ID

4900

Description

ODM derived from http://clinicaltrials.gov/show/NCT00326027

Link

http://clinicaltrials.gov/show/NCT00326027

Keywords

Versions (2)
  1. 3/22/12 3/22/12 -
  2. 4/14/14 4/14/14 - Julian Varghese
Uploaded on

April 14, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00326027 Gastroesophageal Reflux

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age 18 Years and older
Description

age >=18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
Inpatients (hospitalization during the entire study period is mandatory)
Description

Inpatients (hospitalization during the entire study period is mandatory)

Data type

boolean

Alias
UMLS CUI 1
C0021562
SNOMED CT 1
416800000
LOINC Version 232
MTHU015923
UMLS CUI 2
C0019993
SNOMED 2
394656005
MedDRA 14.1
10054112
UMLS CUI 3
C0008976
SNOMED CT 3
110465008
UMLS CUI 4
C1514873
Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D)
Description

Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D)

Data type

boolean

Alias
UMLS CUI 1
C0011900
SNOMED CT 1
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2
C0231220
SNOMED CT
264931009
UMLS CUI 2011AA
C2242528
MedDRA 14.1
10067856
UMLS CUI 2011AA
C0017168
SNOMED CT 2011_0131
235595009
MedDRA 14.1
10017885
ICD-10-CM Version 2010
K21
ICD-9-CM Version 2011
530.81
CTCAE 1105E
E10739
UMLS CUI 2011AA
C1881447
UMLS CUI 2011AA
C1883701
UMLS CUI 2011AA
C1881342
UMLS CUI 2011AA
C1881343
UMLS CUI 2011AA
C1881344
UMLS CUI 2011AA
C0018834
SNOMED CT 2011_0131
16331000
MedDRA 14.1
10019326
ICD-10-CM Version 2010
R12
ICD-9-CM Version 2011
787.1
UMLS CUI 2011AA
C0856449
MedDRA 14.1
10066872
UMLS CUI 2011AA
C2004489
SNOMED CT 2011_0131
78104003
MedDRA 14.1
10067171
UMLS CUI 2011AA
C0011168
SNOMED CT 2011_0131
40739000
MedDRA 14.1
10013950
LOINC Version 232
MTHU029874
ICD-10-CM Version 2010
R13
ICD-9-CM Version 2011
787.2
CTCAE 1105E
E10621
UMLS CUI 2011AA
C0184666
SNOMED CT 2011_0131
32485007
Exclusion Criteria
Description

Exclusion Criteria

Known Zollinger-Ellison syndrome or other gastric hypersecretory condition
Description

Known Zollinger-Ellison syndrome or other gastric hypersecretory condition

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0043515
SNOMED CT 2011_0131
53132006
MedDRA 14.1
10048281
ICD-10-CM Version 2010
E16.4
UMLS CUI 2011AA
C0542029
MedDRA 14.1
10020747
Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
Description

Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)

Data type

boolean

Alias
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
C0001128
SNOMED CT 2011_0131
34957004
UMLS CUI 2011AA
C2003888
UMLS CUI 2011AA
C0014876
SNOMED CT 2011_0131
32849002
LOINC Version 232
MTHU011962
UMLS CUI 2011AA
C0203057
SNOMED CT 2011_0131
241157000
MedDRA 14.1
10046285
ICD-9-CM Version 2011
87.62
UMLS CUI 2011AA
C0521210
SNOMED CT 2011_0131
82035006
MedDRA 14.1
10053308
UMLS CUI 2011AA
C0008320
SNOMED CT 2011_0131
38102005
MedDRA 14.1
10008611
ICD-9-CM Version 2011
51.22
On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm
Description

On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm

Data type

boolean

Alias
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0014245
SNOMED CT 2011_0131
423827005
MedDRA 14.1
10014805
LOINC Version 232
MTHU008659
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0239296
SNOMED CT 2011_0131
405247003
MedDRA 14.1
10030178
ICD-10-CM Version 2010
K22.2
CTCAE 1105E
E10655
UMLS CUI 2011AA
C0014866
SNOMED CT 2011_0131
63305008
MedDRA 14.1
10015449
ICD-10-CM Version 2010
K22.2
ICD-9-CM Version 2011
530.3
CTCAE 1105E
E10670
UMLS CUI 2011AA
C0341137
SNOMED CT 2011_0131
235623002
UMLS CUI 2011AA
C0014854
SNOMED CT 2011_0131
414133009
MedDRA 14.1
10013563
UMLS CUI 2011AA
C0014867
SNOMED CT 2011_0131
28670008
MedDRA 14.1
10030209
ICD-10-CM Version 2010
I85
UMLS CUI 2011AA
C1321756
SNOMED CT 2011_0131
48531003
MedDRA 14.1
10000420
ICD-10-CM Version 2010
K22.0
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C1334003
ICD-10-CM Version 2010
C27835
UMLS CUI 2011AA
C2230970
Acute peptic ulcer and/or ulcer complications
Description

Acute peptic ulcer and/or ulcer complications

Data type

boolean

Alias
UMLS CUI 2011AA
C0729245
SNOMED CT 2011_0131
196682000
UMLS CUI 2011AA
C0041582
SNOMED CT 2011_0131
10045285
MedDRA 14.1
10045285
LOINC Version 232
MTHU022920
UMLS CUI 2011AA
C0009566
SNOMED CT 2011_0131
116223007
LOINC Version 232
MTHU008883
Pyloric stenosis (disorder)
Description

Pyloric stenosis

Data type

boolean

Alias
UMLS CUI 2011AA
C0034194
SNOMED CT 2011_0131
367403001
MedDRA 14.1
10037621
ICD-10-CM Version 2010
K31.1
Known inflammatory bowel diseases
Description

Known inflammatory bowel diseases

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0021390
SNOMED CT 2011_0131
24526004
MedDRA 14.1
10021972
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age >=18 Years
Item
Age 18 Years and older
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Inpatients (hospitalization during the entire study period is mandatory)
Item
Inpatients (hospitalization during the entire study period is mandatory)
boolean
C0021562 (UMLS CUI 1)
416800000 (SNOMED CT 1)
MTHU015923 (LOINC Version 232)
C0019993 (UMLS CUI 2)
394656005 (SNOMED 2)
10054112 (MedDRA 14.1)
C0008976 (UMLS CUI 3)
110465008 (SNOMED CT 3)
C1514873 (UMLS CUI 4)
Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D)
Item
Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D)
boolean
C0011900 (UMLS CUI 1)
439401001 (SNOMED CT 1)
MTHU008876 (LOINC Version 232)
C0231220 (UMLS CUI 2 )
264931009 (SNOMED CT)
C2242528 (UMLS CUI 2011AA)
10067856 (MedDRA 14.1)
C0017168 (UMLS CUI 2011AA)
235595009 (SNOMED CT 2011_0131)
10017885 (MedDRA 14.1)
K21 (ICD-10-CM Version 2010)
530.81 (ICD-9-CM Version 2011)
E10739 (CTCAE 1105E)
C1881447 (UMLS CUI 2011AA)
C1883701 (UMLS CUI 2011AA)
C1881342 (UMLS CUI 2011AA)
C1881343 (UMLS CUI 2011AA)
C1881344 (UMLS CUI 2011AA)
C0018834 (UMLS CUI 2011AA)
16331000 (SNOMED CT 2011_0131)
10019326 (MedDRA 14.1)
R12 (ICD-10-CM Version 2010)
787.1 (ICD-9-CM Version 2011)
C0856449 (UMLS CUI 2011AA)
10066872 (MedDRA 14.1)
C2004489 (UMLS CUI 2011AA)
78104003 (SNOMED CT 2011_0131)
10067171 (MedDRA 14.1)
C0011168 (UMLS CUI 2011AA)
40739000 (SNOMED CT 2011_0131)
10013950 (MedDRA 14.1)
MTHU029874 (LOINC Version 232)
R13 (ICD-10-CM Version 2010)
787.2 (ICD-9-CM Version 2011)
E10621 (CTCAE 1105E)
C0184666 (UMLS CUI 2011AA)
32485007 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Known Zollinger-Ellison syndrome or other gastric hypersecretory condition
Item
Known Zollinger-Ellison syndrome or other gastric hypersecretory condition
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0043515 (UMLS CUI 2011AA)
53132006 (SNOMED CT 2011_0131)
10048281 (MedDRA 14.1)
E16.4 (ICD-10-CM Version 2010)
C0542029 (UMLS CUI 2011AA)
10020747 (MedDRA 14.1)
Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
Item
Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
boolean
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
C0001128 (UMLS CUI 2011AA)
34957004 (SNOMED CT 2011_0131)
C2003888 (UMLS CUI 2011AA)
C0014876 (UMLS CUI 2011AA)
32849002 (SNOMED CT 2011_0131)
MTHU011962 (LOINC Version 232)
C0203057 (UMLS CUI 2011AA)
241157000 (SNOMED CT 2011_0131)
10046285 (MedDRA 14.1)
87.62 (ICD-9-CM Version 2011)
C0521210 (UMLS CUI 2011AA)
82035006 (SNOMED CT 2011_0131)
10053308 (MedDRA 14.1)
C0008320 (UMLS CUI 2011AA)
38102005 (SNOMED CT 2011_0131)
10008611 (MedDRA 14.1)
51.22 (ICD-9-CM Version 2011)
On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm
Item
On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm
boolean
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0239296 (UMLS CUI 2011AA)
405247003 (SNOMED CT 2011_0131)
10030178 (MedDRA 14.1)
K22.2 (ICD-10-CM Version 2010)
E10655 (CTCAE 1105E)
C0014866 (UMLS CUI 2011AA)
63305008 (SNOMED CT 2011_0131)
10015449 (MedDRA 14.1)
K22.2 (ICD-10-CM Version 2010)
530.3 (ICD-9-CM Version 2011)
E10670 (CTCAE 1105E)
C0341137 (UMLS CUI 2011AA)
235623002 (SNOMED CT 2011_0131)
C0014854 (UMLS CUI 2011AA)
414133009 (SNOMED CT 2011_0131)
10013563 (MedDRA 14.1)
C0014867 (UMLS CUI 2011AA)
28670008 (SNOMED CT 2011_0131)
10030209 (MedDRA 14.1)
I85 (ICD-10-CM Version 2010)
C1321756 (UMLS CUI 2011AA)
48531003 (SNOMED CT 2011_0131)
10000420 (MedDRA 14.1)
K22.0 (ICD-10-CM Version 2010)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C1334003 (UMLS CUI 2011AA)
C27835 (ICD-10-CM Version 2010)
C2230970 (UMLS CUI 2011AA)
Acute peptic ulcer and/or ulcer complications
Item
Acute peptic ulcer and/or ulcer complications
boolean
C0729245 (UMLS CUI 2011AA)
196682000 (SNOMED CT 2011_0131)
C0041582 (UMLS CUI 2011AA)
10045285 (SNOMED CT 2011_0131)
10045285 (MedDRA 14.1)
MTHU022920 (LOINC Version 232)
C0009566 (UMLS CUI 2011AA)
116223007 (SNOMED CT 2011_0131)
MTHU008883 (LOINC Version 232)
Pyloric stenosis
Item
Pyloric stenosis (disorder)
boolean
C0034194 (UMLS CUI 2011AA)
367403001 (SNOMED CT 2011_0131)
10037621 (MedDRA 14.1)
K31.1 (ICD-10-CM Version 2010)
Known inflammatory bowel diseases
Item
Known inflammatory bowel diseases
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0021390 (UMLS CUI 2011AA)
24526004 (SNOMED CT 2011_0131)
10021972 (MedDRA 14.1)
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