ID

14135

Descripción

Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01930461

Link

https://clinicaltrials.gov/show/NCT01930461

Palabras clave

Versiones (1)
  1. 31/03/2016 31/03/2016 -
Subido en

31 de março de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Asthma NCT01930461

Inglés

Eligibility Asthma NCT01930461

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01930461
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent.
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
male or female from 18 to 50 years of age.
Descripción

Age | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
diagnosed asthma and rhinitis with medical history consistent with hdm-induced allergic asthma and rhinitis.
Descripción

Asthma | Rhinitis | house dust mites | Allergic asthma | Allergic rhinitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0035455
UMLS CUI [3,1]
C3539110
UMLS CUI [3,2]
C0155877
UMLS CUI [4,1]
C3539110
UMLS CUI [4,2]
C2607914
positive spt to hdm and and hdm-specific ige serum value ≥ 0.7 ku/l.
Descripción

Skin prick test | house dust mites | serum IgE measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430561
UMLS CUI [1,2]
C3539110
UMLS CUI [2]
C2229760
stable asthma therapies.
Descripción

Asthma therapy | Stable status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [1,3]
C0205360
spirometry (pre-bronchodilator) with best fev1 ≥ 70 percent of the predicted value.
Descripción

FEV1 | Spirometry | pre bronchodilator

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2,1]
C0037981
UMLS CUI [2,2]
C2599602
spirometry with reversibility in fev1 of ≥ 12 percent and ≥ 200 ml.
Descripción

Spirometry reversibility | FEV1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272658
UMLS CUI [2]
C0748133
asthma control test™ (act) score ≤ 19.
Descripción

Asthma control test score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2733224
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
former smoker with > 10 pack year history or current smoker.
Descripción

Former smoker | pack-years history | Current Smoker

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0337671
UMLS CUI [1,2]
C2230126
UMLS CUI [2]
C3241966
patient with a urine level of cotinine ≥ 500 ng/ml.
Descripción

urine continine measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2188552
co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
Descripción

Sensitization | Allergens | Asthma | Symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1325847
UMLS CUI [1,2]
C0002092
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0004096
UMLS CUI [2,3]
C1457887
patient who received allergen immunotherapy for hdm within the past 10 years.
Descripción

Allergen Immunotherapy | house dust mites

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0162352
UMLS CUI [1,2]
C3539110
ongoing immunotherapy for an aeroallergen other than house dust mite.
Descripción

Immunotherapy | Aeroallergen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0001697
UMLS CUI [2]
C3539110
patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
Descripción

condition of oral cavity | Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2010703
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0549076
UMLS CUI [4]
C0040440
patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (maois).
Descripción

Therapeutic procedure | Adrenergic beta-1 Receptor Antagonists | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0304516
UMLS CUI [2]
C0003290
UMLS CUI [3]
C0026457
pregnant women or breast-feeding/lactating.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women with childbearing potential who are not using a medically accepted birth control method.
Descripción

Woman | Childbearing Potential | Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C3831118
UMLS CUI [2]
C0700589
patient with a past or current disease, which as judged by the investigator, may affect the patient's participation in, or the outcome of this study.
Descripción

Disease | Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
Volver a la parte superior de la página

Similar models

Eligibility Asthma NCT01930461

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT01930461
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age | Gender
Item
male or female from 18 to 50 years of age.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Asthma | Rhinitis | house dust mites | Allergic asthma | Allergic rhinitis
Item
diagnosed asthma and rhinitis with medical history consistent with hdm-induced allergic asthma and rhinitis.
boolean
C0004096 (UMLS CUI [1])
C0035455 (UMLS CUI [2])
C3539110 (UMLS CUI [3,1])
C0155877 (UMLS CUI [3,2])
C3539110 (UMLS CUI [4,1])
C2607914 (UMLS CUI [4,2])
Skin prick test | house dust mites | serum IgE measurement
Item
positive spt to hdm and and hdm-specific ige serum value ≥ 0.7 ku/l.
boolean
C0430561 (UMLS CUI [1,1])
C3539110 (UMLS CUI [1,2])
C2229760 (UMLS CUI [2])
Asthma therapy | Stable status
Item
stable asthma therapies.
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
FEV1 | Spirometry | pre bronchodilator
Item
spirometry (pre-bronchodilator) with best fev1 ≥ 70 percent of the predicted value.
boolean
C0748133 (UMLS CUI [1])
C0037981 (UMLS CUI [2,1])
C2599602 (UMLS CUI [2,2])
Spirometry reversibility | FEV1
Item
spirometry with reversibility in fev1 of ≥ 12 percent and ≥ 200 ml.
boolean
C1272658 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
Asthma control test score
Item
asthma control test™ (act) score ≤ 19.
boolean
C2733224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Former smoker | pack-years history | Current Smoker
Item
former smoker with > 10 pack year history or current smoker.
boolean
C0337671 (UMLS CUI [1,1])
C2230126 (UMLS CUI [1,2])
C3241966 (UMLS CUI [2])
urine continine measurement
Item
patient with a urine level of cotinine ≥ 500 ng/ml.
boolean
C2188552 (UMLS CUI [1])
Sensitization | Allergens | Asthma | Symptoms
Item
co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
boolean
C1325847 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Allergen Immunotherapy | house dust mites
Item
patient who received allergen immunotherapy for hdm within the past 10 years.
boolean
C0162352 (UMLS CUI [1,1])
C3539110 (UMLS CUI [1,2])
Immunotherapy | Aeroallergen
Item
ongoing immunotherapy for an aeroallergen other than house dust mite.
boolean
C0021083 (UMLS CUI [1,1])
C0001697 (UMLS CUI [1,2])
C3539110 (UMLS CUI [2])
condition of oral cavity | Study Subject Participation Status
Item
patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
boolean
C2010703 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0549076 (UMLS CUI [3])
C0040440 (UMLS CUI [4])
Therapeutic procedure | Adrenergic beta-1 Receptor Antagonists | Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors
Item
patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (maois).
boolean
C0087111 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
C0003290 (UMLS CUI [2])
C0026457 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant women or breast-feeding/lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Woman | Childbearing Potential | Contraceptive methods
Item
women with childbearing potential who are not using a medically accepted birth control method.
boolean
C0043210 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
Disease | Study Subject Participation Status
Item
patient with a past or current disease, which as judged by the investigator, may affect the patient's participation in, or the outcome of this study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial