ID

5721

Description

ODM derived from http://clinicaltrials.gov/show/NCT00322621

Link

http://clinicaltrials.gov/show/NCT00322621

Keywords

Versions (3)
  1. 3/21/12 3/21/12 -
  2. 3/19/14 3/19/14 - Martin Dugas
  3. 8/11/14 8/11/14 - Martin Dugas
Uploaded on

August 11, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00322621 Diabetic Neuropathies

German English

Eligibility

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

Inclusion Criteria

Age 18 Years and older
Description

ageGE18

Data type

boolean

Alias
SNOMED CT 2011_0131
397669002
UMLS CUI
C0001779
Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
Description

painneuropathyGE6mon

Data type

boolean

Alias
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
SNOMED CT 2011_0131
22253000
MedDRA 14.1
10033371
LOINC Version 232
MTHU029813
ICD-10-CM Version 2010
R52
ICD-9-CM Version 2011
338-338.9
CTCAE 1105E
E11167
SNOMED CT 2011_0131
51440002
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
SNOMED CT 2011_0131
134198009
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
SNOMED CT 2011_0131
47933007
MedDRA 14.1
10016974
SNOMED CT 2011_0131
52101004
SNOMED CT 2011_0131
246062003
LOINC Version 232
MTHU026300
UMLS CUI
C0011900
UMLS CUI
C0030193
UMLS CUI
C0238767
UMLS CUI
C0031117
UMLS CUI
C1314792
UMLS CUI
C0011854
UMLS CUI
C0011860
UMLS CUI
C0016512
UMLS CUI
C0150312
UMLS CUI
C0439659
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
Description

notpregnant

Data type

boolean

Alias
SNOMED CT 2011_0131
60001007
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
SNOMED CT 2011_0131
371881003
UMLS CUI
C0232973
UMLS CUI
C0680240
UMLS CUI
C0700589
UMLS CUI
C0347984
UMLS CUI
C2348568
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
Description

painScoreGE4

Data type

boolean

Alias
SNOMED CT 2011_0131
443223005
UMLS CUI
C2732532
UMLS CUI
C1510992
UMLS CUI
CL414978
Exclusion Criteria
Description

Exclusion Criteria

History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Description

Substance abuse

Data type

boolean

Alias
SNOMED CT 2011_0131
417662000
LOINC Version 232
MTHU027722
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
SNOMED CT 2011_0131
2403008
SNOMED CT 2011_0131
68540007
LOINC Version 232
MTHU003222
SNOMED CT 2011_0131
255641001
LOINC Version 232
MTHU012263
UMLS CUI-1
C0740858
Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study.
Description

SeriousConditions

Data type

boolean

Alias
SNOMED CT 2011_0131
42745003
SNOMED CT 2011_0131
263922001
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
MedDRA 14.1
20000005
SNOMED CT 2011_0131
39400004
MedDRA 14.1
10067125
ICD-10-CM Version 2010
S36.11
ICD-9-CM Version 2011
864
SNOMED CT 2011_0131
29001004
MedDRA 14.1
10019717
SNOMED CT 2011_0131
19943007
MedDRA 14.1
10019641
ICD-10-CM Version 2010
K74.60
SNOMED CT 2011_0131
24484000
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
SNOMED CT 2011_0131
50043002
MedDRA 14.1
10038683
ICD-10-CM Version 2010
J98.9
ICD-9-CM Version 2011
519.9
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
SNOMED CT 2011_0131
400047006
MedDRA 14.1
10034636
LOINC Version 232
MTHU020791
ICD-10-CM Version 2010
I73.9
ICD-9-CM Version 2011
443.9
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
SNOMED CT 2011_0131
288524001
SNOMED CT 2011_0131
110465008
UMLS CUI
C0205404
UMLS CUI
C0443343
UMLS CUI
C0007222
UMLS CUI
C1869009
UMLS CUI
C0160390
UMLS CUI
C0019158
UMLS CUI
C0023890
UMLS CUI
C0205082
UMLS CUI
C0022658
UMLS CUI
C0035204
UMLS CUI
C0018939
UMLS CUI
C0014544
UMLS CUI
C0085096
UMLS CUI
C0815173
UMLS CUI
C2348568
UMLS CUI
C0019993
UMLS CUI
C0750729
UMLS CUI
C0008976
Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
Description

MAOI

Data type

boolean

Alias
SNOMED CT 2011_0131
373281001
SNOMED CT 2011_0131
278308006
UMLS CUI
C0026457
UMLS CUI
C0457454
Fluoxetine
Description

fluoxetine

Data type

boolean

Alias
SNOMED CT 2011_0131
372767007
LOINC Version 232
MTHU003396
UMLS CUI
C0016365
Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
Description

BloodSugarUnstableORHypertension

Data type

boolean

Alias
SNOMED CT 2011_0131
263922001
SNOMED CT 2011_0131
33747003
MedDRA 14.1
10005553
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
SNOMED CT 2011_0131
31509003
SNOMED CT 2011_0131
556001
UMLS CUI
C0443343
UMLS CUI
C0392201
UMLS CUI
C0020538
UMLS CUI
C2587213
UMLS CUI
C0205169
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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
ageGE18
Item
Age 18 Years and older
boolean
397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI)
painneuropathyGE6mon
Item
Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
boolean
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
51440002 (SNOMED CT 2011_0131)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
134198009 (SNOMED CT 2011_0131)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
47933007 (SNOMED CT 2011_0131)
10016974 (MedDRA 14.1)
52101004 (SNOMED CT 2011_0131)
246062003 (SNOMED CT 2011_0131)
MTHU026300 (LOINC Version 232)
C0011900 (UMLS CUI)
C0030193 (UMLS CUI)
C0238767 (UMLS CUI)
C0031117 (UMLS CUI)
C1314792 (UMLS CUI)
C0011854 (UMLS CUI)
C0011860 (UMLS CUI)
C0016512 (UMLS CUI)
C0150312 (UMLS CUI)
C0439659 (UMLS CUI)
notpregnant
Item
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
boolean
60001007 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
371881003 (SNOMED CT 2011_0131)
C0232973 (UMLS CUI)
C0680240 (UMLS CUI)
C0700589 (UMLS CUI)
C0347984 (UMLS CUI)
C2348568 (UMLS CUI)
painScoreGE4
Item
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
boolean
443223005 (SNOMED CT 2011_0131)
C2732532 (UMLS CUI)
C1510992 (UMLS CUI)
CL414978 (UMLS CUI)
Item Group
Exclusion Criteria
Substance abuse
Item
History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
boolean
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
2403008 (SNOMED CT 2011_0131)
68540007 (SNOMED CT 2011_0131)
MTHU003222 (LOINC Version 232)
255641001 (SNOMED CT 2011_0131)
MTHU012263 (LOINC Version 232)
C0740858 (UMLS CUI-1)
SeriousConditions
Item
Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study.
boolean
42745003 (SNOMED CT 2011_0131)
263922001 (SNOMED CT 2011_0131)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
20000005 (MedDRA 14.1)
39400004 (SNOMED CT 2011_0131)
10067125 (MedDRA 14.1)
S36.11 (ICD-10-CM Version 2010)
864 (ICD-9-CM Version 2011)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
24484000 (SNOMED CT 2011_0131)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
400047006 (SNOMED CT 2011_0131)
10034636 (MedDRA 14.1)
MTHU020791 (LOINC Version 232)
I73.9 (ICD-10-CM Version 2010)
443.9 (ICD-9-CM Version 2011)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
288524001 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI)
C0443343 (UMLS CUI)
C0007222 (UMLS CUI)
C1869009 (UMLS CUI)
C0160390 (UMLS CUI)
C0019158 (UMLS CUI)
C0023890 (UMLS CUI)
C0205082 (UMLS CUI)
C0022658 (UMLS CUI)
C0035204 (UMLS CUI)
C0018939 (UMLS CUI)
C0014544 (UMLS CUI)
C0085096 (UMLS CUI)
C0815173 (UMLS CUI)
C2348568 (UMLS CUI)
C0019993 (UMLS CUI)
C0750729 (UMLS CUI)
C0008976 (UMLS CUI)
MAOI
Item
Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
boolean
373281001 (SNOMED CT 2011_0131)
278308006 (SNOMED CT 2011_0131)
C0026457 (UMLS CUI)
C0457454 (UMLS CUI)
fluoxetine
Item
Fluoxetine
boolean
372767007 (SNOMED CT 2011_0131)
MTHU003396 (LOINC Version 232)
C0016365 (UMLS CUI)
BloodSugarUnstableORHypertension
Item
Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
boolean
263922001 (SNOMED CT 2011_0131)
33747003 (SNOMED CT 2011_0131)
10005553 (MedDRA 14.1)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
31509003 (SNOMED CT 2011_0131)
556001 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI)
C0392201 (UMLS CUI)
C0020538 (UMLS CUI)
C2587213 (UMLS CUI)
C0205169 (UMLS CUI)
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