Age
Item
1. male or female, age 18-75;
boolean
C0001779 (UMLS CUI [1])
Degenerative polyarthritis | Myocardial Ischemia Stable
Item
2. subjects with osteoarthritis and documented stable ischemic heart disease;
boolean
C0029408 (UMLS CUI [1])
C0151744 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Aspirin prophylaxis for ischemic heart disease Long-term
Item
3. the patient is on long-term aspirin prophylaxis for the ischemic condition;
boolean
C0579114 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
Anti-Inflammatory Agents chronic control Degenerative polyarthritis Symptoms | Analgesics chronic control Degenerative polyarthritis Symptoms
Item
4. the patient requires or is eligible for chronic treatment with an antiinflammatory and/or analgesic drugs given to control osteoarthritis symptoms;
boolean
C0003209 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,3])
C0029408 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,5])
C0002771 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0243148 (UMLS CUI [2,3])
C0029408 (UMLS CUI [2,4])
C1457887 (UMLS CUI [2,5])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Breast Feeding
Item
5. female subjects of childbearing potential must have a negative pregnancy test, use adequate contraception during the study and not be lactating;
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Informed Consent
Item
6. written informed consent before undergoing any study procedure.
boolean
C0021430 (UMLS CUI [1])
Gastrointestinal Diseases | Crohn Disease | Ulcerative Colitis | Comorbidity Evidence Resulting in Early Termination of Clinical Trial
Item
1. active gastrointestinal disease (e.g. crohn's disease or ulcerative colitis) or any evidence of concomitant disease which may lead to early termination of the study;
boolean
C0017178 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0009488 (UMLS CUI [4,1])
C3887511 (UMLS CUI [4,2])
C0332294 (UMLS CUI [4,3])
C2718058 (UMLS CUI [4,4])
Peptic Ulcer | Gastrointestinal Hemorrhage | Ulcer of esophagus | Gastric ulcer | Duodenal Ulcer
Item
2. history of active peptic ulceration, gastrointestinal bleeding, esophageal, gastric or duodenal ulcer;
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0151970 (UMLS CUI [3])
C0038358 (UMLS CUI [4])
C0013295 (UMLS CUI [5])
allergy to COX-2 inhibitors | Analgesic allergy | Hypersensitivity Antipyretics | Allergy to sulfonamides | allergy to nonsteroidal anti-inflammatory agents
Item
3. known hypersensitivity to cox-2 inhibitors, analgesics, antipyretics, sulfonamides or nsaids;
boolean
C2136452 (UMLS CUI [1])
C0570511 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0003419 (UMLS CUI [3,2])
C0038757 (UMLS CUI [4])
C0746949 (UMLS CUI [5])
Investigational New Drugs
Item
4. treatment with any investigational drug within the previous 30 days;
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status
Item
5. previous participation in this study;
boolean
C2348568 (UMLS CUI [1])
Neoplasm Evidence of | body organ Severe disorder | Mental disorders
Item
6. evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
boolean
C0027651 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1280836 (UMLS CUI [2,1])
C1836348 (UMLS CUI [2,2])
C0004936 (UMLS CUI [3])
Laboratory test result abnormal Relevant Clinical
Item
7. clinically relevant deviations from the normal range in laboratory tests;
boolean
C0438215 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Alcohol abuse | Drug Dependence
Item
8. recent history or suspicion of alcohol abuse or drug addiction;
boolean
C0085762 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
Compliance behavior Limited
Item
9. subjects unlikely to be collaborative or to give reliable answers;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
10. pregnancy or lactation; female or childbearing potential without a clinical accepted contraceptive method;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Pathology Severe Interferes with Study Protocol
Item
11. any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial;
boolean
C0677042 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Platelet Aggregation Inhibitors | Anticoagulants | Diuretics | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Lithium | Methotrexate | Cimetidine | Digoxin
Item
12. intake of antiaggregant, anticoagulant, diuretic, beta-blocker, ace- inhibitor, lithium, methotrexate, cimetidine, digoxin;
boolean
C0032177 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
C0012798 (UMLS CUI [3])
C0001645 (UMLS CUI [4])
C0003015 (UMLS CUI [5])
C0023870 (UMLS CUI [6])
C0025677 (UMLS CUI [7])
C0008783 (UMLS CUI [8])
C0012265 (UMLS CUI [9])
Medical contraindication Anti-Inflammatory Agents, Non-Steroidal
Item
13. contraindications to nsaids.
boolean
C1301624 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])