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ID
44774
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00291746
Link
http://clinicaltrials.gov/show/NCT00291746
Palabras clave
Versiones (4)
- 6/3/12 6/3/12 -
- 4/8/15 4/8/15 - Martin Dugas
- 20/9/21 20/9/21 -
- 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
Eligibility Gastroesophageal Reflux NCT00291746
- StudyEvent: Eligibility
Similar models
Eligibility Gastroesophageal Reflux NCT00291746
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
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
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
medical advice
Item
Encounter for medical advice NOS
string
C2911105 (UMLS CUI)
Z71.9 (ICD-10-CM Version 2010)
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])
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)
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)
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)
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)
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)
65801008 (SNOMED CT 2010_0731)
Contraindication
Item
Kontraindikation
string
C1301624 (UMLS CUI)
397745006 (SNOMED CT 2010_0731)
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)
70815009 (SNOMED CT 2010_0731)
Bleeding diathesis
Item
Blutungsneigung
string
C1458140 (UMLS CUI)
248250000 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)
248250000 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)
Stricture
Item
Fibrous stenosis
string
C0333190 (UMLS CUI)
27551008 (SNOMED CT 2010_0731)
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)
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)
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
cardiac defibrillator
Item
Defibrillator
text
C1391956 (UMLS CUI [1])
Neurostimulator
Item
Neurostimulator
string
C0582124 (UMLS CUI)
25937001 (SNOMED CT 2010_0731)
25937001 (SNOMED CT 2010_0731)
Esophagitis grade IV
Item
Esophagitis grade IV
string
C0940068 (UMLS CUI)
413228005 (SNOMED CT 2010_0731)
413228005 (SNOMED CT 2010_0731)