Results 41 to 50 of about 100,822 (314)

REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States. [PDF]

, 2020
BackgroundSome trials have found that patients from the United States derive less benefit than patients enrolled outside the United States. This prespecified REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial ...
Ballantyne, Christie M, Bhatt, Deepak L, Brinton, Eliot A, Budoff, Matthew J, Chung, Mina K, Doyle, Ralph T, Gibson, C Michael, Giugliano, Robert P, Granowitz, Craig, Jacobson, Terry A, Jiao, Lixia, Juliano, Rebecca A, Ketchum, Steven B, Miller, Michael, Olshansky, Brian, REDUCE-IT Investigators, Steg, Ph Gabriel, Tardif, Jean-Claude   +17 more
core   +1 more source

"You have to keep your nerve on a DMC." Challenges for Data Monitoring Committees in neonatal intensive care trials: Qualitative accounts from the BRACELET Study.

PLoS ONE, 2018
BackgroundData Monitoring Committees (DMCs) are essential to the good conduct of many trials. Typically they comprise a small expert group which monitors safety, efficacy, progress and early outcome data as trials recruit.
Claire Snowdon, Peter Brocklehurst, Robert C Tasker, Martin Ward Platt, Diana Elbourne   +4 more
doaj   +1 more source

Sex-Divergent Clinical Outcomes and Precision Medicine: An Important New Role for Institutional Review Boards and Research Ethics Committees

Frontiers in Pharmacology, 2017
The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have
Ignacio Segarra, Pilar Modamio, Cecilia Fernández, Eduardo L. Mariño   +3 more
doaj   +1 more source

Adverse events following immunization against SARS-CoV-2 (covid-19) in the state of Minas Gerais

Revista de Saúde Pública
OBJECTIVE To analyze adverse events following immunization (AEFI) against SARS-CoV-2 (covid-19) in the state of Minas Gerais (MG), Brazil. METHODS Epidemiological, descriptive study, with data from e-SUS Notifica (e-SUS Notification) in the state of ...
Roberta Barros da Silva, Thales Philipe Rodrigues da Silva, Ana Paula Sayuri Sato, Francisco Carlos Felix Lana, Josianne Dias Gusmão, Janaina Fonseca Almeida Souza, Fernanda Penido Matozinhos   +6 more
doaj   +2 more sources

Mismatch-based delayed thrombolysis: a meta-analysis [PDF]

, 2010
<p><b>Background and Purpose</b>: Clinical benefit from thrombolysis is reduced as stroke onset to treatment time increases. The use of "mismatch" imaging to identify patients for delayed treatment has face validity and has been used in
Anthony J. Furlan, Geoffrey A. Donnan, Gregory W. Albers, Kennedy R. Lees, Nishant K. Mishra, Stephen M. Davis, Werner Hacke   +6 more
core   +1 more source

The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias

BMC Medical Research Methodology, 2008
Background Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs). Data Monitoring Committees (DMCs) often undertake such analyses, but their widening role may lead to extended ...
Hampton John, Calvert Melanie, Tharmanathan Puvan, Freemantle Nick   +3 more
doaj   +1 more source

Statistics, ethics, and probiotica

, 2008
A randomized clinical trial comparing an experimental new treatment to a standard therapy for a life-threatening medical condition should be stopped early on ethical grounds, in either of the following scenarios: (1) it has become overwhelmingly clear ...
Gill, Richard D.
core   +5 more sources

Validating a novel web-based method to capture disease progression outcomes in multiple sclerosis [PDF]

, 2013
The Expanded Disability Status Scale (EDSS) is the current ‘gold standard’ for monitoring disease severity in multiple sclerosis (MS). The EDSS is a physician-based assessment.
Dobson, Ruth, Giovannoni, Gavin, Hadavi, Shahrzad, Leddy, Sara, McCarren, Andrew   +4 more
core   +1 more source

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial [PDF]

, 2013
Background: Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish
Bender, Stephan, Cholemkery, Hannah, Elsuni, Leyla, Freitag, Christine M., Kieser, Meinhard, Kroeger, Anne K., Kunz, Cornelia Ursula   +6 more
core   +1 more source

Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study):study protocol for a randomized, controlled, multicenter, international clinical trial [PDF]

, 2019
BACKGROUND: Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake.
A Van Gossum, A.M. Eltweri, Alastair Forbes, AR Heller, Bernhard Glotzbach, CJ Jones, Cécile Chambrier, DL Burns, E Venecourt-Jackson, EM Tillman, Farooq Rahman, Geert Wanten, GJ Wanten, H Baldermann, Ivan R. Diamond, J Wang, Jacek Sobocki, K Mayer, Kinga Szczepanek, KM Gura, L Pironi, L Pironi, Loris Pironi, M Cavicchi, M Rubin, M Staun, Marek Kunecki, MS Mundi, MS Mundi, MW Wichmann, Nicole Lincke, O Goulet, PB Jeppesen, PT Clayton, RT Hurt, S Klek, S Klek, Sheldon C. Cooper, Simon Gabe, Stanislaw Klek, T Grau-Carmona, W Lehmacher, Z Xu   +42 more
core   +3 more sources