Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT04771104
Eligibility Criteria:
Inclusion Criteria:
* Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
* Written informed consent
* \>20 and \<80 years of age
Exclusion Criteria:
* Misuse of alcohol in the preceding 6 months,
* Episodes of hepatic decompensation leading to in-patient admissions during the previous month
* History or clinical signs of overt HE or severe sleep-wake disturbances
* On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino)
* History of significant head injury
* Neurological/psychiatric comorbidity needing medical treatment
* Taking neuroactive medication/medication known to affect sleep
* Travel across more than two time zones in the preceding 3 months
* Shift work in the preceding 5 years
* Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT04771104
Study Brief:
Protocol Section:
NCT04771104