ID

18290

Beschreibung

Safety and Efficacy Study of Doxycycline in Combination With Interferon-B-1a to Treat Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00246324

Link

https://clinicaltrials.gov/show/NCT00246324

Stichworte

Versionen (1)
  1. 28.10.16 28.10.16 -
Hochgeladen am

28. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00246324

Englisch

Eligibility Multiple Sclerosis NCT00246324

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-55
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
relapsing-remitting multiple sclerosis (rrms)
Beschreibung

Multiple Sclerosis, Relapsing-Remitting

Datentyp

boolean

Alias
UMLS CUI [1]
C0751967
avonex therapy for 6 months prior continuous
Beschreibung

Avonex

Datentyp

boolean

Alias
UMLS CUI [1]
C0594372
annualized relapse rate >2 during avonex therapy
Beschreibung

Avonex | Relapse Rate Annual

Datentyp

boolean

Alias
UMLS CUI [1]
C0594372
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C1521828
UMLS CUI [2,3]
C0332181
most recent relapse within 60 days of baseline
Beschreibung

Relapse Most Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1513491
entry expanded disability status scale (edss) 1.5-4.5
Beschreibung

EDSS

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
one or more gadolinium (gd+) mri lesions on a baseline mri
Beschreibung

Gadolinium-Enhancing Lesion | Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1]
C1333400
UMLS CUI [2]
C0024485
no history of immune modulator or immunosuppressant therapy used in combination with avonex (other then gsc administer for clinical relapses)
Beschreibung

Immunomodulation | Therapeutic immunosuppression | Avonex | Glucocorticoids Relapse Clinical

Datentyp

boolean

Alias
UMLS CUI [1]
C1963758
UMLS CUI [2]
C0021079
UMLS CUI [3]
C0594372
UMLS CUI [4,1]
C0017710
UMLS CUI [4,2]
C0035020
UMLS CUI [4,3]
C0205210
not participating in any other study of ms therapeutics
Beschreibung

Study Subject Participation Status | Therapeutic procedure Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0026769
serum neutralizing antibodies (nabs) titer to avonex <20
Beschreibung

Avonex | Serum Neutralizing Antibodies Titer

Datentyp

boolean

Alias
UMLS CUI [1]
C0594372
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0475463
UMLS CUI [2,3]
C0475208
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
medical or psychiatric conditions that will affect patients ability to provide informed consent
Beschreibung

Medical condition Affecting Informed Consent | Mental condition Affecting Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0021430
inability to undergo mri
Beschreibung

Magnetic Resonance Imaging Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
clinically serious medical conditions or significantly abnormal labs
Beschreibung

Medical condition Serious Clinical | Laboratory Results Abnormal Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0205161
UMLS CUI [2,3]
C0750502
no use of these medications or procedures within six months prior to study:
Beschreibung

Pharmaceutical Preparations Use | Therapeutic procedure Use

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1524063
*monoclonal antibodies,total lymphoid radiation,systemic steroids,cytotoxic or immunosuppressive medications such as mitoxantrone or cyclophosphamide or any other investigational drugs
Beschreibung

Monoclonal Antibodies | Total Lymphatic Radiation Therapy | systemic steroids | Cytotoxic agent | Immunosuppressive Agents | Mitoxantrone | Cyclophosphamide | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0003250
UMLS CUI [2,1]
C0086572
UMLS CUI [2,2]
C0439810
UMLS CUI [3]
C2825233
UMLS CUI [4]
C0304497
UMLS CUI [5]
C0021081
UMLS CUI [6]
C0026259
UMLS CUI [7]
C0010583
UMLS CUI [8]
C0013230
interferon neutralizing antibody titers >20
Beschreibung

Interferon Neutralizing Antibodies Titer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021747
UMLS CUI [1,2]
C0475463
UMLS CUI [1,3]
C0475208
no breast feeding or pregnant
Beschreibung

Breast Feeding | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
no patients with any systemic illness,psychiatric condition or other disorder that would concern safety of patient to complete procedures of protocol
Beschreibung

Systemic disease Affecting patient safety | Systemic disease Affecting Protocol Compliance | Mental condition Affecting patient safety | Mental condition Affecting Protocol Compliance | Disease Affecting patient safety | Disease Affecting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1113679
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0525058
abnormal blood test
Beschreibung

Blood test abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0854146
clinically significant abnormality on chest x-ray (cxr)
Beschreibung

Chest X-ray abnormal Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0436503
UMLS CUI [1,2]
C2826293
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT00246324

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-55
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
relapsing-remitting multiple sclerosis (rrms)
boolean
C0751967 (UMLS CUI [1])
Avonex
Item
avonex therapy for 6 months prior continuous
boolean
C0594372 (UMLS CUI [1])
Avonex | Relapse Rate Annual
Item
annualized relapse rate >2 during avonex therapy
boolean
C0594372 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C1521828 (UMLS CUI [2,2])
C0332181 (UMLS CUI [2,3])
Relapse Most Recent
Item
most recent relapse within 60 days of baseline
boolean
C0035020 (UMLS CUI [1,1])
C1513491 (UMLS CUI [1,2])
EDSS
Item
entry expanded disability status scale (edss) 1.5-4.5
boolean
C0451246 (UMLS CUI [1])
Gadolinium-Enhancing Lesion | Magnetic Resonance Imaging
Item
one or more gadolinium (gd+) mri lesions on a baseline mri
boolean
C1333400 (UMLS CUI [1])
C0024485 (UMLS CUI [2])
Immunomodulation | Therapeutic immunosuppression | Avonex | Glucocorticoids Relapse Clinical
Item
no history of immune modulator or immunosuppressant therapy used in combination with avonex (other then gsc administer for clinical relapses)
boolean
C1963758 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C0594372 (UMLS CUI [3])
C0017710 (UMLS CUI [4,1])
C0035020 (UMLS CUI [4,2])
C0205210 (UMLS CUI [4,3])
Study Subject Participation Status | Therapeutic procedure Multiple Sclerosis
Item
not participating in any other study of ms therapeutics
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
Avonex | Serum Neutralizing Antibodies Titer
Item
serum neutralizing antibodies (nabs) titer to avonex <20
boolean
C0594372 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0475463 (UMLS CUI [2,2])
C0475208 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical condition Affecting Informed Consent | Mental condition Affecting Informed Consent
Item
medical or psychiatric conditions that will affect patients ability to provide informed consent
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Magnetic Resonance Imaging Receive Unable
Item
inability to undergo mri
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Medical condition Serious Clinical | Laboratory Results Abnormal Significant
Item
clinically serious medical conditions or significantly abnormal labs
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C1254595 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
Pharmaceutical Preparations Use | Therapeutic procedure Use
Item
no use of these medications or procedures within six months prior to study:
boolean
C0013227 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
Monoclonal Antibodies | Total Lymphatic Radiation Therapy | systemic steroids | Cytotoxic agent | Immunosuppressive Agents | Mitoxantrone | Cyclophosphamide | Investigational New Drugs
Item
*monoclonal antibodies,total lymphoid radiation,systemic steroids,cytotoxic or immunosuppressive medications such as mitoxantrone or cyclophosphamide or any other investigational drugs
boolean
C0003250 (UMLS CUI [1])
C0086572 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C2825233 (UMLS CUI [3])
C0304497 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
C0010583 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Interferon Neutralizing Antibodies Titer
Item
interferon neutralizing antibody titers >20
boolean
C0021747 (UMLS CUI [1,1])
C0475463 (UMLS CUI [1,2])
C0475208 (UMLS CUI [1,3])
Breast Feeding | Pregnancy
Item
no breast feeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Systemic disease Affecting patient safety | Systemic disease Affecting Protocol Compliance | Mental condition Affecting patient safety | Mental condition Affecting Protocol Compliance | Disease Affecting patient safety | Disease Affecting Protocol Compliance
Item
no patients with any systemic illness,psychiatric condition or other disorder that would concern safety of patient to complete procedures of protocol
boolean
C0442893 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Blood test abnormal
Item
abnormal blood test
boolean
C0854146 (UMLS CUI [1])
Chest X-ray abnormal Clinical Significance
Item
clinically significant abnormality on chest x-ray (cxr)
boolean
C0436503 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
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