ID

256

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00322621

Nyckelord

Versioner (3)
  1. 2012-03-21 2012-03-21 -
  2. 2014-03-19 2014-03-19 - Martin Dugas
  3. 2014-08-11 2014-08-11 - Martin Dugas
Uppladdad den

21 mars 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00322621 Diabetic Neuropathies

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alter 18 Jahre und älter
Beskrivning

age >=18 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
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.
Beskrivning

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.

Datatyp

boolean

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

May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.

Datatyp

boolean

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

Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C2732532
SNOMED CT 2011_0131
443223005
UMLS CUI 2011AA
C1510992
UMLS CUI 2011AA
CL414978
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

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

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

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0262926
SNOMED CT 2011_0131
417662000
LOINC Version 232
MTHU027722
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
UMLS CUI 2011AA
C0038580
SNOMED CT 2011_0131
2403008
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0028040
SNOMED CT 2011_0131
68540007
LOINC Version 232
MTHU003222
UMLS CUI 2011AA
C0006644
SNOMED CT 2011_0131
255641001
LOINC Version 232
MTHU012263
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.
Beskrivning

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.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C1869009
MedDRA 14.1
20000005
UMLS CUI 2011AA
C0160390
SNOMED CT 2011_0131
39400004
MedDRA 14.1
10067125
ICD-10-CM Version 2010
S36.11
ICD-9-CM Version 2011
864
UMLS CUI 2011AA
C0019158
SNOMED CT 2011_0131
29001004
MedDRA 14.1
10019717
UMLS CUI 2011AA
C0023890
SNOMED CT 2011_0131
19943007
MedDRA 14.1
10019641
ICD-10-CM Version 2010
K74.60
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0035204
SNOMED CT 2011_0131
50043002
MedDRA 14.1
10038683
ICD-10-CM Version 2010
J98.9
ICD-9-CM Version 2011
519.9
UMLS CUI 2011AA
C0018939
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
UMLS CUI 2011AA
C0014544
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
UMLS CUI 2011AA
C0085096
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
UMLS CUI 2011AA
C0815173
UMLS CUI 2011AA
C2348568
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
UMLS CUI 2011AA
C0750729
SNOMED CT 2011_0131
288524001
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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.
Beskrivning

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.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0026457
SNOMED CT 2011_0131
373281001
UMLS CUI 2011AA
C0457454
SNOMED CT 2011_0131
278308006
Fluoxetin
Beskrivning

Treatment with fluoxetine within 30 days of starting the study.

Datatyp

boolean

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

Unstable blood sugar control and uncontrolled or poorly controlled hypertension.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0392201
SNOMED CT 2011_0131
33747003
MedDRA 14.1
10005553
UMLS CUI 2011AA
C0020538
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
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0205169
SNOMED CT 2011_0131
556001
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
age >=18 Years
Item
Alter 18 Jahre und älter
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
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.
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
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0030193 (UMLS CUI 2011AA)
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)
C0238767 (UMLS CUI 2011AA)
51440002 (SNOMED CT 2011_0131)
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0016512 (UMLS CUI 2011AA)
47933007 (SNOMED CT 2011_0131)
10016974 (MedDRA 14.1)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0439659 (UMLS CUI 2011AA)
246062003 (SNOMED CT 2011_0131)
MTHU026300 (LOINC Version 232)
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
Item
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
boolean
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
Item
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
boolean
C2732532 (UMLS CUI 2011AA)
443223005 (SNOMED CT 2011_0131)
C1510992 (UMLS CUI 2011AA)
CL414978 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Item
History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0038580 (UMLS CUI 2011AA)
2403008 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0028040 (UMLS CUI 2011AA)
68540007 (SNOMED CT 2011_0131)
MTHU003222 (LOINC Version 232)
C0006644 (UMLS CUI 2011AA)
255641001 (SNOMED CT 2011_0131)
MTHU012263 (LOINC Version 232)
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.
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
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0160390 (UMLS CUI 2011AA)
39400004 (SNOMED CT 2011_0131)
10067125 (MedDRA 14.1)
S36.11 (ICD-10-CM Version 2010)
864 (ICD-9-CM Version 2011)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
C0023890 (UMLS CUI 2011AA)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0035204 (UMLS CUI 2011AA)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0014544 (UMLS CUI 2011AA)
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)
C0085096 (UMLS CUI 2011AA)
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)
C0815173 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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.
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
C0026457 (UMLS CUI 2011AA)
373281001 (SNOMED CT 2011_0131)
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
Treatment with fluoxetine within 30 days of starting the study.
Item
Fluoxetin
boolean
C0016365 (UMLS CUI 2011AA)
372767007 (SNOMED CT 2011_0131)
MTHU003396 (LOINC Version 232)
Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
Item
Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0392201 (UMLS CUI 2011AA)
33747003 (SNOMED CT 2011_0131)
10005553 (MedDRA 14.1)
C0020538 (UMLS CUI 2011AA)
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)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
Tillbaka till toppen 

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