Eaubonne

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Small Bowel Obstruction (SBO) often leads to emergency department visits and is usually diagnosed using an abdominal CT scan. Although CT scans help guide treatment decisions such as surgery or medical management, they have drawbacks including radiation exposure, higher costs, and longer emergency department stays. Researchers are evaluating the use of Point of Care Ultrasound (POCUS) combined with a clinical assessment called Gestalt probability to safely rule out SBO in patients with low or moderate risk, potentially reducing the need for CT scans. In this diagnostic multicenter study, trained emergency physicians perform POCUS on patients presenting with suspected SBO who have been assessed as having low or moderate Gestalt clinical probability. The ultrasound looks for signs of SBO in nine abdominal zones using a curvilinear probe. After POCUS, all patients undergo a CT scan, which serves as the gold standard for confirming SBO. The study aims to assess the ability of POCUS to exclude SBO in this patient group, with participation lasting 28 days including follow-up. Participants are involved during their emergency department visit with POCUS and CT imaging, followed by a phone call at 28 days. Researchers collect information on POCUS findings, duration, difficulty, and investigator details, while CT results are interpreted independently. The main outcome measures include the accuracy of POCUS to rule out SBO in patients with low or moderate Gestalt probability, aiming to improve patient care by reducing unnecessary CT scans, radiation exposure, costs, and radiologist workload.

Researchers are evaluating a new ultrasound algorithm called EMERALD-US designed to diagnose acute dyspnea causes in emergency department patients. Acute dyspnea occurs twice as often as chest pain and has a higher mortality rate. The study highlights the importance of quick and accurate diagnosis to improve treatment outcomes for conditions like heart failure, pneumonia, and obstructive pulmonary disease exacerbation. Current ultrasound methods lack formal validation in emergency settings, so this study aims to fill that gap. The study uses the EMERALD-US algorithm, which applies lung, heart, and vascular ultrasound within the first hour after the patient's arrival in the emergency department. The ultrasound exams are performed by a physician not directly caring for the patient, and the results are kept separate from the treating physician. This approach helps assess the algorithm's diagnostic accuracy for the main causes of acute dyspnea, as well as less common causes like pulmonary embolism and pleural effusion. Participants with acute non-traumatic dyspnea will undergo ultrasound scans, with images reviewed blindly by a core lab. The study will compare the ultrasound diagnosis to the final hospital discharge diagnosis made by a team of senior physicians. Researchers will also examine the algorithm's feasibility, its correlation with other tests, and its impact on improving diagnosis and patient survival at 30 days. The main outcome measured is the discharge diagnosis averaged over about two weeks from emergency admission to hospital discharge.

Researchers are evaluating the use of the DBLG1 System, a CE-marked medical device, in people with Type 1 Diabetes (T1D) under real-life conditions. This observational, prospective, and uncontrolled national study involves multiple centers and includes 348 patients to understand how the system affects blood glucose control, quality of life, and safety over one year. The study compares data collected during a 2-week run-in period before activating the system's loop mode with data gathered throughout the year of treatment. Participants use the DBLG1 System as part of their usual care without any changes to their regular treatment or training. They first undergo a 2-week run-in period, followed by one year using the system with activated loop mode for at least 75% of the time. The study spans an inclusion period of 6 months, after which patients continue treatment and follow-up visits at the discretion of their clinicians. The device is provided on medical prescription, and patients may keep it for up to 4 years. During the study, patients complete two questionnaires and share HbA1c results from their routine care. Researchers collect data on glucose levels, adverse events, quality of life, and healthcare professional support. Monitoring includes time spent in the target glucose range (70-180 mg/dL), hypoglycemia and hyperglycemia episodes, continuous glucose monitoring statistics, and device usage. Patients may contact their clinicians anytime for issues or questions, and visits or calls are recorded. An interim analysis will be done after 6 months on the first 100 patients.

Researchers are evaluating an optimized strategy to reduce complications related to emergency tracheal intubation in adults experiencing vital distress. The study focuses on combining three interventions: using rocuronium as a paralytic agent to ease intubation, providing bag face-mask ventilation before intubation, and systematically using a Gum Elastic Bougie (GEB) to assist the first intubation attempt. This approach aims to lower the risks and morbidity associated with emergency intubations, especially in out-of-hospital settings. The study compares two approaches for rapid sequence intubation (RSI). One group receives rocuronium at 1.2 mg/kg with bag-mask ventilation between induction and laryngoscopy, and GEB is used systematically on the first attempt. The other group follows standard recommendations using succinylcholine at 1 mg/kg without systematic bag-mask ventilation, and GEB is only used if intubation fails under direct laryngoscopy. Emergency physicians will record immediate outcomes after out-of-hospital care and hospital data will be collected on day 28 after inclusion. Participants will undergo medical history review and physical examination including measurements of arterial pressure, oxygen saturation, and heart rate. The main outcome measured is the occurrence of severe complications related to intubation during the first hour after the procedure. Data collection includes out-of-hospital and intra-hospital monitoring, with follow-up to 28 days. This trial seeks to assess whether the combined strategy can improve safety and reduce intubation-related complications in emergency situations.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score \<7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms. The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

Researchers are comparing two models of midwifery care for women with low-risk pregnancies in France: Alternative Midwifery Units (AMU) versus Standard Obstetric Units (SOU). The study focuses on how these care approaches affect the psychological health of mothers and their partners, as well as the health of the mother and child two years after birth. AMUs provide a less medicalized, more natural childbirth experience within hospital settings, aiming to support physiological labor and reduce unnecessary interventions. In this observational study, women who gave birth in AMUs and those who received standard care in SOUs are followed up for two years after delivery. Participants complete various standardized questionnaires online measuring post-traumatic stress disorder symptoms, postpartum depression, mother-to-infant bonding, parental competence, social support, child development, and breastfeeding data. Additionally, interviews with some couples and professionals explore perceptions of care. The study uses matched groups and detailed statistical analyses to assess outcomes. Participants who were previously part of the initial PhysioCare study and their partners are invited to continue in this follow-up study. Researchers collect data through questionnaires and interviews to assess long-term mental health and family well-being. The main goal is to determine the impact of AMU care compared to standard care on maternal post-traumatic stress disorder two years after childbirth, alongside other psychological and child health outcomes. The findings aim to inform perinatal care improvements in France over the short, medium, and long term.