A novel semantic representation for eligibility criteria in clinical trials.

Eligibility Criteria (EC) comprise an important part of a clinical study, being determinant of its cost, duration and overall success. Their formal, computer-processable description can significantly improve clinical trial design and conduction by enabling their intelligent processing, replicability and linkability with other data. For EC representation purposes, related standards were investigated, along with published literature. Moreover, a considerable number of clinicaltrials.gov studies was analyzed in collaboration with clinical experts for the determination and classification of parameters of clinical research importance. The outcome of this process was the EC Representation; a CDISC-compliant schema for organizing criteria along with a patient-centric model for their formal expression, properly linked with international classifications and codifications. Its evaluation against 200 randomly selected EC indicated that it can adequately serve its purpose, while it can be also combined with existing tools and components developed for both EC specification and especially application to Electronic Health Records.

Effect of modeling parameters on the frequency response of the middle ear by means of finite element analysis.

A 3D finite element model of the human middle ear was developed for the investigation of the modeling parameters' effect on the frequency response. In this study, we incorporated realistic reconstructed geometries from microCT imaging data. The geometric representation of the stapedial annular ligament provided additional damping and the Rayleigh parameter ß was adjusted to lower values in comparison to previous computational studies. The maximum displacement of the stapes footplate, equal to 0.168 µm, was observed at a frequency of 1050 Hz. The computational results were validated with experimental measurements. Good agreement is observed between our results and the experimental data and other finite element studies.

PAT: an intelligent authoring tool for facilitating clinical trial design.

Great investments are made by both private and public funds and a wealth of research findings is published, the research and development pipeline phases quite low productivity and tremendous delays. In this paper, we present a novel authoring tool which has been designed and developed for facilitating study design. Its underlying models are based on a thorough analysis of existing clinical trial protocols (CTPs) and eligibility criteria (EC) published in clinicaltrials.gov by domain experts. Moreover, its integration with intelligent decision support services and mechanisms linking the study design process with healthcare patient data as well as its direct access to literature designate it as a powerful tool offering great support to researchers during clinical trial design.