ID

28063

Description

Study of Efficacy and Safety of Valproic Acid in Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT00810680

Link

https://clinicaltrials.gov/show/NCT00810680

Keywords

  1. 12/13/17 12/13/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 13, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Chronic Lymphocytic Leukemia NCT00810680

Eligibility Chronic Lymphocytic Leukemia NCT00810680

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
active cll (as defined by the national cancer institute working group)
Description

Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023434
patients must have received at least one prior therapy for cll and have been treated with a nucleoside analogue.
Description

Prior Therapy Quantity Chronic Lymphocytic Leukemia | Nucleoside Analogs

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023434
UMLS CUI [2]
C1579410
age 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
good general condition as defined by an eastern cooperative oncology group-
Description

General health good

Data type

boolean

Alias
UMLS CUI [1]
C1277245
performance status (ecog-ps) </=2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count>1500/cmm and platelet count >30,000/cmm unless the low counts are due to the disease.
Description

Absolute neutrophil count | Platelet Count measurement | Exception Count Due to Disease

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0750480
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0012634
adequate liver function (bilirubin<2 mg/dl,astoralt <3xthe upper limit of normal) and renal function (serum creatinine<2 mg/dl or creatinine clearance>30 ml/min) unless abnormalities are as a result of disease involvement.
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Exception Abnormality Due to Disease

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0373595
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C1704258
UMLS CUI [8,3]
C0678226
UMLS CUI [8,4]
C0012634
full recovery from previous treatments.
Description

Prior Therapy Recovery

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2004454
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any therapy for cll within 4 weeks before initiating treatment on this study.
Description

Therapeutic procedure Recent CLL

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0023434
pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00810680

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia
Item
active cll (as defined by the national cancer institute working group)
boolean
C0023434 (UMLS CUI [1])
Prior Therapy Quantity Chronic Lymphocytic Leukemia | Nucleoside Analogs
Item
patients must have received at least one prior therapy for cll and have been treated with a nucleoside analogue.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C1579410 (UMLS CUI [2])
Age
Item
age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
General health good
Item
good general condition as defined by an eastern cooperative oncology group-
boolean
C1277245 (UMLS CUI [1])
ECOG performance status
Item
performance status (ecog-ps) </=2.
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Exception Count Due to Disease
Item
absolute neutrophil count>1500/cmm and platelet count >30,000/cmm unless the low counts are due to the disease.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0750480 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0012634 (UMLS CUI [3,4])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Exception Abnormality Due to Disease
Item
adequate liver function (bilirubin<2 mg/dl,astoralt <3xthe upper limit of normal) and renal function (serum creatinine<2 mg/dl or creatinine clearance>30 ml/min) unless abnormalities are as a result of disease involvement.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C1704258 (UMLS CUI [8,2])
C0678226 (UMLS CUI [8,3])
C0012634 (UMLS CUI [8,4])
Prior Therapy Recovery
Item
full recovery from previous treatments.
boolean
C1514463 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Recent CLL
Item
any therapy for cll within 4 weeks before initiating treatment on this study.
boolean
C0087111 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])

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