ID

31046

Descrição

A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00680940

Link

https://clinicaltrials.gov/show/NCT00680940

Palavras-chave

Versões (1)
  1. 13/07/2018 13/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

13 de julho de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Non Small Cell Lung Cancer NCT00680940

Inglês

Eligibility Non Small Cell Lung Cancer NCT00680940

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to understand and the willingness to sign a written informed consent document.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
histologically or cytologically confirmed non-small cell cancer, stage iiib or iv.
Descrição

Non-Small Cell Lung Carcinoma TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
age should be 18 years or above.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog should be in 0-1 range.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count ≥ 1,00,000/mm3
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin ≥ 9.0g/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
ast and alt ≤ 2.5 times upper limit of normal (uln)range of institution (5times uln if liver metastasis present).
Descrição

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
bilirubin not greater than 1.5 times uln range of institution (3 times uln if liver involvement).
Descrição

Serum total bilirubin measurement | Relationship Involvement with Liver

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0023884
creatinine ≤ upper limit of normal (uln) range of institution.
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
negative pregnancy test for women of child bearing potential prior to entry into the trial.
Descrição

Childbearing Potential Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
Descrição

Cytotoxic Chemotherapy | Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C1522449
patient with systematic brain metastasis.
Descrição

Metastatic malignant neoplasm to brain systematic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0220922
history of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients.
Descrição

Paclitaxel allergy | Cisplatin allergy | Allergic Reaction Mycobacterium w | Allergic Reaction Paclitaxel Ingredient | Allergic Reaction Cisplatin Ingredient | Allergic Reaction Mycobacterium w Ingredient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2]
C0570702
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1940778
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0144576
UMLS CUI [4,3]
C1550600
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0008838
UMLS CUI [5,3]
C1550600
UMLS CUI [6,1]
C1527304
UMLS CUI [6,2]
C1940778
UMLS CUI [6,3]
C1550600
pregnant women or nursing women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
uncontrolled intercurrent illness that would limit compliance with study requirements.
Descrição

Comorbidity Uncontrolled | Protocol Compliance Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0439801
hiv positive patients.
Descrição

HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
previous splenectomy.
Descrição

Splenectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0037995
Voltar ao início da página

Similar models

Eligibility Non Small Cell Lung Cancer NCT00680940

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically or cytologically confirmed non-small cell cancer, stage iiib or iv.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
age should be 18 years or above.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog should be in 0-1 range.
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 1,00,000/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 9.0g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
ast and alt ≤ 2.5 times upper limit of normal (uln)range of institution (5times uln if liver metastasis present).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Serum total bilirubin measurement | Relationship Involvement with Liver
Item
bilirubin not greater than 1.5 times uln range of institution (3 times uln if liver involvement).
boolean
C1278039 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
Creatinine measurement, serum
Item
creatinine ≤ upper limit of normal (uln) range of institution.
boolean
C0201976 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for women of child bearing potential prior to entry into the trial.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy | Therapeutic radiology procedure
Item
patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study
boolean
C0677881 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Metastatic malignant neoplasm to brain systematic
Item
patient with systematic brain metastasis.
boolean
C0220650 (UMLS CUI [1,1])
C0220922 (UMLS CUI [1,2])
Paclitaxel allergy | Cisplatin allergy | Allergic Reaction Mycobacterium w | Allergic Reaction Paclitaxel Ingredient | Allergic Reaction Cisplatin Ingredient | Allergic Reaction Mycobacterium w Ingredient
Item
history of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients.
boolean
C0570707 (UMLS CUI [1])
C0570702 (UMLS CUI [2])
C1527304 (UMLS CUI [3,1])
C1940778 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0144576 (UMLS CUI [4,2])
C1550600 (UMLS CUI [4,3])
C1527304 (UMLS CUI [5,1])
C0008838 (UMLS CUI [5,2])
C1550600 (UMLS CUI [5,3])
C1527304 (UMLS CUI [6,1])
C1940778 (UMLS CUI [6,2])
C1550600 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
pregnant women or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Uncontrolled | Protocol Compliance Limited
Item
uncontrolled intercurrent illness that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
HIV Seropositivity
Item
hiv positive patients.
boolean
C0019699 (UMLS CUI [1])
Splenectomy
Item
previous splenectomy.
boolean
C0037995 (UMLS CUI [1])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial