Results 31 to 40 of about 30,760,747 (299)

Guideline on the design and conduct of cystic fibrosis clinical trials: The European Cystic Fibrosis Society–Clinical Trials Network (ECFS-CTN) [PDF]

, 2011
We describe the rationale for disease specific research networks in general as well as the aims and function of the European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) specifically.
S. Conway, Tiddens, H., I. Fajac, T. Lee, F. Dufour, Wagner, T., Conway, S., B. Kassai, Bulteel, V., S. Elborn, Fajac, I., V. Bulteel, Elborn, S., De Boeck, K., Dufour, F., Smyth, A. R.; id_orcid, K. De Boeck, T. Wagner, Lee, T., A.R. Smyth, Serment, I., Kassai Koubai, Behrouz, Kassai, B., Sermet, I., H. Tiddens, I. Sermet, MELOTTI, Paola Maria, De Boeck K1, Bulteel V, ECFS CTN, network partners, Smyth, Ar.   +29 more
core   +2 more sources

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

Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute.

, 1997
PURPOSE To describe the rationale for independent data monitoring committees (DMCs) for National Cancer Institute (NCI)-sponsored phase III cooperative group clinical trials.
E L Korn, R S Ungerleider, R Simon, L Rubinstein, M A Smith   +4 more
core   +1 more source

Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study

BMJ Global Health
Introduction A data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data.
Dorcas Kamuya, Annette Rid, Seema K Shah, Alex Hinga, Akram Ibrahim, Diego Vintimilla, Mickayla Jones, Lisa Eckstein   +7 more
doaj   +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

Challenging Issues in Clinical Trial Design: Part 4 of a 4-Part Series on Statistics for Clinical Trials. [PDF]

, 2015
As a sequel to last week's paper on the fundamentals of clinical trial design, this paper tackles related controversial issues: noninferiority trials, the value of factorial designs, the importance and challenges of strategy trials, Data Monitoring ...
Clayton, Tim C, Pocock, Stuart J, Stone, Gregg W   +2 more
core   +1 more source

Central Nervous System Tumors Among Infants in Canada: A Report From CYP‐C

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Central nervous system (CNS) tumors in infants are rare, pose unique clinical challenges, and lack large‐scale evidence‐based data to guide management. This study seeks to describe CNS tumors in Canadian infants and to compare their outcomes with those of older children.
Samuel Sassine, Hallie Coltin, Sylvia Cheng, Lucie Lafay‐Cousin, Vanan Issai Magimairajan, Craig Erker, Stéphanie Vairy, Lynette Bowes, Adam Fleming, Donna Johnston, Sarah McKillop, Roona Sinha, Julie Bennett, Christina Coleman, Laura Wheaton, Shayna Zelcer, Samuele Renzi, Thai Hoa Tran   +17 more
wiley   +1 more source

Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial

BMJ Open, 2020
Introduction The development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a ...
Anushka Patel, Stephen Jan, Rohina Joshi, Devarsetty Praveen, Nikhil Tandon, Helena J Teede, Deksha Kapoor, Lakshmi K Josyula, Yashdeep Gupta, Ankush Desai   +9 more
doaj   +1 more source

Addressing the Maternal Mental Health Crisis Through a Novel Tech-Enabled Peer-to-Peer Driven Perinatal Collaborative Care Model

Voices in Bioethics, 2023
Photo by 193001056 © Yee Xin Tan on Dreamstime.com ABSTRACT Suicide and overdose, associated with perinatal mental health conditions, are the leading causes of maternal mortality in the United States.
Bridget McKinney
doaj   +1 more source

Impact of Radiation Therapy on Physical and Psychosocial Health of Adolescents and Young Adults: A Joint Report From the Children's Oncology Group AYA and Radiation Oncology Committees

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Rates of cancer among adolescents and young adults (AYA), age 15–39 years, are increasing. Consequently, radiation oncologists are treating more AYAs who have diagnoses spanning both pediatric and adult practices. Compared to pediatric and older adult patients, AYAs face a unique set of challenges.
Hesham Elhalawani, Rachel K. Peterson, Avani D. Rao, Laurie J. McKenzie, Ahmed Magdy Elmotayam, Leslie Chang, Michael Roth, Susan L. McGovern   +7 more
wiley   +1 more source