bioihbjkbjnl/mcl2 huggingface dataset:
CANVAS - CANagliflozin cardioVascular Assessment Study
Condition: Diabetes Mellitus, Type 2; Cardiovascular Diseases; Risk Factors
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Canagliflozin (JNJ-28431754) 100 mg; Canagliflozin (JNJ-28431754) 300 mg
Intervention description: One placebo capsule taken orally (by mouth) once daily; One 100 mg capsule taken orally (by mouth) once daily; One 300 mg capsule taken orally (by mouth) once daily
Intervention MeSH terms: Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4330.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Diabetes; Type 2 diabetes mellitus; Cardiovascular risk; Cardiovascular outcomes; Canagliflozin (JNJ-28431754); Placebo

Summary:

      The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2
      diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac
      events (MACE). Other objectives include evaluating the overall safety, tolerability, and
      effectiveness of canagliflozin.

      The data from this study will be combined with the data from CANVAS-R study (Study of the
      Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a
      pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing
      requirements for canagliflozin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal
             to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with
             high risk of CV events

          -  Patients must have inadequate diabetes control (as defined by glycosylated hemoglobin
             greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be
             either (1) not currently on diabetes drug therapy or (2) on therapy with any approved
             class of diabetes drugs

        Exclusion Criteria:

          -  A history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell
             transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6
             months before 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
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Fumaderm; risankizumab
Intervention description: Fumaderm tablet administered orally; Risankizumab administered by subcutaneous (SC) injection
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: ABBV-0066; BI 655066; risankizumab

Summary:

      The purpose of this study is to compare the efficacy and safety of subcutaneous (SC)
      risankizumab and oral FUMADERM provided as study medication in participants with moderate to
      severe plaque psoriasis who are naïve to and candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first
             administration of study drug. Duration since diagnosis may be reported by the
             participant

          -  Participant has stable moderate to severe plaque psoriasis (body surface area [BSA]
             >10, Psoriasis Area and Severity Index [PASI] >10, and Dermatology Quality of Life
             Index [DLQI] >10) with or without psoriatic arthritis at Baseline

          -  Must be naïve to and candidate for systemic therapy, as assessed by the investigator

          -  Participant has an inadequate response, intolerance or contraindication to topical
             psoriasis treatment

        Exclusion Criteria:

          -  Participants with non-plaque forms of psoriasis

          -  Participant has previously received systemic therapy for psoriasis, whether biologic
             or non-biologic or photochemotherapy

          -  Active systemic infection during the last 2 weeks (exception: common cold) prior to
             screening.

          -  Any documented active or suspected malignancy or history of malignancy within 5 years
             prior to screening, except appropriately treated basal or squamous cell carcinoma of
             the skin or in situ carcinoma of uterine cervix

          -  Participant has any condition or contraindication to Fumaderm that would preclude the
             patient's participation in the present study
A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: FKB327; Humira®
Intervention description: Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.; Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 645.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid; Arthritis

Summary:

      The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity
      of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study
      FKB327-002 and have inadequate disease control on methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791)
             and are continuing with methotrexate

          2. In the investigator's opinion, the patient showed a clinical response to treatment
             during Study FKB327-002 (NCT02260791)

        Exclusion Criteria:

          1. Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002

          2. Patient has presence of active and/or untreated latent tuberculosis (TB)

        Other Inclusion/Exclusion criteria may apply.
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.; Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIN457; psoriatic arthritis; chronic inflammatory disease; loading regimen; secukinumab; self-injection

Summary:

      The purpose of this study was to provide 16-week efficacy, safety and tolerability data
      versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.)
      self-administration with or without a loading regimen and maintenance dosing using pre-filled
      syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with
      active PsA despite current or previous NSAID or DMARD therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for
             Psoriatic ARthritis (CASPAR) criteria.

          -  Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

          -  Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

          -  Inadequate control of symptoms with NSAID.

          -  Other protocol-defined inclusion criteria do apply.

        Exclusion Criteria:

          -  Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
             infectious or malignant process.

          -  Subjects taking high potency opioid analgesics.

          -  Previous exposure to secukinumab or other biologic drug directly targeting
             interleukin-17 (IL-17) or IL-17 receptor.

          -  Ongoing use of prohibited psoriasis treatments / medications.

          -  Subjects who have ever received biologic immunomodulating agents except for those
             targeting TNFα.

          -  Previous treatment with any cell-depleting therapies.
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Faster-acting insulin aspart; insulin aspart; insulin degludec
Intervention description: For subcutaneous (s.c., under the skin) injection once daily.; For subcutaneous (s.c., under the skin) injection once daily.; For subcutaneous (s.c., under the skin) injection once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 834.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate efficacy and safety
      of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin
      degludec in children and adolescents with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at the
        time of signing informed consent and below 18 years at the time of randomisation -
        Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by
        laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus
        insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin
        for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below
        or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit
        Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiring
        hospitalisation within the last 90 days prior to the screening visit - Treatment with any
        medication for the indication of diabetes or obesity other than stated in the inclusion
        criteria in a period of 90 days before screening
Metformin for the Prevention of Episodic Migraine (MPEM)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Metformin; Matching Placebo
Intervention description: Metformin 500mg twice daily; Matching Placebo twice daily
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The investigators will evaluate the safety and efficacy of metformin for preventive treatment
      of migraine in a randomized, double-blind, placebo-controlled, crossover trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age 18-65 years

          2. a diagnosis of migraine with or without aura for >1 year according to the
             International Classification of Headache Disorders-IIIb

        Exclusion Criteria:

          1. a diagnosis of diabetes mellitus or polycystic ovarian syndrome

          2. overuse of acute migraine treatments

          3. failure to respond to 3 or more classes of preventive drug treatments

          4. change in dose of migraine-preventive medication within 2 months of beginning the
             baseline diary phase

          5. significant somatic or psychiatric disease

          6. known alcohol or other substance abuse

          7. pregnant or breastfeeding.
Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Intervention: 68Ga-DOTATOC
Intervention description: The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.
Intervention MeSH terms: Edotreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga)
      -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging
      techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT).
      Participants with histologically and/or clinically confirmed and/or suspected NET will be
      enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Patients of either gender, aged ≥18 years.

          -  Karnofsky status ≥60.

          -  Life expectancy of at least 12 weeks.

          -  Histologically and/or clinically confirmed and/or suspicious of NET.

          -  A diagnostic CT or MRI of the tumour region or suspected area within the previous 12
             weeks prior to dosing day is available.

          -  Somatostatin-analogue scintigraphy scan with result (positive or negative) within the
             last 12 weeks.

          -  Recent Blood test results up to 4-6 weeks as follows:

               1. White Blood Cell (WBC): >2*109/L

               2. Haemoglobin: >8.0g/Dl

               3. Platelets: >50x109/L

               4. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline
                  phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal
                  (ULN)

               5. Bilirubin less than, or equal to, three times its ULN

          -  Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or
             older.

          -  Negative pregnancy test in women capable of child-bearing.

        Exclusion Criteria:

          -  Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of
             68Ga-DOTATOC.

          -  Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting
             Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If
             a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the
             injection of the study drug.

          -  Pregnant or breast-feeding women.

          -  Current somatic or psychiatric disease/condition that may interfere with the
             objectives and assessments of the study.
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
Condition: Cervical Preparation
Intervention: Mifepristone; osmotic dilators
Intervention description: 200 mg po 20-24 hours prior to the procedure; osmotic dilators placed in the cervix 20-24 hours prior to the procedure
Intervention MeSH terms: Mifepristone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      In this study the investigators plan to compare mifepristone and misoprostol use to osmotic
      dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be
      given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2
      hours prior to abortion. Osmotic dilators are the method currently used in our institution,
      and are placed 24 hours prior to abortion. The primary outcome will be the length of the
      procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure,
      participant's assessment of discomfort before mifepristone or dilators, discomfort during the
      abortion procedure, acceptability to participants, and acceptability to staff.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18-50 years of age undergoing surgical termination of pregnancy

          -  English or Spanish speaking

          -  Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by
             ultrasound dating

          -  Eligible for a dilation and evacuation abortion with local anesthesia and sedation

          -  Ultrasound for dating purposes done within the last two weeks

        Exclusion Criteria:

          -  Intrauterine infection

          -  Fetal demise

          -  Ruptured membranes

          -  Multiple gestation

          -  Uterine anomaly or significant distortion of the uterus with fibroids

          -  BMI greater than 45

          -  Inability to place osmotic dilators

          -  Active substance abuse or intoxication

          -  Adrenal failure, chronic corticosteroid use, anticoagulant usage

          -  Severe cervicitis, until treated and resolved

          -  Prior Cesarean section
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
Condition: Acute Gouty Arthritis Flares
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: ACZ885; Triamcinolone acetonide 40 mg
Intervention description: canakinumab 150 mg s.c., given on demand upon new flares; Participants received 40 mg intramuscular (IM)
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gouty arthritis

Summary:

      This was an 18-month, multi-center, open-label, clinical extension study. Patients completing
      earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated
      in this combined extension 3 study for any new gouty arthritis flare on demand with one
      subcutaneous (s.c.) injection of canakinumab 150 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed the second extension studies CACZ885H2356E2 or
             CACZ885H2357E2

          -  Patients treated with canakinumab in the core studies or subsequent extensions

        Exclusion Criteria:

        - Pregnant or nursing (lactating) women