Eligibility Osteoarthritis NCT00298974

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StudyEvent: Eligibility
1. Eligibility Osteoarthritis NCT00298974

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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])

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Eligibility Osteoarthritis NCT00298974