ID

37979

Description

LLLT Combined With CDT in Breast Cancer-Related Lymphedema; ODM derived from: https://clinicaltrials.gov/show/NCT01351376

Link

https://clinicaltrials.gov/show/NCT01351376

Keywords

Versions (1)
  1. 9/5/19 9/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01351376

English

Eligibility Breast Cancer NCT01351376

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
Description

Unilateral Breast Carcinoma | Segmental Mastectomy Ipsilateral | Mastectomy | Lymph node excision | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C1710547
UMLS CUI [2,1]
C0024885
UMLS CUI [2,2]
C0441989
UMLS CUI [3]
C0024881
UMLS CUI [4]
C0024203
UMLS CUI [5]
C0796693
UMLS CUI [6]
C0193867
stage ii or iii unilateral secondary upper extremity lymphedema (as defined by the international society of lymphology)
Description

Lymphedema of upper limb Secondary Unilateral Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C3265926
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0205092
UMLS CUI [1,4]
C1306673
girth ≥ 2 cm circumferential difference and/or volume ≥ 200 ml compared to the uninvolved upper extremity at any 4 cm segment
Description

Measurement of girth | Difference Circumferential | Body volume | Segment Comparison Upper Extremity Uninvolved

Data type

boolean

Alias
UMLS CUI [1]
C0203911
UMLS CUI [2,1]
C1705242
UMLS CUI [2,2]
C0205113
UMLS CUI [3]
C0178521
UMLS CUI [4,1]
C0441635
UMLS CUI [4,2]
C1707455
UMLS CUI [4,3]
C1140618
UMLS CUI [4,4]
C0205429
able to commit to a long term follow-up schedule
Description

Follow-up Schedule Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0030703
UMLS CUI [1,3]
C0443252
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active cancer/metastatic cancer
Description

Malignant Neoplasms | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0027627
currently receiving or have plans for adjuvant radiation or chemotherapy
Description

Adjuvant Radiation Therapy | Chemotherapy, Adjuvant | Adjuvant Radiation Therapy Planned | Adjuvant Chemotherapy Planned

Data type

boolean

Alias
UMLS CUI [1]
C1706721
UMLS CUI [2]
C0085533
UMLS CUI [3,1]
C1706721
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0085533
UMLS CUI [4,2]
C1301732
pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
presence of other extremity lymphedema (primary or secondary)
Description

Extremity Lymphedema Primary | Extremity Lymphedema Secondary

Data type

boolean

Alias
UMLS CUI [1,1]
C0015385
UMLS CUI [1,2]
C0024236
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0015385
UMLS CUI [2,2]
C0024236
UMLS CUI [2,3]
C0175668
pacemaker
Description

Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0030163
artificial joints in the upper quadrants
Description

Artificial joints Quadrant Upper

Data type

boolean

Alias
UMLS CUI [1,1]
C3815857
UMLS CUI [1,2]
C1631280
UMLS CUI [1,3]
C1282910
renal failure
Description

Kidney Failure

Data type

boolean

Alias
UMLS CUI [1]
C0035078
arterial insufficiency
Description

Arterial insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0003834
congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
chronic inflammatory conditions
Description

Condition inflammatory chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0333348
UMLS CUI [1,3]
C0205191
history of deep vein thrombosis (dvt) in the lymphedematous upper extremity
Description

Deep Vein Thrombosis | Lymphedema Upper Extremity

Data type

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2,1]
C0024236
UMLS CUI [2,2]
C1140618
previous treatment with low level laser (regardless of indication)
Description

Laser Therapy, Low-Level

Data type

boolean

Alias
UMLS CUI [1]
C0279027
medication(s) known to affect body fluid balance
Description

Pharmaceutical Preparations Affecting Body Fluid Balance

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005889
UMLS CUI [1,4]
C0014653
body mass index (bmi) > 40 (morbid obesity)
Description

Body mass index | Obesity, Morbid

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0028756
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Similar models

Eligibility Breast Cancer NCT01351376

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Unilateral Breast Carcinoma | Segmental Mastectomy Ipsilateral | Mastectomy | Lymph node excision | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes
Item
unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
boolean
C1710547 (UMLS CUI [1])
C0024885 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C0024881 (UMLS CUI [3])
C0024203 (UMLS CUI [4])
C0796693 (UMLS CUI [5])
C0193867 (UMLS CUI [6])
Lymphedema of upper limb Secondary Unilateral Stage
Item
stage ii or iii unilateral secondary upper extremity lymphedema (as defined by the international society of lymphology)
boolean
C3265926 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0205092 (UMLS CUI [1,3])
C1306673 (UMLS CUI [1,4])
Measurement of girth | Difference Circumferential | Body volume | Segment Comparison Upper Extremity Uninvolved
Item
girth ≥ 2 cm circumferential difference and/or volume ≥ 200 ml compared to the uninvolved upper extremity at any 4 cm segment
boolean
C0203911 (UMLS CUI [1])
C1705242 (UMLS CUI [2,1])
C0205113 (UMLS CUI [2,2])
C0178521 (UMLS CUI [3])
C0441635 (UMLS CUI [4,1])
C1707455 (UMLS CUI [4,2])
C1140618 (UMLS CUI [4,3])
C0205429 (UMLS CUI [4,4])
Follow-up Schedule Long-term
Item
able to commit to a long term follow-up schedule
boolean
C3274571 (UMLS CUI [1,1])
C0030703 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Neoplasm Metastasis
Item
active cancer/metastatic cancer
boolean
C0006826 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Adjuvant Radiation Therapy | Chemotherapy, Adjuvant | Adjuvant Radiation Therapy Planned | Adjuvant Chemotherapy Planned
Item
currently receiving or have plans for adjuvant radiation or chemotherapy
boolean
C1706721 (UMLS CUI [1])
C0085533 (UMLS CUI [2])
C1706721 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0085533 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
Extremity Lymphedema Primary | Extremity Lymphedema Secondary
Item
presence of other extremity lymphedema (primary or secondary)
boolean
C0015385 (UMLS CUI [1,1])
C0024236 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0015385 (UMLS CUI [2,1])
C0024236 (UMLS CUI [2,2])
C0175668 (UMLS CUI [2,3])
Artificial cardiac pacemaker
Item
pacemaker
boolean
C0030163 (UMLS CUI [1])
Artificial joints Quadrant Upper
Item
artificial joints in the upper quadrants
boolean
C3815857 (UMLS CUI [1,1])
C1631280 (UMLS CUI [1,2])
C1282910 (UMLS CUI [1,3])
Kidney Failure
Item
renal failure
boolean
C0035078 (UMLS CUI [1])
Arterial insufficiency
Item
arterial insufficiency
boolean
C0003834 (UMLS CUI [1])
Congestive heart failure
Item
congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Condition inflammatory chronic
Item
chronic inflammatory conditions
boolean
C0348080 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Deep Vein Thrombosis | Lymphedema Upper Extremity
Item
history of deep vein thrombosis (dvt) in the lymphedematous upper extremity
boolean
C0149871 (UMLS CUI [1])
C0024236 (UMLS CUI [2,1])
C1140618 (UMLS CUI [2,2])
Laser Therapy, Low-Level
Item
previous treatment with low level laser (regardless of indication)
boolean
C0279027 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Body Fluid Balance
Item
medication(s) known to affect body fluid balance
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005889 (UMLS CUI [1,3])
C0014653 (UMLS CUI [1,4])
Body mass index | Obesity, Morbid
Item
body mass index (bmi) > 40 (morbid obesity)
boolean
C1305855 (UMLS CUI [1])
C0028756 (UMLS CUI [2])
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