ID

23444

Description

Responsible Party: Prof. Dr. Dr. Ursula Mirastschijski, Principal Investigator, University of Bremen ClinicalTrials.gov Identifier: NCT02985437 History of Changes Other Study ID Numbers: SMWH01 2015-000890-11 ( EudraCT Number ) DRKS00011353 ( Other Identifier: German Clinical Trials Register (DRKS) ) Study First Received: November 28, 2016 Last Updated: May 2, 2017 Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin (SATOSU) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02985437

Link

https://clinicaltrials.gov/ct2/show/NCT02985437

Keywords

Versions (1)
  1. 7/4/17 7/4/17 -
Uploaded on

July 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Surfactant on Intact Skin DRKS00011353 NCT02985437 DRKS00011353

English

Eligibility Surfactant on Intact Skin NCT02985437 DRKS00011353

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Ages Eligible for Study: 18 Years to 60 Years (Adult)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Two healthy forearms,
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
No known chronical skin diseases,
Description

Chronic disease of skin

Data type

boolean

Alias
UMLS CUI [1]
C1290009
Dermatoses or allergies,
Description

Dermatoses, Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0037274
UMLS CUI [2]
C0020517
Signed form of consent,
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Caucasian
Description

Caucasian

Data type

boolean

Alias
UMLS CUI [1]
C0007457
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Pregnancy or nursing period,
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Diabetes (Type I or II),
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
Systemic or infectious diseases,
Description

Systemic or infectious diseases

Data type

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0009450
Skin disease,
Description

Skin disease

Data type

text

Alias
UMLS CUI [1]
C0037274
Known allergies against bovine products or wound dressings,
Description

Hypersensitivity to bovine products

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3667982
Mental diseases, missing ability to consent,
Description

Mental Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
Addictive disorders (e.g. alcohol, drugs),
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Peripheral circulatory disorder, Morbus Raynaud,
Description

Peripheral Vascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0085096
Current (or < 4 weeks ago) participation in clinical trials
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Surfactant on Intact Skin NCT02985437 DRKS00011353

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Ages Eligible for Study: 18 Years to 60 Years (Adult)
boolean
C0001779 (UMLS CUI [1])
Control Group
Item
Two healthy forearms,
boolean
C0009932 (UMLS CUI [1])
Chronic disease of skin
Item
No known chronical skin diseases,
boolean
C1290009 (UMLS CUI [1])
Dermatoses, Hypersensitivity
Item
Dermatoses or allergies,
boolean
C0037274 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
Informed Consent
Item
Signed form of consent,
boolean
C0021430 (UMLS CUI [1])
Caucasian
Item
Caucasian
boolean
C0007457 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Gynaecological Status
Item
Pregnancy or nursing period,
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus
Item
Diabetes (Type I or II),
boolean
C0011849 (UMLS CUI [1])
Systemic or infectious diseases
Item
Systemic or infectious diseases,
boolean
C0442893 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Skin disease
Item
Skin disease,
text
C0037274 (UMLS CUI [1])
Hypersensitivity to bovine products
Item
Known allergies against bovine products or wound dressings,
boolean
C0020517 (UMLS CUI [1,1])
C3667982 (UMLS CUI [1,2])
Mental Disorders
Item
Mental diseases, missing ability to consent,
boolean
C0004936 (UMLS CUI [1])
Substance Use Disorder
Item
Addictive disorders (e.g. alcohol, drugs),
boolean
C0038586 (UMLS CUI [1])
Peripheral Vascular Diseases
Item
Peripheral circulatory disorder, Morbus Raynaud,
boolean
C0085096 (UMLS CUI [1])
Study Participation Status
Item
Current (or < 4 weeks ago) participation in clinical trials
boolean
C2348568 (UMLS CUI [1])
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