ID

43778

Descrição

Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01382147

Link

https://clinicaltrials.gov/show/NCT01382147

Palavras-chave

Versões (2)
  1. 07/03/2016 07/03/2016 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01382147

Inglês

Eligibility Acute Myeloid Leukemia NCT01382147

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with newly diagnosed aml (except acute promyelocytic leukemia) according to the who classification including patients with secondary aml and aml after preceding hematologic disorders
Descrição

aml de novo

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
age 18 years or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
informed consent. before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute promyelocytic leukemia (apl)
Descrição

APL

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023487
previous or concurrent malignancies other than aml
Descrição

previous or concurrent malignancies

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205420
previous treatment with colony-stimulating factors, interleukins or interferons
Descrição

colony stimulating factor, interleukins or interferons

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009392
UMLS CUI [2]
C0021764
UMLS CUI [3]
C0021747
known hypersensitivity to escherichia coli derived products (e.g. filgrastim, humulin® insulin, l-asparaginase, humatrope® growth hormone, intron a®)
Descrição

hypersensitivity to escherichia coli derived products

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014834
antibody-based or cell-based immunotherapies
Descrição

immunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021083
respiratory insufficiency with po2 <60 mmhg
Descrição

respiratory insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035229
UMLS CUI [2]
C0202155
heart failure nyha iii° or iv°
Descrição

heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1275491
elevated creatinine >2.0 mg/dl
Descrição

creatinine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
elevated bilirubin >2.0 mg/dl
Descrição

bilirubin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
pregnancy or lactation
Descrição

pregnancy or lactation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
females without adequate contraception
Descrição

contraception females

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0086287
known hiv and/or hepatitis c infection
Descrição

hiv and/or hepatitis c

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0019196
severe neurologic or psychiatric disease
Descrição

severe neurologic or psychiatric disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study
Descrição

disorder limiting informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
concerns for subject's compliance with the protocol procedures
Descrição

compliance behavior

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
lack of willingness to record and circulate personal disease-related informations defined in the study protocol
Descrição

compliance behaviour

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Acute Myeloid Leukemia NCT01382147

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
aml de novo
Item
patients with newly diagnosed aml (except acute promyelocytic leukemia) according to the who classification including patients with secondary aml and aml after preceding hematologic disorders
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
informed consent. before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL
Item
acute promyelocytic leukemia (apl)
boolean
C0023487 (UMLS CUI [1])
previous or concurrent malignancies
Item
previous or concurrent malignancies other than aml
boolean
C2735088 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
colony stimulating factor, interleukins or interferons
Item
previous treatment with colony-stimulating factors, interleukins or interferons
boolean
C0009392 (UMLS CUI [1])
C0021764 (UMLS CUI [2])
C0021747 (UMLS CUI [3])
hypersensitivity to escherichia coli derived products
Item
known hypersensitivity to escherichia coli derived products (e.g. filgrastim, humulin® insulin, l-asparaginase, humatrope® growth hormone, intron a®)
boolean
C0020517 (UMLS CUI [1,1])
C0014834 (UMLS CUI [1,2])
immunotherapy
Item
antibody-based or cell-based immunotherapies
boolean
C0021083 (UMLS CUI [1])
respiratory insufficiency
Item
respiratory insufficiency with po2 <60 mmhg
boolean
C0035229 (UMLS CUI [1])
C0202155 (UMLS CUI [2])
heart failure
Item
heart failure nyha iii° or iv°
boolean
C1275491 (UMLS CUI [1])
creatinine
Item
elevated creatinine >2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
elevated bilirubin >2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
pregnancy or lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
contraception females
Item
females without adequate contraception
boolean
C0700589 (UMLS CUI [1])
C0086287 (UMLS CUI [2])
hiv and/or hepatitis c
Item
known hiv and/or hepatitis c infection
boolean
C0019682 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
severe neurologic or psychiatric disease
Item
severe neurologic or psychiatric disease
boolean
C0009488 (UMLS CUI [1])
disorder limiting informed consent
Item
psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
compliance behavior
Item
concerns for subject's compliance with the protocol procedures
boolean
C1321605 (UMLS CUI [1])
compliance behaviour
Item
lack of willingness to record and circulate personal disease-related informations defined in the study protocol
boolean
C1321605 (UMLS CUI [1])
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