La Rochelle

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are conducting a prospective, multicenter cohort study to follow children with idiopathic nephrotic syndrome INS, a rare kidney disease. The study aims to collect data on pediatric patients treated by pediatric nephrologists in France and its overseas territories to better understand the diseases characteristics and support future clinical trials. The study involves regularly recording medical, biological, psychological, and social data through routine clinical follow-ups, hospitalizations, and consultations. Additionally, annual telephone interviews will be conducted for patients in remission. Quality of life, treatment adherence, and treatment impact questionnaires will also be collected. A biobank is established to collect blood, urine, hair, and nail samples at the disease onset before immunosuppressive treatment begins. Participants will be followed from disease onset until age 18 or transfer to adult nephrology care. Data is collected via a secure website, medically validated and entered by clinical research staff. The main outcome is the number of cases included and their characteristics over two years. Participation involves routine care visits, interviews, and questionnaires, with continued monitoring planned through the study period ending in 2048.

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 conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

Researchers are evaluating the clinical effectiveness of combining physiological pacing with atrioventricular node ablation in patients who have heart failure with preserved ejection fraction HFpEF and well-controlled permanent atrial fibrillation. The study aims to determine if this combination can reduce mortality and hospitalizations for heart failure compared to standard drug therapy. This research focuses on heart rate regularization to prevent the harmful effects of right ventricular apical pacing in this patient group. Participants will be randomly assigned to one of two groups the intervention group receiving pacemaker implantation and atrioventricular node ablation, or the control group receiving optimized drug therapy. The pacemaker will be programmed in VVIR mode with a set lower rate. Procedures will occur within one week after randomization, and drug therapies will be adjusted according to current guidelines in both groups. During the study, participants will visit the clinic at 3, 12, and 24 months after randomization for checkups and tests. Researchers will monitor time to the combined outcome of death, heart failure hospitalizations, or use of intravenous diuretics over 24 months. Secondary measures include changes in heart function scores, biomarker levels, and adverse events related to the procedures. The total follow-up period is 24 months.

Researchers are studying children aged 6 to 11 years to better understand motor difficulties linked to Autism Spectrum Disorder ASD. This study aims to capture detailed and standardized measurements of general motor skills, fine motor skills, and eye movement control, while also exploring how these motor challenges relate to cognitive and social difficulties in children with ASD. The study compares motor performance across three key domains and examines differences based on clinical assessments, age, IQ, and other factors. Participants undergo a series of behavioral tests that assess eye movements using an eye-tracking system, fine motor tasks like graphics and pointing, and gross motor skills through biomechanical analysis. Children also complete self and parent questionnaires related to their motor and social functioning. Data collection occurs during visits spaced around three months apart to evaluate motor skills and related cognitive and social measures. Throughout the study, childrens motor performance is measured using objective tasks and eye-tracking technology, along with assessments of IQ, social responsiveness, ADHD symptoms, and motor coordination disorders. Researchers monitor changes and scores over visits to identify patterns and correlations. Participation involves completing motor tests and questionnaires, with outcomes focused on success rates, errors, reaction times, and clinical scores. The total study duration includes at least two visits spaced by approximately three months for comprehensive assessment.

Researchers are investigating a cognitive stimulation program adapted for elderly patients with bipolar disorder to address cognitive impairments that commonly worsen after age 65. Bipolar disorder is a mood disorder that significantly affects cognitive functions such as attention, memory, and executive skills, which in turn impact quality of life and relapse risk. This study compares the adapted cognitive stimulation program to usual psychiatric care to evaluate its effects on residual cognitive symptoms. Participants in the study will either undergo cognitive stimulation sessions using Liliane Israls TRAIN YOUR MEMORY software or receive standard care involving psychiatric consultations and possible home nurse visits. The cognitive stimulation includes weekly sessions focusing on sensory stimulation, language and expression, attention, memory structuring, social communication, and temporal-spatial orientation. This program is designed to enhance memory mechanisms through pedagogical and psychotherapeutic methods. During the trial, participants will be assessed with various cognitive and functional tests at inclusion, 3 months, and 6 months to measure changes in executive function, memory, daily activities, and mood. Key outcomes include scores on the Frontal Assessment Battery and other neuropsychological tests. Researchers will monitor hospitalizations due to relapse and caregiver burden. The total participation duration is at least 6 months, with assessments conducted throughout this period to evaluate treatment effects and safety.

Researchers are studying acute hidrosadenitis to better understand its different types or phenotypes. This is important because recognizing these subtypes can help tailor more suitable treatments and care. The study aims to define the natural history of the disease and identify environmental factors linked to its chronic form over an average period of three years. This is an observational study where no treatments or interventions are tested. Instead, patients diagnosed with acute hidrosadenitis are followed over time to observe their condition. The study collects detailed information about the clinical forms of the disease and tracks how it progresses in patients. Participants will be monitored for about three years during which researchers will record data about their disease severity, clinical characteristics, and environmental exposures. The main outcomes measured include the different clinical forms of hidrosadenitis and factors that may influence chronic disease development. There is no specific treatment given rather, the study observes patients to gather valuable information for future care approaches.