0 Ratings
ID

17739

Description

Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin; ODM derived from: https://clinicaltrials.gov/show/NCT00565500

Link

https://clinicaltrials.gov/show/NCT00565500

Keywords

Versions (1)
  1. 10/1/16 10/1/16 -
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October 1, 2016

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Creative Commons BY 4.0
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    Eligibility Ischemic Heart Disease NCT00565500

    English

    Eligibility Ischemic Heart Disease NCT00565500

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. male or female, age 18-75;
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. subjects with osteoarthritis and documented stable ischemic heart disease;
    Description

    Degenerative polyarthritis | Myocardial Ischemia Stable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0029408
    UMLS CUI [2,1]
    C0151744
    UMLS CUI [2,2]
    C0205360
    3. the patient is on long-term aspirin prophylaxis for the ischemic condition;
    Description

    Aspirin prophylaxis for ischemic heart disease Long-term

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0579114
    UMLS CUI [1,2]
    C0443252
    4. the patient requires or is eligible for chronic treatment with an antiinflammatory and/or analgesic drugs given to control osteoarthritis symptoms;
    Description

    Anti-Inflammatory Agents chronic control Degenerative polyarthritis Symptoms | Analgesics chronic control Degenerative polyarthritis Symptoms

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003209
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [1,3]
    C0243148
    UMLS CUI [1,4]
    C0029408
    UMLS CUI [1,5]
    C1457887
    UMLS CUI [2,1]
    C0002771
    UMLS CUI [2,2]
    C0205191
    UMLS CUI [2,3]
    C0243148
    UMLS CUI [2,4]
    C0029408
    UMLS CUI [2,5]
    C1457887
    5. female subjects of childbearing potential must have a negative pregnancy test, use adequate contraception during the study and not be lactating;
    Description

    Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0427780
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0700589
    UMLS CUI [3]
    C0006147
    6. written informed consent before undergoing any study procedure.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    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;
    Description

    Gastrointestinal Diseases | Crohn Disease | Ulcerative Colitis | Comorbidity Evidence Resulting in Early Termination of Clinical Trial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0017178
    UMLS CUI [2]
    C0010346
    UMLS CUI [3]
    C0009324
    UMLS CUI [4,1]
    C0009488
    UMLS CUI [4,2]
    C3887511
    UMLS CUI [4,3]
    C0332294
    UMLS CUI [4,4]
    C2718058
    2. history of active peptic ulceration, gastrointestinal bleeding, esophageal, gastric or duodenal ulcer;
    Description

    Peptic Ulcer | Gastrointestinal Hemorrhage | Ulcer of esophagus | Gastric ulcer | Duodenal Ulcer

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030920
    UMLS CUI [2]
    C0017181
    UMLS CUI [3]
    C0151970
    UMLS CUI [4]
    C0038358
    UMLS CUI [5]
    C0013295
    3. known hypersensitivity to cox-2 inhibitors, analgesics, antipyretics, sulfonamides or nsaids;
    Description

    allergy to COX-2 inhibitors | Analgesic allergy | Hypersensitivity Antipyretics | Allergy to sulfonamides | allergy to nonsteroidal anti-inflammatory agents

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2136452
    UMLS CUI [2]
    C0570511
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0003419
    UMLS CUI [4]
    C0038757
    UMLS CUI [5]
    C0746949
    4. treatment with any investigational drug within the previous 30 days;
    Description

    Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    5. previous participation in this study;
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    6. evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
    Description

    Neoplasm Evidence of | body organ Severe disorder | Mental disorders

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027651
    UMLS CUI [1,2]
    C0332120
    UMLS CUI [2,1]
    C1280836
    UMLS CUI [2,2]
    C1836348
    UMLS CUI [3]
    C0004936
    7. clinically relevant deviations from the normal range in laboratory tests;
    Description

    Laboratory test result abnormal Relevant Clinical

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0438215
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [1,3]
    C0205210
    8. recent history or suspicion of alcohol abuse or drug addiction;
    Description

    Alcohol abuse | Drug Dependence

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085762
    UMLS CUI [2]
    C1510472
    9. subjects unlikely to be collaborative or to give reliable answers;
    Description

    Compliance behavior Limited

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    10. pregnancy or lactation; female or childbearing potential without a clinical accepted contraceptive method;
    Description

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0332268
    11. any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial;
    Description

    Pathology Severe Interferes with Study Protocol

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0677042
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0521102
    UMLS CUI [1,4]
    C2348563
    12. intake of antiaggregant, anticoagulant, diuretic, beta-blocker, ace- inhibitor, lithium, methotrexate, cimetidine, digoxin;
    Description

    Platelet Aggregation Inhibitors | Anticoagulants | Diuretics | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Lithium | Methotrexate | Cimetidine | Digoxin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032177
    UMLS CUI [2]
    C0003280
    UMLS CUI [3]
    C0012798
    UMLS CUI [4]
    C0001645
    UMLS CUI [5]
    C0003015
    UMLS CUI [6]
    C0023870
    UMLS CUI [7]
    C0025677
    UMLS CUI [8]
    C0008783
    UMLS CUI [9]
    C0012265
    13. contraindications to nsaids.
    Description

    Medical contraindication Anti-Inflammatory Agents, Non-Steroidal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0003211
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    Similar models

    Eligibility Ischemic Heart Disease NCT00565500

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    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])
    Item Group
    C0680251 (UMLS CUI)
    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])
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