Ars Laquenexy

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

This research aims to evaluate treatment options for adults with recurrent or metastatic head and neck squamous cell carcinoma HNSCC who have experienced disease progression after first-line treatment with pembrolizumab, with or without chemotherapy. The study focuses on patients who need a second line of treatment and investigates the objective response rate to a combination therapy called PCC Paclitaxel, Carboplatin, and Cetuximab. It also monitors disease progression, treatment tolerance, and quality of life over 12 months. Participants receive the PCC protocol, which involves intravenous injections of paclitaxel, carboplatin, and cetuximab administered in cycles lasting one week each for 16 cycles. The carboplatin and paclitaxel are given three weeks out of four, alongside weekly cetuximab. After these cycles, maintenance treatment with cetuximab is given every 14 days until unacceptable side effects, disease progression, or death occurs. During the study, patients will undergo evaluations every 90 days for up to 12 months to measure tumor response and progression. Researchers will assess survival outcomes, treatment safety, and quality of life. Follow-ups may continue according to local practice for up to five years, including monitoring progression-free survival and overall survival. The total participation duration is 12 months, with ongoing safety and quality of life assessments.

Researchers are evaluating the new 2024 McDonald criteria for diagnosing multiple sclerosis MS compared to the previous 2017 version. These updated criteria introduce new diagnostic elements such as additional imaging techniques, ophthalmological data, and the kappa index test in cerebrospinal fluid. The study aims to see if the 2024 criteria improve early diagnosis rates and to determine the best threshold for the kappa index test. The study involves applying both the 2017 and 2024 McDonald diagnostic criteria to patients consulting neurology departments for suspected MS between September 2025 and December 2026. Patients undergo routine diagnostic tests including brain MRIs, optic nerve imaging, ophthalmological exams, and cerebrospinal fluid analysis. The kappa index test is performed for patients seen at Nancy University Hospital, with no additional procedures beyond standard care. Follow-up assessments continue over two years to compare diagnosis rates using both criteria. Participants will be followed through their usual clinical visits and standard care procedures, with data collected from imaging reports, neurological assessments, and laboratory tests. Researchers will measure the percentage of patients diagnosed with MS at initial assessment and at intervals over two years. They will also evaluate the diagnostic value of each test and identify optimal thresholds for the kappa index. The study will help clarify which tests are most useful for timely MS diagnosis and may guide future updates to diagnostic guidelines.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are studying the effects of early treatment with Empagliflozin in patients experiencing cardiogenic shock, a serious heart condition where the heart suddenly cant pump enough blood. This trial aims to see if adding Empagliflozin to standard care can reduce death, the need for heart transplantation or mechanical assistance, and rehospitalization, while improving heart function over 12 weeks. The study is a randomized, open-label Phase 3 trial sponsored by Central Hospital, Nancy, France. Participants are randomly assigned to receive either Empagliflozin 10 mg daily, taken by mouth or through a tube if intubated, alongside standard management, or standard management alone. The treatment lasts for 12 weeks. After hospitalization, patients in the standard group may receive SGLT2 inhibitors according to routine care guidelines. The trial focuses on the early use of Empagliflozin right after cardiogenic shock. During the study, patients will have heart function monitored by ultrasound to measure left ventricular ejection fraction and other heart performance indicators. Researchers will track outcomes including time to death, heart transplantation, mechanical assistance, and rehospitalization for heart failure within 12 weeks. Kidney function and various blood tests will also be assessed. The total study participation lasts at least 12 weeks after randomization, during which safety and effectiveness measures are closely observed.

Researchers are evaluating the early use of levosimendan compared to a placebo added to standard inotropic treatment in adults with cardiogenic shock, a condition with a high mortality rate of about 40%. The study aims to determine whether levosimendan can improve heart function and speed recovery by allowing earlier discontinuation of dobutamine, which is commonly used but lacks strong evidence for its effectiveness in this setting. This is a phase 3 randomized clinical trial with triple masking to ensure unbiased results. Participants are randomly assigned to one of two groups an experimental group receiving levosimendan infusion and a control group receiving a placebo infusion, both alongside conventional inotropic therapy. The infusion is administered continuously over 24 hours, starting at 0.1 mcgkgmin and potentially increased to 0.2 mcgkgmin after 2 to 4 hours if needed. The study evaluates the combination of levosimendan or placebo with current standard care, following strict dosing protocols. During the study, participants will be closely monitored for mortality, use of life support devices, dialysis, and other cardiovascular events at multiple time points up to one year. Researchers will measure outcomes including death rates, need for extracorporeal life support, dialysis, heart transplant, and hospital stay duration. Safety will be assessed alongside heart function indicators and biomarkers. The total follow-up extends to 12 months after randomization to capture both short- and long-term effects.

Type I interferonopathies are rare genetic disorders causing inflammation and affecting mainly the central nervous system, with common joint problems and occasional blood or immune system issues. These diseases often begin in childhood but can also start in adulthood and are resistant to usual immunosuppressive treatments. Researchers aim to better understand how these conditions develop over time in both children and adults to identify diagnostic and monitoring biomarkers and improve future therapies. This observational study includes patients with genetically confirmed type I interferonopathy who are part of a social security system. The study will follow patients from 2025 to 2045, collecting information to characterize disease progression, identify genotype-related immune factors, discover biomarkers for diagnosis and prognosis, and monitor treatment responses based on patient phenotypes and genotypes. Participants will be observed over many years with regular assessments to track how their condition changes and how they respond to treatments. The main focus is on understanding the natural history of the disease by reviewing clinical features, biological markers, and genetic information. This long-term follow-up will help researchers define patient subgroups and guide more personalized treatment approaches in the future.

Researchers are investigating whether using a catheter-based endovascular device called the WATCHMAN to close off the left atrial appendage can help prevent ischemic stroke or systemic embolism in people with atrial fibrillation who remain at high risk of stroke despite ongoing treatment with oral blood thinners. This study is a multicenter, randomized controlled trial with an open-label design but with blinded assessment of results to ensure unbiased evaluation. Participants will be randomly assigned to either receive the left atrial appendage occlusion with the WATCHMAN device or continue their standard medical care without the device. Those in the device group will undergo the procedure to close off the left atrial appendage using the WATCHMAN device. Both groups will continue their oral anticoagulant treatment as prescribed. The study will continue until 265 primary events of ischemic stroke or systemic embolism occur, with an average follow-up estimated at about 4 years. Throughout the study, participants will be monitored for occurrences of ischemic stroke, systemic embolism, transient ischemic attacks, cognitive function using the Montreal Cognitive Assessment, cardiovascular and all-cause mortality, and new disabling ischemic strokes. Safety and effectiveness will be assessed during the event-driven study period. Participants will be followed for approximately 4 years on average to gather the necessary outcome data and ensure ongoing monitoring of their health status.