Groslay

Researchers are collecting and creating a labeled ultrasound image data set from patients undergoing routine ultrasound scans of their lower limbs due to suspected deep vein thrombosis DVT. This observational study aims to gather imaging data, patient information, and ultrasound metadata to train artificial intelligence AI models that can automatically detect DVT from conventional ultrasound scans. The study is part of the ThrombUS project, which focuses on developing tools for early and automated DVT diagnosis to improve patient safety and outcomes. The study involves selecting patients suspected of having DVT who are referred for ultrasound scans. These patients, both inpatients and outpatients, will be consecutively included to ensure diversity of demographics, medical conditions, and ultrasound operators. The collected data will include ultrasound image series and video clips, along with anonymized patient demographics, referral notes, medical conditions, scan diagnoses, operator IDs, and ultrasound equipment details. The anonymized data set will be prepared according to regulations for research use and shared publicly through European science portals. Participants will undergo routine ultrasound scans for suspected DVT, and their scan data and related information will be collected and anonymized. The primary outcome is the ultrasound data collected on the day of the scan. The data set will support AI model training and research, with the anonymized information made available for further study. Participation involves providing informed consent and allowing the inclusion of their scan data and metadata. The study will monitor data quality and maintain privacy throughout, with no interventional treatments involved.

This research aims to evaluate the real-life effectiveness, safety, and usage patterns of Octapharmas factor VIII FVIII concentratesNuwiq, Octanate, and Wilatein patients with severe haemophilia A who have either never been treated or have had minimal treatment. The study focuses on previously untreated patients, often young children, and minimally treated patients, gathering more data on treatment outcomes and inhibitor development to better understand optimal treatment approaches in routine clinical practice. Participants receive one of the three FVIII concentrates Nuwiq recombinant FVIII, Octanate plasma-derived FVIII, or Wilate plasma-derived FVIII combined with von Willebrand factor. The study observes how these products are used, including dosing and frequency, without altering prescribed treatments. This non-interventional study collects data during routine care to assess product utilization, safety, and effectiveness, including responses to surgical prophylaxis. During the study, researchers monitor participants for breakthrough bleeding rates and any adverse drug reactions over 100 exposure days to assess treatment effectiveness and safety. They also collect information on FVIII dosing and physicians evaluations of surgical prophylaxis effectiveness. The study involves patients of all ages and follows them through their usual clinical visits, with data gathered via observation rather than treatment changes. The study is designed to provide valuable real-world evidence on these FVIII concentrates in severe haemophilia A patients.