ID

4880

Beschrijving

ODM derived from http://clinicaltrials.gov/show/NCT00264056

Link

http://clinicaltrials.gov/show/NCT00264056

Trefwoorden

Versies (2)
  1. 23-02-12 23-02-12 -
  2. 13-04-14 13-04-14 - Julian Varghese
Geüploaded op

13 april 2014

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility NCT00264056 Advanced Metastastic Malignant Melanoma Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases

Duits Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschrijving

Einschlusskriterien

Alter zwischen 18 und 70
Beschrijving

Age

Datatype

boolean

histologically proven malignant melanoma with advanced inoperable soft tissue metastases
Beschrijving

malignant melanoma

Datatype

boolean

progressive disease upon systemic first-line chemotherapy
Beschrijving

systemic first-line chemotherapy

Datatype

boolean

2 or more bidimensionally measurable soft tissue lesions
Beschrijving

soft tissue lesions

Datatype

boolean

WHO performance status (ECOG) of 2 or more
Beschrijving

ECOG score 2

Datatype

boolean

life expectancy of 8 weeks and more
Beschrijving

life expectancy of 8 weeks and more

Datatype

boolean

prior informed consent
Beschrijving

informed consent

Datatype

boolean

Ausschlusskriterien
Beschrijving

Ausschlusskriterien

participation in other therapy studies
Beschrijving

participation in other therapy studies

Datatype

boolean

pregnancy or breast feeding
Beschrijving

pregnancy or breast feeding

Datatype

boolean

concomitant clinically significant infection
Beschrijving

clinically significant infection

Datatype

boolean

cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
Beschrijving

cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region

Datatype

boolean

lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)
Beschrijving

lack of physiological heat sensitivity within the hyperthermia treated region

Datatype

boolean

Medizinische Konzepte
Beschrijving

Medizinische Konzepte

Alter
Beschrijving

Age

Datatype

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnose
Beschrijving

Diagnosis

Datatype

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Malignes Melanom
Beschrijving

Melanoma

Datatype

string

Alias
UMLS CUI
C0025202
SNOMED CT 2010_0731
2092003
MedDRA 13.1
10025650
Secondary malignant neoplasm of soft tissues
Beschrijving

soft tissue metastases

Datatype

string

Alias
UMLS CUI
C0684686
SNOMED CT 2010_0731
94264008
MedDRA 13.1
10062197
Progressive Disease
Beschrijving

Progressive Disease

Datatype

string

Alias
UMLS CUI
C1335499
Systemic Chemotherapy
Beschrijving

Systemic Chemotherapy

Datatype

string

Alias
UMLS CUI
C1883256
Soft tissue lesion
Beschrijving

Soft tissue lesion

Datatype

string

Alias
UMLS CUI
C0410013
SNOMED CT 2010_0731
239953001
ECOG Status
Beschrijving

ECOG

Datatype

string

Alias
UMLS CUI
C1520224
SNOMED CT 2010_0731
424122007
ECOG performance status - grade 2
Beschrijving

ECOG performance status - grade 2

Datatype

string

Alias
UMLS CUI
C1828242
SNOMED CT 2010_0731
422894000
Life expectancy
Beschrijving

Life expectancy

Datatype

string

Alias
UMLS CUI
C0023671
LOINC Version 232
MTHU021387
Einverständniserklärung
Beschrijving

Informed Consent

Datatype

string

Alias
UMLS CUI
C0021430
Pregnancy
Beschrijving

Pregnancy

Datatype

string

Alias
UMLS CUI
C0549206
SNOMED CT 2010_0731
289908002
MedDRA 13.1
10036556
LOINC Version 232
MTHU035048
Stillzeit
Beschrijving

Lactation

Datatype

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Infektion
Beschrijving

Infection

Datatype

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Artificial cardiac pacemaker
Beschrijving

cardiac pacemaker

Datatype

string

Alias
UMLS CUI
C0030163
SNOMED CT 2010_0731
14106009
LOINC Version 232
MTHU024521
Biomedical implant
Beschrijving

Implant

Datatype

string

Alias
UMLS CUI
C0021102
SNOMED CT 2010_0731
40388003
Hyperthermia Treatment
Beschrijving

Hyperthermia Treatment

Datatype

string

Alias
UMLS CUI
C0203597
SNOMED CT 2010_0731
31847002
Intolerant of heat
Beschrijving

Heat sensitivity

Datatype

string

Alias
UMLS CUI
C0231274
SNOMED CT 2010_0731
69215007
MedDRA 13.1
10056596
Terug naar het begin van de pagina

Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Einschlusskriterien
Age
Item
Alter zwischen 18 und 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
Ausschlusskriterien
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
Medizinische Konzepte
Age
Item
Alter
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Melanoma
Item
Malignes Melanom
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 Status
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
Einverständniserklärung
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
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Infection
Item
Infektion
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)
Terug naar het begin van de pagina 

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