Postmenopausal state Duration | Bilateral oophorectomy | Hysterectomy | Female sterility
Item
if female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility
boolean
C0232970 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0278321 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0917730 (UMLS CUI [4])
Male sterility | Vasectomy | Gender Barrier Contraception | Sperm donation Absent
Item
if male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product
boolean
C0917731 (UMLS CUI [1])
C0042387 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
C0871414 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Coronary heart disease Stable | Unstable Angina Absent | Acute Coronary Syndrome Absent
Item
stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months
boolean
C0010068 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0948089 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Pharmaceutical Preparations cardiac Dose Stable | Adrenergic beta-1 Receptor Antagonists | Renin-angiotensin system inhibitors | Aldosterone Antagonists | Hydralazine | Nitrates
Item
all cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to day 1
boolean
C0013227 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0304516 (UMLS CUI [2])
C0035096 (UMLS CUI [3,1])
C0243077 (UMLS CUI [3,2])
C0002007 (UMLS CUI [4])
C0020223 (UMLS CUI [5])
C0028125 (UMLS CUI [6])
Exposure to GGF2 | Exposure to Neuregulins
Item
any previous exposure to ggf2 or other neuregulins
boolean
C0332157 (UMLS CUI [1,1])
C1448481 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0752253 (UMLS CUI [2,2])
Initiation Prescription Drugs | Change Prescription Drugs | Pharmacotherapy Change Expected
Item
initiation or change of a prescription medication within the 2 weeks prior to day 1, and/or concomitant medication regimen is expected to change during the course of the study
boolean
C1704686 (UMLS CUI [1,1])
C0304227 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0304227 (UMLS CUI [2,2])
C0013216 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Midazolam allergy | Allergic Reaction Midazolam Syrup Component | Allergic Reaction Cherry Flavor | Allergic Reaction GGF2 diluent Component
Item
known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of ggf2 diluent
boolean
C0570821 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0026056 (UMLS CUI [2,2])
C0991550 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C0770609 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C1448481 (UMLS CUI [4,2])
C0304221 (UMLS CUI [4,3])
C1705248 (UMLS CUI [4,4])
Liver disease | Serum total bilirubin measurement | Aspartate aminotransferase measurement
Item
known specific hepatic disease; total bilirubin >2 mg/dl, ast > 100 iu
boolean
C0023895 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Hepatic impairment | Hepatitis B | Hepatitis C
Item
history of hepatic impairment (hepatitis b and c)
boolean
C0948807 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
type i diabetes
boolean
C0011854 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
documented stroke or transient ischemic attack (tia) within 2 months of study enrollment
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])