ID

23148

Description

Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00493428

Link

https://clinicaltrials.gov/show/NCT00493428

Keywords

Versions (1)
  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00493428

English

Eligibility Hepatocellular Carcinoma NCT00493428

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of hcc and no evidence of extra-hepatic metastases on ct/mri scan of the abdomen, ct of the chest and brain and a negative bone scan.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0445092
patients undergoing local therapy (resection, ablation or chemoembolization) and those listed for liver transplantation will not be excluded from participating in the study.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C3697559
patients with multiple space occupying lesions within the liver (but no evidence of extra-hepatic metastases) will continue to be eligible (the distinction between regenerative nodules and multi-focal hcc versus intra-hepatic metastases can not be made with certainty by presently available techniques).
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0577053
karnofsky performance status (kps) ≥ 60 %.
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0206065
age 18 years or greater.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of at least 12 weeks.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0023671
concomitant medications
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C2347852
patients should be on stable doses of other medications (no change in dose for two weeks prior to study initiation) when entered into the study.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1,1]
C1547311
UMLS CUI [1,2]
C0013227
patient consent must be obtained from all patients prior to entry into the trial.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must be accessible for treatment and follow-up i.e. residing within reasonable geographical limits of the study site.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C2346719
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any investigational agent within a minimum of 6 weeks prior to study treatment.
Description

ID.11

Data type

boolean

pregnant or lactating women; women or men of childbearing potential unless using effective contraception. patients capable of reproduction must agree to use appropriate methods of contraception during the study and for six months afterwards. female patients of childbearing potential must have a negative urine pregnancy test within 14 days of study enrollment.
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0009862
patients whose partners are pregnant.
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C0032961
other serious illness or medical conditions which would not permit the patient to be managed according to the protocol including:
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1]
C0012634
history of a psychiatric disorder which would impair the ability to obtain consent or follow-up tumor imaging.
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1]
C0004936
active uncontrolled infection.
Description

ID.16

Data type

boolean

Alias
UMLS CUI [1]
C3714514
any known defect in gaba metabolism or hypersensitivity to baclofen.
Description

ID.17

Data type

boolean

Alias
UMLS CUI [1,1]
C1156893
UMLS CUI [1,2]
C0571150
patients with previous organ allograft or taking immunomodulatory drugs.
Description

ID.18

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0029216
renal failure not being managed by dialysis.
Description

ID.19

Data type

boolean

Alias
UMLS CUI [1]
C0035078
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Similar models

Eligibility Hepatocellular Carcinoma NCT00493428

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
a diagnosis of hcc and no evidence of extra-hepatic metastases on ct/mri scan of the abdomen, ct of the chest and brain and a negative bone scan.
boolean
C2239176 (UMLS CUI [1,1])
C0445092 (UMLS CUI [1,2])
ID.2
Item
patients undergoing local therapy (resection, ablation or chemoembolization) and those listed for liver transplantation will not be excluded from participating in the study.
boolean
C1517925 (UMLS CUI [1,1])
C3697559 (UMLS CUI [1,2])
ID.3
Item
patients with multiple space occupying lesions within the liver (but no evidence of extra-hepatic metastases) will continue to be eligible (the distinction between regenerative nodules and multi-focal hcc versus intra-hepatic metastases can not be made with certainty by presently available techniques).
boolean
C0577053 (UMLS CUI [1])
ID.4
Item
karnofsky performance status (kps) ≥ 60 %.
boolean
C0206065 (UMLS CUI [1])
ID.5
Item
age 18 years or greater.
boolean
C0001779 (UMLS CUI [1])
ID.6
Item
life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
ID.7
Item
concomitant medications
boolean
C2347852 (UMLS CUI [1])
ID.8
Item
patients should be on stable doses of other medications (no change in dose for two weeks prior to study initiation) when entered into the study.
boolean
C1547311 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
ID.9
Item
patient consent must be obtained from all patients prior to entry into the trial.
boolean
C0021430 (UMLS CUI [1])
ID.10
Item
patients must be accessible for treatment and follow-up i.e. residing within reasonable geographical limits of the study site.
boolean
C2346719 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.11
Item
any investigational agent within a minimum of 6 weeks prior to study treatment.
boolean
ID.12
Item
pregnant or lactating women; women or men of childbearing potential unless using effective contraception. patients capable of reproduction must agree to use appropriate methods of contraception during the study and for six months afterwards. female patients of childbearing potential must have a negative urine pregnancy test within 14 days of study enrollment.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,3])
ID.13
Item
patients whose partners are pregnant.
boolean
C0032961 (UMLS CUI [1])
ID.14
Item
other serious illness or medical conditions which would not permit the patient to be managed according to the protocol including:
boolean
C0012634 (UMLS CUI [1])
ID.15
Item
history of a psychiatric disorder which would impair the ability to obtain consent or follow-up tumor imaging.
boolean
C0004936 (UMLS CUI [1])
ID.16
Item
active uncontrolled infection.
boolean
C3714514 (UMLS CUI [1])
ID.17
Item
any known defect in gaba metabolism or hypersensitivity to baclofen.
boolean
C1156893 (UMLS CUI [1,1])
C0571150 (UMLS CUI [1,2])
ID.18
Item
patients with previous organ allograft or taking immunomodulatory drugs.
boolean
C0021081 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
ID.19
Item
renal failure not being managed by dialysis.
boolean
C0035078 (UMLS CUI [1])
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