Development of a Natural Language Processing Tool to Enable Clinical Research in Emergency Medicine

NCT06240572 | Recruiting DMC

• 1 other identifier: 8780
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 8

Brief Summary

The goal of this retrospective cohort study is to develop and validate a language model that can interpret the contents of emergency department electronic medical records and extract relevant information for research purposes in all adult patients who arrived at the participating emergency departments in a three-year period. The main question it aims to answer is: is the language model able to interpret the contents of emergency department electronic medical records and extract the requested information from them so that it can be used to make accurate analyses and predictions? The study is retrospective and data will be extracted automatically from the medical health records.

Conditions

Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Concordance in filling in the virtual case report form

  Level of concordance in filling in the virtual case report form between the expert physicians and the eCREAM\_LM language model

  1 month

Study Arms (1)

Adults who attended the emergency department

Other: no intervention

Interventions

no intervention OTHER

no intervention

Adults who attended the emergency department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients who arrived at participating emergency departments between January 1, 2021 and December 31, 2023

You may qualify if:

• Adult
• Arrived at emergency department between 1 January 2021 and 31 December 2023

You may not qualify if:

• None

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Astir S.r.l.: collaborator
• Fondazione Bruno Kessler: collaborator
• Orobix Life S.r.l.: collaborator

Study Sites (8)

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Milan, Milan, 20156, Italy

NOT YET RECRUITING

AOU Policlinico 'G.Rodolico - San Marco'

Catania, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

NOT YET RECRUITING

Ospedale Luigi Sacco

Milan, Italy

NOT YET RECRUITING

Ospedale San Luigi Gonzaga

Orbassano, Italy

NOT YET RECRUITING

Ospedale Santa Maria delle Grazie

Pozzuoli, Italy

NOT YET RECRUITING

Ospedale San Giovanni Bosco

Torino, Italy

RECRUITING

Ospedale Sant'Andrea

Vercelli, Italy

NOT YET RECRUITING

Study Officials

• Guido Bertolini

  Istituto Di Ricerche Farmacologiche Mario Negri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Pandolfini

CONTACT

0039 02 39014 253; chiara.pandolfini@marionegri.it

Giulia Ghilardi

CONTACT

0039 035 4535 313; giulia.ghilardi@marionegri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Starting from December 2025

Locations

IT (8)