ID

31000

Beschrijving

A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00743769

Link

https://clinicaltrials.gov/show/NCT00743769

Trefwoorden

Versies (1)
  1. 09-07-18 09-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Myocardial Infarction NCT00743769

Engels

Eligibility Myocardial Infarction NCT00743769

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
in good health with no underlying medical condition that, according to the investigator, would place a subject at risk
Beschrijving

Good health | Absence Other medical condition At risk Patient

Datatype

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C3843040
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0030705
having given written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of any malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
use of any tobacco product within 7 years of study entry
Beschrijving

Tobacco use

Datatype

boolean

Alias
UMLS CUI [1]
C0543414
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of drug abuse
Beschrijving

Drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
clinically significant abnormal screening ecg
Beschrijving

Electrocardiogram abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0522055
abnormal vital signs
Beschrijving

Abnormal vital signs

Datatype

boolean

Alias
UMLS CUI [1]
C0277804
use of systemic steroidal therapy), immunotherapy, cytotoxic, chemotherapy or any investigational drug or device within 30 days of study entry. topical steroids are allowed
Beschrijving

Steroid therapy Systemic | Immunotherapy | Cytotoxic therapy | Chemotherapy | Investigational New Drugs | Investigational Medical Device | Topical steroids allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0021083
UMLS CUI [3]
C0677881
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0013230
UMLS CUI [6]
C2346570
UMLS CUI [7,1]
C2064827
UMLS CUI [7,2]
C0683607
women, 40 years of age and above, who have not had a mammography within one year of study entry
Beschrijving

Gender | Age | Mammography Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0024671
UMLS CUI [3,2]
C0332197
men and women, 50 years of age and above, who have not had a sigmoidoscopy within 5 years and colonoscopy within 10 years of study entry
Beschrijving

Age | Sigmoidoscopy Absent | Colonoscopy Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0037075
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0009378
UMLS CUI [3,2]
C0332197
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Similar models

Eligibility Myocardial Infarction NCT00743769

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Good health | Absence Other medical condition At risk Patient
Item
in good health with no underlying medical condition that, according to the investigator, would place a subject at risk
boolean
C3813622 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C3843040 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0030705 (UMLS CUI [2,4])
Informed Consent
Item
having given written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms
Item
evidence of any malignancy
boolean
C0006826 (UMLS CUI [1])
Tobacco use
Item
use of any tobacco product within 7 years of study entry
boolean
C0543414 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Drug abuse
Item
history of drug abuse
boolean
C0013146 (UMLS CUI [1])
Electrocardiogram abnormal
Item
clinically significant abnormal screening ecg
boolean
C0522055 (UMLS CUI [1])
Abnormal vital signs
Item
abnormal vital signs
boolean
C0277804 (UMLS CUI [1])
Steroid therapy Systemic | Immunotherapy | Cytotoxic therapy | Chemotherapy | Investigational New Drugs | Investigational Medical Device | Topical steroids allowed
Item
use of systemic steroidal therapy), immunotherapy, cytotoxic, chemotherapy or any investigational drug or device within 30 days of study entry. topical steroids are allowed
boolean
C0149783 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
C2346570 (UMLS CUI [6])
C2064827 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
Gender | Age | Mammography Absent
Item
women, 40 years of age and above, who have not had a mammography within one year of study entry
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0024671 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Age | Sigmoidoscopy Absent | Colonoscopy Absent
Item
men and women, 50 years of age and above, who have not had a sigmoidoscopy within 5 years and colonoscopy within 10 years of study entry
boolean
C0001779 (UMLS CUI [1])
C0037075 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0009378 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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