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Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : SHIfTing evidence in heart failure management.

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : SHIfTing evidence in heart failure management.Speaker: Jeffrey BORER, New York, USAAbstract : SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) involved 6505 patients with moderate to severe heart failure (HF), heart rate ?70bpm in sinus rhythm, at least one HF hospitalization during the year prior to study, and LVEF ?35% who were receiving guidelinesbased HF therapy including maximized beta blockade, who were randomized to add either placebo or ivabradine (pure HR slowing drug) during a median 22.9 months follow-up. The results of SHIFT unambiguously demonstrated the benefits of HR ...
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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable. Should there be a position statement establishing rules for biomarker studies?

...Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable.Should there be a position statement establishing rules for biomarker studies?John JARCHO,...
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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable. Should there be a position statement establishing rules for biomarker studies?

...Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable.Should there be a position statement establishing rules for biomarker studies?John JARCHO,...
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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement

... Understanding the differences in the clinical and regulatory environments in the United States and Europe helps explain why much early device testing takes place outside of the United States, and why the introduction of new devices into clinical practice is...
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