Age
Item
males and females ages 21 to 80
boolean
C0001779 (UMLS CUI [1])
Gender Childbearing Potential Absent | Gender Contraceptive methods
Item
if female, must be of non-child bearing potential or practicing birth control
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Osteoarthritis of hip | Osteoarthritis, Knee
Item
has osteoarthritis of the hip or knee
boolean
C0029410 (UMLS CUI [1])
C0409959 (UMLS CUI [2])
Pharmacotherapy Degenerative polyarthritis Pain
Item
requires therapeutic doses of medication for osteoarthritis pain
boolean
C0013216 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Opioids Around the Clock Pain
Item
has sufficient pain to justify the use of around-the-clock opioids
boolean
C0242402 (UMLS CUI [1,1])
C1879738 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Study Subject Participation Status | Vicodin
Item
is associated with any currently ongoing research study, or has previously participated in a vicodin cr study
boolean
C2348568 (UMLS CUI [1])
C0483514 (UMLS CUI [2])
Hypersensitivity Hydrocodone | Allergic Reaction Hydrocodone | Hypersensitivity Opioids | Allergic Reaction Opioids | Hypersensitivity Acetaminophen | Allergic Reaction Acetaminophen
Item
is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
boolean
C0020517 (UMLS CUI [1,1])
C0020264 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0020264 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0242402 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0242402 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0000970 (UMLS CUI [5,2])
C1527304 (UMLS CUI [6,1])
C0000970 (UMLS CUI [6,2])
Analgesics Unable to discontinue
Item
cannot discontinue pain medications, even for the short time prior to the study start
boolean
C0002771 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
Illness Significant | Traumatic injury | Laboratory test result abnormal | major surgery
Item
has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C3263723 (UMLS CUI [2])
C0438215 (UMLS CUI [3])
C0679637 (UMLS CUI [4])
Gastric Bypass | Stenosis gastrointestinal Severe Pre-existing | Disease Narrowing Gastrointestinal tract
Item
has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
boolean
C0017125 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C0521362 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C2347662 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C0333164 (UMLS CUI [3,2])
C0017189 (UMLS CUI [3,3])
Malnutrition | Starvation
Item
has a history of malnutrition or starvation
boolean
C0162429 (UMLS CUI [1])
C0038187 (UMLS CUI [2])
Substance Use Disorders | Illicit drug use | Substance Dependence | Alcohol consumption Quantity per day
Item
has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
boolean
C0038586 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0001948 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0439505 (UMLS CUI [4,3])
Single major depressive episode | Depressive disorder Pharmaceutical Preparations Patient need for | Mental disorder Major
Item
has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
boolean
C0024517 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disability | Bedridden | WHEELCHAIR CONFINEMENT
Item
is incapacitated, bedridden or confined to a wheelchair
boolean
C0231170 (UMLS CUI [1])
C0741453 (UMLS CUI [2])
C0241735 (UMLS CUI [3])
New therapy Degenerative polyarthritis | New medication commenced Degenerative polyarthritis
Item
has initiated any new therapy or medication for oa within 1 month of screening
boolean
C3242274 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0420250 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Operative Surgical Procedures Degenerative polyarthritis | Interventional procedure Degenerative polyarthritis | Pharmaceutical Preparations Degenerative polyarthritis
Item
has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
boolean
C0543467 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0029408 (UMLS CUI [3,2])
Condition Causing Pain | Rheumatoid Arthritis | Gout
Item
has other conditions that may cause pain, such as rheumatoid arthritis or gout
boolean
C0348080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2])
C0018099 (UMLS CUI [3])