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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT02411318
Eligibility Criteria:
Inclusion Criteria:
* Capacity to provide informed consent and ability to speak and read English.
* Male or female with no chronic or acute health concerns that might affect subject safety during the study or interfere with the study results
* No intake of medication that the researchers believe will significantly influence immune function in the 48 hours proceeding the lancet puncture (examples given in the section entitled "Exclusion Criteria")
* In good physical health
* Regularly exercise at least 30 minutes 3 times per week (exercise cohort)
Exclusion Criteria:
* Currently participating in another clinical trial
* History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease)
* Use of beta blockers or corticosteroids
* Currently taking medications that are not recommended to be taken in conjunction with alcohol
* Acute illness or evidence of clinically significant active infection
* Currently receiving immunotherapy
* Pregnant women
* Ingested medication (e.g. systemic corticosteroids) within 48 hours preceding the draw that the researchers believe may have an effect on immune response or the immune system
* Performed any activity that conflicts (eg. drinking any alcohol prior to the study), in the judgment of the investigator, with the external factor to be tested in the study (if any)
* Alcoholic or other health conditions for which alcohol consumption is contraindicated
* Consume more than 7 drinks per week (women alcohol cohort)
* Consume more than 14 drinks per week (men alcohol cohort)
* Consume more than three (8 oz.) servings of coffee, caffeinated soft drinks/tea (12 oz.) per day (caffeine cohort)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT02411318
Study Brief:
Protocol Section:
NCT02411318