ID

38240

Beskrivning

HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02165605

Länk

https://clinicaltrials.gov/show/NCT02165605

Nyckelord

Versioner (1)
  1. 2019-10-01 2019-10-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02165605

Engelsk

Eligibility Breast Cancer NCT02165605

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female, age 18 or older
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosis of breast cancer
Beskrivning

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
intact breast (not surgically absent)
Beskrivning

Breast Intact

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0205266
planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 gy in 28 fractions with a planned photon or electron boost of 10gy in 5 fractions (for a total of 33 fractions)
Beskrivning

Teleradiotherapy Fractionated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0419095
UMLS CUI [1,2]
C1979893
ability to understand and comply with the requirements of this study
Beskrivning

Comprehension Study Protocol | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
ability to give informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
for sexually active females, patient agrees to use acceptable method of birth control
Beskrivning

Gender Sexually active Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or lactating
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of concomitant skin care preparations at any of the treated or control portal areas to be observed
Beskrivning

Skin Care Preparations Portal triad area

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0150773
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0734842
any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
Beskrivning

Communicable Disease Therapeutic radiology procedure Portal triad area | Non-healed wound Therapeutic radiology procedure Portal triad area | Generalized dermatitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0734842
UMLS CUI [2,1]
C0750433
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0734842
UMLS CUI [3]
C0262995
severe renal failure creatinine > 3.0 within 6 months of study registration
Beskrivning

Kidney Failure Severe | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
Beskrivning

Patient allergic history | Anaphylaxis | Severe allergy Investigational New Drugs | Severe allergy Placebo products

Datatyp

boolean

Alias
UMLS CUI [1]
C3841443
UMLS CUI [2]
C0002792
UMLS CUI [3,1]
C2945656
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C2945656
UMLS CUI [4,2]
C1696465
UMLS CUI [4,3]
C1514468
planned relocation which would make follow-up visits impossible during the course of the study
Beskrivning

Relocation of home Planned | Follow-up visit Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C1272705
collagen vascular disease such as lupus, or scleroderma
Beskrivning

Collagen-vascular disease | Lupus Erythematosus | Scleroderma

Datatyp

boolean

Alias
UMLS CUI [1]
C0262428
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0011644
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Similar models

Eligibility Breast Cancer NCT02165605

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female, age 18 or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Breast Intact
Item
intact breast (not surgically absent)
boolean
C0006141 (UMLS CUI [1,1])
C0205266 (UMLS CUI [1,2])
Teleradiotherapy Fractionated
Item
planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 gy in 28 fractions with a planned photon or electron boost of 10gy in 5 fractions (for a total of 33 fractions)
boolean
C0419095 (UMLS CUI [1,1])
C1979893 (UMLS CUI [1,2])
Comprehension Study Protocol | Protocol Compliance
Item
ability to understand and comply with the requirements of this study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Informed Consent
Item
ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
Gender Sexually active Contraceptive methods
Item
for sexually active females, patient agrees to use acceptable method of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Skin Care Preparations Portal triad area
Item
use of concomitant skin care preparations at any of the treated or control portal areas to be observed
boolean
C0150773 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0734842 (UMLS CUI [1,3])
Communicable Disease Therapeutic radiology procedure Portal triad area | Non-healed wound Therapeutic radiology procedure Portal triad area | Generalized dermatitis
Item
any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
boolean
C0009450 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0734842 (UMLS CUI [1,3])
C0750433 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0734842 (UMLS CUI [2,3])
C0262995 (UMLS CUI [3])
Kidney Failure Severe | Creatinine measurement, serum
Item
severe renal failure creatinine > 3.0 within 6 months of study registration
boolean
C0035078 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Patient allergic history | Anaphylaxis | Severe allergy Investigational New Drugs | Severe allergy Placebo products
Item
allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
boolean
C3841443 (UMLS CUI [1])
C0002792 (UMLS CUI [2])
C2945656 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C2945656 (UMLS CUI [4,1])
C1696465 (UMLS CUI [4,2])
C1514468 (UMLS CUI [4,3])
Relocation of home Planned | Follow-up visit Unsuccessful
Item
planned relocation which would make follow-up visits impossible during the course of the study
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Collagen-vascular disease | Lupus Erythematosus | Scleroderma
Item
collagen vascular disease such as lupus, or scleroderma
boolean
C0262428 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0011644 (UMLS CUI [3])
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