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Trial Database (trial + database)
Selected AbstractsStatin Use Is Associated With Improved Survival in Patients With Advanced Heart Failure Receiving Resynchronization TherapyCONGESTIVE HEART FAILURE, Issue 4 2009Andrew D. Sumner MD It is unknown whether statin use improves survival in patients with advanced chronic heart failure (HF) receiving cardiac resynchronization therapy (CRT). The authors retrospectively assessed the effect of statin use on survival in patients with advanced chronic HF receiving CRT alone (CRT-P) or CRT with implantable cardioverter-defibrillator therapy (CRT-D) in 1520 patients with advanced chronic HF from the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial database. Six hundred three patients (40%) were taking statins at baseline. All-cause mortality was 18% in the statin group and 22% in the no statin group (hazard ratio [HR] 0.85; confidence interval (CI), 0.67,1.07; P=.15). In a multivariable analysis controlling for significant baseline characteristics and use of CRT-P/CRT-D, statin use was associated with a 23% relative risk reduction in mortality (HR, 0.77; CI, 0.61,0.97; P=.03). Statin use is associated with improved survival in patients with advanced chronic HF receiving CRT. No survival benefit was seen in patients receiving statins and optimal pharmacologic therapy without CRT. [source] Does Glucocorticoid Administration Prevent Late Seizures after Head Injury?EPILEPSIA, Issue 6 2004Nathaniel F. Watson Summary: Purpose: Preventing posttraumatic epilepsy has been a difficult challenge. In this study we evaluated the association between glucocorticoid administration after traumatic brain injury (TBI) and posttraumatic seizures. Methods: We examined a seizure-prevention trial database of 404 patients with severe TBI for exposure to glucocorticoids in the early (<1 week) posttraumatic period. After controlling for seizure risk, we compared the odds of developing first and second late posttraumatic seizures between those that received glucocorticoids and those that did not. Results: Patients dosed with glucocorticoids within 1 day of their TBI were more likely to develop first late seizures than were those without [p = 0.04; hazard ratio = 1.74; 95% confidence interval (CI), 1.01,2.98]; whereas those receiving glucocorticoids ,2 days after their injury had no similar association (p = 0.66; hazard ratio = 0.77; 95% CI, 0.23,2.56; p = 0.10 among the three groups). Receiving glucocorticoids within 1 day, or ,2 days after TBI was not associated with second late seizure development. Conclusions: Glucocorticoid treatment after TBI is not associated with decreased late posttraumatic seizures, and early treatment is associated with increased seizure activity. [source] How long should a trial of escitalopram treatment be in patients with major depressive disorder, generalised anxiety disorder or social anxiety disorder?HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 4 2009An exploration of the randomised controlled trial database Abstract Objective To extend the knowledge of course of improvement in patients with major depressive disorder (MDD), social anxiety disorder (SAD) or generalised anxiety disorder (GAD) participating in randomised placebo-controlled trials (RCTs) and to infer the optimal duration of initial escitalopram treatment in clinical practice, after which intervention might be reasonable in case of non-response. Methods Post hoc analysis of pooled clinical trial database for escitalopram in MDD (14 studies), GAD (4 studies) and SAD (2 studies). ,Onset' of action was defined as a 20% or more decrease from baseline score in disorder-specific psychopathological rating scales: ,response' as a 50% or more decrease from baseline score. Results In MDD, the probability of responding at week 8 if no onset was apparent at week 2 was 43%; in patients with an onset of effect the probability was nearly 80%. Similar patterns were observed in GAD and SAD. The chance of responding beyond week 4 in MDD, GAD and SAD was 20% or less if no effect had occurred by week 2. Conclusions The pattern of response in these RCTs suggests that in patients with MDD, GAD or SAD in wider clinical practice, a period of at least 4,weeks is worthwhile before considering further intervention. Copyright © 2009 John Wiley & Sons, Ltd. [source] Robust QT Interval Estimation,From Algorithm to ValidationANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 2009Joel Q. Xue Ph.D. Background: This article presents an effort of measuring QT interval with automatic computerized algorithms. The aims of the algorithms are consistency as well as accuracy. Multilead and multibeat information from a given segment of ECG are used for more consistent QT interval measurement. Methods: A representative beat is generated from selected segment of each lead, and then a composite beat is formed by the representative beats of all independent leads. The end result of the QT measure is so-called global QT measurement, which usually correlates with the longest QT interval in multiple leads. Individual lead QT interval was estimated by using the global measurement as a starting point, and then adapted to the signal of the particular lead and beat. In general, beat-by-beat QT measurement is more prone to noise, therefore less reliable than the global estimation. It is usually difficult to know if difference of beat-by-beat QT interval is due to true physiological change or noise fluctuation. Results: The algorithm was tested independently by a clinical database. It is also tested against action potential duration (APD) generated by a Cell-to-ECG forward-modeling based simulation signals. The modeling approach provided an objective test for the QT estimation. The modeling approach allowed us to evaluate the QT measurement versus APD. The mean error between the algorithm and cardiologist QT intervals is 3.95 ± 5.5 ms, based on the large clinical trial database consisting of 15,910 ECGs. The mean error between QT intervals and maximum APD is 17 ± 2.4, and the correlation coefficient is 0.99. Conclusions: The global QT interval measurement method presented in this study shows very satisfactory results against the CSE database and a large clinical trial database. The modeling test approach used in this study provides an alternative "gold standard" for QT interval measurement. [source] |