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

Informazioni relative al progetto

REALM

ID dell’accordo di sovvenzione: 101095435

DOI

10.3030/101095435

Data della firma CE 24 Novembre 2022

Data di avvio 1 Gennaio 2023

Data di completamento 31 Dicembre 2026

Finanziato da

• Health

Costo totale

€ 6 659 650,00

Contributo UE

€ 6 659 650,00

Coordinato da

UNIVERSITEIT MAASTRICHT
Netherlands

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

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).

Pubblicazioni

Peer reviewed articles (14)

Generating unseen diseases patient data using ontology enhanced generative adversarial networks

Autori: Chang Sun 0001; Michel Dumontier
Pubblicato in: npj Digital Medicine, 2025, ISSN 2398-6352
Editore: 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

Autori: Babu C. S., Holsinger F.C., Zuchowski L/, Ratti E., Rameau A.
Pubblicato in: American Academy of Otolaryngology—Head and Neck Surgery Foundation, 2023, ISSN 2644-1276
Editore: 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

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

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

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

Science and values: a two-way direction

Autori: Emanuele Ratti, Federica Russo
Pubblicato in: European Journal for Philosophy of Science, 2024, ISSN 2644-1276
Editore: 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

Autori: Mahmoud K. Ibrahim; Yasmina Al Khalil; Sina Amirrajab; Chang Sun 0001; Marcel Breeuwer; Josien P. W. Pluim; Bart Elen; Gökhan Ertaylan; Michel Dumontier
Pubblicato in: Computers in Biology and Medicine, 2025, ISSN 1879-0534
Editore: 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

Autori: Marie Seret, Vincent Uyttendaele, J. Geoffrey Chase, Geoffrey M Shaw, Thomas Desaive
Pubblicato in: Journal of Diabetes Science and Technology, ISSN 1932-2976
Editore: Sage
DOI: 10.1177/193229682514128

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

Autori: Avigail Ferdman & Emanuele Ratti
Pubblicato in: Science and Engineering Ethics, 2024, ISSN 2644-1276
Editore: 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

Autori: Nikolaos Ntampakis, Konstantinos Diamantaras, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Pubblicato in: Biomedical Signal Processing and Control, Numero 113, 2025, ISSN 1746-8094
Editore: 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

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

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

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

BMC Medical Ethics

Autori: Ratti, E; Morrison, M; Jakab, I
Pubblicato in: BMC Medical Ethics, 2025, ISSN 1472-6939
Editore: BioMed Central
DOI: 10.1186/S12910-025-01198-1

User acceptability of blockchain technology for enabling electronic health record exchange

Autori: Lilly Marie Baltruschat, Vikas Jaiman, Visara Urovi
Pubblicato in: Journal of Systems and Information Technology, Numero 25, 2025, ISSN 1328-7265
Editore: Emerald
DOI: 10.1108/JSIT-09-2022-0225

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

Autori: Jionghui Gu, Xian Zhong, Chengyu Fang, Wenjing Lou, Peifen Fu, Henry C Woodruff, Baohua Wang, Tianan Jiang, Philippe Lambin
Pubblicato in: The Oncologist, Numero 29, 2024, ISSN 1083-7159
Editore: 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

Autori: Kakkamani, S., JUNG, F., Verbiest, J., & PEETERS, L.
Pubblicato in: European OHDSI Symposium 2025
Editore: 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

Autori: 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
Pubblicato in: CoRR, 2024
Editore: arXiv (Cornell University Library)
DOI: 10.48550/ARXIV.2408.03771

Enhancing transparency in AI for healthcare with OMOP Model Card reporting

Autori: JUNG, F., Lohachab, A., Madureira Sanches Ribeiro, G., Rommes, S., Urovi, V., Sun, C., & Ertaylan, G.
Pubblicato in: European OHDSI Symposium 2025
Editore: OHDSI Europe
DOI: 10.5281/ZENODO.18788825

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

Autori: JUNG, F., Madureira Sanches Ribeiro, G., Lohachab, A., Rommes, S., Urovi, V., Sun, C., Ertaylan, G., & Attipoe, A.
Pubblicato in: European OHDSI Symposium 2025
Editore: OHDSI Europe
DOI: 10.5281/ZENODO.18788892

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

Autori: JUNG, F., Sun, C., Ibrahim, M., & Ertaylan, G.
Pubblicato in: European OHDSI Symposium 2024 , Rotterdam
Editore: 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

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

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

Autori: Ankur Lohachab, Visara Urovi
Pubblicato in: Lecture Notes in Business Information Processing, Advanced Information Systems Engineering Workshops, 2024
Editore: 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

Autori: Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda, Vasileios Argyriou, Panagiotis Sarigiannidis
Pubblicato in: Lecture Notes in Computer Science, Medical Image Understanding and Analysis, 2024
Editore: 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

Autori: Tomasz Braun, Dominika Ewa Harasimiuk
Pubblicato in: 2023 IEEE Conference on Computational Intelligence in Bioinformatics and Computational Biology (CIBCB), 2023
Editore: IEEE
DOI: 10.1109/CIBCB56990.2023.10264892

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

Autori: JUNG, F., Sakkalis, V., Sun, C., Ibrahim, M., & Ertaylan, G.
Pubblicato in: European OHDSI Symposium 2024, Rotterdam
Editore: OHDSI Europe
DOI: 10.5281/ZENODO.18783801

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

Autori: Georgios Tsoumplekas, Ilias Siniosoglou, Vasileios Argyriou, Ioannis D. Moscholios, Panagiotis Sarigiannidis
Pubblicato in: Lecture Notes in Computer Science, Artificial Intelligence in Healthcare, 2024
Editore: 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

Autori: Nikolaos Ntampakis, Konstantinos Diamantaras, Konstantinos Goulianas, Ioanna Chouvarda
Pubblicato in: 2023 IEEE 23rd International Conference on Bioinformatics and Bioengineering (BIBE), 2024
Editore: IEEE
DOI: 10.1109/BIBE60311.2023.00066