La Reunion

Pediatric acute myeloid leukemias are serious diseases with a poor outlook and a high chance of relapse. This research aims to collect biological samples to study the genetic makeup of leukemic cells from children, teenagers, and young adults at diagnosis or relapse. The goal is to better understand the key genetic changes that cause resistance and may predict relapse risk. The study also explores bone marrow stem cells and tests how leukemic cells respond to multiple drugs outside the body. Participants include those under 25 years old with acute myeloid leukemia at first diagnosis or relapse, as well as patients with a genetic risk for leukemia or those undergoing bone marrow sampling without leukemia to serve as controls. Blood and bone marrow samples are collected, with multiple tubes taken at diagnosis and relapse for those with leukemia, and single samples for others. These samples are used for genetic sequencing, expression profiling, and drug testing. During the study, researchers will analyze the number of genetic mutations and other molecular features up to five years after sample collection. They will monitor relapse rates, survival without events, and disease-free survival. Other measurements include stem cell profiles, drug response patterns, and clearance of minimal residual disease. Participants may be followed for up to five years to assess these outcomes and better understand leukemia biology and treatment resistance.

Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy ADT with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.

This research aims to reduce extubation failure in critically ill patients with acute brain injuries who have impaired consciousness. These patients often require mechanical ventilation with tracheal intubation, and after their acute neurological condition is treated, doctors need to carefully wean them off ventilators to avoid complications like pneumonia. Current guidelines for ventilator weaning do not include brain-injured patients with impaired consciousness, so this study evaluates a simple clinical score to help decide when to safely remove the breathing tube. Participants will be assigned by random clusters of intensive care units to receive either usual care or care guided by the extubation readiness clinical score. After a successful spontaneous breathing trial, clinicians in the intervention group will use the score based on swallowing, gag reflex, cough, and consciousness level to decide on extubation. If the score is above 9, extubation should proceed. Those in the usual care group will follow standard ICU ventilator weaning protocols. The study uses a stepped wedge cluster randomized design. During the study, patients are assessed daily for readiness to breathe without the ventilator. Researchers will monitor extubation failure from the time of extubation up to five days later. They will also track other outcomes such as time to extubation, duration of mechanical ventilation, reintubation rates, pneumonia occurrence, hospital stay length, and neurological outcomes up to 90 days. This thorough evaluation helps understand how the score may improve the timing and success of extubation in this vulnerable group.

This research evaluates the effect of intravenous milrinone on brain blood flow and prevention of delayed cerebral ischemia DCI in adults with severe subarachnoid hemorrhage caused by ruptured brain aneurysms. The study focuses on patients who are comatose or sedated shortly after the hemorrhage and aims to determine how 10 days of milrinone compared to placebo affects the volume of brain lesions related to DCI. This randomized, double-blind, multi-center trial addresses a major cause of death and disability where current treatments lack strong scientific evidence. Participants receive either standard care plus milrinone infusion or standard care plus a placebo infusion starting from day 4 to day 14 after aneurysm treatment. Milrinone is given intravenously at a dose of 0.75 micrograms per kilogram per minute. Both groups are closely monitored for signs of vasospasm and may receive additional endovascular treatment if needed. Daily clinical exams and collection of biological data occur during this high-risk period. The study observes complications related to intensive care such as neurological, pulmonary, cardiac, and septic events. Throughout the study, brain CT scans are done at 48 hours post-treatment and again at 1 month to measure DCI lesion volumes. Neurological outcomes, quality of life, and mortality are assessed at multiple points up to one year. Safety is monitored continuously, and detailed data on complications and time spent in intensive care are recorded. This comprehensive follow-up helps researchers evaluate the impact of milrinone on brain injury and recovery after severe subarachnoid hemorrhage.

Researchers are evaluating treatments for moderate acne in patients with darker skin types Fitzpatrick phototypes IV-VI, focusing on acne-related pigmentation that affects quality of life. This randomized controlled trial compares oral isotretinoin as a first-line treatment against the current standard of care involving oral antibiotics and topical creams. The study aims to assess which approach better improves pigmentation severity after six months. Participants will be assigned to one of two groups. One group receives oral isotretinoin starting at 0.5 mgkg daily for six months, with dose adjustments possible based on tolerance and effectiveness. The other group follows standard care, receiving topical tretinoin or adapalene along with doxycycline or lymecycline for three months, followed by evaluation at three and six months. Dose changes may occur according to clinical response. During the study, participants will attend monthly visits if receiving isotretinoin or visits at three and six months for the standard care group. Researchers will assess acne-related pigmentation severity, quality of life, and any adverse events. Participants must have a cell phone capable of taking high-definition selfies to assist in monitoring. The total study duration for each participant is six months, with ongoing safety and effectiveness checks.

Vitiligo affects about 1 to 2% of people worldwide and can greatly reduce quality of life. Researchers are studying how the drug ritlecitinib, which blocks certain enzymes involved in the immune response, works alone or combined with narrowband UVB light therapy to treat vitiligo. This study aims to compare the improvement in vitiligo severity on the face and body after 52 weeks between these two treatment approaches. Participants will be randomly assigned to receive either ritlecitinib 100 mg once daily by mouth alone or combined with narrowband UVB light therapy twice weekly for 52 weeks. After this period, all participants will continue taking ritlecitinib 100 mg daily in an open-label phase. The study will include patients with different skin types and vitiligo that is either active or stable. Treatment effects will be evaluated across these groups. Participants will attend eight study visits over about 72 weeks for assessments including skin evaluations, blood sample collection, and pregnancy tests every four weeks for women who can become pregnant. Some volunteers will have skin biopsies at baseline, week 4, and week 52. Researchers will measure changes in vitiligo severity using scoring indexes focused on the face and total body. Safety and quality of life will also be monitored throughout the study.

Researchers are studying congenital nevus CN, a pigmented skin lesion present at birth that grows as the child grows. CN varies in size from small to giant and is linked to genetic mutations mainly in NRASBRAF genes. Larger CNs may lead to neurological problems such as neuro-meningeal melanosis and developmental delays, as well as an increased risk of melanoma. The study also looks at the social and emotional impact on children and their families, aiming to improve monitoring and treatment guidelines. The study involves children under 2 years old with medium to giant CN. It includes neurodevelopmental assessments using the ASQ-3 screening tool, meetings with parents to assess acceptance and quality of life via the MARKS test, and evaluations of patient quality of life. The study is non-randomized and observational in nature, focusing on monitoring and understanding CN characteristics and related risks. Participants will be followed for 3 years, during which the study will measure neurodevelopmental abnormalities, neurological issues such as epilepsy, MRI findings, melanoma occurrence, and changes in CN features. It will also assess parental satisfaction with care, lesion acceptance, and patient well-being through questionnaires. This long-term follow-up aims to gather detailed information to guide future CN management and improve outcomes for affected children.

Researchers are studying how inhaled aromatherapy using a mixture of ginger and lemon essential oils can help manage nausea and vomiting caused by chemotherapy in patients with blood cancers. This study aims to see if adding this aromatherapy to standard anti-nausea treatments improves nausea scores, quality of life, and appetite during the first day of chemotherapy treatment. The trial is conducted across multiple centers with experienced medical and nursing staff coordinating the safe and scientific use of aromatherapy. Participants are randomly assigned to one of two groups one receives the usual anti-nausea treatment plus inhalation of the ginger and lemon essential oil blend, while the other receives the same standard care plus a placebo aromastick with a neutral, odorless oil. Patients will use their assigned aromastick during three chemotherapy cycles. The study uses a double-blind design to compare the effects of the inhaled aromatherapy against placebo. During the study, participants will be monitored for nausea and vomiting intensity at various times up to three months after treatment begins. Researchers will also assess quality of life, dietary intake, and the use of antiemetic medications. The study includes evaluations at one day, four days, one month, two months, and three months to gather comprehensive data on symptoms and overall well-being. The total participation period covers multiple chemotherapy cycles and follow-up assessments to understand the impact of aromatherapy on chemotherapy-induced nausea and vomiting.

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.

This observational study focuses on adults aged 18 years and older diagnosed with Philadelphia chromosome positive Ph or BCRABL1 acute lymphoblastic leukemia ALL. It aims to collect real-world data on patients treated with a combination of BCRABL1 inhibitors alongside chemotherapy, corticosteroids, or monoclonal antibodies. The study is sponsored by Versailles Hospital and seeks to better understand treatment outcomes in this specific patient group. Participants have already received or are receiving treatment that combines BCRABL1 inhibitors with other therapies such as chemotherapy, corticosteroids, or monoclonal antibodies. This study observes these treatments without assigning any new interventions, focusing on the natural course and outcomes of this combined treatment approach in routine clinical care. Throughout the study, participants health and treatment responses are monitored over several years. Researchers will evaluate overall survival at 12 and 36 months, remission rates, molecular responses in bone marrow and blood, event-free and relapse-free survival, mutation incidence, treatment tolerance, and deaths during induction and remission. Data collection will involve regular assessments aligned with standard medical care, and participation may last until study completion in late 2027.