Informations:
Erreur:
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
Lien
https://clinicaltrials.gov/show/NCT00493428
Mots-clés
Versions (1)
- 26/06/2017 26/06/2017 -
Téléchargé le
26 juin 2017
DOI
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Licence
Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT00493428
Eligibility Hepatocellular Carcinoma NCT00493428
- StudyEvent: Eligibility
Similar models
Eligibility Hepatocellular Carcinoma NCT00493428
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
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])
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])
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])
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])
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])
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])
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])
C0029216 (UMLS CUI [1,2])
ID.19
Item
renal failure not being managed by dialysis.
boolean
C0035078 (UMLS CUI [1])