Integrated clustering of multiple immune marker trajectories reveals different immunotypes in severely injured patients.

Background: The immune response of critically ill patients, such as those with sepsis, severe trauma, or major surgery, is heterogeneous and dynamic, but its characterization and impact on outcomes are poorly understood. Until now, the primary challenge in advancing our understanding of the disease has been to concurrently address both multiparametric and temporal aspects.

Methods: We used a clustering method to identify distinct groups of patients, based on various immune marker trajectories during the first week after admission to ICU.

Olaparib in recurrent isocitrate dehydrogenase mutant high-grade glioma: A phase 2 multicenter study of the POLA Network.

Background: Based on preclinical studies showing that IDH-mutant (IDHm) gliomas could be vulnerable to PARP inhibition we launched a multicenter phase 2 study to test the efficacy of olaparib monotherapy in this population.

Methods: Adults with recurrent IDHm high-grade gliomas (HGGs) after radiotherapy and at least one line of alkylating chemotherapy were enrolled. The primary endpoint was a 6-month progression-free survival rate (PFS-6) according to response assessment in neuro-oncology criteria.

Correlation between antifungal clinical practices and a new clinical decision support system ANTIFON-CLIC® for the treatment of invasive candidiasis: a retrospective multicentre study.

Background: Invasive candidiasis is still recognized as a major cause of morbidity and mortality. To support clinicians in the optimal use of antifungals for the treatment of invasive candidiasis, a computerized decision support system (CDSS) was developed based on institutional guidelines.

Objectives: To evaluate the correlation of this newly developed CDSS with clinical practices, we set-up a retrospective multicentre cohort study with the aim of providing the concordance rate between the CDSS recommendation and the medical prescription (NCT05656157).

Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass at 5 years (YOMEGA): a prospective, open-label, non-inferiority, randomised extension study.

Background: The multicentre randomised trial YOMEGA (NCT02139813) comparing the one anastomosis gastric bypass (OAGB) with the Roux-en-Y gastric bypass (RYGB) confirmed the non-inferiority of OAGB on weight loss outcomes at 24 months. We aimed to report weight loss, metabolic, and safety outcomes at 5 years.

Methods: YOMEGA is a prospective, open-label, non-inferiority, randomised trial conducted at nine centres in France.

Fusion-negative rhabdomyosarcoma 3D organoids to predict effective drug combinations: A proof-of-concept on cell death inducers.

Rhabdomyosarcoma (RMS) is the main form of pediatric soft-tissue sarcoma. Its cure rate has not notably improved in the last 20 years following relapse, and the lack of reliable preclinical models has hampered the design of new therapies. This is particularly true for highly heterogeneous fusion-negative RMS (FNRMS).

An Overview of Regression Models for Adverse Events Analysis.

Over the last few years, several review articles described the adverse events analysis as sub-optimal in clinical trials. Indeed, the context surrounding adverse events analyses often imply an overwhelming number of events, a lack of power to find associations, but also a lack of specific training regarding those complex data. In randomized controlled trials or in observational studies, comparing the occurrence of adverse events according to a covariable of interest (e.

Improved 30-Day Survival Estimation in ICU Patients: A Comparative Analysis of Different Approaches With Real-World Data.

Objectives: The objective of this study was to compare three different approaches for estimating 30-day survival in ICU studies, considering the issue of informative censoring that occurs when patients are lost to follow-up after discharge.

Design: A comparative analysis was conducted to evaluate the effect of different approaches on the estimation of 30-day survival. Three methods were compared: the classical approach using the Kaplan-Meier (KM) estimator and Cox regression modeling, the competing risk approach using the Fine and gray model, considering censoring as a competing event, and the logistic regression approach.

Neurological outcomes in immune checkpoint inhibitor-related neurotoxicity.

While the spectrum of neurological immune checkpoint inhibitor-related adverse events is expanding, patients' outcomes are not well documented. This study aimed to assess outcomes of neurological immune-related adverse events and to identify prognostic factors. All patients experiencing grade ≥2 neurological immune-related adverse events identified at two clinical networks (French Reference Center for Paraneoplastic Neurological Syndromes, Lyon; and OncoNeuroTox, Paris) over five years were included.

Granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients presenting sepsis-induced immunosuppression: The GRID randomized controlled trial.

Purpose: Septic shock is associated in some patients with a profound immunosuppression. We hypothesized that GM-CSF would reduce the occurrence of ICU-acquired infections in immunosuppressed septic patients.

Methods: Randomized double-blind trial conducted between 2015 and 2018.

A Multimodal Cardioprotection Strategy During Cardiac Surgery: The ProCCard Study.

Objective: The ProCCard study tested whether combining several cardioprotective interventions would reduce the myocardial and other biological and clinical damage in patients undergoing cardiac surgery.

Design: Prospective, randomized, controlled trial.

Setting: Multicenter tertiary care hospitals.

Prognostic Value of Persistent CSF Antibodies at 12 Months in Anti-NMDAR Encephalitis.

Background And Objectives: Anti-NMDA receptor (NMDAR) encephalitis is defined by the presence of antibodies (Abs) targeting the NMDAR in the CSF. This study aimed to determine the prognostic value of persistent CSF NMDAR-Abs during follow-up.

Methods: This retrospective observational study included patients diagnosed with anti-NMDAR encephalitis in the French Reference Center for Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis and for whom CSF samples were obtained at diagnosis and >4 months of follow-up to evaluate CSF NMDAR-Ab persistence.

Occurrence of focal myositis during Behçet's disease: The identification of a specific vasculitis-associated focal myopathy.

Aims: This study aimed to report the association of focal myositis (FM) and Behçet's disease (BD) and to analyse the main characteristics of such an association.

Methods: This is a retrospective multicentre study of patients with BD and FM (BD + FM+ group) and those without FM (BD - FM+ group). Clinical, laboratory, radiological, pathological, treatment and outcome data were analysed.

Long-term outcome of liver transplantation for autoimmune hepatitis: A French nationwide study over 30 years.

Background & Aims: Autoimmune hepatitis (AIH) is a rare indication for liver transplantation (LT). The aims of this study were to evaluate long-term survival after LT for AIH and prognostic factors, especially the impact of recurrent AIH (rAIH).

Methods: A multicentre retrospective nationwide study including all patients aged ≥16 transplanted for AIH in France was conducted.

An in vivo avian model of human melanoma to perform rapid and robust preclinical studies.

Metastatic melanoma patients carrying a BRAF mutation can be treated with a combination of BRAF and MEK inhibitors (BRAFi/MEKi), but innate and acquired resistance invariably occurs. Predicting patient response to targeted therapies is crucial to guide clinical decision. We describe here the development of a highly efficient patient-derived xenograft model adapted to patient melanoma biopsies, using the avian embryo as a host (AVI-PDX ).

Individualized Net Benefit estimation and meta-analysis using generalized pairwise comparisons in N-of-1 trials.

Background: The Net Benefit (Δ) is a measure of the benefit-risk balance in clinical trials, based on generalized pairwise comparisons (GPC) using several prioritized outcomes and thresholds of clinical relevance. We extended Δ to N-of-1 trials, with a focus on patient-level and population-level Δ.

Methods: We developed a Δ estimator at the individual level as an extension of the stratum-specific Δ, and at the population-level as an extension of the stratified Δ.

Impact of procedural success on clinical outcome after MitraClip: Results from the MITRA-FR trial.

Background: Differences in procedural success rates have been proposed to explain the divergent results between the MITRA-FR trial (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation).

Aim: To examine whether MITRA-FR patients who had successful clip implantation achieved a better outcome than the control group.

Methods: Based on the per protocol population of MITRA-FR, we compared the outcome in 71 patients in whom optimal clip implantation was achieved (group 1: mitral regurgitation grade ≤ 1 + at discharge) with that in 23 patients with non-optimal clip implantation (group 2: mitral regurgitation grade ≥ 2 + at discharge) and that in 137 patients in the control group (group 3).

Determining the outcomes of urethral construction in phalloplasty.

Objective: To evaluate the surgical and functional outcomes of urethral reconstruction associated with phalloplasty, depending on the surgical techniques and patient history.

Materials And Methods: We conducted a single-centre retrospective study including 89 patients who underwent phalloplasty with urethral reconstruction between 2007 and 2018. Patients included were trans-male patients undergoing gender-affirming surgery and cis-male patients undergoing penile reconstruction after trauma, congenital malformation, or cancer.