ID

17739

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00565500

Stichworte

Versionen (1)
  1. 01.10.16 01.10.16 -
Hochgeladen am

1. Oktober 2016

DOI

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Creative Commons BY 4.0
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Eligibility Ischemic Heart Disease NCT00565500

Englisch

Eligibility Ischemic Heart Disease NCT00565500

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Degenerative polyarthritis | Myocardial Ischemia Stable

Datentyp

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;
Beschreibung

Aspirin prophylaxis for ischemic heart disease Long-term

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

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;
Beschreibung

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

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Investigational New Drugs

Datentyp

boolean

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

Study Subject Participation Status

Datentyp

boolean

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

Neoplasm Evidence of | body organ Severe disorder | Mental disorders

Datentyp

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;
Beschreibung

Laboratory test result abnormal Relevant Clinical

Datentyp

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;
Beschreibung

Alcohol abuse | Drug Dependence

Datentyp

boolean

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

Compliance behavior Limited

Datentyp

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;
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datentyp

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;
Beschreibung

Pathology Severe Interferes with Study Protocol

Datentyp

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;
Beschreibung

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

Datentyp

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.
Beschreibung

Medical contraindication Anti-Inflammatory Agents, Non-Steroidal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003211
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Ähnliche Modelle

Eligibility Ischemic Heart Disease NCT00565500

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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