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Informações:
Falhas:
ID
39796
Descrição
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT01643447
Link
https://clinicaltrials.gov/show/NCT01643447
Palavras-chave
Versões (2)
- 20/02/2020 20/02/2020 -
- 27/09/2021 27/09/2021 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
20 de fevereiro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01643447
Eligibility Hepatocellular Carcinoma NCT01643447
- StudyEvent: Eligibility
Similar models
Eligibility Hepatocellular Carcinoma NCT01643447
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C2347612 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C2347612 (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])
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])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
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])
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])
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])
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])
C2347612 (UMLS CUI [4,2])
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])
C2347612 (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])
C0558080 (UMLS CUI [1,2])