Ars Laquenexy

Researchers are evaluating a treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have not responded to first-line therapy with pembrolizumab, with or without chemotherapy. This study focuses on patients needing a second-line treatment after failure of pembrolizumab and aims to assess the objective response rate of a combination therapy called PCC (Paclitaxel, Carboplatin, and Cetuximab). The study also monitors disease progression, treatment tolerance, side effects, and quality of life over a 12-month participation period. The treatment involves the PCC protocol, which consists of intravenous injections of paclitaxel, carboplatin, and cetuximab given over 16 weekly cycles. The dosing schedule allows carboplatin and paclitaxel administration three weeks out of four, with weekly cetuximab doses. After completing 16 cycles, patients continue with maintenance cetuximab every 14 days until unacceptable toxicity, disease progression, or death. This approach follows evidence suggesting potential benefits of combining these drugs after anti-PD-1 immunotherapy failure. Participants will undergo regular assessments throughout the study, including evaluations of tumor response every 90 days for up to 12 months. Researchers will collect data on tumor measurements, adverse effects, and quality of life. The study includes laboratory tests and clinical evaluations to monitor patient health, treatment safety, and disease status, ensuring comprehensive follow-up during the entire study period.

Researchers are evaluating the performance of the new 2024 McDonald criteria compared to the 2017 version for diagnosing multiple sclerosis (MS) in patients with initial symptoms or signs suggestive of MS. The 2024 criteria introduce significant changes, including new imaging techniques, the use of ophthalmological data, and a new cerebrospinal fluid test called the kappa index. The study aims to see if these updated criteria can diagnose patients earlier or differently than the 2017 criteria and to determine the best threshold for the kappa index test. Patients consulting or hospitalized in the neurology departments of Nancy University Hospital or Metz-Thionville Regional Hospital between September 1, 2025, and December 31, 2026, will be included and followed for two years. Diagnostic tests used include MRI scans of the brain, optic nerves, and spinal cord with various sequences, cerebrospinal fluid analysis for oligoclonal IgG bands and kappa index, and ophthalmological exams. The study compares diagnoses made using both 2017 and 2024 criteria at initial assessment and during follow-up visits at 6 months, 1 year, and 2 years. Participants undergo routine clinical care and testing without additional procedures beyond standard practice, except for kappa index analysis in some patients. Data collected include MRI reports, ophthalmological findings, and cerebrospinal fluid results. Researchers will measure the percentage of patients diagnosed by each criteria set, evaluate how new tests contribute to diagnosis, and analyze the optimal kappa index threshold. The total study participation includes initial assessment and follow-up over two years with standard care visits and tests.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are studying the long-term outcomes of cardiogenic shock, a serious heart condition, focusing on how early treatment with Empagliflozin might improve survival, reduce rehospitalization, and enhance heart function. This Phase 3 trial explores the use of Empagliflozin, a drug already known to benefit chronic and acute heart failure patients, to see if adding it early after cardiogenic shock can improve outcomes compared to standard care alone. Participants will receive Empagliflozin at a dose of 10 mg daily, either by mouth or through a nasogastric tube if intubated, alongside standard care for 12 weeks. The trial is open-label and multicenter, meaning patients will be treated at various hospitals and both patients and doctors know the treatment being given during the study period. Throughout the 12-week study, researchers will monitor several key outcomes including time to death from any cause, time to heart transplantation, time to use of mechanical heart support, rehospitalization for heart failure, and heart function measured by ultrasound. These measures will help understand the drug's impact on survival, heart recovery, and kidney function after cardiogenic shock.

Cardiogenic shock is a serious condition with a high death rate of about 40%. This trial explores the early use of levosimendan, a drug that may help improve heart function without increasing harmful substances in the body, compared to a placebo. The study aims to see if levosimendan can help patients recover heart function faster and reduce the need for other drugs like dobutamine, which is commonly used but may fail in some cases. This is a Phase 3 study designed to provide clearer evidence on the best inotropic agent for treating cardiogenic shock. Participants will receive either levosimendan or a placebo, both diluted in Glucose G5%, administered as a continuous 24-hour intravenous infusion. The infusion starts at a low dose and may increase after 2 to 4 hours if signs of low blood flow persist and there are no side effects limiting the dose. This approach is added on top of the usual care involving norepinephrine and dobutamine. The study compares these two groups to evaluate the effects of early levosimendan use. During the study, researchers will monitor participants for key outcomes such as death from any cause, the need for extracorporeal life support, and dialysis within 30 days after randomization. Patients will be closely assessed for heart function and signs of low blood flow. Safety and effectiveness will be evaluated throughout the study, with detailed follow-up to collect important information about recovery and treatment impact over the 30-day period.

Type I interferonopathies are rare genetic autoinflammatory disorders that mainly begin in childhood but can also start in adulthood. These diseases cause significant health problems and are resistant to standard immunosuppressive treatments. They primarily affect the central nervous system and often involve joints, with occasional blood-related issues like low blood cell counts or weakened immune function. Researchers aim to understand how these diseases progress over time in both children and adults to help identify markers for diagnosis and prognosis and to better characterize the variety of interferonopathies. This research focuses on tracking the natural history of type I interferonopathies in patients confirmed by genetic testing. The goal is to gather detailed information about disease evolution to uncover underlying mechanisms and find biomarkers related to disease activity. Ultimately, the study seeks to classify patient subgroups and develop personalized treatment options that can improve future clinical trials. Participants will be followed over a long period from 2025 to 2045 to monitor disease progression. The main outcome measure is the characterization of how type I interferonopathies develop in pediatric and adult patients. Throughout the study, data will be collected to better understand the clinical course, helping researchers propose targeted therapies and improve patient care in the future.