bioihbjkbjnl/mcl2 huggingface dataset:
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Prednisone; sunitinib; Placebo; Prednisone
Intervention description: 5 mg BID, oral; 37.5 mg/day, oral, administered on a continuous daily dosing regimen; 37.5 mg/day, oral, administered on a continuous daily dosing regimen; 5 mg BID, oral
Intervention MeSH terms: Prednisone; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 873.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Docetaxel-refractory mCRPC; Second-line treatment with sunitinib and prednisone

Summary:

      This study will compare the safety and efficacy of sunitinib in combination with prednisone
      versus placebo and prednisone in patients that have metastatic castration-resistant prostate
      cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen.
      This is a second-line study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate.

          -  Progressive, metastatic castration-resistant prostate cancer after failure of
             docetaxel chemotherapy (resistant or intolerant).

          -  Progressive disease based on PSA progression, RECIST, or positive bone scan.

          -  ECOG 0 or 1.

        Exclusion Criteria:

          -  Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the
             metastatic disease setting.

          -  Chemotherapy within 3 weeks.

          -  Impending complications from bone metastases.

          -  Ongoing urinary obstruction.

          -  Cardiac dysfunction, QTc >470 msec.

          -  CNS involvement.
Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone furoate; albuterol/salbutamol
Intervention description: Inhaled corticosteroid; Provided as rescue relief of asthma symptoms
Intervention MeSH terms: Fluticasone; Xhance; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 238.0
Sex: All
Minimum age: 12 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: fluticasone furoate

Summary:

      A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two
      doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and
      adolescents currently receiving mid to high strength inhaled corticosteroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior
             to first visit

          -  Both genders; females of child bearing potential must be willing to use appropriate
             contraception

          -  Pre-bronchodilator FEV1 of 40-90% predicted

          -  Reversibility FEV1 of at least 12% and 200mLs

          -  Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior
             to first visit

        Exclusion Criteria:

          -  History of life threatening asthma

          -  Respiratory infection or candidiasis

          -  Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay
             within the last 3 months

          -  Concurrent respiratory disease or other disease that would confound study
             participation of affect subject safety

          -  Allergies to study drugs, study drug excipients, medications related to study drugs

          -  Taking another investigational medication or medication prohibited for use during the
             study

          -  Previous treatment with FF or FF/VI in a phase II or III study

          -  Night shift workers

          -  Children in care
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Omiganan
Intervention description: Topical gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the long-term safety of once-daily application of Omiganan topical gel
      in subjects with severe papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, male and nonpregnant female subjects, 18 years of age or older.

          2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment
             grading scale at baseline

          3. Subjects with the presence of telangiectasia at Baseline

          4. Subjects with the presence of facial erythema associated with their rosacea at
             Baseline

        Exclusion Criteria:

          1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

          2. Subjects with nodular rosacea

          3. Standard exclusion criteria.
Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Buprenorphine transdermal patch; Buprenorphine transdermal patch
Intervention description: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear; Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic pain; osteoarthritis; transdermal

Summary:

      The original objective of this study was to demonstrate the effectiveness and tolerability of
      the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the
      buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis
      pain currently treated with oral opioids. The double-blind treatment intervention duration is
      12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen)
      will be provided to all subjects in addition to study drug.

      This study was terminated early due to administrative reasons with only 20% of the planned
      sample size; therefore, the primary objective was changed to focus on the safety evaluation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  osteoarthritis of the hip, knee, or spine for 1 year or longer.

          -  taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at
             least 4 days a week.

        Exclusion Criteria:

          -  taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days
             of enrollment.

          -  requiring frequent analgesic therapy for chronic conditions in addition to
             osteoarthritis.

        Other protocol-specific exclusion/inclusion criteria may apply.
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ipilimumab; Nivolumab; Carboplatin; Paclitaxel; Pemetrexed; Cisplatin
Intervention description: Specified dose on specified day; Specified dose on specified day; Specified dose on specified day; Specified dose on specified day; Specified dose on specified day; Specified dose on specified day
Intervention MeSH terms: Paclitaxel; Carboplatin; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 719.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with
      chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as
      the first treatment given for the disease
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or
             non-squamous histology, with no prior systemic anticancer therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

          -  Measurable disease by CT or MRI per response evaluation criteria in solid tumors
             version 1.1 (RECIST 1.1) criteria

          -  Participants must have PD-L1 IHC testing with results performed by a central
             laboratory during the screening period

        Exclusion Criteria:

          -  Participants with known epidermal growth factor receptor (EGFR) mutations which are
             sensitive to available targeted inhibitor therapy (including, but not limited to,
             deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded

          -  Participants with known anaplastic lymphoma kinase (ALK) translocations which are
             sensitive to available targeted inhibitor therapy are excluded

          -  Participants with untreated CNS metastases are excluded. Participants are eligible if
             CNS metastases are adequately treated and participants are neurologically returned to
             baseline (except for residual signs or symptoms related to the CNS treatment) for at
             least 2 weeks prior to first treatment

        Other protocol inclusion/exclusion criteria may apply
Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation
Condition: Tachycardia, Ventricular; Catheter Ablation
MeSH terms: Tachycardia; Tachycardia, Ventricular
Intervention: Antiarrhythmic drug
Intervention description: Continuation of amiodarone or sotalol.
Intervention MeSH terms: Amiodarone; Sotalol; Anti-Arrhythmia Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients that meet inclusion criteria and agree to participate will be randomized and allocated to continue class III AADs or discontinuation using block randomization, stratified by type of AADs and type of cardiomyopathy (ischemic vs nonischemic) used until goal enrollment is achieved. The randomization sequence was created using STATA 14.2 (StataCorp, College Station, TX, USA) statistical software.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventricular Tachycardia; Catheter Ablation; Antiarrhythmic drugs

Summary:

      The investigators aim to study if patients that undergo catheter ablation for ventricular
      tachycardia benefit from continuation of Vaughan-Williams class III antiarrhythmic drugs for
      3 months after their ablation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18 years.

          2. Able to give written, informed consent

          3. Structural heart disease.

          4. Implanted and normally functioning ICD or undergoing ICD implant at index admission.

          5. Undergoing initial radiofrequency ablation procedure for sustained monomorphic VT.

          6. Receiving a class III AADs prior to VT ablation.

          7. No VT inducible at the end of VT ablation.

          8. No VT inducible on non-invasive programmed stimulation following VT ablation.

        Exclusion Criteria:

          1. LV assist device in place

          2. Decompensated heart failure and/or requiring continuous inotropic therapy and/or
             awaiting cardiac transplantation

          3. Ongoing acute coronary syndrome.

          4. Mechanical prosthetic aortic and mitral valves.

          5. Pedunculated or mobile left ventricular thrombus.

          6. Persistent VT at the end of index catheter ablation.

          7. Absolute contraindications for class III AADs.

          8. Participation in other trial.

          9. VT induced on NIPS after VT ablation.

         10. Another reason for continuation of class III AADs (i.e., atrial fibrillation).
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Condition: Anesthesia
Intervention: Rocuronium bolus maintenance; rocuronium continuous infusion maintenance
Intervention description: Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation; Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Intervention MeSH terms: Rocuronium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine the dose requirements of rocuronium bromide
      when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube
      through the nose or mouth into the trachea to provide artificial ventilation) and when
      administered by either continuous infusion or bolus doses for maintenance of muscle
      relaxation in term neonates (birth to <28 days old), infants (28 days to <=3 months) and
      toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of
      age), and adolescents (>11 years to less than or equal to 17 years of age).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects from birth up to 17 years of age who are scheduled for
             surgery with an anticipated duration of anesthesia of about 2 hours or more requiring
             a maintenance muscle relaxation dose(s).

        Exclusion Criteria:

          -  Subjects whose parent(s) or legal guardian(s) are not willing to give written consent
             and where applicable, subjects who have not given appropriate assent to participate in
             the trials will not be allowed to enter.
A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Fluoxetine; Placebo
Intervention MeSH terms: Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 513.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in
      Japanese adult participants with Major Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient Japanese participants diagnosed with MDD

          -  Diagnosis of moderate or greater severity of MDD

          -  Agree to abstain from sexual activity or to use a reliable method of birth control

          -  Judged to be reliable (agree to keep appointments for clinic visits and to undergo all
             tests and examinations required by the protocol)

        Exclusion Criteria:

          -  Have previously been exposed to fluoxetine (LY110140) for any indication in the past

          -  Significant suicidal risk

          -  Have a current or previous diagnosis of bipolar disorder, psychotic depression,
             schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive
             disorder, or post-traumatic stress disorder

          -  Have a history of substance abuse or dependence within the past 6 months, excluding
             caffeine and nicotine

          -  Have initiated, stopped, or changed the type or intensity of psychotherapy within 6
             weeks

          -  Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation
             (TMS), or vagus nerve stimulation (VNS) within 1 year

          -  Have had treatment with a Monoamine oxidase inhibitor (MAOI) within 14 days

          -  Need to use thioridazine or pimozide during the study

          -  Have previously enrolled, completed, or withdrawn from this study

          -  Have a positive urine drug screen for drugs with abuse potential

          -  Female participants who are either pregnant, nursing, or have recently given birth, or
             male participants who are planning for their partners to be or become pregnant

          -  Have a history of seizure disorder

          -  Have frequent or severe allergic reactions to multiple medications

          -  Have a serious or unstable medical illness or condition, or psychological condition

          -  Participants deemed ineligible by the investigator or sub-investigator for other
             reasons
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: BG00012; Placebo
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1234.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: relapsing; oral; remitting; multiple sclerosis

Summary:

      To determine if treatment with BG00012 can decrease the number of MS relapses during a
      certain time period. To determine if, over time, BG00012 treatment can decrease the number of
      certain types of brain lesions commonly seen in MS patients and slow down the time it takes
      for the disease to get worse.

      The purpose of this study is also to determine the safety of BG00012 and how well it is
      tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used
      to assess MS.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Unless otherwise specified, to be eligible to participate in this study, candidates
             must meet the following eligibility criteria at the time of the randomization:

          -  Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.

          -  Must have a baseline EDSS between 0.0 and 5.0, inclusive.

          -  Must have relapsing-remitting disease course.

        Key Exclusion Criteria:

          -  Unless otherwise specified, candidates will be excluded from study entry if any of the
             following exclusion criteria exist at randomization:

          -  Other chronic disease of the immune system, malignancies, acute urologic, pulmonary,
             gastrointestinal disease.

          -  Pregnant or nursing women.

        Note: Other protocol-defined inclusion/exclusion criteria may apply.
A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: rituximab; Dexamethasone
Intervention MeSH terms: Dexamethasone; Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy, safety, and pharmacokinetics of standard treatment
      versus standard treatment plus MabThera in patients with ITP. The anticipated time on study
      treatment is <3 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  untreated ITP.

        Exclusion Criteria:

          -  ITP with relapse;

          -  positive test result for HIV or hepatitis B or C;

          -  active infection requiring systemic therapy;

          -  malignancy within 3 years before study.
Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
Condition: PONV
Intervention: APD421; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic
      in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting
      (PONV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years of age

          -  Patients undergoing elective surgery (open or laparoscopic technique) under general
             anaesthesia, expected to last at least one hour from induction of anaesthesia to wound
             closure

          -  Patients with at least 3 "Apfel" risk factors for PONV

        Exclusion Criteria:

          -  Patients scheduled to undergo transplant surgery

          -  Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal
             or epidural) block

          -  Patients who are expected to remain ventilated for a period after surgery

          -  Patients who are expected to need a naso- or orogastric tube in situ after surgery is
             completed