ID

42707

Description

ODM derived from http://clinicaltrials.gov/show/NCT01019473

Link

http://clinicaltrials.gov/show/NCT01019473

Keywords

Versions (2)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 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.

Back to model comments
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 NCT01019473 Huntington's Disease

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 30 Years to 85 Years
Description

age 30 Years to 85 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Huntington's disease (based on DNA testing polyQ >36) with a UHDRS maximal chorea score of >10
Description

Huntington's disease (based on DNA testing polyQ >36) with a UHDRS maximal chorea score of >10

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
C1705938
UMLS CUI 2011AA
C0200898
SNOMED CT 2011_0131
62302004
UMLS CUI 2011AA
C0384782
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
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization
Description

patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C2347852
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
C0003289
SNOMED CT 2011_0131
372720008
LOINC Version 232
MTHU006782
UMLS CUI 2011AA
C0040615
SNOMED CT 2011_0131
10784006, 372482001
LOINC Version 232
MTHU003337
UMLS CUI 2011AA
C0005064
SNOMED CT 2011_0131
16047007
LOINC Version 232
MTHU001123
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception
Description

female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0038288
MedDRA 14.1
10062116
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0205173
SNOMED CT 2011_0131
1305003
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
patients with marked cognitive impairment (MMSE < 18), with presence of psychosis and/or confusional states
Description

patients with marked cognitive impairment (MMSE < 18), with presence of psychosis and/or confusional states

Data type

boolean

Alias
UMLS CUI 2011AA
C1706089
UMLS CUI 2011AA
C0338656
SNOMED CT 2011_0131
386806002
MedDRA 14.1
10009846
UMLS CUI 2011AA
C0451306
SNOMED CT 2011_0131
273617000
MedDRA 14.1
10067001
UMLS CUI 2011AA
C0033975
SNOMED CT 2011_0131
69322001
MedDRA 14.1
10061920
ICD-9-CM Version 2011
290-299.99
CTCAE 1105E
E12954
UMLS CUI 2011AA
C0009676
SNOMED CT 2011_0131
286933003
MedDRA 14.1
10010305
LOINC Version 232
MTHU019384
ICD-10-CM Version 2010
R41.0
CTCAE 1105E
E12889
patients with a history or presence of renal impairment and/or liver disease
Description

patients with a history or presence of renal impairment and/or liver disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
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
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 30 Years to 85 Years
Item
age 30 Years to 85 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Huntington's disease (based on DNA testing polyQ >36) with a UHDRS maximal chorea score of >10
Item
Huntington's disease (based on DNA testing polyQ >36) with a UHDRS maximal chorea score of >10
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)
C1705938 (UMLS CUI 2011AA)
C0200898 (UMLS CUI 2011AA)
62302004 (SNOMED CT 2011_0131)
C0384782 (UMLS CUI 2011AA)
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)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization
Item
patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization
boolean
C2347852 (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)
C0003289 (UMLS CUI 2011AA)
372720008 (SNOMED CT 2011_0131)
MTHU006782 (LOINC Version 232)
C0040615 (UMLS CUI 2011AA)
10784006, 372482001 (SNOMED CT 2011_0131)
MTHU003337 (LOINC Version 232)
C0005064 (UMLS CUI 2011AA)
16047007 (SNOMED CT 2011_0131)
MTHU001123 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception
Item
female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0038288 (UMLS CUI 2011AA)
10062116 (MedDRA 14.1)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205173 (UMLS CUI 2011AA)
1305003 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
patients with marked cognitive impairment (MMSE < 18), with presence of psychosis and/or confusional states
Item
patients with marked cognitive impairment (MMSE < 18), with presence of psychosis and/or confusional states
boolean
C1706089 (UMLS CUI 2011AA)
C0338656 (UMLS CUI 2011AA)
386806002 (SNOMED CT 2011_0131)
10009846 (MedDRA 14.1)
C0451306 (UMLS CUI 2011AA)
273617000 (SNOMED CT 2011_0131)
10067001 (MedDRA 14.1)
C0033975 (UMLS CUI 2011AA)
69322001 (SNOMED CT 2011_0131)
10061920 (MedDRA 14.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE 1105E)
C0009676 (UMLS CUI 2011AA)
286933003 (SNOMED CT 2011_0131)
10010305 (MedDRA 14.1)
MTHU019384 (LOINC Version 232)
R41.0 (ICD-10-CM Version 2010)
E12889 (CTCAE 1105E)
patients with a history or presence of renal impairment and/or liver disease
Item
patients with a history or presence of renal impairment and/or liver disease
boolean
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
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)
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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