ID

3805

Description

ODM derived from http://clinicaltrials.gov/show/NCT01357681

Link

http://clinicaltrials.gov/show/NCT01357681

Keywords

Versions (1)
  1. 4/11/13 4/11/13 - Martin Dugas
Uploaded on

April 11, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01357681 Huntington's Disease (HD)

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Chorea Huntington (CAG repeats >39)
Description

Chorea Huntington (CAG repeats >39)

Data type

boolean

Alias
UMLS CUI 2011AA
C0020179
SNOMED CT 2011_0131
58756001
MedDRA 14.1
10070668
ICD-10-CM Version 2010
G10
ICD-9-CM Version 2011
333.4
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C2751801
UMLS CUI 2011AA
C1547730
UHDRS TFC >5
Description

UHDRS TFC >5

Data type

boolean

Alias
UMLS CUI 2011AA
C1706076
UMLS CUI 2011AA
C0020179
SNOMED CT 2011_0131
58756001
MedDRA 14.1
10070668
ICD-10-CM Version 2010
G10
ICD-9-CM Version 2011
333.4
UMLS CUI 2011AA
C0681889
UMLS CUI 2011AA
C0439810
SNOMED CT 2011_0131
255619001
UMLS CUI 2011AA
C0205245
SNOMED CT 2011_0131
40143009
UMLS CUI 2011AA
C1516240
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
Normal liver function laboratory test
Description

Normal liver function laboratory test

Data type

boolean

Alias
UMLS CUI 2011AA
C1848676
UMLS CUI 2011AA
C0022885
SNOMED CT 2011_0131
15220000
MedDRA 14.1
10059938
Stable concomitant medication regimen > 4 weeks prior to Baseline
Description

Stable concomitant medication regimen > 4 weeks prior to Baseline

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1442488
Motivation for women with childbearing potential to use highly efficient contraception
Description

Motivation for women with childbearing potential to use highly efficient contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0026605
SNOMED CT 2011_0131
363882003
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Description

Exclusion Criteria

Clinically relevant abnormal findings in the ECG, vital signs, physical examination or laboratory values at Screening,
Description

Clinically relevant abnormal findings in the ECG, vital signs, physical examination or laboratory values at Screening,

Data type

boolean

Alias
UMLS CUI 2011AA
C2826279
UMLS CUI 2011AA
C1623258
SNOMED CT 2011_0131
46825001
MedDRA 14.1
10014084
UMLS CUI 2011AA
C0518766
SNOMED CT 2011_0131
46680005
LOINC Version 232
MTHU024540
UMLS CUI 2011AA
C0031809
SNOMED CT 2011_0131
5880005
MedDRA 14.1
10034986
LOINC Version 232
MTHU028014
ICD-9-CM Version 2011
89.7
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1522609
Long-term treatment with potentially hepatoxic medication
Description

Long-term treatment with potentially hepatoxic medication

Data type

boolean

Alias
UMLS CUI 2011AA
C0443252
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL415205
UMLS CUI 2011AA
C0235378
MedDRA 14.1
10019851
UMLS CUI 2011AA
C0013227
Any unstable medical condition
Description

Any unstable medical condition

Data type

boolean

Alias
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
Depression (BDI Depression score > 9)
Description

Depression (BDI Depression score > 9)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011581
SNOMED CT 2011_0131
35489007
MedDRA 14.1
10012401
ICD-10-CM Version 2010
F32.9
UMLS CUI 2011AA
C2960571
SNOMED CT 2011_0131
446053003
Cognitive dysfunction defined as a score < 23 in the Mini-Mental State Examination (MMSE) at Screening
Description

Cognitive dysfunction defined as a score < 23 in the Mini-Mental State Examination (MMSE) at Screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0338656
SNOMED CT 2011_0131
386806002
MedDRA 14.1
10009846
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C0451306
SNOMED CT 2011_0131
273617000
MedDRA 14.1
10067001
Liver or renal disease
Description

Liver or renal disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
Consumption of > two cups of black tea per day, consumption of green tea, consumption of > 500 ml /day of grapefruit juice
Description

Consumption of > two cups of black tea per day, consumption of green tea, consumption of > 500 ml /day of grapefruit juice

Data type

boolean

Alias
UMLS CUI 2011AA
C1947907
UMLS CUI 2011AA
C0439505
SNOMED CT 2011_0131
259032004
UMLS CUI 2011AA
C0452440
SNOMED CT 2011_0131
226476000
UMLS CUI 2011AA
C0795620
UMLS CUI 2011AA
C0452456
SNOMED CT 2011_0131
226493000
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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 at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Chorea Huntington (CAG repeats >39)
Item
Chorea Huntington (CAG repeats >39)
boolean
C0020179 (UMLS CUI 2011AA)
58756001 (SNOMED CT 2011_0131)
10070668 (MedDRA 14.1)
G10 (ICD-10-CM Version 2010)
333.4 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2751801 (UMLS CUI 2011AA)
C1547730 (UMLS CUI 2011AA)
UHDRS TFC >5
Item
UHDRS TFC >5
boolean
C1706076 (UMLS CUI 2011AA)
C0020179 (UMLS CUI 2011AA)
58756001 (SNOMED CT 2011_0131)
10070668 (MedDRA 14.1)
G10 (ICD-10-CM Version 2010)
333.4 (ICD-9-CM Version 2011)
C0681889 (UMLS CUI 2011AA)
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
C0205245 (UMLS CUI 2011AA)
40143009 (SNOMED CT 2011_0131)
C1516240 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
Normal liver function laboratory test
Item
Normal liver function laboratory test
boolean
C1848676 (UMLS CUI 2011AA)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
Stable concomitant medication regimen > 4 weeks prior to Baseline
Item
Stable concomitant medication regimen > 4 weeks prior to Baseline
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C2347852 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
Motivation for women with childbearing potential to use highly efficient contraception
Item
Motivation for women with childbearing potential to use highly efficient contraception
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0026605 (UMLS CUI 2011AA)
363882003 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
Clinically relevant abnormal findings in the ECG, vital signs, physical examination or laboratory values at Screening,
Item
Clinically relevant abnormal findings in the ECG, vital signs, physical examination or laboratory values at Screening,
boolean
C2826279 (UMLS CUI 2011AA)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C0518766 (UMLS CUI 2011AA)
46680005 (SNOMED CT 2011_0131)
MTHU024540 (LOINC Version 232)
C0031809 (UMLS CUI 2011AA)
5880005 (SNOMED CT 2011_0131)
10034986 (MedDRA 14.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Long-term treatment with potentially hepatoxic medication
Item
Long-term treatment with potentially hepatoxic medication
boolean
C0443252 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
CL415205 (UMLS CUI 2011AA)
C0235378 (UMLS CUI 2011AA)
10019851 (MedDRA 14.1)
C0013227 (UMLS CUI 2011AA)
Any unstable medical condition
Item
Any unstable medical condition
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
Depression (BDI Depression score > 9)
Item
Depression (BDI Depression score > 9)
boolean
C0011581 (UMLS CUI 2011AA)
35489007 (SNOMED CT 2011_0131)
10012401 (MedDRA 14.1)
F32.9 (ICD-10-CM Version 2010)
C2960571 (UMLS CUI 2011AA)
446053003 (SNOMED CT 2011_0131)
Cognitive dysfunction defined as a score < 23 in the Mini-Mental State Examination (MMSE) at Screening
Item
Cognitive dysfunction defined as a score < 23 in the Mini-Mental State Examination (MMSE) at Screening
boolean
C0338656 (UMLS CUI 2011AA)
386806002 (SNOMED CT 2011_0131)
10009846 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0451306 (UMLS CUI 2011AA)
273617000 (SNOMED CT 2011_0131)
10067001 (MedDRA 14.1)
Liver or renal disease
Item
Liver or renal disease
boolean
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
Consumption of > two cups of black tea per day, consumption of green tea, consumption of > 500 ml /day of grapefruit juice
Item
Consumption of > two cups of black tea per day, consumption of green tea, consumption of > 500 ml /day of grapefruit juice
boolean
C1947907 (UMLS CUI 2011AA)
C0439505 (UMLS CUI 2011AA)
259032004 (SNOMED CT 2011_0131)
C0452440 (UMLS CUI 2011AA)
226476000 (SNOMED CT 2011_0131)
C0795620 (UMLS CUI 2011AA)
C0452456 (UMLS CUI 2011AA)
226493000 (SNOMED CT 2011_0131)
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