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The Abbott Vascular Medical Device Registry (AV-MDR) is a prospective, non-randomized, open-label, multi-center registry designed to collect and evaluate clinical data on various Abbott vascular devices. The study focuses on confirming the safety and performance of these devices throughout their expected lifetime, monitoring risks, detecting new issues based on actual evidence, and ensuring that the benefit-risk balance remains favorable. It also aims to identify any possible misuse or off-label use to verify appropriate device use in patients with conditions such as acute myocardial infarction, coronary artery lesions, restenoses, and embolisms. Participants receive one or more Abbott vascular devices including coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging devices such as fractional flow reserve (FFR) and optical coherence tomography (OCT), peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closure and compression devices, or vascular access introducers. The devices are used during planned or completed vascular procedures, with treatment and device types depending on the participant's medical needs and the study scope. Throughout the study, participants are monitored during the vascular procedure and followed up at multiple time points including during the procedure, at 30 days, and at 12 months. Researchers assess outcomes such as death, myocardial infarction, target lesion revascularization, amputations, device success, complications, and imaging quality. The study involves collecting data on device performance and safety events, ensuring adherence to follow-up schedules, and aims to provide comprehensive information on the long-term use and risks associated with Abbott vascular devices.

Researchers are evaluating the effectiveness of different antimicrobial treatments for infections caused by difficult-to-treat Pseudomonas aeruginosa bacteria. This infection is especially challenging for patients who are critically ill or have weakened immune systems. The study focuses on comparing new beta-lactam/beta-lactamase inhibitor combinations, cefiderocol, and older drugs like aminoglycosides and colistin in real-life clinical settings across multiple hospital centers in France. Participants will receive intravenous antimicrobial therapy tailored to treat their difficult-to-treat P. aeruginosa infection. The study observes the use of new and older antimicrobial drugs to assess their clinical efficacy. Patient data and bacterial samples will be collected and analyzed centrally to better understand drug resistance mechanisms and treatment outcomes. Participants will be monitored for clinical cure shortly after completing therapy and on Day 7 ± 2 days. Researchers will collect clinical information through electronic case-report forms and send bacterial isolates to a national center for detailed testing. Outcomes include cure rates, resistance development, adverse events, and mortality rates, with follow-up during hospitalization and up to 28 days after treatment. The study aims to provide valuable real-world data on treating these challenging infections.

This research focuses on patients without a functioning spleen, known as asplenic patients, which can result from surgical removal due to trauma, cancer, auto-immune diseases, or diagnostic purposes, as well as from treatments like radiotherapy or splenic artery embolization. These patients face increased risks of infections caused by encapsulated bacteria, cancer, and thromboembolic diseases. The study aims to assess the complications that occur in French asplenic patients and to introduce new diagnostic tools for better follow-up and management. The study observes different groups of asplenic patients including those who underwent splenectomy, splenic artery embolization, or radiotherapy. It seeks to understand how splenic function and immunity change over time in these patients, recognizing that infectious risks may vary among these groups. The research emphasizes the limitations of current tools that assess splenic function and aims to implement new methods to accurately evaluate residual splenic function. Participants will be followed over time to monitor infectious and non-infectious complications. The study includes assessments of complication risk factors over a period of three years. Researchers will collect data on patient health outcomes to better estimate the incidence of complications and improve understanding of these risks. This longitudinal follow-up helps in advancing care for asplenic patients through improved diagnostic and management strategies.

Researchers are evaluating the best hypnotic drug to balance good intubation conditions and stable blood pressure during rapid sequence induction (RSI) in the operating room. This Phase 3 trial, called the HyPnotiKs study, compares the effects of propofol, ketamine, and their combination in patients undergoing RSI. The main goal is to see which drug helps achieve successful tracheal intubation on the first try without causing major drops in blood pressure. Participants receive one of three treatments: a direct IV injection of propofol at 2 mg/kg (adjusted for body weight if BMI is over 30), a direct IV injection of ketamine at 1 mg/kg plus propofol at 1 mg/kg given consecutively, or propofol alone as described. These drugs are given after pre-oxygenation and do not require dilution in the combination treatment. The study focuses on comparing these methods during the induction phase for anesthesia. During the study, patients are monitored for the success of the first intubation attempt and the stability of their blood pressure within 10 minutes after starting the hypnotic injection. Researchers collect data on intubation conditions and any episodes of low blood pressure. The study includes adults aged 18 to 80 years who need orotracheal intubation during general anesthesia in the operating room. Participation involves informed consent and close monitoring during the procedure to assess safety and treatment effects.

Researchers are evaluating the EkiYou V2 Digital Therapy in adults with type 1, type 2, or pancreatic diabetes who use multiple daily insulin injections. This multicenter randomized controlled trial involves 154 adults treated with basal-bolus insulin regimens and continuous glucose monitors (CGM). The study aims to compare EkiYou V2 with standard care for insulin dose management and to assess participant satisfaction, user experience, and quality of life. Participants will be randomly assigned to two groups. One group will use the EkiYou V2 mobile application from the start for six months. The other group will continue standard care for the first three months and then receive EkiYou V2 for the last three months. The device helps estimate daily bolus and basal insulin doses and adjusts insulin parameters weekly, including basal insulin dose, insulin-to-carb ratios, and correction factors. It also provides carbohydrate counting with a large food database, bolus calculation based on meals, physical activity, and blood glucose, bolus correction advice, insulin reminders, and automatic titration. Participants will attend three visits over six months, including at study start. Researchers will monitor glucose data via CGM devices and collect quality of life and satisfaction data through electronic questionnaires. The main outcome measured is the change in the percentage of time blood glucose levels are in the target range (70-180 mg/dL) after three months compared to baseline. Safety and adherence will be tracked throughout the study period.

Researchers are conducting a phase 3, multicenter, open-label, randomized study to evaluate new treatments for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation (ASCT). The study aims to compare the effectiveness and safety of a combination of elranatamab and lenalidomide as a replacement for standard chemotherapy during the consolidation phase, and to assess elranatamab alone versus standard care during maintenance therapy. Participants will first receive standard induction therapy with four cycles of a drug combination called D-VRd. After this, they will be randomly assigned to either receive standard consolidation therapy involving high-dose chemotherapy and ASCT followed by D-VRd consolidation (Arm A), or elranatamab combined with lenalidomide for consolidation (Arm B). Upon completing consolidation, patients will be re-randomized to receive maintenance treatment with either lenalidomide alone (Arm C) or elranatamab alone (Arm D). During the study, participants will be monitored for treatment effects including minimal residual disease negativity at the end of consolidation, progression-free survival, and overall survival. The study involves various assessments including clinical evaluations, laboratory tests, and monitoring for disease progression or side effects. The entire treatment and follow-up period may last up to several years, allowing researchers to evaluate long-term outcomes and safety.

Researchers are investigating the best length of prednisone treatment to prevent relapses in patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). These conditions can be controlled with immunosuppressive therapy, particularly with rituximab, but many patients experience recurring relapses that cause damage and require repeated treatments. While rituximab is used to maintain remission, the ideal duration of prednisone use remains unclear, with US studies favoring early withdrawal (6-12 months) and European studies supporting longer use (>18 months) due to lower relapse rates. Participants will be randomly assigned to receive either prednisone 5 mg/day orally for an additional 12 months with weekly tapering or a placebo after an initial tapering period. Both groups receive maintenance rituximab treatment. The study compares the effects of extended prednisone use versus early withdrawal on relapse rates to determine the best approach to maintenance therapy for these patients. During the study, participants will be monitored for relapse-free survival over 30 months, with relapse defined by a Birmingham Vasculitis Activity Score (BVAS) greater than zero. Researchers will track disease activity, medication adherence, and safety throughout the trial. The study includes assessments at screening and regular follow-up visits to evaluate the benefits and risks of prolonged prednisone treatment in combination with rituximab.

Patients in intensive care units often require a central venous catheter to deliver medications safely. These catheters, however, can sometimes cause infections, especially the longer they remain in place. Most prevention efforts focus on how the catheter is inserted and handled, but less attention is given to how long the catheter and its connected infusion sets stay in place, which is a key factor in infection risk. This research compares two schedules for changing the infusion sets connected to central venous catheters. One group will have their infusion sets replaced every 7 days, while the other group will follow the usual practice of replacing them every 4 days. During each replacement, all tubing and connectors will be disconnected and swapped with new sterile equipment to reduce contamination risk. Participants will be monitored from catheter insertion until 48 hours after removal, or up to 90 days in the ICU, to track infection rates related to the catheters. Researchers will collect data on infection complications and assess whether the less frequent 7-day replacement increases infection risk compared to the standard 4-day schedule. This study also considers the impacts on nursing workload and medical resource use.

Chronic kidney disease (CKD) is a widespread health concern linked to high risks of mortality, cardiovascular disease, and progression to end-stage kidney disease, especially when paired with hypertension. Lowering blood pressure (BP) is known to reduce these risks, but optimal drug treatment strategies for patients with moderate to severe CKD and uncontrolled hypertension remain unclear. This trial evaluates whether a diuretic-based blood pressure lowering approach is more effective than usual care in reducing cardiovascular events, death, and kidney failure in this population. Participants will be assigned to either an antihypertensive treatment plan using a specific diuretic-based algorithm or to standard care for intensifying blood pressure control. All participants have moderate to severe CKD and uncontrolled hypertension despite treatment with at least one renin-angiotensin system blocker at the highest tolerated dose. The study compares these two approaches to blood pressure management over time, focusing on their impact on health outcomes. Throughout the study, participants will be monitored for up to 36 months to track the occurrence of end-stage kidney disease, significant declines in kidney function, cardiovascular events, and overall survival. Blood pressure control will be assessed by office, home, or ambulatory monitoring. Safety and treatment effects will be evaluated regularly to understand how these blood pressure strategies affect patients with CKD and uncontrolled hypertension.

Head injuries are common reasons for emergency room visits, with most being minor traumas. This research evaluates whether patients treated with antiplatelet inhibitors who have a head injury but no other risk factors listed in the NICE criteria truly require a CT scan to check for cerebral hemorrhage. The study addresses the uncertainty in medical literature about whether antiplatelet treatment alone indicates the need for a CT scan after head trauma. Participants who take antiplatelet inhibitors and have experienced a head injury will first undergo a clinical examination. Following this exam, they will receive a CT scan to detect any cerebral hemorrhage. This is a diagnostic, prospective, multicenter study where the primary outcome—the presence of cerebral hemorrhage—is assessed blindly. After one month, participants will be contacted to report any related health issues or mortality. During the study, researchers will collect clinical exam data, CT scan results, and follow-up information on participant health status. The main outcome measured is the detection of cerebral hemorrhage via CT scan one day after injury. Safety and health status will be monitored for a month post-injury to observe any delayed complications. Total participation involves initial clinical and imaging assessments plus a one-month follow-up call.