ID

12737

Beschrijving

Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:; ODM derived from: https://clinicaltrials.gov/show/NCT02070523

Link

https://clinicaltrials.gov/show/NCT02070523

Trefwoorden

  1. 17-12-15 17-12-15 -
Geüploaded op

17 december 2015

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT02070523

Eligibility Acute Lymphoblastic Leukemia NCT02070523

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligible men or women were age over 14,but less than 60 years;
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group performance status of 0 to2;
Beschrijving

ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
diagnosed with all (who classification, the primitive cells ≥ 20%);
Beschrijving

all

Datatype

boolean

Alias
UMLS CUI [1]
C0023449
previous untreated all patients had not received chemotherapy before (excluding dexamethasone, prednisone, and hydroxyurea). history of receiving blood transfusion, hematopoietic growth factors, vitamin, and palliative measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, more than three days) is allowed;
Beschrijving

untreated all

Datatype

boolean

Alias
UMLS CUI [1]
C0279088
the levels of lscs in bone marrow were measured with flow cytometry before treatment;
Beschrijving

bone marrow flow cytometry

Datatype

boolean

Alias
UMLS CUI [1]
C1511242
subjects must be able to provide written informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
mixed type of all patients;
Beschrijving

mixed all

Datatype

boolean

Alias
UMLS CUI [1]
C2826025
clinically significant active infections;
Beschrijving

infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
nursing (breastfeeding) or intending to be nursing during the study;
Beschrijving

breastfeeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
pregnancy, or intending to become pregnant during the study;
Beschrijving

pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
patients with cardiac dysfunction currently (especially congestive heart failure) or history of congestive heart failure;
Beschrijving

cardiac disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
patients with severe liver failure (alt ≥ 5 times the upper limit of normal (uln), total bilirubin ≥ 3mg/dl)
Beschrijving

severe liver failure

Datatype

boolean

Alias
UMLS CUI [1]
C0085605
patients with renal insufficiency, creatinine clearance <30ml/min, creatinine clearance rate is calculated as follows: men: ccr (ml / min) = (140 - age) × weight (kg) / [0.8136 ×serum creatinine (μmol / l )] female: ccr (ml / min) = (140 - age) × weight (kg) × 0.85 /[0.8136 × serum creatinine (μmol / l)];
Beschrijving

renal insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
patients did not or will not participate in other trials of drugs 30 days before or 90 days after the beginning of this study,
Beschrijving

study subject participation status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT02070523

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
eligible men or women were age over 14,but less than 60 years;
boolean
C0001779 (UMLS CUI [1])
ecog
Item
eastern cooperative oncology group performance status of 0 to2;
boolean
C1520224 (UMLS CUI [1])
all
Item
diagnosed with all (who classification, the primitive cells ≥ 20%);
boolean
C0023449 (UMLS CUI [1])
untreated all
Item
previous untreated all patients had not received chemotherapy before (excluding dexamethasone, prednisone, and hydroxyurea). history of receiving blood transfusion, hematopoietic growth factors, vitamin, and palliative measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, more than three days) is allowed;
boolean
C0279088 (UMLS CUI [1])
bone marrow flow cytometry
Item
the levels of lscs in bone marrow were measured with flow cytometry before treatment;
boolean
C1511242 (UMLS CUI [1])
informed consent
Item
subjects must be able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
mixed all
Item
mixed type of all patients;
boolean
C2826025 (UMLS CUI [1])
infection
Item
clinically significant active infections;
boolean
C0009450 (UMLS CUI [1])
breastfeeding
Item
nursing (breastfeeding) or intending to be nursing during the study;
boolean
C0006147 (UMLS CUI [1])
pregnancy
Item
pregnancy, or intending to become pregnant during the study;
boolean
C0549206 (UMLS CUI [1])
cardiac disease
Item
patients with cardiac dysfunction currently (especially congestive heart failure) or history of congestive heart failure;
boolean
C0018799 (UMLS CUI [1])
severe liver failure
Item
patients with severe liver failure (alt ≥ 5 times the upper limit of normal (uln), total bilirubin ≥ 3mg/dl)
boolean
C0085605 (UMLS CUI [1])
renal insufficiency
Item
patients with renal insufficiency, creatinine clearance <30ml/min, creatinine clearance rate is calculated as follows: men: ccr (ml / min) = (140 - age) × weight (kg) / [0.8136 ×serum creatinine (μmol / l )] female: ccr (ml / min) = (140 - age) × weight (kg) × 0.85 /[0.8136 × serum creatinine (μmol / l)];
boolean
C1565489 (UMLS CUI [1])
study subject participation status
Item
patients did not or will not participate in other trials of drugs 30 days before or 90 days after the beginning of this study,
boolean
C2348568 (UMLS CUI [1])

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