ID

21885

Description

The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00720668

Link

https://clinicaltrials.gov/show/NCT00720668

Keywords

Versions (1)
  1. 5/6/17 5/6/17 -
Uploaded on

May 6, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00720668

English

Eligibility Hepatitis B NCT00720668

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 - 75 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hbv carrier with hcc
Description

hbv hcc

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C2239176
after percutaneous radiofrequency ablation;
Description

hcc percutaneous radiofrequency ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C2052891
no history of encephalopathy, ascites refractory to diuretics or variceal bleeding
Description

encephalopathy, ascites refractory to diuretics, variceal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0085584
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0012798
UMLS CUI [3]
C0333106
no hcv or hiv co-infection
Description

hcv, hiv

Data type

boolean

Alias
UMLS CUI [1]
C0220847
UMLS CUI [2]
C0019682
no previous treatment of hcc
Description

hcc treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0087111
no previous treatment of hbv except lamivudine
Description

hbv treatment, lamivudine

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0209738
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient compliance is poor
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
active clinically serious infections ( > grade 2 national cancer institute [nci]-common terminology criteria for adverse events [ctcae] version 3.0)
Description

serious infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
known history of human immunodeficiency virus (hiv) infection
Description

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
known central nervous system tumors including metastatic brain disease
Description

cns tumor or metastatic brain disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0085136
UMLS CUI [1,2]
C0220650
patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Description

gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0017181
distantly extrahepatic metastasis
Description

extrahepatic metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
history of organ allograft
Description

organ allograft

Data type

boolean

Alias
UMLS CUI [1,1]
C0040739
UMLS CUI [1,2]
C0178784
substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Description

substance abuse, condition interferes with participation or result evaluation

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0679823
UMLS CUI [2,4]
C0814849
excluded therapies and medications, previous and concomitant
Description

excluded therapie and medications

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013227
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 be stopped at least 4 weeks prior randomization
Description

systemic cancer treatment, antiviral interferon therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C2363964
UMLS CUI [2,2]
C0279030
prior use of systemic investigational agents for hcc
Description

investigational agents for hcc

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0013230
autologous bone marrow transplant or stem cell rescue within four months of start of study drug
Description

autologous bone marrow transplant or stem cell rescue

Data type

boolean

Alias
UMLS CUI [1,1]
C0194037
UMLS CUI [1,2]
C2825926
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Similar models

Eligibility Hepatitis B NCT00720668

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age 18 - 75 years
boolean
C0001779 (UMLS CUI [1])
hbv hcc
Item
hbv carrier with hcc
boolean
C0019163 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
hcc percutaneous radiofrequency ablation
Item
after percutaneous radiofrequency ablation;
boolean
C2239176 (UMLS CUI [1,1])
C2052891 (UMLS CUI [1,2])
encephalopathy, ascites refractory to diuretics, variceal bleeding
Item
no history of encephalopathy, ascites refractory to diuretics or variceal bleeding
boolean
C0085584 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C0012798 (UMLS CUI [2,2])
C0333106 (UMLS CUI [3])
hcv, hiv
Item
no hcv or hiv co-infection
boolean
C0220847 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
hcc treatment
Item
no previous treatment of hcc
boolean
C2239176 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
hbv treatment, lamivudine
Item
no previous treatment of hbv except lamivudine
boolean
C0019163 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0209738 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
compliance
Item
patient compliance is poor
boolean
C1321605 (UMLS CUI [1])
serious infections
Item
active clinically serious infections ( > grade 2 national cancer institute [nci]-common terminology criteria for adverse events [ctcae] version 3.0)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
hiv
Item
known history of human immunodeficiency virus (hiv) infection
boolean
C0019682 (UMLS CUI [1])
cns tumor or metastatic brain disease
Item
known central nervous system tumors including metastatic brain disease
boolean
C0085136 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
gastrointestinal bleeding
Item
patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
boolean
C0017181 (UMLS CUI [1])
extrahepatic metastasis
Item
distantly extrahepatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
organ allograft
Item
history of organ allograft
boolean
C0040739 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
substance abuse, condition interferes with participation or result evaluation
Item
substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0038586 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
C0814849 (UMLS CUI [2,4])
excluded therapie and medications
Item
excluded therapies and medications, previous and concomitant
boolean
C2828389 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
systemic cancer treatment, antiviral interferon therapy
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 be stopped at least 4 weeks prior randomization
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2363964 (UMLS CUI [2,1])
C0279030 (UMLS CUI [2,2])
investigational agents for hcc
Item
prior use of systemic investigational agents for hcc
boolean
C2239176 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
autologous bone marrow transplant or stem cell rescue
Item
autologous bone marrow transplant or stem cell rescue within four months of start of study drug
boolean
C0194037 (UMLS CUI [1,1])
C2825926 (UMLS CUI [1,2])
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