Informações:
Falhas:
ID
43766
Descrição
Testing of ADI-PEG in Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00056992
Link
https://clinicaltrials.gov/show/NCT00056992
Palavras-chave
Versões (2)
- 15/06/2016 15/06/2016 -
- 20/09/2021 20/09/2021 -
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT00056992
Eligibility Carcinoma, Hepatocellular NCT00056992
- StudyEvent: Eligibility
Similar models
Eligibility Carcinoma, Hepatocellular NCT00056992
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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
C2826210 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
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])
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])