Unlabelled: The general objective of this study was to proceed an inventory of measures which could help to improve the efficiency of clinical research in France.
Method: Thanks to the discussion between the members of the round-table conference (composed of medical doctors (MD)/investigators; hospital managers; representatives of industrial promoters; general practitioners...), we have looked over the difficulties that meets clinical research in France nowadays.
Results: We identified four fields of action: 1) availability of resources for carrying out the trials in time and in quality; 2) feasibility of the clinical trials, in their design and for the recruitment which depends on both of the investigation centers and patients (what is the image of human testing in the society?); 3) skills and motivation of all the elements of staffs in charge of clinical trials (MD; nurses; and the new jobs in medical research); 4) promptness and efficiency of the administrative organisation for a fast starting up of the trials.
Conclusion: This study, which doesn't pretend to sufficiency, shows the gap of improvement for French clinical trials organisation.
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http://dx.doi.org/10.2515/therapie:2008046 | DOI Listing |
Crit Care
January 2025
Centre for Trauma Sciences, Blizard Institute, Queen Mary University of London, London, England.
Background: In severely injured trauma patients, hypofibrinoginaemia is associated with increased mortality. There is no evidence-based consensus for what constitutes optimal fibrinogen therapy, treatment dose or timing of administration. The aim of this systematic review was to evaluate the effects of early fibrinogen replacement, either cryoprecipitate or fibrinogen concentrate (FgC) on mortality, transfusion requirements and deep venous thrombosis (DVT).
View Article and Find Full Text PDFBMC Med Ethics
January 2025
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Thunphayathai, Bangkok, 10400, Thailand.
Background: Thailand has made significant progress in malaria control efforts in the past decade, with a decline in the number of reported cases. However, due to cross-border movements over the past 5 years, reported malaria cases in Thailand have risen. The Malaria Infection Study in Thailand (MIST) involves deliberate infection of healthy volunteers with Plasmodium vivax malaria parasites, and the assessment of the efficacy of potential vaccine and drug candidates in order to understand acquired protection against malaria parasites.
View Article and Find Full Text PDFCardiooncology
January 2025
Department of Hematology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Background: Dexrazoxane has been studied for its ability to prevent anthracycline-induced cardiac dysfunction (AICD) in several trials but its use in clinical practice remains limited. This is related to the low to moderate quality of the generated evidence, safety concerns and restricted prescribing indications. Additional randomized trials are needed before this drug can be routinely integrated into cardio-oncology clinical practice.
View Article and Find Full Text PDFVirol J
January 2025
Virology Laboratory, Faculty of Life Sciences and Biotechnology, South Asian University (SAU), New Delhi, 110068, India.
Maturation inhibitors (MIs) block HIV-1 maturation by preventing the cleavage of the capsid protein and spacer peptide 1 (CA-SP1). Bevirimat (BVM), a first-in-class MI, displayed sub-optimal efficacy in clinical trials due to presence of SP1:V7A polymorphism in the Gag protein.This polymorphism is inherently present in HIV-1 subtype C and conferred resistance to BVM.
View Article and Find Full Text PDFJ Transl Med
January 2025
Department of Life, Health & Environmental Sciences, University of L'Aquila, Building Rita Levi Montalcini, Coppito, L'Aquila, 67100, Italy.
Background: A growing number of in vitro and in vivo studies suggest the application of probiotics as a natural approach to maintaining oral health. This double-blind, randomized controlled trial aimed to evaluate the efficacy of Levilactobacillus brevis CD2 (CNCM I-5566), a multifunctional probiotic frequently used in oral medicine, in preserving or improving several recognized oral health indicators.
Methods: Thirty consenting healthy adults were randomized to receive four lozenges per day of L.
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