ID
43409
Description
ODM derived from http://clinicaltrials.gov/show/NCT00450684
Link
http://clinicaltrials.gov/show/NCT00450684
Keywords
Versions (3)
- 12/9/13 12/9/13 - Martin Dugas
- 4/15/14 4/15/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility NCT00450684 Congenital Heart Defects
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
PTCA, cardiomyoplasty, myocardium infarction, instable angina pectoris or cerebral insult within 6 weeks before the planned cardiac resynchronization therapy
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2936173
- SNOMED CT 2011_0131
- 11101003
- MedDRA 14.1
- 10050339
- UMLS CUI 2011AA
- C0242637
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- UMLS CUI 2011AA
- C0002965
- SNOMED CT 2011_0131
- 4557003
- MedDRA 14.1
- 10002388
- ICD-10-CM Version 2010
- I20.0
- ICD-9-CM Version 2011
- 411.1
- UMLS CUI 2011AA
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
- UMLS CUI 2011AA
- C0205452
- SNOMED CT 2011_0131
- 68244004
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1301732
- SNOMED CT 2011_0131
- 397943006
- UMLS CUI 2011AA
- C1167956
- MedDRA 14.1
- 10059862
Description
pulmonary hypertension/Eisenmenger syndrome
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020542
- SNOMED CT 2011_0131
- 70995007
- MedDRA 14.1
- 10037400
- ICD-10-CM Version 2010
- I27.2
- ICD-9-CM Version 2011
- E13539
- UMLS CUI 2011AA
- C0013743
- SNOMED CT 2011_0131
- 445928005
- MedDRA 14.1
- 10058554
- ICD-10-CM Version 2010
- I27.89
Description
univentricular heart without Fontan procedure
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0152424
- SNOMED CT 2011_0131
- 45503006
- MedDRA 14.1
- 10045545
- ICD-10-CM Version 2010
- Q20.4
- ICD-9-CM Version 2011
- 745.3
- UMLS CUI 2011AA
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C0190010
- SNOMED CT 2011_0131
- 56527009
Description
life expectancy less than 1 year due to a non-cardiac disease
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0023671
- LOINC Version 232
- LP75025-4
- UMLS CUI 2011AA
- C0439092
- SNOMED CT 2011_0131
- 276139006
- HL7 V3 2006_05
- LT
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
Description
expected poor compliance of the patient, e.g. Trisomic 21 or other mental retardation
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1517001
- UMLS CUI 2011AA
- C0032646
- UMLS CUI 2011AA
- CL333417
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0025362
- SNOMED CT 2011_0131
- 91138005
- MedDRA 14.1
- 10027378
- ICD-10-CM Version 2010
- F79
- ICD-9-CM Version 2011
- 319
Description
ergospirometry cannot be performed
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0085143
- UMLS CUI 2011AA
- C0037981
- SNOMED CT 2011_0131
- 127783003
- MedDRA 14.1
- 10041629
- UMLS CUI 2011AA
- C1882330
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0332149
- SNOMED CT 2011_0131
- 371930009
Description
pregnancy
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0549206
Description
participation in a clinical trial within the last 4 weeks or current participation in a clinical trial (except studies of the Competence Network for Congenital Heart Defects)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1517741
- UMLS CUI 2011AA
- C0205450
- SNOMED CT 2011_0131
- 9362000
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0086035
- SNOMED CT 2011_0131
- 32082000
- UMLS CUI 2011AA
- C1882071
- UMLS CUI 2011AA
- C0018798
- SNOMED CT 2011_0131
- 13213009
- MedDRA 14.1
- 10002626
- ICD-10-CM Version 2010
- Q24.9
- ICD-9-CM Version 2011
- 746.9
Description
diseases or functional disorders that exclude participation according to physician's convenience
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0277785
- SNOMED CT 2011_0131
- 386585008
- UMLS CUI 2011AA
- C0332196
- SNOMED CT 2011_0131
- 77765009
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0680240
- UMLS CUI 2011AA
- C0031831
- SNOMED CT 2011_0131
- 309343006
- LOINC Version 232
- MTHU010489
- HL7 V3 2006_05
- PHYS
- UMLS CUI 2011AA
- C0814633
Description
poor cooperation
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0424350
- SNOMED CT 2011_0131
- 248042003
Description
known or continuous drug or alcohol abuse
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0549178
- UMLS CUI 2011AA
- C0013146
- SNOMED CT 2011_0131
- 26416006
- MedDRA 14.1
- 10013654
- LOINC Version 232
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
- UMLS CUI 2011AA
- C0085762
- SNOMED CT 2011_0131
- 15167005
- MedDRA 14.1
- 10001584
- LOINC Version 232
- LP36309-0
- ICD-10-CM Version 2010
- F10.1
- ICD-9-CM Version 2011
- 305.0
Similar models
Eligibility
- StudyEvent: Eligibility
13213009 (SNOMED CT 2011_0131)
10002626 (MedDRA 14.1)
Q24.9 (ICD-10-CM Version 2010)
746.9 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0225897 (UMLS CUI 2011AA)
87878005 (SNOMED CT 2011_0131)
MTHU001535 (LOINC Version 232)
C0225883 (UMLS CUI 2011AA)
53085002 (SNOMED CT 2011_0131)
MTHU001537 (LOINC Version 232)
C0232174 (UMLS CUI 2011AA)
70822001 (SNOMED CT 2011_0131)
C0205344 (UMLS CUI 2011AA)
56136002 (SNOMED CT 2011_0131)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
CL428482 (UMLS CUI 2011AA)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0680240 (UMLS CUI 2011AA)
C1535514 (UMLS CUI 2011AA)
414152003 (SNOMED CT 2011_0131)
2108-9 (HL7 V3 2006_05)
C0037459 (UMLS CUI 2011AA)
C0007189 (UMLS CUI 2011AA)
394579002 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
39632005 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
90734009 (SNOMED CT 2011_0131)
C1292856 (UMLS CUI 2011AA)
122545008 (SNOMED CT 2011_0131)
C0446978 (UMLS CUI 2011AA)
244380000 (SNOMED CT 2011_0131)
C0018827 (UMLS CUI 2011AA)
21814001 (SNOMED CT 2011_0131)
MTHU024371 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0018827 (UMLS CUI 2011AA)
21814001 (SNOMED CT 2011_0131)
MTHU024371 (LOINC Version 232)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
C0225883 (UMLS CUI 2011AA)
53085002 (SNOMED CT 2011_0131)
MTHU001537 (LOINC Version 232)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0231179 (UMLS CUI 2011AA)
87828008 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0225924 (UMLS CUI 2011AA)
11124005 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
10071186 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
11101003 (SNOMED CT 2011_0131)
10050339 (MedDRA 14.1)
C0242637 (UMLS CUI 2011AA)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C1167956 (UMLS CUI 2011AA)
10059862 (MedDRA 14.1)
70995007 (SNOMED CT 2011_0131)
10037400 (MedDRA 14.1)
I27.2 (ICD-10-CM Version 2010)
E13539 (ICD-9-CM Version 2011)
C0013743 (UMLS CUI 2011AA)
445928005 (SNOMED CT 2011_0131)
10058554 (MedDRA 14.1)
I27.89 (ICD-10-CM Version 2010)
45503006 (SNOMED CT 2011_0131)
10045545 (MedDRA 14.1)
Q20.4 (ICD-10-CM Version 2010)
745.3 (ICD-9-CM Version 2011)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0190010 (UMLS CUI 2011AA)
56527009 (SNOMED CT 2011_0131)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
CL420107 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0032646 (UMLS CUI 2011AA)
CL333417 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0025362 (UMLS CUI 2011AA)
91138005 (SNOMED CT 2011_0131)
10027378 (MedDRA 14.1)
F79 (ICD-10-CM Version 2010)
319 (ICD-9-CM Version 2011)
C0037981 (UMLS CUI 2011AA)
127783003 (SNOMED CT 2011_0131)
10041629 (MedDRA 14.1)
C1882330 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0086035 (UMLS CUI 2011AA)
32082000 (SNOMED CT 2011_0131)
C1882071 (UMLS CUI 2011AA)
C0018798 (UMLS CUI 2011AA)
13213009 (SNOMED CT 2011_0131)
10002626 (MedDRA 14.1)
Q24.9 (ICD-10-CM Version 2010)
746.9 (ICD-9-CM Version 2011)
64572001 (SNOMED CT 2011_0131)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0814633 (UMLS CUI 2011AA)
248042003 (SNOMED CT 2011_0131)
36692007 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)