Morlaix

Researchers are studying advanced non-small cell lung cancer NSCLC with ALK gene rearrangement treated with next-generation tyrosine kinase inhibitors TKIs as first-line therapy. This prospective study, part of the national EXPLORE ALK cohort, aims to understand the biological characteristics and resistance mechanisms of this cancer type. It involves patients with stage IIIB or IV NSCLC who are not eligible for curative locoregional treatment and have confirmed ALK rearrangement. The study collects tumor tissue samples at diagnosis and at disease progression, if available, to analyze ALK fusion partners, variants, and co-mutations using RNA sequencing. Blood samples are taken at diagnosis, first tumor evaluation, and disease progression to analyze circulating tumor DNA ctDNA with next-generation sequencing. Treatments studied include alectinib, brigatinib, lorlatinib, and entrectinib, either marketed or under early access programs. Participants provide blood samples and allow use of tumor tissue for centralized biological analyses. Researchers measure progression-free survival up to 72 months as the primary outcome, along with overall survival, response rates, duration of response, ctDNA clearance, and resistance mechanisms associated with treatment and ALK fusion partners. The study involves regular evaluations over several years to monitor treatment outcomes and biological changes.

Philadelphia-negative myeloproliferative neoplasms MPNs such as Polycythemia Vera, Essential Thrombocythemia, and Prefibrotic Myelofibrosis are chronic blood cancers caused by mutations affecting blood cell growth. These diseases carry a high risk of blood clots, which can cause serious complications and death. Current treatments include low-dose aspirin, but blood clots still occur in some patients despite therapy. This trial aims to study whether direct oral anticoagulants DOACs, which have shown benefits in other cancer patients, might help prevent blood clots in MPN patients with a specific mutation called JAK2V617F. Participants will be randomly assigned to receive either a direct oral anticoagulanteither Apixaban 2.5 mg twice daily or Rivaroxaban 10 mg once dailyor low-dose aspirin 100 mg once daily. The choice of DOAC is up to the investigator. The treatments will be given to high-risk patients for up to 24 months to compare their effects on clot prevention. Throughout the study, participants will be closely monitored for any thrombotic or bleeding events. During the trial, researchers will track the time until any arterial or venous blood clots occur, as well as any major or clinically relevant bleeding events. They will also evaluate survival, adherence to therapy, quality of life, and healthcare costs related to these treatments. Participants will have regular follow-ups over 24 months, including assessments for heart rhythm problems and safety monitoring. This comprehensive approach aims to better understand the benefits and risks of DOACs compared to aspirin in preventing clots in MPN patients.

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.

Vestibular neuritis is a severe and ongoing dizzying condition caused by inflammation of the nerve connected to the inner ears balance canals. It causes sudden, intense vertigo with balance problems, nausea, and vomiting, but without hearing loss or other neurological symptoms. This condition is the second most common cause of peripheral vertigo and accounts for about 7% of vertigo cases. The study aims to determine if wearing Boarding Ring glasses can help speed up recovery of balance in people with vestibular neuritis. Participants are randomly assigned to one of three groups wearing Boarding Ring glasses, wearing placebo glasses, or not wearing any glasses. Each group undergoes several tests including caloric tests, measurement of eye movement speed nystagmus, angle of deviation in the Fukuda test, Alexanders degree of nystagmus, and completes questionnaires assessing balance disorder impact and anxiety. These evaluations occur at the start and over the course of one year to monitor changes. During the study, participants will perform balance-related tests such as walking in place and have eye movements recorded with special helmets. Questionnaires will assess the impact of vertigo on daily life and anxiety levels. The main outcome is the change in angle of deviation in the Fukuda test from day 0 to day 7. Secondary outcomes include eye movement speed, degree of nystagmus, hospitalization duration if applicable, and questionnaire scores over one year. The study monitors participants closely to understand how Boarding Ring glasses affect recovery from vestibular neuritis.

Researchers are evaluating whether electrodialyzed seawater can reduce the length of symptoms in infants with acute bronchiolitis compared to saline solution. This is a multicenter, prospective, randomized, double-blind study involving infants aged 1 month to less than 1 year. The study aims to measure how quickly illness resolves in these young patients. Infants will be randomly assigned to receive either the experimental electrodialyzed seawater solution or a control saline solution. Both treatments are sterile, isotonic seawater-based medical devices administered through the nose. Dosage varies by age, with infants under 6 months receiving up to 8 doses per day and those over 6 months receiving up to 6 doses per day. Parents will administer the treatments for up to 10 days. During the study, parents will be contacted by phone at days 1, 3, 6, 10, and 21 after starting treatment to monitor progress. The main outcome measured is the duration of illness resolution over the first 10 days. Secondary outcomes include cough improvement, nasal congestion, respiratory discomfort, sleep quality, hospitalizations, antibiotic use, and other health-related factors. The study will continue to monitor participants until December 2028.

This trial investigates the PREVENTURE program aimed at preventing alcohol and substance use among vulnerable teenagers aged 14 to 17. Researchers are evaluating how this program impacts adolescents identified as having personality traits that increase their risk for problematic substance use. The study addresses the lack of reliable primary prevention strategies for addictive behaviors in youth, focusing on vulnerable groups outside school settings and building on previous trials showing PREVENTUREs potential to reduce alcohol consumption. Participants will be assessed using the Substance Use Risk Profile Scale SURPS to identify risk personality traits. Those with at-risk traits are randomized into two groups one follows the PREVENTURE program involving two 90-minute videoconference sessions within three months plus routine care, while the other receives routine care alone. Both groups will have follow-up phone calls at 1, 3, 6, and 12 months to complete assessments using various tests and scales. Throughout the study, participants complete questionnaires on substance use, alcohol, tobacco, cannabis consumption, anxiety, depression, alcohol-related harm, quality of life, and study acceptability at multiple time points up to 12 months. The main outcome measure is the frequency of intensive punctual alcohol use at 6 months. This prospective, controlled, randomized, open-label study is sponsored by the University Hospital, Brest and includes detailed monitoring through phone interviews and questionnaires over the year following intervention or routine care.

Researchers are evaluating the long-term benefits of a nurse-led prevention program for adults starting extended corticosteroid therapy. This therapy is commonly used in various medical conditions but can cause serious side effects including bone, metabolic, and infectious complications. The study aims to compare this nurse-led program to routine care in reducing these adverse events and improving quality of life over one year. Participants are randomly assigned to one of two groups one group receives standard care plus a general summary sheet of preventive measures without individual assessment the other group participates in a nurse-led prevention program that includes an educational video, personal nurse interviews, dietitian consultations, tailored preventive advice sheets for patients and their doctors, and follow-up phone calls at 12, 24, and 36 weeks. Both groups are monitored for 52 weeks. Throughout the study, participants will attend baseline and week-52 visits involving clinical evaluations, routine lab tests, bone density scans, and quality of life questionnaires. Corticosteroid use is tracked continuously via a dedicated notebook. An independent physician blinded to group assignment assesses the overall burden of corticosteroid-related adverse events at the end of the study using the glucocorticoid toxicity index. The study will also monitor the occurrence of specific complications, adherence to preventive measures, and cumulative steroid dosage.

Researchers are studying patients with hemopathies who are starting oral therapy treatments to better understand how electronic monitoring might improve treatment adherence and safety. The study compares standard follow-up care with follow-up using a digital telemonitoring platform called Cureety, designed to help cancer patients report side effects and support medical teams. This research focuses on patients taking oral therapies for six months or more and aims to detect and manage side effects in real time to improve patient safety and quality of life. Participants will be randomly assigned to one of two groups one receiving standard care and the other using the Cureety telemonitoring platform. The platform allows patients to self-report adverse events, which helps healthcare providers monitor treatment effects more closely. Both groups may receive intravenous treatments alongside oral therapy when recommended. The study will last at least six months for each participant, focusing on treatment adherence and safety. During the study, participants will be regularly assessed for medication compliance at months 1, 3, and 6. Researchers will monitor adverse events continuously or at specified times and track unexpected hospitalizations, including their number, duration, and reasons over six months. Patients will be supported to follow prescribed treatments correctly, and the study will evaluate how electronic monitoring affects treatment adherence and patient health outcomes over time.

Lung cancer is a common and serious disease, with many patients diagnosed at an advanced or metastatic stage where surgery is no longer an option, and treatment focuses on palliative care. Respiratory rehabilitation has been shown to help patients with other lung conditions by reducing symptoms and improving quality of life, but its benefits for patients with advanced, non-operable non-small cell lung cancer NSCLC are not well studied. This research evaluates the effect of a respiratory rehabilitation program on quality of life for NSCLC patients undergoing maintenance chemotherapy and immunotherapy. Participants are randomly assigned to one of two groups one receiving standard maintenance chemotherapy and immunotherapy without respiratory rehabilitation, and the other receiving the same maintenance treatment combined with a respiratory rehabilitation program. The rehabilitation consists of two sessions per week for eight weeks, including personalized assessments, exercise training on ergocycle and treadmill, muscle strengthening, therapeutic education, group gymnastics, smoking cessation support, and socio-psychological and nutritional assistance. During the study, participants will have their quality of life measured at the start and after eight weeks using specific questionnaires EORTC QLQ-C30 and QLQ-LC13. Additional assessments include exercise capacity tests, evaluation of symptoms like dyspnea, anxiety and depression scales, and monitoring of hospitalizations and tumor response. The study aims to track these outcomes to understand the impact of respiratory rehabilitation on patients well-being over time.

This research aims to evaluate the importance of monitoring CALR allele burden as a molecular marker to understand disease progression in patients with CALR-mutated myeloproliferative neoplasms MPNs. It builds on earlier findings from a local study of 45 patients, which showed that quantifying CALR mutations could predict outcomes independently of established risk scores. The study plans to include a large group of 260 patients with various types of CALR-mutated MPNs to better model how CALR allele burden changes over time. Participants will have their blood collected at diagnosis and during follow-up visits, with up to one sample per year for a maximum of three years. This allows researchers to measure the CALR allele burden through DNA extraction and fragment analysis. Additionally, at diagnosis, a mutational profile will be studied using advanced sequencing methods. The study will also assess a clinical and biological scoring system to determine disease progression in Essential Thrombocythemia and Myelofibrosis cases. During the study, participants will provide blood samples at diagnosis and annually for up to three years. Researchers will evaluate the relationship between CALR allele burden changes and disease progression using this data. They will also analyze characteristics like pathology type, treatment, and additional mutations to understand their impact on allele burden trajectories. The main outcome is to determine how these trajectories relate to the time until disease progression, supporting better monitoring and management of CALR-mutated MPNs.