Zobrazeno 1 - 10 of 122 pro vyhledávání: '"Scott S Emerson"'
1
Semaglutide for cardiovascular event reduction in people with overweight or obesity: SELECT study baseline characteristics
Autor: Ildiko, Lingvay, Kirstine, Brown-Frandsen, Helen M, Colhoun, John, Deanfield, Scott S, Emerson, Sille, Esbjerg, Søren, Hardt-Lindberg, G Kees, Hovingh, Steven E, Kahn, Robert F, Kushner, A Michael, Lincoff, Steven P, Marso, Tea Monk, Fries, Jorge, Plutzky, Donna H, Ryan
Publikováno v: Obesity (Silver Spring, Md.)REFERENCES. 31(1)
This paper describes the baseline characteristics of the Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity (SELECT) study, one of the largest cardiovascular (CV) outcome studies in the field of obesity, which eval
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::37a6af1eb02584d339ec534369af255a
https://pubmed.ncbi.nlm.nih.gov/36502289
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2
Evaluating group-sequential non-inferiority clinical trials following interim stopping – the HIV Prevention Trials Network 083 Trial
Autor: Brett S Hanscom, Deborah J Donnell, Thomas R Fleming, James P Hughes, Marybeth McCauley, Beatriz Grinsztejn, Raphael J Landovitz, Scott S Emerson
Publikováno v: Clin Trials
Background/Aims: The HIV Prevention Trials Network 083 trial was a group-sequential non-inferiority trial designed to compare HIV incidence under a novel experimental regimen for HIV prevention, long-acting injectable cabotegravir, with an active-con
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2635b744d1e45de9b059a37f02b49fef
https://europepmc.org/articles/PMC9691580/
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3
Revisiting FDA Approval of Aducanumab
Autor: G. Caleb Alexander, Bruce Ovbiagele, Aaron S. Kesselheim, Scott S. Emerson, David S. Knopman, Richard J. Kryscio, Joel S. Perlmutter
Publikováno v: New England Journal of Medicine. 385:769-771
Revisiting FDA Approval of Aducanumab Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, it’s essential to consider b...
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8d368d437752a03182ce8e84e2204241
https://doi.org/10.1056/nejmp2110468
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4
Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design
Autor: Helen M. Colhoun, Scott S. Emerson, Steve Marso, G. Kees Hovingh, Kirstine Brown-Frandsen, Steven E. Kahn, John E. Deanfield, Robert F. Kushner, A. Michael Lincoff, Henrik Ravn, Jorge Plutzky, Ildiko Lingvay, Donna H. Ryan, Anders G. Holst, Marianne O. L. Gronning
Publikováno v: American heart journal, 229, 61-69. Mosby Inc.
Ryan, D H, Lingvay, I, Colhoun, H M, Deanfield, J, Emerson, S S, Kahn, S E, Kushner, R F, Marso, S, Plutzky, J, Brown-Frandsen, K, Gronning, M O L, Hovingh, G K, Holst, A G, Ravn, H & Lincoff, A M 2020, ' Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design ', American Heart Journal, vol. 229, pp. 61-69 . https://doi.org/10.1016/j.ahj.2020.07.008
Cardiovascular disease (CVD) is a major cause of morbidity and mortality. Although it has been widely appreciated that obesity is a major risk factor for CVD, treatments that produce effective, durable weight loss and the impact of weight reduction i
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ddfd743696aa295b876c97fc2357306
https://doi.org/10.1016/j.ahj.2020.07.008
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5
Non-inferiority designs comparing placebo to a proven therapy for childhood pneumonia in low-resource settings
Autor: Scott S. Emerson, Amy Sarah Ginsburg, Robert H. Schmicker, Susanne May, Evangelyn Nkwopara, Siobhan P. Brown
Publikováno v: Clinical Trials. 17:129-137
Background/aims: After a new treatment is recommended to be first-line treatment for a specific indication, outcome and population, it may be unethical to use placebo as a comparator in trials for that setting. Nevertheless, in specific circumstances
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::08723e830f401e67aefdc9496388fc96
https://doi.org/10.1177/1740774519888460
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7
Rejoinder to Discussions on 'Approval policies for modifications to machine learning‐based software as a medical device: A study of bio‐creep'
Autor: Scott S. Emerson, Noah Simon, Jean Feng
Publikováno v: Biometrics
I applaud the authors of Feng et al. (2020) for tackling a challenging statistical problem on approval policies for software as a medical device (SaMD). Their work exploring methodology that could autonomously build algorithmic change protocols sound
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::52addfc35adb8d8655a6da6474db310c
https://doi.org/10.1111/biom.13380
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8
Approval policies for modifications to machine learning-based software as a medical device: A study of bio-creep
Autor: Jean Feng, Scott S. Emerson, Noah Simon
Publikováno v: Biometrics
Biometrics, vol 77, iss 1
Successful deployment of machine learning algorithms in healthcare requires careful assessments of their performance and safety. To date, the FDA approves locked algorithms prior to marketing and requires future updates to undergo separate premarket
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4770df7c64b473f63b11c76bf176657c
https://pubmed.ncbi.nlm.nih.gov/33040357
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