Objective: To investigate how to protect participants in the artificial womb technology (AWT) human trials.
Method: We compared randomized controlled trials and single arm trials to understand which trial design best balances the interests of science and participants. We also compared AWT trials with comparable settings to understand how to protect participants.
Results: Randomized trials might fail in reaching a sizeable sample, which could pointlessly expose participants to risks. Furthermore, parents who choose to participate in the trial might expect to receive AWT. Failed expectations might distress parents and hinder the therapeutic relationship. The trial is divided into two steps. First, delivery into AWT involves two participants: the mother and the fetus. As AWT requires a C-section, the procedure cannot be carried out without the mother's consent regardless of fetal benefit. Treatment in AWT, involves one participant: the infant. As for any other invasive intervention, the AWT trial should be suspended if harmful.
Conclusions: A single arm trial could prevent some of the methodological and ethical challenges of the randomized trials. Moreover, better decisional tools should be developed to help parents decide whether to participate in the AWT trial. For example, using visual aids or showing the AWT.
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http://dx.doi.org/10.1002/pd.6521 | DOI Listing |
Antibiotics (Basel)
December 2024
Division of Gastroenterology & Endoscopy, IRCCS, Fondazione "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy.
Abdominal ultrasound (US) is a reliable method for visualizing gastric wall layers and measuring their thickness. The objective of this study is to characterize the ultrasound features of -induced gastritis and assess its predictive potential role for this condition. A cohort of 119 patients underwent gastroscopy with biopsy and abdominal US to evaluate antral wall thickness (AWT), submucosal wall thickness (SLT), mucosal wall thickness (MLT), gastric motility, and the presence of ingested material.
View Article and Find Full Text PDFBMC Health Serv Res
January 2025
Department of Human Nutrition and Dietetics, School of Health Care Sciences, Sefako Makgatho Health Sciences University, Pretoria, South Africa.
Background: Quality nutrition services are dependent upon the accessibility and availability of nutrition professionals. In this study, we used the World Health Organization's Workload Indicators of Staffing Need (WISN) methodology to develop a dietetic staffing norm framework and implementation tool for South African central and tertiary public hospitals.
Methods: We followed the eight step WISN methodology as a basis for this developmental study.
Front Cell Dev Biol
January 2025
Quzhou Aliated Hospital of Wenzhou Medical University, Quzhou People's Hospital, Quzhou, Zhejiang, China.
Background: Gestational diabetes mellitus (GDM) is a temporary metabolic disorder in which small retinal vessels may have experience subtle changes before clinical lesions of the fundus retina appear. An innovative artificial intelligence image processing technology was applied to locate and analyze the small retinal vessel morphology and accurately evaluate the changes of the small retinal vessels in GDM patients and pregnant women with normal blood glucose and non-pregnant women with normal blood glucose.
Methods: The subjects were divided into three groups:GDM group, pregnant control group (PC), and normal control group (NC).
Trends Microbiol
December 2024
Department of Biology, Portland State University, PO Box 751, Portland, OR 97201, USA. Electronic address:
The Earth's most abundant photosynthetic cells, the picocyanobacteria - Prochlorococcus and Synechococcus - play a fundamental global role in aquatic ecosystems. The success of these picocyanobacteria is interpreted through a cross-scale systems framework that integrates bottom-up controls on growth (e.g.
View Article and Find Full Text PDFAesthetic Plast Surg
December 2024
Section of Anatomy and Histology, Department of Neuroscience, Biomedicine, and Movement, University of Verona, P.le L.A. Scuro 10, 37134, Verona, Italy.
Background: Polymethylmethacrylate (PMMA) fillers are permanent fillers known for their possible side effects. In case of complications, the only possible treatment is surgical removal, followed by procedures to minimize resulting deformity. The aims of this study were (1) to analyse the morphology of the PMMA material in the nodules, (2) to demonstrate that treatment by acoustic wave therapy (AWT) can help the removal of the nodules, and (3) to present an easy procedure to solve deformities.
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