[c09aa8]: / clusters / clustall9k / 214.txt

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History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled with anti arrhythmic medication.
Current cardiac arrhythmic condition requiring concurrent use of anti-arrhythmic drug; rate controlled atrial fibrillation is allows
Current cardiac arrhythmia requiring concurrent use of anti-arrhythmic drugs
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy are not eligible
History of cardiac ventricular arrhythmias requiring anti-arrhythmic therapy within past 3 months
Patients with history of atrial arrhythmia (requiring any anti-arrhythmic therapy) or patients with any history of ventricular arrhythmia are excluded
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to first dose of study drugs are eligible)
> Class II Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Patients on anti-arrhythmic drugs
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled with anti-arrhythmic medication.
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Anti-arrhythmic and heart rate lowering drugs.
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Significant cardiovascular disease including:\r\n* Active, clinically symptomatic left ventricular failure\r\n* Uncontrolled symptomatic hypertension that cannot be controlled with anti-hypertensive agents\r\n* Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug\r\n* History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) \r\n* Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication) \r\n* Coronary or peripheral artery bypass graft within 6 months of screening
Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
Need for anti-arrhythmic therapy for a ventricular arrhythmias
Patients with cardiac arrhythmias must not be receiving anti-arrhythmic medication at time of study entry (or while on study).
High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade atrioventricular [AV]-block, supra-ventricular arrhythmias which are not adequately rate-controlled) that require current treatment with the following anti-arrhythmic drugs: flecainide, moricizine or propafenone
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Patients on anti-arrhythmic drugs
Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
Calcium channel blockers: verapamil, diltiazem
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Contraindications to the use of beta-blockers, like, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (grade III or IV), hypotension (systolic blood pressure < 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (glycosylated hemoglobin [HbA1C] > 8.5 or fasting plasma glucose > 160 mg/dl at screening), symptomatic peripheral arterial disease or Raynaud’s syndrome, untreated pheochromocytoma, current use or past use in the last two years of beta-blockers or calcium channel blockers
Clinically significant cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded.
Inability to suspend treatment with anti-hypertensive medication (including but not limited to: diuretics, beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, etc) for 48 hours pre and post each Pexa-Vec administration
Patients requiring treatment with one or more beta-blockers (metoprolol, atenolol, propranolol) or calcium channel blockers with atrioventricular (AV)-nodal blocking activity (verapamil, diltiazem); patients being treated with AV nodal blocker (beta-blocker or calcium channel blocker) are allowed if the agent is being used only for correcting hypertension, and if an acceptable alternative is available (for example, transitioning from a drug such as atenolol to Lisinopril or amlodipine) prior to starting treatment on therapy
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Patients currently on beta blockers
Patients on chronic nitrate therapy or alpha-blockers
Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
Anti-arrhythmia medication other than beta-blockers or digoxin
Anti-arrhythmic therapy other than beta blockers or digoxin
Concomitant use of these drugs at baseline and for the duration of digoxin administration (if randomized to receive it):\r\n* The calcium channel blockers diltiazem or verapamil\r\n* Cardiac arrhythmic agents (such as quinidine, amiodarone)\r\n* Other cytochrome P450 (P450) inducer/inhibitors\r\n* NOTE: patients already receiving digoxin are also excluded; patients who take calcium carbonate antacids (e.g., Maalox, Tums, Rolaids) or antidiarrheal adsorbents (kaolin and pectin) should avoid taking these at the same time as the digoxin dose
Unstable angina, symptomatic congestive heart failure or cardiac arrhythmia requiring anti-arrhythmic therapy (beta-blockers, calcium channel blockers and digoxin are allowed)
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
Patients with third degree or complete heart block are not eligible unless a pacemaker is in place; patients on medications, which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction could be entered at the discretion of the investigators
Cardiac arrhythmias requiring anti-arrhythmic therapy; Note: pace makers, beta blockers, or digoxin are permitted
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Clinically significant cardiac arrhythmias and/or patients who require anti-arrhythmic therapy (excluding beta blockers or digoxin); patients with controlled atrial fibrillation are not excluded
On beta-blocker treatment; if discontinued, patients must have been off beta-blockers for at least 3 months
Normotensive individuals not already on beta blockers (may be on other anti hypertensives): SBP =< 140, DBP =< 90
Any patients already on beta-blockers or contraindicated to receive beta-blockers
Hypersensitivity to propranolol, or beta-blockers
Cardiac disease: Congestive heart failure (CHF) > Class II NYHA; active coronary artery disease (Myocardial infarction [MI] more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Clinically significant cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded
Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin.
Patients on beta blockers
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
Patients with other established indications for ivabradine: stable, symptomatic chronic heart failure (HF) with a left ventricular ejection fraction ? 35% and in sinus rhythm with a resting heart rate (HR) ? 70 bpm, who are taking maximally tolerated doses of beta-blockers or have contraindications to beta-blocker use
Use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of randomization
Patient requires regular use of beta blockers or calcium channel blockers
No use of any anti-arrhythmic medication (except for beta-blockers and calcium channel blockers) including intravenous lidocaine, linezolid, ipratropium, or medications with anti-cholinergic potency (including neostigmine, a tricyclic antidepressant or a monoamine oxidase inhibitor) within 2 weeks prior to registration
Current treatment with angiotensin converting enzyme (ACE)-inhibitors or beta blockers
No other concurrent angiotensin-converting enzyme (ACE) inhibitors, ?-blockers, or digoxin
Current use of (1) medications/supplements to control blood pressure (e.g. beta-blockers, nitrates, calcium channel blockers, phosphodiesterase-5 [PGE5] inhibitors) or (2) the use of statins for cholesterol;
Use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of enrollment
Taking medication that may impair PA tolerance or performance (e.g., beta blockers)
Daily treatment with thiazides or ?-blockers (exclusion only if < 3 months)
Use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, diuretics, aldosterone, renin blockers, aspirin, statins, sildenafil (or other PDE5 inhibitors) and non-steroidal antiinflammatory drugs (NSAIDs)
Medical illness unrelated to HL, which in the opinion of the study physician will preclude administration of chemotherapy safely; this includes patients with uncontrolled infection (including opportunistic), chronic renal failure, myocardial infarction (MI) within the past 6 months, unstable angina, or cardiac arrhythmias other than chronic atrial fibrillation, or second malignancy requiring active treatment
No history of atrial fibrillation or myocardial infarction
Patients must not have any grade II/III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia; abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis]) can be entered on study; patients with a history of atrial fibrillation must have atrial fibrillation controlled for at least 30 days prior to registration
Unstable angina pectoris or cardiac arrhythmia (except atrial fibrillation);
Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
Symptomatic atrial fibrillation
History or presence of clinically significant ventricular or atrial dysrhythmia > grade 2 (National Cancer Institute [NCI] CTCAE version 4.0 [v4.0])\r\n* Patients with chronic, rate-controlled atrial arrhythmias who do not have other cardiac abnormalities are eligible
History of long QT syndrome or clinically significant cardiac arrhythmias (except stable atrial fibrillation)
Uncontrolled cardiac arrhythmia (subjects with rate-controlled atrial fibrillation are not excluded).
History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia.
Clinically significant cardiovascular disease, active or within 3 months prior to enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation, bradycardia or congenital long QT syndrome
History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.
Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical therapy Ipatasertib-Specific Exclusion Criteria:
History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
History of:\r\n* Symptomatic congestive heart failure\r\n* Unstable angina pectoris or cardiac arrhythmia (subjects with stable atrial fibrillation are not excluded)\r\n* Adrenal insufficiency
Supraventricular arrhythmias including atrial fibrillation, which are uncontrolled.
Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
Mitral and/or tricuspid valvopathy or valvular prosthesis; angina; severe arterial hypertension; chronic and/or paroxysmal atrial fibrillation; previous myocardial infarction
Ongoing cardiac dysrhythmias of NCI CTCAE version 4.03 grade >= 2. Controlled atrial fibrillation is permitted.
Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmias or bradycardia, unless arrhythmia is controlled and after Cardiology has cleared patient to receive ONC201. Receiving therapeutic agents known to prolong QT interval will be excluded History of CHF, or MI or stroke in the last 3 months will be excluded.
Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmias or bradycardia, unless arrhythmia is controlled and after cardiology has cleared patient to receive ONC 201; receiving therapeutic agents known to prolong QT interval will be excluded; history of congestive heart failure (CHF), or myocardial infarction (MI) or stroke in the last 3 months will be excluded
Any episode of atrial fibrillation in the prior 12 months.
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Subjects must not have a known history of congestive heart failure, unstable angina pectoris, or cardiac arrhythmia (with the exception of chronic and rate-controlled atrial fibrillation)
Symptomatic atrial fibrillation or other cardiac arrhythmia for which the therapy is not stable or requiring changes in therapy within 1 month of treatment initiation; atrial fibrillation or other cardiac arrhythmia which is clinically stable on stable therapy is allowed
Have documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments; for example, atrial fibrillation, bundle branch blocks, or as approved by the sponsors).
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible)
Have chronic atrial fibrillation or QTc of greater than 470 msec, as calculated by Bazett's correction formula.
Symptomatic atrial fibrillation, or other symptomatic cardiac arrhythmia
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
Clarification: subjects with atrial fibrillation controlled for > 30 days prior to dosing are eligible
Patients with persistent and uncontrolled atrial fibrillation even if rate controlled.
Uncontrolled cardiac arrhythmia - patients with rate-controlled atrial fibrillation are not excluded
Presence of unstable atrial fibrillation (ventricular response > 100 beats per minute)
Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria
CLINICAL/LABORATORY CRITERIA: Patients must have corrected QT (QTc) interval =< 480 msec (using the Bazett’s formula) on electrocardiogram (ECG) performed within 42 days prior to registration; history or evidence of current clinically significant uncontrolled arrhythmias are not eligible; however, patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible; patients must not have atrial fibrillation > grade 2 on the screening ECG; patients with CTCAE grade 1-2 atrial fibrillation on their screening ECG must have a second ECG performed prior to registration and more than 30 days from the screening ECG (either before or after) with the most recent ECG showing stable or improving grade of atrial fibrillation
Chronic persistent atrial flutter or atrial fibrillation. Patients with intermittent atrial fibrillation may be enrolled if without episode for >= 6 months and without indication for anti-coagulation
Have uncontrolled chronic atrial fibrillation.
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation.
Symptomatic arrhythmia (excluding grade ? 2 anemia-related sinusal tachycardia) or any arrhythmia requiring ongoing treatment, and/or prolonged grade ? 2 QT-QTc, or presence of unstable atrial fibrillation. Patients with stable atrial fibrillation on treatment are allowed provided they do not meet any other cardiac or prohibited drug exclusion criterion.
Ongoing cardiac dysrhythmias of NCI CTCAE version 4.03 grade >= 2; controlled atrial fibrillation is permitted
Patients with persistent and uncontrolled atrial fibrillation
History or evidence of current, clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to the initiation of therapy on this protocol are eligible)
A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year prior to screening
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Atrial fibrillation or other cardiac arrhythmia requiring therapy
A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year before screening
History of uncontrolled arrhythmias; subjects with controlled atrial fibrillation for > 1 month prior to study enrollment are not excluded
Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation
Patients must not have a history of heart block or cardiac arrhythmia, including asymptomatic arrhythmias and atrial fibrillation/flutter.
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs, or electrocardiographic (ECG) examination (e.g., atrial fibrillation; with the exception of subjects for whom the ventricular rate is controlled) that precludes continuation or initiation of treatment with NEOD001 or participation in the study
Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs, or electrocardiogram (ECG) examination (e.g., atrial fibrillation; with the exception of subjects for whom the ventricular rate is controlled) that precludes continued or initiation of treatment with NEOD001 or participation in the study
Subject has ongoing cardiac arrhythmia (including atrial fibrillation) that is grade ?
Persistent or uncontrolled ventricular arrhythmias or atrial fibrillation.
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
Cardiac arrhythmia requiring medication (does not include asymptomatic atrial fibrillation with controlled ventricular rate)
Arrhythmia (example, history of polymorphic ventricular fibrillation or torsade de pointes). However, participants with < Grade 3 atrial fibrillation for a period of at least 6 months may enroll. Grade 3 atrial fibrillation is defined as symptomatic and incompletely controlled medically, or controlled with device (example, pacemaker) or ablation, and is excluded. Participants with paroxysmal atrial fibrillation are permitted to enroll.
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Unstable atrial fibrillation (ventricular response >100 bpm)
A history or evidence of current clinically significant uncontrolled arrhythmias (exception: subjects with controlled atrial fibrillation for > 30 days prior to randomization are eligible)
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
Donor must have adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
Recent history of ischemic heart disease, electrocardiogram (ECG) abnormalities, or atrial fibrillation.
Presence of unstable atrial fibrillation (ventricular response > 100 bpm
Serious cardiac arrhythmia requiring medication; this does not include atrial fibrillation
Atrial fibrillation,
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
Atrial fibrillation; and
Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (i.e., atrial flutter, atrial fibrillation)
Severe comorbidities (atrial fibrillation, pulmonary hypertension, etc...)
Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia
Clear indication for anticoagulation (e.g., atrial fibrillation) anticipated during the study period
Medical history of atrial fibrillation or arrhythmia
Atrial fibrillation
Have arrhythmia/atrial fibrillation
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
Presence of atrial fibrillation
Acute heart disease or history of heart attack, atrial fibrillation, or angina
Electrocardiogram (ECG) demonstrating clinically significant arrhythmias; subjects with chronic atrial\r\narrhythmia, (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia), are eligible
Serious cardiac arrhythmia (well-controlled atrial fibrillation is permitted) currently or within the past 6 months.
Arrhythmia or conduction abnormality requiring medication. Note: patients with atrial fibrillation/flutter controlled by medication and arrhythmias controlled by pacemakers are eligible.