La Reunion

Pediatric acute myeloid leukemia (AML) is a serious disease with a survival rate of 60-75% and a relapse rate of 35-45%. This research aims to better understand the biological factors behind AML, especially the genetic changes in leukemic cells at diagnosis and relapse, to identify key genetic markers linked to treatment resistance and relapse risk. The study also explores the role of bone marrow mesenchymal stem cells and tests the effects of multiple drugs outside the body. Participants in this study will provide additional blood and bone marrow samples. For one group, three extra tubes of blood and bone marrow will be collected at diagnosis and if relapse occurs. For other groups, one extra tube of blood and bone marrow will be collected at the start of the study. These samples will be used for genetic profiling and drug testing to better understand the disease. During the study, researchers will monitor the number of genetic mutations in leukemic cells from diagnosis through relapse over a period of up to five years. Participants will undergo sample collections as part of their standard care, and informed consent is required from patients or their guardians. The study will gather detailed information to improve identification of high-risk patients and develop better treatment strategies.

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

This research aims to reduce extubation failure in critically ill patients with severe brain injuries who have ongoing impaired consciousness. These patients require mechanical ventilation through tracheal intubation after acute neurological injury. Because of residual neurological problems affecting airway control, extubation failure is common, and current guidelines for ventilator weaning exclude these patients. A clinical score developed in 2017 uses four neurological and airway reflex elements to predict extubation success with good accuracy. The study compares two approaches to extubation readiness after patients have passed a spontaneous breathing trial. In the intervention group, clinicians use the clinical score to decide if extubation should proceed when the score is above 9. In the control group, extubation is done according to usual care practices. Eligibility for the spontaneous breathing trial is assessed daily, and patients must have residual impaired consciousness and meet other criteria. The study uses a stepped wedge cluster randomized design involving intensive care units. Participants will be monitored from extubation through five days afterward to assess extubation failure. Researchers will measure whether using the clinical score improves timing and success of extubation compared to standard care. The study involves detailed neurological assessments and daily evaluations during the weaning process. The total study involvement includes screening, intervention with extubation decisions, and monitoring of respiratory outcomes within this critical care setting.

Researchers are evaluating the effect of intravenous milrinone on cerebral blood flow and the prevention of delayed cerebral ischemia (DCI) in adults with severe aneurysmal subarachnoid hemorrhage (SAHa) caused by intracranial aneurysm rupture. This Phase 2, randomized, multi-center, double-blind study focuses on patients who are comatose or sedated three days after severe SAHa (WFNS grades IV-V). The study aims to determine whether 10 days of milrinone treatment can reduce the volume of DCI lesions seen on CT scans one month after treatment compared to placebo, alongside standard care. Participants are randomly assigned to receive either intravenous milrinone at a dose of 0.75 µg/kg/min or a placebo (intravenous glucose 5%) from day 4 to day 14. All patients undergo a baseline brain CT scan 48 hours after aneurysm treatment. If vasospasm occurs and medical treatments are ineffective, endovascular therapy may be offered. During the treatment period, daily clinical exams, biological and general data collection, and close monitoring of cerebral tissue oxygen pressure (PtiO2) and complications in the intensive care unit are conducted. Throughout the study, researchers measure the volume of DCI lesions on a CT scan at one month and assess neurological outcomes, quality of life, and mortality at 1, 3, 6, and 12 months. Safety is closely monitored by tracking adverse events and complications related to neurological, pulmonary, cardiac, and infectious issues. Participant involvement lasts up to one year with scheduled follow-ups to evaluate long-term effects and recovery.

Researchers are studying moderate acne in patients with darker skin types (Fitzpatrick phototypes IV-VI) to compare the effects of oral isotretinoin against the current standard treatment on acne-related pigmentation (ARP). ARP affects about 65% of these patients and impacts quality of life by causing discoloration. The study aims to see if isotretinoin, usually prescribed only after antibiotics fail, is better as a first-line treatment for ARP severity after six months. This is a Phase 3, multicenter, randomized controlled trial involving 420 subjects. Participants will receive either oral isotretinoin starting at 0.5 mg/kg daily (adjusted based on tolerance and response, with a total cumulative dose target of 120 to 150 mg/kg) or a topical cream (retinoic acid or adapalene) combined with oral antibiotics (doxycycline or lymecycline) for the first three months. After three months, the effectiveness will be checked; if acne improves, antibiotics stop but topical treatment continues. If acne remains moderate or severe, isotretinoin may be started. The study compares these approaches over six months. During the study, participants will be monitored for acne severity and pigmentation changes. They must have a cell phone capable of taking high-quality selfie pictures for monitoring. Safety tests include blood work for liver function and lipids. Women of childbearing potential will have pregnancy tests and require effective contraception. Researchers will assess the severity of acne-related pigmentation at six months as the primary outcome. The study will last six months with close follow-up and clinical evaluations to track treatment response and safety.

This research focuses on infants and young children under 2 years old who have medium to giant congenital nevi, which are pigmented skin lesions present at birth that grow as the child grows. These nevi vary in size and are linked to genetic mutations in NRAS and BRAF genes. Large congenital nevi can lead to neurological issues like neuro-meningeal melanosis, hydrocephalus, or brain malformations, which may cause early neurodevelopmental delays. There is also an increased risk of melanoma with larger nevi, and parents often experience anxiety due to cancer risk and social stigma. The study aims to better understand these neurodevelopmental and melanoma risks as well as psychosocial impacts to improve monitoring and treatment guidelines. Participants will undergo neurodevelopmental assessments using the Ages and Stages Questionnaires, Third Edition (ASQ-3), which evaluates developmental progress. Parents will meet with researchers to assess their acceptance of the lesion and quality of life through the MARKS test. Additionally, data on the child's quality of life will be collected. These evaluations will help understand the impact of the nevus and associated risks over time. During the study, children will be followed until they reach 3 years old to determine the prevalence of neurodevelopmental abnormalities related to their nevus size and characteristics. Parents' perspectives and the child's quality of life will be monitored as part of the study. This comprehensive approach aims to provide clearer evidence-based recommendations for monitoring and managing children with medium to giant congenital nevi.

Researchers are evaluating the effectiveness of inhaling a mixture of ginger and lemon essential oils to reduce nausea and vomiting caused by chemotherapy in patients with blood cancers. This study compares the essential oil blend to a placebo, alongside regular anti-nausea treatments, to see if it can improve symptoms during the early phase after chemotherapy. The trial takes place in five centers specializing in blood and cancer care and emphasizes a patient-focused approach to supportive care. Participants will receive aromasticks containing either the essential oil blend or a neutral oil to inhale. The study follows strict procedures for making and using the oils safely, coordinated by healthcare professionals trained in aromatherapy and research methods. This double-blind, randomized trial ensures that neither the participants nor the researchers know who receives the active treatment or placebo. During the study, participants' nausea levels will be tracked at one, two, and three months to assess the treatment's effectiveness. Researchers will also monitor quality of life and appetite. Patients must be able to use the aromasticks and communicate in French. Safety and adherence are carefully monitored throughout the trial.

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.

Researchers are evaluating new treatments for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS) in this multi-arm, multi-stage Phase 1 and Phase 2 study called FaR-RMS. The study aims to assess the effects of new drug combinations, changes in maintenance therapy duration, dose adjustments, radiotherapy timing, and the use of genetic and imaging markers to improve outcomes and quality of life. It also explores risk classification using the PAX-FOXO1 fusion gene and FDG PET-CT scans as prognostic tools after initial chemotherapy. Participants may receive various chemotherapy drugs including Irinotecan, Actinomycin D, Doxorubicin, Ifosfamide, Vincristine, Vinorelbine, Cyclophosphamide, Temozolomide, and Regorafenib. Radiotherapy is also part of the treatment options. The study includes multiple randomizations and registrations depending on patient risk and disease status. Newly diagnosed patients are ideally enrolled before chemotherapy, but those at other treatment stages or with relapsed disease can also join. Some patients may enter more than one randomization based on their condition. During the study, participants undergo regular assessments to monitor tumor progression, treatment response, and side effects. Researchers track event-free survival and local failure-free survival over time, with follow-up ranging from 36 months to a minimum of 6 years for some groups. Safety, quality of life, and the impact of treatments are closely monitored through clinical exams, imaging, and laboratory tests. Participants provide informed consent and agree to contraception use if applicable. The total study involvement varies based on the treatment arm and disease status.

Electroconvulsive therapy (ECT) has been used since the 1930s primarily to treat drug-resistant depressive illnesses and has shown effectiveness in other psychiatric disorders. Despite its benefits, ECT can cause side effects, and in France, there is no current consensus on the best medical care for patients receiving this treatment. This project aims to identify how ECT is administered in France and to develop research that evaluates and improves its effectiveness based on updated healthcare models and national recommendations. The study focuses on observing and collecting data about ECT procedures in France without testing specific interventions or treatments. It seeks to understand current practices and patient outcomes to help maintain and enhance the guidance provided by the French National Agency for Accreditation and Evaluation in Health. Participants who are referred for ECT will be observed for treatment efficiency between 2018 and 2022. Researchers will monitor the therapeutic effects and side effects of ECT to assess its overall efficiency. The study involves tracking patient progress and outcomes to inform future recommendations and improve care standards.