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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00678834
Eligibility Criteria:
Aim 1 Surgical candidate with a surgery schedule date with a time period of 4-24 weeks (\<4 weeks will be excluded; last dose until 24h before surgery) In Aim 1 we expect to have patients, with diverse co-morbidity and medication conditions.
Patient Selection: Because of limitation in obtaining healthy human tissues (as in Aim 2), we plan to obtain these tissues from patients who are scheduled for the following surgeries for subjects in group one:
Heart Heart Transplant Heart Failure- Biopsy taken from diseased heart Lung Lung Transplant, Lung-wedge/resection, Lobectomy Cancer- Tissue sample taken from removed lung or resected portion of lung Liver Liver Transplant, Biopsy, Resection Hepatic Malignancy- Biopsy taken from resected portion of liver Adipose Tissue Panniculectomy Excessive Tissue of the Abdomen Brain \& CSF Epilepsy Excised brain tissue and cerebrospinal fluid
To ensure higher enrollment we are not controlling for age of subjects as long as the subjects are 21 years of age or older.
Inclusion Criteria Aim 1:
* age 21 and older
* good health
* non- smoker
* no current medications
* non- pregnant or non-breastfeeding
* no previous use of OTC medications or other form of supplements containing vitamin-E.
Inclusion Criteria Aim 2:
* age 21 - 40 years
* good health
* non- smoker
* no current medications
* non- pregnant or non-breastfeeding
* no previous use of OTC medications or other form of supplements containing vitamin-E.
Exclusion Criteria Aim 1:
* Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements
* Scheduled surgery date lesser than 4 weeks or greater than 24 weeks.
Exclusion Criteria Aim 2:
* Over 40 or under 21 years of age
* Current smoker
* Pregnant and breastfeeding
* Diabetes and HIV diagnosis
* Immunosuppression therapy
* Any neurological problems
* Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements
* ETOH or drug abuse
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00678834
Study Brief:
Protocol Section:
NCT00678834