Blois

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 the use of circulating tumour DNA ctDNA analysis to detect early molecular relapse in patients with estrogen receptor positive ER and HER2 negative breast cancer who are undergoing adjuvant endocrine therapy. This trial aims to determine if treatment with palbociclib plus fulvestrant can delay or prevent relapse in patients who show positive ctDNA results. The study is a Phase 2, multi-centre, randomized, open-label trial focusing on high-risk patients with early-stage breast cancer. The trial has two main phases a surveillance phase and a treatment phase. During the surveillance phase, patients receive ctDNA testing every three months for up to three years to monitor for molecular relapse. If ctDNA is detected without visible disease on imaging, patients enter the treatment phase, where they are randomly assigned to receive either standard endocrine therapy or a combination of palbociclib and fulvestrant for up to 24 months. Palbociclib is taken orally daily for 21 days of each 28-day cycle, while fulvestrant is given as intramuscular injections on specific days of each cycle. Imaging is performed every six months to check for overt disease. Participants undergo regular blood tests for ctDNA monitoring during the surveillance phase and receive clinical assessments, imaging scans, and quality of life questionnaires during the treatment phase. Researchers measure the incidence of positive ctDNA results, relapse-free survival, and monitor adverse events. The total follow-up for relapse-free survival extends up to 60 months from randomization, while safety and quality of life are assessed up to 24 months. If macroscopic disease appears, participants stop trial treatment and receive standard care outside the study.

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position lying face down while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

This research evaluates whether non-invasive vagal stimulation can better prevent chemotherapy-induced nausea in breast cancer patients undergoing cyclophosphamide and anthracycline treatment. Chemotherapy-induced nausea remains common and negatively impacts quality of life despite existing medications. Non-invasive vagal stimulation is approved for other conditions like headache and gastroparesis and may reduce nausea. Participants receive standard antiemetic treatment along with either active non-invasive auricular vagal stimulation or a sham stimulation twice daily, starting the day before chemotherapy until four days after, during the first three chemotherapy cycles. The stimulation uses a transcutaneous auricular device to assess if adding this method improves nausea control compared to standard care alone. Throughout the study, participants are monitored for nausea occurrence after each chemotherapy cycle, vomiting, use of rescue medications, emergency visits, hydration needs, and hospitalizations related to nausea. Quality of life questionnaires specific to breast cancer and general health are completed during the first three cycles. Safety and side effects related to vagal stimulation are also evaluated. The trial measures outcomes over up to 12 weeks, with primary focus on nausea after the first chemotherapy cycle.

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

Schizophrenia, affecting about 0.7% of the population, often leads to poor insight and medication compliance, resulting in relapses and a reduced quality of life. Researchers are evaluating an individual early psychoeducation program called PEPITS for inpatients with schizophrenia or related disorders. The study aims to see if PEPITS can reduce relapses, improve medication adherence and insight, and enhance quality of life. The PEPITS program is delivered by nurses during the initial hospitalization phase and consists of three parts an introduction session, sessions focused on understanding the illness and care, and sessions on recovery and building coping skills. Participants are randomly assigned to either the PEPITS program or to usual psychiatric care without PEPITS. Participants will be monitored from the start of the study until one year after randomization to assess changes in insight, quality of life, and medication compliance. Additional evaluations include quality of life and psychological well-being at work, job satisfaction, self-efficacy, and work commitment over six months. The study involves regular assessments to track these outcomes and better understand the programs impact.

Researchers are studying patients with advanced cutaneous squamous cell carcinoma cSCC, a skin cancer with rising incidence and evolving treatment options. The study aims to describe how systemic therapies are used long-term in real-life settings for patients receiving treatments as curative, adjuvant, or neoadjuvant. This observational study collects data to better understand patient characteristics, treatment use, effectiveness, and safety. The study involves collecting information on patients starting first-line systemic therapy for cSCC from January 2020 onward. It includes both a retrospective phase and a prospective phase, gathering data from about 30 centers in France. Treatments studied include systemic drug therapies given with different intentions such as curative, adjuvant, or neoadjuvant. There is no intervention or randomization the study observes real-world treatment practices and changes over time. Participants are followed long term, with an average follow-up of 5 years to monitor treatment frequency, duration, and outcomes like response rates and survival. Researchers collect baseline patient data at diagnosis and track effectiveness and safety of therapies over time. The study also aims to identify new factors that predict treatment response or side effects. Data collection includes clinical characteristics and treatment details, contributing to a national database for cSCC management.

Researchers are investigating metastatic melanoma and other advanced skin cancers to improve treatment decisions involving immune checkpoint inhibitors like anti-PD-1. Although these immunotherapies have changed care for advanced melanoma, only some patients benefit. This research aims to develop an artificial intelligence AI tool that analyzes visible skin damage called dermatoheliosis near the melanoma scar, which may predict response to anti-PD-1 therapy. The study is observational and includes both retrospective and prospective patient groups. The study collects photographs of the skin around melanoma scars to train and validate the AI algorithm. This tool will assess dermatoheliosis as a marker linked to tumor mutation burden TMB and treatment response. The research also examines skin and tumor samples to study genetic and immune profiles. The goal is to create a straightforward, non-invasive method to help doctors select the best immunotherapy for patients with unresectable locally advanced or metastatic melanoma or inoperable skin carcinomas. Participants provide skin photographs and may have their tumor and skin analyzed using advanced genetic and immune testing. Researchers will monitor tumor progression over six months to evaluate the AIs predictive performance. The study lasts from July 2023 to July 2028 and includes follow-up assessments. Participation involves no treatment changes, focusing on data and image collection to support future clinical decisions.

Researchers are conducting a global registry to monitor the long-term safety and effectiveness of Increlex therapy in children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency SPIGFD. This observational, non-interventional registry collects data from multiple countries including Austria, France, Germany, Italy, Poland, Spain, Sweden, the United Kingdom, and the USA. The main goal is to gather safety information during treatment and for at least five years after treatment ends. The registry includes participants who are starting, planning to start, or already receiving Increlex treatment as per local prescribing information. Increlex mecasermin is given as an injection with doses ranging from 40 to 120 mcgkg twice daily, prescribed by a physician. Data may be collected retrospectively for those already on treatment. The study tracks participants over long periods to observe treatment exposure, dose, and various health outcomes related to growth and development. Participants will be monitored for adverse events, including serious events and neoplasia, during treatment and up to five years afterward. Researchers will also assess changes in height, bone age, body mass index, pubertal stage, and quality of life. Biological markers like growth hormone and IGF-1 levels will be measured periodically. The registry collects comprehensive data on safety, effectiveness, and other health indicators to better understand outcomes in children and adolescents receiving Increlex therapy.

Researchers are conducting a long-term observational study to understand how dupilumab is used and its effects in patients with Chronic Obstructive Pulmonary Disease COPD who are treated as part of routine care. This study will follow about 350 to 500 participants in multiple sites across France over 36 months, collecting detailed information on patient characteristics, safety, and patient-reported outcomes. The goal is to describe various aspects of COPD and treatment history to better characterize this patient group. Participants in this study are those newly starting dupilumab treatment for COPD, as prescribed by their doctors in line with approved guidelines. The study does not involve any additional treatment but observes the use of dupilumab over time. No placebo or comparator group is included. Data will be collected retrospectively and prospectively, covering medical history before dupilumab initiation and ongoing treatment effects during the 36-month follow-up. Throughout the study, researchers will gather detailed data on demographics, disease characteristics, lung function, exacerbations, comorbidities, and patient-reported assessments such as quality of life and symptom scores. Safety outcomes, including adverse events and reasons for stopping treatment, will be monitored. The study duration for each participant is about 36 months, allowing long-term observation of treatment and disease progression in real-world conditions.