ID

37979

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01351376

Nyckelord

  1. 2019-09-05 2019-09-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 september 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01351376

Eligibility Breast Cancer NCT01351376

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

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)
Beskrivning

Lymphedema of upper limb Secondary Unilateral Stage

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Follow-up Schedule Long-term

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
active cancer/metastatic cancer
Beskrivning

Malignant Neoplasms | Neoplasm Metastasis

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Pregnancy

Datatyp

boolean

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

Extremity Lymphedema Primary | Extremity Lymphedema Secondary

Datatyp

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
Beskrivning

Artificial cardiac pacemaker

Datatyp

boolean

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

Artificial joints Quadrant Upper

Datatyp

boolean

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

Kidney Failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0035078
arterial insufficiency
Beskrivning

Arterial insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0003834
congestive heart failure
Beskrivning

Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
chronic inflammatory conditions
Beskrivning

Condition inflammatory chronic

Datatyp

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
Beskrivning

Deep Vein Thrombosis | Lymphedema Upper Extremity

Datatyp

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)
Beskrivning

Laser Therapy, Low-Level

Datatyp

boolean

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

Pharmaceutical Preparations Affecting Body Fluid Balance

Datatyp

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)
Beskrivning

Body mass index | Obesity, Morbid

Datatyp

boolean

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

Similar models

Eligibility Breast Cancer NCT01351376

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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