Results 61 to 70 of about 29,514,683 (309)

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

Safety of Daprodustat for the Treatment of Chronic Kidney Disease Anemia: Final Analysis of a Multicenter Postmarketing Surveillance Study in Japan

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Introduction This final analysis of a multicenter, prospective postmarketing surveillance study evaluated the safety of daprodustat in patients with chronic kidney disease anemia in routine clinical practice in Japan. Methods Patients who initiated daprodustat between September 2020 and July 2022 were registered.
Tadao Akizawa, Kyomi Kanaya, Kiyomi Aizawa, Masanori Onoki, Hirofumi Ozeki, Kazuko Suzuki, Ai Hayashi, Tomohiko Asamura   +7 more
wiley   +1 more source

Structural insights and therapeutic targets in Acinetobacter baumannii capsule biosynthesis

FEBS Letters, EarlyView.
Hypervirulent KL49 A. baumannii's capsular polysaccharide contains the nonulosonic acid 8‐epi‐Leg5,7Ac2, synthesized by epimerization via ElaA, ElaB, and ElaC. Crystal structures of ElaA, ElaB, and ElaC reveal their role in CMP‐Leg5,7Ac2 synthesis and regioselective C8 epimerization.
Woo Cheol Lee, Junho Jeong, Chae Yeong Lee, Hyunjoon Cho, Man Hwan Oh, Je Chul Lee, Jee‐Young Lee, Yangmee Kim   +7 more
wiley   +1 more source

Assessment of outcome in clinical trials in mild Alzheimer 19s disease: urgent time for a rethink? [PDF]

, 2013
Introduction: A major barrier for clinical trials in Alzheimer's disease is the lack of sensitive clinical endpoints for the early stages. Until recently, regulatory agencies have required demonstration of improvement in two disease domains, cognition ...
McGoldrick, S., Duffy, Fiona, McGoldrick, Susan, Reynish, Emma, Kelly, Fiona, Morrison, Y., Wilson, L., Bennett, Crispin, Wilson, J T Lindsay, Bennett, C., Morrison, Yvonne, Duffy, F., Reynish, E.   +12 more
core  

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

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

Comparison of the completed and discontinued pediatric drug clinical trials in Mainland China: a cross-sectional analysis based on the data from 2003 to 2023

BMC Pediatrics
Background Pediatric drug clinical trials are essential for ensuring the accessibility and safety of medications intended for children. In recent years, the Chinese government has implemented various measures to foster the development of pediatric drug ...
Zi-Ming Wang, Rui-Rui Du, Li Yang
doaj   +1 more source

Data Monitoring Committees: Current Issues

Clinical Trials, 2018
Maintaining confidentiality of emerging data and ensuring the independence of Data Monitoring Committees are best practices of considerable importance to the ability of these committees to achieve their mission of safeguarding the interests of study ...
T. Fleming, S. Ellenberg, D. DeMets
semanticscholar   +1 more source

What can we learn from clinical trials of anticonvulsant drugs in epilepsy?

, 2002
Any physician who intends to utilize the available antiepileptic drugs (AEDs) judiciously, cannot do so without being well versed on their pharmacological properties and the large body of evidence that is continuously accumulating on their relative ...
What Can We Learn From Clinical Trials Of Anticonvulsant Drugs In Epilepsy?, PERUCCA, EMILIO   +1 more
core   +1 more source