ID

14424

Beschreibung

A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis; ODM derived from: https://clinicaltrials.gov/show/NCT02345928

Link

https://clinicaltrials.gov/show/NCT02345928

Stichworte

Versionen (1)
  1. 14.04.16 14.04.16 -
Hochgeladen am

14. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Asthma NCT02345928

Englisch

Eligibility Asthma NCT02345928

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02345928
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
part 1 (healthy participants): participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (bmi) of 19 to 30 kilogram per meter square (kg/m^2) inclusive
Beschreibung

Healthy | Body Weight | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0005910
UMLS CUI [3]
C1305855
part 1 (healthy participants): participant must be healthy on the basis of physical examination, medical history, vital signs and 12-lead ecg performed at screening
Beschreibung

Healthy | Physical Examination | Medical History | Vital signs | 12 lead ECG

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0518766
UMLS CUI [5]
C0430456
part 2 (asthma participants): participant must have a body weight in the range of 50 to 125 kg inclusive and have a bmi of 19 to 32 kg/m^2 inclusive
Beschreibung

Asthma | Body Weight | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0005910
UMLS CUI [3]
C1305855
part 2 (asthma participants): 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
part 2 (atopic dermatitis participants): participant must have a body weight in the range of 50 to 100 kg inclusive and have a bmi of 19 to 30 kg/m^2 inclusive
Beschreibung

Dermatitis, Atopic | Body Weight | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C0011615
UMLS CUI [2]
C0005910
UMLS CUI [3]
C1305855
part 2 (atopic dermatitis participants): participant has physician documented diagnosis of atopic dermatitis for at least 12 months before screening based on uk refinements of the rajka and hanifin criteria
Beschreibung

Dermatitis, Atopic

Datentyp

boolean

Alias
UMLS CUI [1]
C0011615
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
part 1 (healthy participants): participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the screening visit
Beschreibung

Healthy | Malignant Neoplasms | Basal cell carcinoma | Intraepithelial Squamous Cell Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0334245
part 1 (healthy participants): participant currently has or has a history of any clinically significant cardiovascular disease, including but not limited to a history of angina or myocardial infarction, congestive heart failure, symptomatic atherosclerotic vascular disease, or arrhythmia.
Beschreibung

Healthy | Cardiovascular Diseases | Angina Pectoris | Myocardial Infarction | Congestive heart failure | Atherosclerosis | Cardiac Arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0004153
UMLS CUI [7]
C0003811
part 2 (asthma participants): participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the screening visit
Beschreibung

Asthma | Malignant Neoplasms | Basal cell carcinoma | Intraepithelial Squamous Cell Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0334245
part 2 (asthma participants): participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received iv antibiotics for a serious infection during the 4 months prior to the screening visit
Beschreibung

Asthma | Communicable Diseases | Sepsis | Pneumonia | Pyelonephritis | Hospitalization | Intravenous Antibiotics

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0243026
UMLS CUI [4]
C0032285
UMLS CUI [5]
C0034186
UMLS CUI [6]
C0019993
UMLS CUI [7,1]
C0348016
UMLS CUI [7,2]
C0003232
part 2 (atopic dermatitis participants): participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the screening visit.
Beschreibung

Dermatitis, Atopic | Malignant Neoplasms | Basal cell carcinoma | Intraepithelial Squamous Cell Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0011615
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0334245
part 2 (atopic dermatitis participants): participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received iv antibiotics for a serious infection during the 4 months prior to the screening visit
Beschreibung

Dermatitis, Atopic | Communicable Diseases | Sepsis | Pneumonia | Pyelonephritis | Hospitalization | Intravenous Antibiotics

Datentyp

boolean

Alias
UMLS CUI [1]
C0011615
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0243026
UMLS CUI [4]
C0032285
UMLS CUI [5]
C0034186
UMLS CUI [6]
C0019993
UMLS CUI [7,1]
C0348016
UMLS CUI [7,2]
C0003232
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Ähnliche Modelle

Eligibility Asthma NCT02345928

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02345928
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy | Body Weight | Body mass index
Item
part 1 (healthy participants): participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (bmi) of 19 to 30 kilogram per meter square (kg/m^2) inclusive
boolean
C3898900 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
Healthy | Physical Examination | Medical History | Vital signs | 12 lead ECG
Item
part 1 (healthy participants): participant must be healthy on the basis of physical examination, medical history, vital signs and 12-lead ecg performed at screening
boolean
C3898900 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0518766 (UMLS CUI [4])
C0430456 (UMLS CUI [5])
Asthma | Body Weight | Body mass index
Item
part 2 (asthma participants): participant must have a body weight in the range of 50 to 125 kg inclusive and have a bmi of 19 to 32 kg/m^2 inclusive
boolean
C0004096 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
Asthma
Item
part 2 (asthma participants): participant must have a physician documented diagnosis of asthma for at least 12 months before screening
boolean
C0004096 (UMLS CUI [1])
Dermatitis, Atopic | Body Weight | Body mass index
Item
part 2 (atopic dermatitis participants): participant must have a body weight in the range of 50 to 100 kg inclusive and have a bmi of 19 to 30 kg/m^2 inclusive
boolean
C0011615 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
Dermatitis, Atopic
Item
part 2 (atopic dermatitis participants): participant has physician documented diagnosis of atopic dermatitis for at least 12 months before screening based on uk refinements of the rajka and hanifin criteria
boolean
C0011615 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Healthy | Malignant Neoplasms | Basal cell carcinoma | Intraepithelial Squamous Cell Carcinoma
Item
part 1 (healthy participants): participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the screening visit
boolean
C3898900 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0334245 (UMLS CUI [4])
Healthy | Cardiovascular Diseases | Angina Pectoris | Myocardial Infarction | Congestive heart failure | Atherosclerosis | Cardiac Arrhythmia
Item
part 1 (healthy participants): participant currently has or has a history of any clinically significant cardiovascular disease, including but not limited to a history of angina or myocardial infarction, congestive heart failure, symptomatic atherosclerotic vascular disease, or arrhythmia.
boolean
C3898900 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0004153 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
Asthma | Malignant Neoplasms | Basal cell carcinoma | Intraepithelial Squamous Cell Carcinoma
Item
part 2 (asthma participants): participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the screening visit
boolean
C0004096 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0334245 (UMLS CUI [4])
Asthma | Communicable Diseases | Sepsis | Pneumonia | Pyelonephritis | Hospitalization | Intravenous Antibiotics
Item
part 2 (asthma participants): participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received iv antibiotics for a serious infection during the 4 months prior to the screening visit
boolean
C0004096 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0243026 (UMLS CUI [3])
C0032285 (UMLS CUI [4])
C0034186 (UMLS CUI [5])
C0019993 (UMLS CUI [6])
C0348016 (UMLS CUI [7,1])
C0003232 (UMLS CUI [7,2])
Dermatitis, Atopic | Malignant Neoplasms | Basal cell carcinoma | Intraepithelial Squamous Cell Carcinoma
Item
part 2 (atopic dermatitis participants): participant has any known malignancy or history of malignancy, with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the screening visit.
boolean
C0011615 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0334245 (UMLS CUI [4])
Dermatitis, Atopic | Communicable Diseases | Sepsis | Pneumonia | Pyelonephritis | Hospitalization | Intravenous Antibiotics
Item
part 2 (atopic dermatitis participants): participant has or have had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received iv antibiotics for a serious infection during the 4 months prior to the screening visit
boolean
C0011615 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0243026 (UMLS CUI [3])
C0032285 (UMLS CUI [4])
C0034186 (UMLS CUI [5])
C0019993 (UMLS CUI [6])
C0348016 (UMLS CUI [7,1])
C0003232 (UMLS CUI [7,2])
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