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:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT01069133
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 years
* cirrhosis diagnosed by clinical or biopsy grounds
* Minimal hepatic encephalopathy defined by impaired performance on at least 2 of the following: number connection tests A/B, digit symbol and block design tests (NCT-A, NCT-B, DST and BDT) compared to age and education-matched controls.
* No contraindications to MRI
* TIPS (transjugular intra-hepatic porto-systemic shunt) procedure or elective surgery planned within the next 8 weeks
Exclusion Criteria:
* Current therapy with lactulose, rifaximin or other treatment for hepatic encephalopathy.
* Prior episodes of overt HE
* MMSE \<25
* TIPS placement
* Unable to give informed consent.
* Contra-indications to MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01069133
Study Brief:
Protocol Section:
NCT01069133