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The goal of this clinical study is to evaluate the effectiveness of an AI agent in diagnosing and predicting diseases using electronic health records (EHR) and multimodal imaging data. The AI agent leverages advanced machine learning algorithms to process and analyze diverse health data sources, aiming to assist healthcare providers in making more accurate diagnoses and predictions.
This multi-center, retrospective clinical study is designed to evaluate the application and effectiveness of an AI agent in the medical decision-making process. The AI agent integrates and analyzes multimodal data, including electronic health records (EHR) and various imaging data (e.g., X-rays, MRIs, CT scans, ultrasounds) to predict and diagnose a range of diseases. By leveraging the power of machine learning and data fusion techniques, the AI agent can identify patterns in large and complex datasets, offering insights that may not be immediately apparent through traditional diagnostic methods.The study will compare the AI agent's diagnostic accuracy and disease prediction capabilities with traditional diagnostic practices to assess its potential benefits in clinical settings. Key questions include whether the AI agent can assist in early diagnosis, predict disease progression, and support healthcare professionals in making personalized treatment decisions. Participants will not be required to undergo any additional interventions; they will only provide historical health data, including EHR and relevant imaging data, which will be analyzed by the AI agent. The AI system will then use this data to assist healthcare providers by offering predictions and diagnostic suggestions based on the analysis of the multimodal information. The ultimate goal is to determine whether this AI-driven approach can improve diagnostic accuracy, optimize treatment strategies, and enhance patient outcomes in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Assisted Disease Prediction Using EHR and Imaging Data | This cohort consists of patients whose historical health data, including electronic health records (EHR) and multimodal imaging data (e.g., X-rays, MRIs, CT scans, ultrasounds), will be analyzed by an AI agent. The AI system will assist in diagnosing and predicting diseases by processing and integrating these diverse data sources. The primary focus is to evaluate the ability of the AI agent to identify patterns and predict disease progression with high accuracy. Participants will not be required to take any additional actions beyond providing their medical history and imaging data. The aim is to assess how well the AI system can support clinical decision-making and improve diagnostic outcomes based on the provided data. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) | AUC of the ROC curve, used to quantify diagnostic accuracy. No unit (a ratio or percentage, typically expressed as a number between 0 and 1). | 1 year |
| F1 Score | The F1 score is the harmonic mean of precision and sensitivity (recall). It is a good measure of the model's ability to identify both true positives and minimize false positives, especially in cases where the classes are imbalanced (e.g., when the number of healthy cases is much higher than disease cases). The F1 score ranges from 0 to 1, with 1 indicating perfect precision and recall. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity (True Positive Rate) | Sensitivity measures how well the AI model identifies true positive cases, such as correctly diagnosing pregnant women with complications or identifying neonatal disorders. | 1 year |
| Specificity (True Negative Rate) |
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Inclusion Criteria:
Exclusion Criteria:
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The participants for this study will be selected from multiple healthcare centers and hospitals that maintain comprehensive electronic health records (EHR) and multimodal imaging data. The study population will include patients who have a variety of diseases or health conditions, with data available for diagnosis and disease progression. Participants will have confirmed diagnoses based on clinical records or imaging data, including but not limited to conditions captured by X-rays, CT scans, MRIs, and ultrasounds. Both those with complex health conditions and those with more common illnesses will be included to evaluate the AI system's diagnostic and predictive capabilities across a broad spectrum of cases.Participants from these centers will provide historical health data, and there will be no active intervention beyond the use of their existing clinical and imaging data for training and testing the AI system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Liu, MD | Contact | +86 13810512704 | liufei_2359@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital | Recruiting | Guangzhou | Guangdong | China |
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Specificity measures the ability of the AI model to correctly identify cases without diseases, ensuring that healthy mothers and infants are correctly identified as negative.
| 1 year |
| Sun Yat-Sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Sun Yat-sen University Cancer Hospital | Recruiting | Guangzhou | Guangdong | China |
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| West China Hospital | Recruiting | Chengdu | Sichuan | China |
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| First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
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| Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
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