ID

14934

Beschrijving

Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02144623

Link

https://clinicaltrials.gov/show/NCT02144623

Trefwoorden

Versies (1)
  1. 09-05-16 09-05-16 -
Geüploaded op

9 mei 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT02144623

Engels

Eligibility Chronic Lymphocytic Leukemia NCT02144623

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed chronic lymphocytic leukemia
Beschrijving

Chronic Lymphocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023434
leucocyte count more than 20 x 10 9/l
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
no other simultaneous treatment for lymphoma
Beschrijving

Therapeutic procedure Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0024299
no treatment indicated for chronic lymphocytic leukemia
Beschrijving

Indication Therapeutic procedure Chronic Lymphocytic Leukemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0023434
who performance status 0-2
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
hiv negativity
Beschrijving

HIV Seronegativity

Datatype

boolean

Alias
UMLS CUI [1]
C0019698
negativity for hepatitis c virus , hbsag, anti-hepatitis b core antigen, or other active infection uncontrolled by treatment
Beschrijving

Hepatitis C virus Negative | Hepatitis B Surface Antigens | Antibody to hepatitis B core antigen | Communicable Diseases Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C0205160
UMLS CUI [2]
C0019168
UMLS CUI [3]
C0312631
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
Beschrijving

Abstinence donating blood | Investigational New Drugs Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843422
UMLS CUI [1,2]
C0425264
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0087111
agree not to share study medication with another person and to return all unused study drug to the investigator
Beschrijving

Sharing Investigational New Drugs | Return to investigator Investigational New Drugs Not used

Datatype

boolean

Alias
UMLS CUI [1,1]
C0237876
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0332156
UMLS CUI [2,2]
C0035173
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C0445107
written informed concent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study
Beschrijving

Mental disorders Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
neurological or neuropsychiatric disorder, interfering with the requirements of the study
Beschrijving

nervous system disorder Interferes with Study Protocol | Neuropsychiatric syndrome Interferes with Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C3203509
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348563
hearing impairment over grade 2
Beschrijving

hearing impairment

Datatype

boolean

Alias
UMLS CUI [1]
C1384666
porphyria
Beschrijving

Porphyria

Datatype

boolean

Alias
UMLS CUI [1]
C3463940
history of acute or chronic hepatitis
Beschrijving

Hepatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0019158
family history of severe drug-induced hepatitis
Beschrijving

FH: Hepatitis Drug-Induced Hepatitis Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0559141
UMLS CUI [1,2]
C1262760
UMLS CUI [1,3]
C0205082
pregnancy and lactation
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT02144623

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-80 years
boolean
C0001779 (UMLS CUI [1])
Chronic Lymphocytic Leukemia
Item
histologically confirmed chronic lymphocytic leukemia
boolean
C0023434 (UMLS CUI [1])
White Blood Cell Count procedure
Item
leucocyte count more than 20 x 10 9/l
boolean
C0023508 (UMLS CUI [1])
Therapeutic procedure Lymphoma
Item
no other simultaneous treatment for lymphoma
boolean
C0087111 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Indication Therapeutic procedure Chronic Lymphocytic Leukemia
Item
no treatment indicated for chronic lymphocytic leukemia
boolean
C3146298 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
HIV Seronegativity
Item
hiv negativity
boolean
C0019698 (UMLS CUI [1])
Hepatitis C virus Negative | Hepatitis B Surface Antigens | Antibody to hepatitis B core antigen | Communicable Diseases Uncontrolled
Item
negativity for hepatitis c virus , hbsag, anti-hepatitis b core antigen, or other active infection uncontrolled by treatment
boolean
C0220847 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2])
C0312631 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Abstinence donating blood | Investigational New Drugs Therapeutic procedure
Item
agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
boolean
C3843422 (UMLS CUI [1,1])
C0425264 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Sharing Investigational New Drugs | Return to investigator Investigational New Drugs Not used
Item
agree not to share study medication with another person and to return all unused study drug to the investigator
boolean
C0237876 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332156 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0445107 (UMLS CUI [2,4])
Informed Consent
Item
written informed concent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorders Compliance behavior Limited
Item
psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
nervous system disorder Interferes with Study Protocol | Neuropsychiatric syndrome Interferes with Study Protocol
Item
neurological or neuropsychiatric disorder, interfering with the requirements of the study
boolean
C0027765 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C3203509 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
hearing impairment
Item
hearing impairment over grade 2
boolean
C1384666 (UMLS CUI [1])
Porphyria
Item
porphyria
boolean
C3463940 (UMLS CUI [1])
Hepatitis
Item
history of acute or chronic hepatitis
boolean
C0019158 (UMLS CUI [1])
FH: Hepatitis Drug-Induced Hepatitis Severe
Item
family history of severe drug-induced hepatitis
boolean
C0559141 (UMLS CUI [1,1])
C1262760 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnancy and lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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