Valence

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 evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

This research aims to evaluate the anxiolytic effects of socio-aesthetic care in cancer patients undergoing chemotherapy. The study focuses on measuring the average "State Anxiety" score from the State Trait Inventory Anxiety before treatment and at the end of the third chemotherapy cycle. Two groups of patients receiving chemotherapy every 14 or 21 days for various cancers, including lung, breast, digestive, colorectal, or gynecological cancer, are studied to assess the impact on anxiety levels. Participants are divided into two groups: one group receives three socio-aesthetic care sessions conducted by a socio-esthetician during the first chemotherapy administration, while the control group receives standard supportive care such as psychology consultation, sophrology, art therapy, physiotherapy, or hypnosis during chemotherapy cycles. The treatment schedule includes visits at inclusion, during the first four chemotherapy courses, and at the end of chemotherapy. Throughout the study, patients are seen six times for assessments including questionnaires to measure anxiety scores. Researchers monitor changes in the "State Anxiety" score between inclusion and the end of the third chemotherapy cycle, which may last up to 21 days per cycle. The study involves informed consent, language comprehension, and ongoing support care monitoring to evaluate the effects and safety of the interventions.

This research aims to reduce extubation failure in critically ill patients with severe brain injuries who have ongoing impaired consciousness. These patients require mechanical ventilation through tracheal intubation after acute neurological injury. Because of residual neurological problems affecting airway control, extubation failure is common, and current guidelines for ventilator weaning exclude these patients. A clinical score developed in 2017 uses four neurological and airway reflex elements to predict extubation success with good accuracy. The study compares two approaches to extubation readiness after patients have passed a spontaneous breathing trial. In the intervention group, clinicians use the clinical score to decide if extubation should proceed when the score is above 9. In the control group, extubation is done according to usual care practices. Eligibility for the spontaneous breathing trial is assessed daily, and patients must have residual impaired consciousness and meet other criteria. The study uses a stepped wedge cluster randomized design involving intensive care units. Participants will be monitored from extubation through five days afterward to assess extubation failure. Researchers will measure whether using the clinical score improves timing and success of extubation compared to standard care. The study involves detailed neurological assessments and daily evaluations during the weaning process. The total study involvement includes screening, intervention with extubation decisions, and monitoring of respiratory outcomes within this critical care setting.

Researchers are exploring a treatment approach for women with early-stage hormone receptor-positive, HER2-negative breast cancer who face an intermediate risk of cancer recurrence. This phase III trial builds on previous findings that adding the drug ribociclib, a CDK4/6 inhibitor, to standard hormone therapy after surgery can extend the time patients remain free from invasive disease. The study aims to see if using ribociclib allows some patients to avoid chemotherapy and its side effects without compromising treatment effectiveness. Participants will either receive chemotherapy followed by hormone therapy combined with ribociclib or a de-escalated treatment plan that reduces or omits chemotherapy while still using ribociclib and hormone therapy. Ribociclib will be administered for three years as part of the adjuvant treatment after surgery. The study is designed to reflect routine clinical practices for deciding chemotherapy eligibility, using standard pathological assessments and genomic tests. Throughout the trial, women will undergo regular monitoring, including clinical visits, laboratory tests, and heart function assessments, to ensure safety and treatment adherence. Researchers will measure invasive breast cancer-free survival over a period of up to 12 years from randomization. The study also tracks patients' ability to comply with treatment schedules and evaluates long-term outcomes to confirm if chemotherapy can be safely reduced or avoided in this group.

Researchers are evaluating the safety and performance of remote monitoring functions in pacemakers, specifically the ALIZEA, BOREA, and CELEA devices. These remote features include the Right Atrial Autothreshold (RAAT), Right Ventricular Autothreshold (RVAT), and technical remote alerts. The study focuses on patients with bradycardia who have recently received one of these pacemakers as part of their cardiac care. Participants will undergo implantation or device upgrade with an ALIZEA, BOREA, or CELEA dual chamber pacemaker. The study involves activating remote monitoring functions on these devices to track cardiac pacing performance and system safety. Follow-up visits will occur at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion, during which device function and remote monitoring data will be assessed. During each follow-up, either in person or remotely, researchers will measure the pacemaker's performance, including pacing thresholds and remote alerts. Safety will be closely monitored throughout the entire 48-month study period. The main outcomes include changes in right atrial and right ventricular pacing thresholds and documentation of technical remote alerts between 1 and 3 months after device implantation.

Researchers are studying gene variants of uncertain significance (VUS) found in genes linked to hereditary breast, ovarian, and other cancers. The goal is to better classify these VUS using data from a large French genetic database to improve genetic counseling and help guide clinical decisions, including preventive surgeries. The study originally focused on BRCA1 and BRCA2 genes but now includes multiple cancer-related genes identified through ongoing genetic testing in French families. Participants include index cases who carry specific VUS classified as uncertain or likely causal, along with their selected family members. Saliva samples are collected from these relatives to test for the presence of the variants. The study uses co-segregation analysis, which examines how the variant tracks with disease within families, applying a Bayesian model alongside other genetic and clinical data to estimate the likelihood that a variant causes cancer. Participants provide informed consent and saliva samples for genetic testing. Researchers compile data from multiple families to strengthen the classification of variants. The primary outcome is to perform co-segregation analysis over a period of up to 15 years. This long-term study aims to refine the clinical relevance of genetic variants to support personalized cancer risk assessment and counseling for affected families.

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.

Researchers are studying the effects of a physical activity program on patients with localized upper aerodigestive tract cancer, including head and neck cancer. This study aims to understand how adding a physical activity program to the usual care affects patients' sedentary behavior, physical activity levels, quality of life, and fatigue. It is a randomized, open-label, controlled study involving 96 participants. Participants are randomly assigned to one of two groups: the control group receives standard care with physical activity recommendations, while the experimental group follows the standard care plus a structured physical activity program. The study tracks physical activity and sedentary behavior using questionnaires and actimetry, which measures movement and prolonged sedentary periods over 24 hours. Participants will be monitored over an 18-month period with assessments at multiple time points. Researchers will collect data using physical activity questionnaires, quality of life and fatigue questionnaires, and continuous actimetry recordings. The main outcome measured is the change in sedentary behavior from the start of the study to 3, 6, 12, and 18 months. The study also includes safety and behavioral evaluations throughout the follow-up.

About 30% of patients aged 65 and older experience a decline in functional ability due to hospital stays. Physical inactivity is common during hospitalization, often without medical reasons, leading to loss of independence, muscle strength, and higher risks after leaving the hospital. Research shows that walking slowly for 25 to 40 minutes daily can improve patients' function, but this can be hard to achieve without enough physiotherapists available in hospitals. This study is testing the use of a vibrating watch that reminds patients to be active by walking or doing strengthening exercises. The watch will vibrate six times a day to encourage movement tailored to each patient's physical abilities and environment. There is a control group where the watch vibrates only once a day. This simple device aims to increase physical activity without needing extra hospital staff or resources. Participants will be monitored for changes in their functional capacity during their hospital stay. Assessments include a physical performance test within 24 hours of admission and within 48 hours before discharge. Researchers will measure how the vibrating reminders affect patients' ability to move and perform daily activities safely and independently. The study focuses on hospitalized patients aged 50 and over who are frail but able to get up from a chair and communicate with staff.