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Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System

Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06389058
Enrollment
31795
Registered
2024-04-29
Start date
2023-05-01
Completion date
2026-12-01
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Asthma

Brief summary

The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility. Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR. * Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy. * Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a. * Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a.

Detailed description

Asthma is a heterogeneous disease. The heterogeneity of asthma is supported by clinical observations and genome wide association studies (GWASs) that have identified over 200 asthma susceptibility loci in the DNA. These genetic 'hot spots' are near inflammatory cytokines, growth factors, and other inflammatory proteins knowingly linked to airway inflammation, including cytokines IL-4, -5, -13, -25, -33, and TSLP. Novel monoclonal antibody therapies have drastically changed the treatment of moderate-to-severe asthma. Novel monoclonal antibody therapies introduced in the last 7 years have greatly advanced treatment options for moderate-to-severe asthma patients. These therapies effectively reduce or eliminate severe exacerbations, prevent hospitalizations, and improve patients' quality of life. However, many severe asthma patients, particularly those living in underserved areas, are still being overtreated with steroids and undertreated with monoclonal antibodies. The 21st Century Cures Act will Change the Landscape of Research. The 21st Century Cures Act reinforced the use of real-world data (RWD) and real-world evidence (RWE) to support clinical trials, aid in drug coverage decisions, develop national treatment guidelines as well as standardized decision support tools. An underutilized source of RWE/D are electronic health records (EHR). Machine Learning (ML), AI, and natural language processing (NLP) are developing technologies that will greatly advance our ability to leverage data in EHR systems. The study aims to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility. Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR. * Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy. * Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a. * Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a.

Interventions

OTHERRecommendation for the diagnoses and treatment of Severe Asthma

No intervention planned in this phase for the patients. Recommendations to be developed for healthcare and condition.

Sponsors

San Diego State University
Lead SponsorOTHER
GlaxoSmithKline
CollaboratorINDUSTRY
Scripps Health
CollaboratorOTHER
Modena Allergy + Asthma, La Jolla, CA
CollaboratorUNKNOWN
University of California, San Diego
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

\- Demographics: Males \~ 40%, Blacks \~ 5-10%, Hispanic \~15-30%, Urban \~80-90%

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Identification of Patients with Severe Asthma4 yearsIdentify patients with severe asthma and compare diagnoses to that of medical professionals

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORyusuf Ozturk, Ph.D.

San Diego State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026