bioihbjkbjnl/mcl2 huggingface dataset:
Cognition in the Study of Tamoxifen and Raloxifene
Condition: Cognition; Aging
Intervention: tamoxifen; raloxifene
Intervention description: oral tamoxifen plus placebo daily for 5 years; oral raloxifene plus placebo daily for 5 years
Intervention MeSH terms: Tamoxifen; Raloxifene Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1498.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: breast cancer; Tamoxifen; Raloxifene; hormone therapy

Summary:

      The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive
      aging in selected cognitively-healthy women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women enrolled in STAR trial at a site participating in Co-STAR

          -  65 years of age or older

          -  Have been randomized into STAR but have not started taking the study drug OR enrolled
             in STAR for a minimum of one year

          -  Have not been diagnosed with dementia

          -  Have signed a separate consent document for the Co-STAR Study

          -  Previous diagnoses of chronic neurologic disease (Parkinson's disease, stroke,
             epilepsy, multiple sclerosis), history of head injury, depression, alcohol addiction,
             drug addiction, and other neurologic or psychiatric conditions will be recorded but
             will not serve as exclusion factors for this study

        Exclusion Criteria:

          -  Not enrolled in the STAR Trial

          -  Younger than 65 years of age

          -  Diagnosed with dementia
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51
Intervention description: 6 mcg, intramuscularly [i.m.], 0.5 mL
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 639.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean
      Titers for anti-JEV neutralizing antibody.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Male and female subjects aged at least 18 years with written informed consent and
             either no childbearing potential or negative pregnancy test

        Main Exclusion Criteria:

          -  History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction
             including alcohol dependence
A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Sitaxsentan
Intervention description: Sitaxsentan 100 mg tablets once daily
Intervention MeSH terms: Sitaxsentan
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1192.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Open-label study

Summary:

      This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily
      by subjects with PAH until sitaxsentan, in a particular country or region, is commercially
      available for the treatment of PAH or the study is closed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac
             catheterization.

          -  Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

        Exclusion Criteria:

          -  Has portal hypertension or chronic liver disease.

          -  Has history of left sided heart disease or significant cardiac disease.
Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: DE-114 ophthalmic solution; Placebo ophthalmic solution; Olopatadine Hydrochloride 0.1% Ophthalmic Solution
Intervention MeSH terms: Olopatadine Hydrochloride; Pharmaceutical Solutions; Ophthalmic Solutions; Epinastine
Phase: Phase 3
Study type: Interventional
Enrollment: 87.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years

Summary:

      The purpose of the study is to demonstrate safety and efficacy of DE-114 ophthalmic solution
      compared to its Placebo and Olopatadine hydrochloride 0.1% ophthalmic solution in patients
      with allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided signed, written informed consent.

          -  Has a positive result from an allergen-specific IgE antibody test.

          -  If a subject is a female of childbearing potential, she must utilize reliable
             contraceptive throughout the study, and must have a negative urine pregnancy test
             prior to enrollment into this study.

        Exclusion Criteria:

          -  Females who are pregnant, nursing or planning a pregnancy, or females of childbearing
             potential who are not using a reliable method of contraception.

          -  Presence of any abnormality or significant illness that could be expected to interfere
             with the study.
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin; Teneligliptin; Placebo
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: 154.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: MT-2412; MP-513; TA-7284; Teneligliptin; Canagliflozin

Summary:

      The purpose of this study is to evaluate the efficacy and safety of co-administration of
      Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese
      patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and
      have inadequate glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women who are 20 - 75 years old

          -  HbA1c of ≥7.0% and <10.5%

          -  FPG of ≤ 270 mg/dL

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 8 weeks before run-in period

        Exclusion Criteria:

          -  Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder,
             or secondary diabetes

          -  Patients with serious diabetic complications

          -  Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Patients with Class III/IV heart failure symptoms according to New York Heart
             Association (NYHA) functional classification

          -  Patients with severe hepatic disorder or severe renal disorder.
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
Condition: Antibody-mediated Rejection
Intervention: C1-esterase inhibitor; Placebo
Intervention description: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution; Excipients of C1-INH plus albumin
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized-withdrawal
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibody-mediated kidney transplant rejection; Renal

Summary:

      This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant
      patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase
      inhibitor as add-on to standard of care (IVIG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age;

          -  Evidence of at least one donor-specific antibody (DSA);

          -  Recipient of a kidney transplant;

          -  Achieved a steady-state, post-transplant eGFR ≥ 40 mL/min/1.73 m2 within 60 days of
             post-transplant OR a 50% increase in urine output with a 50% decrease in serum
             creatinine over the first 7 days post-transplant in subjects with slow or delayed
             graft function;

          -  Acute AMR.

        Exclusion Criteria:

          -  Recipient of an en bloc kidney transplant;

          -  Current active hepatitis C virus (HCV) infection;

          -  Active bacterial or fungal infection;

          -  Ongoing dialysis >2 weeks;

          -  Known congenital bleeding or coagulopathy disorder;

          -  Current cancer or a history of cancer;

          -  Female subjects who are pregnant or breast feeding;

          -  Male or female subjects who are unwilling to use contraception or who are not
             surgically sterile.
Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Glatiramer Acetate 20 mg/0.5 mL; Glatiramer acetate 20 mg/0.5 mL
Intervention description: 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.; 20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsing Remitting Multiple Sclerosis; RRMS; Clinically Isolated Syndrome; CIS; Copaxone; glatiramer acetate; Autoject 2

Summary:

      This is an open-label, multicenter study conducted at approximately 20 sites. Each patient
      will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall
      injection satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis
             (RRMS) or Clinically Isolated Syndrome (CIS)

          -  Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a
             minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of
             daily injections

          -  Willing and able to complete all procedures and evaluations related to the study

          -  Willing to continue to follow usual injection site preparation and routine adjunctive
             local injection site reactions (LISR) management techniques

          -  Willing and able to provide written informed consent

        Exclusion Criteria:

          -  Currently using or treated with another immunomodulating therapy (IMT) in conjunction
             with GA in the 30 days prior to screening for this study

          -  Currently using an investigational drug or using treatment with any other
             investigational agent in the 30 days prior to screening for this study

          -  Pregnant or planning pregnancy or breastfeeding

          -  Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.)
             either currently or in the past 30 days prior to screening for this study

          -  Any other medical or psychiatric conditions that would make the patient unsuitable for
             this research, as determined by the Investigator

          -  Unwilling to perform all daily injections with an autoject 2 device

          -  Previous participation in any study evaluating the new 20 mg/0.5 mL formulation
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: edoxaban; enoxaparin sodium
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 716.0
Sex: All
Minimum age: 20 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: anticoagulant; venus thromboembolism; thrombosis; thromboembolism; embolism and thrombosis; deep vein thrombosis; DU-176b; Edoxaban; factor Xa; total knee arthroplasty; Enoxaparin sodium

Summary:

      The objective of this study is to assess the efficacy and safety of DU-176b compared with
      enoxaparin sodium for the prevention of venous thromboembolism in patients after elective
      total knee arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing unilateral total knee arthroplasty

        Exclusion Criteria:

          -  Subjects with risks of hemorrhage

          -  Subjects with thromboembolic risks

          -  Subjects who weigh less than 40 kg

          -  Subjects who are pregnant or suspect pregnancy, or subjects who want to become
             pregnant.
Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Intervention: Magnesium Sulfate; Normal Saline
Intervention description: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.; Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
Intervention MeSH terms: Magnesium Sulfate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1700.0
Sex: All
Minimum age: 40 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: stroke; brain attack; magnesium sulfate; neuroprotection; prehospital care; emergency medical services

Summary:

      The goal of this study is to evaluate the effectiveness and safety of field-initiated
      magnesium sulfate in improving the long-term functional outcome of patients with acute
      stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suspected stroke identified by the Los Angeles Prehospital Stroke Screen

          -  Age 40-95, inclusive

          -  Last known well time within 2 hours of treatment initiation

          -  Deficit present for >/= 15 minutes

        Exclusion Criteria:

          -  Coma

          -  Rapidly improving neurologic deficit

          -  Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound
             the neurological or functional outcome evaluations

          -  Systolic Blood Pressure (SBP) < 90 or > 220

          -  Known severe renal dysfunction (on dialysis or known chronic creatinine > 3.0)

          -  Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or >/= 24)

          -  Known second or third degree heart block with no pacemaker in place

          -  Major head trauma in the last 24 hours

          -  Recent stroke within prior 30 days

          -  Patient unable to give informed consent and no available on scene consent or assent
             provider
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
A Study of Galcanezumab in Participants With Chronic Cluster Headache
Condition: Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: Galcanezumab 300 mg; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug known as
      galcanezumab in participants with chronic cluster headache.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a history of chronic cluster headache occurring without a remission
             period, or with remissions lasting <1 month, for at least 1 year.

          -  Participants are able to distinguish cluster headache attacks from other headaches.

        Exclusion Criteria:

          -  Current enrollment in or discontinuation within the last 30 days from, a clinical
             trial involving any investigational drug or device.

          -  Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)
             antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).

          -  Are taking indomethacin and/or are suspected of having another distinct trigeminal
             autonomic cephalalgia.

          -  A history of migraine variants that could implicate or could be confused with
             ischemia.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins.

          -  A history or presence of other medical illness that indicates a medical problem that
             would preclude study participation.

          -  Evidence of significant active or unstable psychiatric disease, in the opinion of the
             investigator.

          -  Women who are pregnant or nursing.
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bempedoic Acid + Ezetimibe Fixed-Dose Combination; Bempedoic Acid; Ezetimibe; Placebos
Intervention description: bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet; bempedoic acid 180 mg tablet; ezetimibe 10 mg overencapsulated tablet; placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease; high cholesterol; ASCVD; HeFH; LDL

Summary:

      The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a
      fixed-dose combination (FDC) is effective and safe versus its individual components and
      placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Require lipid-modifying therapy for primary or secondary prevention of cardiovascular
             disease

          -  Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary
             prevention (history of HeFH and/or ASCVD)

          -  Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks
             prior to screening

        Exclusion Criteria:

          -  Total Fasting Triglyceride ≥ 400 mg/dL

          -  Renal Dysfunction or nephrotic syndrome or history of nephritis

          -  Significant cardiovascular disease or cardiovascular event within the past 3 months