ID

14871

Description

Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts; ODM derived from: https://clinicaltrials.gov/show/NCT01801878

Link

https://clinicaltrials.gov/show/NCT01801878

Keywords

Versions (1)
  1. 5/2/16 5/2/16 -
Uploaded on

May 2, 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.

Back to model comments
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 Neoplasms NCT01801878

English

Eligibility Breast Neoplasms NCT01801878

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female aged between 40 and 60
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subjects who diagnosed breast ductal carcinoma in situ of surgical staging t1an0, negative resection margin of below 2mm in histopathologic examination
Description

Noninfiltrating Intraductal Carcinoma | Tumor Stage Classification | Negative Surgical Margin Histopathologic examination

Data type

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C0178759
UMLS CUI [3,1]
C1709157
UMLS CUI [3,2]
C0677043
subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy
Description

Relapse | Interval | Breast-Conserving Surgery Breast Carcinoma | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0035020
UMLS CUI [2]
C1272706
UMLS CUI [3,1]
C0917927
UMLS CUI [3,2]
C0678222
UMLS CUI [4]
C1522449
subjects who understand the study contents and sign the informed consent
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have radiodermatitis
Description

Radiodermatitis

Data type

boolean

Alias
UMLS CUI [1]
C0034561
subjects who planned breast reconstruction with autogenous tissue (ex.transverse rectus abdominis muscle flap)
Description

Breast reconstruction, bilateral, with bilateral TRAM free flaps Planned | Body tissue Autogenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0521246
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0040300
UMLS CUI [2,2]
C0443145
subjects who have a history of smoking within 3months recently
Description

Smoking History

Data type

boolean

Alias
UMLS CUI [1]
C1519384
subjects who participated in other clinical trial within 30 days recently
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
pregnant or lactating subjects
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who have a active infectious disease
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
subjects who are not eligible for this study at the discretion of the investigator
Description

Eligibility Determination | clinical research investigator

Data type

boolean

Alias
UMLS CUI [1]
C0013893
UMLS CUI [2]
C1552025
Back to the top of the page

Similar models

Eligibility Breast Neoplasms NCT01801878

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female aged between 40 and 60
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Noninfiltrating Intraductal Carcinoma | Tumor Stage Classification | Negative Surgical Margin Histopathologic examination
Item
subjects who diagnosed breast ductal carcinoma in situ of surgical staging t1an0, negative resection margin of below 2mm in histopathologic examination
boolean
C0007124 (UMLS CUI [1])
C0178759 (UMLS CUI [2])
C1709157 (UMLS CUI [3,1])
C0677043 (UMLS CUI [3,2])
Relapse | Interval | Breast-Conserving Surgery Breast Carcinoma | Therapeutic radiology procedure
Item
subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy
boolean
C0035020 (UMLS CUI [1])
C1272706 (UMLS CUI [2])
C0917927 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4])
Comprehension Study Protocol | Informed Consent
Item
subjects who understand the study contents and sign the informed consent
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Radiodermatitis
Item
subjects who have radiodermatitis
boolean
C0034561 (UMLS CUI [1])
Breast reconstruction, bilateral, with bilateral TRAM free flaps Planned | Body tissue Autogenous
Item
subjects who planned breast reconstruction with autogenous tissue (ex.transverse rectus abdominis muscle flap)
boolean
C0521246 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0040300 (UMLS CUI [2,1])
C0443145 (UMLS CUI [2,2])
Smoking History
Item
subjects who have a history of smoking within 3months recently
boolean
C1519384 (UMLS CUI [1])
Study Subject Participation Status
Item
subjects who participated in other clinical trial within 30 days recently
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating subjects
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Diseases
Item
subjects who have a active infectious disease
boolean
C0009450 (UMLS CUI [1])
Eligibility Determination | clinical research investigator
Item
subjects who are not eligible for this study at the discretion of the investigator
boolean
C0013893 (UMLS CUI [1])
C1552025 (UMLS CUI [2])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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