--- a +++ b/clusters/3009knumclusters/clust_293.txt @@ -0,0 +1,178 @@ +Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below:\r\n* Major criteria\r\n** Forced expiratory volume in 1 second (FEV1) =< 50% predicted\r\n** DLCO =< 50% predicted\r\n* Minor criteria\r\n** FEV1 51-60% predicted\r\n** DLCO 51-60% predicted\r\n** Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization\r\n** Poor left ventricular function (defined as an ejection fraction of 40% or less)\r\n** Resting or exercise arterial partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%\r\n** Partial pressure of carbon dioxide (pCO2) > 45 mm Hg\r\n** Modified medical research council (MMRC) dyspnea scale >= 3\r\n** Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by the patient for tangible or intangible reasons +For subjects planned to potentially receive bevacizumab, they have no evidence of uncontrolled hypertension (defined as a blood pressure of ? 150 mm Hg systolic and/or ? 100 mm Hg diastolic on medication) or active GI perforation +Uncontrolled hypertension defined as systolic > 150 or diastolic > 100 mm Hg on the average of the 3 most recent BP readings. Anti-hypertensives may be started prior to randomization. +Significant active cardiovascular or pulmonary disease at the time of study entry, including\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg) \r\n* Pulmonary hypertension \r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air \r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement \r\n* Medically significant (symptomatic) bradycardia +Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are INELIGIBLE including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n* QT syndrome, or torsades de pointes\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long +Systolic blood pressure (BP) =< 150 mg HG +Diastolic BP =< 90 mg HG +Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment; if severe hearing impairment is measured or if significant neuropathy is reported at baseline the treating physician will discuss the risks for further permanent hearing loss and neuropathy with the patient +Patients with persistently uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical therapy +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) on repeated measurement) despite optimal medical management +Significant active cardiovascular or pulmonary disease at the time of study registration, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 160 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Uncontrolled hypertension (diastolic blood pressure > 90 mm Hg; systolic > 140 mm Hg); patients with hypertension should be under treatment on study entry to effect blood pressure control +Heart disease including congestive heart failure (New York Heart Association [NYHA] grade II or greater); unstable angina; prior myocardial infarction (non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]) within 6 months prior to study enrollment; hypertension with a systolic blood pressure of > 150 mm Hg or diastolic blood pressure of >100 mm Hg while on antihypertensive medication +Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of antihypertensive agents to control hypertension before week 1, day 1 is allowed. +Participant with an uncontrolled intercurrent illness including, but not limited to;\r\n* Ongoing or active infection, \r\n* Symptomatic congestive heart failure, \r\n* Unstable angina pectoris, \r\n* Cardiac arrhythmia, \r\n* A persistent grade 3 hypertension (as defined as stage 2 hypertension with systolic blood pressure [BP] >= 160 mm Hg or diastolic BP >= 100 mm Hg and medical intervention indicated) based on the baseline and previous BP readings if available\r\n* Psychiatric illness/social situations that will limit compliance with study requirements +Clinically significant, uncontrolled heart diseases\r\n* Unstable angina within 6 months prior to screening\r\n* Myocardial infarction within 6 months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication; initiation or adjustment of antihypertensive medication (s) is allowed prior to screening\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Fridericia's correction formula (QTcF) > 480 msec +Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE v4.0)] on repeated measurement) despite optimal medical management +Significant active cardiovascular or pulmonary disease at the time of study entry, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas (ABG) analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* History or presence of serious uncontrolled ventricular arrhythmias\r\n* Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n* Uncontrolled hypertension (defined as systolic blood pressure [SBP] >= 160 mm Hg or diastolic blood pressure [DBP] >= 100 mm Hg while on anti-hypertensive medications) +History of any of the following cardio-vascular condition:\r\n* Myocardial infarction (MI)\r\n* Unstable angina\r\n* Coronary artery bypass grafting (CABG)\r\n* Coronary angioplasty or stenting\r\n* Symptomatic peripheral arterial disease (PAD)\r\n* History of symptomatic chronic congestive heart failure (CHF)\r\n* History of cerebrovascular accidents including transient ischemic attacks (TIA)\r\n* Corrected QT interval (QTc) > 480 msec\r\n* Uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg or diastolic BP of > 90 mm Hg); if the screening BP is elevated, adjustments in anti-hypertensives are permitted and a re-screening will be permitted for BP assessment with three consecutive values obtained 2 minutes apart; the 3 values have to be below 150/90 mm Hg for eligibility and can only be obtained after 2 days of the last change in anti-hypertensive medication; use of clonidine is not permissible for adjusting the BP during this period +No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) +No evidence of uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart; the baseline systolic BP readings must be =< 140 mm Hg, and the baseline diastolic BP readings must be =< 90 mm Hg; use of antihypertensive medications to control BP is allowed +The patient has uncontrolled hypertension defined as a blood pressure measurement greater than 150 mm Hg systolic or 90 mm Hg diastolic with medication +Blood pressure less than 140/90 mm Hg with or without anti-hypertensive therapy\r\n* Patients may be rescreened after initial ineligibility if due to elevated blood pressure, if adequately medically managed within approximately 30 days +Uncontrolled hypertension (systolic pressure >140 mm Hg and/or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.0] on repeated measurement) despite optimal medical management +Uncontrolled hypertension (above 150/95 mm Hg) +Significant active cardiovascular or pulmonary disease including: a) Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed. b) Pulmonary hypertension c) Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air d) Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement e) Medically significant (symptomatic) bradycardia f) History of arrhythmia requiring an implantable cardiac defibrillator g) Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes). +Has inadequately controlled hypertension (defined as systolic blood pressure greater than 150 mm Hg or diastolic blood pressure greater than 95 mm Hg); the use of antihypertensive medications to control blood pressure is permitted; retesting is permitted +Absence of uncontrolled angina or hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment +Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg on repeated measurement) despite optimal medical management +Hypertension defined as blood pressure (BP) systolic > 150 or diastolic > 90 mm Hg (Note: Initiation or adjustment of antihypertensive medication prior to study entry is allowed provided that the average of 3 BP readings prior to study treatment is ?150/90 mm Hg.) +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0] on repeated measurement) despite optimal medical management +Sustained systolic blood pressure (BP) >140 mm Hg or <90 mm Hg, diastolic BP >100 mm Hg or <60 mm Hg +Patients must not have uncontrolled hypertension (systolic >180 mm hg or diastolic > 100 mg Hg), angina pectoris, cardiac dysrhythmia, or recent (within 6 weeks) intracranial hemorrhage. +Hypertension defined as sustained BP > 140 millimeter of mercury (mm Hg) systolic, or > 90 mm Hg diastolic within 7 days before the first dose of study treatment and/or receiving medication to treat hypertension +Uncontrolled hypertension (that is, either systolic blood pressure > 180 millimeter of mercury [mm Hg] or diastolic blood pressure > 95 mm Hg). +Significant active cardiovascular or pulmonary disease at the time of study entry, including: uncontrolled high blood pressure (i.e., systolic blood pressure > 150 mm Hg, diastolic blood pressure > 90 mm Hg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed; pulmonary hypertension; uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air; significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement; medically significant (symptomatic) bradycardia; history of arrhythmia requiring an implantable cardiac defibrillator; baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Significant active cardiovascular or pulmonary disease including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Systolic blood pressure >140mm Hg or diastolic blood pressure > 90 mm Hg +Significant cardiac history:\r\n* History of myocardial infarction or ischemic heart disease within 1 year before first study drug administration;\r\n* Uncontrolled arrhythmia;\r\n*History of congenital QT prolongation;\r\n* New York Heart Association class III or IV cardiac disease;\r\n* Uncontrolled hypertension: blood pressure consistently greater than 150 mm Hg systolic and 100 mm Hg diastolic in spite of antihypertensive medication +Clinically significant cardiovascular disease defined as follows: \r\n* Inadequately controlled hypertension (i.e., systolic blood pressure [SBP] > 160 mm Hg and/or diastolic pressure [DBP] > 90 mm Hg despite antihypertensive therapy) \r\n* History of cerebrovascular accident (CVA) within 6 months \r\n* Myocardial infarction or unstable angina within 6 months +PONATINIB \r\n* Patients with cytogenetically ‘favorable risk' AML (core-binding factor leukemias) will not be enrolled on the ponatinib arm; testing with cytogenetics and fluorescence in situ hybridization (FISH) can establish this subtype within 7 days of the diagnostic bone marrow biopsy\r\n* History of acute pancreatitis within 1 year of study or history of chronic pancreatitis\r\n* Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)\r\n* Any history of myocardial infarction, stroke, or revascularization\r\n** Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism with the exception of upper Extremity/Line associated deep vein thrombosis (DVTs) which are adequately treated (line removed and/or patient anti-coagulated)\r\n* Uncontrolled hypertension (diastolic blood pressure > 90 mm Hg; systolic > 140 mm Hg); patients with hypertension should be under treatment on study entry to effect blood pressure control +No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 30 minutes apart; the baseline systolic blood pressure readings must be =< 140 mm Hg, and the baseline diastolic blood pressure readings must be =< 90 mm Hg; patients whose hypertension is controlled by antihypertensive therapies are eligible +The patient has uncontrolled or poorly-controlled hypertension (>= 150 / >= 90 mm Hg) despite standard medical management +Significant active cardiovascular or pulmonary disease at the time of study entry, including: uncontrolled high blood pressure (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed; pulmonary hypertension; uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air; significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement; medically significant (symptomatic) bradycardia; history of arrhythmia requiring an implantable cardiac defibrillator; baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Significant active cardiovascular or pulmonary disease including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging\r\nindependent of symptom control with medical intervention, or history of valve\r\nreplacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mg Hg within 14 days prior to study registration +Significant active cardiovascular or pulmonary disease at the time of study entry, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsade de pointes) +Pre-existing uncontrolled hypertension defined as > 150/90 mm Hg with medication +Poorly controlled arterial hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg), with or without antihypertensive medication; patients presenting with high blood pressure are eligible if the dose or adjustment of anti-hypertensive lowers blood pressure to meet the inclusion criteria of the study +Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management +PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAdequately controlled blood pressure (SBP < 140 mm Hg and DBP < 90mmHg) on a maximum of three anti-hypertensive medications +Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of blood pressure (BP) medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 140/90 mm Hg) +Uncontrolled hypertension (systolic blood pressure > 140 mm Hg and diastolic blood pressure of > 90 mm Hg which cannot be controlled by anti-hypertensive therapy), congestive heart failure (CHF), or other major medical illness +Clinically significant, uncontrolled intercurrent illness including, but not limited to:\r\n* Symptomatic or active infection\r\n* Uncontrolled hypertension (diastolic blood pressure > 90 mm Hg; systolic > 140 mm Hg); patients with hypertension should be under treatment on study entry to effect blood pressure control\r\n* Psychiatric illness/social situations that would limit compliance with study requirements +Significant active cardiovascular or pulmonary disease at the time of study entry, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 150 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator +Uncontrolled hypertension as defined by SBP > 160 mm/Hg or DBP > 100 mm/Hg despite medical therapy. +Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mg Hg within 14 days prior to registration +Systolic blood pressure (BP) > 160 mm Hg or diastolic pressure > 100 mm Hg despite optimal medical management +Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening +Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:\r\n* Diffusion lung capacity for carbon monoxide (DLCO) corrected >= 70% mm Hg\r\n* DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) >= 70 mm Hg\r\n* DLCO corrected between 50% - 59% mm Hg and pO2 >= 80 mm Hg\r\n* Pediatric patients unable to perform pulmonary function tests must have O2 saturation > 92% on room air; may not be on supplemental oxygen +Uncontrolled high blood pressure (ie, systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg) +Uncontrolled hypertension defined as an average systolic blood pressure of >= 140 mm Hg or an average diastolic pressure >= 95 mm Hg +Have diastolic blood pressure of > 90 mm Hg resting at baseline despite medication. +Systolic blood pressure =< 100 mm Hg at baseline, diastolic =< 60 mm Hg at baseline within 4 weeks prior to start of any therapy +Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management +No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart; the baseline systolic BP readings must be =< 150 mm Hg, and the baseline diastolic BP readings must be =< 90 mm Hg +The subject has uncontrolled or significant intercurrent illness including, but not limited to,\r\nthe following conditions:\r\n* Cardiovascular disorders such as symptomatic congestive heart failure (CHF), uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 100 mm Hg diastolic despite optimal antihypertensive treatment (BP must be controlled at screening), unstable angina pectoris, clinically-significant cardiac arrhythmias, history of stroke (including transient ischemic attack [TIA], or other ischemic event) within 6 months of study treatment, myocardial infarction within 6 months of study treatment, history of thromboembolic event requiring therapeutic anticoagulation within 6 months of study treatment or main portal vein or vena cava thrombosis or occlusion; (Note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study) +Uncontrolled hypertension (systolic pressure >= 140 mm Hg or diastolic pressure >= 90 mm Hg on repeated measurement) despite optimal medical management +Baseline blood pressure must be adequately controlled with or without antihypertensive medications prior to enrollment (systolic =< 150 mm Hg, diastolic =< 90 mm Hg) +Uncontrolled hypertension, defined as systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg, despite optimal medical management +Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg +Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 150/90 mm Hg) +Uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg) +Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage +Has poorly controlled hypertension defined as systolic blood pressure (SBP) ?150 mm Hg and/or diastolic blood pressure (DBP) ?90 mm Hg. +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0)] on repeated measurement) despite optimal medical management +Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 150/90 mm Hg) +Uncontrolled blood pressure and hypertension: systolic blood pressure (SBP) > 140 mm Hg or diastolic blood pressure (DBP) > 90 mm Hg within 14 days prior to registration; patients are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study); all blood pressure measurements within the 14 days prior to registration and on day 1 of cycle 1 must be SBP =< 140 and DBP =< 90; an exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a normal blood pressure +Uncontrolled hypertension (ie, either systolic blood pressure greater than [>] 160 millimeter of mercury [mm Hg]; diastolic blood pressure >95 mm Hg). Use of anti-hypertensive agents to control hypertension before Cycle 1 Day 1 is allowed; +Have an uncontrolled arterial hypertension with systolic blood pressure ?150 or diastolic blood pressure ?90 millimeters of mercury (mm Hg) despite standard medical management. +Patients who are ? 18 years of age must have a systolic blood pressure that is > 160 or diastolic < 90 mm of Hg at the time of enrollment +Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03] on repeated measurement) despite optimal medical management. +Uncontrolled hypertension, defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm Hg despite antihypertensive medications. +Treatment refractory hypertension systolic blood pressure (SBP) > 140 mm Hg and/or diastolic blood pressure (DBP) > 90 mm Hg +Uncontrolled hypertension (mean systolic blood pressure [BP] >= 160 mm Hg and/or mean diastolic BP >= 100 mm Hg on 3 determinations 5 minutes apart while on 2 anti-hypertensive agents) or hypertension requiring treatment with more than 2 anti-hypertensive agents +Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP less than or equal to 150/90 mm Hg at Screening and no change in antihypertensive therapy within 1 week prior to the Cycle1/Day1 +Clinically significant cardiac disease such as history of ventricular arrhythmia requiring therapy, currently uncontrolled hypertension (defined as persistent systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications), or any history of symptomatic CHF +Uncontrolled hypertension (> 160/100 mm Hg despite optimal medical therapy) +Significant active cardiovascular or pulmonary disease at the time of study entry,\r\nincluding:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Clinically significant cardiovascular disease including:\r\n* Myocardial infarction within 6 months prior to screening\r\n* Uncontrolled angina within 3 months prior to screening\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition (MUGA) scan performed within 3 months results in a left ventricular ejection fraction that is >= 45%\r\n* History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes)\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening; patients with initially elevated systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg are eligible if they undergo medical management and are re-screened +Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management +Has inadequately controlled hypertension (defined as systolic blood pressure greater than 150 mm Hg or diastolic blood pressure greater than 95 mm Hg); the use of antihypertensive medications to control blood pressure is permitted +Patients with clinically significant cardiovascular disease; this includes:\r\n* Poorly controlled hypertension (> 140 mm Hg and > 90 mm Hg for systolic and diastolic blood pressure [BP]) are ineligible\r\n* Myocardial infarction or unstable angina within 6 months prior to registration; New York Heart Association (NYHA) grade II or greater congestive heart failure \r\n* Cardiac arrhythmia requiring medication +Clinically uncontrolled hypertension (diastolic blood pressure > 90 mm mercury [Hg]; systolic > 140 mm Hg); Note: patients with hypertension should be undergoing treatment at study entry for blood pressure control +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg on repeated measurement) despite optimal medical management per physician discretion +Poorly controlled hypertension (e.g. systolic >160milimiter (mm) Mercury (Hg) or diastolic >100mm Hg) +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management +Uncontrolled hypertension (defined as blood pressure > 140/90 mm Hg not controlled with anti-hypertensives) +Sustained systolic blood pressure (BP) >140 mm Hg or <90 mm Hg, diastolic BP >100 mm Hg or <60 mm Hg +Moderate or severe pulmonary hypertension defined as pulmonary arterial systolic pressure (PASP) > 50 mm Hg +Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg) +PART B: Uncontrolled intercurrent illness including, but not limited to:\r\n* Ongoing or active infection requiring intravenous antibiotics\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Congestive heart failure, transient ischemic attack or unstable angina pectoris, within the 6 months prior to enrollment in part B of the study, or known left ventricular ejection fraction less than lower limit of normal per local institutional standards\r\n* History of clinically significant (as determined by the treating medical doctor [MD]) atrial arrhythmia \r\n* Uncontrolled hypertension (diastolic blood pressure [BP] > 90 mm Hg and/or systolic > 140 mm Hg) +Patients must not have uncontrolled hypertension (defined as systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg which cannot be controlled by anti-hypertensive therapy) +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management +Systolic blood pressure > 100 mm/Hg +Patients with a history of hypertension must have blood pressure that is adequately controlled on antihypertensives; (< 140/90 mm Hg) +Baseline systolic blood pressure (SBP) > 100 mm Hg; this is based on the average of two values-separate seated, resting measurements taken five minutes apart; blood pressure (BP) does not need to be checked in both arms unless a reading is below 110 mm Hg, in which case the other arm can be checked as well; if BP is checked in both arms, the higher value is deemed accurate for calculating the average +Patients cannot have baseline hypotension, defined as systolic BP lower than 100 mm Hg on two readings obtained on two separate days prior to study enrollment +Patients must have a systolic blood pressure =< 150 mm Hg and diastolic blood pressure =< 100 mm Hg (the use of antihypertensive medications to achieve these goals is allowed) +Uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg +Uncontrolled intercurrent illness including, but not limited to:\r\n* Uncontrolled hypertension (for the purpose of this trial, well-controlled hypertension is defined as systolic blood pressure of < 140 mm Hg and diastolic pressure < 90 mm Hg)\r\n** NOTE: the use of anti-hypertensive medication to control hypertension is permitted, provided it is not noted as a prohibited med elsewhere in protocol\r\n* Ongoing or active infection\r\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or \r\n* Psychiatric illness/social situations that would limit compliance with study requirements +Poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic > 100 mm Hg) +The participant has uncontrolled arterial hypertension ?150 / ?90 millimeters of mercury (mm Hg) despite standard medical management +Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg on medication) +Clinically significant cardio-vascular disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension (defined as persistent systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications), or any history of symptomatic congestive heart failure (CHF) +Blood pressure\r\n* Systolic blood pressure (SBP) < 150 mm/Hg\r\n* Diastolic blood pressure (DBP) < 90 mm/Hg +Patients must not have uncontrolled hypertension as defined by systolic blood pressure >= 150 mm Hg or diastolic blood pressure >= 90 mm Hg; patient may be eligible once hypertension is adequately controlled with medications +Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening; +Uncontrolled hypertension defined by a systolic blood pressure (SBP) > 150 and/or a diastolic blood pressure (DBP) > 100 mm Hg with or without anti-hypertensive medication +History of newly diagnosed or uncontrolled glaucoma/intraocular pressure > 21 mm Hg as measured by tonography +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management +Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on mean of 3 consecutive readings despite optimal medical management; hypertension may be corrected by adding or adjusting antihypertensives prior to the initiation of treatment at the discretion of the practitioner +Uncontrolled glaucoma with intra-ocular pressures >21mm Hg +Has NYHA Class III or IV heart failure or uncontrolled hypertension (SBP ?160 mm Hg; DBP ?100 mm Hg). +Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication +The subject has uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment (BP must be controlled at screening) +Hypertension which is not controlled to systolic < 160 mm Hg and diastolic < 90 mm Hg; +Recent (< 6 months) myocardial infarction, unstable angina, coronary artery bypass surgery (CABG) or stent placement in the last 2 years, difficult-to-control congestive heart failure, uncontrolled hypertension (systolic blood pressure > 160 mm or a diastolic blood pressure [BP] > 110 mm under normal conditions and while on appropriate anti-hypertensive medications), or difficult-to-control cardiac arrhythmias +Hypertension: systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) > 100 mm mercury (Hg) despite antihypertensive medications +Inadequately controlled hypertension defined as BP > 150/100 mm Hg despite medication +Uncontrolled hypertension, defined as systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg, despite medical management +Uncontrolled glaucoma with intraocular pressure greater than (>) 21 millimeters of mercury (mm Hg) +Treatment refractory hypertension defined as a blood pressure of systolic >140 mmHg and/or diastolic >90 mm Hg which cannot be controlled by anti-hypertensive therapy +The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week). +Blood pressure > 140/90 mm/Hg on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged) +Supine systolic blood pressure < 90 mm Hg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure upon standing of > 20 mm Hg despite medical management (e.g. midodrine, fludrocortisones) +No history of uncontrolled hypertension (blood pressure > 160/100 mm Hg despite anti-hypertensive medication) +Cardiovascular disorders including\r\n* Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening\r\n* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) >= 150 mm Hg systolic, or >= 90 mm Hg diastolic despite optimal antihypertensive treatment (Note: if there is any BP measurement that is performed within the screening period that is < 150 mm Hg systolic and < 90 mm Hg diastolic, then BP does not meet definition of sustained)\r\n* Any congenital history of long QT syndrome\r\n* Any of the following within 6 months before the first dose of study treatment:\r\n** Unstable angina pectoris\r\n** Clinically-significant cardiac arrhythmias\r\n** Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n** Myocardial infarction\r\n** Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study) +Uncontrolled hypertension defined as optimally treated baseline blood pressure that exceeds 140/90 mm Hg despite optimal medical management +Patients with clinically significant cardiovascular or cerebrovascular disease:\r\n* History of cerebrovascular accident or transient ischemic attack within past 6 months\r\n* Uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg or systolic blood pressure (BP) > 180 mm Hg if diastolic blood pressure < 90 mm Hg, on at least 2 repeated determinations on separate days within past 3 months\r\n* Myocardial infarction, coronary artery bypass graft (CABG) or unstable angina within the past 6 Months\r\n* New York Heart Association grade III or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris within past 6 months\r\n* Clinically significant peripheral vascular disease within past 6 months\r\n* Pulmonary embolism, deep vein thrombosis (DVT), or other thromboembolic event within past 6 months +Hypertension not controlled by medical therapy (systolic blood pressure greater than 150 mm Hg or diastolic blood pressure greater than 100 mm Hg) +Uncontrolled hypertension, defined as systolic > 140 mm Hg or diastolic > 90 mm Hg +Intraocular pressure greater than 21mm Hg as measured by tonography. +Treatment refractory hypertension defined as a blood pressure of systolic> 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy +Significant active cardiovascular or pulmonary disease including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed,\r\n* Pulmonary hypertension,\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air,\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement,\r\n* Medically significant (symptomatic) bradycardia,\r\n* History of arrhythmia requiring an implantable cardiac defibrillator,\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Clinically significant hypotension (systolic blood pressure [SBP] < 80 mm HG or symptomatic) +Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mg Hg within 14 days prior to registration +Patients must have a systolic blood pressure >= 80 mm Hg within 14 days prior to registration +Patients with systolic blood pressure < 90 mm Hg +Uncontrolled hypertension (defined by a SBP ? 160 mm Hg or DBP ? 100 mm Hg while on anti-hypertensive medications) within 14 days prior to registration. +Low resting systolic blood pressure: < 90 mm hemoglobin (Hg) +Resting systolic blood pressure (SBP) > 180 mm HG and/or diastolic blood pressure (DBP) > 100 mm HG, or resting heart rate > 100 beats per minute at the baseline assessment +Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0] on repeated measurement) despite optimal medical management +Pressure readings >= 140/90 mm Hg, as defined by the 7th Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, will be deemed ineligible to participate and excluded from the study; they will be referred to their family physician or community services; those ineligible based on their initial blood pressure reading are allowed to participate if they provide a letter from a physician who will continue to monitor the participant during the research study +Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg). +Sitting systolic BP > 90 mm Hg +No history of hypotension (defined as resting systolic blood pressure of < 110 mm Hg or diastolic blood pressure of < 70 mm Hg) or orthostasis (defined as drop in systolic blood pressure of > 20 mm Hg or increase in HR of > 20 from supine to standing position) +Patients with resting hypotension (blood pressure [BP] < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg) at screening +Within the past month:\r\n* Heart attack\r\n* Unstable or stable angina (cardiac chest pain)\r\n* Left main coronary artery disease\r\n* Symptomatic heart failure\r\n* Uncontrolled hypertension (systolic blood pressure [SBP] > 180 mm Hg or diastolic blood pressure [DBP] > 100mm Hg)\r\n* Severe valvular heart disease\r\n* Uncontrolled metabolic disease (diabetes with fasting blood sugar [BS] > 300 mg/dl, thyrotoxicosis, myxedema)\r\n* Aortic aneurism (> 45 mm diameter) or aortic dissection\r\n* Hypertrophic obstructive cardiomyopathy +Uncontrolled severe hypertension at enrollment. Severe hypertension is defined as a systolic or diastolic blood pressure (BP) > 5 mm Hg above the 95th percentile as defined by the National High Blood Pressure Education Program Working Group (NHBPEP) established guidelines for the definition of normal and elevated blood pressure in children +Uncontrolled hypertension (blood pressure > 160/95 mm Hg) +Participants must not have blood pressure < 95 mm Hg systolic +Have at least one other component of metabolic syndrome reported below:\r\n* Elevated triglycerides (>= 150 mg/dL [1.7 mmol/L]) or on drug treatment for elevated triglycerides \r\n* Reduced high-density lipoprotein-cholesterol (HDL-C) (< 50 mg/dL [1.3 mmol/L]) or on drug treatment for reduced HDL-C\r\n* Elevated blood pressure (>= 130 mm mercury [Hg] systolic blood pressure or >= 85 mm Hg diastolic blood pressure) or on antihypertensive drug treatment in a patient with a history of hypertension\r\n* Elevated fasting glucose (>= 100 mg/dL) +Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm mercury [Hg] or diastolic blood pressure greater than 100 mm Hg) +Poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg; the addition of anti-hypertensives to control blood pressure is allowed +Poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg; the addition of anti-hypertensives to control blood pressure is allowed +Active cardiac disease including any of the following:\r\n* Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)\r\n* Unstable angina\r\n* Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T- wave, multifocal complexes)\r\n* Myocardial infarction within 14 days prior to the date of proposed Definity administration\r\n* Uncontrolled systemic hypertension (systolic blood pressure [BP] > 180 mm Hg and/or diastolic BP > 100 mm Hg) despite optimal medical management +Uncontrolled hypertension (>170/100 millimeter of mercury [mm Hg]) currently or within the past 7 days, or +Uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; subjects with known HTN should be stable within these ranges while under pharmaceutical therapy. +Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 150 mm Hg, or diastolic blood pressure > 95 mm Hg; those subjects with known HTN should be stable within these ranges while under pharmaceutical therapy +The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 130 mm Hg. +The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 130 mm Hg. +Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy