Statins Reduce Neurologic Injury in Asymptomatic Carotid Endarterectomy Patients

​STROKEAHA: February 12, 2013 Background and Purpose—Statins are neuroprotective in a variety of experimental models of cerebral injury. We sought to determine whether patients taking statins before asymptomatic carotid endarterectomy exhibit a lower incidence of neurological injury (clinical stroke and cognitive dysfunction). Methods—A total of 328 patients with asymptomatic carotid stenosis scheduled for elective carotid endarterectomy […]

Representation of people with aphasia in randomized controlled trials of acute stroke interventions

International Journal of Stroke: March 19, 2013 Background Aphasia affects up to a third of the stroke population and is associated with poor social participation and quality of life. Yet people with aphasia may be excluded from some types of stroke research due to challenges in informing, consenting, and conducting follow-up in this population. Aims […]

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

PLOS Medicine: Background At the time of approval of a new medicine, there are few long-term data on the medicine’s benefit–risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient exposure and length of follow-up. This study of the number of patients who had […]

Ushering in a New Era of Open Science Through Data Sharing

JAMA: March 18, 2013 It may appear that the clinical research enterprise is functioning well, even thriving. Nearly 30 000 trials globally are recruiting patients, and results from 75 trials are published daily in biomedical journals.However, there is a crisis, with an attendant opportunity, that requires change. A wall surrounds much of these clinical research data, sequestering knowledge, impeding the […]

Safety and feasibiLIty of Metformin in patients with Impaired glucose Tolerance and a recent TIA or minor ischemic stroke (LIMIT) trial – a multicenter, randomized, open-label phase II trial

 International Journal of Stroke: March 15, 2013 Background and purpose We aimed to assess the safety, feasibility, and effects on glucose metabolism of treatment with metformin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. Methods We performed a multicenter, randomized, controlled, open-label phase II trial with blinded outcome assessment. Patients with […]

Rescuing clinical trials in the United States and beyond: A call for action

American Heart Journal: March 13, 2013 Numerous challenges—financial, regulatory, and cultural—are hindering US participation and performance in multinational clinical trials. Consequently, it is increasingly unclear how the results of these trials should be applied to American patients, practice patterns, and systems of care. Both incremental and transformative changes are needed to revitalize US participation as […]

The Effect of Graduated Compression Stockings on Long-term Outcomes After Stroke

STROKEAHA: March 12, 2013 Background and Purpose—Most randomized controlled trials of venous thromboembolism prophylaxis have focused on reduction of deep vein thrombosis, predominantly asymptomatic deep vein thrombosis, detected on imaging. We aimed to estimate the effects of graduated compression stockings on venous thromboembolism events, survival, and functional status at 6 months after stroke. Methods—The CLOTS Trials […]

Brain-machine-interface in chronic stroke rehabilitation: A controlled study

Wiley: March 12, 2013 Objective. Chronic stroke patients with severe hand weakness, respond poorly to rehabilitation efforts. Here, we evaluated efficacy of daily brain-machine-interface training to increase the hypothesized beneficial effects of physiotherapy alone in patients with severe paresis in a double blind sham-controlled design proof of concept study. Methods. 32 chronic stroke patients with […]

Effect of Aerobic Exercise (Walking) Training on Functional Status and Health-related Quality of Life in Chronic Stroke Survivors

STROKEAHA: March 7, 2013 Background and Purpose—Little is known about the effects of community-based walking programs in persons with chronic stroke. The purpose of this study was to determine the effects of aerobic (walking) training on functional status and health-related quality of life in stroke survivors. Methods—A single-blind randomized controlled trial was conducted. The intervention group […]

A Randomized Trial to Assess Catheter Ablation versus Rate Control in the Management of Persistent Atrial Fibrillation in Heart Failure (ARC-HF) ONLINE FIRST

JACC: March 1, 2013 Objectives  To compare catheter ablation with rate-control for persistent atrial fibrillation (AF) in heart failure (HF). Background  The optimal therapy for AF in HF is unclear. Drug-based rhythm-control has not proved clinically beneficial. Catheter ablation improves cardiac function in patients with HF, but impact on physiological performance has not been formally evaluated in […]

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