ID

13962

Descripción

Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00169169

Link

https://clinicaltrials.gov/show/NCT00169169

Palabras clave

Versiones (1)
  1. 20/3/16 20/3/16 -
Subido en

20 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility CD20-Positive Large B-Cell Lymphoma NCT00169169

Inglés

Eligibility CD20-Positive Large B-Cell Lymphoma NCT00169169

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient with histologically proven cd20+ diffuse large b cell lymphoma (who classification).
Descripción

Cd20+ diffuse large b cell lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C0054946
aged from 18 to 59 years, eligible for transplant.
Descripción

Age and eligibility criteria for transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0040732
patient not previously treated.
Descripción

Treatment status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0749659
age adjusted international prognostic index equal to 2 or 3.
Descripción

International prognostic index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512894
having previously signed a written informed consent.
Descripción

Written informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
women of childbearing potential currently practicing an adequate method of contraception.
Descripción

Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any other histological type of lymphoma.
Descripción

Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024299
any history of treated or non-treated indolent lymphoma.
Descripción

Indolent lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1334170
central nervous system or meningeal involvement by lymphoma.
Descripción

CNS and meningeal involvement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0449389
UMLS CUI [2]
C2213017
contra-indication to any drug contained in the chemotherapy regimens.
Descripción

Contraindication to chemotherapy regimen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1301624
poor renal function (creatinin level>150mmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
Descripción

Renal and liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0002594
poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l, unless related to bone marrow infiltration.
Descripción

Bone marrow function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0005821
any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
Descripción

Cancer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007114
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C2216722
any serious active disease (according to the investigator’s decision).
Descripción

Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
hiv, htlv1 or hbv related disease.
Descripción

Viral diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0020097
UMLS CUI [3]
C0019163
any organ transplantation before inclusion.
Descripción

Organ transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029216
pregnant women.
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility CD20-Positive Large B-Cell Lymphoma NCT00169169

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Cd20+ diffuse large b cell lymphoma
Item
patient with histologically proven cd20+ diffuse large b cell lymphoma (who classification).
boolean
C0079744 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
Age and eligibility criteria for transplantation
Item
aged from 18 to 59 years, eligible for transplant.
boolean
C0001779 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
Treatment status
Item
patient not previously treated.
boolean
C0749659 (UMLS CUI [1])
International prognostic index
Item
age adjusted international prognostic index equal to 2 or 3.
boolean
C1512894 (UMLS CUI [1])
Written informed consent
Item
having previously signed a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods
Item
women of childbearing potential currently practicing an adequate method of contraception.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lymphoma
Item
any other histological type of lymphoma.
boolean
C0024299 (UMLS CUI [1])
Indolent lymphoma
Item
any history of treated or non-treated indolent lymphoma.
boolean
C1334170 (UMLS CUI [1])
CNS and meningeal involvement
Item
central nervous system or meningeal involvement by lymphoma.
boolean
C0449389 (UMLS CUI [1])
C2213017 (UMLS CUI [2])
Contraindication to chemotherapy regimen
Item
contra-indication to any drug contained in the chemotherapy regimens.
boolean
C0392920 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
Renal and liver function
Item
poor renal function (creatinin level>150mmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
boolean
C0201976 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
Bone marrow function
Item
poor bone marrow reserve as defined by neutrophils < 1.5 g/l or platelets < 100 g/l, unless related to bone marrow infiltration.
boolean
C0200633 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
Cancer
Item
any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007114 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2216722 (UMLS CUI [2,3])
Comorbidity
Item
any serious active disease (according to the investigator’s decision).
boolean
C0009488 (UMLS CUI [1])
Viral diseases
Item
hiv, htlv1 or hbv related disease.
boolean
C0019693 (UMLS CUI [1])
C0020097 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
Organ transplantation
Item
any organ transplantation before inclusion.
boolean
C0029216 (UMLS CUI [1])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
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