Cholet

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

Researchers are evaluating a new approach for adults with moderate to severe ulcerative colitis who need treatment with adalimumab. This Phase IV randomized trial compares standard care with a treat-to-target strategy that includes telemonitoring and patient education. The study aims to assess the impact of using home fecal calprotectin tests and e-monitoring combined with education on disease control by week 48. All participants will initially receive adalimumab with doses starting at 1608040 mg every other week until week 14, then 40 mg every other week until week 26. Dosage may be adjusted up to 80 mg every other week or 40 mg every week based on patient or investigator choice. In addition, patients may receive azathioprine or methotrexate alongside adalimumab until week 38. The study groups differ by follow-up method one group receives standard care with doctor visits every three months, while the other group has e-monitoring, home fecal calprotectin testing, and therapy education. Participants will be involved for about 144 weeks and complete regular assessments including endoscopic exams, clinical evaluations, quality of life surveys, and treatment adherence questionnaires. The study measures success primarily by endoscopic remission at week 48 and also tracks clinical remission, healing rates, patient satisfaction, hospitalizations, colectomies, and safety. Monitoring includes frequent e-monitoring questionnaires and fecal calprotectin testing at home. The trial also evaluates medication compliance and economic outcomes related to treatment.

Critical Limb Ischaemia CLI is the last stage of arterial disease and requires urgent diagnosis and treatment. This conditions diagnosis varies internationally and is usually based on clinical signs like persistent ischemic pain or necrotic wounds lasting more than two weeks, along with blood flow measurements such as ankle or toe systolic pressures or transcutaneous oxygen pressure. The study aims to validate a reliable and easy-to-use diagnostic tool to screen patients with CLI early and refer them to specialized centers promptly. The study involves performing arterial ultrasound scans of the lower limbs, including pulsed Doppler analysis of blood flow in key arteries such as the abdominal aorta and arteries in the foot. This observational study will assess the diagnostic value of the maximum systolic rise time in the foot arteries over a 12-month period to determine its usefulness in predicting CLI. Participants will be evaluated through arterial Doppler ultrasound scans and measurements of systolic pressure at the toe. The main outcome measured is the diagnostic accuracy of the maximum systolic rise time in distal foot arteries. The study will monitor participants for up to 12 months to assess this measure. Other clinical and hemodynamic data will be collected to support the evaluation and safety monitoring throughout the study duration.

Researchers are studying cannabinoid hyperemesis syndrome CHS, a condition causing severe abdominal pain and vomiting in people who use cannabis regularly. This syndrome is hard to diagnose and often leads to repeated emergency room visits. The study aims to estimate how common CHS is among patients visiting adult emergency departments in Maine et Loire with abdominal pain or vomiting. It is a prospective, observational study involving multiple centers. The study includes patients aged 18 to 65 who visit an emergency department for abdominal pain or vomiting for the first time during the study period. Those who report using cannabis at least once a week for more than six months complete a questionnaire either online or on paper while in the emergency room. Patients identified with CHS will be followed up by telephone three months later to track symptom changes, recurrences, treatments, and cannabis use. Participants complete questionnaires during their emergency visit, providing information about their symptoms and cannabis use. For those with CHS, follow-up calls occur three months later to assess their health and treatment outcomes. Researchers will measure the number of patients diagnosed with CHS, their age and gender distribution, clinical features, cannabis use patterns, hospital treatments, and recurrence of symptoms. The study lasts 15 months, with a 12-month inclusion period and a 3-month follow-up for CHS patients.

Researchers are evaluating the best way to set mechanical ventilators for patients with acute respiratory distress syndrome ARDS, including those with COVID-19 and non-COVID-19 ARDS. This multicenter randomized controlled trial uses an adaptive design to compare ventilation strategies based on respiratory mechanics, aiming to reduce mortality 60 days after treatment begins. ARDS causes severe lung inflammation that makes ventilation challenging and can lead to ventilator-induced lung injury VILI. The trial includes two groups one receiving standard ventilation care following existing guidelines, and the other receiving individualized ventilation settings based on bedside measurements of lung recruitability and breathing effort. The experimental group undergoes specific maneuvers to assess airway closure and recruitability to set ventilator parameters such as tidal volume and positive end-expiratory pressure PEEP. Both groups receive volume control ventilation, with adjustments made as patients begin spontaneous breathing. Participants will be closely monitored during their ICU stay, with assessments including duration of ventilation, ICU and hospital stay length, organ dysfunction, barotrauma, and mortality at several time points up to 60 days. The main outcome measured is all-cause mortality at 60 days. Data collection, analysis, and patient management follow a shared protocol across both COVID-19 and non-COVID-19 patient groups, with safety and effectiveness monitored throughout the study period.

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 investigating the clonal architecture of ASXL1-mutated primary and secondary myelofibrosis to better understand its impact on patient prognosis. This study aims to clarify inconsistent findings about the prognostic value of ASXL1 mutations by evaluating a group of 50 patients. The goal is to refine how these mutations affect outcomes like survival and disease progression. Participants will have blood samples collected within 18 months of diagnosis. The study involves determining clonal architecture through sorting circulating CD34 positive cells, cell culture with colony genotyping, andor single-cell DNA sequencing. Additionally, a transcriptomic study using RNA sequencing will explore functional characteristics of each clonal subtype. This research is conducted as part of a multicenter cohort under the University Hospital, Angers. Patients will be followed for 4 years as part of their usual care, during which researchers will collect data on survival and leukemic transformation. Outcomes include identifying subgroups based on clonal architecture at 24 months and evaluating overall and leukemia-free survival at 4 years. Various clinical and laboratory parameters like age, blood counts, LDH levels, and symptom presence will also be compared within clonal subtypes to understand their prognostic significance.

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.