Informationen: Dieses ist nicht die aktuellste Version des Datenmodells. Eine Versionsübersicht finden Sie links unter Versionen. Die aktuellste Version finden Sie hier.
Informationen:
Fehler:
ID
39796
Beschreibung
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT01643447
Link
https://clinicaltrials.gov/show/NCT01643447
Stichworte
Versionen (2)
- 20.02.20 20.02.20 -
- 27.09.21 27.09.21 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
20. Februar 2020
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Eligibility Hepatocellular Carcinoma NCT01643447
Eligibility Hepatocellular Carcinoma NCT01643447
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Hepatocellular Carcinoma NCT01643447
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])