ID

15070

Beschreibung

A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants; ODM derived from: https://clinicaltrials.gov/show/NCT02343783

Link

https://clinicaltrials.gov/show/NCT02343783

Stichworte

Versionen (1)
  1. 14.05.16 14.05.16 -
Hochgeladen am

14. Mai 2016

DOI

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Creative Commons BY 4.0
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Eligibility Dermatitis, Atopic NCT02343783

Englisch

Eligibility Dermatitis, Atopic NCT02343783

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Beschreibung

Informed Consent | Comprehension Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions and restrictions specified in this protocol
Beschreibung

Compliance behavior Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
* for participants with asthma:
Beschreibung

Study Subject | Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0681850
UMLS CUI [2]
C0004096
participant must have a physician documented diagnosis of asthma for at least 12 months before screening
Beschreibung

Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
participant must have an asthma control questionnaire 6 (acq6) less than (<) 1.5 at screening
Beschreibung

Asthma control questionnaire

Datentyp

boolean

Alias
UMLS CUI [1]
C2919686
* for participants with atopic dermatitis:
Beschreibung

Study Subject | Dermatitis, Atopic

Datentyp

boolean

Alias
UMLS CUI [1]
C0681850
UMLS CUI [2]
C0011615
participant must have a physician documented diagnosis of atopic dermatitis for at least 12 months before screening based on uk refinement of the hanifin and rajka's diagnostic criteria
Beschreibung

Dermatitis, Atopic

Datentyp

boolean

Alias
UMLS CUI [1]
C0011615
participant must have atopic dermatitis with and investigators global assessment (iga) score of 2 to 4 at screening
Beschreibung

Dermatitis, Atopic | Assessment scale Clinical Investigators

Datentyp

boolean

Alias
UMLS CUI [1]
C0011615
UMLS CUI [2,1]
C0450973
UMLS CUI [2,2]
C0008961
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has taken any prohibited or restricted medications as noted below under prestudy and concomitant therapy
Beschreibung

Drugs, Non-Prescription | Pre-study Therapeutic procedure | Concomitant Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2,1]
C1527048
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C1707479
participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 6 weeks or 5 half-lives (whichever is longer) before the screening visit
Beschreibung

Investigational New Drugs | INVESTIGATIONAL VACCINES | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C1875384
UMLS CUI [3]
C2346570
* for participants with asthma:
Beschreibung

Study Subject | Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0681850
UMLS CUI [2]
C0004096
participant has a history of life-threatening asthma, defined as a history of respiratory arrest or requiring intubation for asthma
Beschreibung

Asthma Life Threatening | Respiratory arrest | Requirement Intubation Asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0162297
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0021925
UMLS CUI [3,3]
C0004096
participant had been admitted to a hospital for asthma in the 1 year before screening
Beschreibung

Hospitalization Asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004096
* for participants with atopic dermatitis:
Beschreibung

Study Subject | Dermatitis, Atopic

Datentyp

boolean

Alias
UMLS CUI [1]
C0681850
UMLS CUI [2]
C0011615
participant has evidence of any other skin condition that would interfere with assessment of atopic dermatitis (ad)
Beschreibung

Other Skin condition Interferes with Evaluation Atopic Dermatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1719933
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C1261322
UMLS CUI [1,5]
C0011615
participant has active ad related infection or has had an active ad infection within 2 weeks of screening (participants with evidence of colonization on skin swab testing but with no infection are allowed)
Beschreibung

Atopic Dermatitis Related Communicable Disease | Skin swab (lab test)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011615
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0009450
UMLS CUI [2]
C2266652
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Ähnliche Modelle

Eligibility Dermatitis, Atopic NCT02343783

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Comprehension Study Protocol
Item
participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Compliance behavior Study Protocol
Item
participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions and restrictions specified in this protocol
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Study Subject | Asthma
Item
* for participants with asthma:
boolean
C0681850 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
Asthma
Item
participant must have a physician documented diagnosis of asthma for at least 12 months before screening
boolean
C0004096 (UMLS CUI [1])
Asthma control questionnaire
Item
participant must have an asthma control questionnaire 6 (acq6) less than (<) 1.5 at screening
boolean
C2919686 (UMLS CUI [1])
Study Subject | Dermatitis, Atopic
Item
* for participants with atopic dermatitis:
boolean
C0681850 (UMLS CUI [1])
C0011615 (UMLS CUI [2])
Dermatitis, Atopic
Item
participant must have a physician documented diagnosis of atopic dermatitis for at least 12 months before screening based on uk refinement of the hanifin and rajka's diagnostic criteria
boolean
C0011615 (UMLS CUI [1])
Dermatitis, Atopic | Assessment scale Clinical Investigators
Item
participant must have atopic dermatitis with and investigators global assessment (iga) score of 2 to 4 at screening
boolean
C0011615 (UMLS CUI [1])
C0450973 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Drugs, Non-Prescription | Pre-study Therapeutic procedure | Concomitant Therapy
Item
participant has taken any prohibited or restricted medications as noted below under prestudy and concomitant therapy
boolean
C0013231 (UMLS CUI [1])
C1527048 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1707479 (UMLS CUI [3])
Investigational New Drugs | INVESTIGATIONAL VACCINES | Investigational Medical Device
Item
participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 6 weeks or 5 half-lives (whichever is longer) before the screening visit
boolean
C0013230 (UMLS CUI [1])
C1875384 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Study Subject | Asthma
Item
* for participants with asthma:
boolean
C0681850 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
Asthma Life Threatening | Respiratory arrest | Requirement Intubation Asthma
Item
participant has a history of life-threatening asthma, defined as a history of respiratory arrest or requiring intubation for asthma
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0162297 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0021925 (UMLS CUI [3,2])
C0004096 (UMLS CUI [3,3])
Hospitalization Asthma
Item
participant had been admitted to a hospital for asthma in the 1 year before screening
boolean
C0019993 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
Study Subject | Dermatitis, Atopic
Item
* for participants with atopic dermatitis:
boolean
C0681850 (UMLS CUI [1])
C0011615 (UMLS CUI [2])
Other Skin condition Interferes with Evaluation Atopic Dermatitis
Item
participant has evidence of any other skin condition that would interfere with assessment of atopic dermatitis (ad)
boolean
C0205394 (UMLS CUI [1,1])
C1719933 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0011615 (UMLS CUI [1,5])
Atopic Dermatitis Related Communicable Disease | Skin swab (lab test)
Item
participant has active ad related infection or has had an active ad infection within 2 weeks of screening (participants with evidence of colonization on skin swab testing but with no infection are allowed)
boolean
C0011615 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C2266652 (UMLS CUI [2])
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