ID

22041

Descripción

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

Palabras clave

  1. 16/5/17 16/5/17 -
  2. 16/5/17 16/5/17 -
  3. 20/9/21 20/9/21 -
Subido en

16 de mayo de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0

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Eligibility Neoplasm Metastasis NCT00327652

Eligibility Neoplasm Metastasis NCT00327652

Criteria
Descripción

Criteria

1. documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). hepatocellular carcinoma (hcc) is not allowed.
Descripción

ID.1

Tipo de datos

boolean

2. hepatic metastases
Descripción

ID.2

Tipo de datos

boolean

3. ecog performance status of 0 or 1, or karnofsky performance status (kps) of 80% to 100%.
Descripción

ECOG performance status | Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
4. adequate organ function as defined by clinical hematology and chemistry assays.
Descripción

ID.4

Tipo de datos

boolean

exclusion criteria (abbreviated):
Descripción

Exclusion Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
1. known central nervous system metastases.
Descripción

ID.6

Tipo de datos

boolean

2. history of allergic reactions attributed to sulfa or beta-lactam antibiotics.
Descripción

ID.7

Tipo de datos

boolean

3. cardiac conditions associated with high- or moderate-risk of endocarditis.
Descripción

ID.8

Tipo de datos

boolean

4. intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
Descripción

ID.9

Tipo de datos

boolean

5. artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
Descripción

ID.10

Tipo de datos

boolean

6. known coagulation disorder or recent thromboembolic event.
Descripción

ID.11

Tipo de datos

boolean

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.
Descripción

ID.12

Tipo de datos

boolean

8. current history of gallstones or kidney stones.
Descripción

ID.13

Tipo de datos

boolean

9. infection with hiv, human t-lymphotropic virus type 1 (htlv-1), hepatitis c virus (hcv), or hepatitis b virus (hbv).
Descripción

ID.14

Tipo de datos

boolean

10. pregnant or lactating
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Neoplasm Metastasis NCT00327652

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
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])
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])

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