ID

13676

Description

A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00001669

Link

https://clinicaltrials.gov/show/NCT00001669

Keywords

Versions (1)
  1. 2/27/16 2/27/16 -
Uploaded on

February 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00001669

English

Eligibility Multiple Sclerosis NCT00001669

1 forms  
Criteria
Description

Criteria

stage i - known by history to have a mean enhancing lesion frequency of 0.3 per month or greater;
Description

Multiple sclerosis, disease stage, frequency

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0699749
stage ii - known by history to have a mean enhancing lesion frequency of 0.5 per month or greater;
Description

Multiple sclerosis, disease stage, frequency

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0699749
ability to comply with protocol requirements;
Description

comply with protocol

Data type

boolean

Alias
UMLS CUI [1]
C1321605
provide written informed consent;
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
if a female patient, not of child bearing potential (surgically sterilized or post-menopausal) or if of child bearing potential, documented to be nonpregnant by urine pregnancy test and not lactating with adequate contraception and counseling.
Description

Gender, childbearing potential, pregnancy, breast feeding, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
UMLS CUI [5]
C0700589
male patients should also receive adequate counseling and exercise adequate contraception.
Description

Gender, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0700589
no clinically significant abnormalities on the prestudy laboratory evaluations, physical examination, electrocardiogram (ecg), chest x-ray, mammogram or ophthalmologic exam.
Description

prestudy assessment

Data type

boolean

Alias
UMLS CUI [1]
C3899485
no connective tissue or rheumatic disorder (systemic lupus erythematosus [sle] ; rheumatoid arthritis [ra]; progressive systemic sclerosis [pss]; sjogren's syndrome [ss]).
Description

connective tissue or rheumatic disorder

Data type

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2]
C3495832
patient may not be hiv (human immunodeficiency virus), htlv-1 (human t cell leukemia virus), or hb/c ag (hepatitis b or c surface antigen) positive.
Description

hiv, htlv-1, hep b or c

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2,1]
C0020094
UMLS CUI [2,2]
C0019163
UMLS CUI [3]
C0019196
no history of insulin-producing tumors or reactive hypoglycemia.
Description

history of insulin-producing tumors or reactive hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0021670
UMLS CUI [2]
C0271710
no clinically significant medical condition (e.g., within 6 months of screen had myocardial infarction, angina pectoris, untreated hypertension, and/or congestive heart failure [chf] that, in the opinion of the investigator would compromise the safety of the patient.
Description

clinically significant medical condition

Data type

boolean

Alias
UMLS CUI [1]
C0009488
ability to tolerate mri examinations due to claustrophobia, or have contraindications to mri scanning, such as pacemakers, aneurysm clips, or shrapnel fragments. welders and metal workers must have radiographic evidence to document lack of foreign bodies in the eyes or they will be excluded, due to the risk of eye injury while in the mri machine.
Description

MRI complications

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0024485
no history of substance use disorder (dsm-iv criteria) within the past two years.
Description

substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
no type i or type ii diabetes treated with hypoglycemic agents (diet-controlled type ii diabetes may be included.)
Description

type i or type ii diabetes treated with hypoglycemic agents

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0020616
no history of cancer (with the exception of localized skin cancers with no evidence of metastasis, significant invasion, or recurrence) within three years of screening.
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
no first or second degree relatives with breast cancer.
Description

relatives with breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0559119
have not used an investigational drug within 30 days of the screen visit.
Description

investigational drug use

Data type

boolean

Alias
UMLS CUI [1]
C0013230
have previously received interferon-alpha, interferon-beta, copolymer 1, cyclophosphamide, intravenous immunoglobulin, oral myelin, or other immunosuppressive drugs within 6 months of screen.
Description

Immunosuppressive agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
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Similar models

Eligibility Multiple Sclerosis NCT00001669

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Multiple sclerosis, disease stage, frequency
Item
stage i - known by history to have a mean enhancing lesion frequency of 0.3 per month or greater;
boolean
C0026769 (UMLS CUI [1])
C0699749 (UMLS CUI [2])
Multiple sclerosis, disease stage, frequency
Item
stage ii - known by history to have a mean enhancing lesion frequency of 0.5 per month or greater;
boolean
C0026769 (UMLS CUI [1])
C0699749 (UMLS CUI [2])
comply with protocol
Item
ability to comply with protocol requirements;
boolean
C1321605 (UMLS CUI [1])
written informed consent
Item
provide written informed consent;
boolean
C0021430 (UMLS CUI [1])
Gender, childbearing potential, pregnancy, breast feeding, contraception
Item
if a female patient, not of child bearing potential (surgically sterilized or post-menopausal) or if of child bearing potential, documented to be nonpregnant by urine pregnancy test and not lactating with adequate contraception and counseling.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
Gender, contraception
Item
male patients should also receive adequate counseling and exercise adequate contraception.
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
prestudy assessment
Item
no clinically significant abnormalities on the prestudy laboratory evaluations, physical examination, electrocardiogram (ecg), chest x-ray, mammogram or ophthalmologic exam.
boolean
C3899485 (UMLS CUI [1])
connective tissue or rheumatic disorder
Item
no connective tissue or rheumatic disorder (systemic lupus erythematosus [sle] ; rheumatoid arthritis [ra]; progressive systemic sclerosis [pss]; sjogren's syndrome [ss]).
boolean
C0009782 (UMLS CUI [1])
C3495832 (UMLS CUI [2])
hiv, htlv-1, hep b or c
Item
patient may not be hiv (human immunodeficiency virus), htlv-1 (human t cell leukemia virus), or hb/c ag (hepatitis b or c surface antigen) positive.
boolean
C0019682 (UMLS CUI [1])
C0020094 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3])
history of insulin-producing tumors or reactive hypoglycemia
Item
no history of insulin-producing tumors or reactive hypoglycemia.
boolean
C0021670 (UMLS CUI [1])
C0271710 (UMLS CUI [2])
clinically significant medical condition
Item
no clinically significant medical condition (e.g., within 6 months of screen had myocardial infarction, angina pectoris, untreated hypertension, and/or congestive heart failure [chf] that, in the opinion of the investigator would compromise the safety of the patient.
boolean
C0009488 (UMLS CUI [1])
MRI complications
Item
ability to tolerate mri examinations due to claustrophobia, or have contraindications to mri scanning, such as pacemakers, aneurysm clips, or shrapnel fragments. welders and metal workers must have radiographic evidence to document lack of foreign bodies in the eyes or they will be excluded, due to the risk of eye injury while in the mri machine.
boolean
C1321605 (UMLS CUI [1])
C0024485 (UMLS CUI [2])
substance use disorder
Item
no history of substance use disorder (dsm-iv criteria) within the past two years.
boolean
C0038586 (UMLS CUI [1])
type i or type ii diabetes treated with hypoglycemic agents
Item
no type i or type ii diabetes treated with hypoglycemic agents (diet-controlled type ii diabetes may be included.)
boolean
C0011849 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
malignancies
Item
no history of cancer (with the exception of localized skin cancers with no evidence of metastasis, significant invasion, or recurrence) within three years of screening.
boolean
C0006826 (UMLS CUI [1])
relatives with breast cancer
Item
no first or second degree relatives with breast cancer.
boolean
C0559119 (UMLS CUI [1])
investigational drug use
Item
have not used an investigational drug within 30 days of the screen visit.
boolean
C0013230 (UMLS CUI [1])
Immunosuppressive agents
Item
have previously received interferon-alpha, interferon-beta, copolymer 1, cyclophosphamide, intravenous immunoglobulin, oral myelin, or other immunosuppressive drugs within 6 months of screen.
boolean
C0021081 (UMLS CUI [1])
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