ID

31186

Beskrivning

Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00888511

Länk

https://clinicaltrials.gov/show/NCT00888511

Nyckelord

Versioner (1)
  1. 2018-07-25 2018-07-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00888511

Engelsk

Eligibility Non-small Cell Lung Cancer NCT00888511

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with histologically or cytologically documented diagnosis locally advanced nsclc stage iib to iiib without pleural effusion
Beskrivning

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Pleural effusion Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0032227
UMLS CUI [2,2]
C0332197
performance status ≤2 on the ecog scale
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
serum bilirubin must be ≤1.5 upper limit of normal (uln)
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
alat ≤2 x uln
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
able to comply with study and follow-up procedures
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
patients with reproductive potential must use effective contraception
Beskrivning

Females & males of reproductive potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
written (signed) informed consent to participate in the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
Beskrivning

Systemic disease Unstable | Communicable Disease | Angina, Unstable | Congestive heart failure | Liver disease Severe | Kidney Disease Severe | Metabolic Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0025517
UMLS CUI [7,2]
C0205082
any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
Beskrivning

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
inability to take oral medication, or requirement of intravenous alimentation
Beskrivning

Lacking Able to swallow Oral medication | Requirement Intravenous Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0021910
nursing mothers
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00888511

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Pleural effusion Absent
Item
patients with histologically or cytologically documented diagnosis locally advanced nsclc stage iib to iiib without pleural effusion
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0032227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
performance status ≤2 on the ecog scale
boolean
C1520224 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin must be ≤1.5 upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alat ≤2 x uln
boolean
C0201836 (UMLS CUI [1])
Protocol Compliance
Item
able to comply with study and follow-up procedures
boolean
C0525058 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
patients with reproductive potential must use effective contraception
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
written (signed) informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic disease Unstable | Communicable Disease | Angina, Unstable | Congestive heart failure | Liver disease Severe | Kidney Disease Severe | Metabolic Disease Severe
Item
any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0025517 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Lacking Able to swallow Oral medication | Requirement Intravenous Feeding
Item
inability to take oral medication, or requirement of intravenous alimentation
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0021910 (UMLS CUI [2,2])
Breast Feeding
Item
nursing mothers
boolean
C0006147 (UMLS CUI [1])
Tillbaka till toppen 

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