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NCT07721454

Overview

NCT ID: NCT07721454
Lead Sponsor: Antonio GalanteOTHER
Official Title: Application of Artificial Intelligence Using Wearable Technology in Patients With Advanced Chronic Liver Disease (ACLD): a Trajectomics Approach.
Brief Summary: The research project studies the possibility of using an artificial intelligence-based system in patients with advanced chronic liver disease (liver cirrhosis) to record variations in a patient's health status, with the aim of early identification of clinical improvement or deterioration. The system is based on the collection and processing of various clinical parameters through an Apple Watch. The study aims to evaluate whether the data generated by this system correlate with patients' clinical evolution and whether its use may ultimately contribute to improved care management and quality of life.
Conditions: Advance Chronic Liver Disease (ACLD)

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adults aged 18-75 years

Diagnosis of advanced chronic liver disease (ACLD).

Either:

hospitalized for hepatic decompensation or acute-on-chronic liver failure (ACLF), including ascites, hepatorenal syndrome, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding, or jaundice; or

outpatient with Child-Pugh B cirrhosis and no evidence of hepatic decompensation or ACLF at enrolment.

Willing and able to provide written informed consent.

Exclusion Criteria:

Inability or refusal to provide written informed consent

Inability to wear or correctly use the Apple Watch

Patients with hepatocellular carcinoma beyond the Milan Criteria (one lesion up to 5 cm or 3 lesions up to 3 cm in diameter)

Presence of hepatic decompensation or ACLF