Bastia

Researchers are evaluating the safety and effectiveness of increasing doses of IPN10200 to understand its pharmacodynamics and identify the best dose for treating adults with upper limb spasticity. This integrated Phase I/II, multicenter, double-blind, randomized study also compares IPN10200 with Dysport and placebo to find the optimal balance of efficacy and safety in adults aged 18 to 70 years with spastic hemiparesis following stroke or traumatic brain injury. Participants receive either IPN10200, Dysport, or placebo as a powder and solvent solution for injection. The study includes dose escalation and dose-finding phases to assess different dosing levels. Treatments are administered in the affected upper limb muscles, with eligibility based on specific muscle tone and spasticity angle criteria. The study monitors participants for up to 9 months, including a safety follow-up period. During the study, participants undergo regular assessments including vital signs (blood pressure and heart rate), clinical lab tests, physical examinations, and monitoring for treatment-emergent adverse events and antibodies to the study drugs. Researchers use these measures to evaluate safety and treatment effects over the 9-month period from baseline through the end of the study.

Researchers are evaluating whether adding repeated 30-minute periods of 30° side positioning can improve lung aeration in patients with moderate to severe acute respiratory distress syndrome (ARDS). This prospective, open, single-group study aims to assess how lateral positioning combined with prone positioning affects lung ventilation and oxygenation. The study focuses on changes in lung aeration measured by electrical impedance tomography (EIT) and the distribution of tidal volume in different lung regions. Secondary objectives include examining blood oxygen and carbon dioxide levels, ventilatory parameters, and potential side effects related to lateral positioning. Participants will undergo sessions involving 30-minute periods of lateral positioning at 30° tilt on each side while in both lying on the back (supine) and lying on the stomach (prone) positions. The upper bed will be inclined by 30° during lateral phases. After initial lateral sessions in the supine position, patients will be placed in strict prone position for 6 hours, followed by 12 hours of alternating lateral positioning while remaining prone. The study concludes with a 1-hour observation period after returning to the supine position, totaling 20 hours of intervention. Throughout the study, patients will be monitored using electrical impedance tomography to track lung aeration changes, along with regular measurements of oxygen and carbon dioxide levels in the blood and ventilatory pressures. Researchers will evaluate the percentage of patients achieving improved oxygenation and compare lung function across different positions and time points. Safety and potential adverse effects of lateral positioning will also be assessed. The primary outcome measure is modification of pulmonary aeration up to 25 hours.

Researchers are studying patients who have metastatic lung cancer and have survived for more than three years after their diagnosis without receiving cytotoxic chemotherapy. The focus is on understanding their clinical features, health status, quality of life, and socio-economic impacts, including the effects of cancer treatments, the occurrence of new diseases, and return to work. This observational study aims to better identify the needs of these long-term survivors to improve their management. Participants will complete several questionnaires, including the Hospital Anxiety and Depression Scale (HAD), the Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13), and the Aix-Marseille-University (AMU) questionnaire. These are designed to assess anxiety, depression, lung cancer symptoms, treatment side effects, and overall quality of life. Questionnaires are completed at the start of the study, at 6 and 12 months, and then yearly for up to 5 years. Participants will be followed during their regular medical consultations as per usual care at participating centers. Throughout the study, researchers will collect information on clinical characteristics, treatment details, health status, socio-demographic factors, and quality of life measures. Data will be gathered at baseline and during follow-up visits up to 5 years. This information will help assess the long-term impact of lung cancer and its treatments on patients who are living well beyond initial expectations.

Researchers are gathering real-world data on patients aged 70 years and older who are receiving first-line treatment for thoracic tumors, specifically Non-Small-Cell Lung Carcinoma (NSCLC). This Phase 4 study aims to characterize patients in terms of their geriatric, biological, and cancer-related features. It will also describe treatment methods by disease stage and evaluate outcomes related to treatment effectiveness, safety, and quality of life. Subgroups of patients treated with the same medication or innovative strategies will also be explored. Participants will receive systemic treatments that are authorized and available through standard care or compassionate use. Blood samples will be collected before starting treatment and stored in a biobank for up to 10 years. Quality of life will be assessed using specific questionnaires at various time points depending on disease stage and treatment type. Geriatric assessments including autonomy scales, cognitive tests, depression screening, fall history, and social environment evaluations will be performed. During the study, participants will follow their usual clinical care with regular visits, laboratory tests, imaging, and biopsies as needed to monitor their general health, treatment effectiveness, and side effects. They will complete quality of life questionnaires and undergo assessments tailored for older adults. Researchers will measure progression-free survival, defined as the time from first treatment dose until disease progression or death, with follow-up lasting up to two years.