Le Puy En Velay

Researchers are studying patients with metastatic colorectal cancer (mCRC) who have a specific BRAFV600E mutation. This rare subtype of mCRC has poor prognosis and resistance to current treatments, especially in tumors with microsatellite stability or proficient mismatch repair. The study aims to collect detailed clinical data and biological samples to better understand treatment outcomes, resistance, and survival in real-world settings. Participants will provide blood samples and tumor tissue samples to support various research goals. The study will evaluate circulating tumor DNA during different lines of metastatic treatment to predict treatment response and resistance. It will also analyze the immune environment of BRAFV600E mCRC tumors and study specific subgroups with mismatch repair deficiencies. Clinical management data will be collected to inform future therapeutic approaches. During the study, patients will be monitored regularly with blood sample collections of 30 mL at each time point. Researchers will gather information about treatments, survival, and biological markers over time. The main outcome measured is overall survival from diagnosis up to five years. Patients must be able to comply with study procedures and provide informed consent. The study aims to improve knowledge of this aggressive cancer subtype and support development of new treatments.

This research aims to evaluate the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis. The study is conducted in France and focuses on understanding how this treatment performs outside of controlled clinical trial settings. Participants in this observational study will be newly starting deucravacitinib as prescribed by their treating clinician. There are no additional study treatments or placebo groups, as the study observes the outcomes of the treatment during routine clinical care. During the study, researchers will assess clinical outcomes including the Physician's Global Assessment (PGA) and the Dermatology Life Quality Index (DLQI) at baseline and at months 4, 12, 18 (optional), and 24. They will also monitor how long participants remain on deucravacitinib treatment, up to 24 months. These evaluations help to measure both the effectiveness and impact on quality of life for participants with plaque psoriasis.

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 a new approach to methadone treatment for people with opioid use disorder (OUD) in France. This study focuses on the role of nurses in specialized addiction centers, called CSAPA, where methadone treatment usually starts under hospital doctor supervision. The research aims to see if allowing nurses to manage methadone initiation more independently, following a standardized protocol, can improve patient retention in care during the first three months after treatment begins. The study compares two strategies: the DIADEME strategy, where nurses adjust methadone doses weekly based on clinical assessments and follow a specific protocol including initial medical consultation and testing, versus the control strategy which follows the standard practice with hospital doctors leading care supported by nurses. Methadone syrup is mainly used for initiation, with prescriptions renewed every 14 days. Follow-up visits with nurses occur at least weekly, and doctors are consulted only if serious issues arise or at patient request. Additional interviews with patients and healthcare professionals will explore experiences and impacts of the intervention. Participants will be followed for three months, with regular consultations and clinical monitoring including ECG and tests for infections. Researchers will assess patient retention in care as the primary outcome. Semi-structured interviews will also be conducted one month after follow-up ends to understand patient commitment, satisfaction, and effects on healthcare teams. The study involves adults starting methadone treatment for OUD at CSAPA centers and tracks their progress and adherence to care over time.

Venous thromboembolism (VTE) and atherosclerotic cardiovascular disease often occur together and share similar risk factors. Managing these conditions requires antithrombotic treatments, including anticoagulant therapy (AC) to prevent VTE recurrence and antiplatelet therapy (AP) to prevent major cardiovascular and cerebrovascular events. The combination of AC and AP can increase the risk of side effects, especially bleeding, which is a leading cause of emergency admissions related to adverse drug reactions. This Phase 3 trial compares two treatment strategies in patients with acute VTE who are also taking antiplatelet therapy for atherosclerotic cardiovascular disease. One group receives full-dose anticoagulant therapy alone, while the other group receives combined full-dose anticoagulant therapy plus antiplatelet therapy (aspirin or clopidogrel). The anticoagulant choice is at the investigator's discretion following international guidelines. The study aims to evaluate which strategy better balances the risk of bleeding and cardiovascular events. Participants are monitored for clinically relevant bleeding events during up to 12 months of full-dose treatment. The study also assesses recurrent venous thromboembolism and major adverse ischemic cardiovascular and cerebrovascular events. Throughout the study, researchers collect data on safety and effectiveness to determine the net clinical benefit of each treatment approach. Participation involves regular evaluations and follow-up over the treatment period.

This research aims to create the largest possible real-life group of patients with chronic myeloid leukemia (CML) to study their long-term health outcomes. The study focuses on collecting observational data to understand different patient subgroups based on their treatment responses, the effects of new medications used in everyday practice, treatment discontinuations, and how changes in medical recommendations impact patients. The study involves gathering clinical and biological information from patients with CML both prospectively and retrospectively, starting from diagnosis and continuing during long-term follow-up, even after treatment has stopped. There are no specific treatments or interventions being tested, as the study is observational and collects data from real-life patient experiences. Participants will have their clinical and biological data collected and monitored until death or the last follow-up visit, which may last up to 30 years. This allows researchers to observe how the disease and treatments evolve over time. The study does not involve procedures, but collects information to better understand CML in real-world settings and evaluate various outcomes related to patient care.

Researchers are investigating whether adding dance classes twice a week for four months can reduce behavioral and psychological symptoms of dementia (BPSD) in older adults living in institutions, compared to usual care. Dementia affects a significant portion of people over 65, with behavioral problems being a common and challenging symptom. While no cure exists for dementia, physical activities like dance, which combine movement, cognition, and social interaction, may help improve symptoms and quality of life. Previous studies suggest dance may benefit cognition and behavior, but high-quality evidence is lacking, motivating this study called the APAISE project. Participants will be randomly assigned to one of two groups. The experimental group will attend dance therapy sessions with a professional dancer twice weekly for four months, then return to their usual activities. The control group will continue their usual nursing home activities for the first four months and then receive dance sessions led by a nurse trained by the dancer. This design allows comparison of the effects of early dance intervention versus delayed introduction. Throughout the study, researchers will assess participants' behavioral symptoms using the Neuropsychiatric Inventory (NPI) over the four-month period. They will monitor changes in symptoms to evaluate the impact of dance therapy compared to usual care. The study includes elderly institutionalized patients with measurable behavioral issues who can participate in upper body movement. Consent from patients or legal representatives is required, and the study monitors safety and adherence during the intervention period.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Endometriosis is a chronic condition where tissue similar to the uterine lining grows outside the uterus, affecting 2 to 10% of women of reproductive age and up to 50% of those with chronic pelvic pain. In France alone, it impacts an estimated 1.5 to 2.5 million women, diminishing quality of life by affecting cognitive, behavioral, sexual, and emotional well-being. Current treatments mainly focus on pain relief and fertility preservation but have limited success and often cause side effects leading to discontinuation. Many women use self-management strategies that may not be safe without proper guidance. Therefore, a multidisciplinary and integrative approach, including therapeutic patient education (TPE), is important but not yet widely implemented in endometriosis care. This research evaluates a multidisciplinary educational program combined with regular nurse-led telephone follow-up to improve the quality of life for women with endometriosis. Participants will first have an educational assessment with a coordinating nurse to identify their needs and receive information about the workshops and support options. The program includes at least three workshops over two days covering topics such as endometriosis, diet, sexuality, pain management, fatigue, emotions, Pilates, and hypnoanalgesia. Monthly telephone follow-ups will continue for six months, with additional calls at nine and twelve months to monitor symptoms and provide referrals to supportive care as needed. Participants will be involved in completing study questionnaires and attending workshops while receiving ongoing nurse support through scheduled calls. Researchers will measure outcomes using the Endometriosis Health Profile-30 (EHP-30) at the start, six months, and twelve months to assess quality of life changes. The study also aims to demonstrate the program's potential for broader use across France, aligning with public health goals and improving care for women living with endometriosis.

This research aims to find out if ultraviolet germicidal irradiation (UVGI) devices can reduce serious respiratory infections in elderly people living in nursing homes. The study is conducted in 12 nursing homes in central France, starting in October 2024, with results expected by mid-2026. It focuses on whether active UVGI devices lower the number of severe respiratory infections that require oxygen therapy, hospitalization, or cause death. The nursing homes will have UVGI devices installed in common areas like dining rooms and lounges. These devices can be turned off by installing an invisible filter, and the process will be done by a technical team without the knowledge of care staff or researchers. Nursing homes will be randomly assigned to one of two groups: one group will have the devices active for the first 7-month period and deactivated for the second 7-month period, while the other group will have the opposite schedule. These two 7-month periods will occur over two consecutive years from October 1 to April 30, separated each year by a 5-month wash-out period when all devices are off. Participants include all residents in the nursing homes at the start or who move in during the study periods. Researchers will track the incidence of severe upper and lower respiratory infections from enrollment through 19 months later. The study monitors infections leading to serious outcomes and compares the effects of active versus inactive UVGI devices during the study periods. Privacy preferences of residents who do not want their data used will be respected.