Tarbes

Researchers are evaluating the use of stereotactic radiotherapy SRT as a treatment strategy for patients with oligoprogressive metastatic renal cell carcinoma RCC who are already undergoing systemic therapies. This phase II study focuses on patients whose cancer has progressed in a limited number of sites despite ongoing treatment, aiming to control local tumors and delay the need for additional systemic therapies. The study builds on evidence that SRT can effectively target RCC metastases and may also stimulate the immune system when combined with immunotherapy. The study involves delivering high-dose stereotactic radiotherapy to metastatic sites showing progression in patients receiving systemic therapies such as targeted drugs or immunotherapy. Eligible patients have 1 to 3 progressing metastases in up to 2 organs, with lesions measuring 4 cm or less, and will continue their current systemic treatment while receiving SRT either concurrently or sequentially. This approach aims to locally control progressing tumors and potentially extend the effectiveness of ongoing therapy. Participants will undergo imaging assessments to confirm disease progression and measure tumor response, with follow-up visits to monitor tumor control and treatment side effects. Researchers will evaluate progression-free survival six months after randomization as the primary outcome, along with local and overall control rates and treatment-related adverse events. The study includes monitoring for safety and effectiveness up to 12 months post-treatment, with participants involvement lasting until at least one month after treatment completion.

Non-muscle-invasive bladder cancer NMIBC is a type of bladder tumor that affects the inner lining of the bladder without invading the muscle layer. This research aims to collect and analyze real-world data on how NMIBC is managed and followed up in clinical practice across France. The study seeks to assess the performance of urine tests used to detect tumor recurrence and to understand variations in treatment and patient outcomes. The study is observational and involves collecting medical data from patients being monitored for NMIBC, including results from urine biomarker tests done before biopsies or resections. Urologists participating in the French Urology Association will record findings from regular bladder endoscopic exams and urine test results during routine care visits. Data analysis will focus on the accuracy of urine tests in predicting tumor recurrence and how this varies by tumor characteristics and prior treatments. Participants will have their medical history, treatments, and urine test results entered into a registry at enrollment. During follow-up visits scheduled as part of their personalized care, data on bladder exams and urine tests will be collected. Researchers will evaluate outcomes such as recurrence-free survival and the diagnostic value of urine biomarkers over a five-year period. The study plans to include around 8,000 patients over six years to improve understanding of NMIBC management and follow-up.

Researchers are studying the World Health Organizations Integrated Care for Older People ICOPE program to see if it helps prevent age-related decline in older adults. This study compares the comprehensive ICOPE program with usual care from primary doctors. The goal is to determine if regular screening, personalized care plans, and follow-up can better maintain functions like mobility, cognition, and nutrition in people aged 65 and older living at home. The trial randomly assigns participants to either receive the full ICOPE program or usual care. The ICOPE program includes screening every six months using a digital tool, a thorough assessment of six key functions, a personalized intervention plan, and ongoing follow-up, including phone calls and annual visits over 60 months. After an initial 36-month intervention, all participants receive the ICOPE program during a 24-month extension phase. Participants have annual visits at 12, 24, 36, 48, and 60 months, during which a research nurse collects data while unaware of which group they are in. Phone calls occur between visits to support the care plan and gather information about life events. The primary outcome measured is functional decline at 36 months. The study runs until 2031, with continuous monitoring of participants health and program adherence.

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

This observational study evaluates the Polymer Free Sirolimus Eluting Coronary Stent System, known as the Vivo ISAR, in everyday clinical practice for patients with coronary artery stenosis. The purpose is to collect real-world data on clinical outcomes over a 12-month follow-up period, focusing on patients who receive this stent system as part of their routine care. The study is sponsored by Translumina GmbH and involves standard procedures and medications with known safety profiles. Participants will be treated with the Vivo ISAR stent during percutaneous coronary intervention to improve coronary artery diameter in those experiencing symptoms of ischemic heart disease. The study monitors patients who receive the stent in one or multiple vessels, observing their progress without altering standard care practices. The follow-up extends to 12 months after the procedure to assess various success rates and treatment effects. During the study, participants undergo routine clinical evaluations including assessments of device and procedural success shortly after treatment, and measures of target lesion failure and reperfusion at 12 months. Researchers also evaluate antiplatelet therapy adherence and effectiveness. The total participation involves regular check-ups and data collection to understand long-term outcomes and safety of the Vivo ISAR stent system in typical healthcare settings.

Researchers are investigating the best way to manage fever in patients with septic shock, a severe condition caused by infection leading to organ failure and requiring mechanical ventilation. This study compares two fever management strategies allowing fever to run its course or controlling fever to maintain normal body temperature using external cooling. The trial aims to determine which approach better improves survival by looking at death rates 60 days after treatment starts. Participants will be randomly assigned to one of two groups one group will receive external cooling to keep their body temperature normal for 48 hours, while the other group will have their fever left untreated without antipyretic therapy. The study uses a special randomization method to ensure groups are comparable and includes a subgroup of patients with lung injury. Safety is closely monitored by an independent committee that can stop the study if needed. During the trial, patients will be monitored for various health outcomes including organ function, need for ventilator support, kidney therapy, and blood pressure support over specific time points. Researchers will also track side effects such as shivering, seizures, low body temperature, heart rhythm problems, infections, and development of lung or kidney complications. The total study duration includes follow-up to assess these outcomes and safety events up to 60 days after randomization.

Bronchiectasis is a chronic lung disease involving permanent widening of parts of the airways, leading to mucus buildup, infections, and ongoing inflammation. Researchers are evaluating whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups compared to enhanced standard care in patients with non-cystic fibrosis bronchiectasis. This study focuses on long-term effects over about two years. Participants will be randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device daily at home along with remote physiotherapy and standard care. The SIMEOX device delivers short pulses of negative air pressure through a mouthpiece to help loosen and move mucus from the lungs. Remote physiotherapy sessions occur once a month for the first three months and then every three months thereafter. During the study, participants will be monitored for changes in quality of life using questionnaires at 6, 12, and 24 months, and the number of lung exacerbations over about 24 months will be recorded. Lung function tests spirometry will also be conducted periodically. Researchers will track treatment adherence, hospitalizations, and any adverse events. The total study duration per participant is around two years, with regular assessments to evaluate the impact of the SIMEOX device combined with physiotherapy.

Researchers are studying a new way to give immunotherapy as maintenance treatment for patients with metastatic non-squamous lung cancer. This phase III clinical trial compares a pulse dosing schedule with a conventional dosing schedule to see if the less frequent pulse dosing is not worse than the standard treatment. The study focuses on pembrolizumab alone or combined with pemetrexed as the maintenance therapy after initial chemotherapy and immunotherapy induction. Participants are randomly assigned to one of two groups. In the Pulse arm, pembrolizumab 200 mg is given every 6 weeks, and pemetrexed 500 mgm is given every 3 weeks if there is no contraindication. In the Control arm, pembrolizumab is given either 200 mg every 3 weeks or 400 mg every 6 weeks, plus pemetrexed 500 mgm every 3 weeks when appropriate. This treatment is given after patients have completed 3 or 4 cycles of induction therapy with pembrolizumab plus platinum and pemetrexed. During the study, participants will be monitored for overall survival over 6 years, along with progression-free survival, response duration, quality of life using several questionnaires, treatment tolerance, and economic factors. Researchers will also perform population pharmacokinetic analyses and study the drugs effect on immune cells. Patients will undergo regular assessments including clinical evaluations and laboratory tests to track treatment effects and safety throughout the study period.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

Researchers are studying the Scratch Collapse Test SCT, a reflex used to detect nerve compression in conditions like carpal tunnel syndrome. This study focuses on patients with one-sided carpal tunnel syndrome and aims to analyze muscle response loss using myography after sensory stimulation. Though the SCT is known for showing transient muscle weakness on the affected side, this study will specifically measure this loss of muscle tone and its temporary and one-sided nature. Participants will undergo electromyography, which uses electrodes to measure nerve impulse transmission along the median nerve in both hands for comparison. The SCT involves applying sensory stimulation to the wrist and then testing muscle strength on both sides. The test is expected to show transient muscle tone loss on the affected side only. This is an interventional study focused on diagnostic testing procedures. During the study, patients diagnosed with unilateral carpal tunnel syndrome will have myographic tracings recorded and analyzed to observe changes after sensory stimulation. The main outcome measured is the evolution of these myographic tracings on the day of testing. Participants will be closely monitored for the muscle response changes related to nerve compression. The study will last for a short period focused on these diagnostic evaluations.