ID

24628

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00461955

Nyckelord

  1. 2017-08-10 2017-08-10 -
Uppladdad den

10 augusti 2017

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00461955

Eligibility Multiple Myeloma NCT00461955

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

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

Datatyp

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%)
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

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

Life Expectancy

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
multiple myeloma not requiring a treatment
Beskrivning

Multiple Myeloma Unnecessary Therapy

Datatyp

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
Beskrivning

Malignant Neoplasms | Mental disorder Progressing

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Insufficiency Hepatocellular

Datatyp

boolean

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

Renal Insufficiency Severe | Creatinine clearance measurement

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding | Gender Contraceptive methods Absent

Datatyp

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.
Beskrivning

Heart Disease Serious

Datatyp

boolean

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

Hypersensitivity Product Escherichia coli Derived

Datatyp

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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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