Le Puy En Velay

Researchers are investigating metastatic colorectal cancer mCRC patients who have a specific genetic change called the BRAFV600E mutation. This rare subtype of mCRC often shows poor response to current treatments and has a generally poor outlook. The study aims to collect detailed clinical data and biological samples to better understand this condition, including how patients respond to treatments and what factors predict their survival. It focuses on real-world treatment outcomes and biological markers that might influence therapy choices and resistance. Participants will provide blood samples at multiple times during their treatment, including before and during the first three treatment cycles, at 3 and 6 months after starting each treatment line, and when disease progression occurs following certain therapies. The study gathers up to 390 mL of blood per participant over time to analyze circulating tumor DNA and immune environment factors. This observational approach will help researchers identify biomarkers related to treatment response and disease progression. During the study, participants clinical progress and survival will be tracked for up to five years. Researchers will review overall survival from diagnosis to death and assess how prognostic markers relate to progression-free survival and response to treatments. The study involves collecting tumor tissue samples and blood tests, along with routine follow-up visits. All data collected will contribute to understanding BRAFV600E mCRC and improving future treatment strategies.

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.

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.

This research focuses on patients with opioid use disorder OUD who are starting methadone treatment. It evaluates whether allowing nurses in specialized addiction centers CSAPA to manage methadone initiation semi-autonomously helps improve patients adherence to care and retention in treatment over the first three months. The study compares this nursing-led approach to the standard care pathway where hospital doctors manage methadone prescriptions with nursing support. Participants are assigned to one of two groups the DIADEME group, where nurses adjust methadone doses based on a standardized clinical protocol including assessment of withdrawal and overdose symptoms, or the control group following usual practice with hospital doctors prescribing methadone. The DIADEME strategy includes an initial medical consultation, ECG and infection testing, provision of an emergency naloxone kit, and weekly or more frequent nurse follow-ups. Medical consultations occur only if serious issues arise or at the patients request. During the study, participants will be followed for three months with regular assessments of retention in care, opioid withdrawal symptoms, overdose episodes, hospital admissions, satisfaction, depression and anxiety scores, substance use, and methadone dosing. Healthcare professionals involved in the care will also participate in focus groups after patient enrollment ends. The study measures both patient outcomes and the acceptability and fidelity of the nurse-led intervention over three months.

This trial investigates the best antithrombotic treatment for patients with acute venous thromboembolism VTE who are also taking antiplatelet therapy due to a history of stable atherosclerotic cardiovascular disease. VTE and atherosclerotic cardiovascular disease share common risk factors and often occur together, requiring the use of anticoagulant and antiplatelet drugs. The study aims to compare the benefits and risks of two treatment strategies to address concerns about bleeding and cardiovascular events in these patients. Participants will be randomly assigned to one of two groups. The experimental group will receive full-dose anticoagulant therapy alone, stopping antiplatelet therapy. The control group will continue combined full-dose anticoagulant and antiplatelet therapies, including aspirin or clopidogrel. Anticoagulant treatment will be given according to international guidelines for deep vein thrombosis DVT or pulmonary embolism PE, and treatment duration will be up to 12 months. During the study, participants will be monitored for clinically relevant bleeding, recurrent VTE, and major adverse ischemic cardiovascular and cerebrovascular events MACCE. Researchers will evaluate safety and effectiveness across these outcomes at the end of the treatment period. Secondary measures include non-major bleeding, arterial events, and VTE complications. The study involves regular assessments over up to one year to determine which treatment strategy offers the best overall clinical benefit.

Researchers are creating the largest possible real-life group of patients with Chronic Myeloid Leukemia CML to collect long-term follow-up data. This observational study aims to analyze epidemiological trends, identify patient subgroups based on treatment response, evaluate new medications used in everyday care, study treatment discontinuations, and assess the effects of evolving treatment recommendations. The study collects clinical and biological information from CML patients both prospectively and retrospectively starting from diagnosis. Data gathering continues throughout the long-term follow-up period, even after treatment has stopped. There are no specific drugs or interventions administered in this observational study it focuses on monitoring and recording real-world patient experiences and responses. Participants provide data throughout their disease course, which may be collected for up to 30 years or until death or last follow-up. Researchers evaluate multiple outcomes including molecular and cytogenetic responses, treatment efficacy and tolerance, prognosis scores at diagnosis, body measurements, and medical history related to CML. This extensive monitoring helps better understand CML progression and treatment in real-life settings.

Dementia affects a significant portion of the elderly population, with behavioral and psychological symptoms of dementia BPSD often leading to institutionalization. This study investigates the potential benefits of dance-based physical activity in reducing BPSD and improving cognitive and physical functions in institutionalized seniors with dementia. The project addresses the challenge of adherence to exercise programs in very elderly patients and explores dance as a combined physical, cognitive, and social activity that may help slow BPSD progression. Participants are randomly assigned to two groups. The experimental group receives 4 months of biweekly dance classes led by a professional dance teacher, followed by a return to usual activities. The control group starts with usual activities for 4 months, then receives dance sessions led by a nurse trained by the dance teacher. This approach compares the effects of dance therapy added to standard care versus standard care alone. During the study, participants undergo assessments of behavioral symptoms using the Neuropsychiatric Inventory, cognitive function, autonomy, activity frequency, depression, motor abilities, medication use, and caregiver contributions at multiple time points up to 16 months. Researchers track adherence to the program and evaluate outcomes at 4, 8, 12, and 16 months. Safety monitoring and long-term follow-up are integrated into the study design, with the total participation duration extending over more than a year.

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.

Endometriosis is a chronic condition where tissue similar to the lining inside the uterus grows outside it, causing pain and affecting quality of life in many women of reproductive age. This research evaluates a multidisciplinary educational program combined with nurse-led telephone follow-up to improve the quality of life of women living with endometriosis. The study is supported by the Centre Hospitalier Emile Roux and aligns with public health priorities to offer better care options. The study involves an educational program where patients participate in workshops led by healthcare professionals covering topics like endometriosis, diet, sexuality, pain management, emotions, Pilates, and fertility. Patients in the experimental group will also have monthly nurse-led phone calls for the first six months, then calls at nine and twelve months to monitor symptoms and provide support. Workshops require attending at least three sessions over two days, alongside usual gynecological care. A control group will continue with conventional care without this additional support. Participants will be evaluated at the start, six months, and twelve months through questionnaires measuring quality of life, anxiety, pain, sexual function, sleep, and medication use. Researchers will also assess healthcare visits, hospitalizations, work absences, and supportive care use. The study includes an initial educational assessment with a nurse to set personalized goals and ongoing follow-up to help meet patients evolving needs. Total participation spans at least one year with scheduled assessments and support.

Researchers are studying the impact of a foot health program that includes minimalist footwear on mobility and fall risk factors in older adults living in nursing homes. This pilot study focuses on people aged 65 and older, aiming to improve their foot health and reduce falls, which are a leading cause of accidental death and hospitalization in this group in France. The program lasts 12 weeks and is divided into three phases. The first phase involves weekly individual plantar massage sessions combined with foot stimulation exercises. The second phase introduces weekly workshops on foot mobility, posture, and walking, during which participants start wearing minimalist shoes provided free of charge. The third phase continues with these workshops while participants wear the minimalist shoes both during and outside the sessions. Participants will attend weekly workshops and receive foot massages by trained health professionals. Researchers will measure changes in mobility before and immediately after the program. They will also assess factors like balance, toe strength, ankle movement, fear of falling, foot pain, shoe satisfaction, shoe usage hours, and the number of falls before, after, and up to 12 weeks following the program. The study aims to monitor these outcomes to understand how the program affects fall risk over time.