ID

35028

Beschrijving

Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02455154

Link

https://clinicaltrials.gov/show/NCT02455154

Trefwoorden

Versies (1)
  1. 11-02-19 11-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 februari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT02455154

Engels

Eligibility Breast Cancer NCT02455154

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive breast cancer;
Beschrijving

Invasive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
post-surgery, primary lesion been removed;
Beschrijving

Status post Operative Surgical Procedures | Primary Lesion Removed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C1402294
UMLS CUI [2,2]
C0849355
post-menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
Beschrijving

Postmenopausal state | Premenopausal state Impending Ovarian Function Tests

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0332190
UMLS CUI [2,3]
C0029930
histologically confirmed er and/or pr positive ;
Beschrijving

Estrogen receptor positive | Progesterone receptor positive

Datatype

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
receiving adjuvant ais therapy in the following one years;
Beschrijving

Aromatase Inhibitors Adjuvant therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0677850
leukocyte ≥ 3*10(9)/l; platelets ≥ 75*10(9)/l;
Beschrijving

White Blood Cell Count procedure | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
serum glutamate oxaloacetate(ast/sgot) or serum glutamic-pyruvic transaminase(alt/sgpt) <2.5 times of upper limit of normal range;
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine/blood urea nitrogen(bun) ≤ upper limit of normal (unl) range;
Beschrijving

Creatinine measurement, serum | Blood urea nitrogen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0005845
written informed consent according to the local ethics committee equirements;
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic breast cancer;
Beschrijving

Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0346993
received neo-adjuvant endocrine therapy;
Beschrijving

Hormone Therapy Neoadjuvant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1298676
history of pelvic fracture or bone metabolic disease;
Beschrijving

Fracture of pelvis | Metabolic Bone Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0149531
UMLS CUI [2]
C0005944
received drugs interfering bone metabolism in the last 12 months;
Beschrijving

Pharmaceutical Preparations Interfering Bone metabolism

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596204
baseline bone mineral density: t < -2sd;
Beschrijving

Bone Mineral Density T score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0177804
UMLS CUI [1,2]
C3854607
with other primary malignant disease;
Beschrijving

Primary tumor Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205394
with severe non-malignant co-morbidity that will influence long-term follow up;
Beschrijving

Comorbidity Severe Influence Long-term Follow-up | Exception Malignant disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C1517942
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0442867
known severe hypersensitivity to any drugs in this study;
Beschrijving

Severe allergy Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0013230
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT02455154

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
histologically confirmed invasive breast cancer;
boolean
C0853879 (UMLS CUI [1])
Status post Operative Surgical Procedures | Primary Lesion Removed
Item
post-surgery, primary lesion been removed;
boolean
C0231290 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1402294 (UMLS CUI [2,1])
C0849355 (UMLS CUI [2,2])
Postmenopausal state | Premenopausal state Impending Ovarian Function Tests
Item
post-menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
boolean
C0232970 (UMLS CUI [1])
C0232969 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C0029930 (UMLS CUI [2,3])
Estrogen receptor positive | Progesterone receptor positive
Item
histologically confirmed er and/or pr positive ;
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
Aromatase Inhibitors Adjuvant therapy
Item
receiving adjuvant ais therapy in the following one years;
boolean
C0593802 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
White Blood Cell Count procedure | Platelet Count measurement
Item
leukocyte ≥ 3*10(9)/l; platelets ≥ 75*10(9)/l;
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum glutamate oxaloacetate(ast/sgot) or serum glutamic-pyruvic transaminase(alt/sgpt) <2.5 times of upper limit of normal range;
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Blood urea nitrogen measurement
Item
serum creatinine/blood urea nitrogen(bun) ≤ upper limit of normal (unl) range;
boolean
C0201976 (UMLS CUI [1])
C0005845 (UMLS CUI [2])
Informed Consent
Item
written informed consent according to the local ethics committee equirements;
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer;
boolean
C0346993 (UMLS CUI [1])
Hormone Therapy Neoadjuvant
Item
received neo-adjuvant endocrine therapy;
boolean
C0279025 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
Fracture of pelvis | Metabolic Bone Disorder
Item
history of pelvic fracture or bone metabolic disease;
boolean
C0149531 (UMLS CUI [1])
C0005944 (UMLS CUI [2])
Pharmaceutical Preparations Interfering Bone metabolism
Item
received drugs interfering bone metabolism in the last 12 months;
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
Bone Mineral Density T score
Item
baseline bone mineral density: t < -2sd;
boolean
C0177804 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Primary tumor Other
Item
with other primary malignant disease;
boolean
C0677930 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comorbidity Severe Influence Long-term Follow-up | Exception Malignant disease
Item
with severe non-malignant co-morbidity that will influence long-term follow up;
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C1517942 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0442867 (UMLS CUI [2,2])
Severe allergy Investigational New Drugs
Item
known severe hypersensitivity to any drugs in this study;
boolean
C2945656 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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