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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT00859859
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a diagnosis of RA based on the ACR guidelines. Disease activity measured as activity score (DAS-28 CRP) will be used
2. None of the exclusion criteria (see below).
Exclusion Criteria:
1. Minors (\<18 years of age) and mentally incompetent individuals
2. One or more of the following conditions: immunosuppressive condition (which includes malignancy, chronic alcoholism, diabetes), severe chronic dementia, psychiatric illness with active psychosis, current intravenous or other serious illicit drug use
3. Pregnancy
4. Terminal status referred for palliative care only
5. Homeless status
6. IDDM and NIDDM patients will not be enrolled in this study
7. Previous history of ischemic cardiovascular disease including myocardial infarction, unstable angina, and bradytachyarrythmias
8. Moderate or severe anemia. Hemoglobin levels will be determined at screening. A cut-off level of \< 10 mg/dL in women and \< 11 mg/dL in men is selected.
9. Smoking
10. Subjects taking concomitant medications potentially affecting autonomic function such as anti-cholinergic medications and beta-blockers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00859859
Study Brief:
Protocol Section:
NCT00859859