ID

44774

Beschreibung

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

Link

http://clinicaltrials.gov/show/NCT00291746

Stichworte

Versionen (4)
  1. 06.03.12 06.03.12 -
  2. 04.08.15 04.08.15 - Martin Dugas
  3. 20.09.21 20.09.21 -
  4. 17.11.21 17.11.21 -
Rechteinhaber

AstraZeneca

Hochgeladen am

17. November 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Gastroesophageal Reflux NCT00291746

Deutsch Englisch

Eligibility Gastroesophageal Reflux NCT00291746

1 Formulare  
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alter 18 Jahre bis 79 Jahre
Beschreibung

Age 18 Years to 79 Years

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

boolean

Ausschlusskriterien
Beschreibung

Ausschlusskriterien

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

Upper GI endoscopy

Datentyp

boolean

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

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

Datentyp

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)
Beschreibung

Contra-indication to the BravoTM procedure

Datentyp

boolean

Medizinische Konzepte
Beschreibung

Medizinische Konzepte

Encounter for medical advice NOS
Beschreibung

medical advice

Datentyp

string

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

Primary Care Physician (PCP)

Datentyp

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
Beschreibung

Upper GI

Datentyp

string

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

visit

Datentyp

string

Alias
UMLS CUI
C1512346
Schweregrad
Beschreibung

Severity

Datentyp

string

Alias
UMLS CUI
C0439793
SNOMED CT 2010_0731
246112005
Endoskopie
Beschreibung

Endoscopy

Datentyp

string

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

Period

Datentyp

string

Alias
UMLS CUI
C1948053
Anti-reflux surgery
Beschreibung

Anti-reflux surgery

Datentyp

string

Alias
UMLS CUI
C0399651
Gastroduodenales Ulkus
Beschreibung

Gastroduodenal ulcer

Datentyp

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
Beschreibung

surgery

Datentyp

string

Alias
UMLS CUI
C0038895
Resection
Beschreibung

Excision

Datentyp

string

Alias
UMLS CUI
C0728940
SNOMED CT 2010_0731
65801008
Kontraindikation
Beschreibung

Contraindication

Datentyp

string

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

Esophageal pH Monitoring

Datentyp

string

Alias
UMLS CUI
C0430701
SNOMED CT 2010_0731
70815009
Blutungsneigung
Beschreibung

Bleeding diathesis

Datentyp

string

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

Stricture

Datentyp

string

Alias
UMLS CUI
C0333190
SNOMED CT 2010_0731
27551008
Ösophagusvarizen
Beschreibung

Esophageal Varices

Datentyp

string

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

Esophageal obstruction

Datentyp

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
Beschreibung

Cardiac pacemaker

Datentyp

string

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

cardiac defibrillator

Datentyp

text

Alias
UMLS CUI [1]
C1391956
Neurostimulator
Beschreibung

Neurostimulator

Datentyp

string

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

Esophagitis grade IV

Datentyp

string

Alias
UMLS CUI
C0940068
SNOMED CT 2010_0731
413228005
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Gastroesophageal Reflux NCT00291746

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Zum Seitenanfang zurückkehren 

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