ID

35033

Descrição

Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02468739

Link

https://clinicaltrials.gov/show/NCT02468739

Palavras-chave

Versões (1)
  1. 11/02/2019 11/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02468739

Inglês

Eligibility Breast Cancer NCT02468739

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18-65 years old, female
Descrição

Age | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
histologically confirmed diagnosis of invasive adenocarcinoma
Descrição

Adenocarcinoma Invasive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C0205281
intends to receive at least 4 cycles taxanes-based adjuvant chemotherapy
Descrição

taxane | Chemotherapy cycle Adjuvant Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0215136
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C1265611
prior any level of peripheral nerve system disease
Descrição

Peripheral Neuropathy CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
with the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
Descrição

Neurotoxicity Questionnaire Completion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
with normal functions of major organs
Descrição

Organ Major Function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0031843
no contraindication to chemotherapy
Descrição

Medical contraindication Absent Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0392920
patients have provided a signed informed consent form
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients are expected not be able to complete adjuvant chemotherapy
Descrição

Adjuvant Chemotherapy Completion Unlikely

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0750558
be allergic to gm1
Descrição

Hypersensitivity GM1

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016895
hereditary abnormal metabolism of glucose and lipid
Descrição

Glucose metabolism abnormal Hereditary | Lipid Metabolism Abnormal Hereditary

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1142273
UMLS CUI [1,2]
C0439660
UMLS CUI [2,1]
C0598783
UMLS CUI [2,2]
C0205161
UMLS CUI [2,3]
C0439660
doctors believe that patients are not suitable for receiving gm1 treatment
Descrição

Patients Inappropriate GM1 Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0016895
UMLS CUI [1,4]
C0087111
with confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
Descrição

Nervous system disorder | Mental disorders | Epilepsy | Dementia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0497327
with concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
Descrição

Comorbidity Affecting Patient safety | Comorbidity Impact Completion of clinical trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C2732579
patients have fertility possibility but not willing or not to take effective contraceptive measures
Descrição

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Breast Cancer NCT02468739

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender
Item
age: 18-65 years old, female
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Adenocarcinoma Invasive
Item
histologically confirmed diagnosis of invasive adenocarcinoma
boolean
C0001418 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
taxane | Chemotherapy cycle Adjuvant Quantity
Item
intends to receive at least 4 cycles taxanes-based adjuvant chemotherapy
boolean
C0215136 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Peripheral Neuropathy CTCAE Grades
Item
prior any level of peripheral nerve system disease
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Neurotoxicity Questionnaire Completion
Item
with the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
boolean
C0235032 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Organ Major Function
Item
with normal functions of major organs
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
Medical contraindication Absent Chemotherapy
Item
no contraindication to chemotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Informed Consent
Item
patients have provided a signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adjuvant Chemotherapy Completion Unlikely
Item
patients are expected not be able to complete adjuvant chemotherapy
boolean
C0085533 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
Hypersensitivity GM1
Item
be allergic to gm1
boolean
C0020517 (UMLS CUI [1,1])
C0016895 (UMLS CUI [1,2])
Glucose metabolism abnormal Hereditary | Lipid Metabolism Abnormal Hereditary
Item
hereditary abnormal metabolism of glucose and lipid
boolean
C1142273 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0598783 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0439660 (UMLS CUI [2,3])
Patients Inappropriate GM1 Therapy
Item
doctors believe that patients are not suitable for receiving gm1 treatment
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0016895 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Nervous system disorder | Mental disorders | Epilepsy | Dementia
Item
with confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
Comorbidity Affecting Patient safety | Comorbidity Impact Completion of clinical trial
Item
with concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
patients have fertility possibility but not willing or not to take effective contraceptive measures
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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