ID

31046

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00680940

Nyckelord

Versioner (1)
  1. 2018-07-13 2018-07-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 juli 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Non Small Cell Lung Cancer NCT00680940

Engelsk

Eligibility Non Small Cell Lung Cancer NCT00680940

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Informed Consent

Datatyp

boolean

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

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

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

Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Absolute neutrophil count

Datatyp

boolean

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

Hemoglobin measurement

Datatyp

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).
Beskrivning

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

Datatyp

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).
Beskrivning

Serum total bilirubin measurement | Relationship Involvement with Liver

Datatyp

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.
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

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

Childbearing Potential Pregnancy test negative

Datatyp

boolean

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

Exclusion Criteria

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

Cytotoxic Chemotherapy | Therapeutic radiology procedure

Datatyp

boolean

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

Metastatic malignant neoplasm to brain systematic

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Comorbidity Uncontrolled | Protocol Compliance Limited

Datatyp

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.
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
previous splenectomy.
Beskrivning

Splenectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0037995
Tillbaka till toppen

Similar models

Eligibility Non Small Cell Lung Cancer NCT00680940

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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