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This column contains the presidential address presented during the Third Annual Meeting of the American Association of Heart Failure Nurses on June 28, 2007, in San Diego, California, titled "Building the Foundation of Excellence in Heart Failure Nursing." 相似文献
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Participation in pediatric oncology research protocols: Racial/ethnic,language and age‐based disparities
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Choice of Vein‐Harvest Technique for Coronary Artery Bypass Grafting: Rationale and Design of the REGROUP Trial
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Marco A. Zenati MD MSc J. Michael Gaziano MD MPH Joseph F. Collins ScD Kousick Biswas PhD Jennifer M. Gabany MSN CRNP CCRC Jacquelyn A. Quin MD MPH Jerene M. Bitondo PA‐C Faisal G. Bakaeen MD Rosemary F. Kelly MD A. Laurie Shroyer PhD Deepak L. Bhatt MD MPH 《Clinical cardiology》2014,37(6):325-330
The Randomized Endo‐vein Graft Prospective (REGROUP) trial ( ClinicalTrials.gov NCT01850082) is a randomized, intent‐to‐treat, 2‐arm, parallel‐design, multicenter study funded by the Cooperative Studies Program (CSP No. 588) of the US Department of Veterans Affairs. Cardiac surgeons at 16 Veterans Affairs (VA) medical centers with technical expertise in performing both endoscopic vein harvesting (EVH) and open vein harvesting (OVH) were recruited as the REGROUP surgeon participants. Subjects requiring elective or urgent coronary artery bypass grafting using cardiopulmonary bypass with use of ≥1 saphenous vein graft will be screened for enrollment using pre‐established inclusion/exclusion criteria. Enrolled subjects (planned N = 1150) will be randomized to 1 of the 2 arms (EVH or OVH) after an experienced vein harvester has been assigned. The primary outcomes measure is the rate of major adverse cardiac events (MACE), including death, myocardial infarction, or revascularization. Subject assessments will be performed at multiple times, including at baseline, intraoperatively, postoperatively, and at discharge (or 30 days after surgery, if still hospitalized). Assessment of leg‐wound complications will be completed at 6 weeks after surgery. Telephone follow‐ups will occur at 3‐month intervals after surgery until the participating sites are decommissioned after the trial's completion (approximately 4.5 years after the full study startup). To assess long‐term outcomes, centralized follow‐up of MACE for 2 additional years will be centrally performed using VA and non‐VA clinical and administrative databases. The primary MACE outcome will be compared between the 2 arms, EVH and OVH, at the end of the trial duration. 相似文献
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Andrew Farb MD Sheila A. Brown RN CCRC Deborah A. Wolf JD Bram Zuckerman MD 《Catheterization and cardiovascular interventions》2010,76(4):E126-E129
Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion. © 2010 Wiley‐Liss, Inc. 相似文献
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Eugene H. Chang MD Xiao Xiao Tang PhD Viral S. Shah BA Janice L. Launspach RN CCRC Sarah E. Ernst BS Brieanna Hilkin BS Philip H. Karp BS Mahmoud H. Abou Alaiwa MD Scott M. Graham MD Douglas B. Hornick MD Michael J. Welsh MD David A. Stoltz MD PhD Joseph Zabner MD 《International forum of allergy & rhinology》2015,5(2):178-181
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