Results 51 to 60 of about 30,760,747 (299)

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

PLoS ONE, 2018
BackgroundAfter the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the
Rainer Erices, Andreas Frewer, Antje Gumz   +2 more
doaj   +1 more source

Bone and Soft Tissue Neoplasms in Infants Versus Older Children: A Report From the Cancer in Young People in Canada Program

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background and Aims Infant bone and soft tissue neoplasms present distinct clinical challenges and lack large‐scale data to inform treatment decisions. This study aims to characterize bone and soft tissue neoplasms in infants in Canada and to compare their outcomes with those of older pediatric patients.
Samuel Sassine, Hallie Coltin, Maria Kondyli, Monia Marzouki, Nicolas Prud'homme, Nida Usmani, Rebecca J. Deyell, Lesleigh Abbott, Tony H. Truong, Sapna Oberoi, Ketan Kulkarni, Josée Brossard, Lynette Bowes, Paul Gibson, Sarah McKillop, Roona Sinha, Lillian Sung, Catherine Vezina, Laura Wheaton, Alexandra P. Zorzi, Marie‐Claude Pelland‐Marcotte, Thai Hoa Tran   +21 more
wiley   +1 more source

Effectiveness of Resistance Intradialytic Exercise Compared to Aerobic Intradialytic Exercise for Patients With Chronic Kidney Disease: A Randomized Controlled Clinical Trial

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Background Patients with chronic kidney disease undergoing hemodialysis commonly experience reduced physical function, fatigue, poor sleep quality, and impaired health‐related quality of life. Intradialytic exercise has been proposed as a non‐pharmacological strategy to improve these outcomes.
Klebson da Silva Almeida, Gisela Cristiane Miyamoto, Daniel da Costa Torres, Ian Setubal Reis Chaves, Jonas do Carmo Paschoalin, Braúlio Lima Nascimento, Luciana Dias Chiavegato   +6 more
wiley   +1 more source

The International Council for Harmonisation E6 (R3) revision and its impact on clinical research practice: A narrative review

Cancer Research, Statistics, and Treatment
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), established in April 1990, has released an updated version of its ICH E6 guidelines for Good Clinical Practice (GCP). This new version, ICH E6 (
Bhavesh A P Bandekar, Akriti Sood, Gargi Ganguly, Natasha Sisodia, Soumitra Saha, Akhil Kapoor, Satyajit Pradhan   +6 more
doaj   +1 more source

Selection bias in clinical stroke trials depending on ability to consent

BMC Neurology, 2017
Background Clinical trials are the hallmark of evidence-based medicine, but recruitment is often challenging, especially in stroke trials investigating patients not being able to give informed consent.
Benjamin Hotter, Lena Ulm, Sarah Hoffmann, Mira Katan, Joan Montaner, Alejandro Bustamante, Andreas Meisel   +6 more
doaj   +1 more source

Design and analysis strategies for robust microbiome ageing research

FEBS Letters, EarlyView.
The gut microbiome changes with age and associates with age‐related morbidity and mortality, establishing it as a potential biomarker and intervention target for ageing. Realising this potential requires methodological rigour, yet distinguishing biological signals from methodological artefacts remains challenging across cohorts. This review provides an
Mark Olenik, İsmail Güderer, Yi Wang, Tayyaba Alvi, Prasoon Pandey, Handan Melike Dönertaş   +5 more
wiley   +1 more source

Application of methods for central statistical monitoring in clinical trials [PDF]

, 2013
Background On-site source data verification is a common and expensive activity, with little evidence that it is worthwhile. Central statistical monitoring (CSM) is a cheaper alternative, where data checks are performed by the coordinating centre ...
Cox, T, Hackshaw, A, Kirkwood, AA
core  

Partial depletion of plasminogen activator inhibitor‐1 decreases subcutaneous fat cell hypertrophy and liver cholesterol in high‐fat‐fed female mice

FEBS Letters, EarlyView.
Obesity raises blood levels of PAI‐1, a protein linked to metabolic dysfunction‐associated steatotic liver disease in people with obesity. In female mice fed a high‐fat diet, partially lowering PAI‐1 led to smaller subcutaneous fat cells and lower liver cholesterol, without changing body weight or insulin sensitivity.
Claudia E. Ramirez Bustamante, Robert Sharp, Pradip K. Saha, Elizabeth S. Anaya, Elizabeth L. Lieu, Evelyn L. de Groot, Pooja Patel, Mi Jeong Heo, Aaron R. Cox, Kang Ho Kim, Sean M. Hartig   +10 more
wiley   +1 more source

Data monitoring committees: Promoting best practices to address emerging challenges

, 2017
Background and Purpose: Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials.
David L DeMets, Susan S Ellenberg, Janet Wittes, Thomas R Fleming, David J Gordon, Matthew T Roe, Marvin A Konstam, Gail D Pearson, Alan Meisel, Raymond P Bain, Michael J Pencina, James D Neaton, Karim A Calis, Marc A Pfeffer, Charles H Hennekens, Kenneth W Mahaffey, Amit N Vora, Tomas LG Andersson   +17 more
core   +1 more source

Charting the content of data monitoring committee charters for clinical trials

Clinical Trials
Background: Data monitoring committees play a critical role in ensuring the ethical conduct of clinical trials. Data monitoring committee charters set out the role and processes for data monitoring committees in monitoring clinical trials; however, little is known about the information charters contain.
Lisa Eckstein, Akram Ibrahim, Olivia Orr, Annette Rid, Seema K Shah   +4 more
openaire   +2 more sources