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Autori principali: Sun, Zenan, Abeysinghe, Rashmie, Li, Xiaojin, Hu, Xinyue, Cui, Licong, Zhang, Guo-Qiang, Bian, Jiang, Tao, Cui
Natura: Preprint
Pubblicazione: 2025
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Accesso online:https://arxiv.org/abs/2511.21724
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author Sun, Zenan
Abeysinghe, Rashmie
Li, Xiaojin
Hu, Xinyue
Cui, Licong
Zhang, Guo-Qiang
Bian, Jiang
Tao, Cui
author_facet Sun, Zenan
Abeysinghe, Rashmie
Li, Xiaojin
Hu, Xinyue
Cui, Licong
Zhang, Guo-Qiang
Bian, Jiang
Tao, Cui
contents Objective This study introduces the Alzheimer's Disease Common Data Element Ontology for Clinical Trials (AD-CDO), a lightweight, semantically enriched ontology designed to represent and standardize key eligibility criteria concepts in Alzheimer's disease (AD) clinical trials. Materials and Methods We extracted high-frequency concepts from more than 1,500 AD clinical trials on ClinicalTrials.gov and organized them into seven semantic categories: Disease, Medication, Diagnostic Test, Procedure, Social Determinants of Health, Rating Criteria, and Fertility. Each concept was annotated with standard biomedical vocabularies, including the UMLS, OMOP Standardized Vocabularies, DrugBank, NDC, and NLM VSAC value sets. To balance coverage and manageability, we applied the Jenks Natural Breaks method to identify an optimal set of representative concepts. Results The optimized AD-CDO achieved over 63% coverage of extracted trial concepts while maintaining interpretability and compactness. The ontology effectively captured the most frequent and clinically meaningful entities used in AD eligibility criteria. We demonstrated AD-CDO's practical utility through two use cases: (a) an ontology-driven trial simulation system for formal modeling and virtual execution of clinical trials, and (b) an entity normalization task mapping raw clinical text to ontology-aligned terms, enabling consistency and integration with EHR data. Discussion AD-CDO bridges the gap between broad biomedical ontologies and task-specific trial modeling needs. It supports multiple downstream applications, including phenotyping algorithm development, cohort identification, and structured data integration. Conclusion By harmonizing essential eligibility entities and aligning them with standardized vocabularies, AD-CDO provides a versatile foundation for ontology-driven AD clinical trial research.
format Preprint
id arxiv_https___arxiv_org_abs_2511_21724
institution arXiv
publishDate 2025
record_format arxiv
spellingShingle AD-CDO: A Lightweight Ontology for Representing Eligibility Criteria in Alzheimer's Disease Clinical Trials
Sun, Zenan
Abeysinghe, Rashmie
Li, Xiaojin
Hu, Xinyue
Cui, Licong
Zhang, Guo-Qiang
Bian, Jiang
Tao, Cui
Computation and Language
Objective This study introduces the Alzheimer's Disease Common Data Element Ontology for Clinical Trials (AD-CDO), a lightweight, semantically enriched ontology designed to represent and standardize key eligibility criteria concepts in Alzheimer's disease (AD) clinical trials. Materials and Methods We extracted high-frequency concepts from more than 1,500 AD clinical trials on ClinicalTrials.gov and organized them into seven semantic categories: Disease, Medication, Diagnostic Test, Procedure, Social Determinants of Health, Rating Criteria, and Fertility. Each concept was annotated with standard biomedical vocabularies, including the UMLS, OMOP Standardized Vocabularies, DrugBank, NDC, and NLM VSAC value sets. To balance coverage and manageability, we applied the Jenks Natural Breaks method to identify an optimal set of representative concepts. Results The optimized AD-CDO achieved over 63% coverage of extracted trial concepts while maintaining interpretability and compactness. The ontology effectively captured the most frequent and clinically meaningful entities used in AD eligibility criteria. We demonstrated AD-CDO's practical utility through two use cases: (a) an ontology-driven trial simulation system for formal modeling and virtual execution of clinical trials, and (b) an entity normalization task mapping raw clinical text to ontology-aligned terms, enabling consistency and integration with EHR data. Discussion AD-CDO bridges the gap between broad biomedical ontologies and task-specific trial modeling needs. It supports multiple downstream applications, including phenotyping algorithm development, cohort identification, and structured data integration. Conclusion By harmonizing essential eligibility entities and aligning them with standardized vocabularies, AD-CDO provides a versatile foundation for ontology-driven AD clinical trial research.
title AD-CDO: A Lightweight Ontology for Representing Eligibility Criteria in Alzheimer's Disease Clinical Trials
topic Computation and Language
url https://arxiv.org/abs/2511.21724