Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
age between 18 and 70
boolean
malignant melanoma
Item
histologically proven malignant melanoma with advanced inoperable soft tissue metastases
boolean
systemic first-line chemotherapy
Item
progressive disease upon systemic first-line chemotherapy
boolean
soft tissue lesions
Item
2 or more bidimensionally measurable soft tissue lesions
boolean
ECOG score 2
Item
WHO performance status (ECOG) of 2 or more
boolean
life expectancy of 8 weeks and more
Item
life expectancy of 8 weeks and more
boolean
informed consent
Item
prior informed consent
boolean
Item Group
Exclusion Criteria
participation in other therapy studies
Item
participation in other therapy studies
boolean
pregnancy or breast feeding
Item
pregnancy or breast feeding
boolean
clinically significant infection
Item
concomitant clinically significant infection
boolean
cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region
Item
cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
boolean
lack of physiological heat sensitivity within the hyperthermia treated region
Item
lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)
boolean
Item Group
Medical Concepts
Age
Item
Age
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Melanoma
Item
Malignant melanoma
string
C0025202 (UMLS CUI)
2092003 (SNOMED CT 2010_0731)
10025650 (MedDRA 13.1)
soft tissue metastases
Item
Secondary malignant neoplasm of soft tissues
string
C0684686 (UMLS CUI)
94264008 (SNOMED CT 2010_0731)
10062197 (MedDRA 13.1)
Progressive Disease
Item
Progressive Disease
string
C1335499 (UMLS CUI)
Systemic Chemotherapy
Item
Systemic Chemotherapy
string
C1883256 (UMLS CUI)
Soft tissue lesion
Item
Soft tissue lesion
string
C0410013 (UMLS CUI)
239953001 (SNOMED CT 2010_0731)
ECOG
Item
ECOG performance status finding
string
C1520224 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
ECOG performance status - grade 2
Item
ECOG performance status - grade 2
string
C1828242 (UMLS CUI)
422894000 (SNOMED CT 2010_0731)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
MTHU021387 (LOINC Version 232)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Pregnancy
Item
Pregnancy
string
C0549206 (UMLS CUI)
289908002 (SNOMED CT 2010_0731)
10036556 (MedDRA 13.1)
MTHU035048 (LOINC Version 232)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
cardiac pacemaker
Item
Artificial cardiac pacemaker
string
C0030163 (UMLS CUI)
14106009 (SNOMED CT 2010_0731)
MTHU024521 (LOINC Version 232)
Implant
Item
Biomedical implant
string
C0021102 (UMLS CUI)
40388003 (SNOMED CT 2010_0731)
Hyperthermia Treatment
Item
Hyperthermia Treatment
string
C0203597 (UMLS CUI)
31847002 (SNOMED CT 2010_0731)
Heat sensitivity
Item
Intolerant of heat
string
C0231274 (UMLS CUI)
69215007 (SNOMED CT 2010_0731)
10056596 (MedDRA 13.1)

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