Sainte Colombe Les Vienne, France

Descriptive Study of the Initial Management of Young Children With Moderate Acute BRONCHiotitis With Home Hospitalisation

Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Response in Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour

Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared with the Standard Approach to Peripheral Venous Line Placement in People with Difficult Venous Access

Peripheral venous catheterization (PVC) is the most common invasive medical procedure performed worldwide. Improving the success rate of PVC on the first attempt is crucial for patients in terms of pain, anxiety, risk of extravasation, rapid access to care, maintenance of the patient-caregiver relationship, and for caregivers in terms of self-confidence and autonomy, and for institutions in terms of image and societal cost. One in ten catheters used in the Territorial Hospital Group of Vienne is used in imaging services, according to the 2021-2022 estimate. Particularly, the scanner services account for 66.3% of catheters ordered in imaging, in relation to the injection of iodinated contrast agent. The literature presents two techniques that can improve the success rate of PVC, namely ultrasound-guided and infrared illumination methods. Their use appears to be effective only in patients with difficult venous access. Furthermore, the prediction of the success rate on the first attempt has been made possible thanks to the A-DIVA clinical score. No study has compared the effectiveness of these two techniques in Europe, in imaging, or based on this clinical score. The objective of the study is to determine the most effective technique for successful PVC in patients with difficult venous access. Compare the proportion of successful peripheral venous catheterizations on the first attempt between the classical method (Gold Standard), ultrasound-guided technique, and infrared illumination technique in adult patients with difficult venous access. Catheterization is defined as the successful administration of 5 ml of NaCl without pain expressed by the patient or visible edema (absence of diffusion or hematoma) immediately after the first skin puncture by the catheter. The primary outcome measure is binary and evaluated on the first attempt. Compare the proportion of successful peripheral venous catheterizations on the second attempt (if the first attempt fails) between the classical method (Gold Standard), ultrasound-guided technique, and infrared illumination technique in adult patients with difficult venous access. Compare the total number of attempts Evaluate the maximum pain experienced by the patient when PVC is successful Evaluate the patient's overall satisfaction when PVC is successful Evaluate the operator's overall satisfaction Time required for catheterization from the end of material preparation to successful catheterization. Analyze the recourse system chosen by the caregiver after a first failure (calling a colleague, continuing with the classical method, ultrasound-guided technique, infrared illumination technique, or abandoning PVC). Describe the catheter calibers chosen by caregivers based on the A-DIVA score and the number of failed attempts. The success of catheterization is defined as the absence of pain expressed by the patient, or visible edema downstream of the perfusion site (absence of diffusion or hematoma) after the administration of 5 ml of NaCl, during the second skin puncture by the catheter (1 puncture = 1 attempt). Total number of skin punctures by a catheter. The maximum pain will be evaluated using a numerical scale from 0 to 10. This scale is sensitive, reproducible, reliable, and widely used in scientific literature. The evaluation will follow the question "On a scale of 0 to 10, with 0 being no pain and 10 being the maximum imaginable pain, how would you rate the maximum pain you experienced during your perfusion?" The patient's satisfaction will be measured using a numerical scale by answering the question "On a scale of 0 to 10, with 0 being very dissatisfied and 10 being completely satisfied, how would you rate your overall satisfaction with your perfusion?" The operator's satisfaction will be evaluated using a numerical scale from 0 (very dissatisfied) to 10 (completely satisfied) by answering the question "Are you satisfied with the placement of this catheter?" The time will be recorded in minutes, starting after the preparation of the PVC tray by the operator. This includes vein location, skin disinfection, tourniquet placement, catheterization, connection to the perfusion line, securing with bandages, and occlusive dressing. If a failure is observed, the timer will not be stopped, and the time will be recorded until vascular access is obtained, including the time required for alternative procedures. In case of failure, indicate the success or need for recourse for the caregiver. The type of recourse chosen will be recorded: calling a colleague, continuing with the classical method, ultrasound-guided technique, infrared illumination technique, or abandoning PVC. For each attempt, describe the catheter caliber chosen: 14 Ga (Orange) / 16 Ga (Gray) / 18 Ga (Green) / 20 Ga (Pink) / 22 Ga (Blue) / 24 Ga (Yellow) / 26 Ga (Purple) This is a comparative, prospective, controlled, randomized trial.

Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease

Contribution of Point of Care Ultrasound by the Emergency Physician to Rule Out the Small Bowel Obstruction: a Diagnostic, Multicenter Study

Small Bowel Obstruction (SBO) is a frequent pathology, leading to admissions to emergency departments (ED). Diagnosis is currently based on an abdominal CT scan (CT). However, CT is associated with drawbacks such as radiation exposure, increased cost and ED length-of-stay. A recent meta-analysis including 1178 patients showed that Point of care ultrasound (POCUS) had a good diagnostic accuracy (sensitivity 83% [95%CI 71.7%-90.4%]), specificity 93% [95%CI 55.3% -99.3%]). Another meta-analysis with 433 patients, found rather similar results: sensitivity 83% [95% CI 89.0% to 94.7%], specificity 96,6% [95% CI 88.4% to 99.1%]). Since CT is almost warranted to guide the treatment strategy, which could include surgery, medical treatment or both, CHU of Nantes emergency unit explored a different approach focusing on POCUS rule-out ability. This study also introduced the notion of SBO Gestalt probability which is a global clinical evaluation by the physician. Gestalt probability has mainly been explored in patients with suspected pulmonary embolism and was found as effective as clinical prediction rules. It is used in the routine clinical evaluation of patient with suspicion of pulmonary embolism. When applied to patients with SBO suspicion, the physician chooses between low, moderate or high risk of SBO. Based on CT results, prevalence of SBO based on Gestalt probability were 21%, 45% and 87% in the low, moderate and high risks, respectively. Our team studied POCUS with the following items that were searched in the whole abdomen divided into nine zones: dilated incompressible fluid-filled intestinal loop (>25 mm) with back-and-forth fluid movement. When at least one of these signs was present in one zone, the SBO was highly suspected. As it was an observational study, a CT was performed in all patients and was the gold standard. This approach was associated with a POCUS sensitivity in the whole population of 99% [95% CI: 93-99.8] [2]. POCUS would thus have a role in patients with low and moderate SBO risks because the prevalence of SBO was major in the high risk Gestalt probability category of patients, and thus CT is the only imaging needed in these latter. Furthermore, in patients with low or moderate probability, the sensitivity was 100% [95% CI: 88-100] In previous studies, the sensitivity was not able to exclude SBO with sufficient security since the lower 95% confidence interval margin was near 90%. By (i) focusing on patients with a low or moderate clinical Gestalt probability and (ii) increasing the number of patients, CHU of Nantes emergency unit intends to demonstrate that POCUS should be able to safely exclude SBO in this population. In case of positive results, the diagnostic strategy in case of SBO suspicion could be modified in: firstly, assess the clinical Gestalt probability; secondly perform a POCUS in patients with low or moderate Gestalt probability and thirdly, prescribe a CT only for patients with high clinical probability or presence of POCUS signs of SBO. This would avoid unnecessary CT and thus lower patient's. exposure, costs, ED length-of-stay and radiologist workload. A study performed in the USA simulated a POCUS first approach in patients with suspected SBO and found that it could save ED length of stay, radiation and money. In France in 2017, about ¾ of ED were equipped with ultrasound machines and half of the emergency physicians were trained in POCUS. Furthermore, SBO detection is easily performed: in our study, the operator self-assessed ultrasound experience was beginner or intermediate for 59% of patients. In case of positive results, this technique would be largely deployed. Inclusion criteria will be patients with low or moderate Gestalt clinical probability of SBO. A POCUS will be performed followed by a CT (gold standard). This CT will be realized and interpreted blindly from the POCUS results. The main objective will be the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability

Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development (PERMICA)

Methodology: Pilot, single-center regional study, with a descriptive and comparative design (patients with colorectal cancer / patients without suspected colorectal cancer = controls). In each group, a stool, hair and urine sample will be collected and an endocrine disruptor exposure questionnaire completed. Sample Size and Duration: A total of 200 patients will be included, divided into two groups of 100 patients (100 patients with colorectal cancer and 100 patients without suspected colorectal cancer). The inclusion period will last 48 months, with each participant enrolled for a maximum of one month. Routine care data will be collected over 5 years. The total duration of the clinical investigation will be approximately 9 years. Expected Outcomes: The investigators aim at determining whether the most common endocrine disruptors in the French population are involved in colorectal carcinogenesis and if these substances are correlated with dysbiotic colorectal microbiota. The findings from this study should help identify the endocrine disruptors most frequently associated with colorectal cancer and thereby enhance vigilance regarding these substances. Benefits for Patients: There are no individual but collective benefits, as the results will colorectal cancer related knowledge and its relationship with lifestyle.

Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir

Title Etude multicentrique prospective de la relation entre efficacité virologique et observance chez des patients infectés par le VIH-1 traités par BICTEGRAVIR Type or research Non interventional research (NIR) Target population People living with HIV (PLWH) Objectives Primary objective: - To explore the effectiveness of antiretroviral treatment with B/F/TAF by virological suppression rate (plasma HIV-RNA) at 6 months in real life according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay. Secondary objective(s): - To explore the effectiveness of antiretroviral treatment with B/F/TAF by the rate of virological suppression (plasma HIV-RNA) at 12 months in real life, according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps). - Evaluate the risk of emergence of resistance mutations in cases of HIV RNA replication with B/F/TAF. - Evaluate the safety profile of B/F/TAF in real-life practice. - Evaluate the quality of life of participants treated with B/F/TAF in real-life practice. Inclusion Criteria - - Person living with HIV-1 - 18 years of age or older - Having been informed about the study (non-opposition) - Accepts the use of electronic antiretroviral monitoring caps (MEMS caps) - Person treated or starting treatment with bictegravir/emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure) Exclusion criteria - - Pregnant women - People living with HIV (PLHIV) unable to assume responsibility for treatment compliance (impaired judgment, guardianship, institutionalization) - PLWH receiving assistance incompatible with the use of the electronic pillbox Endpoints Primary : - Virological failure at 6 months defined as a confirmed plasma viral load >50 copies/mL or a single plasma viral load >200 copies/mL (HIV RNA). Secondary : - Virological failure at 12 months as defined above - Rate of side effects measured by CTCAE V.5 - Emergence of drug resistance mutations according to ANRS AC11 V35 in case of virological replication - Quality of life measured by questionnaires Procedure(s) or visit(s) added by research none Nomber of patients 120 patients : Accuracy of at least +/-7% on virological failure rate Number of centers 8 centers : - CHU CAEN NORMANDIE - CHU d'Orléans - APHP Pitié-Salpêtrière - CHU Poitiers - CHU Nantes - CHD La Roche sur Yon - CH de Niort - HCL Lyon Project Milestone - Expected start date of inclusions: 01/09/2024 - Inclusion duration: 2 years - Duration of follow-up period: 12 months - Planned end of study (issue of final report summary 1 year after last visit to last included subject): 01/09/2027

Examining the Medium-term Effect on Non Inferiority of the Previous Training With the DMD Poppins Clinical for Cognitive, Musical Training in Addition to Reduced Conventional Care on the Reading and Writing Abilities of Pediatric Patients With SLD Reading VS Control Group Receiving Conventional SOC

The POPPINS-02-b follow-up study consists in following up patients who took part in the POPPINS-02 clinical trial: a randomized non-inferiority trial with a control group designed to assess the effect of adding the Poppins Clinical digital medical device to reduced conventional care (one speech therapy session every two weeks) on the skills of patients with reading disorders. Patients included in the original POPPINS-02 study were randomized into one of two groups: 1. Experimental group (EXPE group): will receive the Poppins Clinical digital medical device in addition to reduced conventional treatment (one speech therapy session every two weeks). 2. Control group (CONT group): will receive conventional treatment only (one speech therapy session per week). In the original POPPINS-02 study, the experimental phase lasts 12 weeks in total, with a preliminary evaluation (T1) and a final evaluation (T2) after this period. All patients enrolled in the POPPINS-02 study will be included, if they so wish, in the POPPINS-02-b follow-up study. This study consists of a 12-week follow-up phase after the final POPPINS-02 protocol visit (T2). During this follow-up phase, all patients will return to their usual speech therapy management with the frequency planned before their participation in POPPINS-02. During this follow-up phase, patients in both groups will not have access to the Poppins Clinical application. At the end of the 12-week follow-up period, an evaluation (T3) is scheduled. Assessments will cover primary, secondary and exploratory endpoints. A questionnaire will also be submitted to parents and speech therapists caring for the children during T3 in order to collect information on the dates of speech therapy sessions during this follow-up period, and to benefit from their perspective on the medium-term effect of the study protocol on speech therapy follow-up. Access to the Poppins Clinical digital medical device will be offered to children in the two POPPINS-02 study groups who decide to participate in the POPPINS-02-b follow-up study at the end of the experiment. The investigator and his team will remain blind as to which groups will be assigned to the POPPINS-02 study.

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

An Ophthalmic Safety Study in Patients With Breast Cancer

This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each. To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.