ID

18291

Description

Phase II High-Dose Cyclophosphamide for Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00296205

Link

https://clinicaltrials.gov/show/NCT00296205

Keywords

Versions (1)
  1. 28/10/2016 28/10/2016 -
Uploaded on

28 de outubro de 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00296205

English

Eligibility Multiple Sclerosis NCT00296205

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of secondary progressive (spms), primary progressive (ppms) or progressive relapsing (prms) multiple sclerosis
Description

Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Progressive Relapsing

Data type

boolean

Alias
UMLS CUI [1]
C0751965
UMLS CUI [2]
C0751964
UMLS CUI [3]
C0393666
a diagnosis of ms will be established by fulfilling criteria "recommended diagnostic criteria for multiple sclerosis: guidelines from the internal panel on the diagnosis of multiple sclerosis"
Description

Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
the subtype of ms will be established by the natural history of the disease
Description

Multiple Sclerosis Subtype | natural history of disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0449560
UMLS CUI [2]
C0599879
age >18 but < 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
an extended disability status scale (edss) score of >3.5 after two standard treatment regimens ifnb1a ifnb1b glatiramer acetate mitoxanthrone steroids, plasmapheresis or ivig individually or in combination constitute a single treatment regimen
Description

EDSS | Standard of Care Quantity | Interferon beta-1a | interferon beta-1b | glatiramer acetate | Mitoxantrone | Plasmapheresis | Immunoglobulins, Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C0451246
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0254119
UMLS CUI [4]
C0244713
UMLS CUI [5]
C0289884
UMLS CUI [6]
C0026259
UMLS CUI [7]
C0032134
UMLS CUI [8]
C0085297
patient must have a left ventricular ejection fraction of > 45%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
serum creatinine <3mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
for women of childbearing potential, serum βhcg (less than seven days before start of cyclophosphamide)
Description

Childbearing Potential Serum Beta-HCG Test | Cyclophosphamide

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C1255526
UMLS CUI [2]
C0010583
willingness to participate in a clinical trial
Description

Study Subject Participation Status Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are preterminal or moribund
Description

pre-terminal | Moribund

Data type

boolean

Alias
UMLS CUI [1]
C0184771
UMLS CUI [2]
C0424547
patients with active malignancies
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patients with chromosomal abnormalities or peripheral blood counts suggestive of myelodysplastic syndrome
Description

Chromosome Aberrations | Peripheral blood Cell Count Suggestive of MYELODYSPLASTIC SYNDROME

Data type

boolean

Alias
UMLS CUI [1]
C0008625
UMLS CUI [2,1]
C0229664
UMLS CUI [2,2]
C0005771
UMLS CUI [2,3]
C0332299
UMLS CUI [2,4]
C3463824
patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection
Description

Bacterial Infections Requirement Microbicides Oral | Mycoses Requirement Microbicides Oral | Bacterial Infections Requirement Intravenous injection of antimicrobial substance | Mycoses Requirement Intravenous injection of antimicrobial substance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1136254
UMLS CUI [1,4]
C1527415
UMLS CUI [2,1]
C0026946
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1136254
UMLS CUI [2,4]
C1527415
UMLS CUI [3,1]
C0004623
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C1960380
UMLS CUI [4,1]
C0026946
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C1960380
pregnant women and breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with known intolerance to g-csf
Description

intolerance to G-CSF

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0079459
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Similar models

Eligibility Multiple Sclerosis NCT00296205

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
diagnosis of secondary progressive (spms), primary progressive (ppms) or progressive relapsing (prms) multiple sclerosis
boolean
C0751965 (UMLS CUI [1])
C0751964 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Multiple Sclerosis
Item
a diagnosis of ms will be established by fulfilling criteria "recommended diagnostic criteria for multiple sclerosis: guidelines from the internal panel on the diagnosis of multiple sclerosis"
boolean
C0026769 (UMLS CUI [1])
Multiple Sclerosis Subtype | natural history of disease
Item
the subtype of ms will be established by the natural history of the disease
boolean
C0026769 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C0599879 (UMLS CUI [2])
Age
Item
age >18 but < 75 years
boolean
C0001779 (UMLS CUI [1])
EDSS | Standard of Care Quantity | Interferon beta-1a | interferon beta-1b | glatiramer acetate | Mitoxantrone | Plasmapheresis | Immunoglobulins, Intravenous
Item
an extended disability status scale (edss) score of >3.5 after two standard treatment regimens ifnb1a ifnb1b glatiramer acetate mitoxanthrone steroids, plasmapheresis or ivig individually or in combination constitute a single treatment regimen
boolean
C0451246 (UMLS CUI [1])
C2936643 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0254119 (UMLS CUI [3])
C0244713 (UMLS CUI [4])
C0289884 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
C0032134 (UMLS CUI [7])
C0085297 (UMLS CUI [8])
Left ventricular ejection fraction
Item
patient must have a left ventricular ejection fraction of > 45%
boolean
C0428772 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine <3mg/dl
boolean
C0201976 (UMLS CUI [1])
Childbearing Potential Serum Beta-HCG Test | Cyclophosphamide
Item
for women of childbearing potential, serum βhcg (less than seven days before start of cyclophosphamide)
boolean
C3831118 (UMLS CUI [1,1])
C1255526 (UMLS CUI [1,2])
C0010583 (UMLS CUI [2])
Study Subject Participation Status Willing
Item
willingness to participate in a clinical trial
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
pre-terminal | Moribund
Item
patients who are preterminal or moribund
boolean
C0184771 (UMLS CUI [1])
C0424547 (UMLS CUI [2])
Malignant Neoplasms
Item
patients with active malignancies
boolean
C0006826 (UMLS CUI [1])
Chromosome Aberrations | Peripheral blood Cell Count Suggestive of MYELODYSPLASTIC SYNDROME
Item
patients with chromosomal abnormalities or peripheral blood counts suggestive of myelodysplastic syndrome
boolean
C0008625 (UMLS CUI [1])
C0229664 (UMLS CUI [2,1])
C0005771 (UMLS CUI [2,2])
C0332299 (UMLS CUI [2,3])
C3463824 (UMLS CUI [2,4])
Bacterial Infections Requirement Microbicides Oral | Mycoses Requirement Microbicides Oral | Bacterial Infections Requirement Intravenous injection of antimicrobial substance | Mycoses Requirement Intravenous injection of antimicrobial substance
Item
patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection
boolean
C0004623 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1136254 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
C0026946 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1136254 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
C0004623 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1960380 (UMLS CUI [3,3])
C0026946 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C1960380 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant women and breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
intolerance to G-CSF
Item
patients with known intolerance to g-csf
boolean
C1744706 (UMLS CUI [1,1])
C0079459 (UMLS CUI [1,2])
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