ID

38257

Description

Night-time Compression Systems for Breast Cancer Related Lymphedema; ODM derived from: https://clinicaltrials.gov/show/NCT01550250

Link

https://clinicaltrials.gov/show/NCT01550250

Keywords

Versions (1)
  1. 10/4/19 10/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2019

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 NCT01550250

English

Eligibility Breast Neoplasms NCT01550250

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 10% and maximum 40% increase in arm volume over the unaffected arm (mild to moderate lymphedema).
Description

Gender | Breast Carcinoma | Edema Arm Ipsilateral | Arm % volume Increase | Lymphedema Mild | Lymphedema Moderate

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3,1]
C0013604
UMLS CUI [3,2]
C1269078
UMLS CUI [3,3]
C0441989
UMLS CUI [4,1]
C1269078
UMLS CUI [4,2]
C1690016
UMLS CUI [4,3]
C0442805
UMLS CUI [5,1]
C0024236
UMLS CUI [5,2]
C2945599
UMLS CUI [6,1]
C0024236
UMLS CUI [6,2]
C0205081
2. patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization.
Description

Primary treatment Completed | Adjuvant therapy Completed | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0543467
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1522449
3. patients must have their own fitted compression garment for daytime maintenance.
Description

Compression garment Daytime Maintenance

Data type

boolean

Alias
UMLS CUI [1,1]
C2985539
UMLS CUI [1,2]
C0332169
UMLS CUI [1,3]
C0024501
4. no past or current use of a night-time compression system for maintenance. those patients who have trialed a night-time compression system in the past year must observe a six-month washout period before entering the trial.
Description

Night time Compression System Absent | Night time Compression System Washout Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0240526
UMLS CUI [1,2]
C0728907
UMLS CUI [1,3]
C0449913
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0240526
UMLS CUI [2,2]
C0728907
UMLS CUI [2,3]
C0449913
UMLS CUI [2,4]
C1710661
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinical or radiological evidence of active disease, either local or metastatic.
Description

Local disease | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0277565
UMLS CUI [2]
C0027627
2. history of contralateral breast cancer and axillary surgery.
Description

Contralateral Breast Carcinoma | Operative Surgical Procedure Axillary lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C3274709
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0729594
3. serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up.
Description

Disease Serious | Exception Malignant disease | Treatment Daily Excluded | Kidney Failure | Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0442867
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332173
UMLS CUI [3,3]
C0332196
UMLS CUI [4]
C0035078
UMLS CUI [5]
C0018801
4. patients for whom compression is contraindicated.
Description

Medical contraindication Compression

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0728907
5. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Description

Mental disorder Excludes Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorder Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0085281
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0525058
6. unable to comply with the protocol, measurement and follow-up schedule.
Description

Protocol Compliance Unable | Compliance Follow-up Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C1299582
Back to the top of the page

Similar models

Eligibility Breast Neoplasms NCT01550250

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma | Edema Arm Ipsilateral | Arm % volume Increase | Lymphedema Mild | Lymphedema Moderate
Item
1. women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 10% and maximum 40% increase in arm volume over the unaffected arm (mild to moderate lymphedema).
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0013604 (UMLS CUI [3,1])
C1269078 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
C1269078 (UMLS CUI [4,1])
C1690016 (UMLS CUI [4,2])
C0442805 (UMLS CUI [4,3])
C0024236 (UMLS CUI [5,1])
C2945599 (UMLS CUI [5,2])
C0024236 (UMLS CUI [6,1])
C0205081 (UMLS CUI [6,2])
Primary treatment Completed | Adjuvant therapy Completed | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure
Item
2. patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization.
boolean
C1708063 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0677850 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Compression garment Daytime Maintenance
Item
3. patients must have their own fitted compression garment for daytime maintenance.
boolean
C2985539 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
Night time Compression System Absent | Night time Compression System Washout Period
Item
4. no past or current use of a night-time compression system for maintenance. those patients who have trialed a night-time compression system in the past year must observe a six-month washout period before entering the trial.
boolean
C0240526 (UMLS CUI [1,1])
C0728907 (UMLS CUI [1,2])
C0449913 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0240526 (UMLS CUI [2,1])
C0728907 (UMLS CUI [2,2])
C0449913 (UMLS CUI [2,3])
C1710661 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Local disease | Neoplasm Metastasis
Item
1. clinical or radiological evidence of active disease, either local or metastatic.
boolean
C0277565 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Contralateral Breast Carcinoma | Operative Surgical Procedure Axillary lymph nodes
Item
2. history of contralateral breast cancer and axillary surgery.
boolean
C3274709 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0729594 (UMLS CUI [2,2])
Disease Serious | Exception Malignant disease | Treatment Daily Excluded | Kidney Failure | Heart failure
Item
3. serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0442867 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0035078 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
Medical contraindication Compression
Item
4. patients for whom compression is contraindicated.
boolean
C1301624 (UMLS CUI [1,1])
C0728907 (UMLS CUI [1,2])
Mental disorder Excludes Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorder Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance
Item
5. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0085281 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Protocol Compliance Unable | Compliance Follow-up Unable
Item
6. unable to comply with the protocol, measurement and follow-up schedule.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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