bioihbjkbjnl/mcl2 huggingface dataset:
Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
Condition: Ankylosing Spondylitis; Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis
Intervention: Infliximab; Placebo; Naproxen
Intervention MeSH terms: Infliximab; Naproxen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to assess the proportion of participants in the
      infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of
      participants with moderate-to-severe active axial spondyloarthritis and disease duration of
      ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission
      criteria.
    

Eligibility criteria:

        Inclusion Criteria:

        Participant must:

          -  be 18 to 48 years of age

          -  have diagnosis of active axial spondyloarthritis, with disease duration of less than
             or equal to 3 years.

          -  have active disease during trial enrollment

          -  have limited treatment history for axial spondyloarthritis (must meet certain
             criteria)

          -  agree to an acceptable method of contraception (for women of childbearing potential
             and all men)

          -  must meet certain tuberculosis screening requirements

          -  must meet certain laboratory screening safety requirements

          -  have an x-ray of the sacroiliac joints available from within the previous 12 months
             (or have one performed during the Screening visit if site is outside of Germany).

        Exclusion Criteria:

        Participant will be excluded:

          -  for certain medical conditions and/or recent history of certain medical disorders

          -  for current or recent treatment with certain other medications and certain
             vaccinations.

          -  for being a woman who is breastfeeding, pregnant, or intending to become pregnant.

          -  if known to have had a substance abuse problem within the previous 3 years prior to
             screening.

          -  if currently participating in any other clinical study.

          -  for other administrative reasons.
The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: bococizumab (PF-04950615); Placebo
Intervention description: 150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.; Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16784.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: myocardial infarction; stroke; hyperlipidemia

Summary:

      This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to
      placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular
      death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization,
      in high risk subjects who are receiving background lipid lowering therapy and have
      cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL
      (2.6 mmol/L).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be on background lipid lowering treatment.

          -  Must be at high risk of a CV event.

          -  Must have an LDL C >/=70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg/dL (2.6 mmol/L).

        Exclusion Criteria:

          -  Planned coronary (PCI or CABG) or other arterial revascularization.

          -  New York Heart Association Class IV congestive heart failure or left ventricular
             ejection fraction < 25% by cardiac imaging.

          -  Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD
             formula or with end state renal disease on dialysis.

          -  History of hemorrhagic stroke.

          -  Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054)
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: MK0826 (ertapenem); Comparator: meropenem
Intervention description: A single dose of 1.0g IV infused over a 30 minute interval at hour 0; 500 mg IV infused over a 30 minute interval at hours 0, 8, and 16 for at least 4 days
Intervention MeSH terms: Meropenem; Ertapenem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the
      treatment of complicated Urinary Tract Infections (UTIs) in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a clinically suspected and /or bacteriologically documented complicated
             UTI or acute pyelonephritis judged by the investigator to be serious

          -  Patient has one positive urine culture within 48 hours of enrollment

          -  Patient has one or more signs or symptoms of either upper or lower UTI

          -  Patient is male with or without a bladder catheter or urologic abnormalities; OR
             patient is a female with a history or clinical evidence of one or more urologic
             abnormalities

        Exclusion Criteria:

          -  Patient has received any amount of effective concomitant antibiotic therapy after
             obtaining the urine culture for admission to this study (admission urine culture) and
             prior to the administration of the first dose of study antibiotics

          -  Patient's infection has been treated with greater than 24 hours of systemic antibiotic
             therapy known to be effective against the presumed or documented pathogens within the
             72 hour period immediately prior to consideration for entry into the study

          -  Patient has complete obstruction of any portion of the urinary tract. Patient has a
             history of seizures other than an uncomplicated febrile seizure
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response
Condition: Leukemia, Myeloid, Chronic-Phase
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Imatinib Mesylate 600 MG Oral Tablet; Imatinib Mesylate 400 MG Oral Tablet; Imatinib Mesylate
Intervention description: Imatinib Mesylate for CP CML; Imatinib Mesylate for CP CML; Imatinib Mesylate for CP CML
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: IM concentration < 1000ng/mL Randomized Cohort : "adapted strategy" versus "standard strategy" / IM concentration >= 1000ng/mL Parallel Cohort: "standard strategy"
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic myeloid leukemia in chronic phase; residual plasma IM concentration; adapted strategy

Summary:

      The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with
      CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response
      and major molecular response rate) is dependent on the residual plasma Imatinib.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,

          2. Patients in complete cytogenetic response for at least 1 year

          3. Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)

          4. ECOG ≤ 2,

          5. Age ≥ 18 years

          6. Signed informed consent,

          7. Membership of a social security system

        Exclusion Criteria:

          1. Patients with CML-CP Philadelphia chromosome negative diagnosis.

          2. Patients previously treated with Imatinib Mesylate at doses above 400 mg / day

          3. Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg /
             d

          4. Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic
             or cardiac progressive uncontrolled by medical treatment

          5. Pregnant or breastfeeding women, women of childbearing potential not using a
             contraceptive method effective

          6. Known HIV positive

          7. Patients previously treated with another tyrosine kinase inhibitor

          8. Patient participating in another interventional clinical trial

          9. History of non-compliance to Imatinib Mesylate
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
Condition: Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Lampalizumab
Intervention description: Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 994.0
Sex: All
Healthy volunteers: No

Summary:

      This multicenter open-label extension study is designed to evaluate the safety and
      tolerability of lampalizumab intravitreal injections in participants with GA secondary to
      age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176
      (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the
      parent studies who received investigational lampalizumab, as well as lampalizumab-naive
      participants exposed to sham comparator. All participants will receive open-label
      lampalizumab in the present study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with
             completion of treatment and the Week 96 visit

          -  Agreement to remain abstinent or use a reliable form of contraception among all men
             and among women of child-bearing potential

        Exclusion Criteria:

          -  Concurrent ocular conditions that contraindicate use of lampalizumab or might affect
             interpretation of study results or that might increase the risk of treatment
             complications

          -  Concurrent disease, metabolic dysfunction, or physical or laboratory finding that
             contraindicates use of lampalizumab or might affect interpretation of study results or
             that might increase the risk of treatment complications

          -  Increased risk of infection

          -  Pregnancy or lactation
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
Condition: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta; epoetin alfa; darbepoetin alfa
Intervention description: Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in a 1-mL prefilled syringe containing 0.3 mL or 0.6 mL solution. The methoxy polyethylene glycol-epoetin beta injectable solution was formulated in sodium phosphate, sodium sulfate, mannitol, methionine and poloxamer 188, pH 6.2 and did not contain any preservative. Participants received methoxy polyethylene glycol-epoetin beta subcutaneous once a month.; Standard of care as prescribed, per individual participant, subcutaneous once per week. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.; Standard of care as prescribed, per individual participant, darbepoetin alfa subcutaneous once every two weeks. Subcutaneous injections were to be administered in the same part of the body (ie, thigh,abdomen or arm) throughout the study.
Intervention MeSH terms: Epoetin Alfa; Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta
      (Mircera) in the maintenance of hemoglobin levels in patients who have previously received
      treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic
      kidney disease stage 4 through dialysis. Patients will be randomized either to receive
      Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc)
      Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or
      darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation
      of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a
      starting dose based on their previous (sc) dose, and those in the control group will receive
      weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the
      target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic kidney disease stage IV not requiring dialysis;

          -  expected to initiate dialysis within 18 months;

          -  15<=Glomerular Filtration Rate (GFR)<=29.

        Exclusion Criteria:

          -  failing renal allograft in place;

          -  acute or chronic bleeding within 8 weeks prior to screening;

          -  transfusion of red blood cells within 8 weeks prior to screening;

          -  poorly controlled hypertension;

          -  immunosuppressive therapy in the 12 weeks prior to screening.
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: OnabotulinumtoxinA
Intervention description: OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 95.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum
      toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor
      overactivity in participants who successfully completed Study 191622-120 (NCT01852045).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed participation in Study 191622-120

          -  Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120

          -  Regularly using clean intermittent catheterization to empty the bladder

        Exclusion Criteria:

          -  Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

          -  Current or planned use of a baclofen pump

          -  Current or planned use of an electrostimulation/neuromodulation device for urinary
             incontinence

          -  Use of an indwelling catheter for urinary incontinence instead of using clean
             intermittent catheterization to empty the bladder

          -  Previous or current use of botulinum toxin therapy of any serotype for any urological
             condition, or treatment with botulinum toxin of any serotype for any other condition
             since entering study 191622-120
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Geodon (Ziprasidone); Geodon (Ziprasidone); Placebo
Intervention description: Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial; Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial; Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 536.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder

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
             Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text
             Revision (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 not otherwise specified (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.
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
Condition: Gastric Cancer; Gastroesophageal Junction Cancer; Esophageal Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Nivolumab; Ipilimumab; Oxaliplatin; Capecitabine; Leucovorin; Fluorouracil
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil; Oxaliplatin; Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2031.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare how long patients with gastric or
      gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab
      and chemotherapy compared with patients receiving chemotherapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female at least 18 years of age

          -  Must have gastric cancer or gastroesophageal junction cancer that cannot be operated
             on and that is advanced or has spread out

          -  Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or
             both) for their disease within the last 6 months

          -  Must have full activity or, if limited, must be able to walk and carry out light
             activities such as light house work or office work

          -  Must agree to provide tumor tissue sample, either from a previous surgery or biopsy
             within 6 months or fresh, prior to the start of treatment in this study

        Exclusion Criteria:

          -  Presence of tumor cells in the brain or spinal cord that have not been treated

          -  Active known or suspected autoimmune disease

          -  Any serious or uncontrolled medical disorder or active infection

          -  Known history of positive test for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome (AIDS)

          -  Any positive test result for hepatitis B or C indicating acute or chronic infection

        Other protocol-defined inclusion/exclusion criteria apply