Eligibility NCT00395070 Metastatic Melanoma

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

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Eligibility

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  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Inclusion Criteria
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)
Exclusion Criteria
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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