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])
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])