Tarbes

Researchers are studying metastatic renal cell carcinoma (RCC), a type of kidney cancer that spreads to other parts of the body, affecting many patients annually in France. This study focuses on patients with oligoprogressive disease, where only a few metastatic sites (1 to 3) show progression while the rest remain controlled under ongoing systemic treatments like targeted therapies or immunotherapy. The goal is to evaluate stereotactic radiotherapy (SRT) as a focused treatment to control these progressing sites and potentially delay the need for changing systemic therapies. The study involves delivering stereotactic radiotherapy, which uses high doses of radiation in one or a few sessions to target metastatic sites specifically. Patients with up to three progressive metastases eligible for SRT will receive this treatment concurrently or sequentially alongside their current systemic therapy. This approach aims to control tumor growth locally and possibly stimulate a broader immune response. The trial is a Phase II study, assessing this treatment strategy in patients receiving first or second-line systemic therapies. Participants will undergo imaging scans to confirm disease progression and lesion sizes, with follow-up assessments to monitor progression-free survival six months after randomization. Researchers will evaluate how well the targeted radiotherapy controls tumor sites and delays further disease progression. Patients will be closely monitored for treatment effects, ability to continue systemic therapy, and overall safety throughout the study period.

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Researchers are evaluating the effectiveness of the World Health Organization's Integrated Care for Older People (ICOPE) program in preventing age-related functional decline among elderly individuals aged 70 and over living at home. The program focuses on maintaining autonomy by assessing six key functional areas: mobility, cognition, nutrition, vision, hearing, and psychological well-being. The study compares the comprehensive ICOPE strategy to usual care provided by primary care physicians in a randomized controlled trial. Participants are randomly assigned to either receive the full ICOPE program or continue with usual care. The ICOPE intervention includes repeated screenings every six months using the ICOPE tool, a comprehensive assessment of the six functions, a personalized prevention and care plan based on participant preferences, and follow-up support. Telephone follow-ups occur 1.5 months after starting the program and between annual visits to help participants adhere to their intervention plans. The intervention lasts 36 months, followed by a 24-month extension during which all participants receive the ICOPE program. Participants attend follow-up visits at 12, 24, 36, 48, and 60 months where functional data are collected by a research nurse blinded to treatment assignment. Additional phone calls at 6, 18, 30, 42, and 54 months gather information on relevant life events. Researchers monitor functional decline over 36 months as the primary outcome, with the extended follow-up providing further data on the program's lasting effects and cost-effectiveness.

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 evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System called Vivo ISAR in patients with coronary artery stenosis. The study aims to collect clinical outcome data in real-world patients with coronary artery disease, following standard care procedures. The goal is to assess results and safety with a 12-month follow-up after treatment. Participants receive treatment using the Vivo ISAR stent device, which is designed to improve blood flow by widening narrowed coronary arteries in patients with symptomatic ischemic heart disease. The study involves patients undergoing percutaneous coronary intervention, with the Vivo ISAR stent used exclusively when stenting one or more vessels. During the study, participants will be monitored for clinical outcomes including the rate of target lesion failure within 12 months after the procedure. Researchers will collect relevant data on health status and treatment effects as part of routine clinical practice. The study is observational and follows patients over a year to evaluate the device's performance and safety in everyday medical care.

Researchers are investigating the best way to manage fever in patients with septic shock, a severe condition characterized by infection leading to organ failure and requiring mechanical ventilation. The study compares two fever management strategies: allowing fever to run its course versus controlling fever to maintain normal body temperature using external cooling. This trial follows a prior pilot study that suggested fever control might improve shock resolution and organ function, but its effect on mortality is still unclear. Participants will be randomly assigned to either respect fever or receive external cooling to maintain normothermia for 48 hours. The study uses an adaptive randomization method to balance groups and includes a subgroup of patients with acute respiratory distress syndrome (ARDS). Safety will be monitored closely by an independent committee, which may stop the trial if one strategy shows harm. An interim analysis will assess if fever control benefits patients with ARDS and guide continuation of the trial. Patients involved will be adults with septic shock, fever above 38.3°C, requiring invasive mechanical ventilation and sedation. Researchers will monitor mortality up to 60 days after randomization as the primary outcome. The study includes ongoing infection treatment and close safety monitoring. Participation involves observing the effects of fever management on survival and organ function over the study period.

Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.

Researchers are evaluating a new way to give immunotherapy for adults with metastatic non-squamous lung cancer. This phase III randomized study compares a longer interval between pembrolizumab infusions as maintenance treatment against the usual schedule. Both groups may receive pembrolizumab alone or combined with pemetrexed, depending on eligibility and absence of contraindications. In the experimental Pulse arm, patients receive pembrolizumab 200 mg every 6 weeks plus pemetrexed 500 mg/m² every 3 weeks if appropriate. In the Control arm, patients get pembrolizumab either 200 mg every 3 weeks or 400 mg every 6 weeks, also with pemetrexed 500 mg/m² every 3 weeks when suitable. This study tests whether the longer dosing interval is not worse than the standard approach for maintenance therapy. Participants undergo regular evaluations including scans and clinical assessments to measure overall survival over 6 years. Eligibility checks include lung cancer diagnosis, prior induction therapy, and health status. Safety monitoring and follow-up continue throughout the study to track treatment effects and patient well-being.

Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.

Researchers are studying patients with unilateral carpal tunnel syndrome to better understand muscle response changes during the Scratch Collapse Test (SCT). This test involves stimulating the skin over the suspected nerve compression and then testing muscle strength on both sides. The study aims to analyze the transient loss of muscle tone seen on the affected side using myography, a technique measuring muscle electrical activity, to provide detailed insight into this phenomenon. Participants will undergo two main procedures: the Scratch Collapse Test and electromyography. Electromyography involves placing electrodes along the median nerve in both hands to measure nerve impulse transmission, comparing results between the affected and healthy sides. The SCT involves sensory stimulation at the wrist and bilateral muscle strength testing to detect transient muscle weakness on the affected side. During the study, researchers will record myographic tracings to observe muscle tone changes following sensory stimulation. They will measure the evolution of these tracings over one day. Participants will be evaluated through clinical examination, history, and electromyography to confirm diagnosis and monitor muscle response. The study focuses on the immediate muscle response patterns and their changes after stimulation to better characterize carpal tunnel syndrome effects.