ID

27312

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00418457

Nyckelord

Versioner (1)
  1. 2017-11-07 2017-11-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00418457

Engelsk

Eligibility Breast Neoplasms NCT00418457

1 Formulär  
Inclusion Criteria
Beskrivning

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)
Beskrivning

Breast Carcinoma Primary TNM Breast tumor staging

Datatyp

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)
Beskrivning

Simple mastectomy Scheduled | Bilateral mastectomy Scheduled | Implant

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Informed Consent | Randomization Morphine | Randomization Regional Anesthesia

Datatyp

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
Beskrivning

Exclusion Criteria

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

Prior surgery Breast Carcinoma | Exception Biopsy

Datatyp

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
Beskrivning

Inflammatory Breast Carcinoma

Datatyp

boolean

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

Age

Datatyp

boolean

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

Breast reconstruction with free flap Scheduled

Datatyp

boolean

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

ASA physical status classification

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Other Cancer Remission Long-term Unexpected

Datatyp

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
Beskrivning

Systemic disease Mortality Assessment

Datatyp

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