ID

16304

Description

Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT00409071

Link

https://clinicaltrials.gov/show/NCT00409071

Keywords

  1. 7/10/16 7/10/16 -
Uploaded on

July 10, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT00409071

Eligibility Breast Cancer NCT00409071

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histologically proven non metastatic breast cancer
Description

women with non metastatic breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C1300072
no previous chemotherapy
Description

Previous chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
treatment planning including 6 adjuvant ct courses with the first 3 being necessarily of the fac50, fec100 or tac type
Description

treatment planning including 6 adjuvant ct courses

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C1301732
age>= 18 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status (ps) <= 2 (who scale)
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patient able to read and understand french
Description

language

Data type

boolean

Alias
UMLS CUI [1]
C1145677
written, voluntary, informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with chemotherapy (including neo-adjuvant chemotherapy for breast cancer)
Description

previous treatment with chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
previous malignancies (except basal cell skin cancer or cervical cancer in situ or any other curatively treated malignancy in complete remission for more than 5 years)
Description

previous malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
contraindication to corticosteroids or 5-ht3 receptor antagonists
Description

contraindication to corticosteroids or 5-ht3 receptor antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C2936526
treatment with cocculine® or any other anti-emetic drug in the 15 days before inclusion
Description

treatment with anti-emetic drugs

Data type

boolean

Alias
UMLS CUI [1]
C0003297
pregnant or lactating women
Description

pregnant or lactating women

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
follow-up impossible for social, geographical, familial or psychological reasons
Description

follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1522577
patients who cannot be contacted by phone
Description

Telephone

Data type

boolean

Alias
UMLS CUI [1]
C0039457

Similar models

Eligibility Breast Cancer NCT00409071

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
women with non metastatic breast cancer
Item
women with histologically proven non metastatic breast cancer
boolean
C0079399 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1300072 (UMLS CUI [1,3])
Previous chemotherapy
Item
no previous chemotherapy
boolean
C1514457 (UMLS CUI [1])
treatment planning including 6 adjuvant ct courses
Item
treatment planning including 6 adjuvant ct courses with the first 3 being necessarily of the fac50, fec100 or tac type
boolean
C0085533 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
age
Item
age>= 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
ecog performance status (ps) <= 2 (who scale)
boolean
C1520224 (UMLS CUI [1])
language
Item
patient able to read and understand french
boolean
C1145677 (UMLS CUI [1])
Informed Consent
Item
written, voluntary, informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
previous treatment with chemotherapy
Item
previous treatment with chemotherapy (including neo-adjuvant chemotherapy for breast cancer)
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
previous malignancies
Item
previous malignancies (except basal cell skin cancer or cervical cancer in situ or any other curatively treated malignancy in complete remission for more than 5 years)
boolean
C0006826 (UMLS CUI [1])
contraindication to corticosteroids or 5-ht3 receptor antagonists
Item
contraindication to corticosteroids or 5-ht3 receptor antagonists
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C2936526 (UMLS CUI [1,3])
treatment with anti-emetic drugs
Item
treatment with cocculine® or any other anti-emetic drug in the 15 days before inclusion
boolean
C0003297 (UMLS CUI [1])
pregnant or lactating women
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
follow-up
Item
follow-up impossible for social, geographical, familial or psychological reasons
boolean
C1522577 (UMLS CUI [1])
Telephone
Item
patients who cannot be contacted by phone
boolean
C0039457 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial