ID

44774

Description

ODM derived from http://clinicaltrials.gov/show/NCT00291746

Link

http://clinicaltrials.gov/show/NCT00291746

Keywords

Versions (4)
  1. 3/6/12 3/6/12 -
  2. 8/4/15 8/4/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
  4. 11/17/21 11/17/21 -
Copyright Holder

AstraZeneca

Uploaded on

November 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Gastroesophageal Reflux NCT00291746

German English

Eligibility Gastroesophageal Reflux NCT00291746

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Age 18 Years to 79 Years
Description

Age 18 Years to 79 Years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Subjects who seek medical advice at their family doctor (primary care physician) for symptoms thought by the primary care physician to arise from the upper GI tract
Description

medical advice for symptoms thought to arise from the upper GI tract

Data type

boolean

The symptoms thought to pertain to the upper GI tract must have been present for at least 4 weeks prior to Visit 1 and to have occurred at least twice a week during that period
Description

The symptoms have been present for at least 4 weeks and have occurred at least twice a week

Data type

boolean

The symptoms thought to pertain to the upper GI tract must have been of at least mild severity for a minimum of 3 days during the week prior to Visit 1
Description

The symptoms must have been of at least mild severity for a minimum of 3 days

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Upper GI endoscopy performed within a year prior to Visit 1
Description

Upper GI endoscopy

Data type

boolean

Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery
Description

Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastro-intestinal resective surgery

Data type

boolean

Contra-indication to the BravoTM procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the GI-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (NB: subjects with severe esophagitis (grade D) confirmed by endoscopy at Visit 2 can continue the study without performing the BravoTM procedure)
Description

Contra-indication to the BravoTM procedure

Data type

boolean

Medical Concepts
Description

Medical Concepts

Encounter for medical advice NOS
Description

medical advice

Data type

string

Alias
UMLS CUI
C2911105
ICD-10-CM Version 2010
Z71.9
General practitioner (GP)
Description

Primary Care Physician (PCP)

Data type

text

Alias
UMLS CUI [1,1]
C0033131
UMLS CUI [1,2]
C0017319
SNOMED CT 2010_0731
446050000
SNOMED CT 2010_0731[2]
59058001
Upper Gastrointestinal System
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
patient encounter
Description

visit

Data type

string

Alias
UMLS CUI
C1512346
Severity (qualifier value)
Description

Severity

Data type

string

Alias
UMLS CUI
C0439793
SNOMED CT 2010_0731
246112005
Endoscopy (procedure)
Description

Endoscopy

Data type

string

Alias
UMLS CUI
C0014245
SNOMED CT 2010_0731
423827005
MedDRA 13.1
10014805
LOINC Version 232
MTHU008659
Period (temporal concept)
Description

Period

Data type

string

Alias
UMLS CUI
C1948053
Anti-reflux surgery
Description

Anti-reflux surgery

Data type

string

Alias
UMLS CUI
C0399651
Peptic Ulcer
Description

Gastroduodenal ulcer

Data type

string

Alias
UMLS CUI
C0030920
SNOMED CT 2010_0731
13200003
MedDRA 13.1
10034341
ICD-10-CM Version 2010
K27
ICD-9-CM Version 2011
533
operative procedures
Description

surgery

Data type

string

Alias
UMLS CUI
C0038895
Resection
Description

Excision

Data type

string

Alias
UMLS CUI
C0728940
SNOMED CT 2010_0731
65801008
Medical Contraindication
Description

Contraindication

Data type

string

Alias
UMLS CUI
C1301624
SNOMED CT 2010_0731
397745006
Esophagus acid reflux test with intraluminal pH electrode
Description

Esophageal pH Monitoring

Data type

string

Alias
UMLS CUI
C0430701
SNOMED CT 2010_0731
70815009
Bleeding tendency
Description

Bleeding diathesis

Data type

string

Alias
UMLS CUI
C1458140
SNOMED CT 2010_0731
248250000
MedDRA 13.1
10005134
Fibrous stenosis
Description

Stricture

Data type

string

Alias
UMLS CUI
C0333190
SNOMED CT 2010_0731
27551008
Oesophageal Varices
Description

Esophageal Varices

Data type

string

Alias
UMLS CUI
C0014867
SNOMED CT 2010_0731
28670008
MedDRA 13.1
10030209
ICD-10-CM Version 2010
I85
Obstruction of esophagus
Description

Esophageal obstruction

Data type

string

Alias
UMLS CUI
C0239296
SNOMED CT 2010_0731
405247003
MedDRA 13.1
10030178
ICD-10-CM Version 2010
K22.2
CTCAE Version 4.03
E10655
Artificial cardiac pacemaker
Description

Cardiac pacemaker

Data type

string

Alias
UMLS CUI
C0030163
SNOMED CT 2010_0731
14106009
LOINC Version 232
MTHU024521
cardiac defibrillator
Description

cardiac defibrillator

Data type

text

Alias
UMLS CUI [1]
C1391956
Neurostimulator
Description

Neurostimulator

Data type

string

Alias
UMLS CUI
C0582124
SNOMED CT 2010_0731
25937001
Esophagitis grade IV
Description

Esophagitis grade IV

Data type

string

Alias
UMLS CUI
C0940068
SNOMED CT 2010_0731
413228005
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Similar models

Eligibility Gastroesophageal Reflux NCT00291746

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age 18 Years to 79 Years
Item
Age 18 Years to 79 Years
boolean
C0001779 (UMLS CUI [1])
medical advice for symptoms thought to arise from the upper GI tract
Item
Subjects who seek medical advice at their family doctor (primary care physician) for symptoms thought by the primary care physician to arise from the upper GI tract
boolean
The symptoms have been present for at least 4 weeks and have occurred at least twice a week
Item
The symptoms thought to pertain to the upper GI tract must have been present for at least 4 weeks prior to Visit 1 and to have occurred at least twice a week during that period
boolean
The symptoms must have been of at least mild severity for a minimum of 3 days
Item
The symptoms thought to pertain to the upper GI tract must have been of at least mild severity for a minimum of 3 days during the week prior to Visit 1
boolean
Item Group
Exclusion Criteria
Upper GI endoscopy
Item
Upper GI endoscopy performed within a year prior to Visit 1
boolean
Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastro-intestinal resective surgery
Item
Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery
boolean
Contra-indication to the BravoTM procedure
Item
Contra-indication to the BravoTM procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the GI-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (NB: subjects with severe esophagitis (grade D) confirmed by endoscopy at Visit 2 can continue the study without performing the BravoTM procedure)
boolean
Item Group
Medical Concepts
medical advice
Item
Encounter for medical advice NOS
string
C2911105 (UMLS CUI)
Z71.9 (ICD-10-CM Version 2010)
Primary Care Physician (PCP)
Item
General practitioner (GP)
text
C0033131 (UMLS CUI [1,1])
C0017319 (UMLS CUI [1,2])
446050000 (SNOMED CT 2010_0731)
59058001 (SNOMED CT 2010_0731[2])
Upper GI
Item
Upper Gastrointestinal System
string
C0203057 (UMLS CUI)
241157000 (SNOMED CT 2010_0731)
10046285 (MedDRA 13.1)
87.62 (ICD-9-CM Version 2011)
visit
Item
patient encounter
string
C1512346 (UMLS CUI)
Severity
Item
Severity (qualifier value)
string
C0439793 (UMLS CUI)
246112005 (SNOMED CT 2010_0731)
Endoscopy
Item
Endoscopy (procedure)
string
C0014245 (UMLS CUI)
423827005 (SNOMED CT 2010_0731)
10014805 (MedDRA 13.1)
MTHU008659 (LOINC Version 232)
Period
Item
Period (temporal concept)
string
C1948053 (UMLS CUI)
Anti-reflux surgery
Item
Anti-reflux surgery
string
C0399651 (UMLS CUI)
Gastroduodenal ulcer
Item
Peptic Ulcer
string
C0030920 (UMLS CUI)
13200003 (SNOMED CT 2010_0731)
10034341 (MedDRA 13.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
surgery
Item
operative procedures
string
C0038895 (UMLS CUI)
Excision
Item
Resection
string
C0728940 (UMLS CUI)
65801008 (SNOMED CT 2010_0731)
Contraindication
Item
Medical Contraindication
string
C1301624 (UMLS CUI)
397745006 (SNOMED CT 2010_0731)
Esophageal pH Monitoring
Item
Esophagus acid reflux test with intraluminal pH electrode
string
C0430701 (UMLS CUI)
70815009 (SNOMED CT 2010_0731)
Bleeding diathesis
Item
Bleeding tendency
string
C1458140 (UMLS CUI)
248250000 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)
Stricture
Item
Fibrous stenosis
string
C0333190 (UMLS CUI)
27551008 (SNOMED CT 2010_0731)
Esophageal Varices
Item
Oesophageal Varices
string
C0014867 (UMLS CUI)
28670008 (SNOMED CT 2010_0731)
10030209 (MedDRA 13.1)
I85 (ICD-10-CM Version 2010)
Esophageal obstruction
Item
Obstruction of esophagus
string
C0239296 (UMLS CUI)
405247003 (SNOMED CT 2010_0731)
10030178 (MedDRA 13.1)
K22.2 (ICD-10-CM Version 2010)
E10655 (CTCAE Version 4.03)
Cardiac pacemaker
Item
Artificial cardiac pacemaker
string
C0030163 (UMLS CUI)
14106009 (SNOMED CT 2010_0731)
MTHU024521 (LOINC Version 232)
cardiac defibrillator
Item
cardiac defibrillator
text
C1391956 (UMLS CUI [1])
Neurostimulator
Item
Neurostimulator
string
C0582124 (UMLS CUI)
25937001 (SNOMED CT 2010_0731)
Esophagitis grade IV
Item
Esophagitis grade IV
string
C0940068 (UMLS CUI)
413228005 (SNOMED CT 2010_0731)
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