Chalon Sur Saone

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This observational study aims to collect medical data on the devices effectiveness and safety over 12 and 36 months after implantation. The study is conducted in multiple centers across Europe and focuses on real-world use by experienced urologists. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and help manage urinary incontinence caused by intrinsic sphincter deficiency. This study involves men who have already received the sling during routine clinical care. Follow-up includes visits at baseline before implantation, between 1 and 3 months post-operation, and at 12 months, with additional annual questionnaires sent out at 24 and 36 months. Participants will undergo routine clinical assessments, including questionnaires about their urinary symptoms and quality of life, pad weight testing, uroflowmetry, and measurement of urine remaining after voiding at several points during the study. Researchers will monitor patient-reported improvement and any adverse events at 12 months. The study extends to 36 months with ongoing questionnaires to track long-term outcomes and satisfaction. Participation involves regular clinical visits and mailed surveys over three years.

Malignant hypertension is a very serious form of high blood pressure that can be fatal if untreated. This research aims to create the first large, multicenter database to better understand this disease, including its modern epidemiology, how patients are currently managed, and the diseases diagnostic criteria. The study will help improve knowledge and may lead to new treatment trials and evidence-based recommendations. The study is an observational registry enrolling patients diagnosed with malignant hypertension based on classic definitions, including severe blood pressure elevation and organ damage. It plans to recruit 500 patients and follow them for five years to study their prognosis and the impact of different patient characteristics and organ involvement. By collecting detailed data on disease features and care pathways, the study hopes to update definitions and management approaches. Participants will be observed over five years, with researchers collecting information on their health status, organ damage, and treatment. The main outcome measured is the five-year prognosis of patients. This long-term follow-up will provide detailed knowledge about the disease course and help identify factors influencing outcomes, without any study treatments or interventions being assigned.

Researchers are evaluating the real-world effectiveness of deucravacitinib in adults diagnosed with moderate-to-severe plaque psoriasis. This observational study aims to understand how this treatment works outside of controlled clinical trials, focusing on health outcomes important to patients and doctors. It is sponsored by Bristol-Myers Squibb and conducted in France. Participants in this study have started treatment with deucravacitinib as prescribed by their doctors. The study observes these patients over time without altering their treatment plans. There are no placebo or comparison groups since this is an observational study that follows patients initiating deucravacitinib treatment. During the study, doctors will assess skin condition using the Physicians Global Assessment and measure quality of life with the Dermatology Life Quality Index at baseline and several points up to 24 months. Patients will also report symptoms like itch, skin pain, and fatigue using visual scales. Researchers will track how long patients remain on treatment and reasons for stopping. The study involves regular follow-ups at months 1, 4, 12, 18 optional, and 24 to gather this information.

Researchers are evaluating the safety and effects of Abrocitinib in adults with moderate to severe atopic dermatitis, a long-lasting skin condition that causes inflammation, redness, and irritation. This observational study aims to understand how Abrocitinib works in real-life clinical settings for patients aged 18 and older who do not have other medical conditions that would prevent them from taking the medication. All participants will take Abrocitinib as a daily tablet and may also use medicated topical treatments for their condition. The study lasts 24 months, during which participants will be monitored regularly. They will visit the study clinic approximately five times, about once every 4 to 6 months, to report their experiences and health status while using the medication. Throughout the study, researchers will assess participants using various measures such as skin condition scores, itching severity scales, and sleep quality assessments. They will also track treatment adherence, any changes in medication dosage, and any side effects. The main outcome focuses on the proportion of patients achieving clear or almost clear skin after 16 weeks, with ongoing evaluations through 24 months to monitor safety and effectiveness.

Researchers are investigating treatments for metastatic clear cell renal cell carcinoma RCC, a type of kidney cancer. The study compares two combination therapies one using two immune checkpoint inhibitors ICI-ICI and the other combining an immune checkpoint inhibitor with a vascular endothelial growth factor receptor tyrosine kinase inhibitor ICI-VEGFR TKI. The goal is to determine which approach better improves overall survival and progression-free survival based on PD-L1 biomarker status, addressing the current lack of direct comparison between these treatments. Participants will receive one of two treatment plans. One group will get nivolumab and ipilimumab infusions every three weeks, followed by maintenance nivolumab for up to two years. The other group receives an investigators choice among three combinations axitinib plus pembrolizumab, cabozantinib plus nivolumab, or lenvatinib plus pembrolizumab. Oral and intravenous medications are administered at specified doses and schedules, with treatment continued until progression, unacceptable side effects, or two years of therapy. During the study, participants will undergo evaluations including survival tracking, tumor response assessments, and quality of life questionnaires at regular intervals. Researchers will also monitor treatment duration, adverse events, health economics, and collect biological samples for future research. The study plans to enroll 1,250 patients over four years across multiple European countries, with a total follow-up period extending up to 97 months to assess long-term outcomes.

Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

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 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.

Researchers are evaluating the combination of a CD4 helper T-inducer cancer vaccine called UCPVax with anti-PD-L1 therapy atezolizumab and bevacizumab in patients with unresectable hepatocellular carcinoma HCC. This randomized Phase II trial aims to determine the clinical interest and immune response effectiveness by measuring the objective response rate at 6 months. The study involves 105 patients across 10 centers and is sponsored by the Centre Hospitalier Universitaire de Besancon. Participants are assigned to one of two groups one receiving atezolizumab plus bevacizumab combined with the UCPVax vaccine, and the other receiving only atezolizumab plus bevacizumab. Atezolizumab is given intravenously at 1200 mg every 3 weeks, bevacizumab at 15 mgkg every 3 weeks, and UCPVax vaccine is administered subcutaneously at 0.5 mg with an adjuvant. Treatment continues until disease progression or unacceptable side effects occur. During the study, patients will undergo regular assessments to evaluate tumor response using mRECIST guidelines at 6 months. Researchers will also monitor overall survival, progression-free survival, and disease control rate over approximately 2 years. Safety is closely followed through monitoring for adverse events and treatment tolerance. Participants overall health, performance status, and liver function will be evaluated throughout the study period.