bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)
Condition: Anesthesia, General
Intervention: sugammadex; neostigmine; vecuronium; rocuronium; glycopyrrolate
Intervention description: Administered as an intravenous (IV) infusion; Administered as an IV infusion; Administered as an IV infusion; Administered as an IV infusion; Administered as an IV infusion
Intervention MeSH terms: Glycopyrrolate; Rocuronium; Vecuronium Bromide; Neostigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB)
      induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with
      reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Class 1 to 4

          -  18 years or older

          -  Scheduled to undergo an elective surgical procedure under general anesthesia requiring
             the use of rocuronium or vecuronium for endotracheal intubation and maintenance of
             neuromuscular block

          -  Scheduled for surgery in supine position

          -  Given written informed consent

        Exclusion Criteria:

          -  Participants in whom a difficult intubation is expected due to anatomical
             malformations

          -  Known or suspected to have neuromuscular disorders impairing neuromuscular blockade
             and/or significant renal dysfunction

          -  Known or suspected to have a (family) history of malignant hyperthermia

          -  Known or suspected to have an allergy to narcotics, muscle relaxants, or other
             medications used during surgery

          -  Receiving medication known to interfere with neuromuscular blocking agents such as
             anticonvulsants, antibiotics, and magnesium (Mg2+)

          -  Participants in whom the use of neostigmine and/or glycopyrrolate may be
             contraindicated

          -  Female participants who are pregnant or breast-feeding

          -  Females participants of childbearing potential not using an acceptable method of birth
             control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD,
             abstinence]

          -  Participants who had already participated in an Org 25969 trial

          -  Participants who had participated in another clinical trial, not pre-approved by
             Organon, within 30 days of entering into Protocol 19.4.302
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
Condition: Onychomycosis of Toenails
MeSH terms: Onychomycosis
Intervention: AN2690 Topical Solution, 5%; Solution Vehicle
Intervention description: AN2690 Topical Solution, 5%, applied once daily for 48 weeks; AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
Intervention MeSH terms: Tavaborole; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 594.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onychomycosis; nail fungus; toenail fungus; fungal nail; hyperkeratosis; nail infection; nail treatment; toenail infection; toenail treatment; foot dermatoses; fungal culture; onycholysis; podiatrist; podiatry; subungual; tinea unguium; antifungal; anti-fungal; dermatologist; dermatology; dermatophyte; distal subungual onychomycosis; yellow nail; thick nail; brittle nail; crumbling nail; discolored nail; weak nail

Summary:

      The purpose of this study is to determine whether AN2690 topical solution is a safe and
      effective treatment for onychomycosis of the toenail.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of distal subungual onychomycosis affecting at least one great
             toenail

          -  KOH positive at screening

          -  Willingness not to use any other products including nail polish applied to the
             toenails during the study

          -  Women of childbearing potential who are currently sexually active must agree to use
             contraception for the entire study period

        Exclusion Criteria:

          -  Concurrent or recent use of certain topical or systemic medications without a
             sufficient washout period

          -  History of any significant chronic fungal disease other than onychomycosis

          -  Significant confounding conditions as assessed by study doctor

          -  Participated in any other trial of an investigational drug or device within 30 days or
             participation in a research study concurrent with this study

          -  Pregnancy or lactation
To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study
Condition: Asthma
MeSH terms: Asthma
Intervention: Terbutaline Turbuhaler®; Salbutamol pMDI; pMDI placebo pMDI; Placebo Turbuhaler®
Intervention description: 0.4 mg, inhalation, single dose; 200 μg, inhalation, single dose; Placebo pMDI 2 inhalations; Placebo Turbuhaler 1 inhalation
Intervention MeSH terms: Albuterol; Terbutaline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 24.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Terbutaline; Turbuhaler; Efficacy; Asthma; Japanese; salbutamol; Bricanyl

Summary:

      This is a single blind, single dose, crossover study to investigate the relative efficacy of
      terbutaline Turbuhaler® 0.4 mg in relation to salbutamol pressurized Metered Dose Inhaler
      (pMDI) 200 μg in Japanese adult asthmatic patients.The secondary objective of this study is
      to investigate safety of terbutaline Turbuhaler® 0.4 mg in Japanese adult asthma patients by
      means of adverse events (AEs) and vital signs (blood pressure, pulse rate). The subject
      population includes Japanese patients (16 years of age or older) with asthma who need
      treatment with inhaled Glucocorticosteroids (ICS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  On ICS for at least 3 months from Visit 2 and with a prescribed constant dose during
             the 4 weeks prior to Visit 2

          -  Forced Expiratory Volume in 1 Second (FEV1) of at least 50 % of predicted normal value
             pre-bronchodilator

          -  Reversible airway obstruction according to reversibility test performed at Visit 2,
             defined as an increase in Forced Expiratory Volume in 1 Second (FEV1) ≥12% relative
             baseline at 15-30 minutes after inhalation of in total 400 μg salbutamol

        Exclusion Criteria:

          -  Treatment with oral, parenteral or rectal GCS (Glucocorticosteroids)within 4 weeks or
             depot parenteral GCS (Glucocorticosteroids) within 3 months prior to Visit 2.

          -  Change in prescribed asthma medication due to exacerbation of asthma within 4 weeks
             prior to Visit 2 or being hospitalized due to exacerbation of asthma within 8 weeks
             prior to Visit 2.
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
Condition: Muckle Wells Syndrome
MeSH terms: Cellulitis; Eosinophilia; Cryopyrin-Associated Periodic Syndromes; Syndrome
Intervention: ACZ885; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 4 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Muckle-Wells Syndrome; children; systemic autoinflammatory disease; CIAS-1 gene; NALP-3; ACZ885; human monoclonal anti-human interleukin-1beta (IL-1beta); antibody; autosomal dominant; familial autoinflammatory syndrome

Summary:

      This study is designed to provide efficacy and safety data for ACZ885 (a fully human
      anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection
      subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.

      Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.

      Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of
      ACZ885 compared to placebo.

      Part III is an open-label, active treatment period where patients will receive ACZ885 every 8
      weeks after withdrawal or completion of Part II.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Molecular diagnosis of NALP3 mutations and clinical picture resembling Muckle-Wells
             Syndrome.

          -  Muckle-Wells Syndrome patients who participated in the CACZ885A2102 study, will have
             the option to participate in this study upon disease flare

          -  Muckle-Wells Syndrome patients requiring medical intervention either untreated or
             treated (i.e. under ACZ885, anakinra, or any other investigational IL-1 blocking
             therapy).

        Exclusion Criteria:

          -  History of being immunocompromised, including a positive HIV at screening test result.

          -  No live vaccinations within 3 months prior to the start of the trial, during the
             trial, and up to 3 months following the last dose.

          -  History of significant medical conditions, which in the Investigator's opinion would
             exclude the patient from participating in this trial.

          -  History of recurrent and/or evidence of active bacterial, fungal, or viral infections.

          -  Positive tuberculin skin test at 48 to 72 hours after administration at the screening
             visit or within 2 months prior to the screening visit, according to national
             guidelines.

        Other protocol-defined inclusion/exclusion criteria may apply
Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
Condition: Caries
Intervention: Silver Diamine Fluoride; Conventional Caries Management
Intervention description: No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet.; These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Caries; Cavity

Summary:

      The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF)
      for treatment of cavities in baby teeth. The investigators will compare the effectiveness of
      stopping the cavity, cost of the treatments and the opinions of the families and the dental
      providers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of at least one active (soft) cavitated carious lesions in the primary
             dentition, extending into dentin (ICDAS 5 or 6)

          -  The selected tooth must have a one or two surface lesion (more than 1/3 of the crown
             of the tooth must be remaining) and must allow for direct application of SDF

          -  Study teeth will not have any spontaneous or elicited pain due to caries, tooth
             mobility, or signs of pulpal infection

          -  Selected primary teeth must have an anticipated exfoliation date greater than 12
             months away

        Exclusion Criteria:

          -  Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis
             Imperfecta

          -  Severe medical conditions that do not allow the child to be managed in the clinic

          -  Known allergy /sensitivity to dental materials being used, including SDF

          -  Inability of the child to cooperate for treatment, recall examinations, or periapical
             radiographs

          -  Wards of the State, for consenting reasons
Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: etanercept
Intervention description: Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly
      dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg
      etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be
      more convenient for most patients. This once-weekly regimen is used in countries outside of
      Japan.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Subjects of Japanese ancestry and living in Japan.

          -  Subjects who are receiving the approved dose of 25 mg etanercept BIW for at least 6
             months and have stable disease activity, as determined by investigator's judgment for
             3 months before test articles administration.

          -  Subjects who have mildly active rheumatoid arthritis as demonstrated by 5 swollen
             joints and 5 tender/painful joints.

        Main Exclusion Criteria:

          -  Prior treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or
             methotrexate (MTX) within 6 months of the baseline visit.

          -  Subjects considered being in disease remission, per investigator's judgment.

          -  Received other biological drugs, rituximab, anti-CD-4 agents, or diphtheria
             interleukin-2 fusion protein (DAB-IL-2) within 6 months prior to baseline.
Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Condition: Chronic Renal Failure; Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia
Intervention: peginesatide; peginesatide; Darbepoetin alfa
Intervention description: Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).; Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.; Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 493.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal failure; CRF; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide™; hemoglobin; Hb; Hgb; Omontys; peginesatide; red blood cell; red blood cell production

Summary:

      The purpose of this study was to evaluate the safety and efficacy of peginesatide for the
      treatment of anemia in participants with chronic kidney disease, who are not on dialysis and
      not on erythropoiesis stimulating agent (ESA) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic renal failure with an estimated glomerular filtration rate < 60 milliliters
             per minute per 1.73 m^2 and not expected to begin dialysis for at least 12 weeks.

          2. Two consecutive hemoglobin values ≥ 8.0 g/dL and < 11.0 g/dL within 4 weeks prior to
             randomization.

        Exclusion Criteria:

          1. Females who are pregnant or breast-feeding.

          2. Treatment with an ESA in the 12 weeks prior to randomization.

          3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.

          4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.

          5. Known bleeding or coagulation disorder.

          6. Known hematologic disease or cause of anemia other than renal disease.

          7. Poorly controlled hypertension.

          8. Evidence of active malignancy within one year prior to randomization

          9. A scheduled kidney transplant.
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Condition: Pneumonia, Bacterial
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: ampicillin sodium/sulbactam sodium
Intervention description: ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Intervention MeSH terms: Ampicillin; Sulbactam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 16 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: ampicillin sodium/sulbactam sodium; Unasyn-S; community acquired pneumonia; bacterial pneumonia

Summary:

      Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity
      for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet
      been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and
      safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin
      sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  16 years of age or older.

          -  Patients who were diagnosed as moderate to severe community acquired pneumonia
             requiring initial intravenous therapy and hospitalization.

        Exclusion Criteria:

          -  Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam
             sodium, other penicillins, or cephems.

          -  Hepatic dysfunction [Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT),
             total bilirubin > 3 times upper limit of normal range values].

          -  Severe renal dysfunction (creatinine clearance < 30 ml/min).

          -  Severe underlying disease; patients in which drug clinical evaluation is difficult
             because of confounding diseases.
Eslicarbazepine Acetate Monotherapy Long Term Study
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Eslicarbazepine acetate
Intervention description: 800 to 2400 mg once daily (QD)
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: open label
Enrollment: 274.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Seizures; Epilepsy; Anticonvulsant; Monotherapy; Epilepsy with simple or complete partial onset seizures

Summary:

      This is a long term, open-label, safety extension study in subjects with partial onset
      seizures.
    

Eligibility criteria:

        Subject Inclusion/Exclusion Criteria:

          -  Subject who completed, exited, or discontinued for reasons other than safety from the
             18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue
             participation in this study are eligible. Subject must have completed at least the
             first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or
             093-046 to be eligible.

          -  Subject must give written informed consent prior to participation in the study. For
             subjects <18 years of age, the informed consent must be signed by the subject's parent
             or legal guardian, and, when appropriate and/or required by state or local law, minor
             subjects must give written informed assent prior to participation in the study. All
             subjects must sign privacy authorization form, if applicable. All females of child
             bearing potential (≤65 years of age) must also sign the "Women of Childbearing
             Potential" Addendum.

          -  Subjects must, in the opinion of the Investigator (with consultation with Medical
             Monitor as appropriate), continue to potentially benefit from continued study
             participation and have no new medical conditions that would preclude study
             participation.

          -  If female subject, must continue the accepted method of birth control defined in
             Protocols 093-045 or 093-046 for the duration of this study as well

          -  Criterion for Continuation into the Post 1 year Part of Study:

        For subjects to continue into the post 1 year part of the study, subjects must, in the
        opinion of the Investigator (with consultation with Medical Monitor, as appropriate),
        continue to potentially benefit from continued study participation and have no new medical
        conditions that would preclude study participation.