ID

38481

Beschreibung

Effect of High Dose Ciclesonide on Asthma Control; ODM derived from: https://clinicaltrials.gov/show/NCT01455194

Link

https://clinicaltrials.gov/show/NCT01455194

Stichworte

Versionen (1)
  1. 21.10.19 21.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Oktober 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Bronchial Asthma NCT01455194

Englisch

Eligibility Bronchial Asthma NCT01455194

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent was provided
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
history of persistent bronchial asthma for at least 6 months
Beschreibung

Persistent asthma Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3266628
UMLS CUI [1,2]
C0872146
current treatment with an inhaled corticosteroid (ics) at a stable dose in the dose range of 200-1000 μg fluticasone propionate (fp)/day or equivalent for a minimum of 12 weeks
Beschreibung

Adrenal Cortex Hormones by Inhalation Dose Stable | Fluticasone propionate U/day | Equivalent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0117996
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0205163
good inhalation technique
Beschreibung

Inhalation technique Good

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1998547
UMLS CUI [1,2]
C0205170
under the current ics pre-treatment the acq score ranges between ≥ 0.75 and ≥ 2
Beschreibung

Adrenal Cortex Hormones by Inhalation Pretreatment | Asthma control questionnaire Score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205535
UMLS CUI [1,3]
C3539076
UMLS CUI [2,1]
C2919686
UMLS CUI [2,2]
C0449820
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
Beschreibung

Laboratory test result abnormal | Suggestive of Disease Unknown | Requirement Clinical Evaluation Additional

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0332299
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0439673
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C4084924
UMLS CUI [3,3]
C1524062
concomitant severe diseases (e.g. malignant diseases during the past 5 years [other than basal or squamous cell carcinoma], hepatitis c, acquired immune deficiency syndrome [aids])
Beschreibung

Comorbidity Severe | Malignant disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma | Hepatitis C | AIDS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0442867
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007137
UMLS CUI [5]
C0019196
UMLS CUI [6]
C0001175
diseases which are contraindications for the use of ics (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
Beschreibung

Medical contraindication Adrenal Cortex Hormones by Inhalation | Tuberculosis, Pulmonary | Inactive tuberculosis of lung | Lower respiratory tract infection fungal | Bacterial lower respiratory infection | Viral lower respiratory infection | Requirement Therapeutic procedure Specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0205535
UMLS CUI [2]
C0041327
UMLS CUI [3]
C0748179
UMLS CUI [4]
C1691221
UMLS CUI [5]
C0729520
UMLS CUI [6]
C0729532
UMLS CUI [7,1]
C1514873
UMLS CUI [7,2]
C0087111
UMLS CUI [7,3]
C0205369
use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
Beschreibung

Glucocorticoids, Systemic | Depot Steroids Injectable

Datentyp

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2,1]
C0086129
UMLS CUI [2,2]
C0038317
UMLS CUI [2,3]
C1272883
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Bronchial Asthma NCT01455194

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent was provided
boolean
C0021430 (UMLS CUI [1])
Persistent asthma Disease length
Item
history of persistent bronchial asthma for at least 6 months
boolean
C3266628 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Adrenal Cortex Hormones by Inhalation Dose Stable | Fluticasone propionate U/day | Equivalent
Item
current treatment with an inhaled corticosteroid (ics) at a stable dose in the dose range of 200-1000 μg fluticasone propionate (fp)/day or equivalent for a minimum of 12 weeks
boolean
C0001617 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0117996 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
Inhalation technique Good
Item
good inhalation technique
boolean
C1998547 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
Adrenal Cortex Hormones by Inhalation Pretreatment | Asthma control questionnaire Score
Item
under the current ics pre-treatment the acq score ranges between ≥ 0.75 and ≥ 2
boolean
C0001617 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
C3539076 (UMLS CUI [1,3])
C2919686 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Laboratory test result abnormal | Suggestive of Disease Unknown | Requirement Clinical Evaluation Additional
Item
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
boolean
C0438215 (UMLS CUI [1])
C0332299 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0439673 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C4084924 (UMLS CUI [3,2])
C1524062 (UMLS CUI [3,3])
Comorbidity Severe | Malignant disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma | Hepatitis C | AIDS
Item
concomitant severe diseases (e.g. malignant diseases during the past 5 years [other than basal or squamous cell carcinoma], hepatitis c, acquired immune deficiency syndrome [aids])
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442867 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007137 (UMLS CUI [4,2])
C0019196 (UMLS CUI [5])
C0001175 (UMLS CUI [6])
Medical contraindication Adrenal Cortex Hormones by Inhalation | Tuberculosis, Pulmonary | Inactive tuberculosis of lung | Lower respiratory tract infection fungal | Bacterial lower respiratory infection | Viral lower respiratory infection | Requirement Therapeutic procedure Specific
Item
diseases which are contraindications for the use of ics (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0205535 (UMLS CUI [1,3])
C0041327 (UMLS CUI [2])
C0748179 (UMLS CUI [3])
C1691221 (UMLS CUI [4])
C0729520 (UMLS CUI [5])
C0729532 (UMLS CUI [6])
C1514873 (UMLS CUI [7,1])
C0087111 (UMLS CUI [7,2])
C0205369 (UMLS CUI [7,3])
Glucocorticoids, Systemic | Depot Steroids Injectable
Item
use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
boolean
C3540777 (UMLS CUI [1])
C0086129 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
C1272883 (UMLS CUI [2,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video