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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT03366168
Eligibility Criteria:
* INCLUSION CRITERIA:
* Age 18 years and older
* Healthy (see exclusion criteria below)
* Are able to understand the study risks and procedures, and consent to participate in the study.
* Are able to read and speak English.
EXCLUSION CRITERIA:
* Have less than 40 fungiform papillae on the anterior third portion of the tongue as evidenced by tongue photo taken during the screen visit.
* Does not agree to the use of their tissue samples to produce stem cells.
* A medical condition that requires the use of chronic anticoagulant medication use such as warfarin, clopidogrel, heparin or antiplatelet agents other than low dose aspirin (81mg).
* History of increased bleeding due to either a known medical condition or an undiagnosed cause.
* Active infections or chronic conditions that would prevent access to the biopsy area.
* Taking non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) and the participant is unable to stop taking them 4 days before and 3 days after the final biopsy procedure.
* Taking more than 81 mg of aspirin a day and the participant is unable to stop taking it for 4 days before and 3 days after the biopsy procedure.
* Allergic to Lidocaine (Xylocaine) or any other local anesthetic or the participant has had in the past a severe allergic reaction to similar drugs.
* Have taken steroids, other than ocular within 30 days of their scheduled biopsy procedure.
* HIV virus infection.
* Hepatitis B or C.
* Kidney disease (Creatinine greater than1.5 mg/dl or calculated creatinine clearance less than 50 cc/min).
* Liver disease (ALT, AST or alkaline phosphatase twice the normal serum concentration).
* Severe gastrointestinal diseases such as Crohn s disease or ulcerative colitis requiring continuous treatment.
* History of severe pulmonary disease such as chronic obstructive pulmonary disease (COPD) or asthma requiring continuous medication use.
* History of using any tobacco products within the past six months.
* History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment.
* Currently pregnant or breastfeeding.
* Current illness that as judged by the study physician substantially increases the risks associated with the tongue biopsy (active infections, allergies, etc.).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT03366168
Study Brief:
Protocol Section:
NCT03366168