ID

4968

Description

ODM derived from http://clinicaltrials.gov/show/NCT00395070

Link

http://clinicaltrials.gov/show/NCT00395070

Keywords

  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
Uploaded on

April 15, 2014

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00395070 Metastatic Melanoma

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
Description

Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0855027
MedDRA 14.1
10025670
UMLS CUI 2011AA
C0854698
MedDRA 14.1
10025671
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0005522
SNOMED CT 2011_0131
418980009
UMLS CUI 2011AA
C1610033
UMLS CUI 2011AA
C0021756
SNOMED CT 2011_0131
68945006
LOINC Version 232
MTHU015779
At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected
Description

At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected

Data type

boolean

Alias
UMLS CUI 2011AA
C0025202
SNOMED CT 2011_0131
2092003
MedDRA 14.1
10025650
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0475440
SNOMED CT 2011_0131
263605001
Normal blood chemistries and blood cell counts
Description

Normal blood chemistries and blood cell counts

Data type

boolean

Alias
UMLS CUI 2011AA
C0205307
SNOMED CT 2011_0131
17621005
HL7 V3 2006_05
N
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C0079107
UMLS CUI 2011AA
C0005771
SNOMED CT 2011_0131
88308000
MedDRA 14.1
10064196
At least 18 years old and able and willing to provide informed consent to participate
Description

At least 18 years old and able and willing to provide informed consent to participate

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1999230
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Previous chemotherapy treatment for melanoma
Description

Previous chemotherapy treatment for melanoma

Data type

boolean

Alias
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C0025202
SNOMED CT 2011_0131
2092003
MedDRA 14.1
10025650
Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
Description

Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)

Data type

boolean

Alias
UMLS CUI 2011AA
C0025202
SNOMED CT 2011_0131
2092003
MedDRA 14.1
10025650
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1269537
SNOMED CT 2011_0131
258335003
UMLS CUI 2011AA
C0023884
SNOMED CT 2011_0131
10200004
LOINC Version 232
MTHU002039
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0024109
SNOMED CT 2011_0131
39607008
LOINC Version 232
MTHU008683
If surgical removal of all lesions would be possible and could be curative
Description

If surgical removal of all lesions would be possible and could be curative

Data type

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0444868
SNOMED CT 2011_0131
261675009
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C1880198
Any melanoma tumors >10cm x 10cm in size
Description

Any melanoma tumors >10cm x 10cm in size

Data type

boolean

Alias
UMLS CUI 2011AA
C0025202
SNOMED CT 2011_0131
2092003
MedDRA 14.1
10025650
UMLS CUI 2011AA
C0475440
SNOMED CT 2011_0131
263605001
Known condition resulting in a suppressed immune system
Description

Known condition resulting in a suppressed immune system

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C1373218
Female subjects who are pregnant
Description

Female subjects who are pregnant

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
Item
Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
boolean
C0750484 (UMLS CUI 2011AA)
C0855027 (UMLS CUI 2011AA)
10025670 (MedDRA 14.1)
C0854698 (UMLS CUI 2011AA)
10025671 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C0005522 (UMLS CUI 2011AA)
418980009 (SNOMED CT 2011_0131)
C1610033 (UMLS CUI 2011AA)
C0021756 (UMLS CUI 2011AA)
68945006 (SNOMED CT 2011_0131)
MTHU015779 (LOINC Version 232)
At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected
Item
At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected
boolean
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0475440 (UMLS CUI 2011AA)
263605001 (SNOMED CT 2011_0131)
Normal blood chemistries and blood cell counts
Item
Normal blood chemistries and blood cell counts
boolean
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
C0005768 (UMLS CUI 2011AA)
C0079107 (UMLS CUI 2011AA)
C0005771 (UMLS CUI 2011AA)
88308000 (SNOMED CT 2011_0131)
10064196 (MedDRA 14.1)
At least 18 years old and able and willing to provide informed consent to participate
Item
At least 18 years old and able and willing to provide informed consent to participate
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1999230 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Previous chemotherapy treatment for melanoma
Item
Previous chemotherapy treatment for melanoma
boolean
C1514457 (UMLS CUI 2011AA)
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
Item
Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
boolean
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1269537 (UMLS CUI 2011AA)
258335003 (SNOMED CT 2011_0131)
C0023884 (UMLS CUI 2011AA)
10200004 (SNOMED CT 2011_0131)
MTHU002039 (LOINC Version 232)
C1524004 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0024109 (UMLS CUI 2011AA)
39607008 (SNOMED CT 2011_0131)
MTHU008683 (LOINC Version 232)
If surgical removal of all lesions would be possible and could be curative
Item
If surgical removal of all lesions would be possible and could be curative
boolean
C0750557 (UMLS CUI 2011AA)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C1880198 (UMLS CUI 2011AA)
Any melanoma tumors >10cm x 10cm in size
Item
Any melanoma tumors >10cm x 10cm in size
boolean
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
C0475440 (UMLS CUI 2011AA)
263605001 (SNOMED CT 2011_0131)
Known condition resulting in a suppressed immune system
Item
Known condition resulting in a suppressed immune system
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C1373218 (UMLS CUI 2011AA)
Female subjects who are pregnant
Item
Female subjects who are pregnant
boolean
C0549206 (UMLS CUI 2011AA)

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