ID

44774

Descrição

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

Link

http://clinicaltrials.gov/show/NCT00291746

Palavras-chave

  1. 06/03/2012 06/03/2012 -
  2. 04/08/2015 04/08/2015 - Martin Dugas
  3. 20/09/2021 20/09/2021 -
  4. 17/11/2021 17/11/2021 -
Titular dos direitos

AstraZeneca

Transferido a

17 de novembro de 2021

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Gastroesophageal Reflux NCT00291746

Eligibility Gastroesophageal Reflux NCT00291746

Inclusion Criteria
Descrição

Inclusion Criteria

Age 18 Years to 79 Years
Descrição

Age 18 Years to 79 Years

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

Exclusion Criteria
Descrição

Exclusion Criteria

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

Upper GI endoscopy

Tipo de dados

boolean

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

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

Tipo de dados

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)
Descrição

Contra-indication to the BravoTM procedure

Tipo de dados

boolean

Medical Concepts
Descrição

Medical Concepts

Encounter for medical advice NOS
Descrição

medical advice

Tipo de dados

string

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

Primary Care Physician (PCP)

Tipo de dados

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
Descrição

Upper GI

Tipo de dados

string

Alias
UMLS CUI
C0203057
SNOMED CT 2010_0731
241157000
MedDRA 13.1
10046285
ICD-9-CM Version 2011
87.62
patient encounter
Descrição

visit

Tipo de dados

string

Alias
UMLS CUI
C1512346
Severity (qualifier value)
Descrição

Severity

Tipo de dados

string

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

Endoscopy

Tipo de dados

string

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

Period

Tipo de dados

string

Alias
UMLS CUI
C1948053
Anti-reflux surgery
Descrição

Anti-reflux surgery

Tipo de dados

string

Alias
UMLS CUI
C0399651
Peptic Ulcer
Descrição

Gastroduodenal ulcer

Tipo de dados

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
Descrição

surgery

Tipo de dados

string

Alias
UMLS CUI
C0038895
Resection
Descrição

Excision

Tipo de dados

string

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

Contraindication

Tipo de dados

string

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

Esophageal pH Monitoring

Tipo de dados

string

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

Bleeding diathesis

Tipo de dados

string

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

Stricture

Tipo de dados

string

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

Esophageal Varices

Tipo de dados

string

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

Esophageal obstruction

Tipo de dados

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
Descrição

Cardiac pacemaker

Tipo de dados

string

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

cardiac defibrillator

Tipo de dados

text

Alias
UMLS CUI [1]
C1391956
Neurostimulator
Descrição

Neurostimulator

Tipo de dados

string

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

Esophagitis grade IV

Tipo de dados

string

Alias
UMLS CUI
C0940068
SNOMED CT 2010_0731
413228005

Similar models

Eligibility Gastroesophageal Reflux NCT00291746

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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