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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT01281995
Eligibility Criteria:
* INCLUSION CRITERIA:
Healthy volunteer (health status confirmed by History and Physical Exam and blood work)
Ages 18 years or older (no upper limit)
Must be willing to allow samples to undergo genetic studies
EXCLUSION CRITERIA:
Patients with diseases with an inflammatory or immune component
Patients who have irregular circadian rhythms, i.e. those who are blind or work night shifts
Patients with active infections requiring systemic antibiotic therapy
Use of immune modifying medications, i.e. NSAIDs (such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), ketorolac (Toradol) within the past month
Systemic fungal, viral, or mycobacterial infections
Persons who are alcoholic or abusers of illicit substances
Abnormal fasting glucose \>100mg/dL
Female subjects may not be pregnant or lactating due to possible side effects of use of hydrocortisone in a non-benefit study
Liver function tests (AST, ALT, total bilirubin, alkaline phosphatase) above the normal laboratory reference range
Other contraindications to corticosteroids (i.e. gastrointestinal ulceration, Cushing s syndrome, congestive heart failure, uncontrolled hypertension, glaucoma, osteoporosis, or known hypersensitivity to corticosteroids)
Corticosteroid use within the last six months prior to enrollment, including topical, intra-articular or intramuscular injections, or inhaled administration
Prior use of systemically administered corticosteroids for \>6 months duration
Use of azole medications or chronic opiates
Patients with psychiatric diagnoses or symptoms, to include hypomania, bipolar disorder, major depression, or dysthymia
Patients with a body mass index greater than 30
Subjects unable to comprehend the investigational nature of the study or those who are unable or unwilling to sign the consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01281995
Study Brief:
Protocol Section:
NCT01281995