ID

32563

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01797913

Nyckelord

Versioner (1)
  1. 2018-11-06 2018-11-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 november 2018

DOI

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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

Engelsk

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

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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:
Beskrivning

Normal Laboratory Test Result

Datatyp

boolean

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

White Blood Cell Count procedure

Datatyp

boolean

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

Neutrophil count

Datatyp

boolean

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

Platelet Count measurement

Datatyp

boolean

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

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
alt and
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

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

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

Datatyp

boolean

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

Exclusion Criteria

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

Pharmaceutical Preparations Consistent with Study Protocol

Datatyp

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
Beskrivning

Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled

Datatyp

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
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
uncontrolled brain metastases
Beskrivning

Metastatic malignant neoplasm to brain Uncontrolled

Datatyp

boolean

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

Pregnancy | Breast Feeding | Contraceptive methods Absent

Datatyp

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

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