A Diagnostic Test on DeepDoc-an AI-based Decision Support System

Study Overview
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Brief Summary
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DeepDoc is an AI-based decision support system for the early etiology diagnosis of neurological diseases using clinical data points from patients admitted to hospital within 24 hours.This study aims to evaluate whether the diagnosis of the DeepDoc AI-based decision support system is better than the doctor's initial diagnosis by a multi-center, superiority diagnostic study.

Detailed Description
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The doctor completes the admission note within 24 hours after the patient is admitted to the hospital. After informed consent is given to the patient who meet the inclusion criteria, open the DeepDoc to fill in the patient identification information. Then take the picture of the initial diagnosis of the admission note page and upload it to DeepDoc, fill the doctor's initial diagnosis into the DeppDoc. And put the patient's clinical data points into the DeepDoc to get a DeepdDoc diagnosis.

Official Title
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DeepDoc - Clinical Validation of an AI-based Decision Support System in the Early Diagnostic Evaluation of Neurological Diseases: a Prospective Multi-center Study

Conditions
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Stroke, Headache, Vertigo, Meningitis/Encephalitis

Intervention / Treatment
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* Device: DeepDoc AI-based Decision Support System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache. Neurological examination results and imaging changes within 24 hours of admission. Exclusion Criteria: Patients discharged, transferred to the hospital, or died within 24 hours after admission.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Meningitis/Encephalitis<br>Patients with clinical signs and symptoms suspected of meningitis/encephalitis | Device: DeepDoc AI-based Decision Support System<br>* Patients are diagnosed by the DeepDoc within 24 hours of admission.<br>|
| Stroke<br>Patients with clinical signs and symptoms suspected of stroke | Device: DeepDoc AI-based Decision Support System<br>* Patients are diagnosed by the DeepDoc within 24 hours of admission.<br>|
| Headache<br>Patients with clinical signs and symptoms suspected of headache | Device: DeepDoc AI-based Decision Support System<br>* Patients are diagnosed by the DeepDoc within 24 hours of admission.<br>|
| Vertigo<br>Patients with clinical signs and symptoms suspected of vertigo | Device: DeepDoc AI-based Decision Support System<br>* Patients are diagnosed by the DeepDoc within 24 hours of admission.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of diagnosis by DeepDoc AI-based Decision Support System | Accuracy of diagnosis by DeepDoc and compare this result with doctors | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of diagnosis by DeepDoc AI-based Decision Support System | Sensitivity of diagnosis by DeepDoc and compare this result with doctors | 24 hours | 
| Specificity of diagnosis by DeepDoc AI-based Decision Support System | Specificity of diagnosis by DeepDoc and compare this result with doctors | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Intelligence