ID

16684

Descrição

HuMax-CD20 in Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00093314

Link

https://clinicaltrials.gov/show/NCT00093314

Palavras-chave

Versões (2)
  1. 31/07/2016 31/07/2016 -
  2. 01/08/2016 01/08/2016 -
Transferido a

1 de agosto de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00093314

Inglês

Eligibility Chronic Lymphocytic Leukemia NCT00093314

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic lymphocytic leukemia
Descrição

Chronic Lymphocytic Leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023434
circulating lymphocytes above a specific level
Descrição

Increased number of circulating lymphocytes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1849238
circulating lymphocytes showing certain markers
Descrição

Lymphocyte Circulating | Lymphocyte markers

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C0175630
UMLS CUI [2]
C0023158
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
Descrição

rituximab | alemtuzumab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2]
C0383429
previous stem cell transplantation.
Descrição

Stem cell transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1504389
received any of the following treatments within 4 weeks prior to entering this trial: a) anti-cancer therapy, b) glucocorticoids unless less than 10 mg per day, c) radiotherapy.
Descrição

cancer treatment | Glucocorticoids | Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0017710
UMLS CUI [3]
C1522449
hiv positivity.
Descrição

HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
hepatitis b or hepatitis c.
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
other cancerous diseases, except certain skin cancers and cervix cancer.
Descrição

Malignant Neoplasms | Skin carcinoma | Cervix carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0302592
certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.
Descrição

medical condition Serious | Kidney Diseases | Liver diseases | Mental disorders | Stomach Diseases | Heart Diseases | Endocrine System Diseases | nervous system disorder | Hematological Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0038354
UMLS CUI [6]
C0018799
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0018939
participation in another trial with a different new drug 4 weeks prior to enrollment in study.
Descrição

Study Subject Participation Status | Investigational New Drug Different

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1705242
current participation in any other clinical study.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
pregnant or breast-feeding women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing age who are unable or unwilling to use adequate contraception.
Descrição

Childbearing Potential Age | Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0001779
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00093314

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia
Item
chronic lymphocytic leukemia
boolean
C0023434 (UMLS CUI [1])
Increased number of circulating lymphocytes
Item
circulating lymphocytes above a specific level
boolean
C1849238 (UMLS CUI [1])
Lymphocyte Circulating | Lymphocyte markers
Item
circulating lymphocytes showing certain markers
boolean
C0024264 (UMLS CUI [1,1])
C0175630 (UMLS CUI [1,2])
C0023158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
rituximab | alemtuzumab
Item
previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
boolean
C0393022 (UMLS CUI [1])
C0383429 (UMLS CUI [2])
Stem cell transplant
Item
previous stem cell transplantation.
boolean
C1504389 (UMLS CUI [1])
cancer treatment | Glucocorticoids | Therapeutic radiology procedure
Item
received any of the following treatments within 4 weeks prior to entering this trial: a) anti-cancer therapy, b) glucocorticoids unless less than 10 mg per day, c) radiotherapy.
boolean
C0920425 (UMLS CUI [1])
C0017710 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
HIV Seropositivity
Item
hiv positivity.
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
hepatitis b or hepatitis c.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Malignant Neoplasms | Skin carcinoma | Cervix carcinoma
Item
other cancerous diseases, except certain skin cancers and cervix cancer.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0302592 (UMLS CUI [3])
medical condition Serious | Kidney Diseases | Liver diseases | Mental disorders | Stomach Diseases | Heart Diseases | Endocrine System Diseases | nervous system disorder | Hematological Disease
Item
certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0038354 (UMLS CUI [5])
C0018799 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
Study Subject Participation Status | Investigational New Drug Different
Item
participation in another trial with a different new drug 4 weeks prior to enrollment in study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
Study Subject Participation Status
Item
current participation in any other clinical study.
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Age | Contraceptive methods Unwilling
Item
women of childbearing age who are unable or unwilling to use adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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