Age
Item
age 18 to 65 years
boolean
C0001779 (UMLS CUI [1])
Gender | Postmenopausal state | Female Sterilization | Hysterectomy | Ovariectomy | Tubal Ligation
Item
male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation)
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0029936 (UMLS CUI [5])
C0520483 (UMLS CUI [6])
Informed Consent | Protocol Compliance
Item
give written informed consent to participate in the study and availability for all study requirements
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
fasting plasma glucose </= the upper limit of the laboratory's reference range (uln)
boolean
C0583513 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c </= uln
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi < 30 kg/m²
boolean
C1305855 (UMLS CUI [1])
Maintenance Hydration Steady | Fluid restriction Absent
Item
agree to maintain steady hydration throughout study participation and agree not to fluid restrict
boolean
C0024501 (UMLS CUI [1,1])
C4520800 (UMLS CUI [1,2])
C0205361 (UMLS CUI [1,3])
C0204700 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential
Item
pregnant women, nursing mothers or women of childbearing potential
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Medical History Abnormality | Physical examination abnormal
Item
clinically significant abnormalities in medical history or physical examination
boolean
C0262926 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0747585 (UMLS CUI [2])
Laboratory test result abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin | Serum creatinine raised | Proteinuria Urine dipstick test | Decreased platelet count | Laboratory test finding Clinical Significance
Item
clinically significant abnormalities in laboratory examination (including alt > uln, ast > uln, bilirubin > uln, creatinine > uln, urine protein positive by urine dipstick, platelets < lower limit of normal and any other clinically significant laboratory findings)
boolean
C0438215 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
C0033687 (UMLS CUI [6,1])
C0430370 (UMLS CUI [6,2])
C0392386 (UMLS CUI [7])
C0587081 (UMLS CUI [8,1])
C2826293 (UMLS CUI [8,2])
Estimated Glomerular Filtration Rate
Item
estimated gfr < 60 ml/min per 1.73m²
boolean
C3811844 (UMLS CUI [1])
Abnormal coagulation profile
Item
history of clinically significant abnormalities in coagulation parameters
boolean
C0375576 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B virus test positive | Hepatitis C virus test positive
Item
positive test result for hiv, hepatitis b virus, and/or hepatitis c virus
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
Communicable Disease Requirement Antiviral Therapy | Communicable Disease Requirement Antimicrobials
Item
active infection requiring antiviral or antimicrobial therapy
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0280274 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1136254 (UMLS CUI [2,3])
Prescribed medication chronic allowed | Prescribed medication allowed | Status post Discussion
Item
subjects on chronic or acute prescription medication may be permitted after discussion with the isis medical monitor
boolean
C2239117 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C2239117 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1283217 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Recurrence Absent Duration
Item
malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0034897 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0449238 (UMLS CUI [4,4])
Comorbidity Study Subject Participation Status Excluded | Comorbidity Interferes with Protocol Compliance
Item
any other concurrent condition which, in the opinion of the investigator, would preclude participation in this study or interfere with compliance
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Substance Use Disorders
Item
past and present history of alcohol or drug abuse (defined as > 3 units daily)
boolean
C0038586 (UMLS CUI [1])
Investigational New Drugs | Biological Agents | Investigational Medical Device
Item
undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to screening
boolean
C0013230 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Blood Donation
Item
blood donation within three months of screening
boolean
C0005794 (UMLS CUI [1])