bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Condition: Hyperlipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bococizumab (PF-04950615; RN316); Placebo
Intervention description: 150 mg every 2 weeks, subcutaneous injection for 52 weeks.; Subcutaneous injection every 2 weeks for 52 weeks.
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 746.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary hyperlipidemia or mixed dyslipidemia; high risk of cardiovascular events; multiple cardiovascular disease risk factors.

Summary:

      This study is a multicenter, double-blind, randomized study to access the efficacy, safety
      and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia
      receiving background statin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated with a statin

          -  Fasting LDL-C >=100 mg/dL and triglyceride <= 400 mg/dL

          -  High or very high risk of incurring a cardiovascular event

        Exclusion Criteria:

          -  Pregnant or breastfeeding females

          -  Cardiovascular or cerebrovascular event or procedure within 90 days

          -  Congestive heart failure NYHA class IV

          -  Poorly controlled hypertension
MT10109L in the Treatment of Lateral Canthal Lines
Condition: Lateral Canthal Lines
Intervention: MT10109L; Placebo
Intervention description: MT10109L will be injected into the LCL.; Placebo will be injected into the LCL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines
      (LCL) in participants with moderate to severe LCL.
    

Eligibility criteria:

        Inclusion Criteria

        • Female participants must not be pregnant or planning to get pregnant and willing to
        minimize the risk of inducing pregnancy for the duration of the clinical study and
        follow-up period.

        Exclusion Criteria

          -  Known immunization or hypersensitivity to any botulinum toxin serotype.

          -  Any medical condition that may put the participant at increased risk with exposure to
             MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function.

          -  History of facial nerve palsy.

          -  Any uncontrolled systemic disease.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study intervention).

          -  Anticipated need for surgery or overnight hospitalization during the study.

          -  Prior exposure to botulinum toxin of any serotype for any reason.

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study.

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.

          -  Participants who plan for an extended absence away from the immediate area of the
             study site that would preclude them from returning for all protocol-specified study
             visits.
A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]
Intervention description: 1g iv on days 1 and 15
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the efficacy and safety of repeated courses of MabThera
      in patients with active rheumatoid arthritis who have participated in ML19070, and have
      completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2
      infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to
      3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2
      years, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients with rheumatoid arthritis who participated in ML19070, and have
             completed the week 24 visit;

          -  eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender
             joint count >=4).

        Exclusion Criteria:

          -  patients who have withdrawn from treatment in ML19070 pre-week 16;

          -  patients with a previous response in DAS28 <0.6 to MabThera after week 16;

          -  concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor,
             or other biologic or investigational agent.
Efficacy and Safety of Different Doses of Indacaterol
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol; Salmeterol; Placebo to Indacaterol; Placebo to Salmeterol
Intervention description: Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.; 50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.; Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.; Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Indacaterol; asthma; salmeterol

Summary:

      This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo
      and salmeterol
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of asthma, and:

               1. Receiving daily treatment with inhaled corticosteroid in a regimen that has been
                  stable for at least a month prior to screening

               2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50
                  and ≤90% of predicted normal

               3. An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30
                  minutes after inhaling albuterol

        Exclusion Criteria:

          -  Smoking history >10 pack-years

          -  Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)

          -  Patients with seasonal allergy whose asthma is likely to deteriorate during the study
             period

          -  Patients who have experienced a severe asthma attack/exacerbation requiring
             hospitalization in the 6 months prior to screening

          -  Patients who have had an intubation for a severe asthma exacerbation

          -  Patients who have had an emergency room visit for an asthma attack/asthma exacerbation
             within 6 weeks prior to screening

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

          -  Patients with concomitant pulmonary disease

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular comorbid conditions

          -  Patients who have ever received or are currently receiving omalizumab or chronic oral
             corticosteroid therapy

        Other protocol-defined inclusion/exclusion criteria may apply
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 751.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: prandial insulin; multiple daily injections; pediatric patients; postmeal dosing

Summary:

      The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)
      in children and adolescents with type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  T1D for at least 6 months at the screening visit.

          -  Have been treated with only one of the following rapid-acting insulin analogs as part
             of an multiple daily injection regimen for at least the last 90 days prior to the
             screening visit:

               -  insulin lispro U-100, or

               -  insulin aspart

               -  insulin glulisine or

               -  fast acting insulin aspart

          -  Have been treated with only one of the following basal insulins for at least the last
             90 days prior to the screening visit:

               -  insulin glargine U-100 (once a day [QD] or twice a day [BID]), or

               -  insulin detemir U-100 (QD or BID), or

               -  insulin degludec U-100 (QD)

          -  Have a HbA1c value ≤ 9.9% at the screening visit.

        Exclusion Criteria:

          -  Have current hypoglycemic unawareness or have had more than 1 episode of severe
             hypoglycemia within 6 months prior to the screening visit.

          -  Have had more than 1 emergency room visit or hospitalization due to poor glucose
             control within 6 months prior to the screening visit.

          -  Have been on a treatment regimen that includes regular human insulin, neutral
             protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed
             insulins or use of diluted insulins within 90 days prior to the screening visit.
A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis
Intervention: Zoledronic acid 4 mg
Intervention description: Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 437.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small-Cell Lung Cancer; Bisphosphonates; Zoledronic acid; Bone metastases; Prevention of bone metastases

Summary:

      30-40% of patients with lung cancer will develop bone metastases during the course of their
      disease, which can lead to pain, decreased mobility and skeletal complications. This study
      will investigate the effect of zoledronic acid on preventing or delaying the development of
      bone metastases and the impact on disease progression/survival in patients with stage IIIA
      and IIIB Non-small Cell Lung Cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed Non-small Cell Lung Cancer (NSCLC)

          -  Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion

          -  Patients must have received primary treatment for their disease and had no progression

        Exclusion Criteria:

          -  Diagnosed with NSCLC longer than 6 months ago

          -  Treatment with other bisphosphonates in past 12 months

          -  Presence of metastases

        Other protocol-defined inclusion and exclusion criteria may apply.
Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide; Aclidinium bromide; Placebo
Intervention description: Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment; Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment; Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 561.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Summary:

      The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium
      bromide doses as compared to placebo in the treatment of moderate to severe chronic
      obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period,
      12-week double-blind treatment, and 2-week follow-up phone visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for
             Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC
             < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted

          -  Current or former cigarette smokers

        Exclusion Criteria:

          -  Patients who have been hospitalized for an acute COPD exacerbation within 3 months
             before the first visit

          -  Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1

          -  Patient with any clinically significant respiratory conditions other than COPD,
             cardiovascular conditions or mental illness

          -  History or presence of asthma verified from medical records

          -  Chronic use of oxygen therapy greater than or equal to 15 hours per day

          -  Patient with uncontrolled infection due to HIV and/or active hepatitis

          -  Patients with a history of hypersensitivity reaction to inhaled anticholinergics

          -  Patients with clinically significant cardiovascular conditions, including myocardial
             infarction during the previous 6 months, newly diagnosed arrhythmia within the
             previous 3 months, unstable angina, unstable arrhythmia that had required changes in
             pharmacological therapy or other intervention.
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Intervention: Placebo; Geodon (Ziprasidone)
Intervention description: Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.; Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar I Depression

Summary:

      This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in
      outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are
      required to undergo a washout period of at least 7 days of any prior med.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode
             depressed, with or without rapid cycling, without psychotic features, as defined in
             DSM-IV-TR (296.5X) and confirmed by a structured Mini International Neuropsychiatric
             Interview (MINI)

        Exclusion Criteria:

          -  Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective
             disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or
             psychotic disorder NOS (298.9).

          -  Subjects with other DSM-IV TR Axis I or Axis II disorder (in addition to Bipolar I
             disorder) are ineligible if the comorbid condition is clinically unstable, requires
             treatment, or has been a primary focus of treatment within the 6 month period prior to
             screening.
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Lifitegrast; Placebo
Intervention description: Lifitegrast Ophthalmic Solution 5.0%; Placebo for Lifitegrast Ophthalmic Solution 5.0%
Intervention MeSH terms: Lifitegrast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 720.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SAR 1118

Summary:

      The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic
      solution compared to placebo in the treatment of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to read, sign and date the informed consent and HIPAA documents

          -  Willing and able to comply with all study procedures

          -  Be at least 18 years of age

          -  Patient-reported history of dry eye in both eyes

          -  A negative urine pregnancy test if female of childbearing potential and must use
             adequate birth control throughout the study period

          -  Artificial tear use within the past 30 days

        Exclusion Criteria:

          -  Any ocular condition that, in the opinion of the Investigator, could affect study
             parameters including, but not limited to, active ocular infection, ocular
             inflammation, glaucoma, and/or diabetic retinopathy

          -  Unwilling to avoid wearing contact lenses for 7 days prior to first visit and for the
             duration of the study

          -  Any blood donation or significant loss of blood within 56 days of Visit 1

          -  Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of
             acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.

          -  Use of any prohibited medications at any time during the study unless otherwise
             specified

          -  Any significant illness that could interfere with study parameters

          -  History of laser assisted in situ keratomileusis (LASIK) or similar type of corneal
             refractive surgery within 12 months prior to first visit, and/or any other ocular
             surgical procedure within 12 months prior to first visit; or any scheduled ocular
             surgical procedure during the study period.

          -  Known history of alcohol and/or drug abuse

          -  Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet
             cells (as with Vitamin A deficiency)
DisCoVisc Comparative Evaluation
Condition: Cataracts
MeSH terms: Cataract
Intervention: DisCoVisc; DuoVisc; BioVisc; Healon5; Amvisc Plus
Intervention description: DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.; DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.; BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.; Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.; Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 173.0
Sex: All
Minimum age: 49 Years
Healthy volunteers: No
Keywords: DisCoVisc OVD; Ophthalmic Viscosurgical Device

Summary:

      A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices
      (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and
      anterior chamber space maintenance during non-eventful cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral operable cataracts

        Exclusion Criteria:

          -  Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2

          -  Intraocular Pressure (IOP) > 21

          -  History of ocular inflammation

          -  Systemic or ocular diseases affecting corneal endothelium