Real-world-data Enabled Assessment for heaLth regulatory decision-Making

Informacje na temat projektu

REALM

Identyfikator umowy o grant: 101095435

DOI

10.3030/101095435

Data podpisania przez KE 24 Listopada 2022

Data rozpoczęcia 1 Stycznia 2023

Data zakończenia 31 Grudnia 2026

Finansowanie w ramach

• Health

Koszt całkowity

€ 6 659 650,00

Wkład UE

€ 6 659 650,00

Koordynowany przez

UNIVERSITEIT MAASTRICHT
Netherlands

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

Websites, patent fillings, videos etc. (1)

Public project website

The website will inform the public about the project’s aims, updates and results. The website will be continuously updated throughout the project’s lifetime. Links to social media will be implemented as well.

Documents, reports (2)

Authorized access agreements with European Medical Data Pools and DT

In this deliverable we aim to bridge REALM’s data infrastructure with ongoing (and completed) European projects with standardized medical data component, Digital Twins Platforms, In-Silico trial technologies and restricted access biobanks.

Data Management Plan

The DMP describes the data management life cycle for the data to be collected, processed and/or generated. As part of making research data findable, accessible, interoperable and re-usable (FAIR), the DMP will include information on:- the handling of research data during & after the end of the project- what data will be collected, processed and/or generated- which methodology & standards will be applied- whether data will be shared/made open access and how data will be curated & preserved (including after the end of the project).

Publikacje

Peer reviewed articles (14)

Generating unseen diseases patient data using ontology enhanced generative adversarial networks

Autorzy: Chang Sun 0001; Michel Dumontier
Opublikowane w: npj Digital Medicine, 2025, ISSN 2398-6352
Wydawca: Springer Nature (Nature Portfolio)
DOI: 10.1038/S41746-024-01421-0

Epistemological Challenges of Artificial Intelligence Clinical Decision Support Tools in Otolaryngology: The Black Box Problem

Autorzy: Babu C. S., Holsinger F.C., Zuchowski L/, Ratti E., Rameau A.
Opublikowane w: American Academy of Otolaryngology—Head and Neck Surgery Foundation, 2023, ISSN 2644-1276
Wydawca: American Academy of Otolaryngology—Head and Neck Surgery Foundation
DOI: 10.1002/ohn.410

Generative AI for Synthetic Data Across Multiple Medical Modalities: A Systematic Review of Recent Developments and Challenges

Autorzy: Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gokhan Ertaylan, Michel Dumontier
Opublikowane w: arXiv, 2024, ISSN 2644-1276
Wydawca: arXiv
DOI: 10.48550/arXiv.2407.00116

Using Generative Artificial Intelligence in the Production and Dissemination of Innovation in Otolaryngology—Ethical Considerations

Autorzy: Carolyn Jane Khoury BA, Necati Enver MD, FEBORL-HNS, Alberto Paderno MD, PhD, Emanuele Ratti PhD, Anaïs Rameau MD, MPhil, MS FACS
Opublikowane w: American Academy of Otolaryngology—Head and Neck Surgery Foundation, 2023, ISSN 2644-1276
Wydawca: American Academy of Otolaryngology—Head and Neck Surgery Foundation
DOI: 10.1002/ohn.601

Science and values: a two-way direction

Autorzy: Emanuele Ratti, Federica Russo
Opublikowane w: European Journal for Philosophy of Science, 2024, ISSN 2644-1276
Wydawca: Springer
DOI: 10.1007/s13194-024-00567-8

Generative AI for synthetic data across multiple medical modalities: A systematic review of recent developments and challenges

Autorzy: Mahmoud K. Ibrahim; Yasmina Al Khalil; Sina Amirrajab; Chang Sun 0001; Marcel Breeuwer; Josien P. W. Pluim; Bart Elen; Gökhan Ertaylan; Michel Dumontier
Opublikowane w: Computers in Biology and Medicine, 2025, ISSN 1879-0534
Wydawca: Elsevier
DOI: 10.48550/ARXIV.2407.00116

Tight Glycemic Control Can Be Achieved in Adult ICU Patients Safely: Results From a 5-Year Single-Center Observational Study Using the STAR Glycemic Control Framework

Autorzy: Marie Seret, Vincent Uyttendaele, J. Geoffrey Chase, Geoffrey M Shaw, Thomas Desaive
Opublikowane w: Journal of Diabetes Science and Technology, ISSN 1932-2976
Wydawca: Sage
DOI: 10.1177/193229682514128

What Do We Teach to Engineering Students: Embedded Ethics, Morality, and Politics

Autorzy: Avigail Ferdman & Emanuele Ratti
Opublikowane w: Science and Engineering Ethics, 2024, ISSN 2644-1276
Wydawca: Springer
DOI: 10.1007/s11948-024-00469-1

Introducing DEFORMISE: A deep learning framework for dementia diagnosis in the elderly using optimized MRI slice selection

Autorzy: Nikolaos Ntampakis, Konstantinos Diamantaras, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Opublikowane w: Biomedical Signal Processing and Control, Numer 113, 2025, ISSN 1746-8094
Wydawca: Elsevier BV
DOI: 10.1016/J.BSPC.2025.109151

Introducing SPINE: A Holistic Approach to Synthetic Pulmonary Imaging Evaluation through End-to-End Data and Model Management

Autorzy: Nikolaos Ntampakis, Vasileios Argyriou, Konstantinos Diamantaras, Konstantinos Goulianas, Panagiotis Sarigiannidis, Ilias Siniosoglou
Opublikowane w: IEEE Open Journal of Engineering in Medicine and Biology, 2024, ISSN 2644-1276
Wydawca: IEEE
DOI: 10.1109/OJEMB.2024.3426910

Generative AI for synthetic data across multiple medical modalities: A systematic review of recent developments and challenges

Autorzy: Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gökhan Ertaylan, Michel Dumontier
Opublikowane w: Computers in Biology and Medicine, Numer 189, 2026, ISSN 0010-4825
Wydawca: Elsevier BV
DOI: 10.1016/J.COMPBIOMED.2025.109834

BMC Medical Ethics

Autorzy: Ratti, E; Morrison, M; Jakab, I
Opublikowane w: BMC Medical Ethics, 2025, ISSN 1472-6939
Wydawca: BioMed Central
DOI: 10.1186/S12910-025-01198-1

User acceptability of blockchain technology for enabling electronic health record exchange

Autorzy: Lilly Marie Baltruschat, Vikas Jaiman, Visara Urovi
Opublikowane w: Journal of Systems and Information Technology, Numer 25, 2025, ISSN 1328-7265
Wydawca: Emerald
DOI: 10.1108/JSIT-09-2022-0225

Deep Learning of Multimodal Ultrasound: Stratifying the Response to Neoadjuvant Chemotherapy in Breast Cancer Before Treatment

Autorzy: Jionghui Gu, Xian Zhong, Chengyu Fang, Wenjing Lou, Peifen Fu, Henry C Woodruff, Baohua Wang, Tianan Jiang, Philippe Lambin
Opublikowane w: The Oncologist, Numer 29, 2024, ISSN 1083-7159
Wydawca: Oxford University Press (OUP)
DOI: 10.1093/ONCOLO/OYAD227

Other (5)

RAG-Enhanced LLM Pipeline for Semantic Mapping of Context-based Features to OMOP Vocabulary

Autorzy: Kakkamani, S., JUNG, F., Verbiest, J., & PEETERS, L.
Opublikowane w: European OHDSI Symposium 2025
Wydawca: OHDSI Europe
DOI: 10.5281/ZENODO.18789039

Methodological Explainability Evaluation of an Interpretable Deep Learning Model for Post-Hepatectomy Liver Failure Prediction Incorporating Counterfactual Explanations and Layerwise Relevance Propagation: A Prospective In Silico Trial

Autorzy: Xian Zhong; Zohaib Salahuddin; Yi Chen; Henry C. Woodruff; Haiyi Long; Jianyun Peng; Nuwan Udawatte; Roberto Casale; Ayoub Mokhtari; Xiaoer Zhang; Jiayao Huang; Qingyu Wu; Li Tan; Lili Chen; Dongming Li; Xiaoyan Xie; Manxia Lin; Philippe Lambin
Opublikowane w: CoRR, 2024
Wydawca: arXiv (Cornell University Library)
DOI: 10.48550/ARXIV.2408.03771

Enhancing transparency in AI for healthcare with OMOP Model Card reporting

Autorzy: JUNG, F., Lohachab, A., Madureira Sanches Ribeiro, G., Rommes, S., Urovi, V., Sun, C., & Ertaylan, G.
Opublikowane w: European OHDSI Symposium 2025
Wydawca: OHDSI Europe
DOI: 10.5281/ZENODO.18788825

RIANA Dashboard: A Blockchain-Enabled Approach for Representing AI Model Intent in OMOP with Atlas-Like Functionality

Autorzy: JUNG, F., Madureira Sanches Ribeiro, G., Lohachab, A., Rommes, S., Urovi, V., Sun, C., Ertaylan, G., & Attipoe, A.
Opublikowane w: European OHDSI Symposium 2025
Wydawca: OHDSI Europe
DOI: 10.5281/ZENODO.18788892

REALM – innovative solutions for the creation and evaluation of AI medical device software

Autorzy: JUNG, F., Sun, C., Ibrahim, M., & Ertaylan, G.
Opublikowane w: European OHDSI Symposium 2024 , Rotterdam
Wydawca: OHDSI Europe
DOI: 10.5281/ZENODO.18788473

Book chapters (3)

Enhancing Performance for Highly Imbalanced Medical Data via Data Regularization in a Federated Learning Setting

Autorzy: Georgios Tsoumplekas; Ilias Siniosoglou; Vasileios Argyriou; Ioannis D. Moscholios; Panagiotis G. Sarigiannidis
Opublikowane w: Lecture Notes in Computer Science ISBN: 9783031672842, 2024
Wydawca: Springer Nature (Springer)
DOI: 10.48550/ARXIV.2405.20430

A Blockchain-Based Approach for Model Card Accountability and Regulatory Compliance

Autorzy: Ankur Lohachab, Visara Urovi
Opublikowane w: Lecture Notes in Business Information Processing, Advanced Information Systems Engineering Workshops, 2024
Wydawca: Springer Nature Switzerland
DOI: 10.1007/978-3-031-61003-5_4

Optimizing Melanoma Prognosis Through Synergistic Preprocessing and Deep Learning Architecture for Dermoscopic Thickness Prediction

Autorzy: Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Opublikowane w: Lecture Notes in Computer Science, Medical Image Understanding and Analysis, 2024
Wydawca: Springer Nature Switzerland
DOI: 10.1007/978-3-031-66958-3_24

Conference proceedings (4)

AI Deployment in Medical Devices-Ethical and Regulaltory Reflections, Beyond Data Protection and Bias – EU perspective

Autorzy: Tomasz Braun, Dominika Ewa Harasimiuk
Opublikowane w: 2023 IEEE Conference on Computational Intelligence in Bioinformatics and Computational Biology (CIBCB), 2023
Wydawca: IEEE
DOI: 10.1109/CIBCB56990.2023.10264892

Open research datasets harmonized to the OMOP CDM can be used to evaluate COPD AI models

Autorzy: JUNG, F., Sakkalis, V., Sun, C., Ibrahim, M., & Ertaylan, G.
Opublikowane w: European OHDSI Symposium 2024, Rotterdam
Wydawca: OHDSI Europe
DOI: 10.5281/ZENODO.18783801

Enhancing Performance for Highly Imbalanced Medical Data via Data Regularization in a Federated Learning Setting

Autorzy: Georgios Tsoumplekas, Ilias Siniosoglou, Vasileios Argyriou, Ioannis D. Moscholios, Panagiotis Sarigiannidis
Opublikowane w: Lecture Notes in Computer Science, Artificial Intelligence in Healthcare, 2024
Wydawca: Springer Nature Switzerland
DOI: 10.1007/978-3-031-67285-9_22

Predicting the Onset of Dementia in Initially Healthy Individuals Using Demographic and Clinical Data

Autorzy: Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda
Opublikowane w: 2023 IEEE 23rd International Conference on Bioinformatics and Bioengineering (BIBE), 2024
Wydawca: IEEE
DOI: 10.1109/BIBE60311.2023.00066