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

Lien

https://clinicaltrials.gov/show/NCT00327652

Mots-clés

  1. 16/05/2017 16/05/2017 -
  2. 16/05/2017 16/05/2017 -
  3. 20/09/2021 20/09/2021 -
Téléchargé le

16 mai 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

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Eligibility Neoplasm Metastasis NCT00327652

Eligibility Neoplasm Metastasis NCT00327652

Criteria
Description

Criteria

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

ID.1

Type de données

boolean

2. hepatic metastases
Description

ID.2

Type de données

boolean

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

ECOG performance status | Karnofsky Performance Status

Type de données

boolean

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

ID.4

Type de données

boolean

exclusion criteria (abbreviated):
Description

Exclusion Criteria

Type de données

boolean

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

ID.6

Type de données

boolean

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

ID.7

Type de données

boolean

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

ID.8

Type de données

boolean

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

ID.9

Type de données

boolean

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

ID.10

Type de données

boolean

6. known coagulation disorder or recent thromboembolic event.
Description

ID.11

Type de données

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.
Description

ID.12

Type de données

boolean

8. current history of gallstones or kidney stones.
Description

ID.13

Type de données

boolean

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

ID.14

Type de données

boolean

10. pregnant or lactating
Description

Pregnancy | Breast Feeding

Type de données

boolean

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

Similar models

Eligibility Neoplasm Metastasis NCT00327652

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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