Iskender, Turkey

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

The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.

This randomized controlled trial will enroll 154 adults with type 1 diabetes who have suboptimal glycemic control and are treated with multiple daily injections (MDI) of insulin using a pen-based basal-bolus regimen. Subjects must be using a continuous glucose monitor (CGM) as part of their standard care and be telemonitored. The study will be conducted at multiple centres in France, with each subject followed for a total duration of six months. During this period, they will have one in-person visit and two follow-up assessments conducted via phone. Data will be collected through the telemonitoring platform. Subjects will be randomly assigned to either the intervention or control group. The intervention group will use the Hedia Diabetes Assistant in addition to their standard treatment for six months, while the control group will continue with their standard treatment.

Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis

The study will evaluate the quality of life in patients with malignant biliary obstruction after the placement of a lumen-apposing metal stent via endoscopic ultrasound, with an emphasis on the improvement of quality of life measured as a reduction in jaundice. Improvement in jaundice is a direct indicator of effective bile drainage and is expected to correlate with an enhancement in overall quality of life. Quality of life will be measured by means of subject response to the EORTC QLQ-BIL21, a component of the European Organization for Research and Treatment of Cancer (EORTC) designed specifically to assess the quality of life in patients with biliary tract cancer. The QLQ-BIL21 consists of 21 questions which aim to evaluate specific symptoms and issues relevant to patients with biliary tract cancer, such as jaundice, pain, digestive problems and the psychosocial impact of the 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

A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)

This study is a randomized, multicenter, double-blind, placebo-controlled phase 2 study (Part 1) followed by an open-label treatment period (Part 2) designed to evaluate the efficacy and safety of pacritinib for the prevention of VEXAS flares after glucocorticoid (GC) taper. The study will enroll patients ≥18 years with inflammatory VEXAS syndrome receiving ongoing GC therapy for ≥4 consecutive weeks, requiring between 15 and 45 mg daily (of prednisone / prednisolone or equivalent) at the time of enrollment (randomization). Patients will be randomized 1:1:1 to receive pacritinib dose A (n=26), pacritinib dose B plus placebo (n=26), or placebo (n=26) for up to 24 weeks during a double-blind treatment period, followed by treatment with pacritinib during an open-label treatment period for up to 48 weeks, and a 30-day post-End of Treatment (EOT) follow-up period. Randomization will be stratified by prescribed GC dose on the day of randomization. All outcomes will be reported by treatment arm, and pair-wise comparison between each pacritinib arm and placebo will be performed in the double-blind treatment period. Patients who complete the double-blind treatment period at End of Week 24 or meet Early Failure criteria at End of Week 12 will transition to an open-label pacritinib treatment period through End of Week 48. In addition, if a study arm closes due to interim futility or safety, all patients currently randomized to that arm will transition to open-label treatment. Study termination is planned approximately 1 year from the first dose of the last patient.

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

This is a Phase II, platform, open-label, multi-drug, multicenter, global study. This is a modular study, that includes a master protocol and substudies. Partcipants will be randomised to one of the following intervention groups: - Volrustomig + FOLFIRI + bevacizumab group (Arm A) - FOLFIRI + bevacizumab group (Arm B) The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.

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.