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ID
22041
Description
Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00327652
Link
https://clinicaltrials.gov/show/NCT00327652
Keywords
Versions (3)
- 5/16/17 5/16/17 -
- 5/16/17 5/16/17 -
- 9/20/21 9/20/21 -
Uploaded on
May 16, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Eligibility Neoplasm Metastasis NCT00327652
Eligibility Neoplasm Metastasis NCT00327652
- StudyEvent: Eligibility
Similar models
Eligibility Neoplasm Metastasis NCT00327652
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
ID.1
Item
1. documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). hepatocellular carcinoma (hcc) is not allowed.
boolean
ID.2
Item
2. hepatic metastases
boolean
ECOG performance status | Karnofsky Performance Status
Item
3. ecog performance status of 0 or 1, or karnofsky performance status (kps) of 80% to 100%.
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
C0206065 (UMLS CUI [2])
ID.4
Item
4. adequate organ function as defined by clinical hematology and chemistry assays.
boolean
Exclusion Criteria
Item
exclusion criteria (abbreviated):
boolean
C0680251 (UMLS CUI [1])
ID.6
Item
1. known central nervous system metastases.
boolean
ID.7
Item
2. history of allergic reactions attributed to sulfa or beta-lactam antibiotics.
boolean
ID.8
Item
3. cardiac conditions associated with high- or moderate-risk of endocarditis.
boolean
ID.9
Item
4. intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
boolean
ID.10
Item
5. artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
boolean
ID.11
Item
6. known coagulation disorder or recent thromboembolic event.
boolean
ID.12
Item
7. use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to crs-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease.
boolean
ID.13
Item
8. current history of gallstones or kidney stones.
boolean
ID.14
Item
9. infection with hiv, human t-lymphotropic virus type 1 (htlv-1), hepatitis c virus (hcv), or hepatitis b virus (hbv).
boolean
Pregnancy | Breast Feeding
Item
10. pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])