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Clinical Trials
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Fifteen years ago the FDA established a registry for clinical trials (www.clinicaltrials.gov) so that scientific investigators and the general public would have a ready source of information about medical research – planned, ongoing, and completed. In 2004 the International Committee of Medical... »
FDA Takes on Sex Disparity in Device Trials
Medical device studies have shown persistent underrepresentation of women – a sex gap that could have a profound impact on the health of women who receive such devices.
In an attempt to correct this disparity, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH)... » SAN DIEGO – Intravenous exenatide appeared to be as effective and safe as IV insulin to treat hyperglycemia patients in the cardiac ICU, but caused nausea in a fifth of patients in a small study.
The prospective, open-label study included 40 adults admitted to the cardiac ICU and treated with IV... » Clinical studies in support of premarket approval applications should ideally be randomized and blinded, the Food and Drug Administration maintains in recent draft guidance for sponsors and staff to help researchers and manufacturers design better quality clinical trials for device... » The Cardiothoracic Surgical Trials Network is a major collaborative effort focusing on surgical approaches for cardiac disease. Two of their trials recently reached enrollment milestones, according to the CTSN.
In August the University of Pennsylvania randomized the 200th patient in the severe... »
Hyperglycemia Treated With Exenatide in Cardiac ICU
FDA Emphasizes Randomized, Blinded Device Trials
Cardiothoracic Clinical Trails Move Forward
SAN DIEGO – Intravenous exenatide appeared to be as effective and safe as IV insulin to treat hyperglycemia patients in the cardiac ICU, but caused nausea in a fifth of patients in a small study. The prospective, open-label... »
FDA Emphasizes Randomized, Blinded Device Trials
Clinical studies in support of premarket approval applications should ideally be randomized and blinded, the Food and Drug Administration maintains in recent draft guidance for sponsors and staff to help researchers and... »
Cardiothoracic Clinical Trails Move Forward
The Cardiothoracic Surgical Trials Network is a major collaborative effort focusing on surgical approaches for cardiac disease. Two of their trials recently reached enrollment milestones, according to the CTSN. In August... »
| May 26 - 29 Birmingham, | European Society of Thoracic Surgeons (ESTS): 21st European Conference on General Thoracic Surgery |
| Jun 12 - 15 Chicago, IL | American Society for Artificial Internal Organs (ASAIO): Annual Conference |
| Jun 12 - 15 Prague, | International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) |
| Jun 26 - 29 Coeur d'Alene, ID | Western Thoracic Surgical Association (WTSA): Annual Meeting |
| Jun 27 - 29 Frankfurt, | Congenital and Structural Interventions (CSI 2013) |