ID

44512

Beskrivning

Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT01643447

Länk

https://clinicaltrials.gov/show/NCT01643447

Nyckelord

Versioner (2)
  1. 2020-02-20 2020-02-20 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01643447

Engelsk

Eligibility Hepatocellular Carcinoma NCT01643447

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients > 35 years and <=55 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. confirmed case (patients with hcc)
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
3. tumors can be radical removed and resection volume was 50% to 70%.
Beskrivning

Tumors Radical excision Possible | Excision Volume Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0184918
UMLS CUI [1,3]
C0332149
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0449468
UMLS CUI [2,3]
C0439165
4. criteria of liver function: child a level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
Beskrivning

Liver function Child-Pugh Classification | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C4050412
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
5. no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal. hbg ≥ 90g/l, wbc ≥ 3.000 cells/mm³,platelets ≥
Beskrivning

Absence Dysfunction Organ Major | Hematologic function | Renal function | Cardiac function | Pulmonary function | Hemoglobin measurement | White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3887504
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0205164
UMLS CUI [2]
C0221130
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232164
UMLS CUI [5]
C0231921
UMLS CUI [6]
C0518015
UMLS CUI [7]
C0023508
80.000 cells/mm³.
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
6. karnofsky performance score performance over 60.
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
7. patients who can understand this trial and have signed information consent.
Beskrivning

Comprehension Study Protocol | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have undergone previous treatment by ulinastatin.
Beskrivning

ulinastatin

Datatyp

boolean

Alias
UMLS CUI [1]
C0077906
2. patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
Beskrivning

Cardiac dysfunction | Pulmonary Dysfunction | Other Coding | Renal dysfunction | Interference Therapy Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C1709770
UMLS CUI [3]
C3846158
UMLS CUI [4]
C3279454
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C2239176
3. patients with other diseases which may affect the treatment mentioned here.
Beskrivning

Disease Affecting Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0087111
4. patients with medical history of other malignant tumors.
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
5. subjects participating in other clinical trials.
Beskrivning

Study Subject Participation Status | Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
6. extrahepatic metastasis, portal vein or other major vascular involvement. liver function: child b c.
Beskrivning

Neoplasm Metastasis Extrahepatic | Portal vein Involvement | Involvement Vascular Major | Liver function Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1314939
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C1801960
UMLS CUI [3,3]
C0205164
UMLS CUI [4,1]
C0232741
UMLS CUI [4,2]
C4050412
7. patients would not sign the consent to the trial.
Beskrivning

Informed Consent Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Hepatocellular Carcinoma NCT01643447

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female patients > 35 years and <=55 years of age.
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma
Item
2. confirmed case (patients with hcc)
boolean
C2239176 (UMLS CUI [1])
Tumors Radical excision Possible | Excision Volume Percentage
Item
3. tumors can be radical removed and resection volume was 50% to 70%.
boolean
C0027651 (UMLS CUI [1,1])
C0184918 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C0728940 (UMLS CUI [2,1])
C0449468 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Liver function Child-Pugh Classification | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
4. criteria of liver function: child a level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
boolean
C0232741 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Absence Dysfunction Organ Major | Hematologic function | Renal function | Cardiac function | Pulmonary function | Hemoglobin measurement | White Blood Cell Count procedure
Item
5. no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal. hbg ≥ 90g/l, wbc ≥ 3.000 cells/mm³,platelets ≥
boolean
C0332197 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0221130 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232164 (UMLS CUI [4])
C0231921 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0023508 (UMLS CUI [7])
Platelet Count measurement
Item
80.000 cells/mm³.
boolean
C0032181 (UMLS CUI [1])
Karnofsky Performance Status
Item
6. karnofsky performance score performance over 60.
boolean
C0206065 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent
Item
7. patients who can understand this trial and have signed information consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
ulinastatin
Item
1. patients who have undergone previous treatment by ulinastatin.
boolean
C0077906 (UMLS CUI [1])
Cardiac dysfunction | Pulmonary Dysfunction | Other Coding | Renal dysfunction | Interference Therapy Liver carcinoma
Item
2. patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
C3279454 (UMLS CUI [4])
C0521102 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C2239176 (UMLS CUI [5,3])
Disease Affecting Therapy
Item
3. patients with other diseases which may affect the treatment mentioned here.
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Cancer Other
Item
4. patients with medical history of other malignant tumors.
boolean
C1707251 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial
Item
5. subjects participating in other clinical trials.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Neoplasm Metastasis Extrahepatic | Portal vein Involvement | Involvement Vascular Major | Liver function Child-Pugh Classification
Item
6. extrahepatic metastasis, portal vein or other major vascular involvement. liver function: child b c.
boolean
C0027627 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C1801960 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0232741 (UMLS CUI [4,1])
C4050412 (UMLS CUI [4,2])
Informed Consent Unwilling
Item
7. patients would not sign the consent to the trial.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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