bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer Metastatic
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Carboplatin; Paclitaxel; ABP 215; Bevacizumab
Intervention description: Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W; Administered 200 mg/m² IV Q3W; Administered 15 mg/kg Q3W by IV infusion; Administered 15 mg/kg Q3W by IV infusion
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 642.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to compare the effectiveness and safety of ABP 215
      against bevacizumab in men and women with advanced non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed non-squamous non-small cell lung cancer
             (NSCLC)

          -  Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8
             days after randomization and expected to receive at least 4 cycles of chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

        Exclusion Criteria:

          -  Small cell lung cancer (SCLC) or mixed SCLC and NSCLC

          -  Central nervous system (CNS) metastases

          -  Malignancy other than NSCLC

          -  Palliative radiotherapy for bone lesions inside the thorax

          -  Prior radiotherapy of bone marrow

          -  Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV),
             or human immunodeficiency virus (HIV)

          -  Life expectancy < 6 months

          -  Woman of child-bearing potential who is pregnant or is breast feeding or who is not
             consenting to use highly effective methods of birth control during treatment and for
             an additional 6 months after the last administration of the protocol specified
             treatment

          -  Man with a partner of childbearing potential who does not consent to use highly
             effective methods of birth control during treatment and for an additional 6 months
             after the last administration of the protocol specified treatment

          -  Subject has known sensitivity to any of the products to be administered during the
             study, including mammalian cell derived drug products

          -  Other inclusion/exclusion criteria may apply
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Teriflunomide (HMR1726)
Intervention description: Tablet, oral administration QD.
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 742.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Oral treatment

Summary:

      The primary objective of this study was to document the long-term safety and tolerability of
      teriflunomide in Multiple Sclerosis (MS) participants with relapse.

      The secondary objective was to document the long-term efficacy on disability progression,
      relapse rate and Magnetic Resonance Imaging (MRI) parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant who completed the previous double-blind placebo-controlled study EFC6049
             and who did not meet criteria for treatment withdrawal.

          -  Willingness to participate in a long-term safety/efficacy trial.

        Exclusion Criteria:

          -  Any known condition or circumstance that would prevent in the investigator's opinion,
             compliance or completion of the study.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome
Condition: Ischemic Stroke; Excitotoxicity; Memantine
MeSH terms: Ischemic Stroke; Ischemia
Intervention: Placebo; Memantine
Intervention description: Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.; Beside the usual treatment for ischemic stroke this group will be treated by memantine.
Intervention MeSH terms: Memantine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The researchers aim to investigate the effect of memantine on stroke outcome in a randomized
      double-blind placebo-controlled clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presentation at first 24hrs of disease onset

          -  Confirmation of ischemic stroke in MCA territory by imaging.

          -  Accepted consent form

        Exclusion Criteria:

          -  Allergy history to memantine

          -  Stage 4 -5 renal failure base on Acute Kidney Injury Network criteria

          -  Moderate to severe hepatic failure (Child-Pugh criteria, grade B and C)

          -  History of epilepsy

          -  History of dementia

          -  History of memantine use in recent 6 months

          -  Pregnancy or breastfeeding

          -  Severe drug adverse effects
Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated
Condition: Healthy
Intervention: Blood draw; Blood draw
Intervention description: Group 1.1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1 Group 1.2- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1; Group 1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPNC was administered in the deltoid muscle at year 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 962.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Antibody persistence

Summary:

      The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the
      second vaccine dose in two groups of adults over the age of 60: (1) those who have previously
      received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have
      previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide
      vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and
      23vPS, administered in different sequential order results in different prolonged antibody
      levels. This study is limited to individuals who participated in either study 6115A1-3010
      (NCT00574548) or 6115A1-3005 (NCT00546572).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Only study volunteers who received both assigned vaccinations at visit 1 and visit 4
             when they participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005
             (NCT00546572)

        Exclusion Criteria:

          -  Vaccination with any licensed or experimental pneumococcal vaccine since being
             enrolled in the 6115A1-3005 (NCT00546572) or 6115A1-3010 (NCT00574548) study (other
             than study vaccines permitted in 6115A1-3010 or 6115A1-3005)
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
Condition: Mixed Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: ABT-335; rosuvastatin calcium; simvastatin; atorvastatin calcium
Intervention description: Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study; Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
Intervention MeSH terms: Calcium, Dietary; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Fenofibric acid; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to assess the continued safety of the daily coadministration of
      ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects who voluntarily sign the informed consent.

          -  Subject has successfully completed the treatment phase of the preceding open-label
             year 1 study.

        Exclusion Criteria:

          -  Subject is using or will use investigational medications, except as approved by
             Abbott.

          -  Subject has prematurely discontinued his/her combination therapy administered in the
             preceding open-label year 1 study.
Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine; Olmesartan medoxomil plus amlodipine
Intervention description: Tablets; Tablets
Intervention MeSH terms: Amlodipine; Olmesartan; Olmesartan Medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Angiotensin Receptor Blocker; Calcium Channel Blocker; Stage I and II Hypertension

Summary:

      This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan
      treatment regimen in stage 1 and stage 2 hypertensive subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females greater than or equal to 18 years of age

          -  Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to
             140 mm Hg but less than or equal to 199 mm Hg or a mean seated diastolic blood
             pressure (MSDBP) greater than or equal to 90 mm Hg and less than or equal to 109 mm
             Hg, following a period of taking only placebo

          -  Patients with a mean daytime (8AM-4PM) systolic blood pressure greater than or equal
             to 135 mm Hg and less than or equal to 199 mm Hg and a mean daytime diastolic blood
             pressure less than or equal to 109 mm Hg as measured by an ambulatory blood pressure
             monitoring device (ABPM), after a period of taking only placebo

          -  If female, must have negative serum pregnancy test at screening and be either
             post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal
             ligation at least 6 months before consent or if of childbearing potential, must
             practice approved measures of birth control throughout study

        Exclusion Criteria:

          -  History of stroke or transient ischemic attack (TIA) within the last one year

          -  History of myocardial infarction, coronary angioplasty, coronary artery bypass graft,
             or heart failure within the past 6 months

          -  Patients with secondary hypertension of any etiology, such as renal disease,
             pheochromocytoma, or Cushing's syndrome

          -  Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting
             glucose <160 mg/dl may enroll

          -  Patients with hemodynamically significant cardiac valvular disease

          -  Patients with clinically significant cardiac conduction defects, including second or
             third degree AV block, left bundle branch block, sick sinus syndrome, atrial
             fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring
             medication
A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Safety parameters; ECG, blood and urine samples; general health state

Summary:

      Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30
      (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of
      degarelix until the drug is launched in their country. Safety parameters such as
      electrocardiogram (ECG), blood and urine samples and general health state will be studied.
      Note: patients completing the CS27 trial did not participate in the CS34 trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31

        Exclusion Criteria:

          -  Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Wilate
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to obtain additional data on the safety and efficacy of Wilate
      in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII
      concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs,
      thus supplementing the existing database to obtain approval of Wilate for the indication
      hemophilia A in the USA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Severe hemophilia A (<1% FVIII:C) according to medical history

          2. Male patients aged ≥12 years

          3. Previous treatment with a FVIII concentrate for at least 150 exposure days (EDs)

          4. Immunocompetence (CD4+ count >200/µL)

          5. Good documentation of the historical bleeding rate (at least for the 6 months
             preceding study start)

          6. Voluntarily given, fully informed written and signed consent obtained by the patient
             (or parent/legal guardian in case of adolescents) before any study-related procedures
             are conducted

        Whenever possible, the interval between the Screening Visit and the PK or Non-PK Visit
        should not exceed 30 days. If the 30-day interval is exceeded, determination of the CD4+
        count is to be repeated and must be >200/µL for patients to be enrolled (i.e., exclusion
        criterion no. 4).

        Exclusion Criteria:

          1. Any coagulation disorders other than hemophilia A

          2. History of FVIII inhibitor activity (≥0.6 BU) or detectable FVIII inhibitory
             anti-bodies (≥0.6 BU using the Nijmegen modification of the Bethesda assay) at
             screening, as determined by the central laboratory

          3. Severe liver or kidney diseases (alanine aminotransferase [ALAT] and aspartate
             transaminase [ASAT] levels >5 times of upper limit of normal, creatinine>120 µmol/L)

          4. Patients receiving or scheduled to receive immunomodulating drugs (other than
             anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10
             mg/day), or similar drugs

          5. Treatment with any investigational medicinal product in another interventional
             clinical study currently or within 4 weeks before enrollment
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B (thiomersal-free) 20µg; 10 μg Engerix™-B (preservative-free); placebo
Intervention description: In the primary study: 2 deep intramuscular injections (Months 0, & 6); In the primary study: 3 deep intramuscular injections (months 0, 1 & 6); In the primary study: 1 deep intramuscular injection (month 1)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 267.0
Sex: All
Minimum age: 13 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Persistence; Hepatitis B vaccine

Summary:

      To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months
      after the first dose of the hepatitis B primary vaccination course.

      Subjects were aged 11 to 15 years at the time of the primary vaccination course.

      At the time of enrollment in the present long-term follow-up study subjects were aged 13 to
      18 years.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects have participated in primary study HBV-280

          -  Written informed consent will be obtained from each subject and/ or parent or guardian
             of the subject before the blood-sampling visit of each year
Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: BI 1356; Placebo
Intervention description: 5mg orally (po) tablet qd; Placebo matching BI 1356 5mg one tablet daily
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have
      insufficient glycaemic control despite treatment with a sulfonylurea drug.
    

Eligibility criteria:

        Inclusion criteria:

        Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control
        [glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug

        Exclusion criteria:

        Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with
        rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3
        months Impaired hepatic function Severe renal impairment Current treatment with systemic
        steroids Change in thyroid hormone dosage Hereditary galactose intolerance
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
Condition: Mycobacterium Infections, Nontuberculous
MeSH terms: Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous
Intervention: LAI (Liposomal Amikacin for Inhalation) 590 mg
Intervention description: LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes.
Intervention MeSH terms: Amikacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ALIS; ARIKAYCE

Summary:

      A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg
      administered once daily (QD) when added to multi-drug regimen (MDR) in participants with
      Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC)
      that were refractory to treatment.

      Participants were randomized 2:1 to LAI 590 mg administered QD + MDR or MDR alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be continually positive for MAC on sputum culture while adhering to a multi-drug
             treatment regimen for a minimum duration of 6 months which is either ongoing or was
             completed no more than 12 months before screening

          2. Be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis
             and/or fibrocavitary disease by chest CT

          3. Be willing to adhere to multi-drug treatment regimen during the course of the study

        Exclusion Criteria:

          1. Patients with cystic fibrosis

          2. Positive pregnancy test or lactation at screening. All women of child bearing
             potential will be tested. Women not of childbearing potential are defined as
             postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally
             sterile.

          3. Active pulmonary tuberculosis requiring treatment at screening

          4. History of lung transplantation

          5. Prior exposure to LAI (including clinical study).