ID

13580

Description

All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00151255

Link

https://clinicaltrials.gov/show/NCT00151255

Keywords

Versions (1)
  1. 2/17/16 2/17/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 17, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00151255

English

Eligibility Acute Myeloid Leukemia NCT00151255

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed aml defined according to the world health organization (who) classification (excluding acute promyelocytic leukemia [apl])
Description

newly diagnosed aml defined according to the world health organization (who) classification (excluding acute promyelocytic leukemia [apl])

Data type

boolean

Alias
UMLS CUI [1]
C0023467
aged > 60 years
Description

aged > 60 years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
all patients have to be informed about the character of the study. written informed consent of each patient at study entry.
Description

all patients have to be informed about the character of the study. written informed consent of each patient at study entry.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.
Description

molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.

Data type

boolean

Alias
UMLS CUI [1]
C2121080
UMLS CUI [2]
C0010802
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bleeding independent of the aml
Description

bleeding independent of the aml

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0023467
acute promyelocytic leukemia
Description

acute promyelocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
uncontrolled infection
Description

uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
participation in a concurrent clinical study
Description

participation in a concurrent clinical study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, ast or ap > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure new york heart association [nyha] iii/iv
Description

insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, ast or ap > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure new york heart association [nyha] iii/iv

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0035204
UMLS CUI [6]
C1275491
severe neurological or psychiatric disorder interfering with ability of giving informed consent
Description

severe neurological or psychiatric disorder interfering with ability of giving informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
no consent for the registration, storage and processing of data concerning the characteristics of the aml and the individual course
Description

no consent for the registration, storage and processing of data concerning the characteristics of the aml and the individual course

Data type

boolean

Alias
UMLS CUI [1]
C0021430
performance status who > 2
Description

performance status who > 2

Data type

boolean

Alias
UMLS CUI [1]
C1298650
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Similar models

Eligibility Acute Myeloid Leukemia NCT00151255

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
newly diagnosed aml defined according to the world health organization (who) classification (excluding acute promyelocytic leukemia [apl])
boolean
C0023467 (UMLS CUI [1])
Age
Item
aged > 60 years
boolean
C0001779 (UMLS CUI [1])
written informed consent
Item
all patients have to be informed about the character of the study. written informed consent of each patient at study entry.
boolean
C0021430 (UMLS CUI [1])
molecular and cytogenetical analyses
Item
molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.
boolean
C2121080 (UMLS CUI [1])
C0010802 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
bleeding independent of the aml
Item
bleeding independent of the aml
boolean
C0019080 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
acute promyelocytic leukemia
Item
acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
uncontrolled infection
Item
uncontrolled infection
boolean
C0009488 (UMLS CUI [1])
participation in a concurrent clinical study
Item
participation in a concurrent clinical study
boolean
C2348568 (UMLS CUI [1])
organ function
Item
insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, ast or ap > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure new york heart association [nyha] iii/iv
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C1275491 (UMLS CUI [6])
severe neurological or psychiatric disorder interfering with ability of giving informed consent
Item
severe neurological or psychiatric disorder interfering with ability of giving informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
no consent
Item
no consent for the registration, storage and processing of data concerning the characteristics of the aml and the individual course
boolean
C0021430 (UMLS CUI [1])
performance status who
Item
performance status who > 2
boolean
C1298650 (UMLS CUI [1])
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