Aurillac

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

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.

Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to \[U\] in DPD-deficient patients with gastrointestinal cancer.

Rigorous assessment of clinical practice plays an important role in improving patient care and outcomes in interventional cardiology. This multicenter observational study called CRAC began in 2014 in the Centre Val de Loire region of France. It uses usual coronary activity report software to collect high-quality, reliable data from five interventional cardiology catheterization labs in the region. This approach aims to create an extensive and trustworthy database that could be expanded to other regions in France. The study collects data continuously from patients who have undergone coronary angiograms or angioplasty procedures. There are no specific interventions or treatments assigned as this is an observational registry monitoring routine clinical activity in interventional cardiology. The data collection and quality assessment are integrated into the regular reporting systems used by participating centers. Participants provide their data while receiving standard care. Researchers regularly evaluate the quality of the collected data to ensure accuracy and completeness. The main outcome being measured is the census of interventional cardiology activity over one year. The study focuses on building a comprehensive national registry to support improved care through careful monitoring and analysis of interventional cardiology procedures.

Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating whether giving amiodarone for 72 hours can reduce the risk of death or severe dangerous heart rhythms in critically ill patients admitted after an out-of-hospital cardiac arrest with a shockable heart rhythm and a confirmed or suspected cardiac cause. This phase 3 study focuses on improving outcomes within 30 days after treatment starts, addressing a critical period following cardiac arrest where complications are common. Participants receive an initial 300 mg loading dose of amiodarone over 30 minutes in a glucose solution, followed by a continuous infusion for 72 hours at a dose of 10 mg/kg per day, not exceeding 900 mg in 24 hours. The treatment is given through a central venous catheter in the intensive care unit. The study compares this preventive approach to standard care to see if it lowers the chance of death or severe ventricular arrhythmias requiring urgent intervention. During the study, participants are closely monitored in the ICU with regular assessments to track heart rhythms and overall health status. Researchers measure the rate of mortality and severe ventricular arrhythmias within 30 days from the start of treatment. Safety and treatment effects are carefully observed during this critical period to determine if prophylactic amiodarone can improve patient outcomes after cardiac arrest.

Researchers are evaluating whether Resilience PRO, a digital tool for remotely monitoring symptoms, can improve the quality of life for adults diagnosed with cancer who are receiving systemic anticancer treatment. This Phase 3 randomized controlled trial compares patients using Resilience PRO alongside their usual care to those receiving usual care alone. The study aims to determine if the use of this mobile app leads to better patient outcomes by timely addressing symptoms during treatment. Participants assigned to the intervention group will use the Resilience PRO mobile application, which regularly asks about their symptoms. When important symptoms are reported, the app sends alerts to the healthcare team, who can then adjust care promptly. Both groups, intervention and control, continue to receive standard care throughout the study. During the study, participants will provide electronic patient-reported outcomes through the app, which will be analyzed to guide care. Researchers will assess health-related quality of life after 3 months. Participants must have access to a smartphone and communicate in the study language. Safety and adherence will be monitored, and the total study duration includes regular symptom tracking alongside usual treatment.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Crohn's disease is a chronic inflammatory bowel condition that can severely impact patients' quality of life and often leads to intestinal damage requiring surgery. This trial investigates whether combining a standard close monitoring strategy using clinical symptoms and fecal calprotectin with additional MRI scans to assess transmural healing improves long-term remission in patients treated with biotherapy. The study explores if this combined "CALM + MRI" approach is better than the traditional "CALM" strategy alone for maintaining symptom-free periods without corticosteroids. Participants are randomly assigned to one of two groups: the reference group follows the CALM strategy with regular visits and treatment adjustments based on clinical symptoms and fecal calprotectin levels at multiple time points up to week 152 (about 3 years). The investigational group receives the same follow-up plus extra MRI scans at weeks 24 and 52, with treatment intensifications if MRI indicates ongoing disease activity. All participants undergo MRI at the beginning, week 76, and week 152. Treatment changes follow established French guidelines. Monthly symptom diaries track abdominal pain and stool frequency. Throughout the 152-week study, patients have evaluations including clinical assessments, fecal calprotectin tests, and MRIs to monitor disease activity and healing. The main outcome measured is the proportion of months patients spend in clinical remission between weeks 24 and 76. Secondary outcomes include response rates and imaging-based healing measures reviewed centrally to minimize bias. Missing data are handled by considering those months as non-remission periods. This comprehensive follow-up aims to determine if adding MRI to close clinical and biological monitoring provides better disease control.