ID

32563

Descripción

The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01797913

Link

https://clinicaltrials.gov/show/NCT01797913

Palabras clave

Versiones (1)
  1. 6/11/18 6/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

6 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer NCT01797913

Inglés

Eligibility THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer NCT01797913

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
18~75 years patients who were diagnosed by the histologic, cytologic diagnosis of iiib-iv non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,sd or pr,the cr patients should accept 6 course of combination chemotherapy.
Descripción

Age | Non-Small Cell Lung Carcinoma TNM clinical staging | Combination Chemotherapy Platinum-Based | Stable Disease | Partial response | In complete remission

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C1521750
UMLS CUI [3,2]
C1514162
UMLS CUI [4]
C0677946
UMLS CUI [5]
C1521726
UMLS CUI [6]
C0677874
3~8 weeks after patients complete first line chemotherapy(include radiotherapy) ecog0-2 expected life time longer than 3 monthes
Descripción

First line Chemotherapy Complete | Therapeutic radiology procedure Complete | ECOG performance status | Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C1520224
UMLS CUI [4]
C0023671
normal laboratory values:
Descripción

Normal Laboratory Test Result

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438214
leucocyte ≥ 4×109/l
Descripción

White Blood Cell Count procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
neutrophil ≥ 1.5×109/l
Descripción

Neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
platelet ≥ 100×109/l
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 10g/l
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
alt and
Descripción

Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
ast ≤ 2.5×uln (≤ 5×uln if liver metastasis) signed written informed consent
Descripción

Aspartate aminotransferase measurement | Relationship Secondary malignant neoplasm of liver | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0494165
UMLS CUI [3]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients have used drugs according to protocol
Descripción

Pharmaceutical Preparations Consistent with Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C2348563
uncontrolled infection of bacterial or virus or fungal
Descripción

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
patients with other malignant tumor
Descripción

Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
uncontrolled brain metastases
Descripción

Metastatic malignant neoplasm to brain Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
female patients during their pregnant and lactation period, or patients without contracep
Descripción

Pregnancy | Breast Feeding | Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197
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Similar models

Eligibility THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer NCT01797913

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Non-Small Cell Lung Carcinoma TNM clinical staging | Combination Chemotherapy Platinum-Based | Stable Disease | Partial response | In complete remission
Item
18~75 years patients who were diagnosed by the histologic, cytologic diagnosis of iiib-iv non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,sd or pr,the cr patients should accept 6 course of combination chemotherapy.
boolean
C0001779 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C1521750 (UMLS CUI [3,1])
C1514162 (UMLS CUI [3,2])
C0677946 (UMLS CUI [4])
C1521726 (UMLS CUI [5])
C0677874 (UMLS CUI [6])
First line Chemotherapy Complete | Therapeutic radiology procedure Complete | ECOG performance status | Life Expectancy
Item
3~8 weeks after patients complete first line chemotherapy(include radiotherapy) ecog0-2 expected life time longer than 3 monthes
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1520224 (UMLS CUI [3])
C0023671 (UMLS CUI [4])
Normal Laboratory Test Result
Item
normal laboratory values:
boolean
C0438214 (UMLS CUI [1])
White Blood Cell Count procedure
Item
leucocyte ≥ 4×109/l
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
neutrophil ≥ 1.5×109/l
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet ≥ 100×109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 10g/l
boolean
C0518015 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alt and
boolean
C0201836 (UMLS CUI [1])
Aspartate aminotransferase measurement | Relationship Secondary malignant neoplasm of liver | Informed Consent
Item
ast ≤ 2.5×uln (≤ 5×uln if liver metastasis) signed written informed consent
boolean
C0201899 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0494165 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Consistent with Study Protocol
Item
patients have used drugs according to protocol
boolean
C0013227 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled
Item
uncontrolled infection of bacterial or virus or fungal
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Cancer Other
Item
patients with other malignant tumor
boolean
C1707251 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Uncontrolled
Item
uncontrolled brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Contraceptive methods Absent
Item
female patients during their pregnant and lactation period, or patients without contracep
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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