Maximizing what we learn from clinical trials: NINDS Common Data Elements

Ninds.nih.gov: 12/26/12 The NINDS mission is to reduce the burden of neurological disorders through research. Patient studies, including clinical trials that test or compare treatments, can provide important insights for understanding disease, lead to better treatments, and are essential to fulfilling our mission.  Many clinical research data sets, however, are only used to address the researchers’ […]

Discerning the Incidence of Symptomatic and Asymptomatic Episodes of Atrial Fibrillation Before and After Catheter Ablation (DISCERN AF)

A Prospective, Multicenter Study JAMA: December 24, 2012 Background  The DISCERN AF study (Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation) monitored atrial fibrillation (AF) using an implantable cardiac monitor (ICM) to assess the incidence and predictors of asymptomatic AF before and after catheter ablation. Methods  Patients with symptomatic AF underwent implantation […]

Omega-3 Fatty Acids for the Prevention of Recurrent Symptomatic Atrial Fibrillation

American College of Cardiology Foundation: December 1, 2012 Results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) Trial Objectives  The aim of this study was to evaluate the efficacy of polyunsaturated fatty acids (n-3 PUFA) for the prevention of recurrent atrial fibrillation (AF) in patients […]

The First 2 Years of the European Medicines Agency’s Policy on Access to Documents: Secret No Longer

JAMA: 12/19/12 On November 30, 2010, the regulatory agency for medications in Europe, the European Medicines Agency (EMA), announced a policy on access to “any document originated, received or held by the Agency.”1 The policy made a wide range of regulatory documents potentially accessible to anyone who asks for them, including clinical study reports.2Documents are released […]

The Future of Scientific Knowledge Discovery in Open Networked Environments:

The National Academies Press: 12/19/12 Digital technologies and networks are now part of everyday work in the sciences, and have enhanced access to and use of scientific data, information, and literature significantly. They offer the promise of accelerating the discovery and communication of knowledge, both within the scientific community and in the broader society, as scientific […]

The Effects of Alteplase 3 to 6 Hours After Stroke in the EPITHET–DEFUSE Combined Dataset

AHA: 12/18/12 Background and Purpose—Two phase 2 studies of alteplase in acute ischemic stroke 3 to 6 hours after onset, Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET; a randomized, controlled, double-blinded trial), and Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution Study (DEFUSE; open-label, treatment only) using MR imaging-based outcomes have been conducted. We have […]

Characteristics of Ischemic Brain Lesions After Stenting or Endarterectomy for Symptomatic Carotid Artery Stenosis

AHA: 12/13/12 Background and Purpose—In a substudy of the International Carotid Stenting Study (ICSS), more patients had new ischemic brain lesions on diffusion-weighted magnetic resonance imaging (MRI) after stenting (CAS) than after endarterectomy (CEA). In the present analysis, we compared characteristics of diffusion-weighted MRI lesions. Methods—Number, individual and total volumes, and location of new diffusion-weighted […]

Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop

SAGE: 12/1/12 Background The clinical trials community has a never-ending search for dependable and reliable ways to improve clinical research. This exploration has led to considerable interest in adaptive clinical trial designs, which provide the flexibility to adjust trial characteristics on the basis of data reviewed at interim stages. Statisticians and clinical investigators have proposed or […]

Advanced imaging improves prediction of hemorrhage after stroke thrombolysis

Wiley: 12/13/12 Objective: Very low cerebral blood volume (VLCBV), diffusion and hypoperfusion lesion volumes have been proposed as predictors of hemorrhagic transformation following stroke thrombolysis. We aimed to compare these parameters, validate VLCBV in an independent cohort using DEFUSE study data and investigate the interaction of VLCBV with regional reperfusion. Methods: The EPITHET and DEFUSE studies […]

Self-Report of Stroke, Transient Ischemic Attack, or Stroke Symptoms and Risk of Future Stroke in the Reasons for Geographic And Racial Differences in Stroke (REGARDS) Study

AHA: December 11, 2012 Background and Purpose—History of stroke and transient ischemic attack (TIA) are documented risk factors for subsequent stroke and all-cause mortality. Recent reports suggest increased risk among those reporting stroke symptoms absent stroke or TIA. However, the relative magnitude of increased stroke risk has not been described across the symptomatic spectrum: (1) […]

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