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http://dx.doi.org/10.1186/s40900-025-00761-9 | DOI Listing |
Open Res Eur
September 2025
Clinical trial unit, Armauer Hansen Research Institute, Addis Ababa, 1005, Ethiopia.
Background: According to the Council of International Organizations and Medical Sciences (CIOMS) 2016, post-trial access (PTA) refers to the ethical imperative that requires the sponsor, researchers, and relevant public health authority, "to make available as soon as possible any intervention or product developed, and knowledge generated, for the population or community in which the research is carried out." Law, policy, and practical guidance for PTA has so far been vague but has recently attracted and increased attention in the context of benefit sharing of scientific research results with low- and middle-income countries (LMICs).Although the number of clinical trials conducted in the Sub Saharan (SSA) countries has increased in the past two decades, plans and practices for PTA are underreported.
View Article and Find Full Text PDFNurs Open
September 2025
Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs, Pécs, Hungary.
Aims: To find out how Kenyan nurses rate their organisational culture, determine their level of job satisfaction, and organisational culture predictors of job satisfaction.
Design: A cross-sectional online survey.
Methodology: A total of 300 nurses across Kenya were invited to participate in this study.
Biom J
October 2025
Novella Clinical Full Service, IQVIA, Melbourne, Australia.
Phase I dose escalation trials in oncology generally aim to find the maximum tolerated dose. However, with the advent of molecular-targeted therapies and antibody drug conjugates, dose-limiting toxicities are less frequently observed, giving rise to the concept of optimal biological dose (OBD), which considers both efficacy and toxicity. The estimand framework presented in the addendum of the ICH E9(R1) guidelines strengthens the dialogue between different stakeholders by bringing in greater clarity in the clinical trial objectives and by providing alignment between the targeted estimand under consideration and the statistical analysis methods.
View Article and Find Full Text PDFWounds
August 2025
Department of Nursing, Federal University of Ceará, Ceará, Brazil.
Background: Diabetic foot ulcers (DFUs) are a major clinical challenge, particularly among patients with refractory ulcers, that often lead to severe complications such as infection, amputation, and high mortality. Innovations supported by strong clinical evidence have the potential to improve healing outcomes, enhance quality of life, and reduce the economic burden on individuals and health care systems.
Objective: To describe the design of the concurrent optical and magnetic stimulation (COMS) therapy Investigational Device Exemption (IDE) study for refractory DFUs (MAVERICKS) trial.
One Health Outlook
September 2025
Department of Tropical Health, High Institute of Public Health, Alexandria University, 165 El Horreya Road, Alexandria, 21561, Egypt.
Background: Brucellosis remains a significant public health and economic challenge in Egypt despite long-standing control efforts. This paper outlines the national strategy for brucellosis control, detailing its legal framework, diagnostic protocols, surveillance mechanisms, vaccination programs, and biosecurity measures.
Main Body: Egypt employs a dual approach of test-and-slaughter and selective vaccination, supported by serological and pathological diagnostics.