BACKGROUND:Idiopathic intracranial hypertension (IIH) predominantly affects individuals with obesity, and weight loss represents the only disease-modifying therapy. While bariatric surgery (BS) effectively treats established IIH, its preventive effect on IIH development in the general population with obesity remains unexplored. This study assessed whether BS is associated with a lower risk of developing IIH in individuals with obesity. METHODS:This nationwide retrospective cohort study utilized data from the French national healthcare database (Système National des Données de Santé [SNDS]) covering 99% of the population. We included adults aged ≥18 years with obesity (body mass index [BMI] ≥30 kg/m2) diagnosed between January 2016 and December 2021, with follow-up through December 2024. The metabolic and bariatric surgery group included patients who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). The primary outcome was incident IIH. Propensity score matching (1:1) was performed using age, sex, obesity degree, and socioeconomic status. Fine and Gray subdistribution hazard models accounting for competing risk of death were used to assess the association between metabolic and bariatric surgery and IIH risk. RESULTS:After propensity score matching, 187,791 individuals in each group were analyzed. During a median follow-up of 5.2 years, the incidence of IIH was significantly lower in the BS group (126 cases, .13 per 1000 person-years) compared to controls (375 cases, .38 per 1000 person-years). BS was associated with a 66% reduction in IIH risk (subdistribution hazard ratio .339, 95% CI .280-.411, P < .0001). The protective effect was consistent across subgroups: age ≤50 years (SHR .305, P < .0001), age >50 years (SHR .550, P = .0077), females (SHR .309, P < .0001), males (SHR .579, P = .0246), BMI 30-40 (SHR .423, P < .0001), and BMI >40 (SHR .316, P < .0001). Both RYGB and SG demonstrated comparable protective effects (SHR .306, P < .0001 and SHR .346, P < .0001, respectively). CONCLUSIONS:BS was associated with a significantly lower the risk of developing IIH in individuals with obesity, with a consistent protective effect across age, sex, and obesity severity subgroups. Both RYGB and SG provided substantial risk reduction with no significant difference between procedures. These findings expand the recognized benefits of BS to include important neurological protection and should inform clinical counseling for patients with severe obesity.
INTRODUCTION:The transition from child and adolescent mental health services (CAMHS) to adult mental health services (AMHS) represents a critical period of vulnerability, often marked by care discontinuities and adverse clinical outcomes. International studies have highlighted the risks associated with this transition, but local epidemiological data remain scarce in France. The Odyssée study aims to provide local data to inform the development of structured transition pathways. METHODS AND ANALYSIS:This prospective monocentric cohort study will be conducted at Lenval University Children's Hospital in Nice, the only paediatric hospital providing dedicated child psychiatry emergency services in the Alpes-Maritimes department. Recruitment started in April 2026 and is ongoing at the time of manuscript submission. Study completion is anticipated in September 2028. The primary objective is to determine the annual prevalence of 17-year-olds living in Nice who attend child and adolescent psychiatry services using administrative data combining census counts from the French National Institute of Statistics and Economy Studies and hospital discharge records (Programme de médicalisation des systèmes d'information (PMSI)).In parallel, a prospective cohort of 100 adolescents aged 17 years will be followed for 12 months to address secondary objectives, including clinical profiles, care trajectories, transition readiness, clinical outcomes and determinants of care continuity. Assessments will be conducted at baseline, 6 months and 12 months using validated instruments (Mini International Neuropsychiatric Interview-simplified (MINI-S), WHO Quality of Life-brief (WHOQOL-BREF), Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA), Transition Readiness and Appropriateness Measure (TRAM), Transition Related Outcome Measure (TROM)). Descriptive and multivariable analyses will be performed to identify factors associated with continuity of care. This study is expected to provide one of the first city-level estimates of psychiatric transition needs in France and contribute to the international literature on continuity of care, youth mental health trajectories and transitional service organisation. ETHICS AND DISSEMINATION:The study has been approved by the Comité de Protection des Personnes Sud-Ouest et Outre-Mer IV (approval number 2025-A01581-48). Written informed consent will be obtained from participants and one parent or legal guardian. Findings will be disseminated through peer-reviewed publications, scientific conferences and reports to regional health authorities. TRIAL REGISTRATION NUMBER:NCT07068945.
Despite recent advances in treating vitiligo, disappointing results are still observed on difficult-to-treat areas, such as the knees, elbows, wrists, hands and feet. A prospective, monocentric, double-blinded randomized placebo-controlled study was performed to assess the efficacy and safety of autologous epidermal-cell suspension followed by ruxolitinib cream for repigmenting resistant areas. Three of the 19 patients achieved at least 50% repigmentation with the combination approach after 24 weeks, when none was observed with the epidermal grafting alone, but most of the lesions failed to respond. These results suggest that not only the differentiation of melanocytes, but most probably also their proliferation and survival are altered in the difficult-to-treat areas.
To investigate the prevalence of the gingival phenotype in the mandibular incisor area and the associated risk indicators. This cross-sectional study involved clinical examination to record main periodontal characteristics (gingival phenotypes) at the tooth level. Then, a phenotype at the subject level was defined as fragile (at least one thin phenotype on one of the four incisors) versus resistant (no thin phenotype on the four incisors). Furthermore, orthodontic parameters were assessed based on photographic examination. Two blinded periodontists and two blinded orthodontists were involved in the data collection. Univariate and multivariate logistic regression models were implemented. A total of 119 students were included, encompassing 476 incisors. The prevalence of gingival phenotypes at the tooth level was as follows: thin/high (63.9
BACKGROUND: Patients with atopic dermatitis (AD) maydiscontinue dupilumab owing to dupilumab-induced ocularadverse events (DOAEs) or dupilumab-induced facial redness(DFR). OBJECTIVE: To evaluate DOAE and DFR outcomes afterswitching to tralokinumab or Janus kinase inhibitor (JAKi). METHODS: This retrospective study included 106 patientsdiscontinuing dupilumab because of DOAEs and/or DFR. Theprimary outcome was the proportion of patients with resolutionof adverse events or improvement between dupilumabdiscontinuation (M0) and 3 to 6 months of tralokinumab orJAKi (M3-M6) treatment; the secondary outcome was thepercentage of patients with controlled AD defined byInvestigator's Global Assessment scores of 0/1 at M3 to M6. RESULTS: Proportions of patients with DOAE (92% vs 72%;P[.0244) and DFR (85% vs 33%;P[.0006) resolution orimprovement were higher with JAKi than with tralokinumab.Proportions of patients reaching an Investigator's GlobalAssessment score of 0/1 increased from M0-M3 through M6(22% vs 42%;P[.0067) in the JAKi group and remainedsimilar (32% vs 35%) in the tralokinumab group. However, 57%discontinued the new treatment after 8 months on average,mainly owing to lack of efficacy. CONCLUSIONS: Janus kinase inhibitor appears to be moreefficient than tralokinumab in managing dupilumab-inducedAE; however, both strategies may fail to control AD.& Oacute;2024American Academy of Allergy, Asthma & Immunology (J AllergyClin Immunol Pract 2025;13:353-60)
Background: Radiotherapy is thought to enhance anti-tumor immunity, particularly when delivered in a hypofractionated and multisite manner. Therefore, we investigated the effects of combining radiotherapy with nivolumab in patients with advanced melanoma. Methods: This was a multicenter, non-randomized, phase 2 trial that enrolled patients with treatment-na & iuml;ve metastatic melanoma. They received nivolumab (240 mg / 2 weeks) plus radiotherapy (day 15, 6 Gy x 3). When feasible, one target from each organ was irradiated (no irradiation of all targets). The primary endpoint was 1year overall survival (OS). Results: This trial included 64 patients between March 2017 and July 2019. The median follow-up was 23.5 (2.3-43.8) months. The median age was 68 (35-95) years, patients were mostly male (67 %) with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 (72 %), stage IV-M1c disease (47 %), and were BRAF-wild-type (67 %). The 2-year OS and 1-year PFS rates were 65.2 % and 56 %, respectively (P = 0.22 and P = 0.03, vs. 58 % and 43 %, respectively, in the Checkmate 066 study). Thirty-seven (58 %) and twentyseven (42 %) patients were irradiated at one and multiple targets, respectively. The ECOG-PS (1 vs. 0; HR = 3.5; P = 0.005) was an independent prognostic factor for OS. Irradiating more than one site and irradiating a smaller cumulative tumor volume tended to correlate with better outcome. Grade 3-4 treatment-related adverse events occurred in 21.9 % of the patients (no grade 5). Conclusions: Combined immunotherapy and hypofractionated radiotherapy did not improve survival compared to historical cohorts. The radiotherapy schedule needs to be optimized in order to improve these results.
Background: Adjuvant immunotherapy (AIO) improved recurrence-free survival (RFS) in patients with resected stages III-IV melanoma. Real-world data, especially in elderly patients, as well as optimal management of patients who relpases, are still limited. ObjectivesTo evaluate real-world outcomes of AIO in a cohort of stages III-IV melanoma patients. Methods: We conducted a monocentric, retrospective, observational study that included patients treated with AIO (nivolumab or pembrolizumab) for stages III/IV melanoma. The primary endpoint was RFS. Subgroup analyses were performed. Results: A total of 76 patients were included, with a mean age of 64.6 years (51.3% and 31.6 age >= 65 and >= 75 years, respectively). Majority received nivolumab (67.1%). Median follow-up period was 26.4 months (interquartile range, 17.9-35.1 months). The RFS rates for the whole cohort were 75.8%, 66.0%, 52.9% and 52.9% for 1, 2, 3 and 4 years, respectively. Patients aged <75 years had a better RFS rate compare to those older >= 75 years (60.4% vs. 38.3% respectively, p = 0.02). A total of 41 patients (53.9%) experienced immune-related adverse events (irAEs) of any grade, and 22.3% of grade 3-5. irAEs >= 3 concerned 17.3% of patients aged <75 years and 33.3% for those aged >= 75 years. Thirteen patients (17.1%) had discontinued IO early due to severe irAEs after a median of 2 months (range 1-7). Median time to first recurrence from starting adjuvant programmed cell death 1 was 6.5 months (range, 1-35). Most patients recurred ON adjuvant IO (15/28 patients, 19.7%). Most of the time, first-line therapy after melanoma recurrence was ipilimumab plus nivolumab. Objective response rate was higher for patients with recurrence within 6 months of stopping adjuvant IO (33.3%). Conclusions Real-world outcomes of AIO for stages III/IV melanoma appeared comparable to clinical trial data. Immunotherapy appears less effective and less well tolerated in elderly patients.
Introduction Epidermolysis bullosa (EB) is a group of rare genetic skin disorders characterised by skin and mucosal fragility, leading to painful blisters and erosions. Among its subtypes, the severe form of EB simplex (EBS-sev, OMIM 131760) is associated with widespread blistering from birth, mucosal involvement and increased neonatal mortality due to infections. EBS is primarily caused by dominant mutations in the KRT5 or KRT14 genes.There is currently no curative treatment for EBS; management is symptomatic and multidisciplinary. Our recent data indicate that EBS-sev is associated with an inflammatory profile involving elevated levels of Th17-polarising cytokines (TGF-β, IL-6, IL-21), suggesting a role for the Th17 immune response in disease pathogenesis.Methods and analysis EBULO is an open-label, multicentre phase 2 study, over a 20-week period, to evaluate the oral daily intake of apremilast (dosage depending on the age and the weight of patients) based on a challenge/dechallenge/rechallenge design. Patients are evaluated during five on-site visits, and apremilast is administered for 16 weeks during two treatment periods, with a 4-week treatment interruption in between. The primary outcome will be to assess the efficacy of apremilast in the treatment of patients with EBS-sev evaluated by counting the number of new blisters, a method specifically developed for this protocol to overcome the lack of reliable assessment tools in EBS-sev. The secondary outcome will include assessing the safety and tolerability of apremilast treatment through the description of the specific events occurring during the treatment periods of the study.Ethics and dissemination The French Ethical Review Authority has approved the EBULO trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.Trial registration number NCT06509984.
ObjectivesTherapeutic response in depression is a major challenge since more than one third of patients are not in remission after two attempts of antidepressant treatment and will present a treatment-resistant depression. In order to better adapt therapeutic strategies for treatment-resistant patients, predictive indicators and markers of therapeutic response still need to be identified. In parallel, patients with depression exhibit disturbances in cognitive functioning. This study aims to describe and compare cognitive performances collected at inclusion of patients presenting treatment-resistant depression who will be responders at 6 months to those of non-responders, and to evaluate the predictive value of cognitive indicators on clinical therapeutic response at 6 months after a therapeutic modification.MethodsObservational study. Patients were evaluated at the clinical (HDRS and BDI-II) and cognitive levels using standardized tools assessing memory, executive functions, attention, and social cognition, prior to a change in antidepressant treatment. Six months after inclusion, they were reassessed and classified into two groups based on the presence or absence of therapeutic response, defined by a 50% improvement on HDRS and BDI-II. The cognitive scores collected at inclusion were then compared. Additionally, univariate logistic regression models were used.ResultsThirty patients were included in this study. Only 13 could be evaluated at 6 months. Among these patients, four had responded to the new treatment while nine were non-responders. Both groups of patients presented deviant cognitive performances compared to norms on tests evaluating executive functions and attention. Statistical analyses did not reveal any difference between the cognitive performances of responders and non-responders at 6 months. Regression analyses showed no association between cognitive scores and therapeutic response at 6 months.ConclusionExecutive functioning plays a significant role in treatment-resistant depression. In order to improve the understanding and identification of subtypes of depression, cognitive indicators should be systematically integrated into future research.
Backgroundhidradenitis suppurativa is a systemic inflammatory condition associated to obesity, metabolic syndrome, and other environmental factors. Bariatric surgery is effective in determining weight loss and obesity-related medical problems resolution.Objectivesthe aim of this case-control study is to evaluate the effects of bariatric surgery on the occurrence and recurrence of hidradenitis suppurative in obese individuals.Settingnationwide administrative data study using the French national discharge database.Methodswe compared 297,776 obese individuals without a history of hidradenitis suppurativa who underwent bariatric surgery (BS group) with 2,735,930 obese individuals who did not receive bariatric surgery (control group) to assess the incidence of de novo hidradenitis suppurativa. From the same database, we compared hospitalization rates for hidradenitis suppurativa recurrence between 310 obese individuals with hidradenitis suppurativa who had bariatric surgery (HS_BS group) and 3,875 obese individuals who did not have bariatric surgery (HS_control group). Propensity score matching using the nearest-neighbor method was implemented to create comparable patient groups.ResultsObese individuals without a history of hidradenitis suppurativa who received bariatric surgery exhibited a significantly reduced risk of developing de novo hidradenitis (RR=0.736 [0.639; 0.847]). Among patients with a history of hidradenitis suppurativa, those who underwent bariatric surgery had a non-significantly reduced risk of hidradenitis recurrence (RR=0.676 [0.369; 1.238]) compared to those who did not.Conclusionbariatric surgery reduces the risk of developing de novo hidradenitis suppurativa and seems to have a protective effect on its recurrence in obese individuals, although the latter effect was not statistically significant.
Background: Urinary tract infections (UTIs) are very common bacterial infections in children. Early detection of renal parenchymal involvement in this setting can help clinicians make more effective treatment choices. The aim of this pilot study was to assess the ability of plasma and urinary neutrophil gelatinase-associated lipocalin (pNGAL and uNGAL) levels, measured using an automated system, to accurately predict renal parenchymal involvement in children with febrile UTIs. Methods: This prospective single-center study included 28 children aged ≥ 4 years with a first episode of febrile UTIs. All patients underwent magnetic resonance imaging. pNGAL, uNGAL, procalcitonin, C-reactive protein (CRP), and white blood cells were measured before antibiotic therapy. Results: The receiver operating characteristic (ROC) area under the curve for predicting acute pyelonephritis was 0.6 for pNGAL, 0.8 for CRP, 0.4 for PCT, and 0.4 for uNGAL. The ROC analyses showed an optimal cutoff of 141.0 ng/mL for pNGAL (sensitivity, 54.2%; specificity, 75.0%; positive predictive value, 92.9%; and negative predictive value, 21.4%). Conclusion: pNGAL and uNGAL did not effectively aid the early prediction of renal parenchymal involvement in children ≥ 4 years with febrile UTIs. The novelties of this study were the use of MRI as the gold standard and an automated biochemical method to measure NGAL.
INTRODUCTION:Wire syndrome (WS) refers to dental displacements that can be described as aberrant, inaccurate, unexplained, or excessive, on teeth still contained by an intact bonded retainer, without detachment or fracture, leading to evolving dental and periodontal, aesthetic and/or functional consequences. The objective of this study was to define the prevalence rate of mandibular WS and the associated risk factors. METHODS:Participants were dental students who had undergone orthodontic treatment and were wearing an intact fixed mandibular retainer. They completed a 20-item questionnaire, after which an extraoral and intraoral clinical examination was conducted. Participants were assigned to either the non-wire syndrome group or the wire syndrome group by two independent practitioners. Univariate and multivariate logistic regression models were used to investigate potential risk factors. RESULTS:A total of 59 students (23.4years±1.7years) were included. Among these, 9 students presented with mandibular WS, resulting in a prevalence rate of 15.25% (95% CI: 6.08%-24.43%). Univariate analysis revealed a significant association between a deep labio-mental fold, a concave profile, and a multi-strand round wire, and an excess risk of WS. The odds ratios were 16.5 (95% CI: 1.9-146.8, P=0.01), 6.4 (95% CI: 1.0-41.0, P=0.05), and 9.0 (95% CI: 1.7-48.7, P=0.01), respectively. Multivariate analysis confirmed these significant associations, except for the concave profile. CONCLUSIONS:The prevalence rate of wire syndrome was 15.25%. Two risk factors associated with WS were identified: a deep labio-mental fold and a multi-strand round wire retainer.
Background. With integrase strand transfer inhibitor (INSTI) use associated with increased body mass index (BMI) and BMI increases associated with higher diabetes mellitus (DM) risk, we explored the relationships between INSTI/non-INSTI regimens, BMI changes, and DM risk. Methods. RESPOND participants were included if they had CD4, human immunodeficiency virus (HIV) RNA, and >= 2 BMI measurements during follow-up. Those with prior DM were excluded. DM was defined as a random blood glucose >= 11.1 mmol/L, hemoglobin A1c >= 6.5%/48 mmol/mol, use of antidiabetic medication, or site-reported clinical diagnosis. Poisson regression was used to assess the association between natural log (ln) of time-updated BMI and current INSTI/non-INSTI and their interactions on DM risk. Results. Among 20 865 people with HIV included, most were male (74%) and White (73%). Baseline median age was 45 years (interquartile range [IQR], 37-52), with a median BMI of 24 kg/m(2) (IQR, 22-26). There were 785 DM diagnoses with a crude rate of 0.73 (95% confidence interval [CI], .68-.78)/100 person-years of follow-up. ln(BMI) was strongly associated with DM (adjusted incidence rate ratio [aIRR], 16.54 per log increase; 95% CI, 11.33-24.13; P < .001). Current INSTI use was associated with increased DM risk (IRR, 1.58; 95% CI, 1.37-1.82; P < .001) in univariate analyses and only partially attenuated when adjusted for variables including ln(BMI) (aIRR, 1.48; 95% CI, 1.29-1.71; P < .001). There were no interactions between ln(BMI), INSTI, and non-INSTI use and DM (P = .130). Conclusions. In RESPOND, compared with non-INSTIs, current use of INSTIs was associated with an increased DM risk, which partially attenuated when adjusted for BMI changes and other variables.
Introduction Lung cancer (LC) is the most common cause of cancer-related deaths worldwide. Its early detection can be achieved with a CT scan. Two large randomised trials proved the efficacy of low-dose CT (LDCT)-based lung cancer screening (LCS) in high-risk populations. The decrease in specific mortality is 20%–25%.Nonetheless, implementing LCS on a large scale faces obstacles due to the low number of thoracic radiologists and CT scans available for the eligible population and the high frequency of false-positive screening results and the long period of indeterminacy of nodules that can reach up to 24 months, which is a source of prolonged anxiety and multiple costly examinations with possible side effects.Deep learning, an artificial intelligence solution has shown promising results in retrospective trials detecting lung nodules and characterising them. However, until now no prospective studies have demonstrated their importance in a real-life setting.Methods and analysis This open-label randomised controlled study focuses on LCS for patients aged 50–80 years, who smoked more than 20 pack-years, whether active or quit smoking less than 15 years ago. Its objective is to determine whether assisting a multidisciplinary team (MDT) with a 3D convolutional network-based analysis of screening chest CT scans accelerates the definitive classification of nodules into malignant or benign. 2722 patients will be included with the aim to demonstrate a 3-month reduction in the delay between lung nodule detection and its definitive classification into benign or malignant.Ethics and dissemination The sponsor of this study is the University Hospital of Nice. The study was approved for France by the ethical committee CPP (Comités de Protection des Personnes) Sud-Ouest et outre-mer III (No. 2022-A01543-40) and the Agence Nationale du Medicament et des produits de Santé (Ministry of Health) in December 2023. The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations.Trial registration number NCT05704920.
A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30). SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires. The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy. ClinicalTrials.gov NCT05691348. Registered on 20 January 2023.
The use of metabolic and bariatric surgery (MBS) is not uniformly distributed within the population, even if it is governed by established guidelines. This disparity seems to be associated, among other factors, with the economic profile of people receiving this surgery. We investigated the disparities in the use of MBS with respect to the socio-economic level in France based on socio-economic status (SES). A descriptive observational study was conducted to compare the population of individuals with obesity who underwent MBS (MBS group) with individuals with obesity with no history of MBS (obese group). Data were extracted from the French National Hospital discharge database (“Programme De Médicalisation des Systèmes d’Information,” PMSI). Socio-economic status (SES) was assessed through the French Deprivation Index (FDep). The use of MBS was significantly lower in patients having a higher SES compared to those having a lower one. There was no statistically significant difference in the use of MBS between individuals within the 4th and 5th SES quintiles compared to those in the 2nd and 3rd quintiles. No difference was found in the specific MBS procedures used depending on the SES. The obesity level was significantly lower in patients from the 1st and 3rd SES quintiles compared to the patients having a lower SES. Our study provides valuable insights into the complex interrelationships between the use of MBS, patients’ SES, and obesity levels according to the FDep. These findings underscore the importance of developing targeted interventions to address disparities in the use of bariatric care.