Informed Consent | Protocol Compliance
Item
able and willing to give written informed consent and comply with the requirements of the study protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test negative
Item
negative serum pregnancy test (for women of child bearing age)
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods
Item
men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Normal IgG levels | Normal IgM levels
Item
igg & igm levels within normal limits
boolean
C1833177 (UMLS CUI [1])
C1855783 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
adequate renal function as indicated by serum creatinine measurements.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Biological Factors Absent | Exception Anti-tumor necrosis factor therapy Quantity
Item
no previous biological use (investigational or approved) except for the three approved anti-tnf alpha therapies
boolean
C0005515 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0281481 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Anti-tumor necrosis factor therapy | Infliximab Discontinued | Adalimumab Discontinued | Etanercept Discontinued
Item
patients who have been treated with anti-tnf alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry
boolean
C0281481 (UMLS CUI [1])
C0666743 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1122087 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0717758 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Phosphodiesterase 5 inhibitor Absent | Sildenafil Absent | Tadalafil Absent | Vardenafil Absent
Item
no use of phosphodiesterase type 5 inhibitors (pde5) (i.e. sildenafil, tadalafil, and vardenafil) 1 week prior to the study and during the course of the study.
boolean
C1318700 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0529793 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1176316 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0971579 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Systolic Pressure
Item
sbp ≤ 140/90 for two months prior to study enrollment
boolean
C0871470 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Peripheral Vascular Diseases
Item
prior history of mi, cva, cabg, ptca, or peripheral vascular disease
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
Comorbidity Interferes with Clinical Trial
Item
any serious concomitant medical condition that could interfere with the study.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
patients with insulin dependent diabetes
boolean
C0011854 (UMLS CUI [1])
Informed Consent failed
Item
failure to provide written consent.
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
HIV Infections
Item
individuals with hiv infections
boolean
C0019693 (UMLS CUI [1])
Systolic Pressure
Item
sbp > 140/90 at two months prior to study enrollment
boolean
C0871470 (UMLS CUI [1])