ID

13066

Description

Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00014755

Link

https://clinicaltrials.gov/show/NCT00014755

Keywords

Versions (1)
  1. 1/14/16 1/14/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 14, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Multiple Sclerosis NCT00014755

English

Eligibility Multiple Sclerosis NCT00014755

1 forms  
Criteria
Description

Criteria

diagnosis of rapidly progressive multiple sclerosis (ms) by proser criteria and at high risk for a fatal outcome or severe disability with one of the following: primary progressive disease relapsing/remitting disease with 2 or more attacks in 2 years secondary progressive disease
Description

Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
extended disability status scale (edss) between 5.0 and 8.0 with deterioration in the edss of 1 or more points over the past year
Description

extended disability status scale

Data type

boolean

Alias
UMLS CUI [1]
C0451246
more than 60 days since relapse of ms
Description

relapse of ms

Data type

boolean

Alias
UMLS CUI [1]
C0035020
no evidence of myelodysplasia
Description

myelodysplasia

Data type

boolean

Alias
UMLS CUI [1]
C0026985
sibling donor proven to be an identical twin by abo typing, hla typing, and vntr analysis (for syngeneic transplantation)
Description

Twin

Data type

boolean

Alias
UMLS CUI [1]
C0005810
UMLS CUI [2]
C0019721
UMLS CUI [3]
C0019721
radiotherapy: no prior total-lymphoid irradiation
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
other: no other concurrent investigational agents
Description

investigational agents

Data type

boolean

Alias
UMLS CUI [1]
C1875319
hepatic: no hepatic impairment that would preclude high-dose immunosuppressive therapy
Description

hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
renal: no renal impairment that would preclude high-dose immunosuppressive therapy
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
cardiovascular: no cardiac impairment that would preclude high-dose immunosuppressive therapy
Description

cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
pulmonary: no pulmonary impairment that would preclude high-dose immunosuppressive therapy
Description

pulmonary function

Data type

boolean

Alias
UMLS CUI [1]
C0231921
no neurologic impairment that would preclude high-dose immunosuppressive therapy
Description

neurologic function

Data type

boolean

Alias
UMLS CUI [1]
C0746866
no active uncontrolled infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
no active malignancy
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
no other illness that would severely limit life expectancy
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
no medical or psychiatric conditions that would preclude study
Description

medical or psychiatric conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
no history of hypersensitivity to murine proteins or e. coli-derived proteins
Description

hypersensitivity to murine proteins or e. coli-derived proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
no demonstrated lack of compliance with prior medical care
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
able to undergo an mri scan
Description

mri scan

Data type

boolean

Alias
UMLS CUI [1]
C0917711
hiv negative
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019682
not pregnant or nursing
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Multiple Sclerosis NCT00014755

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple Sclerosis
Item
diagnosis of rapidly progressive multiple sclerosis (ms) by proser criteria and at high risk for a fatal outcome or severe disability with one of the following: primary progressive disease relapsing/remitting disease with 2 or more attacks in 2 years secondary progressive disease
boolean
C0026769 (UMLS CUI [1])
extended disability status scale
Item
extended disability status scale (edss) between 5.0 and 8.0 with deterioration in the edss of 1 or more points over the past year
boolean
C0451246 (UMLS CUI [1])
relapse of ms
Item
more than 60 days since relapse of ms
boolean
C0035020 (UMLS CUI [1])
myelodysplasia
Item
no evidence of myelodysplasia
boolean
C0026985 (UMLS CUI [1])
Twin
Item
sibling donor proven to be an identical twin by abo typing, hla typing, and vntr analysis (for syngeneic transplantation)
boolean
C0005810 (UMLS CUI [1])
C0019721 (UMLS CUI [2])
C0019721 (UMLS CUI [3])
radiotherapy
Item
radiotherapy: no prior total-lymphoid irradiation
boolean
C1522449 (UMLS CUI [1])
investigational agents
Item
other: no other concurrent investigational agents
boolean
C1875319 (UMLS CUI [1])
hepatic function
Item
hepatic: no hepatic impairment that would preclude high-dose immunosuppressive therapy
boolean
C0232741 (UMLS CUI [1])
renal function
Item
renal: no renal impairment that would preclude high-dose immunosuppressive therapy
boolean
C0232804 (UMLS CUI [1])
cardiac function
Item
cardiovascular: no cardiac impairment that would preclude high-dose immunosuppressive therapy
boolean
C0232164 (UMLS CUI [1])
pulmonary function
Item
pulmonary: no pulmonary impairment that would preclude high-dose immunosuppressive therapy
boolean
C0231921 (UMLS CUI [1])
neurologic function
Item
no neurologic impairment that would preclude high-dose immunosuppressive therapy
boolean
C0746866 (UMLS CUI [1])
infection
Item
no active uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
malignancy
Item
no active malignancy
boolean
C0006826 (UMLS CUI [1])
comorbidity
Item
no other illness that would severely limit life expectancy
boolean
C0009488 (UMLS CUI [1])
medical or psychiatric conditions
Item
no medical or psychiatric conditions that would preclude study
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
hypersensitivity to murine proteins or e. coli-derived proteins
Item
no history of hypersensitivity to murine proteins or e. coli-derived proteins
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
compliance
Item
no demonstrated lack of compliance with prior medical care
boolean
C1321605 (UMLS CUI [1])
mri scan
Item
able to undergo an mri scan
boolean
C0917711 (UMLS CUI [1])
HIV
Item
hiv negative
boolean
C0019682 (UMLS CUI [1])
pregnancy
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
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