ID

27125

Beschrijving

Flexitouch Lymphedema System in Treating Stage II Lymphedema in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01019512

Link

https://clinicaltrials.gov/show/NCT01019512

Trefwoorden

Versies (1)
  1. 02-11-17 02-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01019512

Engels

Eligibility Breast Cancer NCT01019512

1 Formulieren  
Criteria
Beschrijving

Criteria

subjects must have a known, clinical diagnosis of stage ii lymphedema as verified by a physician specializing in this disorder
Beschrijving

Lymphedema Stage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C1306673
subjects must have had a unilateral mastectomy, lymph node (ln) dissection and/or radiation therapy for the treatment of primary breast cancer
Beschrijving

Simple mastectomy | Lymph Node Dissection | Therapeutic radiology procedure Breast Carcinoma Primary

Datatype

boolean

Alias
UMLS CUI [1]
C0024886
UMLS CUI [2]
C0242382
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0678222
UMLS CUI [3,3]
C0205225
subjects must have completed their course of adjuvant chemotherapy
Beschrijving

Adjuvant Chemotherapy Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0205197
clinical assessment of lymphedema demonstrating at least 10% difference between the volumes of the affected and opposite limbs at the time of enrollment
Beschrijving

Lymphedema Physical Examination | Difference Percentage | Volume Limb Affected | Volume Limb Opposite

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1705242
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C0449468
UMLS CUI [3,2]
C0015385
UMLS CUI [3,3]
C0392760
UMLS CUI [4,1]
C0449468
UMLS CUI [4,2]
C0015385
UMLS CUI [4,3]
C1521805
subjects must be completing phase i of their cdt for their initial onset of lymphedema or for an acute flare of lymphedema
Beschrijving

Complex Decongestive Therapy Phase Lymphedema Onset | Complex Decongestive Therapy Phase Lymphedema Flare

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986606
UMLS CUI [1,2]
C0205390
UMLS CUI [1,3]
C0024236
UMLS CUI [1,4]
C0332162
UMLS CUI [2,1]
C2986606
UMLS CUI [2,2]
C0205390
UMLS CUI [2,3]
C0024236
UMLS CUI [2,4]
C1517205
subjects must be capable of giving informed consent exclusion
Beschrijving

Informed Consent | Exclusion Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0680251
history of prior trauma and/or surgery in the affected limb other than that for treatment of breast cancer
Beschrijving

Trauma Limb Affected | Operative Surgical Procedures Limb Affected | Exception Therapeutic procedure Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714660
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C0392760
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0015385
UMLS CUI [2,3]
C0392760
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0678222
patients with recurrent breast cancer
Beschrijving

Breast cancer recurrent

Datatype

boolean

Alias
UMLS CUI [1]
C0278493
history of bilateral breast cancer
Beschrijving

bilateral breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0281267
subjects currently receiving other therapies for lymphedema
Beschrijving

Therapeutic procedure Lymphedema

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0024236
subjects with renal, liver, and/or heart dysfunction
Beschrijving

Renal dysfunction | Liver Dysfunction | Myocardial dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0340515
open wounds or web syndrome
Beschrijving

Open wound | Axillary web syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0332798
UMLS CUI [2]
C3698497
active/acute infection (cellulitis)
Beschrijving

Communicable Diseases | Cellulitis

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0007642
acute dvt/thrombophlebitis
Beschrijving

Deep Vein Thrombosis | Thrombophlebitis

Datatype

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0040046
decompensated or untreated congestive heart failure
Beschrijving

CONGESTIVE HEART FAILURE DECOMPENSATED | Congestive heart failure untreated

Datatype

boolean

Alias
UMLS CUI [1]
C0742746
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0332155
pulmonary embolism - pregnancy as confirmed by urine test; all patients of child bearing potential will be required to have a urine pregnancy test
Beschrijving

Pulmonary Embolism | Pregnancy Urinalysis | Childbearing Potential Urine pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0042014
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430056
subjects cannot be homeless persons
Beschrijving

Homeless persons

Datatype

boolean

Alias
UMLS CUI [1]
C0019863
concomitant chemotherapy and radiation treatment during this study is not permitted
Beschrijving

Chemotherapy Additional | Therapeutic radiology procedure Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1706712
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1706712
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Similar models

Eligibility Breast Cancer NCT01019512

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Lymphedema Stage
Item
subjects must have a known, clinical diagnosis of stage ii lymphedema as verified by a physician specializing in this disorder
boolean
C0024236 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
Simple mastectomy | Lymph Node Dissection | Therapeutic radiology procedure Breast Carcinoma Primary
Item
subjects must have had a unilateral mastectomy, lymph node (ln) dissection and/or radiation therapy for the treatment of primary breast cancer
boolean
C0024886 (UMLS CUI [1])
C0242382 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0205225 (UMLS CUI [3,3])
Adjuvant Chemotherapy Completed
Item
subjects must have completed their course of adjuvant chemotherapy
boolean
C0085533 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Lymphedema Physical Examination | Difference Percentage | Volume Limb Affected | Volume Limb Opposite
Item
clinical assessment of lymphedema demonstrating at least 10% difference between the volumes of the affected and opposite limbs at the time of enrollment
boolean
C0024236 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1705242 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0449468 (UMLS CUI [3,1])
C0015385 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0449468 (UMLS CUI [4,1])
C0015385 (UMLS CUI [4,2])
C1521805 (UMLS CUI [4,3])
Complex Decongestive Therapy Phase Lymphedema Onset | Complex Decongestive Therapy Phase Lymphedema Flare
Item
subjects must be completing phase i of their cdt for their initial onset of lymphedema or for an acute flare of lymphedema
boolean
C2986606 (UMLS CUI [1,1])
C0205390 (UMLS CUI [1,2])
C0024236 (UMLS CUI [1,3])
C0332162 (UMLS CUI [1,4])
C2986606 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
C0024236 (UMLS CUI [2,3])
C1517205 (UMLS CUI [2,4])
Informed Consent | Exclusion Criteria
Item
subjects must be capable of giving informed consent exclusion
boolean
C0021430 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Trauma Limb Affected | Operative Surgical Procedures Limb Affected | Exception Therapeutic procedure Breast Carcinoma
Item
history of prior trauma and/or surgery in the affected limb other than that for treatment of breast cancer
boolean
C3714660 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0015385 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
Breast cancer recurrent
Item
patients with recurrent breast cancer
boolean
C0278493 (UMLS CUI [1])
bilateral breast cancer
Item
history of bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Therapeutic procedure Lymphedema
Item
subjects currently receiving other therapies for lymphedema
boolean
C0087111 (UMLS CUI [1,1])
C0024236 (UMLS CUI [1,2])
Renal dysfunction | Liver Dysfunction | Myocardial dysfunction
Item
subjects with renal, liver, and/or heart dysfunction
boolean
C3279454 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0340515 (UMLS CUI [3])
Open wound | Axillary web syndrome
Item
open wounds or web syndrome
boolean
C0332798 (UMLS CUI [1])
C3698497 (UMLS CUI [2])
Communicable Diseases | Cellulitis
Item
active/acute infection (cellulitis)
boolean
C0009450 (UMLS CUI [1])
C0007642 (UMLS CUI [2])
Deep Vein Thrombosis | Thrombophlebitis
Item
acute dvt/thrombophlebitis
boolean
C0149871 (UMLS CUI [1])
C0040046 (UMLS CUI [2])
CONGESTIVE HEART FAILURE DECOMPENSATED | Congestive heart failure untreated
Item
decompensated or untreated congestive heart failure
boolean
C0742746 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Pulmonary Embolism | Pregnancy Urinalysis | Childbearing Potential Urine pregnancy test
Item
pulmonary embolism - pregnancy as confirmed by urine test; all patients of child bearing potential will be required to have a urine pregnancy test
boolean
C0034065 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0042014 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430056 (UMLS CUI [3,2])
Homeless persons
Item
subjects cannot be homeless persons
boolean
C0019863 (UMLS CUI [1])
Chemotherapy Additional | Therapeutic radiology procedure Additional
Item
concomitant chemotherapy and radiation treatment during this study is not permitted
boolean
C0392920 (UMLS CUI [1,1])
C1706712 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1706712 (UMLS CUI [2,2])
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