ID

4844

Beschreibung

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00071084

Link

http://clinicaltrials.gov/ct2/show/record/NCT00071084

Stichworte

  1. 09.12.13 09.12.13 - Martin Dugas
  2. 11.04.14 11.04.14 - Julian Varghese
  3. 11.04.14 11.04.14 - Julian Varghese
  4. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
Hochgeladen am

11. April 2014

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Criteria NCT00071084

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion
Beschreibung

Inclusion

Medical diagnosis of CTCL, and positivity for the CD4 receptor. - Late stage CTCL
Beschreibung

CTCL

Datentyp

boolean

Have received at least one prior anti-cancer therapy with inadequate effect
Beschreibung

Prior therapy

Datentyp

boolean

WHO performance status 0,1 or 2 - Male or female, age 18 or older. - Signed informed consent.
Beschreibung

Other

Datentyp

boolean

Exclusion
Beschreibung

Exclusion

Certain rare types of CTCL.
Beschreibung

Rare CTCL

Datentyp

boolean

Previous treatment with other anti-CD4 medications. - More than two previous treatments with systemic chemotherapy. - Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. - Some types of steroid treatments less than two weeks before entering the trial
Beschreibung

Previous treatment

Datentyp

boolean

Prolonged exposure to sunlight or UV light during the trial. - Other cancer diseases, except certain skin cancers or cervix cancer. - Chronic infectious disease requiring medication. - Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. - Certain laboratory values which are too high or too low. - HIV positivity
Beschreibung

Other

Datentyp

boolean

Pregnant or breast-feeding women. - Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
Beschreibung

Pregnancy - Lactation

Datentyp

boolean

If you are participating in another trial with a different new drug 4 weeks before you enter this trial
Beschreibung

other trial

Datentyp

boolean

Medical concepts
Beschreibung

Medical concepts

Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Lymphoma, T-Cell, Cutaneous
Beschreibung

CTCL

Datentyp

string

Alias
UMLS CUI
C0079773
SNOMED CT 2010_0731
28054005
Diagnostic Neoplasm Staging
Beschreibung

Tumor Staging

Datentyp

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Therapeutic procedure
Beschreibung

Therapeutic procedure

Datentyp

string

Alias
UMLS CUI
C0087111
WHO performance status finding
Beschreibung

WHO performance status finding

Datentyp

string

Alias
UMLS CUI
C1298651
SNOMED CT 2010_0731
373802001
Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Medication
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Chemotherapy
Beschreibung

Chemotherapy

Datentyp

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Exposure to sunlight
Beschreibung

Exposure to sunlight

Datentyp

string

Alias
UMLS CUI
C0497062
ICD-10-CM Version 2010
X32
Infection
Beschreibung

Infection

Datentyp

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
HIV negative
Beschreibung

HIV negative

Datentyp

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
pregnant
Beschreibung

pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding
Beschreibung

Lactation

Datentyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception
Beschreibung

Contraception

Datentyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Enrollment
Beschreibung

Enrollment

Datentyp

string

Alias
UMLS CUI
C2348568

Ähnliche Modelle

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion
CTCL
Item
Medical diagnosis of CTCL, and positivity for the CD4 receptor. - Late stage CTCL
boolean
Prior therapy
Item
Have received at least one prior anti-cancer therapy with inadequate effect
boolean
Other
Item
WHO performance status 0,1 or 2 - Male or female, age 18 or older. - Signed informed consent.
boolean
Item Group
Exclusion
Rare CTCL
Item
Certain rare types of CTCL.
boolean
Previous treatment
Item
Previous treatment with other anti-CD4 medications. - More than two previous treatments with systemic chemotherapy. - Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. - Some types of steroid treatments less than two weeks before entering the trial
boolean
Other
Item
Prolonged exposure to sunlight or UV light during the trial. - Other cancer diseases, except certain skin cancers or cervix cancer. - Chronic infectious disease requiring medication. - Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. - Certain laboratory values which are too high or too low. - HIV positivity
boolean
Pregnancy - Lactation
Item
Pregnant or breast-feeding women. - Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
boolean
other trial
Item
If you are participating in another trial with a different new drug 4 weeks before you enter this trial
boolean
Item Group
Medical concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
CTCL
Item
Lymphoma, T-Cell, Cutaneous
string
C0079773 (UMLS CUI)
28054005 (SNOMED CT 2010_0731)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
WHO performance status finding
Item
WHO performance status finding
string
C1298651 (UMLS CUI)
373802001 (SNOMED CT 2010_0731)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Exposure to sunlight
Item
Exposure to sunlight
string
C0497062 (UMLS CUI)
X32 (ICD-10-CM Version 2010)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)

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