ID

15842

Description

Testing of ADI-PEG in Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00056992

Lien

https://clinicaltrials.gov/show/NCT00056992

Mots-clés

  1. 15/06/2016 15/06/2016 -
  2. 20/09/2021 20/09/2021 -
Téléchargé le

15 juin 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Carcinoma, Hepatocellular NCT00056992

Eligibility Carcinoma, Hepatocellular NCT00056992

Criteria
Description

Criteria

non-resectable disease.
Description

non-resectable disease

Type de données

boolean

Alias
UMLS CUI [1]
C0854796
progressive disease after chemotherapy, radiotherapy, surgery or immuno-therapy, and be no longer responding to such therapy, or have refused such therapy.
Description

progressive disease

Type de données

boolean

Alias
UMLS CUI [1]
C1335499
been off previous treatment for at least 4 weeks.
Description

off treatment

Type de données

boolean

Alias
UMLS CUI [1]
C1518544
been fully recovered from all prior surgery.
Description

fully recovered

Type de données

boolean

Alias
UMLS CUI [1,1]
C1546957
UMLS CUI [1,2]
C1514463
age of > 18 years.
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status of > 70.
Description

karnofsky performance status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
expected survival of > 12 weeks.
Description

expected survival

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
total bilirubin < 3.0 mg/dl.
Description

total bilirubin

Type de données

boolean

Alias
UMLS CUI [1]
C0201913
serum albumin > 3.0 g/dl.
Description

serum albumin

Type de données

boolean

Alias
UMLS CUI [1]
C0036773
serum sgot < 5 x upper limit of normal.
Description

sgot

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
serum alkaline phosphatase < 5 x upper limit of normal.
Description

alkaline phosphatase

Type de données

boolean

Alias
UMLS CUI [1]
C0201850
serum ammonia < 55 mg/dl.
Description

serum ammonia

Type de données

boolean

Alias
UMLS CUI [1]
C2041390
serum glucose > 60 mg/dl.
Description

glucose

Type de données

boolean

Alias
UMLS CUI [1]
C0202042
serum amylase < 1.5 x upper limit of normal.
Description

serum amylase

Type de données

boolean

Alias
UMLS CUI [1]
C0201883
anc > 1,500 / ml.
Description

anc

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
platelets > 100,000 / ml.
Description

platelets

Type de données

boolean

Alias
UMLS CUI [1]
C0005821
female subjects of childbearing age and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. females must not be pregnant at the start of the study, and a serum hcg pregnancy test must be negative before entry into the study.
Description

pregnancy and contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430060
UMLS CUI [3]
C0700589
informed consent.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
not be enrolled in other ind studies.
Description

participation in other study

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
disease must be measurable or evaluable.
Description

measurable disease

Type de données

boolean

Alias
UMLS CUI [1]
C1513041

Similar models

Eligibility Carcinoma, Hepatocellular NCT00056992

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
non-resectable disease
Item
non-resectable disease.
boolean
C0854796 (UMLS CUI [1])
progressive disease
Item
progressive disease after chemotherapy, radiotherapy, surgery or immuno-therapy, and be no longer responding to such therapy, or have refused such therapy.
boolean
C1335499 (UMLS CUI [1])
off treatment
Item
been off previous treatment for at least 4 weeks.
boolean
C1518544 (UMLS CUI [1])
fully recovered
Item
been fully recovered from all prior surgery.
boolean
C1546957 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
age
Item
age of > 18 years.
boolean
C0001779 (UMLS CUI [1])
karnofsky performance status
Item
karnofsky performance status of > 70.
boolean
C0206065 (UMLS CUI [1])
expected survival
Item
expected survival of > 12 weeks.
boolean
C0023671 (UMLS CUI [1])
total bilirubin
Item
total bilirubin < 3.0 mg/dl.
boolean
C0201913 (UMLS CUI [1])
serum albumin
Item
serum albumin > 3.0 g/dl.
boolean
C0036773 (UMLS CUI [1])
sgot
Item
serum sgot < 5 x upper limit of normal.
boolean
C0201899 (UMLS CUI [1])
alkaline phosphatase
Item
serum alkaline phosphatase < 5 x upper limit of normal.
boolean
C0201850 (UMLS CUI [1])
serum ammonia
Item
serum ammonia < 55 mg/dl.
boolean
C2041390 (UMLS CUI [1])
glucose
Item
serum glucose > 60 mg/dl.
boolean
C0202042 (UMLS CUI [1])
serum amylase
Item
serum amylase < 1.5 x upper limit of normal.
boolean
C0201883 (UMLS CUI [1])
anc
Item
anc > 1,500 / ml.
boolean
C0948762 (UMLS CUI [1])
platelets
Item
platelets > 100,000 / ml.
boolean
C0005821 (UMLS CUI [1])
pregnancy and contraceptive methods
Item
female subjects of childbearing age and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. females must not be pregnant at the start of the study, and a serum hcg pregnancy test must be negative before entry into the study.
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
informed consent
Item
informed consent.
boolean
C0021430 (UMLS CUI [1])
participation in other study
Item
not be enrolled in other ind studies.
boolean
C2348568 (UMLS CUI [1])
measurable disease
Item
disease must be measurable or evaluable.
boolean
C1513041 (UMLS CUI [1])

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