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ID
29812
Beschreibung
Phase II/III Trial of Hepatocellular Carcinoma Patients Treated by ex Vivo Expanded Autologous Immune Killer Cells as the Adjunct Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01024530
Link
https://clinicaltrials.gov/show/NCT01024530
Stichworte
Versionen (2)
- 21.04.18 21.04.18 -
- 20.09.21 20.09.21 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
21. April 2018
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01024530
Eligibility Hepatocellular Carcinoma NCT01024530
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Hepatocellular Carcinoma NCT01024530
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Informed Consent
Item
1. sign and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age≧20 years, but＜80 years.
boolean
C0001779 (UMLS CUI [1])
Liver carcinoma CT | Liver carcinoma MRI | Liver carcinoma Alpha one fetoprotein measurement | Liver carcinoma Angiography | Liver carcinoma Biopsy
Item
3. hepatocellular carcinoma by ct, mri, afp, angiography or cytology/biopsy examinations.
boolean
C2239176 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0201539 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0002978 (UMLS CUI [4,2])
C2239176 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
C0040405 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0201539 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0002978 (UMLS CUI [4,2])
C2239176 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
Hepatocellular Carcinoma by BCLC Stage
Item
4. barcelona staging system stage b and c.
boolean
C3898888 (UMLS CUI [1])
Transarterial Chemoembolization Absent | Compliance behavior TACE Standard therapy
Item
5. never receive tace treatment and comply with the standard of tace treatment.
boolean
C3539919 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3539919 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
C0332197 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3539919 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
Child-Pugh Classification
Item
6. child-pugh stage a and b.
boolean
C2347612 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Study Subject Participation Status
Item
1. participant of other clinical trial within the past 4 weeks of screening period.
boolean
C2348568 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy | Local Therapy | Targeted Therapy
Item
2. receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1517925 (UMLS CUI [5])
C2985566 (UMLS CUI [6])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1517925 (UMLS CUI [5])
C2985566 (UMLS CUI [6])
HIV carrier | HTLV-1 carrier
Item
3. carriers of hiv or htlv within the past 4 weeks of screening period.
boolean
C0853961 (UMLS CUI [1])
C2747810 (UMLS CUI [2])
C2747810 (UMLS CUI [2])
Communicable Disease | Chronic infectious disease
Item
4. with active acute or chronic infection（by investigator's judgement）.
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0151317 (UMLS CUI [2])
Life threatening illness | Exception Liver carcinoma
Item
5. other diseases, except hepatocellular carcinoma, which are life-threatening to the patients（by investigator's judgement)for example:
boolean
C3846017 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
Heart Diseases | Coronary Artery Disease Treatment required for | Congestive heart failure | Cardiac Arrhythmia | Myocardial Infarction
Item
5.1 active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.
boolean
C0018799 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C1956346 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Encephalopathy | Involvement Systemic | CNS disorder | Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
5.2 with previous history of encephalopathy within the past six months. 5.3 involved involving systemically or known central nerve system diseases（brain or meningeal metastasis）.
boolean
C0085584 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0007682 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
C1704231 (UMLS CUI [5])
C1314939 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0007682 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
C1704231 (UMLS CUI [5])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
6. women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])