Aubagne

Researchers are evaluating the use of an AI-assisted method for the second reading of screening mammograms compared to the standard second reading by radiologists. This study aims to determine if the AI-assisted approach is not worse than the standard method and if it offers economic advantages. Participants are women undergoing mammograms as part of the breast cancer screening program in France. The study involves two reading pathways for mammograms eligible for a second reading: the conventional second reading by an accredited radiologist (control arm) and the AI-assisted second reading (experimental arm) using the MammoScreen device. In the AI-assisted arm, the AI first reviews the mammogram, and only if it flags suspicion does a radiologist perform a second review. The final decision uses the more concerning result from either arm to determine if recall for further examination is needed. Participants will undergo screening mammograms with both reading processes applied. Researchers will compare diagnostic performance and economic impact between the two pathways, focusing on recall rates at the end of a 24-month inclusion period. Women will participate according to the breast cancer screening schedule and provide informed consent for study involvement.

Post-thrombotic syndrome (PTS) is a frequent long-term complication of deep vein thrombosis (DVT) that significantly affects patients' quality of life and increases healthcare costs. This research aims to study how the extent of blood clot burden in the veins, measured by a special ultrasound score called the Venous Volumetric Index (VVI), can predict the likelihood and severity of PTS six months after a first episode of symptomatic DVT in the lower limbs. Understanding these predictive factors could help guide better treatment strategies for patients at risk of developing PTS. The study is a multicenter prospective cohort design involving patients diagnosed with a first episode of symptomatic lower limb DVT confirmed by ultrasound. Participants will be followed with clinical assessments and ultrasound scans at one week (only for those in biological research), one month, three months, and six months after diagnosis. Blood samples will be collected at baseline, one week, one month, and three months to examine inflammation and blood clotting factors. Quality of life questionnaires will be completed at three and six months. The VVI score will be calculated from ultrasound data to quantify the clot burden, and the Villalta scale will be used to assess PTS severity over the six-month follow-up period. During each visit, symptoms and clinical signs related to PTS will be evaluated, and color Doppler ultrasound of the lower limbs will be performed. Blood tests will help explore biological markers linked to PTS development. Patients will complete questionnaires about their quality of life to assess the impact of symptoms. The study concludes with the six-month visit, at which point researchers will analyze the association between initial clot burden and PTS outcomes. This comprehensive follow-up aims to improve the prediction and understanding of PTS after DVT.

Researchers are studying the use of Hizentra®, a subcutaneous immunoglobulin treatment, in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a rare autoimmune neurological disorder. The study aims to understand how patients switch from intravenous immunoglobulin (IVIg) treatments to subcutaneous immunoglobulin (SCIg) like Hizentra® in real-life settings. The study also evaluates the tolerability and effectiveness of Hizentra® using patient-reported outcomes collected through a mobile application. This is a national, prospective, non-interventional study conducted over an estimated 36 months, including a 24-month enrollment period and a 12-month follow-up. Participants will receive Hizentra®, which is administered as a subcutaneous injection solution. The study focuses on patients who are planned to switch from IVIg to Hizentra® and have been stable on their treatment for at least three months. The approach allows for treatment to be administered outside of specialist centers. Researchers will observe and document how patients use Hizentra® in everyday practice without changing the usual care. No additional experimental treatments are given as this is a non-interventional study. During the study, participants will use a patient application to report on their treatment experience, including tolerability and efficacy. The main outcome measured is the length of time the treatment continues, up to 12 months. The study monitors patient health and treatment adherence during this period to provide real-world data on Hizentra® use. Participants must have access to a smartphone, tablet, or computer to use the application. Overall, the study aims to gather comprehensive information about switching treatments and managing CIDP with Hizentra® in daily life.

Hospitalisation in intensive care can be a traumatic experience that may lead to lasting psychiatric disorders such as anxiety, depression, and post-traumatic stress disorder (PTSD), collectively known as post-intensive care syndrome (PICS). These conditions can affect a patient’s recovery, cause functional disability, and reduce quality of life. This research explores whether improving intensive care hospitalisation conditions through changes in healthcare practices can help reduce patient discomfort and the long-term psychological impact. The study evaluates the PREMREA program, a tailor-made, multi-component intervention led by a doctor and a non-medical caregiver. This program includes patients completing an 18-item discomfort questionnaire (IPREA) on the day of discharge from intensive care, monthly feedback sessions for intensive care staff to review results, and the implementation and monitoring of specific care measures aimed at humanising the intensive care experience. The program builds on previous research by using a longer nine-month learning period and involving patient experts. Participants will complete the IPREA questionnaire themselves without caregiver involvement to reduce bias. The study tracks the overall discomfort score at three months as the primary outcome. Monthly feedback and care practice changes will be monitored throughout the program. The study includes patients aged 18 and older who were hospitalised in intensive care for at least three days and discharged alive. Safety monitoring and informed consent processes are incorporated, with participant involvement lasting through the intensive care stay and follow-up at three months.

Researchers are studying the use of intrathecal ziconotide to treat patients with chronic non-cancer pain that does not respond to standard treatments. While ziconotide is mainly used for cancer-related pain with well-documented guidelines, its use for non-cancer pain is less understood because this group includes many different conditions. This study aims to provide information on patients with various types of non-malignant chronic pain, such as spinal cord injury, radiculopathy, diabetic neuropathy, complex regional pain syndrome, fibromyalgia, and others, by collecting data over the first two years of treatment. Participants will receive intrathecal ziconotide delivered through an internal pump surgically implanted by a trained neurosurgeon or anesthesiologist under general anesthesia. The study includes both patients already treated with ziconotide-based intrathecal analgesia and those new to this treatment who are candidates for starting or adding ziconotide to their pump therapy. The study monitors treatment use as per standard medical practice without altering the therapy. Throughout the study, researchers will collect detailed baseline information about patients’ demographics, medical history, pain characteristics, psychiatric and disability status, pain intensity, and prior pain management strategies. They will also track reasons for starting ziconotide and any planned changes to intrathecal treatment. This comprehensive data collection aims to better understand the types of patients receiving ziconotide and how they respond to this treatment over time.