ID

24628

Beschrijving

Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT00461955

Link

https://clinicaltrials.gov/show/NCT00461955

Trefwoorden

  1. 10-08-17 10-08-17 -
Geüploaded op

10 augustus 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00461955

Eligibility Multiple Myeloma NCT00461955

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient between 18 and 65 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of multiple myeloma, requiring a treatment, including high dose melphalan whith autologous peripheral blood stem cell transplantation
Beschrijving

Multiple Myeloma Treatment required for | Melphalan High dose | Autologous peripheral blood stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0025241
UMLS CUI [2,2]
C0444956
UMLS CUI [3]
C1960579
performance status: < 2 (karnofsky > 70%)
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
anticipated survival > 3 month
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
collection of a minimum of 10x106 cells (cd34+)/kg of autologous g-csf mobilised peripheral blood stem cells in 2 to 3 pheresis.
Beschrijving

Collection Cell positive for CD34 antigen | G-CSF Mobilized Peripheral Blood Stem Cell Autologous | Pheresis Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0882849
UMLS CUI [2,1]
C0079459
UMLS CUI [2,2]
C2698236
UMLS CUI [2,3]
C0439859
UMLS CUI [3,1]
C0005791
UMLS CUI [3,2]
C1265611
signed and dated informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
multiple myeloma not requiring a treatment
Beschrijving

Multiple Myeloma Unnecessary Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1710572
another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
Beschrijving

Malignant Neoplasms | Mental disorder Progressing

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205329
positive serology for hiv, hepatitis c or hepatitis b
Beschrijving

HIV Seropositivity | Hepatitis C serology test Positive | HEPATITIS B SEROLOGY POSITIVE

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0850489
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0744838
hepato cellular insufficiency
Beschrijving

Insufficiency Hepatocellular

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231179
UMLS CUI [1,2]
C2697585
severe renal insufficiency defined by a creatine clearance < 30 ml/mn
Beschrijving

Renal Insufficiency Severe | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0373595
women pregnant or nursing, or effective absence of contraception
Beschrijving

Pregnancy | Breast Feeding | Gender Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
antecedent of serious cardiac disease in the last 6 months.
Beschrijving

Heart Disease Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
allergy known to the products derived from escherichia coli
Beschrijving

Hypersensitivity Product Escherichia coli Derived

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C0014834
UMLS CUI [1,4]
C1441547

Similar models

Eligibility Multiple Myeloma NCT00461955

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient between 18 and 65 years of age
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma Treatment required for | Melphalan High dose | Autologous peripheral blood stem cell transplant
Item
diagnosis of multiple myeloma, requiring a treatment, including high dose melphalan whith autologous peripheral blood stem cell transplantation
boolean
C0026764 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0025241 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C1960579 (UMLS CUI [3])
Karnofsky Performance Status
Item
performance status: < 2 (karnofsky > 70%)
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
anticipated survival > 3 month
boolean
C0023671 (UMLS CUI [1])
Collection Cell positive for CD34 antigen | G-CSF Mobilized Peripheral Blood Stem Cell Autologous | Pheresis Quantity
Item
collection of a minimum of 10x106 cells (cd34+)/kg of autologous g-csf mobilised peripheral blood stem cells in 2 to 3 pheresis.
boolean
C0200345 (UMLS CUI [1,1])
C0882849 (UMLS CUI [1,2])
C0079459 (UMLS CUI [2,1])
C2698236 (UMLS CUI [2,2])
C0439859 (UMLS CUI [2,3])
C0005791 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Informed Consent
Item
signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multiple Myeloma Unnecessary Therapy
Item
multiple myeloma not requiring a treatment
boolean
C0026764 (UMLS CUI [1,1])
C1710572 (UMLS CUI [1,2])
Malignant Neoplasms | Mental disorder Progressing
Item
another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
boolean
C0006826 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis C serology test Positive | HEPATITIS B SEROLOGY POSITIVE
Item
positive serology for hiv, hepatitis c or hepatitis b
boolean
C0019699 (UMLS CUI [1])
C0850489 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0744838 (UMLS CUI [3])
Insufficiency Hepatocellular
Item
hepato cellular insufficiency
boolean
C0231179 (UMLS CUI [1,1])
C2697585 (UMLS CUI [1,2])
Renal Insufficiency Severe | Creatinine clearance measurement
Item
severe renal insufficiency defined by a creatine clearance < 30 ml/mn
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
Pregnancy | Breast Feeding | Gender Contraceptive methods Absent
Item
women pregnant or nursing, or effective absence of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Heart Disease Serious
Item
antecedent of serious cardiac disease in the last 6 months.
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Hypersensitivity Product Escherichia coli Derived
Item
allergy known to the products derived from escherichia coli
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C0014834 (UMLS CUI [1,3])
C1441547 (UMLS CUI [1,4])

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