ID

37785

Beschrijving

The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01080170

Link

https://clinicaltrials.gov/show/NCT01080170

Trefwoorden

Versies (1)
  1. 24-08-19 24-08-19 -
Houder van rechten

See clinicaltrials.gov

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24 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01080170

Engels

Eligibility Breast Cancer NCT01080170

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. they will not need chemotherapy and will have been prescribed but not yet started anastrazole. all will need a course of radiation therapy as part of usual care. participants are instructed not to change their physical activity or eating habits over the period of the study.
Beschrijving

Ambulatory | Gender | Age | Breast Carcinoma Hormone Receptor Positive nonmetastatic | Lumpectomy of breast | Anastrozole prescribed | Patient need for Course Radiation Therapy | Physical activity unchanged | Eating habits unchanged

Datatype

boolean

Alias
UMLS CUI [1]
C1561561
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0019929
UMLS CUI [4,3]
C1514241
UMLS CUI [4,4]
C1518409
UMLS CUI [5]
C0851238
UMLS CUI [6,1]
C0290883
UMLS CUI [6,2]
C0278329
UMLS CUI [7,1]
C0686904
UMLS CUI [7,2]
C0750729
UMLS CUI [7,3]
C1522449
UMLS CUI [8,1]
C0026606
UMLS CUI [8,2]
C0442739
UMLS CUI [9,1]
C1266864
UMLS CUI [9,2]
C0442739
comparisons are:
Beschrijving

Comparison case

Datatype

boolean

Alias
UMLS CUI [1]
C2594869
identical to the cases except they are hormone-receptor negative and don't need hormonal therapy.
Beschrijving

Case Identical | Exception Hormone Receptor Negative | Exception Independent of Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C0205280
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019929
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0332291
UMLS CUI [3,3]
C0279025
healthy controls.
Beschrijving

Healthy Control

Datatype

boolean

Alias
UMLS CUI [1]
C2986479
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
nicotine usage
Beschrijving

Use of Nicotine

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0028040
metastatic breast cancer
Beschrijving

Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0346993
need for chemotherapy
Beschrijving

Patient need for Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0392920
ai other than anastrazole
Beschrijving

Aromatase Inhibitors | Exception Anastrozole

Datatype

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0290883
usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months)
Beschrijving

Steroid use | Equivalent Prednisone Dose

Datatype

boolean

Alias
UMLS CUI [1]
C0281991
UMLS CUI [2,1]
C0205163
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0178602
clinically significant abnormality of thyroid function
Beschrijving

Thyroid function Abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C2242456
UMLS CUI [1,2]
C0205161
treatment with gonadal hormone replacement therapy within last 3 years
Beschrijving

Hormone replacement therapy Gonadal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C0018067
status post unilateral/bilateral surgical oophorectomy
Beschrijving

Status post Unilateral oophorectomy | Status post Bilateral oophorectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0041687
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0278321
having experienced a medical event, which may confound study outcomes [e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease]
Beschrijving

Event Medical Interferes with Research results | Myocardial Infarction | Cerebrovascular accident | Neoplasm Metastasis | Malignant Neoplasms Newly Diagnosed | Exception Skin carcinoma | Exception Breast Carcinoma | Lupus Erythematosus | Rheumatoid Arthritis | Chronic inflammatory disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0683954
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0027627
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C1518321
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0699893
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0678222
UMLS CUI [8]
C0409974
UMLS CUI [9]
C0003873
UMLS CUI [10]
C1290886
medication-dependent diabetes mellitus or hypercholesterolemia.
Beschrijving

Diabetes Mellitus Pharmaceutical Preparations dependent | Hypercholesterolemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3244310
UMLS CUI [2]
C0020443
gastric surgery
Beschrijving

Operation on stomach

Datatype

boolean

Alias
UMLS CUI [1]
C0192398
weight loss medication (prescription or over the counter)
Beschrijving

Weight-Loss Agents | Non-Prescription Weight-Loss Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
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Similar models

Eligibility Breast Cancer NCT01080170

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Ambulatory | Gender | Age | Breast Carcinoma Hormone Receptor Positive nonmetastatic | Lumpectomy of breast | Anastrozole prescribed | Patient need for Course Radiation Therapy | Physical activity unchanged | Eating habits unchanged
Item
ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. they will not need chemotherapy and will have been prescribed but not yet started anastrazole. all will need a course of radiation therapy as part of usual care. participants are instructed not to change their physical activity or eating habits over the period of the study.
boolean
C1561561 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0678222 (UMLS CUI [4,1])
C0019929 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
C1518409 (UMLS CUI [4,4])
C0851238 (UMLS CUI [5])
C0290883 (UMLS CUI [6,1])
C0278329 (UMLS CUI [6,2])
C0686904 (UMLS CUI [7,1])
C0750729 (UMLS CUI [7,2])
C1522449 (UMLS CUI [7,3])
C0026606 (UMLS CUI [8,1])
C0442739 (UMLS CUI [8,2])
C1266864 (UMLS CUI [9,1])
C0442739 (UMLS CUI [9,2])
Comparison case
Item
comparisons are:
boolean
C2594869 (UMLS CUI [1])
Case Identical | Exception Hormone Receptor Negative | Exception Independent of Hormone Therapy
Item
identical to the cases except they are hormone-receptor negative and don't need hormonal therapy.
boolean
C1706256 (UMLS CUI [1,1])
C0205280 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0332291 (UMLS CUI [3,2])
C0279025 (UMLS CUI [3,3])
Healthy Control
Item
healthy controls.
boolean
C2986479 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Use of Nicotine
Item
nicotine usage
boolean
C1524063 (UMLS CUI [1,1])
C0028040 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Patient need for Chemotherapy
Item
need for chemotherapy
boolean
C0686904 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Aromatase Inhibitors | Exception Anastrozole
Item
ai other than anastrazole
boolean
C0593802 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0290883 (UMLS CUI [2,2])
Steroid use | Equivalent Prednisone Dose
Item
usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months)
boolean
C0281991 (UMLS CUI [1])
C0205163 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Thyroid function Abnormal
Item
clinically significant abnormality of thyroid function
boolean
C2242456 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Hormone replacement therapy Gonadal
Item
treatment with gonadal hormone replacement therapy within last 3 years
boolean
C0282402 (UMLS CUI [1,1])
C0018067 (UMLS CUI [1,2])
Status post Unilateral oophorectomy | Status post Bilateral oophorectomy
Item
status post unilateral/bilateral surgical oophorectomy
boolean
C0231290 (UMLS CUI [1,1])
C0041687 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0278321 (UMLS CUI [2,2])
Event Medical Interferes with Research results | Myocardial Infarction | Cerebrovascular accident | Neoplasm Metastasis | Malignant Neoplasms Newly Diagnosed | Exception Skin carcinoma | Exception Breast Carcinoma | Lupus Erythematosus | Rheumatoid Arthritis | Chronic inflammatory disorder
Item
having experienced a medical event, which may confound study outcomes [e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease]
boolean
C0441471 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
C0006826 (UMLS CUI [5,1])
C1518321 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0699893 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0678222 (UMLS CUI [7,2])
C0409974 (UMLS CUI [8])
C0003873 (UMLS CUI [9])
C1290886 (UMLS CUI [10])
Diabetes Mellitus Pharmaceutical Preparations dependent | Hypercholesterolemia
Item
medication-dependent diabetes mellitus or hypercholesterolemia.
boolean
C0011849 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3244310 (UMLS CUI [1,3])
C0020443 (UMLS CUI [2])
Operation on stomach
Item
gastric surgery
boolean
C0192398 (UMLS CUI [1])
Weight-Loss Agents | Non-Prescription Weight-Loss Agents
Item
weight loss medication (prescription or over the counter)
boolean
C0376606 (UMLS CUI [1])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
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