Valence

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.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

This research aims to evaluate the impact of socio-aesthetic care on anxiety levels in cancer patients undergoing chemotherapy. The study focuses on patients receiving chemotherapy every 14 or 21 days for cancers such as lung, breast, digestive, colorectal, or gynecological types. The main purpose is to compare patients State Anxiety scores before treatment and after the third chemotherapy cycle. Participants will be divided into two groups one group will receive three sessions of socio-aesthetic care during their first chemotherapy administration, provided by a socio-esthetician. The other group will receive supportive care available at the center, including psychology consultations, sophrology, art therapy, physiotherapy, and hypnosis, but will not have socio-aesthetic care. Patients will be seen six times at inclusion, during the first four chemotherapy courses, and at the end of chemotherapy. During the study, patients will complete anxiety questionnaires to measure their anxiety levels at various points. Researchers will assess changes in the State Anxiety score from the start of treatment through the third chemotherapy cycle, which lasts up to 21 days per cycle. Safety and adherence will be monitored throughout the chemotherapy period, with the total participation duration covering the chemotherapy cycles and follow-up visits.

This research aims to reduce extubation failure in critically ill patients with acute brain injuries who have impaired consciousness. These patients often require mechanical ventilation with tracheal intubation, and after their acute neurological condition is treated, doctors need to carefully wean them off ventilators to avoid complications like pneumonia. Current guidelines for ventilator weaning do not include brain-injured patients with impaired consciousness, so this study evaluates a simple clinical score to help decide when to safely remove the breathing tube. Participants will be assigned by random clusters of intensive care units to receive either usual care or care guided by the extubation readiness clinical score. After a successful spontaneous breathing trial, clinicians in the intervention group will use the score based on swallowing, gag reflex, cough, and consciousness level to decide on extubation. If the score is above 9, extubation should proceed. Those in the usual care group will follow standard ICU ventilator weaning protocols. The study uses a stepped wedge cluster randomized design. During the study, patients are assessed daily for readiness to breathe without the ventilator. Researchers will monitor extubation failure from the time of extubation up to five days later. They will also track other outcomes such as time to extubation, duration of mechanical ventilation, reintubation rates, pneumonia occurrence, hospital stay length, and neurological outcomes up to 90 days. This thorough evaluation helps understand how the score may improve the timing and success of extubation in this vulnerable group.

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 evaluating the safety and performance of remote monitoring functions in ALIZEA, BOREA, and CELEA pacemakers for patients with bradycardia. This observational clinical investigation focuses on the devices Right Atrial Autothreshold RAAT, Right Ventricular Autothreshold RVAT, and remote alert features. The study aims to document these functions over time to better understand their reliability and safety. Participants will be included soon after pacemaker implantation and followed for 48 months. Follow-up visits occur both on-site and remotely at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion. During these visits, the remote monitoring functions and the pacing systems performance will be measured, and safety will be continuously monitored throughout the study. Throughout the study, researchers will assess cardiac pacing thresholds, technical remote alerts, and the usability of the pacemaker and remote monitoring systems. Evaluations include Right Atrial and Right Ventricular pacing thresholds at multiple timepoints up to 48 months. Participants will undergo scheduled check-ins involving measurements, monitoring, and safety assessments, with the total study duration lasting four years after enrollment.

This research aims to improve genetic counseling by classifying gene variants found in families with a history of hereditary cancers, especially breast and ovarian cancer. Initially focused on BRCA1 and BRCA2 genes, the study now includes multiple genes from a large French oncogenetics database, covering thousands of families and variants. The goal is to better understand which gene variants are linked to cancer risk and to refine how these variants are classified for clinical use. Participants include index cases carrying specific gene variants and their family members. The study collects saliva samples from relatives to test for the presence of these variants, particularly those classified as uncertain significance class 3, likely pathogenic class 4, or hypomorphic pathogenic class 5. Genetic analyses are performed by specialized laboratories, and data from multiple families is combined to assess how these variants co-segregate with cancer occurrence. Throughout the study, researchers analyze genetic data using statistical models to estimate the likelihood that certain variants cause cancer. They use anonymous results for overall variant classification and share findings with families when variants are found to be pathogenic. This helps guide genetic counseling, possible preventive measures, and clinical management. The study spans up to 15 years and continuously updates classification methods and clinical recommendations based on new data.

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 studying the effect of a physical activity program on reducing sedentary behavior and increasing physical activity levels in patients treated for localized upper aerodigestive tract cancer. This randomized, open-label, controlled study includes 96 patients and aims to assess changes in sedentary behavior, quality of life, and fatigue over an 18-month period. The study compares an experimental group receiving a physical activity program plus standard care to a control group receiving standard care with physical activity recommendations. Participants are randomly assigned to one of two groups. The control group receives standard care along with advice on physical activity and wears a wristband to monitor activity for 7 days before scheduled visits. The experimental group participates in one or two physical activity sessions per week, which can be face-to-face or via videoconference, including low-to-moderate intensity aerobic and muscle-strengthening exercises plus a 40-minute stretching or yoga session. They also wear the wristband continuously for 7 days before each scheduled hospital visit. During the study, participants attend visits at baseline and at 3, 6, 12, and 18 months where their sedentary levels are measured using the wristband data. They also complete several questionnaires assessing physical activity, quality of life, fatigue, personality, and illness identity. Researchers monitor changes in these measures over time to evaluate the impact of the physical activity program. The total participation duration is 18 months, with continuous monitoring and behavioral assessments throughout.

Around 30% of patients aged 65 and older experience a decline in functional ability during hospitalization, often due to physical inactivity without medical reasons. This immobility can lead to loss of independence, muscle strength, and higher risks after discharge. The study evaluates whether a vibrating reminder watch can increase activity and improve functional outcomes in these patients. Participants will be randomly assigned to one of two groups. One group will receive a vibrating watch set to vibrate six times daily, prompting them to perform muscle strengthening exercises or walk prescribed distances. The control group will receive a similar watch vibrating once daily with advice to exercise independently. Both groups will continue receiving usual physiotherapy care and self-rehabilitation exercises as appropriate. Participants will be assessed for functional capacity using the Short Physical Performance Battery SPPB within 24 hours of admission and before discharge. Researchers will also monitor physical activity levels, functional independence, exercise compliance, falls, rehabilitation volume, and quality of life during hospitalization and up to three months after discharge. The total study participation spans from hospital admission through three months post-discharge, with multiple evaluations throughout this period.