ID

35026

Descripción

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

Palabras clave

Versiones (1)
  1. 10/2/19 10/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

10 de febrero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02433067

Inglés

Eligibility Breast Cancer NCT02433067

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 18 to 65 years
Descripción

Age

Tipo de datos

boolean

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

HER2-positive carcinoma of breast First

Tipo de datos

boolean

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

WHO performance status scale

Tipo de datos

boolean

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

Renal function | Creatinine clearance measurement

Tipo de datos

boolean

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

Cardiac function | Left ventricular ejection fraction

Tipo de datos

boolean

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

Liver function | Aspartate aminotransferase normal | Alanine aminotransferase normal

Tipo de datos

boolean

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

Physical activity Confirmed by Cardiologist | Physical activity Confirmed by Oncologist

Tipo de datos

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
Descripción

Contraceptive methods | Postmenopausal state

Tipo de datos

boolean

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

Exclusion Criteria

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

Age

Tipo de datos

boolean

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

HER2-positive carcinoma of breast Absent

Tipo de datos

boolean

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

Neoplasm Metastasis

Tipo de datos

boolean

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

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

Tipo de datos

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)
Descripción

Autoimmune Diseases | Lupus Erythematosus, Systemic | Rheumatoid Arthritis

Tipo de datos

boolean

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

Osteoarthritis Symptomatic

Tipo de datos

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)
Descripción

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

Tipo de datos

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,
Descripción

Malnutrition | Body mass index | Weight loss Percentage Timespan

Tipo de datos

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
Descripción

Mental disorders | Cognition Disorders | Patients Inappropriate Sporting activity

Tipo de datos

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.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02433067

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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