ID

30939

Beschrijving

Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis.; ODM derived from: https://clinicaltrials.gov/show/NCT00630383

Link

https://clinicaltrials.gov/show/NCT00630383

Trefwoorden

Versies (1)
  1. 05-07-18 05-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 juli 2018

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00630383

Engels

Eligibility Multiple Sclerosis NCT00630383

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with documented multiple sclerosis relapsing remitting or secondary progressive with relapses, according to mcdonald's criteria, and an mri scan consistent with ms according to fazekas criteria
Beschrijving

Multiple Sclerosis, Relapsing-Remitting | Secondary Progressive Multiple Sclerosis Associated with Relapses | MRI scan Consistent with Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2,1]
C0751965
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0035020
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0026769
2. patients with at least 1 relapse in the last 12 months
Beschrijving

Relapse Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
3. patients with edss score in the range of 0 to 5.5 at the baseline visit
Beschrijving

EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
4. patients of both genders, age >18 years and < 60 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. women of child bearing potential, (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study.
Beschrijving

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
6. be able and willing to comply with study visits and procedures per protocol.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
7. understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no populations at risk of severe illness or death will be included in this study
Beschrijving

At risk Illness Severe | At risk Death

Datatype

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0221423
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0011065
1. life expectancy < 6 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
2. patient is < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.
Beschrijving

Malignant Neoplasms Free of Duration | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
3. patient with grade iii/iv cardiac problems as defined by the new york heart association criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
Beschrijving

Cardiac problem New York Heart Association Classification | Congestive heart failure | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262402
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0027051
4. patients with severe and/or uncontrolled medical condition.
Beschrijving

Medical condition Severe Uncontrolled | Medical condition Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
5. patient has a known diagnosis of human immunodeficiency virus (hiv) infection.
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
6. anaemia (hb <10 g/dl for females, <11 g/dl for males)
Beschrijving

Anemia | Hemoglobin measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
7. prior or present evidence of parasitic infection; prior treatment with anti-helminthic drugs
Beschrijving

Parasitic infection | Anthelmintics

Datatype

boolean

Alias
UMLS CUI [1]
C0747256
UMLS CUI [2]
C0003158
8. patient with serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol
Beschrijving

Illness Serious Interferes with Treatment completion | Serious mental illness Interferes with Treatment completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0580352
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0580352
9. history of poor compliance or history of drug/alcohol abuse, or excessive alcohol consumption that would interfere with the ability to comply with the study protocol,
Beschrijving

Poor compliance Interferes with Protocol Compliance | Substance Use Disorders Interfere with Protocol Compliance | Alcohol intake above recommended sensible limits Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0560219
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
10. severe asthma, allergy, other autoimmune disease or any condition that the physician judges could be detrimental to subjects participating in this study; including deviations deemed clinically important from normal clinical laboratory
Beschrijving

Severe asthma | Severe allergy | Autoimmune Disease Severe | Condition Study Subject Participation Status Unfavorable | Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C2945656
UMLS CUI [3,1]
C0004364
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C3640815
UMLS CUI [5]
C0438215
previous treatment
Beschrijving

Prior Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
1. treatment with interferon or glatiramer acetate or immunosuppressive drugs within 26 weeks prior to baseline
Beschrijving

Interferon | Glatiramer acetate | Immunosuppressive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0289884
UMLS CUI [3]
C0021081
2. treatment with bone marrow transplantation, total lymphoid irradiation, monoclonal antibodies, umbilical cord stem cells, aimspro at any time prior to baseline
Beschrijving

Bone Marrow Transplantation | Lymphatic Irradiation Total | Monoclonal Antibodies | Umbilical Cord Blood Stem Cell | Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2,1]
C0024230
UMLS CUI [2,2]
C0439810
UMLS CUI [3]
C0003250
UMLS CUI [4]
C1710528
UMLS CUI [5]
C3846158
3. treatment with corticosteroids or acth within 4 weeks prior to baseline
Beschrijving

Adrenal Cortex Hormones | Corticotropin

Datatype

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0001655
4. treatment with any investigational agent within 12 weeks prior to baseline
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Multiple Sclerosis NCT00630383

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting | Secondary Progressive Multiple Sclerosis Associated with Relapses | MRI scan Consistent with Multiple Sclerosis
Item
1. patients with documented multiple sclerosis relapsing remitting or secondary progressive with relapses, according to mcdonald's criteria, and an mri scan consistent with ms according to fazekas criteria
boolean
C0751967 (UMLS CUI [1])
C0751965 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0035020 (UMLS CUI [2,3])
C0024485 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
Relapse Quantity
Item
2. patients with at least 1 relapse in the last 12 months
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
EDSS
Item
3. patients with edss score in the range of 0 to 5.5 at the baseline visit
boolean
C0451246 (UMLS CUI [1])
Age
Item
4. patients of both genders, age >18 years and < 60 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
5. women of child bearing potential, (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Protocol Compliance
Item
6. be able and willing to comply with study visits and procedures per protocol.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
7. understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
At risk Illness Severe | At risk Death
Item
no populations at risk of severe illness or death will be included in this study
boolean
C1444641 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1444641 (UMLS CUI [2,1])
C0011065 (UMLS CUI [2,2])
Life Expectancy
Item
1. life expectancy < 6 months.
boolean
C0023671 (UMLS CUI [1])
Malignant Neoplasms Free of Duration | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
2. patient is < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.
boolean
C0006826 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Cardiac problem New York Heart Association Classification | Congestive heart failure | Myocardial Infarction
Item
3. patient with grade iii/iv cardiac problems as defined by the new york heart association criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
boolean
C0262402 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Medical condition Severe Uncontrolled | Medical condition Uncontrolled
Item
4. patients with severe and/or uncontrolled medical condition.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
HIV Infection
Item
5. patient has a known diagnosis of human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Anemia | Hemoglobin measurement | Gender
Item
6. anaemia (hb <10 g/dl for females, <11 g/dl for males)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Parasitic infection | Anthelmintics
Item
7. prior or present evidence of parasitic infection; prior treatment with anti-helminthic drugs
boolean
C0747256 (UMLS CUI [1])
C0003158 (UMLS CUI [2])
Illness Serious Interferes with Treatment completion | Serious mental illness Interferes with Treatment completion
Item
8. patient with serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0580352 (UMLS CUI [2,3])
Poor compliance Interferes with Protocol Compliance | Substance Use Disorders Interfere with Protocol Compliance | Alcohol intake above recommended sensible limits Interferes with Protocol Compliance
Item
9. history of poor compliance or history of drug/alcohol abuse, or excessive alcohol consumption that would interfere with the ability to comply with the study protocol,
boolean
C0032646 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0560219 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Severe asthma | Severe allergy | Autoimmune Disease Severe | Condition Study Subject Participation Status Unfavorable | Laboratory test result abnormal
Item
10. severe asthma, allergy, other autoimmune disease or any condition that the physician judges could be detrimental to subjects participating in this study; including deviations deemed clinically important from normal clinical laboratory
boolean
C0581126 (UMLS CUI [1])
C2945656 (UMLS CUI [2])
C0004364 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0348080 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C3640815 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5])
Prior Therapy
Item
previous treatment
boolean
C1514463 (UMLS CUI [1])
Interferon | Glatiramer acetate | Immunosuppressive Agents
Item
1. treatment with interferon or glatiramer acetate or immunosuppressive drugs within 26 weeks prior to baseline
boolean
C3652465 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
Bone Marrow Transplantation | Lymphatic Irradiation Total | Monoclonal Antibodies | Umbilical Cord Blood Stem Cell | Other Coding
Item
2. treatment with bone marrow transplantation, total lymphoid irradiation, monoclonal antibodies, umbilical cord stem cells, aimspro at any time prior to baseline
boolean
C0005961 (UMLS CUI [1])
C0024230 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C0003250 (UMLS CUI [3])
C1710528 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
Adrenal Cortex Hormones | Corticotropin
Item
3. treatment with corticosteroids or acth within 4 weeks prior to baseline
boolean
C0001617 (UMLS CUI [1])
C0001655 (UMLS CUI [2])
Investigational New Drugs
Item
4. treatment with any investigational agent within 12 weeks prior to baseline
boolean
C0013230 (UMLS CUI [1])
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