ID

4880

Beskrivning

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

Länk

http://clinicaltrials.gov/show/NCT00264056

Nyckelord

Versioner (2)
  1. 2012-02-23 2012-02-23 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

13 april 2014

DOI

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Licens

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

Tysk Engelsk

Eligibility

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

Einschlusskriterien

Alter zwischen 18 und 70
Beskrivning

Age

Datatyp

boolean

histologically proven malignant melanoma with advanced inoperable soft tissue metastases
Beskrivning

malignant melanoma

Datatyp

boolean

progressive disease upon systemic first-line chemotherapy
Beskrivning

systemic first-line chemotherapy

Datatyp

boolean

2 or more bidimensionally measurable soft tissue lesions
Beskrivning

soft tissue lesions

Datatyp

boolean

WHO performance status (ECOG) of 2 or more
Beskrivning

ECOG score 2

Datatyp

boolean

life expectancy of 8 weeks and more
Beskrivning

life expectancy of 8 weeks and more

Datatyp

boolean

prior informed consent
Beskrivning

informed consent

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

participation in other therapy studies
Beskrivning

participation in other therapy studies

Datatyp

boolean

pregnancy or breast feeding
Beskrivning

pregnancy or breast feeding

Datatyp

boolean

concomitant clinically significant infection
Beskrivning

clinically significant infection

Datatyp

boolean

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

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

Datatyp

boolean

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

lack of physiological heat sensitivity within the hyperthermia treated region

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Alter
Beskrivning

Age

Datatyp

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnose
Beskrivning

Diagnosis

Datatyp

string

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

Melanoma

Datatyp

string

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

soft tissue metastases

Datatyp

string

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

Progressive Disease

Datatyp

string

Alias
UMLS CUI
C1335499
Systemic Chemotherapy
Beskrivning

Systemic Chemotherapy

Datatyp

string

Alias
UMLS CUI
C1883256
Soft tissue lesion
Beskrivning

Soft tissue lesion

Datatyp

string

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

ECOG

Datatyp

string

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

ECOG performance status - grade 2

Datatyp

string

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

Life expectancy

Datatyp

string

Alias
UMLS CUI
C0023671
LOINC Version 232
MTHU021387
Einverständniserklärung
Beskrivning

Informed Consent

Datatyp

string

Alias
UMLS CUI
C0021430
Pregnancy
Beskrivning

Pregnancy

Datatyp

string

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

Lactation

Datatyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Infektion
Beskrivning

Infection

Datatyp

string

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

cardiac pacemaker

Datatyp

string

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

Implant

Datatyp

string

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

Hyperthermia Treatment

Datatyp

string

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

Heat sensitivity

Datatyp

string

Alias
UMLS CUI
C0231274
SNOMED CT 2010_0731
69215007
MedDRA 13.1
10056596
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Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
Tillbaka till toppen 

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