ID

22514

Descrizione

A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss; ODM derived from: https://clinicaltrials.gov/show/NCT00333229

collegamento

https://clinicaltrials.gov/show/NCT00333229

Keywords

versioni (2)
  1. 06/06/17 06/06/17 -
  2. 06/06/17 06/06/17 -
Caricato su

6 giugno 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women NCT00333229

Inglese

Eligibility Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women NCT00333229

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with histologically confirmed incident invasive breast cancer (t1-4) with no evidence of regional lymph node metastasis (n0) or distant metastasis (m0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
Descrizione

ID.1

Tipo di dati

boolean

hormone receptor status is negative
Descrizione

Hormone Receptor Negative

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1513916
patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (>10ng/dl)
Descrizione

Premenopausal | Menstruation Spontaneous Regular | Estradiol level Premenopausal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C0025344
UMLS CUI [2,2]
C0205359
UMLS CUI [2,3]
C0205272
UMLS CUI [3,1]
C1443016
UMLS CUI [3,2]
C0232969
patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. ac 4-6 cycles) (prior neoadjuvant ct is allowed)
Descrizione

Chemotherapy, Adjuvant | Cytotoxic Chemotherapy | Chemotherapy cycle Adjuvant Quantity | Neoadjuvant Chemotherapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2]
C0677881
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1522673
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C0392920
bone density at study entry > -2.5 t-score
Descrizione

Bone Density T score

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005938
UMLS CUI [1,2]
C3854607
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin d
Descrizione

Diphosphonates | Estrogens | Therapeutic procedure Osteoporosis | Calcium | Vitamin D

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0014939
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0029456
UMLS CUI [4]
C0006675
UMLS CUI [5]
C0042866
severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure)
Descrizione

ID.7

Tipo di dati

boolean

known hypersensitivity to bisphosphonates
Descrizione

Hypersensitivity Diphosphonates

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012544
abnormal renal function
Descrizione

Abnormal renal function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0151746
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Descrizione

ID.10

Tipo di dati

boolean

Ritorna all'inizio della pagina

Similar models

Eligibility Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women NCT00333229

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
female patients with histologically confirmed incident invasive breast cancer (t1-4) with no evidence of regional lymph node metastasis (n0) or distant metastasis (m0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
boolean
Hormone Receptor Negative
Item
hormone receptor status is negative
boolean
C0019929 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Premenopausal | Menstruation Spontaneous Regular | Estradiol level Premenopausal
Item
patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (>10ng/dl)
boolean
C0232969 (UMLS CUI [1])
C0025344 (UMLS CUI [2,1])
C0205359 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C1443016 (UMLS CUI [3,1])
C0232969 (UMLS CUI [3,2])
Chemotherapy, Adjuvant | Cytotoxic Chemotherapy | Chemotherapy cycle Adjuvant Quantity | Neoadjuvant Chemotherapy
Item
patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. ac 4-6 cycles) (prior neoadjuvant ct is allowed)
boolean
C0085533 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C1302181 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0600558 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
Bone Density T score
Item
bone density at study entry > -2.5 t-score
boolean
C0005938 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diphosphonates | Estrogens | Therapeutic procedure Osteoporosis | Calcium | Vitamin D
Item
prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin d
boolean
C0012544 (UMLS CUI [1])
C0014939 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0029456 (UMLS CUI [3,2])
C0006675 (UMLS CUI [4])
C0042866 (UMLS CUI [5])
ID.7
Item
severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure)
boolean
Hypersensitivity Diphosphonates
Item
known hypersensitivity to bisphosphonates
boolean
C0020517 (UMLS CUI [1,1])
C0012544 (UMLS CUI [1,2])
Abnormal renal function
Item
abnormal renal function
boolean
C0151746 (UMLS CUI [1])
ID.10
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
boolean
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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