ID

4507

Description

ODM derived from http://clinicaltrials.gov/show/NCT00639483

Link

http://clinicaltrials.gov/show/NCT00639483

Keywords

  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

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 NCT00639483 Schizophrenia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 50 Years
Description

age 18 Years to 50 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization
Description

Diagnosis of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0036341
SNOMED CT 2011_0131
58214004
MedDRA 14.1
10039626
LOINC Version 232
MTHU020814
ICD-10-CM Version 2010
F20
ICD-9-CM Version 2011
295
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0220952
UMLS CUI 2011AA
C1527021
UMLS CUI 2011AA
C0439617
SNOMED CT 2011_0131
272129003
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0033872
SNOMED CT 2011_0131
80584001
HL7 V3 2006_05
2084P0800X
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C1444749
SNOMED CT 2011_0131
410661009
UMLS CUI 2011AA
C0036341
SNOMED CT 2011_0131
58214004
MedDRA 14.1
10039626
LOINC Version 232
MTHU020814
ICD-10-CM Version 2010
F20
ICD-9-CM Version 2011
295
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
Total PANSS score of ?60 at screening
Description

Total PANSS score of ?60 at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0439810
SNOMED CT 2011_0131
255619001
UMLS CUI 2011AA
C0451383
SNOMED CT 2011_0131
273703003
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C1409616
History of schizophrenia of ?10 years (from onset of prodromal symptoms)
Description

History of schizophrenia of ?10 years (from onset of prodromal symptoms)

Data type

boolean

Alias
UMLS CUI 2011AA
C0260457
ICD-9-CM Version 2011
V11.0
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0565928
SNOMED CT 2011_0131
288480009
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Axis-I DSM-IV-TR diagnosis other than schizophrenia
Description

Axis-I DSM-IV-TR diagnosis other than schizophrenia

Data type

boolean

Alias
UMLS CUI 2011AA
C0220952
UMLS CUI 2011AA
C1527021
UMLS CUI 2011AA
C0439617
SNOMED CT 2011_0131
272129003
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0036341
SNOMED CT 2011_0131
58214004
MedDRA 14.1
10039626
LOINC Version 232
MTHU020814
ICD-10-CM Version 2010
F20
ICD-9-CM Version 2011
295
Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
Description

Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic

Data type

boolean

Alias
UMLS CUI 2011AA
C0547044
SNOMED CT 2011_0131
263796003
UMLS CUI 2011AA
C0443225
SNOMED CT 2011_0131
261015003
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C1707889
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C2585377
SNOMED CT 2011_0131
440701009
Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
Description

Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0538927
SNOMED CT 2011_0131
116081000
LOINC Version 232
MTHU013163
UMLS CUI 2011AA
C1707391
UMLS CUI 2011AA
C1257954
SNOMED CT 2011_0131
387050005
UMLS CUI 2011AA
C0003209
SNOMED CT 2011_0131
330901000

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 50 Years
Item
age 18 Years to 50 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization
Item
Diagnosis of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0036341 (UMLS CUI 2011AA)
58214004 (SNOMED CT 2011_0131)
10039626 (MedDRA 14.1)
MTHU020814 (LOINC Version 232)
F20 (ICD-10-CM Version 2010)
295 (ICD-9-CM Version 2011)
C0680240 (UMLS CUI 2011AA)
C0220952 (UMLS CUI 2011AA)
C1527021 (UMLS CUI 2011AA)
C0439617 (UMLS CUI 2011AA)
272129003 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
C0033872 (UMLS CUI 2011AA)
80584001 (SNOMED CT 2011_0131)
2084P0800X (HL7 V3 2006_05)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0036341 (UMLS CUI 2011AA)
58214004 (SNOMED CT 2011_0131)
10039626 (MedDRA 14.1)
MTHU020814 (LOINC Version 232)
F20 (ICD-10-CM Version 2010)
295 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
Total PANSS score of ?60 at screening
Item
Total PANSS score of ?60 at screening
boolean
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
C0451383 (UMLS CUI 2011AA)
273703003 (SNOMED CT 2011_0131)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
History of schizophrenia of ?10 years (from onset of prodromal symptoms)
Item
History of schizophrenia of ?10 years (from onset of prodromal symptoms)
boolean
C0260457 (UMLS CUI 2011AA)
V11.0 (ICD-9-CM Version 2011)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0565928 (UMLS CUI 2011AA)
288480009 (SNOMED CT 2011_0131)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Axis-I DSM-IV-TR diagnosis other than schizophrenia
Item
Axis-I DSM-IV-TR diagnosis other than schizophrenia
boolean
C0220952 (UMLS CUI 2011AA)
C1527021 (UMLS CUI 2011AA)
C0439617 (UMLS CUI 2011AA)
272129003 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0036341 (UMLS CUI 2011AA)
58214004 (SNOMED CT 2011_0131)
10039626 (MedDRA 14.1)
MTHU020814 (LOINC Version 232)
F20 (ICD-10-CM Version 2010)
295 (ICD-9-CM Version 2011)
Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
Item
Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
boolean
C0547044 (UMLS CUI 2011AA)
263796003 (SNOMED CT 2011_0131)
C0443225 (UMLS CUI 2011AA)
261015003 (SNOMED CT 2011_0131)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C1707889 (UMLS CUI 2011AA)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C2585377 (UMLS CUI 2011AA)
440701009 (SNOMED CT 2011_0131)
Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
Item
Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0538927 (UMLS CUI 2011AA)
116081000 (SNOMED CT 2011_0131)
MTHU013163 (LOINC Version 232)
C1707391 (UMLS CUI 2011AA)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C0003209 (UMLS CUI 2011AA)
330901000 (SNOMED CT 2011_0131)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial