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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT02048969
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 and older
2. ICD-9 diagnosis of hepatic encephalopathy
3. Ability to feel comfortable in confined areas (like MRI)
4. Ability to provide informed consent
5. Speaks fluent English without any communication barriers
6. Reliable family member or friend able to stay with participant during abstinence from HE medication prior to visit.
Exclusion Criteria:
1. Current DSM-IV-R diagnosis of Alcohol or Other Drug Abuse or Dependence
2. Positive screen for alcohol abuse as determined by the CAGE questionnaire
3. Positive urine toxicity screen for benzodiazepine medications or illicit drugs
4. History of long-term use of benzodiazepine medications
5. Current use of non-benzodiazepine agonist medications
6. History of Panic Disorder
7. History of any Psychotic Disorder
8. History of seizures and/or Seizure Disorder
9. History of dysrhythmia, cardiovascular collapse, or recent head trauma
10. History of side effects from anticholinergic medications
11. History of cyclic antidepressant overdose or poisoning
12. Pregnant or nursing
13. Resides in nursing home or other long-term care facility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02048969
Study Brief:
Protocol Section:
NCT02048969