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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01529502
Eligibility Criteria:
Inclusion Criteria:
1. Have a photo ID
2. Age\>18 years old (required to provide informed consent)
3. Age \<60 years old
4. Mild impairment of endothelial function, assessed by post ischemic vasodilation (L\_RHI,\<0.7) (38)
5. Body mass index (BMI) \>27 kg/m\^2 and \<40 kg/m\^2
6. Fasting during the days of transfusion.
7. Avoiding intake of high nitrate food (i.e. green leafy vegetables: lettuce, spinach) on the day prior to the study
8. Feel well on the day of blood donation
9. KG within normal limits
10. Normotensive (systolic blood pressure \<140 mmHg and diastolic \<90 mmHg)
11. Normal physical exam and blood test results as indicated by:
1. WBC 4.5-11.0 n x103/μL
2. HGB 12.0-17.5 gm/dl
3. PLT 150-400 n x103/μL
4. Plasma Sodium 135-145 mmol/L
5. Plasma Potassium 3.4-4.8 mmol/L
6. Plasma Chloride 98-108 mmol/L
7. Plasma Carbon Dioxide 23.0-31.9 mmol/L
8. Plasma Urea Nitrogen 8-25 mg/dl
9. Plasma Creatinine 0.60-1.50 mg/dl
10. Plasma Glucose 70-110 mg/dl
11. Transaminase-SGPT 10-55 U/L
12. Transaminase-SGOT 10-40 U/L
13. Total Bilirubin \< 2 mg/dl
14. Fasting plasma glucose \< 110 mg/dl
15. Methemoglobin \< 3%
Exclusion Criteria:
1. Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year
2. Systemic disease with or without any functional limitation
3. Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin (hCG), or less than six weeks postpartum
4. Active smoking. Volunteers may be enrolled if they quit smoking for more than 1 year.
5. Excess alcohol use: more than ½ L/day of wine consumption or equivalent
6. Any current use of a medication other than: over-the-counter oral medications, herbal remedies, nutritional supplements, and oral contraceptives.
7. Antibiotic use within 48 hours of blood donation
8. Use of NSAIDS, corticosteroids, aspirin during the past 7 days
9. Dental work within 24 hours prior to the donation
10. Received or donated blood in the last 4 months
11. Have had any forms of cancer with the exceptions of basal cell skin cancer or treatment for in situ uterine cervical cancer
12. Currently enrolled in another research study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01529502
Study Brief:
Protocol Section:
NCT01529502