and is not able to adhere to the study

          -  Participant is considered by the investigator to be an unsuitable candidate to receive
             ABBV-951 for any reason