ID

35026

Description

Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02433067

Link

https://clinicaltrials.gov/show/NCT02433067

Keywords

Versions (1)
  1. 2/10/19 2/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT02433067

English

Eligibility Breast Cancer NCT02433067

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 18 to 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
first breast cancer her2 + histologically confirmed,
Description

HER2-positive carcinoma of breast First

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C1279901
who grade performance index ≤1
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
normal renal function (creatinine clearance ≥ 60 ml min-1)
Description

Renal function | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0373595
normal heart function with lvef ≥ 50%
Description

Cardiac function | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
normal liver function (ast and alt normal)
Description

Liver function | Aspartate aminotransferase normal | Alanine aminotransferase normal

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0855624
UMLS CUI [3]
C0855620
physical activity certificate issued by a cardiologist or an oncologist,
Description

Physical activity Confirmed by Cardiologist | Physical activity Confirmed by Oncologist

Data type

boolean

Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C0175906
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0521093
UMLS CUI [2,3]
C0259990
active contraception or postmenopausal
Description

Contraceptive methods | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0232970
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients aged under 18 and over 65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients having no breast cancer her2+
Description

HER2-positive carcinoma of breast Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0332197
patients with metastases
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
heart failure (lvef ≤50%) and respiratory (o2 saturation ≤ 92%),
Description

Heart failure | Left ventricular ejection fraction | Respiration Disorder | Oxygen saturation measurement

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0523807
autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
Description

Autoimmune Diseases | Lupus Erythematosus, Systemic | Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0024141
UMLS CUI [3]
C0003873
symptomatic osteoarthritis,
Description

Osteoarthritis Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0231220
cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)
Description

Cardiovascular Diseases | Angina Pectoris | Uncontrolled hypertension | Disease Cardiopulmonary | Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0002962
UMLS CUI [3]
C1868885
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0553534
UMLS CUI [5]
C0024117
patients suffering from malnutrition (body mass index (bmi) <18 kg m-2) or weight loss of over 10% during the last 3 months,
Description

Malnutrition | Body mass index | Weight loss Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1]
C0162429
UMLS CUI [2]
C1305855
UMLS CUI [3,1]
C1262477
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0872291
patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity
Description

Mental disorders | Cognition Disorders | Patients Inappropriate Sporting activity

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0009241
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0840976
pregnant or lactating patients.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT02433067

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients aged 18 to 65 years
boolean
C0001779 (UMLS CUI [1])
HER2-positive carcinoma of breast First
Item
first breast cancer her2 + histologically confirmed,
boolean
C1960398 (UMLS CUI [1,1])
C1279901 (UMLS CUI [1,2])
WHO performance status scale
Item
who grade performance index ≤1
boolean
C1298650 (UMLS CUI [1])
Renal function | Creatinine clearance measurement
Item
normal renal function (creatinine clearance ≥ 60 ml min-1)
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Cardiac function | Left ventricular ejection fraction
Item
normal heart function with lvef ≥ 50%
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Liver function | Aspartate aminotransferase normal | Alanine aminotransferase normal
Item
normal liver function (ast and alt normal)
boolean
C0232741 (UMLS CUI [1])
C0855624 (UMLS CUI [2])
C0855620 (UMLS CUI [3])
Physical activity Confirmed by Cardiologist | Physical activity Confirmed by Oncologist
Item
physical activity certificate issued by a cardiologist or an oncologist,
boolean
C0026606 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0175906 (UMLS CUI [1,3])
C0026606 (UMLS CUI [2,1])
C0521093 (UMLS CUI [2,2])
C0259990 (UMLS CUI [2,3])
Contraceptive methods | Postmenopausal state
Item
active contraception or postmenopausal
boolean
C0700589 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients aged under 18 and over 65
boolean
C0001779 (UMLS CUI [1])
HER2-positive carcinoma of breast Absent
Item
patients having no breast cancer her2+
boolean
C1960398 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
patients with metastases
boolean
C0027627 (UMLS CUI [1])
Heart failure | Left ventricular ejection fraction | Respiration Disorder | Oxygen saturation measurement
Item
heart failure (lvef ≤50%) and respiratory (o2 saturation ≤ 92%),
boolean
C0018801 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0523807 (UMLS CUI [4])
Autoimmune Diseases | Lupus Erythematosus, Systemic | Rheumatoid Arthritis
Item
autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
boolean
C0004364 (UMLS CUI [1])
C0024141 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
Osteoarthritis Symptomatic
Item
symptomatic osteoarthritis,
boolean
C0029408 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Cardiovascular Diseases | Angina Pectoris | Uncontrolled hypertension | Disease Cardiopulmonary | Chronic Obstructive Airway Disease
Item
cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)
boolean
C0007222 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0553534 (UMLS CUI [4,2])
C0024117 (UMLS CUI [5])
Malnutrition | Body mass index | Weight loss Percentage Timespan
Item
patients suffering from malnutrition (body mass index (bmi) <18 kg m-2) or weight loss of over 10% during the last 3 months,
boolean
C0162429 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C1262477 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
Mental disorders | Cognition Disorders | Patients Inappropriate Sporting activity
Item
patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity
boolean
C0004936 (UMLS CUI [1])
C0009241 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0840976 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial