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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT00094406
Eligibility Criteria:
* INCLUSION CRITERIA:
All volunteer subjects, employees and non-employees, must 18 to 40 years of age and must be able to provide informed, written consent for participation in this study. We will not directly advertise the study to employees to avoid the potential for coercion. Eligibility in the study is determined prior to enrollment on the basis of the following inclusion and exclusion criteria.
Normal screening examination including:
1. medical history and physical examination, nonsmoker, no concurrent medications including aspirin or nonsteroidal anti-inflammatory drugs, no active medical problems
2. complete blood count with differential and platelet counts
3. serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes and function tests, electrolytes, prothrombin time, partial thromboplastin time, carboxyhemoglobin measured by venous co-oxymetry.
4. urinalysis
5. female subjects must have negative urine pregnancy test within one week of participation (this will be repeated immediately prior to beginning the screening procedures due to radiation exposure from the chest x-ray)
6. electrocardiogram
7. chest radiograph
Sexually active females not using contraceptive methods will be instructed to abstain from sexual activity or use barrier contraception methods from the time of last negative pregnancy test to 24 hours after completion of the study.
EXCLUSION CRITERIA:
1. active tobacco use
2. baseline caroxyhemoglobin greater than 2%
3. pregnancy
4. lactation
5. medical history of recent clinically significant asthma allergy to both sulfa- and penicillin-based drugs
6. Allergy to both sulfa- and penicillin-based drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00094406
Study Brief:
Protocol Section:
NCT00094406