ID

18656

Description

A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin; ODM derived from: https://clinicaltrials.gov/show/NCT00175032

Link

https://clinicaltrials.gov/show/NCT00175032

Keywords

Versions (1)
  1. 11/14/16 11/14/16 -
Uploaded on

November 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00175032

English

Eligibility Osteoarthritis NCT00175032

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must require the chronic use of a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.
Description

Therapeutic procedure Osteoarthritis | Non-Steroidal Anti-Inflammatory Agents Use of chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0029408
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0205191
must be taking daily aspirin for cardiovascular prophylaxis.
Description

Cardiovascular prophylaxis | Aspirin Daily

Data type

boolean

Alias
UMLS CUI [1]
C1610618
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0332173
clinical laboratory values within normal limits for this population
Description

Laboratory Results Clinical Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0205307
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
Description

Operation on stomach | duodenal surgery | Operation on esophagus | Oversewing Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0192398
UMLS CUI [2]
C3837072
UMLS CUI [3]
C0192259
UMLS CUI [4,1]
C0521212
UMLS CUI [4,2]
C0041582
evidence of uncontrolled, clinically significant disease.
Description

Disease Uncontrolled Clinical Significance Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C2826293
UMLS CUI [1,4]
C0332120
history of cancer within the past 5 years.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
presence of gastroduodenal ulcers, esophageal ulcer or >= 10 gastroduodenal erosions during the screening endoscopy. known history of gastroduodenal ulcer or bleeding within the past year. esophageal stricture requiring dilatation.
Description

Peptic Ulcer | Ulcer of esophagus | Superficial ulcer Gastroduodenal Quantity | Endoscopy | Gastroduodenal haemorrhage | Esophageal Stenosis Requirement Dilate procedure

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0151970
UMLS CUI [3,1]
C0333307
UMLS CUI [3,2]
C0450199
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0014245
UMLS CUI [5]
C1096494
UMLS CUI [6,1]
C0014866
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C1322279
presence of barrett's esophagus with dysplastic changes.
Description

Barretts esophagus with dysplasia

Data type

boolean

Alias
UMLS CUI [1]
C1333324
systemic disease affecting the esophagus or a history of caustic or physiochemical trauma or irradiation to the esophagus.
Description

Systemic disease Affecting Esophagus | Caustic injury | Trauma Physiochemical | irradiation of esophagus

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0014876
UMLS CUI [2]
C0854388
UMLS CUI [3,1]
C3714660
UMLS CUI [3,2]
C1372991
UMLS CUI [4]
C2169047
sero-tests positive for h. pylori.
Description

Helicobacter pylori Test Seropositive

Data type

boolean

Alias
UMLS CUI [1,1]
C0079488
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0521143
evidence of zollinger-ellison syndrome, esophageal varices, cholecystitis, or pancreaticobiliary tract disease.
Description

Zollinger-Ellison syndrome Evidence of | Esophageal Varices Evidence of | Cholecystitis Evidence of | Pancreaticobiliary system Disease Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0043515
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0014867
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0008325
UMLS CUI [3,2]
C0332120
UMLS CUI [4,1]
C2951305
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332120
requires treatment with an excluded medication such as proton pump inhibitors, histamine h2 receptor antagonists, antacids, corticosteroids, lithium, fluconazole, misoprostol, probenecid, methotrexate, anticoagulants, st. john's wart, dong quai, feverfew, garlic, ginger, horse chestnut, red clover or white willow supplements or bisphosphonates.
Description

Pharmaceutical Preparations Excluded Patient need for | Proton Pump Inhibitors | Histamine H2 Antagonists | Antacids | Adrenal Cortex Hormones | Lithium | Fluconazole | Misoprostol | Probenecid | Methotrexate | Anticoagulants | ST. JOHN'S WORT EXTRACT | Angelica sinensis preparation | feverfew extract | Garlic preparation | Ginger extract | Horse Chestnut Preparation | Red Clover Preparation | Salix alba bark extract | Diphosphonates

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C0358591
UMLS CUI [3]
C0019593
UMLS CUI [4]
C0003138
UMLS CUI [5]
C0001617
UMLS CUI [6]
C0023870
UMLS CUI [7]
C0016277
UMLS CUI [8]
C0085174
UMLS CUI [9]
C0033209
UMLS CUI [10]
C0025677
UMLS CUI [11]
C0003280
UMLS CUI [12]
C0813171
UMLS CUI [13]
C1122975
UMLS CUI [14]
C0376266
UMLS CUI [15]
C0885057
UMLS CUI [16]
C0939895
UMLS CUI [17]
C0994438
UMLS CUI [18]
C0939844
UMLS CUI [19]
C2349151
UMLS CUI [20]
C0012544
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Similar models

Eligibility Osteoarthritis NCT00175032

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure Osteoarthritis | Non-Steroidal Anti-Inflammatory Agents Use of chronic
Item
must require the chronic use of a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.
boolean
C0087111 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Cardiovascular prophylaxis | Aspirin Daily
Item
must be taking daily aspirin for cardiovascular prophylaxis.
boolean
C1610618 (UMLS CUI [1])
C0004057 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
Laboratory Results Clinical Normal
Item
clinical laboratory values within normal limits for this population
boolean
C1254595 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Operation on stomach | duodenal surgery | Operation on esophagus | Oversewing Ulcer
Item
history of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
boolean
C0192398 (UMLS CUI [1])
C3837072 (UMLS CUI [2])
C0192259 (UMLS CUI [3])
C0521212 (UMLS CUI [4,1])
C0041582 (UMLS CUI [4,2])
Disease Uncontrolled Clinical Significance Evidence of
Item
evidence of uncontrolled, clinically significant disease.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
Malignant Neoplasms
Item
history of cancer within the past 5 years.
boolean
C0006826 (UMLS CUI [1])
Peptic Ulcer | Ulcer of esophagus | Superficial ulcer Gastroduodenal Quantity | Endoscopy | Gastroduodenal haemorrhage | Esophageal Stenosis Requirement Dilate procedure
Item
presence of gastroduodenal ulcers, esophageal ulcer or >= 10 gastroduodenal erosions during the screening endoscopy. known history of gastroduodenal ulcer or bleeding within the past year. esophageal stricture requiring dilatation.
boolean
C0030920 (UMLS CUI [1])
C0151970 (UMLS CUI [2])
C0333307 (UMLS CUI [3,1])
C0450199 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0014245 (UMLS CUI [4])
C1096494 (UMLS CUI [5])
C0014866 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C1322279 (UMLS CUI [6,3])
Barretts esophagus with dysplasia
Item
presence of barrett's esophagus with dysplastic changes.
boolean
C1333324 (UMLS CUI [1])
Systemic disease Affecting Esophagus | Caustic injury | Trauma Physiochemical | irradiation of esophagus
Item
systemic disease affecting the esophagus or a history of caustic or physiochemical trauma or irradiation to the esophagus.
boolean
C0442893 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0014876 (UMLS CUI [1,3])
C0854388 (UMLS CUI [2])
C3714660 (UMLS CUI [3,1])
C1372991 (UMLS CUI [3,2])
C2169047 (UMLS CUI [4])
Helicobacter pylori Test Seropositive
Item
sero-tests positive for h. pylori.
boolean
C0079488 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0521143 (UMLS CUI [1,3])
Zollinger-Ellison syndrome Evidence of | Esophageal Varices Evidence of | Cholecystitis Evidence of | Pancreaticobiliary system Disease Evidence of
Item
evidence of zollinger-ellison syndrome, esophageal varices, cholecystitis, or pancreaticobiliary tract disease.
boolean
C0043515 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0014867 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0008325 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C2951305 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332120 (UMLS CUI [4,3])
Pharmaceutical Preparations Excluded Patient need for | Proton Pump Inhibitors | Histamine H2 Antagonists | Antacids | Adrenal Cortex Hormones | Lithium | Fluconazole | Misoprostol | Probenecid | Methotrexate | Anticoagulants | ST. JOHN'S WORT EXTRACT | Angelica sinensis preparation | feverfew extract | Garlic preparation | Ginger extract | Horse Chestnut Preparation | Red Clover Preparation | Salix alba bark extract | Diphosphonates
Item
requires treatment with an excluded medication such as proton pump inhibitors, histamine h2 receptor antagonists, antacids, corticosteroids, lithium, fluconazole, misoprostol, probenecid, methotrexate, anticoagulants, st. john's wart, dong quai, feverfew, garlic, ginger, horse chestnut, red clover or white willow supplements or bisphosphonates.
boolean
C0013227 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0358591 (UMLS CUI [2])
C0019593 (UMLS CUI [3])
C0003138 (UMLS CUI [4])
C0001617 (UMLS CUI [5])
C0023870 (UMLS CUI [6])
C0016277 (UMLS CUI [7])
C0085174 (UMLS CUI [8])
C0033209 (UMLS CUI [9])
C0025677 (UMLS CUI [10])
C0003280 (UMLS CUI [11])
C0813171 (UMLS CUI [12])
C1122975 (UMLS CUI [13])
C0376266 (UMLS CUI [14])
C0885057 (UMLS CUI [15])
C0939895 (UMLS CUI [16])
C0994438 (UMLS CUI [17])
C0939844 (UMLS CUI [18])
C2349151 (UMLS CUI [19])
C0012544 (UMLS CUI [20])
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