ID

36067

Description

A Prospective Control Study of Cidan Capsule Combined With TACE in Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02253511

Link

https://clinicaltrials.gov/show/NCT02253511

Keywords

Versions (2)
  1. 4/13/19 4/13/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02253511

English

Eligibility Hepatocellular Carcinoma NCT02253511

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of hcc confirmed by pathology.
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
liver function of child-pugh class a or b.
Description

Liver function Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C2347612
no intrahepatic and extrahepatic metastasis.
Description

Neoplasm Metastasis intrahepatic Absent | Neoplasm Metastasis Extrahepatic Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1512948
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1517058
UMLS CUI [2,3]
C0332197
tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
Description

Absence Tumor Invasion Portal vein | Absence Tumor Invasion Trunk of hepatic vein | Absence Tumor Invasion Branch Secondary

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1269955
UMLS CUI [1,3]
C1305775
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1269955
UMLS CUI [2,3]
C1186314
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1269955
UMLS CUI [3,3]
C1253959
UMLS CUI [3,4]
C0175668
patients undergone operation were confirmed to have the following high-risk recurrence factors:
Description

Operative Surgical Procedures | High risk factors Recurrence

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C1830377
UMLS CUI [2,2]
C0034897
satellite nodules, poor differentiation, tumor diameter > 5cm
Description

Satellite Nodule | Differentiation Poor | Tumor Diameter

Data type

boolean

Alias
UMLS CUI [1]
C1710016
UMLS CUI [2,1]
C1511938
UMLS CUI [2,2]
C0542537
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C1301886
no evidence of coagulopathy: platelet count > 50 × 109/l and a prolonged prothrombin time of < 5 seconds.
Description

Blood Coagulation Disorders Absent | Platelet Count measurement | Prothrombin time prolonged

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0151872
the patients would like to accept postoperative tace.
Description

Transarterial Chemoembolization Postoperative Accept

Data type

boolean

Alias
UMLS CUI [1,1]
C3539919
UMLS CUI [1,2]
C0032790
UMLS CUI [1,3]
C1272684
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
informed consent not available
Description

Informed Consent Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0686905
impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/l or bilirubin > 50micromol/l
Description

Liver Dysfunction | Ascites | Hepatic Encephalopathy | Albumin measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4]
C0201838
UMLS CUI [5]
C1278039
renal impairment with creatinine > 200micromol/l
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
severe concurrent medical illness persisting > 6 weeks after hepatectomy
Description

Comorbidity Severe | Status post Hepatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0019144
history of other cancer
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Hepatocellular Carcinoma NCT02253511

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
diagnosis of hcc confirmed by pathology.
boolean
C2239176 (UMLS CUI [1])
Liver function Child-Pugh Classification
Item
liver function of child-pugh class a or b.
boolean
C0232741 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Neoplasm Metastasis intrahepatic Absent | Neoplasm Metastasis Extrahepatic Absent
Item
no intrahepatic and extrahepatic metastasis.
boolean
C0027627 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C1517058 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Absence Tumor Invasion Portal vein | Absence Tumor Invasion Trunk of hepatic vein | Absence Tumor Invasion Branch Secondary
Item
tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
boolean
C0332197 (UMLS CUI [1,1])
C1269955 (UMLS CUI [1,2])
C1305775 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1269955 (UMLS CUI [2,2])
C1186314 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C1269955 (UMLS CUI [3,2])
C1253959 (UMLS CUI [3,3])
C0175668 (UMLS CUI [3,4])
Operative Surgical Procedures | High risk factors Recurrence
Item
patients undergone operation were confirmed to have the following high-risk recurrence factors:
boolean
C0543467 (UMLS CUI [1])
C1830377 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
Satellite Nodule | Differentiation Poor | Tumor Diameter
Item
satellite nodules, poor differentiation, tumor diameter > 5cm
boolean
C1710016 (UMLS CUI [1])
C1511938 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
Blood Coagulation Disorders Absent | Platelet Count measurement | Prothrombin time prolonged
Item
no evidence of coagulopathy: platelet count > 50 × 109/l and a prolonged prothrombin time of < 5 seconds.
boolean
C0005779 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0151872 (UMLS CUI [3])
Transarterial Chemoembolization Postoperative Accept
Item
the patients would like to accept postoperative tace.
boolean
C3539919 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C1272684 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unavailable
Item
informed consent not available
boolean
C0021430 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
Liver Dysfunction | Ascites | Hepatic Encephalopathy | Albumin measurement | Serum total bilirubin measurement
Item
impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/l or bilirubin > 50micromol/l
boolean
C0086565 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0201838 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Renal Insufficiency | Creatinine measurement, serum
Item
renal impairment with creatinine > 200micromol/l
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Comorbidity Severe | Status post Hepatectomy
Item
severe concurrent medical illness persisting > 6 weeks after hepatectomy
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0019144 (UMLS CUI [2,2])
Cancer Other
Item
history of other cancer
boolean
C1707251 (UMLS CUI [1])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
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