ID

14871

Beschrijving

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

Trefwoorden

  1. 02-05-16 02-05-16 -
Geüploaded op

2 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT01801878

Eligibility Breast Neoplasms NCT01801878

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female aged between 40 and 60
Beschrijving

Gender | Age

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Comprehension Study Protocol | Informed Consent

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have radiodermatitis
Beschrijving

Radiodermatitis

Datatype

boolean

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

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

Datatype

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
Beschrijving

Smoking History

Datatype

boolean

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

Study Subject Participation Status

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Communicable Diseases

Datatype

boolean

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

Eligibility Determination | clinical research investigator

Datatype

boolean

Alias
UMLS CUI [1]
C0013893
UMLS CUI [2]
C1552025

Similar models

Eligibility Breast Neoplasms NCT01801878

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

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