Aurillac

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating circulating DNA as a biomarker to detect residual disease after chemoradiotherapy in patients with locally advanced head and neck squamous cell carcinoma. The main question is whether circulating DNA can identify remaining disease three months after treatment compared to clinical and radiological assessments. This ancillary trial is part of the larger Neck-TAR study. Participants will have blood samples collected at one and three months after completing chemoradiotherapy. These samples will be used to analyze circulating DNA levels and compare them to the objective response of the disease. The trial focuses on monitoring these biomarkers to better understand their potential role in detecting residual disease. During the study, participants will provide blood samples at the specified time points. Researchers will measure circulating DNA detection alongside clinical and radiological evaluations of disease response. The primary outcome is the detection of circulating DNA and its correlation with residual disease three months after treatment. Secondary outcomes include survival measures and genetic analyses from blood samples. The study runs until July 2031, providing long-term follow-up data.

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 studying how to adjust the dose of fluoropyrimidine chemotherapy based on uracilemia levels in patients with DPD deficiency who have gastrointestinal cancers. This phase II multicenter trial aims to find the best dose reduction strategy to reduce side effects while treating digestive cancers. The main question is which dose reduction is needed for patients with this enzyme deficiency. Participants will receive chemotherapy with doses adjusted according to their uracilemia level. Patients with low uracilemia <16 ngmL will get the full dose, while those with higher levels will receive varying dose reductions or random assignments between 25% and 50% reductions depending on their uracilemia range. Treatments include the FOLFOX or CAPOX chemotherapy regimens, given in cycles every 2 to 3 weeks. During the study, participants will visit the clinic every 2 to 3 weeks for checkups and tests to monitor side effects and treatment response. Researchers will measure the occurrence of serious blood and gastrointestinal toxicities after two treatment cycles and track dose adjustments, toxicity, and survival outcomes over several months and years. The study involves close monitoring of health and treatment effects for up to three years, depending on cancer stage.

Researchers are conducting an observational study called the France PCI Registry to monitor and improve care in interventional cardiology, focusing on procedures like coronary angiography and angioplasty. This national observatory started in 2014 in the Centre Val de Loire region and aims to build a reliable database of interventional cardiology activities. The study is led by the Club Rgional des Angioplasticiens de la rgion Centre and seeks to optimize patient care times, especially for those with STEMI a type of heart attack. The study collects data fully integrated with usual coronary activity reporting software across multiple catheterization labs. It tracks interventional cardiology activities over a year and monitors secondary outcomes such as improving care times for STEMI patients within 24 hours. There are no investigational drugs or treatments administered, as this is an observational study gathering information from routine clinical practice. Participants who have undergone coronary angiograms or angioplasty are involved through data collection during their usual care. The study regularly evaluates data quality to maintain an exhaustive and reliable database. Researchers measure the volume and quality of interventional cardiology procedures and how quickly STEMI patients receive care. Participation lasts as long as the data collection period, with ongoing observation but no additional interventions or treatments.

Researchers are investigating the best noninvasive respiratory support method for patients in intensive care units ICUs who develop respiratory failure after planned removal of their breathing tube extubation. This condition affects about 20% of ICU patients, and many require reintubation, which is linked to high mortality rates. The study aims to compare whether alternating non-invasive ventilation NIV with high-flow nasal oxygen reduces death rates compared to high-flow nasal oxygen alone in these patients. The trial is a multicenter, randomized, controlled study where patients with post-extubation respiratory failure are assigned to one of two groups. One group receives continuous high-flow nasal oxygen treatment for 48 hours, while the other group receives NIV alternating with high-flow nasal oxygen during the same period. NIV involves pressure-support breathing with specific settings to help patients breathe, and the study ensures balance in patient groups based on carbon dioxide levels in the blood. Participants will be closely monitored with assessments including timing of death, reintubation events, days without ventilator use, length of ICU and hospital stay, and mortality at different time points up to 90 days. The main outcome measured is death rate 28 days after respiratory failure onset. The study includes clinical evaluations and blood gas tests to guide treatments and decisions. Participation duration includes the initial 48-hour treatment period and follow-up assessments extending to 90 days.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

This research aims to evaluate the effects of combining baxdrostat 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 a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Locally advanced head and neck squamous cell carcinomas HNSCCs often have high rates of locoregional failure after treatment. Detecting remaining disease after therapy is challenging because current imaging methods like PET-CT can give false positives due to inflammation. Researchers are studying whether circulating tumor DNA ctDNA in blood can provide a more reliable way to assess treatment response and detect residual disease in these patients. This is a multicenter, open-label study focusing on patients with locally advanced head and neck cancer receiving potentiated radiotherapy. Participants will have blood samples taken twice first before starting treatment and again three months after radiochemotherapy if PET-CT shows an incomplete response. The study will monitor circulating DNA levels to see how well they correspond to residual lymph node disease detected by PET-CT. The intervention involves biological sampling, and no placebo or comparison group is used since it is a single-arm study. The study also includes assessments of tumor genomics and HPV status. During the study, patients will undergo PET-CT scans and blood tests at specified times to monitor residual disease. Researchers will evaluate the rate of incomplete lymph node response, the presence of circulating DNA, and the match between tumor and blood DNA profiles. The study will collect data over an average of 66 months, including long-term clinical and pathological features. Outcomes include the accuracy of ctDNA detection, prognostic value, and interobserver consistency in PET-CT interpretation. Participants are monitored for disease status and treatment response throughout the follow-up period.

Researchers are evaluating whether giving amiodarone for 72 hours can reduce deaths and severe heart rhythm problems within 30 days in critically ill adults admitted after an out-of-hospital cardiac arrest with an initial shockable heart rhythm and a confirmed or suspected cardiac cause. This phase 3 trial is randomized and compares patients receiving amiodarone to those receiving no intervention. The study is sponsored by Versailles Hospital. Participants in the amiodarone group receive an initial 300 mg loading dose over 30 minutes, followed by a continuous infusion for 72 hours at 10 mgkg per day, not exceeding 900 mg per 24 hours. The control group does not receive amiodarone. Treatment starts shortly after admission to intensive care and screening. The study measures outcomes for up to 90 days, including heart-related events, mortality, ventilation duration, neurological status, vasopressor use, and hospital stay length. During the study, patients are closely monitored in intensive care with regular assessments of their heart condition and overall health. Researchers track serious ventricular arrhythmias and death rates over 30 days as the main outcome. Secondary outcomes include longer-term cardiac events, neurological outcomes, and side effects related to amiodarone within 5 days. The total follow-up lasts up to 90 days, during which participants responses to treatment and safety are carefully observed.