St. Martin D'heres, France

Prospective Evaluation of Imaging Response Biomarkers During [177Lu]Lu-PSMA in Metastatic Castration-resistant Prostate Cancer

Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024

HAE Burden and Crisis Management

The study has been designed as a French, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (HAE). The study will also explore the burden related to the administration of intravenous or subcutaneous on-demand treatments. The study was designed to collect data concerning the burden of HAE in patients with HAE (during HAE attacks and between attacks) and in caregivers. The online survey will collect data to describe the characteristics of patients with HAE, the disease characteristics, details concern various aspects of HAE attacks, and the burden of HAE in patients and their caregivers.

Antimicrobial Therapy for Difficult-to-treat Pseudomonas Aeruginosa

Infections due to Pseudomonas aeruginosa isolates with acquired resistances to all first-line antipseudomonal beta-lactams and fluoroquinolones (difficult-to-treat isolates - DTR), pose serious therapeutical challenges, especially in critically ill and/or immunocompromised patients. Certain new beta-lactam/beta-lactamase inhibitor combinations (BL/BLI (beta lactamine/ beta lactamase inhibitor) - i.e., ceftolozane-tazobactam, ceftazidime-avibactam, imipenem-relebactam, others) and cefiderocol have shown promising results for the treatment of infections due to DTR P. aeruginosa. However, multicenter data on their real-life utilization in this indication are still scarce. The ADDICT study is a prospective, multicenter cohort study including unselected patients with DTR P. aeruginosa infection requiring definite intravenous antimicrobial therapy. The primary objective of the study is to investigate the clinical efficacy of available options (new BL/BLI, cefiderocol or older agents such as aminoglycosides and colistin) in this population. Secondary objectives are to compare the clinical and microbiological efficacy of available options in infections due to DTR P. aeruginosa with in vitro susceptibility to more than one last-resort drug, to compare the incidence of non-ecological adverse events observed with these drugs, to assess the incidence of resistance emergence under therapy and to elucidate the molecular mechanisms of resistance emergence, to assess the benefits and risks of combination therapy in this indication, to compare the acquisition rates of multidrug-resistant bacteria other than DTR P. aeruginosa, and Clostridioides difficile infection, to compare Day-28 and in-hospital all-cause mortality rates. Patients will be recruited in 60 hospital centers contributing to four French networks of research in infectious diseases and critical care (CRICS-TRIGGERSEP, ReaRezo, OutcomeRéa, RENARCI - PROMISE metanetwork). Clinical variables will be collected through an electronic case-report form. DTR P. aeruginosa isolates will be sent to the National Reference Center of Antimicrobial Resistance in P. aeruginosa for centralized analyses (extended antimicrobial susceptibility testing, MLST, whole-genome sequencing of successive isolates if resistance emergence under therapy).

Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy

Predictive Diagnosis of Ulcero-Necrotizing EnteroColitis in Premature Babies Using an Artificial Intelligence Approach Based on Early Analysis of the Fecal Microbiota

Systematic collection of stool (excluding meconium) from premature infants up to 21 days of age. Systematic analysis of the first two stools at the MEDiS laboratory: analysis of fecal microbiota by direct metagenomic sequencing (RiboTaxa), coupled with artificial intelligence (deep neural network previously trained on literature data). The test gives us a dichotomous response (yes/no) for each stool. In the event of discordant analysis between the 2 stools (approximately 35% of cases in our preliminary study), a 3ème stool will be analyzed in order to classify the child as being at risk of NEC or not. The person performing these analyses will not be informed of the child's clinical evolution. The diagnosis of NEC will be made by the clinician in charge of the child, according to the Bell classification. Follow-up until return home or transfer to a peripheral center. A telephone call will be made to parents at 3 months of age, to ensure that no NECN has occurred after transfer to a peripheral center.

Validation of KELIM as a Predictive/Prognostic Factor for Maintenance Treatment With iPARP in First-Line Ovarian Cancer

Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room

Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease

During the progression of Parkinson's disease, a large number of patients experience fluctuations in motor status associated with neuropsychiatric fluctuations (NPF) (alternating episodes of depression, anxiety, and apathy with hypomanic states, impulsivity, and attention disorders). NPF may have a significant impact on patients' quality of life as well as on that of their caregivers. Moreover, the presence of these fluctuations is a risk factor for the development of self-medication behaviors, which can lead to addiction to antiparkinsonian treatments. Due to the lack of specific tools for assessing NPF, our team developed a 20-item self-questionnaire specifically evaluating NPF in acute phases: the Neuropsychological Fluctuations Scale (NFS), which was first published in Movement Disorders, Clinical Practice (Schmitt et al., 2018). Recently, we studied the psychometric properties of the NFS in two populations of Parkinson's disease patients and in the general population (EFN Pre-Validation and EFN-Validation studies: ClinicalTrials.gov NCT04455074). The results regarding internal consistency, sensitivity, and specificity of the NFS, as well as its internal structure and external validity, were published in Frontiers in Neurology in 2023 (Schmitt et al., 2023). It has been demonstrated that the NFS is an innovative tool that complements existing motor and non-motor evaluations, and its utility in diagnosing and managing NPF is significant. In order to finalize the validation of the NFS and further understand its psychometric characteristics, assessing the temporal stability of the NFS through test-retest reliability is an essential step.

Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for P53abn Endometrial Cancer