ID

44774

Descripción

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

Link

http://clinicaltrials.gov/show/NCT00291746

Palabras clave

Versiones (4)
  1. 6/3/12 6/3/12 -
  2. 4/8/15 4/8/15 - Martin Dugas
  3. 20/9/21 20/9/21 -
  4. 17/11/21 17/11/21 -
Titular de derechos de autor

AstraZeneca

Subido en

17 de noviembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Gastroesophageal Reflux NCT00291746

Alemán Inglés

Eligibility Gastroesophageal Reflux NCT00291746

1 formularios  
Einschlusskriterien
Descripción

Einschlusskriterien

Alter 18 Jahre bis 79 Jahre
Descripción

Age 18 Years to 79 Years

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

boolean

Ausschlusskriterien
Descripción

Ausschlusskriterien

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

Upper GI endoscopy

Tipo de datos

boolean

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

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

Tipo de datos

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)
Descripción

Contra-indication to the BravoTM procedure

Tipo de datos

boolean

Medizinische Konzepte
Descripción

Medizinische Konzepte

Encounter for medical advice NOS
Descripción

medical advice

Tipo de datos

string

Alias
UMLS CUI
C2911105
ICD-10-CM Version 2010
Z71.9
Hausarzt
Descripción

Primary Care Physician (PCP)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0033131
UMLS CUI [1,2]
C0017319
SNOMED CT 2010_0731
446050000
SNOMED CT 2010_0731[2]
59058001
oberer Gastrointestinaltrakt
Descripción

Upper GI

Tipo de datos

string

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

visit

Tipo de datos

string

Alias
UMLS CUI
C1512346
Schweregrad
Descripción

Severity

Tipo de datos

string

Alias
UMLS CUI
C0439793
SNOMED CT 2010_0731
246112005
Endoskopie
Descripción

Endoscopy

Tipo de datos

string

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

Period

Tipo de datos

string

Alias
UMLS CUI
C1948053
Anti-reflux surgery
Descripción

Anti-reflux surgery

Tipo de datos

string

Alias
UMLS CUI
C0399651
Gastroduodenales Ulkus
Descripción

Gastroduodenal ulcer

Tipo de datos

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
Descripción

surgery

Tipo de datos

string

Alias
UMLS CUI
C0038895
Resection
Descripción

Excision

Tipo de datos

string

Alias
UMLS CUI
C0728940
SNOMED CT 2010_0731
65801008
Kontraindikation
Descripción

Contraindication

Tipo de datos

string

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

Esophageal pH Monitoring

Tipo de datos

string

Alias
UMLS CUI
C0430701
SNOMED CT 2010_0731
70815009
Blutungsneigung
Descripción

Bleeding diathesis

Tipo de datos

string

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

Stricture

Tipo de datos

string

Alias
UMLS CUI
C0333190
SNOMED CT 2010_0731
27551008
Ösophagusvarizen
Descripción

Esophageal Varices

Tipo de datos

string

Alias
UMLS CUI
C0014867
SNOMED CT 2010_0731
28670008
MedDRA 13.1
10030209
ICD-10-CM Version 2010
I85
Ösophagusobstruktion
Descripción

Esophageal obstruction

Tipo de datos

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
(künstlicher) Herzschrittmacher
Descripción

Cardiac pacemaker

Tipo de datos

string

Alias
UMLS CUI
C0030163
SNOMED CT 2010_0731
14106009
LOINC Version 232
MTHU024521
Defibrillator
Descripción

cardiac defibrillator

Tipo de datos

text

Alias
UMLS CUI [1]
C1391956
Neurostimulator
Descripción

Neurostimulator

Tipo de datos

string

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

Esophagitis grade IV

Tipo de datos

string

Alias
UMLS CUI
C0940068
SNOMED CT 2010_0731
413228005
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Similar models

Eligibility Gastroesophageal Reflux NCT00291746

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Einschlusskriterien
Age 18 Years to 79 Years
Item
Alter 18 Jahre bis 79 Jahre
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
Ausschlusskriterien
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
Medizinische Konzepte
medical advice
Item
Encounter for medical advice NOS
string
C2911105 (UMLS CUI)
Z71.9 (ICD-10-CM Version 2010)
Primary Care Physician (PCP)
Item
Hausarzt
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
oberer Gastrointestinaltrakt
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
Schweregrad
string
C0439793 (UMLS CUI)
246112005 (SNOMED CT 2010_0731)
Endoscopy
Item
Endoskopie
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
Gastroduodenales Ulkus
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
Kontraindikation
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
Blutungsneigung
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
Ösophagusvarizen
string
C0014867 (UMLS CUI)
28670008 (SNOMED CT 2010_0731)
10030209 (MedDRA 13.1)
I85 (ICD-10-CM Version 2010)
Esophageal obstruction
Item
Ösophagusobstruktion
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
(künstlicher) Herzschrittmacher
string
C0030163 (UMLS CUI)
14106009 (SNOMED CT 2010_0731)
MTHU024521 (LOINC Version 232)
cardiac defibrillator
Item
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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