bioihbjkbjnl/mcl2 huggingface dataset:
Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Ruxolitinib; Placebo; Capecitabine
Intervention description: 5 mg tablets to be administered by mouth twice daily (BID); 5 mg tablets to be administered by mouth twice daily (BID); 150 and 500 mg tablets to be administered by mouth twice daily (BID)
Intervention MeSH terms: Capecitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic pancreatic cancer; Metastatic pancreatic adenocarcinoma that is recurrent

Summary:

      Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine
      for the treatment of advanced or metastatic pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas.

          -  Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

          -  Received 1 prior chemotherapy regimen for advanced or metastatic disease (not
             including neoadjuvant and/or adjuvant therapy).

          -  ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants
             must have recovered or be at a new stable baseline from any related toxicities.

          -  Radiographically measurable or evaluable disease

          -  Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

               1. mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L

               2. mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L

        Exclusion Criteria:

          -  Received more than 1 prior regimen for advanced or metastatic disease.

          -  Ongoing radiation therapy, radiation therapy administered within 30 days of
             enrollment.

          -  Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery,
             immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor
             embolization).

          -  Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase
             deficiency (DPD), or other known hypersensitivity to active substances, including
             fluorouracil (5-FU), or ruxolitinib, or any of their excipients.

          -  Prior treatment with a JAK inhibitor for any indication.
Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
Condition: Typical Atrial Flutter
MeSH terms: Atrial Flutter
Intervention: Therapy Cool Path Duo
Intervention description: All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cavo-tricuspid dependent

Summary:

      The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo
      cardiac ablation system can eliminate typical atrial flutter and that its use does not result
      in an unacceptable risk of serious adverse events (SAE's).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed written Informed Consent

          -  Presence of typical atrial flutter (cavotricuspid isthmus dependent)

          -  If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD)for an
             arrhythmia other than typical atrial flutter, then the subject needs to be controlled
             on their medication for at least 3 months. If the subject had typical atrial flutter
             before starting the AAD(s) (Class I or Class III) and then subsequently had another
             arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.

          -  One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry
             strip, or transtelephonic monitor within the past 6 months

          -  In good physical health

          -  18 years of age or older

          -  Agree to comply with follow-up visits and evaluation

        Exclusion Criteria:

          -  Prior typical atrial flutter ablation treatment

          -  Pregnancy

          -  Atypical flutter or scar flutter(non-isthmus dependent)

          -  Significant coronary heart disease or heart failure; that is unstable angina pectoris
             and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of
             enrollment

          -  A recent myocardial infarction within 3 months of the intended procedure date

          -  Permanent coronary sinus pacing lead

          -  Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve
             (i.e. significant)

          -  Evidence of intracardiac thrombus or a history of clotting disorders

          -  Participation in another investigational study

          -  Cardiac surgery within 1 month of the intended procedure date

          -  Allergy or contraindication to Heparin
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Condition: Opiate Dependence
MeSH terms: Recurrence; Opioid-Related Disorders
Intervention: Extended-Release Naltrexone; Motivational Enhancement Counseling
Intervention description: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).; The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Extended-release naltrexone; Prisoners; Opioid addiction prevention; Medication Treatment Alternatives; Prevention of Relapse to Opioid Addiction

Summary:

      This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as
      self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release
      from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults incarcerated in NYC jails with known release date

          -  DSM-IV criteria for current opioid dependence

          -  No current agonist (methadone, buprenorphine) treatment

          -  Currently opioid free by history ('detoxed') and with a negative urine for all opioids

          -  General good health as determined by complete medical interview and physical
             examination

          -  Age 18-60 years.

        Exclusion Criteria:

          -  History of liver failure, cirrhosis, or recent liver function test levels greater than
             three times normal

          -  Pregnancy, lactation, or planning conception

          -  Active medical illness that might make participation hazardous

          -  Untreated psychiatric disorder

          -  History of allergic reaction to naltrexone, PLG (polylactide co-glycolide),
             carboxymethylcellulose, or any other components of the diluent.

          -  Current chronic pain condition treated with opioids.
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: 2 mg perampanel; 4 mg perampanel; placebo comparator
Intervention description: 2 mg perampanel; 4 mg perampanel; placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 752.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of
      E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. Male or female patients with idiopathic Parkinson's Disease fulfilling the United
             Kingdom (UK) Parkinson's disease Society Brain Bank diagnostic criteria 7, with a good
             response to levodopa.

          2. Patients must have been diagnosed with idiopathic PD at > 30 years of age.

          3. Patients must have predictable motor fluctuations of the wearing "OFF" type.

          4. Patients must rate between II-IV on the Hoehn & Yahr scale when in an "OFF" state.

          5. Patients must be taking optimized levodopa therapy.

        EXCLUSION CRITERIA:

          1. Pregnant or lactating women.

          2. Women of child bearing potential unless infertile (including surgically sterile) or
             practicing effective contraception (eg, abstinence, intrauterine device or barrier
             method plus hormonal method). These patients must have a negative serum beta-human
             chorionic gonadotrophin (B-HCG) test at the Screening visit, and a negative urine
             pregnancy test at the Baseline visit (Day 0). These patients must also be willing to
             remain on their current form of contraception for the duration of the study.
             Postmenopausal women may be recruited but must be amenorrheic for at least one year to
             be considered of non-child bearing potential as determined by the Investigator.

          3. Patients with a past or present history of drug or alcohol abuse as per Diagnostic and
             Statistical Manual - 4th edition (DSM IV) criteria.

          4. Patients with a past (within one year) or present history of suicidal ideation or
             suicide attempts.

          5. Patients with unstable abnormalities of the hepatic, renal, cardiovascular,
             respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which
             might complicate assessment of the tolerability of the study medication.
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: MenACWY-CRM197 (two doses); MenC; PCV7; DTPa-IPV-HepB-Hib; MenACWY-CRM197 (one dose)
Intervention description: Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.; One 0.5mL dose of MenC vaccine was administered by intramuscular injection.; One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.; One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.; One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 662.0
Sex: All
Minimum age: 6 Months
Maximum age: 8 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Toddlers; Infants; Concomitant Vaccination

Summary:

      The primary immunogenicity objective is to assess and compare the immunogenicity of one dose
      of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured
      by the percentage of subjects with serum bactericidal titers directed against N. meningitidis
      serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  infants 6 to 8 months old inclusive, who were born after full term pregnancy and
             previously received three doses of both Prevenar and Infanrix-hexa vaccines at least
             30 days before study entry

        Exclusion Criteria:

          -  who previously received any meningococcal vaccine;

          -  who have had a previous confirmed or suspected disease caused by N. meningitidis, C.
             diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;

          -  who have had household contact with and/or intimate exposure to an individual with
             laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib,
             C. diphtheriae, Polio, or pneumococcal infection at any time since birth;

          -  Subjects with any serious, acute or chronic progressive disease
C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: C1 esterase inhibitor [human] (C1INH-nf); Placebo (saline)
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Hereditary angioedema; HAE; C1 esterase inhibitor (human); C1INH-nf

Summary:

      The study objective was to determine the safety and efficacy of C1INH-nf for the prevention
      of acute HAE attacks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HAE

          -  Normal C1q level

          -  Relatively frequent angioedema attacks (at least 2 per month on average)

        Exclusion Criteria:

          -  Low C1q level

          -  B-cell malignancy

          -  Presence of anti-C1INH autoantibody

          -  History of allergic reaction to C1INH or other blood products

          -  Narcotic addiction

          -  Current participation in any other investigational drug study or within the past 30
             days

          -  Participation in a C1 esterase inhibitor trial, or received blood or a blood product
             in the past 90 days

          -  Pregnancy or lactation

          -  Any clinically significant medical condition, such as renal failure, that in the
             opinion of the investigator would interfere with the subject's ability to participate
             in the study
A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study
Condition: Diabetic Macular Edema
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Edema
Intervention: Ranibizumab; Laser; Sham laser; Sham to ranibizumab
Intervention description: 0.5 mg ranibizumab administered by intravitreal injection.; Laser photocoagulation treatment; Sham to laser procedure.; Sham to ranibizumab administered as an intravitreal injection.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DME; Diabetic; macula; edema; ranibizumab; RESTORE

Summary:

      CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab
      (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in
      patients with visual impairment due to diabetic macular edema.

      CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12
      month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as
      symptomatic treatment for visual impairment due to diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Visual acuity impairment

          -  Diabetic macular edema in at least one eye

          -  Type 1 or type 2 diabetes mellitus

          -  Medication for the diabetes treatment must be stable for the last 3 months

        Exclusion Criteria:

          -  Patients with uncontrolled systemic or ocular diseases

          -  Laser photocoagulation in the study eye for the last 3 months

          -  Any history of any intraocular surgery in the study eye within the past 3 months

          -  Blood pressure > 160/100 mmHg

        Extension Inclusion Criteria:

        -Completion of the Core Study
A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density
Condition: Low Bone Mineral Density; Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: denosumab; denosumab
Intervention description: 60 mg denosumab in 1mL; 60 mg denosumab in 1mL
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 311.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteopenia; Osteoporosis; AMG 162; Postmenopausal; Pre-filled syringe

Summary:

      The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled
      syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density
      (BMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have successfully completed the 20050141 study (NCT00330460):

               -  Must have received all SC investigational product administrations in 20050141

               -  Must not have taken any proscribed therapies in 20050141

               -  Subjects who were in the alendronate or denosumab treatment group are allowed

          -  Provide signed informed consent before any study-specific procedures are conducted

        Exclusion Criteria:

          -  Any disorder that, in the opinion of the investigator, may compromise the ability of
             the patient to give written informed consent and/or comply with study procedures
             including:

               -  Any physical or psychiatric disorder

               -  Or evidence of alcohol or substance abuse in the last 12 months

          -  Any clinical evidence, in the medical judgement of the investigator, of the following
             medical conditions:

               -  Impaired thyroid function (subsequent to treatment)

               -  Impaired hepatic function

               -  Impaired renal function

               -  Rheumatoid Arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or
                  cirrhosis of the liver

               -  Known to have tested positive for human immunodeficiency virus, hepatitis C
                  virus, or hepatitis B surface antigen

               -  Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which
                  may interfere with the interpretation of the findings
Ketorolac in Breast Cancer Surgery
Condition: Curative Breast Cancer Surgery; Inflammatory Positive/Negative Status; Pre Surgical Incision Administration
MeSH terms: Breast Neoplasms; Surgical Wound
Intervention: Ketorolac 30 mg IV; Placebos
Intervention description: Active drug; Placebo looking like the Active drug
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Do the use of Ketorolac in one intravenous injection at the moment of the operative incision
      reduce the number of recurrence in patient with advanced breast cancer without inflammation
      signs.
    

Eligibility criteria:

        Inclusion Criteria:

        Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes
        ratio >4 and/or "triple negative" histological status and/or Positive lymph nodes

        Exclusion Criteria:

        Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non
        compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding
        mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation
        NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor
        classification )
MK0462 in Treatment of Migraine With Recurrence (MK0462-022)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Recurrence; Headache
Intervention: rizatriptan benzoate (MK0462); Comparator: placebo
Intervention description: Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.; Placebo to rizatriptan
Intervention MeSH terms: Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1473.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine
      attack and treatment of up to two headache recurrences compared to placebo.

      The long term extension study which pools patients from MK0462-022, -025, and -029 is
      described in NCT01286207.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had at least a 6-month history of migraine, with or without aura

          -  Patient was male, or if female must have been postmenopausal, surgically sterilized,
             or taking adequate contraceptive precautions

          -  Patient was judged to be in good health, apart from migraine

        Exclusion Criteria:

          -  Patient was pregnant or a nursing mother

          -  Patient had abused drugs or alcohol within 12 months prior to entering the study

          -  Patient had a history of cardiovascular disease

          -  Patient had clinically significant ECG abnormality

          -  Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic
             of less than 95 mm Hg at screening

          -  Patient received treatment with an investigational device or compound within 30 days
             of the study start

          -  Patient typically suffered from less then 1 or more than 8 attacks of migraine per
             month

          -  Patient had difficulty in distinguishing his/her migraine attacks from tension or
             interval headaches

          -  Patient had prior exposure to rizatriptan