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ID
5721
Description
ODM derived from http://clinicaltrials.gov/show/NCT00322621
Link
http://clinicaltrials.gov/show/NCT00322621
Keywords
Versions (3)
- 3/21/12 3/21/12 -
- 3/19/14 3/19/14 - Martin Dugas
- 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
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
ageGE18
Item
Age 18 Years and older
boolean
397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI)
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)
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)
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)
C2732532 (UMLS CUI)
C1510992 (UMLS CUI)
CL414978 (UMLS CUI)
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)
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)
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)
278308006 (SNOMED CT 2011_0131)
C0026457 (UMLS CUI)
C0457454 (UMLS CUI)
fluoxetine
Item
Fluoxetine
boolean
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)
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)