ID

16660

Descrizione

Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00017628

collegamento

https://clinicaltrials.gov/show/NCT00017628

Keywords

versioni (1)
  1. 30/07/16 30/07/16 -
Caricato su

30 luglio 2016

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00017628

Inglese

Eligibility Multiple Sclerosis NCT00017628

1 moduli  
Criteria
Descrizione

Criteria

-disease characteristics--
Descrizione

ID.1

Tipo di dati

boolean

diagnosis of multiple sclerosis kurtzke score of 4.0-7.5 increase of 1.0 point over the past 12 months more than 3 relapses in 24 months despite conventional disease modifying therapy failure to stabilize active clinical progression with a 3-day regimen of methylprednisolone iv
Descrizione

ms, kurtzke scor, relapses despite methylprednisolone therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0451246
UMLS CUI [3,1]
C0856120
UMLS CUI [3,2]
C0025815
-prior/concurrent therapy--
Descrizione

prior/concurrent therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C1514463
chemotherapy: no prior cladribine
Descrizione

chemotherapy: no prior cladribine

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0092801
radiotherapy: no prior radiotherapy to greater than 10 cm2 of lung tissue no prior craniospinal irradiation no prior total lymphoid irradiation
Descrizione

prior radiotherapy of lung tissue, craniospinal, lymphoid

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2169076
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C3494227
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0024230
-patient characteristics--
Descrizione

ID.6

Tipo di dati

boolean

hematopoietic: absolute neutrophil count at least 1,000/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9.0 g/dl
Descrizione

absolute neutrophil count , platelet count , hemoglobin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0518015
hepatic: hepatitis b antigen negative bilirubin no greater than 2.0 mg/dl transaminases no greater than 2 times upper limit of normal
Descrizione

hepatitis b antigen negative, bilirubin, transaminases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0919711
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
renal: creatinine no greater than 2.0 mg/dl
Descrizione

creatinine

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201976
cardiovascular: no history of coronary artery disease resting lvef at least 45%
Descrizione

coronary artery disease, lvef

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0428772
pulmonary: fev1/fvc at least 75% predicted dlco at least 50% predicted
Descrizione

fev1/fvc at least 75%, dlco

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4027617
UMLS CUI [2]
C1516251
other:
Descrizione

ID.11

Tipo di dati

boolean

not pregnant
Descrizione

pregnancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
negative pregnancy test
Descrizione

negative pregnancy test

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Descrizione

effective contraception

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0700589
hiv negative
Descrizione

hiv negative

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0481430
no uncontrolled diabetes mellitus
Descrizione

no uncontrolled diabetes mellitus

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011849
no other concurrent medical illness that would preclude study
Descrizione

comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
no concurrent psychiatric illness or mental deficiency that would preclude study
Descrizione

psychiatric illness

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0004936
no prior malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgical therapy such as head and neck cancer or stage i breast cancer, are considered on an individual basis)
Descrizione

prior malignancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
no presence of body shrapnel, metal fragments, or unremovable devices such as a pacemaker or aneurysm clip
Descrizione

foreign objects

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0016542
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Similar models

Eligibility Multiple Sclerosis NCT00017628

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
ID.1
Item
-disease characteristics--
boolean
ms, kurtzke scor, relapses despite methylprednisolone therapy
Item
diagnosis of multiple sclerosis kurtzke score of 4.0-7.5 increase of 1.0 point over the past 12 months more than 3 relapses in 24 months despite conventional disease modifying therapy failure to stabilize active clinical progression with a 3-day regimen of methylprednisolone iv
boolean
C0026769 (UMLS CUI [1])
C0451246 (UMLS CUI [2])
C0856120 (UMLS CUI [3,1])
C0025815 (UMLS CUI [3,2])
prior/concurrent therapy
Item
-prior/concurrent therapy--
boolean
C0009429 (UMLS CUI [1])
C1514463 (UMLS CUI [2])
chemotherapy: no prior cladribine
Item
chemotherapy: no prior cladribine
boolean
C0392920 (UMLS CUI [1,1])
C0092801 (UMLS CUI [1,2])
prior radiotherapy of lung tissue, craniospinal, lymphoid
Item
radiotherapy: no prior radiotherapy to greater than 10 cm2 of lung tissue no prior craniospinal irradiation no prior total lymphoid irradiation
boolean
C1514463 (UMLS CUI [1,1])
C2169076 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C3494227 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0024230 (UMLS CUI [3,2])
ID.6
Item
-patient characteristics--
boolean
absolute neutrophil count , platelet count , hemoglobin
Item
hematopoietic: absolute neutrophil count at least 1,000/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9.0 g/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
hepatitis b antigen negative, bilirubin, transaminases
Item
hepatic: hepatitis b antigen negative bilirubin no greater than 2.0 mg/dl transaminases no greater than 2 times upper limit of normal
boolean
C0919711 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
creatinine
Item
renal: creatinine no greater than 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
coronary artery disease, lvef
Item
cardiovascular: no history of coronary artery disease resting lvef at least 45%
boolean
C0010068 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
fev1/fvc at least 75%, dlco
Item
pulmonary: fev1/fvc at least 75% predicted dlco at least 50% predicted
boolean
C4027617 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
ID.11
Item
other:
boolean
pregnancy
Item
not pregnant
boolean
C0032961 (UMLS CUI [1])
negative pregnancy test
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
effective contraception
Item
fertile patients must use effective contraception
boolean
C0700589 (UMLS CUI [1])
hiv negative
Item
hiv negative
boolean
C0481430 (UMLS CUI [1])
no uncontrolled diabetes mellitus
Item
no uncontrolled diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
comorbidity
Item
no other concurrent medical illness that would preclude study
boolean
C0009488 (UMLS CUI [1])
psychiatric illness
Item
no concurrent psychiatric illness or mental deficiency that would preclude study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
prior malignancy
Item
no prior malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgical therapy such as head and neck cancer or stage i breast cancer, are considered on an individual basis)
boolean
C0006826 (UMLS CUI [1])
foreign objects
Item
no presence of body shrapnel, metal fragments, or unremovable devices such as a pacemaker or aneurysm clip
boolean
C0016542 (UMLS CUI [1])
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