Blois

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 evaluating patients with early-stage estrogen receptor positive (ER+) and HER2 negative breast cancer who are receiving adjuvant endocrine therapy and have high-risk clinical features for relapse. The study aims to detect molecular relapse early using circulating tumor DNA (ctDNA) analysis and to compare whether adding palbociclib and fulvestrant can delay or prevent relapse compared to standard endocrine therapy. This is a phase 2, multi-center, randomized, open-label trial focusing on patients with no visible disease on imaging but positive ctDNA results indicating molecular relapse. The trial has two phases. The first is a surveillance phase where patients undergo 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 second, treatment phase where they are randomly assigned to receive either standard endocrine therapy or a combination of palbociclib (125 mg daily for 21 days in each 28-day cycle) and fulvestrant injections (500 mg intramuscularly on specified days). Treatment lasts up to 24 months, with imaging every six months to check for visible disease. Participants will have regular blood tests and imaging scans to monitor disease status and treatment effects. Researchers will measure the incidence of positive ctDNA results over up to 36 months and relapse-free survival over 60 months from randomization. Safety and treatment adherence will be closely tracked, and patients discontinuing due to visible disease will receive standard care outside the trial. The total follow-up includes the surveillance and treatment phases with ongoing monitoring.

Researchers are studying adults with community-acquired pneumonia who need oxygen therapy due to acute respiratory failure meeting acute respiratory distress syndrome (ARDS) criteria. This condition often leads to tracheal intubation and poor outcomes. Previous studies showed that prone positioning reduces mortality in invasively ventilated ARDS patients and improves oxygenation in non-intubated patients with viral pneumonia, including COVID-19 cases. This trial focuses on patients with non-COVID community-acquired pneumonia using nasal high flow therapy, aiming to see if awake prone positioning can reduce the need for intubation and related treatments like sedation and muscle relaxation. Participants will be encouraged to spend as much time as possible in the prone position, ideally 4 to 8 hours per session, with a goal of up to 16 hours or more within each 24-hour period, depending on their tolerance. This intervention is compared to usual care without prone positioning. The study excludes patients with recent COVID-19 infection or those requiring immediate intubation. During the study, researchers will monitor patients for up to 28 days after randomization, focusing on whether they require intubation. Participants will be admitted to an intensive care or intermediate care unit, and their oxygen levels will be closely assessed using the PaO2/FiO2 ratio or equivalent SpO2/FiO2 measurements. Consent and social security affiliation are required. Safety and effectiveness of awake prone positioning in reducing intubation needs will be evaluated throughout the study period.

Cryoglobulinemia vasculitis (CV) is a systemic immune-related disease affecting small blood vessels. Researchers are studying the safety and effectiveness of belimumab compared to a placebo in adults with active, non-infectious CV who previously received rituximab. The trial is a multicenter, randomized, double-blind Phase 2 study designed to address CV relapse, which occurs in up to 40% of patients after rituximab treatment, possibly due to increased serum Blys levels. Participants receive either belimumab or placebo through weekly subcutaneous injections of 200 mg from week 1 to week 24. Both groups follow the same corticosteroid tapering schedule starting with 30 mg/day of prednisone, gradually reducing the dose every two weeks until discontinuation around week 12, depending on disease activity. The study monitors disease activity closely to guide steroid reduction. During the study, participants will have regular assessments to measure clinical response, focusing on complete clinical response at week 25 after corticosteroid withdrawal at week 12. Researchers will evaluate safety and effectiveness, including signs of vasculitis activity and laboratory tests. The total duration of participation covers the treatment and follow-up periods up to week 25, ensuring thorough monitoring of outcomes and safety.

Researchers are conducting a phase 3, multicenter, open-label, randomized study to evaluate new treatments for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation (ASCT). The study aims to compare the effectiveness and safety of a combination of elranatamab and lenalidomide as a replacement for standard chemotherapy during the consolidation phase, and to assess elranatamab alone versus standard care during maintenance therapy. Participants will first receive standard induction therapy with four cycles of a drug combination called D-VRd. After this, they will be randomly assigned to either receive standard consolidation therapy involving high-dose chemotherapy and ASCT followed by D-VRd consolidation (Arm A), or elranatamab combined with lenalidomide for consolidation (Arm B). Upon completing consolidation, patients will be re-randomized to receive maintenance treatment with either lenalidomide alone (Arm C) or elranatamab alone (Arm D). During the study, participants will be monitored for treatment effects including minimal residual disease negativity at the end of consolidation, progression-free survival, and overall survival. The study involves various assessments including clinical evaluations, laboratory tests, and monitoring for disease progression or side effects. The entire treatment and follow-up period may last up to several years, allowing researchers to evaluate long-term outcomes and safety.

Schizophrenia is a condition affecting about 0.7% of people and often involves poor insight, which can lead to poor medication adherence, relapse, and rehospitalization, negatively impacting quality of life. Psychoeducation has shown potential to improve treatment compliance and the therapeutic relationship. This trial evaluates an individual early psychoeducation program called PEPITS, designed to support patients during the initial hospitalization phase to improve insight, medication adherence, and reduce relapse. The PEPITS program is delivered by nurses and consists of three main phases: an introduction phase, a pathology and care phase, and a recovery and "stepping stone" phase. Each phase involves several sessions that provide patients with information, key knowledge, and new skills related to their illness and recovery process. Participants in the study will either receive the PEPITS program alongside usual psychiatric care or just the usual care without PEPITS. Participants will be followed for one year after randomization. Researchers will assess changes in patients' insight over this period as the primary outcome. Throughout the study, patient progress, relapse, and medication adherence will be monitored to evaluate the program's impact. The total participation lasts up to one year, allowing detailed observation of the program's long-term effects.

Recent advances in immunotherapy using inhibitors like anti-PD-1 and anti-CTLA-4 have transformed treatment options for advanced or metastatic melanoma. However, only some patients benefit from these treatments, so identifying who will respond is crucial. This research focuses on developing a new predictive tool based on visible skin damage called dermatoheliosis around the melanoma scar. This skin marker, linked to tumor mutational burden (TMB), could help predict response to anti-PD-1 therapy without expensive genetic testing. The study will develop and validate an artificial intelligence (AI) algorithm that analyzes photographs of the skin around melanoma scars to assess dermatoheliosis. Patients with inoperable stage III or IV melanoma or skin carcinoma will participate, including both retrospective patients previously treated with immunotherapy and prospective patients starting treatment. The algorithm aims to correlate dermatoheliosis features with tumor and immune profiles to predict treatment outcomes. Participants will have photographs taken of their melanoma scars, and researchers will collect tumor DNA, RNA, and immune data. The main measure is how well the AI predicts tumor progression after six months. Patients' skin, tumor, and immune responses will be studied to understand the link between dermatoheliosis and treatment effects. The study hopes to provide a simple, non-invasive marker to guide immunotherapy decisions and improve patient care.

Researchers are monitoring the long-term safety and effectiveness of Increlex4, a treatment for children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD). This global registry study is observational and non-interventional, designed to collect safety data during treatment and for at least five years after treatment ends. The study includes participants who have already started Increlex4 therapy as well as those beginning treatment, across various countries including the USA and several European nations. Participants receive Increlex4, a mecasermin injection given twice daily at doses ranging from 40 to 120 mcg/kg or 0.04 to 0.12 mg/kg, as prescribed by their physician. The study does not assign treatments but records data from patients undergoing routine care. This registry captures real-world use of Increlex4 according to local approved guidelines for managing SPIGFD. Throughout the study, researchers collect information on serious adverse events, any adverse events, deaths, and withdrawals related to treatment. Data collection continues during the treatment period and up to 30 days after the last dose. Safety monitoring is the primary focus, with long-term follow-up planned for at least five years post-treatment to assess ongoing health outcomes in children and adolescents receiving Increlex4 therapy.

This research aims to evaluate the role of wicking, a common practice after ear surgeries such as myringoplasty and ossicular surgery, which involves placing a wick in the external ear canal. These surgeries often require this procedure after replacing the tympanomeatal flap. Despite its frequent use, the necessity and benefits of wicking remain uncertain, as it can cause discomfort like ear fullness, pain, and temporary hearing loss, and requires removal which patients often fear. No large, prospective, randomized, multicenter studies have yet proven its superiority in healing after middle ear surgery. The study compares two groups of patients undergoing ossicular surgery or myringoplasty. One group will receive absorbable or non-absorbable wicking placed in the ear canal after surgery, while the other group will have no wicking applied. Surgeries may be performed endoscopically or through other ear approaches, and various graft types for tympanic reconstruction are used. The study explores whether healing is affected by the absence of wicking. Participants will be monitored for healing of the ear canal and tympanic membrane, with primary outcomes assessed three months after treatment. Researchers will evaluate healing progress, ear symptoms, and hearing outcomes. The study includes adults who understand French and meet the surgical criteria. Follow-up involves observation of ear function and recovery to understand if avoiding wicking leads to better comfort without compromising healing.

Researchers are conducting a long-term observational study to understand patients with Chronic Obstructive Pulmonary Disease (COPD) who are treated with dupilumab as part of routine care. The study aims to gather information on patient characteristics, safety, and patient-reported outcomes over time. This study includes adults with uncontrolled COPD despite standard treatments and elevated blood eosinophil levels, reflecting real-world use of dupilumab. Participants will be followed for approximately 36 months at up to 50 sites in France. This study is non-interventional, meaning it observes patients receiving dupilumab as prescribed by their doctors without altering treatment. It collects data retrospectively and prospectively from patients newly starting dupilumab under approved guidelines for COPD. During the study, researchers will analyze various baseline and historical clinical data, including demographics, medical history, lung function, symptom patterns, exacerbations, inflammatory markers, comorbidities, and treatment history. Safety and patient-reported measures will also be assessed over the follow-up period. The study will provide detailed descriptive statistics to better characterize this patient population and the long-term outcomes of dupilumab treatment in COPD.