ID

44086

Beschrijving

Capecitabine to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection; ODM derived from: https://clinicaltrials.gov/show/NCT00561522

Link

https://clinicaltrials.gov/show/NCT00561522

Trefwoorden

Versies (2)
  1. 19-04-18 19-04-18 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00561522

Engels

Eligibility Hepatocellular Carcinoma NCT00561522

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
first curative hepatic resection
Beschrijving

Liver resection Curative First

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019144
UMLS CUI [1,2]
C1276305
UMLS CUI [1,3]
C0205435
hepatocellular carcinoma (histologically confirmed)
Beschrijving

Liver carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C2239176
cirrhosis of child-pugh class a or b
Beschrijving

Liver Cirrhosis Child-Pugh Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C4050412
a performance status ≤ 2
Beschrijving

Performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
adequate bone marrow ,hepatic and renal functions (white blood cell (wbc) count > 2.5×10^3/μl, platelet count > 40×10^3/μl, a serum bilirubin level, alanine aminotransferase (alt) and aspartate transaminase (ast) ≤ 2 times the upper limit of the normal value, and serum creatinine level < 1.5 mg/dl)
Beschrijving

Bone Marrow function | Liver function | Renal function | White Blood Cell Count procedure | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0032181
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201976
major organ (heart, lung and brain) function was normal
Beschrijving

Organ major function | Cardiac function | Pulmonary function | Brain function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0031843
UMLS CUI [2]
C0232164
UMLS CUI [3]
C0231921
UMLS CUI [4]
C0678908
an age between 18 and 79 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any active infectious process
Beschrijving

Infectious process

Datatype

boolean

Alias
UMLS CUI [1]
C0745283
known hypersensitivity to capecitabine
Beschrijving

Hypersensitivity Capecitabine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0671970
the presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein or the main bile duct
Beschrijving

Neoplasm Metastasis Extrahepatic | Tumor Thrombus Inferior vena cava | Tumor Thrombus Portal vein | Tumor Thrombus Bile duct

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0087086
UMLS CUI [2,3]
C0042458
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0087086
UMLS CUI [3,3]
C1305775
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C0087086
UMLS CUI [4,3]
C0005400
other previous or synchronous malignant disorders
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
postoperative dysfunction of any organ.
Beschrijving

Organ dysfunction Postoperative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0032790
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Similar models

Eligibility Hepatocellular Carcinoma NCT00561522

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Liver resection Curative First
Item
first curative hepatic resection
boolean
C0019144 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Liver carcinoma
Item
hepatocellular carcinoma (histologically confirmed)
boolean
C2239176 (UMLS CUI [1])
Liver Cirrhosis Child-Pugh Classification
Item
cirrhosis of child-pugh class a or b
boolean
C0023890 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Performance status
Item
a performance status ≤ 2
boolean
C1518965 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | White Blood Cell Count procedure | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
adequate bone marrow ,hepatic and renal functions (white blood cell (wbc) count > 2.5×10^3/μl, platelet count > 40×10^3/μl, a serum bilirubin level, alanine aminotransferase (alt) and aspartate transaminase (ast) ≤ 2 times the upper limit of the normal value, and serum creatinine level < 1.5 mg/dl)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
Organ major function | Cardiac function | Pulmonary function | Brain function
Item
major organ (heart, lung and brain) function was normal
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0232164 (UMLS CUI [2])
C0231921 (UMLS CUI [3])
C0678908 (UMLS CUI [4])
Age
Item
an age between 18 and 79 years.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Infectious process
Item
any active infectious process
boolean
C0745283 (UMLS CUI [1])
Hypersensitivity Capecitabine
Item
known hypersensitivity to capecitabine
boolean
C0020517 (UMLS CUI [1,1])
C0671970 (UMLS CUI [1,2])
Neoplasm Metastasis Extrahepatic | Tumor Thrombus Inferior vena cava | Tumor Thrombus Portal vein | Tumor Thrombus Bile duct
Item
the presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein or the main bile duct
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0087086 (UMLS CUI [2,2])
C0042458 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C0087086 (UMLS CUI [3,2])
C1305775 (UMLS CUI [3,3])
C0027651 (UMLS CUI [4,1])
C0087086 (UMLS CUI [4,2])
C0005400 (UMLS CUI [4,3])
Cancer Other
Item
other previous or synchronous malignant disorders
boolean
C1707251 (UMLS CUI [1])
Organ dysfunction Postoperative
Item
postoperative dysfunction of any organ.
boolean
C0349410 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
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