bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Flurpiridaz F18; 99mTechnicium (sestamibi or tetrofosmin)
Intervention description: Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis; Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis
Intervention MeSH terms: Technetium Tc 99m Sestamibi; Technetium tc-99m tetrofosmin
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 795.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary Artery Disease.; Positron Emission Tomography Myocardial Perfusion Imaging.; Single Positron Emission Computed Tomography.; Flurpiridaz F18 Injection.

Summary:

      The primary objective of the study is to assess the diagnostic efficacy (specificity and
      sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to
      single photon emission computed tomography (SPECT) MPI in the detection of significant
      coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a
      documented history of Myocardial Infarction (MI).
    

Eligibility criteria:

        Inclusion Criteria:

        Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional
        details.

        Exclusion Criteria:

        Women who are pregnant, lactating, or of child bearing potential who are not practicing
        birth control.

        Unstable cardiac status. History of coronary artery bypass graft. History of percutaneous
        coronary intervention within the past six months. See protocol for additional details.
A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: Tocilizumab 8 mg/kg administered intravenously.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm, multicenter long-term extension study will evaluate the safety
      and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe
      rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible
      participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >/= 18 years of age

          -  Participants who complete their last WA19926 core study visit (Week 104) and who may
             benefit from study drug treatment, at baseline or later if they are in remission DAS28
             at Week 104 of WA19926, according to the Investigator's assessment

          -  No current or recent adverse event or laboratory finding preventing the use of the
             study drug dose of tocilizumab 8 mg/kg at baseline visit

          -  Women of childbearing potential must agree to use adequate contraception as defined by
             protocol during and up to 3 months after treatment

        Exclusion Criteria:

          -  Pregnant females

          -  Participants who have withdrawn prematurely from the WA19926 core study for any reason

          -  Treatment with any investigational agent or cell-depleting therapies since the last
             administration of study drug in WA19926

          -  Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,
             or a T-cell costimulation modulator since the last administration of study drug in
             WA19926

          -  Immunization with a live/attenuated vaccine since the last administration of study
             drug in WA19926

          -  Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other
             than rheumatoid arthritis

          -  Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than
             rheumatoid arthritis

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies, including tocilizumab and its excipients

          -  Evidence of severe uncontrolled concomitant disease or disorder

          -  Known active or history of recurrent infections

          -  Active tuberculosis requiring treatment in the previous 3 years

          -  History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
Condition: Nocturia
MeSH terms: Nocturia
Intervention: Desmopressin Melt
Intervention description: An orally disintegrating tablet of desmopressin administered under the tongue (sublingually), without water.
Intervention MeSH terms: Deamino Arginine Vasopressin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 554.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to investigate the long term efficacy and safety of several
      doses of the Melt formulation of desmopressin in a broad population of adult patients with
      nocturia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to the performance of any study-related activity.

          -  Was randomized into Part II of Protocol FE992026 CS29 (NCT00477490), entitled "A
             Randomized, Double Blind,Placebo Controlled, Parallel Group, Multi-Center Study with a
             Double Blind Extension Investigating the Efficacy and Safety of a Fast-Dissolving
             ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults" and have
             completed at least Visit 3E in Part II (Day 15).

        Exclusion Criteria:

          -  Patients using loop diuretics (furosemide, torsemide, ethacrynic acid).
Trial of Decitabine in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Cytarabine or Supportive Care; Dacogen (decitabine) only
Intervention description: Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.); 20mg/m^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.
Intervention MeSH terms: Cytarabine; Decitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 485.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Acute Myeloid Leukemia; Dacogen; Decitabine; Poor or intermediate-risk cytogenetics

Summary:

      The purpose of this study is to compare the results in older patients who have newly
      diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine
      or patient's choice with the physician's advice of either cytarabine or supportive care
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must have diagnosed acute myeloid leukemia.

          2. Must have a life expectancy of at least 12 weeks.

          3. Must sign informed consent.

        Exclusion Criteria:

          1. Must not have acute promyelocytic leukemia (M3 classification)

          2. Must not have any other active systemic malignancies.

          3. Must not have inaspirable bone marrow.

          4. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid
             disorder.

          5. Must not have chronic respiratory disease that requires continuous oxygen use.

          6. Must not have received any experimental drug within 4 weeks before randomization.

          7. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks
             after randomization.

          8. Must not have known HIV.
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Condition: Postoperative Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Amiodarone; DC-cardioversion; Rate Control
Intervention description: Amiodarone Initial Dose
Oral: 400 mg po TID for 3 days is recommended
For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose
Oral: at least 200 mg/day to be continued until 60 days after randomization
If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started; DC-Cardioversion - frequency and duration determined by medical professional as medically needed; Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed
Intervention MeSH terms: Digoxin; Amiodarone; Calcium Channel Blockers
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 523.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart surgery; Cardiac surgery; Coronary artery bypass; Mitral valve surgery; Aortic valve surgery; Atrial fibrillation; Atrial flutter; Cardiac arrhythmia; Valve surgery

Summary:

      The purpose of this study is to compare the therapeutic strategies of rate control versus
      rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial
      fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after
      cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in
      hospital within 60 days of the occurrence of AF compared to a strategy of rate control.
    

Eligibility criteria:

        Enrollment Inclusion Criteria:

          -  Age > 18 years

          -  Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or
             valve repair or replacement (excluding mechanical valves), including re-operations

          -  Hemodynamically stable

        Randomization Inclusion Criteria

          -  AF that persists for > 60 minutes or recurrent (more than one) episodes of AF up to 7
             days after surgery during the index hospitalization.

        Exclusion Criteria:

          -  LVAD insertion or heart transplantation

          -  Maze procedure

          -  TAVR

          -  History of or planned mechanical valve replacement

          -  Correction of complex congenital cardiac defect (excluding bicuspid aortic valve,
             atrial septal defect or PFO)

          -  History of AF or AFL

          -  History of AF or AFL ablation

          -  Contraindications to warfarin or amiodarone

          -  Need for long-term anticoagulation

          -  Concurrent participation in an interventional (drug or device) trial
The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Sildenafil citrate
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 267.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      Determination of the effects of sildenafil citrate and epoprostenol when used in combination
      in patients with pulmonary arterial hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with pulmonary arterial hypertension caused by primary PAH, associated with
             connective tissue disease or following surgical repair of a congenital heart lesion

        Exclusion Criteria:

          -  PH other than PAH
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
Condition: HIV-1-infection
Intervention: B/F/TAF; F/TAF; DTG; DTG Placebo; F/TAF Placebo; B/F/TAF Placebo
Intervention description: 50/200/25 mg FDC tablet(s) administered orally once daily; 200/25 mg FDC tablet(s) administered orally once daily; 50 mg tablet(s) administered orally once daily; Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Intervention MeSH terms: Dolutegravir; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of switching from a regimen
      of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and
      emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of
      bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically
      suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum
             time periods:

               -  ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse
                  transcriptase inhibitor (NRTI) resistance prior to the screening visit)

               -  ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the
                  screening visit)

          -  Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with
             DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable)
             preceding the screening visit

          -  Plasma HIV-1 RNA levels < 50 copies/mL at screening visit

          -  Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the
             Cockcroft-Gault formula for creatinine clearance

          -  No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed
             virologic failure

          -  Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
             infection are permitted to enroll

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine; hydrochlorothiazide; Aliskiren
Intervention description: Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.; Hydrochlorothiazide 12.5 mg capsules were taken orally once daily; Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aliskiren; Amlodipine; Hypertension; SPA1000; Norvasc

Summary:

      This study will compare the safety and efficacy of initial combination treatment with
      aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine
      in patients with hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients ≥ 18 years of age

          -  Participants with essential hypertension:

               -  Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150
                  mmHg and < 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve'
                  if they have never been treated with any antihypertensive medication.)

               -  All participants must have a msSBP ≥ 150 mmHg and < 180 mmHg at Visit 2

          -  Written informed consent to participate in this study prior to any study procedures

        Exclusion Criteria:

          -  Severe hypertension

          -  Pregnant or nursing (lactating) women

          -  Pre-menopausal women not taking accepted form of birth control

          -  Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1

          -  History of cardiovascular conditions

          -  Uncontrolled Type 1 or Type 2 diabetes mellitus

          -  Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with
             similar chemical structures

        Other protocol-defined inclusion/exclusion criteria may apply.
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
Condition: Neoplasms, Prostate
MeSH terms: Prostatic Neoplasms
Intervention: Dutasteride; Placebo
Intervention description: After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.; After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.
Intervention MeSH terms: Dutasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8231.0
Sex: Male
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Prostate cancer prevention; prostate; BPH; enlarged prostate; PSA; prostate cancer

Summary:

      This 4-year study will compare how safe and effective an oral investigational medicine is
      (compared to placebo) in preventing the development of prostate cancer in men that are
      defined by the study entrance criteria as being at an increased risk for prostate cancer.
      Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits),
      and a prostate biopsy will be performed at 2 and 4 years of treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed consent to participate in study.

          -  Have had a single negative prostate biopsy within 6 months prior to enrollment in
             study.

          -  Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a
             PSA between 3.0 and 10 if over age 60.

          -  Ability and will to participate in study for 4 years.

        Exclusion criteria:

          -  More than one previous negative prostate biopsy.

          -  History of prostate cancer.

          -  Previous prostate surgery.

          -  Inability to urinate requiring the need of a catheter during the previous 2 years.

          -  Any condition (other than benign prostatic hypertrophy) which may result in urinary
             symptoms or changes in urine flow rate.

          -  Cancer within previous 5 years (other than basal or squamous cell cancers of the
             skin).

          -  Any unstable serious medical condition.

          -  Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride
             (Avodart), testosterone, or drugs that can block the action of male hormones.
Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)
Condition: Asthma, Exercise-Induced
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Intervention: Comparator: Montelukast; Comparator: Placebo
Intervention description: Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge; Placebo tablet administered orally as a single witnessed dose before exercise challenge
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of an approved medication being studied
      in support of a new approach in the prevention of exercise-induced asthma (a worsening of
      asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have
      a history of worsening asthma after exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with mild-to-moderate asthma

        Exclusion Criteria:

          -  Medical history of a lung disorder (other than asthma) or a recent upper respiratory
             tract infection

          -  Patient is, other than asthma, not in good, stable health

          -  The Primary Investigator will evaluate whether there are other reasons why

        the patient may not participate