ID

27312

Descrição

Regional Anesthesia and Breast Cancer Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT00418457

Link

https://clinicaltrials.gov/show/NCT00418457

Palavras-chave

Versões (1)
  1. 07/11/2017 07/11/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de novembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00418457

Inglês

Eligibility Breast Neoplasms NCT00418457

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be tumor stage 1-3, nodes 0-2)
Descrição

Breast Carcinoma Primary TNM Breast tumor staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0474926
scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)
Descrição

Simple mastectomy Scheduled | Bilateral mastectomy Scheduled | Implant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024886
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0191877
UMLS CUI [2,2]
C0205539
UMLS CUI [3]
C0021102
isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)
Descrição

Segmental Mastectomy Isolated | Excision of axillary lymph nodes | Removal Lymph nodes Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024885
UMLS CUI [1,2]
C0205409
UMLS CUI [2]
C0193867
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C0024204
UMLS CUI [3,3]
C1265611
written informed consent, including willingness to be randomized to morphine or regional analgesia
Descrição

Informed Consent | Randomization Morphine | Randomization Regional Anesthesia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0026549
UMLS CUI [3,1]
C0034656
UMLS CUI [3,2]
C0002911
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous surgery for breast cancer (except diagnostic biopsies)
Descrição

Prior surgery Breast Carcinoma | Exception Biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
inflammatory breast cancer
Descrição

Inflammatory Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0278601
age < 18 or > 85 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
scheduled free flap reconstruction
Descrição

Breast reconstruction with free flap Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0405405
UMLS CUI [1,2]
C0205539
asa physical status ≥ 4
Descrição

ASA physical status classification

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0450990
any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)
Descrição

Medical contraindication Epidural Anesthesia | Medical contraindication Paravertebral anesthesia | Medical contraindication Epidural Analgesia | Medical contraindication Analgesia Paravertebral | Medical contraindication Blood Coagulation Disorders | Medical contraindication Anatomy Abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002913
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0198806
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0002769
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C3202977
UMLS CUI [4,3]
C0442150
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0005779
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0700276
UMLS CUI [6,3]
C0205161
any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
Descrição

Medical contraindication Midazolam | Medical contraindication Propofol | Medical contraindication Sevoflurane | Medical contraindication Fentanyl | Medical contraindication Morphine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0026056
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0033487
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0074414
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0015846
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0026549
other cancer not believed by the attending surgeon to be in long-term remission
Descrição

Other Cancer Remission Long-term Unexpected

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0687702
UMLS CUI [1,3]
C0443252
UMLS CUI [1,4]
C4055646
systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality
Descrição

Systemic disease Mortality Assessment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0026566
UMLS CUI [1,3]
C1516048
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Similar models

Eligibility Breast Neoplasms NCT00418457

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Primary TNM Breast tumor staging
Item
primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be tumor stage 1-3, nodes 0-2)
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Simple mastectomy Scheduled | Bilateral mastectomy Scheduled | Implant
Item
scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)
boolean
C0024886 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0191877 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0021102 (UMLS CUI [3])
Segmental Mastectomy Isolated | Excision of axillary lymph nodes | Removal Lymph nodes Quantity
Item
isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)
boolean
C0024885 (UMLS CUI [1,1])
C0205409 (UMLS CUI [1,2])
C0193867 (UMLS CUI [2])
C0728940 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Informed Consent | Randomization Morphine | Randomization Regional Anesthesia
Item
written informed consent, including willingness to be randomized to morphine or regional analgesia
boolean
C0021430 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C0026549 (UMLS CUI [2,2])
C0034656 (UMLS CUI [3,1])
C0002911 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Prior surgery Breast Carcinoma | Exception Biopsy
Item
previous surgery for breast cancer (except diagnostic biopsies)
boolean
C0455610 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Inflammatory Breast Carcinoma
Item
inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Age
Item
age < 18 or > 85 years old
boolean
C0001779 (UMLS CUI [1])
Breast reconstruction with free flap Scheduled
Item
scheduled free flap reconstruction
boolean
C0405405 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
ASA physical status classification
Item
asa physical status ≥ 4
boolean
C0450990 (UMLS CUI [1])
Medical contraindication Epidural Anesthesia | Medical contraindication Paravertebral anesthesia | Medical contraindication Epidural Analgesia | Medical contraindication Analgesia Paravertebral | Medical contraindication Blood Coagulation Disorders | Medical contraindication Anatomy Abnormal
Item
any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)
boolean
C1301624 (UMLS CUI [1,1])
C0002913 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0198806 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0002769 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C3202977 (UMLS CUI [4,2])
C0442150 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0005779 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0700276 (UMLS CUI [6,2])
C0205161 (UMLS CUI [6,3])
Medical contraindication Midazolam | Medical contraindication Propofol | Medical contraindication Sevoflurane | Medical contraindication Fentanyl | Medical contraindication Morphine
Item
any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
boolean
C1301624 (UMLS CUI [1,1])
C0026056 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0033487 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0074414 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0015846 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0026549 (UMLS CUI [5,2])
Other Cancer Remission Long-term Unexpected
Item
other cancer not believed by the attending surgeon to be in long-term remission
boolean
C1707251 (UMLS CUI [1,1])
C0687702 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C4055646 (UMLS CUI [1,4])
Systemic disease Mortality Assessment
Item
systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality
boolean
C0442893 (UMLS CUI [1,1])
C0026566 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
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