ID

26308

Beschreibung

Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00719966

Link

https://clinicaltrials.gov/show/NCT00719966

Stichworte

Versionen (1)
  1. 16.10.17 16.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00719966

Englisch

Eligibility Breast Cancer NCT00719966

1 Formulare  
Criteria
Beschreibung

Criteria

diagnosis of breast cancer
Beschreibung

Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
ductal carcinoma in situ (dcis) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer
Beschreibung

Noninfiltrating Intraductal Carcinoma | cancer treatment | Tamoxifen Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C0039286
UMLS CUI [3,2]
C0332197
may not have had a prior mastectomy with requirement for mastectomy of the contralateral breast
Beschreibung

Mastectomy Absent | Redundancy Mastectomy Breast Contralateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1313915
UMLS CUI [2,2]
C0024881
UMLS CUI [2,3]
C0006141
UMLS CUI [2,4]
C0441988
no requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection
Beschreibung

Redundancy Excision of axillary lymph nodes | Mastectomy Contralateral | Excision of axillary lymph nodes Contralateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1313915
UMLS CUI [1,2]
C0193867
UMLS CUI [2,1]
C0024881
UMLS CUI [2,2]
C0441988
UMLS CUI [3,1]
C0193867
UMLS CUI [3,2]
C0441988
hormone receptor status meeting 1 of the following criteria:
Beschreibung

Hormone Receptor Status | Criteria Quantity Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1550543
hormone receptor negative and not eligible for aromatase inhibitor therapy (ai)
Beschreibung

Hormone Receptor Negative | Ineligible Aromatase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0593802
hormone receptor positive and are not receiving an ai
Beschreibung

Hormone Receptor Positive | Aromatase Inhibitors Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0593802
UMLS CUI [2,2]
C0332197
patient characteristics:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
postmenopausal
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
no known or symptomatic coronary artery disease
Beschreibung

Coronary Artery Disease Absent | Coronary Artery Disease Symptomatic Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0332197
no significant co-morbidities, including any of the following conditions:
Beschreibung

Comorbidity Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332197
active renal or hepatic disease
Beschreibung

Kidney Disease | Liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
known uncontrolled and/or untreated peripheral arterial disease
Beschreibung

Peripheral Arterial Disease Uncontrolled | Peripheral Arterial Disease untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704436
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1704436
UMLS CUI [2,2]
C0332155
uncontrolled and/or untreated hypertension
Beschreibung

Uncontrolled hypertension | Hypertension untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0745134
uncontrolled and/or untreated diabetes
Beschreibung

Diabetic - poor control | Diabetes Mellitus untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0332155
uncontrolled and/or untreated hyperlipidemia
Beschreibung

Hyperlipidemia Uncontrolled | Hyperlipidemia untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020473
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0020473
UMLS CUI [2,2]
C0332155
prior concurrent therapy:
Beschreibung

Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschreibung

ID.18

Datentyp

boolean

more than 7 days since prior hormone replacement therapy or hormone-based contraception
Beschreibung

Hormone replacement therapy | Hormonal contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C2985296
more than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease
Beschreibung

Tamoxifen Absent Breast Carcinoma | Aromatase Inhibitors Absent Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039286
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0593802
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0678222
more than 12 months since prior and no concurrent chemotherapy for this disease
Beschreibung

Chemotherapy Absent Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
no prior bilateral mastectomy
Beschreibung

Bilateral mastectomy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0191877
UMLS CUI [1,2]
C0332197
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Ähnliche Modelle

Eligibility Breast Cancer NCT00719966

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Breast Carcinoma
Item
diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Noninfiltrating Intraductal Carcinoma | cancer treatment | Tamoxifen Absent
Item
ductal carcinoma in situ (dcis) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer
boolean
C0007124 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C0039286 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Mastectomy Absent | Redundancy Mastectomy Breast Contralateral
Item
may not have had a prior mastectomy with requirement for mastectomy of the contralateral breast
boolean
C0024881 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1313915 (UMLS CUI [2,1])
C0024881 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
C0441988 (UMLS CUI [2,4])
Redundancy Excision of axillary lymph nodes | Mastectomy Contralateral | Excision of axillary lymph nodes Contralateral
Item
no requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection
boolean
C1313915 (UMLS CUI [1,1])
C0193867 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
C0193867 (UMLS CUI [3,1])
C0441988 (UMLS CUI [3,2])
Hormone Receptor Status | Criteria Quantity Fulfill
Item
hormone receptor status meeting 1 of the following criteria:
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Hormone Receptor Negative | Ineligible Aromatase Inhibitors
Item
hormone receptor negative and not eligible for aromatase inhibitor therapy (ai)
boolean
C0019929 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C0593802 (UMLS CUI [2,2])
Hormone Receptor Positive | Aromatase Inhibitors Absent
Item
hormone receptor positive and are not receiving an ai
boolean
C0019929 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Coronary Artery Disease Absent | Coronary Artery Disease Symptomatic Absent
Item
no known or symptomatic coronary artery disease
boolean
C1956346 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Comorbidity Absent
Item
no significant co-morbidities, including any of the following conditions:
boolean
C0009488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Kidney Disease | Liver disease
Item
active renal or hepatic disease
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Peripheral Arterial Disease Uncontrolled | Peripheral Arterial Disease untreated
Item
known uncontrolled and/or untreated peripheral arterial disease
boolean
C1704436 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1704436 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Uncontrolled hypertension | Hypertension untreated
Item
uncontrolled and/or untreated hypertension
boolean
C1868885 (UMLS CUI [1])
C0745134 (UMLS CUI [2])
Diabetic - poor control | Diabetes Mellitus untreated
Item
uncontrolled and/or untreated diabetes
boolean
C0421258 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Hyperlipidemia Uncontrolled | Hyperlipidemia untreated
Item
uncontrolled and/or untreated hyperlipidemia
boolean
C0020473 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0020473 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.18
Item
see disease characteristics
boolean
Hormone replacement therapy | Hormonal contraception
Item
more than 7 days since prior hormone replacement therapy or hormone-based contraception
boolean
C0282402 (UMLS CUI [1])
C2985296 (UMLS CUI [2])
Tamoxifen Absent Breast Carcinoma | Aromatase Inhibitors Absent Breast Carcinoma
Item
more than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease
boolean
C0039286 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0593802 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Chemotherapy Absent Breast Carcinoma
Item
more than 12 months since prior and no concurrent chemotherapy for this disease
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Bilateral mastectomy Absent
Item
no prior bilateral mastectomy
boolean
C0191877 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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