HAL-HCL
Not a member yet
19000 research outputs found
Sort by
PERIGENOMED-CLINICS 1—the first study on feasibility, acceptability and psychosocial impact of PERIGENOMED: a pilot project aimed at providing initial concrete evidence on the relevance of panel-based genome sequencing for newborn screening (NBS) in France
No full textInternational audienceIntroduction: International pilot projects focusing on next-generation sequencing in newborn screening (NBS), that is, genomic NBS (gNBS), have been established thanks to continuous therapeutic progress and the massive development of new genetic technologies with rapidly decreasing costs. Given the highly encouraging results of the French SeDeN project regarding anticipated acceptability among professionals and parents, it is now appropriate to launch a similar pilot project in France, in collaboration with other international initiatives under the International Consortium on Newborn Sequencing framework.Methods and analysis: PERIGENOMED is a large-scale project designed to provide the first concrete evidence on the relevance of gNBS in France. It includes two clinical trials. We present here the design chosen for the first clinical trial (PERIGENOMED-CLINICS 1). PERIGENOMED-CLINICS 1 aims to assess the feasibility, real-world acceptability, psychosocial impact and organisational pathways of panel-based genomic newborn screening in France, involving 2500 participants. Solo-GS targeting two lists of gene-disease dyads responsible for treatable (list 1; 400 genes, 171 diseases/group of diseases) or actionable (list 2 optional; 407 genes, 218 diseases/group of diseases) rare and severe early-onset diseases will be proposed in five health institutions. Ancillary social and impact studies will also be included.Ethics and dissemination: All study procedures have been reviewed and approved by relevant French ethics committees and regulatory authorities (CPP Est II-2024-A02224-43, 1 January 2025). Results of the project will be disseminated through peer-reviewed publications, national and international conferences, and public engagement initiatives, in coordination with stakeholders.Trial registration number: NCT06875089
Antimicrobial GH12-fibrin hydrogel for dental pulp regeneration: An in vitro study
No full textInternational audienceAim: Fibrin hydrogels hold great promise as drug delivery systems in tissue engineering, due to their biocompatibility, degradability, and injectability. However, their inability to prevent bacterial growth limits their usefulness in infection-prone environments such as the dental root canal. GH12 was described as a potent antimicrobial peptide for oral applications. In the present study, we aimed to evaluate the preclinical relevance of an innovative fibrin hydrogel incorporating antimicrobial peptide GH12 to prevent bacterial contamination of the material during the regeneration process.Methodology: Hydrogel’s mechanical properties were characterised by rheology and Scanning Electron Microscopy (SEM). GH12 antibacterial effectiveness against Enterococcus faecalis, Porphyromonas gingivalis, and Streptococcus gordonii was determined using Minimum Inhibitory Concentration (MIC) assays as well as inhibition circle assays. Cytocompatibility was assessed through a Live and Dead assay using Dental Pulp Mesenchymal Stem Cells (DP-MSCs) embedded in GH12-fibrin hydrogels.Results: SEM showed no significant difference in fibre and pore average sizes. MICs were 75 µg/mL for E. faecalis, 4.25 µg/mL for P. gingivalis and 28.15 µg/mL for S. gordonii. GH12 effectively inhibited bacterial growth in both liquid and solid media. DP-MSCs embedded in GH12-fibrin hydrogels (GH12 150 µg/mL) showed a 90 % survival rate at 48 h, compared to fibrin-alone hydrogels.Conclusions: These results suggest that GH12-fibrin hydrogels might control endodontic infection, as it shows significant antibacterial activity without compromising the hydrogel’s structure or cytocompatibility with DP-MSCs. Further studies in vitro and in vivo, are required to optimise GH12 release from the fibrin hydrogel and confirm its safety and effectiveness
AFSOS-SFRO Guidelines on Radiation-Induced Lung Injury
No full textInternational audienceRadiation-induced lung injury (RILI) remains a significant complication of thoracic radiotherapy, with clinical presentations ranging from asymptomatic radiological changes to life-threatening pneumonitis and long-term fibrosis. Given the increasing use of thoracic irradiation and the growing complexity of combined modality treatments, including immunotherapy, a multidisciplinary and standardized approach to the clinical management of RILI is essential. This article presents expert recommendations jointly developed by the French Society of Radiation Oncology (SFRO) and the French Association for Supportive Care in Oncology (AFSOS), with the aim of guiding clinicians in the diagnosis, grading, and supportive management of RILI. Key topics addressed include clinical risk factors, differential diagnosis, therapeutic strategies based on toxicity grade, the role of corticosteroids and supportive treatments, follow-up recommendations, and preventive measures. These consensus guidelines are intended to improve the quality and consistency of care for patients at risk of or experiencing RILI
No difference in revision rate in patella‐friendly total knee arthroplasty with or without patella resurfacing at 5 years' follow‐up. A database analysis
No full textInternational audienceAbstract Purpose Numerous studies have been published on the optimal management of the patella during total knee arthroplasty (TKA), but controversy remains. The aim of this study was to compare survivorship and functional outcomes with or without patella resurfacing, using a single TKA implant. Methods This retrospective database analysis included 6078 TKA of the same cruciate‐sacrificing, mobile‐bearing, ‘patella‐friendly’ model implanted between March 2002 and December 2018 for primary osteoarthritis. TKAs implanted for inflammatory arthritis or bone tumour were excluded. The implant's survivorship was estimated at 5 years' follow‐up using the Kaplan–Meier method. Functional assessments consisted of the KSS score and knee flexion. Results The 1641 patients who had at least 5 years' follow‐up were separated into two groups: patella resurfacing (PR) ( n = 656) and no patella resurfacing (NPR) ( n = 985). Mean age was 69.8 years [25–96] and mean follow‐up time was 98.4 months [60–247]. There was no difference in survivorship without reoperation between the two groups (98.4% [95% confidence interval [CI] 97.8–99] vs. 98.4% [95% CI 97.6–99.1; p = 0.95), nor in the mean KSS score (181.7 [95% CI 158.35–205.0] vs. 179.9 [95% CI 156.5–203.2]; p = 0.51). Survival free of patella‐related revisions was 99.3% [95% CI 98.9–99.7] in the NPR group versus 99.7% [99.3–100.0] in the PR group ( p = 0.02). Mean knee flexion was significantly less in the NPR group than in the PR group (116.1° [95% CI 104.5–127.8] vs. 118.8° [95% CI 106.7–131.0]; p = 0.03). Conclusion Systematic patella resurfacing when doing TKA using the SCORE™ implant does not reduce the overall revision rate and does not improve functional scores. When only the revisions for patella‐related complications are considered, the revision rate is lower in the NPR group. Knee flexion is better in patients who underwent patellar resurfacing, but this difference did not reach the clinically relevant threshold. Level of Evidence Level III, retrospective cohort study
Advocacy by nonprofit scientific institutions needs to be evidence-based: a case study
No full textInternational audienceScientific institutions, including universities and research centers, occasionally engage in advocacy to gain financial support. However, this can be problematic if they selectively present scientific evidence. We describe a case involving a French semi-public foundation dedicated to clinical research on four adult psychiatric disorders: autism without intellectual disability, treatment-resistant depression, schizophrenia, and bipolar disorder. The foundation has claimed that an initial assessment at any of its Expert Centers led to a 50 % reduction in hospitalization days. We analyzed communication directed at the public in the French press, advocacy efforts towards members of the French Parliament (MFPs), evidence supporting this claim within those activities, and MFPs' initiatives that addressed the foundation's request. However, the reduction in hospitalization originated from a single study of bipolar disorder patients, which lacked a control group and had other methodological flaws. No scientific publications supported similar claims for the other three disorders. On May 2, 2024, 70 members of the French Parliament introduced a bill aimed at integrating these Expert Centers into the healthcare system. Justifications for the bill explicitly cited the 50 % reduction in hospitalization for all four conditions. This case highlights the need for policy makers and journalists to verify the robustness of scientific claims before these become policy. It also emphasizes the responsibility of scientists and journal editors to recognize and mitigate spin in research studies and opinion articles and to develop tools that help evaluate advocacy and lobbying claims in scientific contexts
Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation
No full textInternational audienceImportance Correction of tricuspid regurgitation using tricuspid transcatheter edge-to-edge repair (T-TEER) in addition to guideline-directed optimized medical therapy (OMT) may improve clinical outcomes. Objective To evaluate the efficacy of T-TEER + OMT vs OMT alone in patients with severe, symptomatic tricuspid regurgitation. Design, Setting, and Participants Investigator-initiated, prospective, randomized (1:1) trial evaluating T-TEER + OMT vs OMT alone in adult patients with severe, symptomatic tricuspid regurgitation. The trial was conducted at 24 centers in France and Belgium (March 2021 to March 2023; latest follow-up in April 2024). Intervention Patients were randomized to T-TEER + OMT or OMT alone. Main Outcomes and Measures The primary outcome was a composite clinical end point at 1 year comprising change in New York Heart Association class, change in patient global assessment, or occurrence of major cardiovascular events. Tricuspid regurgitation severity was the first of 6 secondary outcomes analyzed in a hierarchical closed-testing procedure, including Kansas City Cardiomyopathy Questionnaire (KCCQ) score, patient global assessment, and a composite outcome of all-cause death, tricuspid valve surgery, KCCQ score improvement, or time to hospitalization for heart failure. Results Of 300 enrolled patients (mean age, 78 [SD, 6] years, 63.7% women), 152 were allocated to T-TEER + OMT and 148 to OMT alone. At 1 year, 109 patients (74.1%) in the T-TEER + OMT group had an improved composite score compared with 58 patients (40.6%) in the OMT-alone group. Massive or torrential tricuspid regurgitation was found in 6.8% of patients in the T-TEER + OMT group and in 53.5% of those in the OMT-alone group ( P < .001). Mean overall KCCQ summary score at 1 year was 69.9 (SD, 25.5) for the T-TEER + OMT group and 55.4 (SD, 28.8) for the OMT-alone group ( P < .001). The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08) ( P < .001). Conclusions and Relevance T-TEER reduces tricuspid regurgitation severity and improves a composite score driven by improved patient-reported outcome measures in patients with severe, symptomatic tricuspid regurgitation. Trial Registration ClinicalTrials.gov Identifier: NCT0464681
Real-world evidence of dalbavancin effectiveness as consolidation therapy in infective endocarditis due to Enterococcus spp.
No full textInternational audienceEnterococcal endocarditis (EIE) affects elderly patients, with high rates of complications and mortality, and dalbavancin (DBV) exhibits significant antimicrobial activity against most enterococci. However, data are lacking on the use of DBV in EIE. The main objective was to evaluate the outcomes of treatment with DBV in the consolidation therapy of IE by Enterococcus spp.Methods: Spanish-French retrospective observational study of patients with EIE enrolled between November 2016 and June 30, 2022 receiving DBV in consolidation phase and followed for ≥12 months.Results: Ninety-eight patients were enrolled, 69.4 % male, with mean age of 71.2 (±12.51) years and median Charlson index of 5 (IQR 3-7). Criteria for definite IE were met by 84.7%; 60.2 % had IE on native valve, 26.5 % late prosthetic IE, 8.2 % early prosthetic IE, 2 % cardiovascular implantable electronic-IE (CIE-IE), and 3.1 % CIE-IE and valve. Aortic valve involvement was observed in 66.3 %. E. faecalis was isolated in 86.7 %, E. faecium in 11.2 %; 32.6 % underwent surgery, and these had a higher cure rate (100 % vs 75.8 %; p = 0.005) and lower mortality (0 vs 13.6 %; p = 0.029). DBV was administered to facilitate discharge in 88.8 %. Total dose was 2500 mg (1500-3000) over 3.5 weeks (2-4). Loss to follow-up was 0 %, relapse rate 8.2 %, 1-year IE-related mortality 3.1 %, and clinical cure rate 81.2 %. Severe adverse events affected 1 % (acute tubular necrosis). Hospital stay was reduced by 21 days (14-28).Conclusions: DBV appears to be highly effective, safe, and cost-effective as consolidation therapy in patients with IE caused by Enterococcus spp., with minimal adverse events
Fièvre Q chronique. Revue de la littérature à propos d’un cas de spondylodicite à hémocultures négatives
No full textInternational audienceFever is a cosmopolit zoonosis due to Coxiella burnetii. The diagnosis of chronic Q fever can be really misleading. The growth of this bacterium is difficult and blood cultures are often negatives
