ID

12647

Descrição

Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT); ODM derived from: https://clinicaltrials.gov/show/NCT01339988

Link

https://clinicaltrials.gov/show/NCT01339988

Palavras-chave

Versões (1)
  1. 07/12/2015 07/12/2015 -
Transferido a

7 de dezembro de 2015

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Acute Leukemias NCT01339988

Inglês

Eligibility Acute Leukemias NCT01339988

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
suitable cord blood from matched unrelated or related donor.
Descrição

suitable cord blood from matched unrelated or related donor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3653065
cardiac (echo/ekg): shortening fraction ≥ 27 percent
Descrição

cardiac (echo/ekg): shortening fraction ≥ 27 percent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1335957
electrolytes within normal cchmc limits.
Descrição

electrolytes within normal cchmc limits

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438240
pulmonary function tests: dlco ≥ 50%
Descrição

pulmonary function tests

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024119
renal: creatinine clearance/gfr ≥ 60 ml/minute/1.73m2
Descrição

creatinine clearance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0373595
lumbar puncture: no leukemic infiltrate.
Descrição

lumbar puncture

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0037943
cbc: anc ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml
Descrição

cbc: anc ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
documented hsv and cmv titers, hepatitis b surface antigen, hepatitis c by serology, hiv by serology: all negative.
Descrição

documented hsv and cmv titers, hepatitis b surface antigen, hepatitis c by serology, hiv by serology: all negative.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
hepatic transaminases < 2.5x normal; total bilirubin < 2 mg/dl patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with program director of blood and marrow transplant
Descrição

hepatic transaminases < 2.5x normal; total bilirubin < 2 mg/dl patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with program director of blood and marrow transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1848701
UMLS CUI [2]
C0201913
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen.
Descrição

patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals. patients on prolonged antifungal therapy with a history of fungal infection should be considered for a non-myeloablative protocol.
Descrição

patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
patients who are pregnant or lactating. patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.
Descrição

patients who are pregnant or lactating. patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
UMLS CUI [3]
C0700589
hiv seropositive patients
Descrição

hiv seropositive patients

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Acute Leukemias NCT01339988

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
suitable cord blood from matched unrelated or related donor
Item
suitable cord blood from matched unrelated or related donor.
boolean
C3653065 (UMLS CUI [1])
cardiac (echo/ekg): shortening fraction ≥ 27 percent
Item
cardiac (echo/ekg): shortening fraction ≥ 27 percent
boolean
C1335957 (UMLS CUI [1])
electrolytes within normal cchmc limits
Item
electrolytes within normal cchmc limits.
boolean
C0438240 (UMLS CUI [1])
pulmonary function tests
Item
pulmonary function tests: dlco ≥ 50%
boolean
C0024119 (UMLS CUI [1])
creatinine clearance
Item
renal: creatinine clearance/gfr ≥ 60 ml/minute/1.73m2
boolean
C0373595 (UMLS CUI [1])
lumbar puncture
Item
lumbar puncture: no leukemic infiltrate.
boolean
C0037943 (UMLS CUI [1])
cbc: anc ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml
Item
cbc: anc ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
documented hsv and cmv titers, hepatitis b surface antigen, hepatitis c by serology, hiv by serology: all negative.
Item
documented hsv and cmv titers, hepatitis b surface antigen, hepatitis c by serology, hiv by serology: all negative.
boolean
C0009450 (UMLS CUI [1])
hepatic transaminases < 2.5x normal; total bilirubin < 2 mg/dl patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with program director of blood and marrow transplant
Item
hepatic transaminases < 2.5x normal; total bilirubin < 2 mg/dl patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with program director of blood and marrow transplant
boolean
C1848701 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen
Item
patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen.
boolean
C0009488 (UMLS CUI [1])
patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals
Item
patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals. patients on prolonged antifungal therapy with a history of fungal infection should be considered for a non-myeloablative protocol.
boolean
C0009450 (UMLS CUI [1])
patients who are pregnant or lactating. patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.
Item
patients who are pregnant or lactating. patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
hiv seropositive patients
Item
hiv seropositive patients
boolean
C0019699 (UMLS CUI [1])
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