--- a +++ b/clusters/9knumclustersv2/clust_1298.txt @@ -0,0 +1,57 @@ +Patients with QTc interval > milliseconds +Patients with baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Corrected QT (QTc) interval =< milliseconds +Corrected QT (QTc) interval =< milliseconds +Marked baseline prolongation of QT/corrected QT (QTc) interval (e.g. demonstration of a QTc interval greater than milliseconds) +Corrected QT interval (QTc) of < milliseconds +Prolongation of QT corrected (QTc) interval to > milliseconds (ms) +Baseline QTc prolongation (e.g., repeated demonstration of QTc interval > milliseconds or history of congenital long QT syndrome or torsades de pointes) +History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful. Screening corrected QT (QTc) interval > msec is excluded (corrected by Fridericia). If a single QTc is > milliseconds, the subject may enroll if the average QTc for the ECGs is < milliseconds. For subjects with an intraventricular conduction delay (QRS interval > milliseconds), the JTc interval may be used in place of the QTc with sponsor approval. The JTc must be < milliseconds if JTc is used in place of the QTc. Subjects with left bundle branch block are excluded. Note: QTc prolongation due to pacemaker may enroll if the JTc is normal or with medical monitor approval. +Corrected QT interval at screening greater than (>) milliseconds (ms) (average of triplicate screening measurements) +Any known cardiac abnormalities such as:\r\n* Congenital long QT syndrome\r\n* Corrected QT(QTc) interval >= milliseconds +Baseline corrected QT (QTc) interval >= milliseconds +History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful; screening corrected QT (QTc) interval > milliseconds is excluded; in the event that a single QTc is > milliseconds, the subject may enroll if the average QTc for the ECGs is < milliseconds; for subjects with an intraventricular conduction delay (QRS interval > milliseconds), the corrected JT (JTc) interval may be used in place of the QTc with sponsor approval; the JTc must be < milliseconds if JTc is used in place of the QTc; subjects with left bundle branch block are excluded\r\n* Note: QTc prolongation due to pacemaker may enroll if the JTc is normal +History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful; screening corrected QT (QTc) interval >= milliseconds is excluded; in the event that a single QTc is >= milliseconds, the subject may enroll if the average QTc for the ECGs is < milliseconds; for subjects with an intraventricular conduction delay (QRS interval > milliseconds), the corrected JT (JTc) interval may be used in place of the QTc with the approval of the principal investigator; the JTc must be < milliseconds if JTc is used in place of the QTc; subjects with left bundle branch block are excluded; note: QTc prolongation due to pacemaker may enroll if the JTc is normal +Baseline prolongation of the rate-corrected QT interval (QTc) > milliseconds or history of congenital long QT syndrome or Torsades de pointes +Prolongation of corrected QT (QTc) interval to > milliseconds (msec) when electrolyte balance is normal +Marked baseline prolongation of QT/corrected QT interval (QTc) interval (e.g. demonstration of a QTc interval greater than milliseconds) +Abnormalities on -lead electrocardiogram (ECG) considered by the investigator to be clinically significant (such as acute ischemia, left bundle branch block, ventricular arrhythmias) or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > milliseconds) +Baseline prolongation of the rate-corrected QT interval (QTc) (e.g. repeated demonstration of QTc interval > milliseconds, or history of congenital long QT syndrome, or torsades de pointes) +Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsades de pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > milliseconds for males, QTc > milliseconds for females); valvular, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure +Screening corrected QT interval (QTc) interval > milliseconds +Marked baseline prolongation of QT/corrected QC (QTc) interval (e.g. demonstration of a QTc interval greater than milliseconds) +Corrected QT interval (QTc) prolongation > milliseconds (msec) +Prolongation of QTc interval to > milliseconds (ms) +History of non-pharmacologically induced prolonged QTc interval > milliseconds. +Corrected QT (QTc) interval =< milliseconds +Prolonged corrected QT interval (QTc) > milliseconds (ms) at the screening visit +Baseline electrocardiogram (EKG) shows normal corrected QT interval (QTc) interval of =< milliseconds (ms) +Prolonged QT interval (corrected QT interval [QTc] > milliseconds) on screening electrocardiogram (EKG) or congenital long QT syndrome +Corrected QT interval less than milliseconds by electrocardiogram (EKG) +Marked baseline prolongation of QT/QT corrected (QTc) interval (e.g. demonstration of a QTc interval greater than milliseconds) +Corrected QT interval (QTc) > milliseconds as corrected by the Fridericia formula +A clinically significant electrocardiogram (ECG) abnormality, including a marked Baseline prolonged QT/QTc interval (e.g., a repeated demonstration of a QTc interval > milliseconds (msec)). +History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > milliseconds). +Have a corrected QT interval > milliseconds as calculated be the Fredericia equation. +Corrected QT interval (QTc) =< milliseconds (ms) +Participants with baseline QTc greater than (>) milliseconds or symptomatic bradycardia +Concurrent use of digoxin due to cardiac disease; corrected QT (QTc) interval >= milliseconds in men and >= milliseconds in women within weeks of registration or known history of QTc prolongation or Torsades de Pointes +Abnormalities on -lead electrocardiogram (ECG) considered by the investigator to be clinically significant or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > milliseconds). +Baseline corrected QT interval (QTc) =< milliseconds (ms) +Corrected QT interval (QTc)/QT Fridericia equation (QTf) interval >= milliseconds; unless secondary to pacemaker or bundle branch block +History of congenital long QT syndrome or corrected QT interval (QTc) greater than (>) milliseconds at screening +Corrected QT (QTc) prolongation, as defined by > milliseconds on ECG +Prolongation of corrected QT interval (QTc) > milliseconds using Bazetts formula +Corrected QT interval (QTc) > milliseconds +Corrected QT interval less than milliseconds by electrocardiogram (EKG) +Prolongation of corrected QT (QTc) interval to > milliseconds (ms) +Clinically significant abnormality on electrocardiogram (ECG). The corrected QT interval (QTc, Fridericia) must be < milliseconds for men and < milliseconds for women (Must be confirmed by at least additional -lead ECGs at least minutes apart such that average manually over-read QTcF based on ECGs exceeds stated thresholds) +Patients must not have QTc prolongation defined as a QTc interval equal to or greater than milliseconds (msecs) +Baseline prolongation of the rate-corrected QT interval (QTc) > milliseconds, or history of congenital long QT syndrome, or torsades de pointes +Corrected QT (QTc) interval >= milliseconds +Prolongation of corrected QT interval (QTc) > milliseconds (msec) +Patients must not have a marked baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration of a QTc interval > milliseconds (ms) +QTc interval < milliseconds (msec) on the baseline electrocardiogram. +Marked baseline prolongation of QT/corrected QT (QTc) interval (e.g. demonstration of a QTc interval greater than milliseconds) +Patients with baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > milliseconds, or history of congenital long QT syndrome, or torsades de pointes) are ineligible +Serious ventricular arrhythmias or high risk for arrhythmias, due to prolongation of the QT-interval (> milliseconds [msec])