bioihbjkbjnl/mcl2 huggingface dataset:
Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis
Condition: Coronary Artery Bypass
MeSH terms: Thrombosis
Intervention: Prasugrel; Placebo
Intervention description: one 10 mg tablet by mouth daily; placebo similar in appearance to prasugrel
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass; thrombosis; prasugrel

Summary:

      This is a randomized-controlled clinical trial that will randomize 120 patients undergoing
      clinically-indicated coronary artery bypass graft surgery to prasugrel at a dose of 10 mg
      daily or matching placebo for 12 months, starting at the time of hospital dismissal from
      surgery. The primary goal of the study is to determine whether prasugrel administration will
      prevent thrombus (clot) formation within a saphenous vein graft at 12 months, as examined by
      optical coherence tomography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or greater

          -  Willing and able to give informed consent. The patients must be able to comply with
             study procedures and follow-up.

          -  Undergoing clinically-indicated coronary artery bypass graft surgery

        Exclusion Criteria:

          -  Known allergy to aspirin or prasugrel

          -  Need for concomitant cardiac procedure, such as valve repair or replacement

          -  Increased risk of bleeding, including need for warfarin or dabigatran administration

          -  Positive pregnancy test or breast-feeding

          -  Coexisting conditions that limit life expectancy to less than 12 months or that could
             affect a patient's compliance with the protocol

          -  Serum creatinine > 2.5 mg/dL

          -  Severe peripheral arterial disease limiting vascular access

          -  Prior stroke or transient ischemic attack

          -  Weight <60 kg or age >75 years

          -  Multiple distal SVG anastomoses

          -  Postoperative complications prolonging hospitalization
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Vitamin D Deficiency
Intervention: Vitamin D
Intervention description: 2000iu once a day
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with clinically significantly low Vitamin D levels (<30 ng/mL) were supplemented with Vitamin D and compared to patients with normal vitamin D levels (50-80 nG/mL).
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Type I; Newly Diagnosis Type I Diabetes Mellitus

Summary:

      Our objective is to demonstrate that providing supplemental vitamin D to children with new
      onset DM will significantly decrease the levels of HbA1c and insulin requirement by the
      following methods.

        1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes
           mellitus (DM).

        2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level
           over the past few months) and document insulin requirements before and after vitamin
           supplementation is given.

      Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin
      requirements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed type I DM.

          -  Age <18 years

        Exclusion Criteria:

          -  Pregnancy
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Revefenacin; Placebo; Formoterol
Intervention description: Revefenacin is administered via a nebulizer.; Placebo version of Revefenacin is administered via a nebulizer.; Administered sequentially in both revefenacin and placebo arms using a nebulizer.
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled, parallel-group study. Each participant will receive treatment daily for a total of 42 days. One group will receive placebo and formoterol and one group will receive revefenacin and formoterol.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease; Pulmonary Function; COPD; Performist

Summary:

      The primary objective of the study was to characterize the safety and tolerability of
      once-daily revefenacin inhalation solution when dosed sequentially with twice-daily
      formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of
      participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over
      21 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a male or female subject 40 years of age or older.

          -  Participant is willing and able to provide signed and dated written informed consent.

          -  Participant has a current or past cigarette smoking history (or equivalent for cigar
             or pipe smoking history) of at least 10 pack-years.

          -  Participant must be willing and able to attend study visits according to the visit
             schedule and adhere to all study assessments/procedures.

        Exclusion Criteria:

          -  Participant has a concurrent disease or condition that, in the opinion of the
             investigator, would interfere with study participation or confound the evaluation of
             safety, tolerability, or pharmacokinetics of the study drug.

          -  Participant has a history of reactions or hypersensitivity to inhaled or nebulized
             anticholinergics, short-acting beta-agonists and long-acting beta-agonists.

          -  Participant with clinically significant and uncontrolled hypertension,
             hypercholesterolemia or Type II diabetes mellitus, as assessed by the investigator.

          -  Participant is unwilling or unable to stop the use of prohibited medications during
             the washout (if required) and treatment period and follow-up period of the study.
Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
Condition: Post-operative Pain; Post-partum Pain; Cesarean Section Complications
MeSH terms: Pain, Postoperative
Intervention: Ketorolac
Intervention description: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
Intervention MeSH terms: Ketorolac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The subjects, care providers, and investigators will be blinded to the assignments of groups.
Enrollment: 148.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ketorolac; opiate; cesarean section

Summary:

      To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean
      section.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women presenting for care at Tufts Medical Center as an outpatient in obstetrics
             clinic or on Labor and Delivery.

          -  The subject must have had a cesarean section for any indication at Tufts Medical
             Center to be randomized to the study

          -  The subject is willing to have a phone call follow up conversation 2 weeks after their
             surgery.

        Exclusion Criteria:

          -  Patients with allergy to ketorolac, NSAIDS or aspirin

          -  Patients with peptic ulcer disease, preexisting kidney or liver disease.

          -  Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean
             section.

          -  Patient is hemodynamically unstable due to hemorrhage.

          -  Patient requires therapeutic anticoagulation in the post-operative period

          -  Patients with peripartum cardiomyopathy

          -  Provider decision to exclude patient.

          -  Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia,
             HELLP syndrome, or eclampsia

          -  A study subject may participate in another research study while participating in this
             research study.
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
Condition: Chemotherapy-induced Neutropenia; Breast Cancer
MeSH terms: Breast Neoplasms; Neutropenia
Intervention: LA-EP2006; Neulasta®
Intervention description: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.; Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 308.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pegfilgrastim; G-CSF; neutropenia; breast cancer; myelosuppressive chemotherapy

Summary:

      The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the
      mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in
      breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically proven breast cancer

          -  eligible for six cycles of neoadjuvant or adjuvant chemotherapy

        Exclusion Criteria:

          -  concurrent or prior chemotherapy for breast cancer

          -  concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy,
             immunotherapy, monoclonal antibodies, and/or biological therapy

          -  concurrent prophylactic antibiotics

          -  previous therapy with any G-CSF (granulocyte-colony stimulating factor) product

        Other protocol-defined inclusion/exclusion criteria may apply.
MSB11022 in Moderate to Severe Rheumatoid Arthritis
Condition: Moderate to Severe Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: MSB11022; EU-Humira
Intervention description: Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.; Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022
      and Humira® in adult participants with rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis based on 2010 American College of
             Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria

          -  At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening
             and baseline

          -  Must have received methotrexate for at least 12 weeks and been on a stable dose for at
             least 4 weeks prior to the first study dose

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Evidence of untreated or inadequately treated latent or active Tuberculosis

          -  Evidence of uncontrolled, clinically significant diseases

          -  Any second disease-modifying antirheumatic drugs must be washed out prior to the first
             study dose

          -  Other protocol defined exclusion criteria could apply
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
Condition: ACL Injury; Postoperative Pain
MeSH terms: Pain, Postoperative; Anterior Cruciate Ligament Injuries
Intervention: Ketorolac; Oxycodone-Acetaminophen
Intervention description: Oral ketorolac for pain control following ACL reconstruction surgery; Oral oxycodone-acetaminophen for post-operative pain control
Intervention MeSH terms: Acetaminophen; Ketorolac; Acetaminophen, hydrocodone drug combination; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ACL reconstruction; Ketorolac; Pain; Narcotic

Summary:

      1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent
           to the standard of care pain protocol for postoperative pain control following ACL
           reconstruction surgery.

        2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the
           standard of care pain protocol will reduce postoperative opioid consumption following
           ACL reconstruction surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 18 and 89 years old

          -  Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

        Exclusion Criteria:

          -  Patients below age 18 or above age 89

          -  Illiterate or non-English speaking individuals

          -  Patients with contraindications to Ketorolac

          -  History of chronic alcohol or drug abuse

          -  Chronic use of psychotropic or analgesic drugs

          -  Known peptic ulcer disease or bleeding diasthesis

          -  Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)

          -  Breastfeeding women

          -  Pregnant women
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Peramivir; Oseltamivir
Intervention MeSH terms: Oseltamivir; Peramivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 0 Days
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of
      IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of
      pediatric subjects with acute uncomplicated influenza.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Clinical signs and symptoms consistent with acute influenza infection consisting of an
             oral temperature ≥ 100°F (37.8°C) or rectal temperature ≥ 101.3ºF (≥ 38.5ºC) with at
             least one respiratory symptom (cough or rhinitis) OR Positive influenza determined by
             PCR or Rapid Antigen Test

          2. Onset of symptoms no more than 72 hours before presentation for screening for subjects
             < 2 years old.

        Key Exclusion Criteria:

          1. Pregnant or breast-feeding females

          2. Development of symptoms while hospitalized

          3. Presence of a chronic disease or illness that may indicate increased risk for
             influenza-related complications

          4. Presence of immunocompromised status
Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: 33A; placebo; azacitidine; decitabine
Intervention description: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push; Volume equivalent to 10 mcg/kg, every 4 weeks via IV push; 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks; 20 mg/m2 given IV x 5 days, every 4 weeks
Intervention MeSH terms: Azacitidine; Decitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies, monoclonal; Antibody drug conjugate; Antigens, cluster of differentiation 33 (CD33); Drug therapy; Immunotherapy

Summary:

      The purpose of this study in AML patients is to test whether vadastuximab talirine
      (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and
      extends overall survival as compared to placebo combined with either azacitidine or
      decitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo
             or secondary AML according to World Health Organization (WHO) classification (except
             for acute promyelocytic leukemia (APL))

          -  Intermediate or adverse cytogenetic risk

          -  Eligible for therapy with either decitabine or azacitidine

          -  Acceptable hematologic and organ function

        Exclusion Criteria:

          -  AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or
             t(15;17)

          -  Patients who are candidates for allogeneic stem cell transplant at the time of
             enrollment

          -  Patients with a history of one of the following myeloproliferative neoplasms:
             essential thrombocythemia, polycythemia vera, and primary myelofibrosis

          -  Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic
             syndrome (MDS)
Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Condition: Keratoconjunctivitis Sicca; Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
Intervention: Tavilermide ophthalmic solution; Placebo
Intervention description: BID topical dosing; BID topical dosing
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 623.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1%
      tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the
      signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject-reported history of dry eye disease in both eyes for at least 6 months;

          -  History of use of artificial tear eye drops for dry eye symptoms;

          -  Total score of ≥40 on SANDE;

          -  TFBUT;

          -  Corneal fluorescein staining;

          -  Lissamine green conjunctival staining;

          -  Schirmer's test score.

        Exclusion Criteria:

          -  Have participated in a previous tavilermide (MIM-D3) study;

          -  Have clinically significant slit lamp findings at Visit 1;

          -  Have a history of lacrimal duct obstruction within 12 months of Visit 1;

          -  Have an uncontrolled systemic disease;

          -  Be a woman who is pregnant, nursing or planning a pregnancy;

          -  Be a woman of childbearing potential who is not using an acceptable means of birth
             control;

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study;

          -  Be currently enrolled in an investigational drug or device study or have used an
             investigational drug or device within 45 days prior to Visit 1.
Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Low Dose Asenapine maleate transdermal patch; High Dose Asenapine maleate transdermal patch; Placebo
Intervention description: The study will evaluate low dose Asenapine maleate transdermal patch; The study will evaluate high dose Asenapine maleate transdermal patch; The study will evaluate placebo transdermal patch.
Intervention MeSH terms: Asenapine; Maleic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 617.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo
      transdermal patch in subjects diagnosed with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current diagnosis of schizophrenia.

          -  Subject has PANSS total score ≥80, AND score of 4 or more in at least 2 of the
             following PANSS items at Screening and at Baseline: conceptual disorganization
             delusions; hallucinatory behavior; unusual thought content.

          -  Subjects must be able to wear a transdermal patch for 24 hours.

        Exclusion Criteria:

          -  Subject has been diagnosed with schizophrenia less than 6 months prior to Screening
             Visit.

          -  Subject has received within 90 days of Screening Visit: electroconvulsive therapy;
             transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulation
             treatments

          -  Subject has experienced acute depressive symptoms within 30 days prior to Screening
             Visit that requires treatment with an antidepressant, as determined by the
             Investigator.

          -  Currently taking clozapine for the treatment of schizophrenia.

          -  Has hypothyroidism or hyperthyroidism.

          -  Subject is currently being treated with insulin for diabetes.

          -  Subject has epilepsy or history of seizures.

          -  Positive urine pregnancy test.