ID

193

Description

ODM derived from http://clinicaltrials.gov/show/NCT00251966

Link

http://clinicaltrials.gov/show/NCT00251966

Keywords

  1. 2/21/12 2/21/12 -
  2. 6/6/17 6/6/17 - Martin Dugas
Uploaded on

February 21, 2012

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility NCT00251966 Gastroesophageal Reflux

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age >= 60 years
Description

Age

Data type

boolean

A clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose ASA, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week)
Description

Medical conditions

Data type

boolean

No gastric and/or duodenal ulcer at the baseline endoscopy
Description

No gastric and/or duodenal ulcer

Data type

boolean

H. pylori negative by serology test at screening
Description

H. pylori negative

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Upper GI symptoms
Description

Upper GI symptoms

Data type

boolean

Erosive oesophagitis
Description

Erosive oesophagitis

Data type

boolean

Malignancy
Description

Malignancy

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Acetylsalicylic Acid (ASA)
Description

Aspirin

Data type

string

Alias
UMLS CUI
C0004057
SNOMED CT 2010_0731
7947003
Gastric ulcer
Description

Gastric ulcer

Data type

string

Alias
UMLS CUI
C0038358
SNOMED CT 2010_0731
397825006
MedDRA 13.1
10017822
ICD-10-CM Version 2010
K25
ICD-9-CM Version 2011
531
CTCAE Version 4.03
E10727
Duodenal Ulcer
Description

Duodenal Ulcer

Data type

string

Alias
UMLS CUI
C0013295
SNOMED CT 2010_0731
367474008
MedDRA 13.1
10013836
ICD-10-CM Version 2010
K26
ICD-9-CM Version 2011
532
CTCAE Version 4.03
E10611
Endoscopy (procedure)
Description

Endoscopy

Data type

string

Alias
UMLS CUI
C0014245
SNOMED CT 2010_0731
423827005
MedDRA 13.1
10014805
LOINC Version 232
MTHU008659
Helicobacter pylori
Description

H. pylori

Data type

string

Alias
UMLS CUI
C0079488
SNOMED CT 2010_0731
80774000
LOINC Version 232
MTHU019876
Negative
Description

Negative

Data type

string

Alias
UMLS CUI
CL415098
Serologic test (procedure)
Description

Serologic tests

Data type

string

Alias
UMLS CUI
C0036743
SNOMED CT 2010_0731
68793005
MedDRA 13.1
10062163
LOINC Version 232
MTHU008384
Screening
Description

Screening

Data type

string

Alias
UMLS CUI
C1409616
Upper Gastrointestinal Series
Description

Upper GI

Data type

string

Alias
UMLS CUI
C0203057
SNOMED CT 2010_0731
241157000
MedDRA 13.1
10046285
ICD-9-CM Version 2011
87.62
Erosive oesophagitis
Description

Erosive esophagitis

Data type

string

Alias
UMLS CUI
C0267055
SNOMED CT 2010_0731
40719004
MedDRA 13.1
10063655
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age >= 60 years
boolean
Medical conditions
Item
A clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose ASA, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week)
boolean
No gastric and/or duodenal ulcer
Item
No gastric and/or duodenal ulcer at the baseline endoscopy
boolean
H. pylori negative
Item
H. pylori negative by serology test at screening
boolean
Item Group
Exclusion Criteria
Upper GI symptoms
Item
Upper GI symptoms
boolean
Erosive oesophagitis
Item
Erosive oesophagitis
boolean
Malignancy
Item
Malignancy
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Aspirin
Item
Acetylsalicylic Acid (ASA)
string
C0004057 (UMLS CUI)
7947003 (SNOMED CT 2010_0731)
Gastric ulcer
Item
Gastric ulcer
string
C0038358 (UMLS CUI)
397825006 (SNOMED CT 2010_0731)
10017822 (MedDRA 13.1)
K25 (ICD-10-CM Version 2010)
531 (ICD-9-CM Version 2011)
E10727 (CTCAE Version 4.03)
Duodenal Ulcer
Item
Duodenal Ulcer
string
C0013295 (UMLS CUI)
367474008 (SNOMED CT 2010_0731)
10013836 (MedDRA 13.1)
K26 (ICD-10-CM Version 2010)
532 (ICD-9-CM Version 2011)
E10611 (CTCAE Version 4.03)
Endoscopy
Item
Endoscopy (procedure)
string
C0014245 (UMLS CUI)
423827005 (SNOMED CT 2010_0731)
10014805 (MedDRA 13.1)
MTHU008659 (LOINC Version 232)
H. pylori
Item
Helicobacter pylori
string
C0079488 (UMLS CUI)
80774000 (SNOMED CT 2010_0731)
MTHU019876 (LOINC Version 232)
Negative
Item
Negative
string
CL415098 (UMLS CUI)
Serologic tests
Item
Serologic test (procedure)
string
C0036743 (UMLS CUI)
68793005 (SNOMED CT 2010_0731)
10062163 (MedDRA 13.1)
MTHU008384 (LOINC Version 232)
Screening
Item
Screening
string
C1409616 (UMLS CUI)
Upper GI
Item
Upper Gastrointestinal Series
string
C0203057 (UMLS CUI)
241157000 (SNOMED CT 2010_0731)
10046285 (MedDRA 13.1)
87.62 (ICD-9-CM Version 2011)
Erosive esophagitis
Item
Erosive oesophagitis
string
C0267055 (UMLS CUI)
40719004 (SNOMED CT 2010_0731)
10063655 (MedDRA 13.1)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)

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