ID

29772

Beschrijving

Study of Thymopentin in Patients After Curative Resection of Small Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00460681

Link

https://clinicaltrials.gov/show/NCT00460681

Trefwoorden

Versies (1)
  1. 19-04-18 19-04-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 april 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00460681

Engels

Eligibility Hepatocellular Carcinoma NCT00460681

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who received curative resection of hbv-related small hcc (pathologically proved, solitary tumour <5cm, or two/ tumours <5cm)
Beschrijving

Excision Curative Liver carcinoma Small | Liver carcinoma Relationship Hepatitis B Virus | Single tumor Size | Neoplasms Quantity Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C1276305
UMLS CUI [1,3]
C2239176
UMLS CUI [1,4]
C0700321
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0019169
UMLS CUI [3,1]
C1298180
UMLS CUI [3,2]
C0456389
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0456389
curative resection was defined as (1) the complete resection of all tumor nodules and the cut surface being free of cancer by histological examination; (2) no macroscopic cancerous thrombus was found in the portal vein (main trunk or two major branches), hepatic veins or bile duct, (3) no extrahepatic metastasis was found
Beschrijving

Complete excision Neoplasm Nodules | Absence Cancer Thrombus Portal vein | Absence Cancer Thrombus Hepatic vein | Absence Cancer Thrombus Bile duct | Absence Neoplasm Metastasis Extrahepatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015250
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C0028259
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0087086
UMLS CUI [2,4]
C1305775
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0087086
UMLS CUI [3,4]
C0019155
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C0087086
UMLS CUI [4,4]
C0005400
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0027627
UMLS CUI [5,3]
C1517058
evidence of a positive serum hbv profile but a negative test for anti-hcv antibody
Beschrijving

Hepatitis B Virus Serology positive | Hepatitis C antibody test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019169
UMLS CUI [1,2]
C0242089
UMLS CUI [2]
C1277806
the major organ (heart, liver,lung and kidney) function was normal
Beschrijving

Organ Major function | Cardiac function | Liver function | Pulmonary function | Renal 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]
C0232741
UMLS CUI [4]
C0231921
UMLS CUI [5]
C0232804
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiac disease
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
active clinically serious infection
Beschrijving

Communicable Disease Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
known history of human immunodeficiency virus (hiv) infection
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
pregnant or breast-feeding patients
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior use of any systemic anti-cancer treatment for hcc, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). antiviral treatment is allowed, however interferon therapy must at least 4 weeks prior randomization
Beschrijving

Cancer treatment Systemic Liver carcinoma | Chemotherapy | Immunotherapy | Hormone Therapy | Exception Hormone Therapy Supportive care allowed | Antiviral Therapy allowed | Interferon therapy Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C2239176
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0279025
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0279025
UMLS CUI [5,3]
C0344211
UMLS CUI [5,4]
C0683607
UMLS CUI [6,1]
C0280274
UMLS CUI [6,2]
C0683607
UMLS CUI [7,1]
C0279030
UMLS CUI [7,2]
C1444662
any condition that is unstable or which could jeopardize the safety of the patient and his / her compliance in the study
Beschrijving

Condition Unstable | Condition compromises Patient safety | Condition compromises Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0525058
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Similar models

Eligibility Hepatocellular Carcinoma NCT00460681

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Excision Curative Liver carcinoma Small | Liver carcinoma Relationship Hepatitis B Virus | Single tumor Size | Neoplasms Quantity Size
Item
patients who received curative resection of hbv-related small hcc (pathologically proved, solitary tumour <5cm, or two/ tumours <5cm)
boolean
C0728940 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0700321 (UMLS CUI [1,4])
C2239176 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0019169 (UMLS CUI [2,3])
C1298180 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0027651 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0456389 (UMLS CUI [4,3])
Complete excision Neoplasm Nodules | Absence Cancer Thrombus Portal vein | Absence Cancer Thrombus Hepatic vein | Absence Cancer Thrombus Bile duct | Absence Neoplasm Metastasis Extrahepatic
Item
curative resection was defined as (1) the complete resection of all tumor nodules and the cut surface being free of cancer by histological examination; (2) no macroscopic cancerous thrombus was found in the portal vein (main trunk or two major branches), hepatic veins or bile duct, (3) no extrahepatic metastasis was found
boolean
C0015250 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0028259 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0087086 (UMLS CUI [2,3])
C1305775 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0087086 (UMLS CUI [3,3])
C0019155 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0087086 (UMLS CUI [4,3])
C0005400 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C1517058 (UMLS CUI [5,3])
Hepatitis B Virus Serology positive | Hepatitis C antibody test negative
Item
evidence of a positive serum hbv profile but a negative test for anti-hcv antibody
boolean
C0019169 (UMLS CUI [1,1])
C0242089 (UMLS CUI [1,2])
C1277806 (UMLS CUI [2])
Organ Major function | Cardiac function | Liver function | Pulmonary function | Renal function
Item
the major organ (heart, liver,lung and kidney) function was normal
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0232164 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Heart Disease
Item
history of cardiac disease
boolean
C0018799 (UMLS CUI [1])
Communicable Disease Serious
Item
active clinically serious infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
HIV Infection
Item
known history of human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer treatment Systemic Liver carcinoma | Chemotherapy | Immunotherapy | Hormone Therapy | Exception Hormone Therapy Supportive care allowed | Antiviral Therapy allowed | Interferon therapy Discontinued
Item
prior use of any systemic anti-cancer treatment for hcc, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). antiviral treatment is allowed, however interferon therapy must at least 4 weeks prior randomization
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0279025 (UMLS CUI [5,2])
C0344211 (UMLS CUI [5,3])
C0683607 (UMLS CUI [5,4])
C0280274 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
C0279030 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
Condition Unstable | Condition compromises Patient safety | Condition compromises Protocol Compliance
Item
any condition that is unstable or which could jeopardize the safety of the patient and his / her compliance in the study
boolean
C0348080 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
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