ID

17870

Descripción

Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00323557

Link

https://clinicaltrials.gov/show/NCT00323557

Palabras clave

Versiones (1)
  1. 6/10/16 6/10/16 -
Subido en

6 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukemia NCT00323557

Inglés

Eligibility Leukemia NCT00323557

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00323557
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1) patients in complete / partial remission or those with active chronic lymphocytic leukemia (cll) with rai stage 0 to 4.
Descripción

In complete remission | partial response | Chronic Lymphocytic Leukemia | Rai Staging System

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C1521726
UMLS CUI [3]
C0023434
UMLS CUI [4]
C1514715
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients will not be entered while neutropenic (pmns < 500 cells/mm3) or having received rituximab within 6 months.
Descripción

Neutropenia | Polymorphonuclear leukocyte count | rituximab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C1271714
UMLS CUI [3]
C0393022
2. patients will not be entered while febrile (temperature > 38 degrees c) within 1 week.
Descripción

Fever | Body temperature measurement degrees Celsius

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2,1]
C0886414
UMLS CUI [2,2]
C0439237
3. active infection.
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
4. patients with known human immunodeficiency virus (hiv) infection.
Descripción

HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
5. known history of allergy to granulocyte/ macrophage colony stimulating factor (gm-csf) or pneumococcal vaccine.
Descripción

Hypersensitivity Granulocyte-Macrophage Colony-Stimulating Factor | Hypersensitivity Pneumococcal vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0079460
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0358314
6. chemotherapy other than campath, fludarabine, cyclophosphamide, in 4 weeks.
Descripción

Chemotherapy | Campath | fludarabine | Cyclophosphamide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0939276
UMLS CUI [3]
C0059985
UMLS CUI [4]
C0010583
7. patients who have previously received pneumococcal vaccine within the preceding 12 months.
Descripción

Pneumococcal vaccine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0358314
8. absolute lymphocyte count less than 500 cells/mm3.
Descripción

Absolute lymphocyte count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3544087
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Similar models

Eligibility Leukemia NCT00323557

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00323557
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
In complete remission | partial response | Chronic Lymphocytic Leukemia | Rai Staging System
Item
1) patients in complete / partial remission or those with active chronic lymphocytic leukemia (cll) with rai stage 0 to 4.
boolean
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C0023434 (UMLS CUI [3])
C1514715 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Neutropenia | Polymorphonuclear leukocyte count | rituximab
Item
1. patients will not be entered while neutropenic (pmns < 500 cells/mm3) or having received rituximab within 6 months.
boolean
C0027947 (UMLS CUI [1])
C1271714 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
Fever | Body temperature measurement degrees Celsius
Item
2. patients will not be entered while febrile (temperature > 38 degrees c) within 1 week.
boolean
C0015967 (UMLS CUI [1])
C0886414 (UMLS CUI [2,1])
C0439237 (UMLS CUI [2,2])
Communicable Disease
Item
3. active infection.
boolean
C0009450 (UMLS CUI [1])
HIV Infection
Item
4. patients with known human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Hypersensitivity Granulocyte-Macrophage Colony-Stimulating Factor | Hypersensitivity Pneumococcal vaccine
Item
5. known history of allergy to granulocyte/ macrophage colony stimulating factor (gm-csf) or pneumococcal vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0079460 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0358314 (UMLS CUI [2,2])
Chemotherapy | Campath | fludarabine | Cyclophosphamide
Item
6. chemotherapy other than campath, fludarabine, cyclophosphamide, in 4 weeks.
boolean
C0392920 (UMLS CUI [1])
C0939276 (UMLS CUI [2])
C0059985 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
Pneumococcal vaccine
Item
7. patients who have previously received pneumococcal vaccine within the preceding 12 months.
boolean
C0358314 (UMLS CUI [1])
Absolute lymphocyte count
Item
8. absolute lymphocyte count less than 500 cells/mm3.
boolean
C3544087 (UMLS CUI [1])
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