0 Bewertungen
ID

22037

Beschreibung

Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01393340

Link

https://clinicaltrials.gov/show/NCT01393340

Stichworte

Versionen (1)
  1. 16.05.17 16.05.17 -
Hochgeladen am

16. Mai 2017

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 :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

    Keine Kommentare

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

    Eligibility Nasal Polyposis NCT01393340

    Englisch

    Eligibility Nasal Polyposis NCT01393340

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects must be at least 18 years of age, of either gender and any race.
    Beschreibung

    Age | Racial group Any

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C0034510
    UMLS CUI [2,2]
    C1552551
    subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system described in table 5. bilateral nasal polyposis is defined as sinus symptoms for more than 3 months, bilateral opacity on ct-scan imaging and visible nasal polyps at endoscopy.
    Beschreibung

    Nasal Polyps Bilateral | Recurrent disease Post Excision | Nasal Polyps Grade Score | Nasal sinus Symptoms | Nasal opacity Bilateral X-Ray Computed Tomography | Nasal Polyps Visible Endoscopy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027430
    UMLS CUI [1,2]
    C0238767
    UMLS CUI [2,1]
    C0277556
    UMLS CUI [2,2]
    C0687676
    UMLS CUI [2,3]
    C0728940
    UMLS CUI [3,1]
    C0027430
    UMLS CUI [3,2]
    C0441800
    UMLS CUI [3,3]
    C0449820
    UMLS CUI [4,1]
    C0030471
    UMLS CUI [4,2]
    C1457887
    UMLS CUI [5,1]
    C3672025
    UMLS CUI [5,2]
    C0238767
    UMLS CUI [5,3]
    C0040405
    UMLS CUI [6,1]
    C0027430
    UMLS CUI [6,2]
    C0205379
    UMLS CUI [6,3]
    C0014245
    subjects must have a diagnosis of asthma for more than 2 years. subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
    Beschreibung

    Asthma Duration | Overall Well Being | Disease Free of | Disease Interferes with Study Protocol | Disease compromises patient safety

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C0449238
    UMLS CUI [2]
    C3813622
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C0332296
    UMLS CUI [4,1]
    C0012634
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C2348563
    UMLS CUI [5,1]
    C0012634
    UMLS CUI [5,2]
    C2945640
    UMLS CUI [5,3]
    C1113679
    subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
    Beschreibung

    Informed Consent | Protocol Compliance | Pharmaceutical Preparations Restriction | Subject Diary Perform

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0525058
    UMLS CUI [3,1]
    C0013227
    UMLS CUI [3,2]
    C0443288
    UMLS CUI [4,1]
    C3890583
    UMLS CUI [4,2]
    C0884358
    subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
    Beschreibung

    Upper Respiratory Infection Free of

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0041912
    UMLS CUI [1,2]
    C0332296
    clinical laboratory tests must be within normal limits or clinically acceptable for the investigator.
    Beschreibung

    Normal Laboratory Test Result

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0438214
    non-pregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. this includes: a) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); b) medically prescribed intra-uterine device (iud); c) condom in combination with a spermicide; d) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. they must have started this birth control method at least three months prior to screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for at least 3 months after last dosing. women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. women who are surgically sterilized or are at least one year postmenopausal are considered not to be of childbearing potential. however, all female subjects must have a urine pregnancy test prior to treatment, which must be negative. a monthly-control pregnancy test is requested.
    Beschreibung

    Childbearing Potential Contraceptive methods | Hormonal contraception | Combined Oral Contraceptives | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Partner had vasectomy | Condoms, Male | Childbearing Potential Sexually active Barrier Contraception | Female Sterilization | Postmenopausal state | Gender Urine pregnancy test negative | Gender Pregnancy Tests Monthly

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2]
    C2985296
    UMLS CUI [3]
    C0009906
    UMLS CUI [4]
    C0021900
    UMLS CUI [5]
    C0221829
    UMLS CUI [6]
    C0087145
    UMLS CUI [7]
    C0420842
    UMLS CUI [8]
    C0009653
    UMLS CUI [9,1]
    C3831118
    UMLS CUI [9,2]
    C0241028
    UMLS CUI [9,3]
    C0004764
    UMLS CUI [10]
    C0015787
    UMLS CUI [11]
    C0232970
    UMLS CUI [12,1]
    C0079399
    UMLS CUI [12,2]
    C0430057
    UMLS CUI [13,1]
    C0079399
    UMLS CUI [13,2]
    C0032976
    UMLS CUI [13,3]
    C0332177
    male subjects must agree to use an adequate form of birth control from first dosing to at least 3 months after last dosing. they must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described above.
    Beschreibung

    Gender Contraceptive methods | Condoms, Male | Spermatocidal Agents | Heterosexual relationship Partner Contraceptive methods

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2]
    C0009653
    UMLS CUI [3]
    C0037862
    UMLS CUI [4,1]
    C0556476
    UMLS CUI [4,2]
    C0682323
    UMLS CUI [4,3]
    C0700589
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    women must not be pregnant, breast feeding, or premenarcheal.
    Beschreibung

    Pregnancy | Breast Feeding | Premenarche

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C2609149
    patients younger than 18 years old.
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    subjects with history of systemic reactions to the study medication.
    Beschreibung

    Systemic Reaction Investigational New Drugs

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1710276
    UMLS CUI [1,2]
    C0013230
    subjects with prohibited medication at screening without full wash-out period.
    Beschreibung

    Illicit Drugs | Washout Period Lacking

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0086190
    UMLS CUI [2,1]
    C1710661
    UMLS CUI [2,2]
    C0332268
    subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within two weeks of the inclusion are excluded.
    Beschreibung

    Acute sinusitis | Nasal infection | Upper Respiratory Infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0149512
    UMLS CUI [2]
    C0555970
    UMLS CUI [3]
    C0041912
    subjects with cystic fibrosis, primary ciliary's dysfunction or kartagener's syndrome by history are excluded.
    Beschreibung

    Cystic Fibrosis | Ciliary Motility Disorders | Kartagener Syndrome

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0010674
    UMLS CUI [2]
    C0008780
    UMLS CUI [3]
    C0022521
    subjects must not have ever been diagnosed with a parasitic infection.
    Beschreibung

    Parasitic Disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0030499
    subjects must not have ever been diagnosed with cancer
    Beschreibung

    Malignant Neoplasm

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    subjects must not have a medical history of human immunodeficiency virus (hiv) or hepatitis b or c. testing will not be done at screening.
    Beschreibung

    HIV Infection | Hepatitis B | Hepatitis C

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
    subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency room visits which resulted in direct discharge without hospitalization) within the four weeks prior to screening.
    Beschreibung

    Asthma attack Requirement Hospital admission | Emergency department patient visit Excluded

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0347950
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0184666
    UMLS CUI [2,1]
    C0586082
    UMLS CUI [2,2]
    C2828389
    subjects must not have received specific immunotherapy within the previous three months.
    Beschreibung

    Immunotherapy Specific

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021083
    UMLS CUI [1,2]
    C0205369
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Nasal Polyposis NCT01393340

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Racial group Any
    Item
    subjects must be at least 18 years of age, of either gender and any race.
    boolean
    C0001779 (UMLS CUI [1])
    C0034510 (UMLS CUI [2,1])
    C1552551 (UMLS CUI [2,2])
    Nasal Polyps Bilateral | Recurrent disease Post Excision | Nasal Polyps Grade Score | Nasal sinus Symptoms | Nasal opacity Bilateral X-Ray Computed Tomography | Nasal Polyps Visible Endoscopy
    Item
    subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system described in table 5. bilateral nasal polyposis is defined as sinus symptoms for more than 3 months, bilateral opacity on ct-scan imaging and visible nasal polyps at endoscopy.
    boolean
    C0027430 (UMLS CUI [1,1])
    C0238767 (UMLS CUI [1,2])
    C0277556 (UMLS CUI [2,1])
    C0687676 (UMLS CUI [2,2])
    C0728940 (UMLS CUI [2,3])
    C0027430 (UMLS CUI [3,1])
    C0441800 (UMLS CUI [3,2])
    C0449820 (UMLS CUI [3,3])
    C0030471 (UMLS CUI [4,1])
    C1457887 (UMLS CUI [4,2])
    C3672025 (UMLS CUI [5,1])
    C0238767 (UMLS CUI [5,2])
    C0040405 (UMLS CUI [5,3])
    C0027430 (UMLS CUI [6,1])
    C0205379 (UMLS CUI [6,2])
    C0014245 (UMLS CUI [6,3])
    Asthma Duration | Overall Well Being | Disease Free of | Disease Interferes with Study Protocol | Disease compromises patient safety
    Item
    subjects must have a diagnosis of asthma for more than 2 years. subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
    boolean
    C0004096 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    C3813622 (UMLS CUI [2])
    C0012634 (UMLS CUI [3,1])
    C0332296 (UMLS CUI [3,2])
    C0012634 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C2348563 (UMLS CUI [4,3])
    C0012634 (UMLS CUI [5,1])
    C2945640 (UMLS CUI [5,2])
    C1113679 (UMLS CUI [5,3])
    Informed Consent | Protocol Compliance | Pharmaceutical Preparations Restriction | Subject Diary Perform
    Item
    subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
    boolean
    C0021430 (UMLS CUI [1])
    C0525058 (UMLS CUI [2])
    C0013227 (UMLS CUI [3,1])
    C0443288 (UMLS CUI [3,2])
    C3890583 (UMLS CUI [4,1])
    C0884358 (UMLS CUI [4,2])
    Upper Respiratory Infection Free of
    Item
    subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
    boolean
    C0041912 (UMLS CUI [1,1])
    C0332296 (UMLS CUI [1,2])
    Normal Laboratory Test Result
    Item
    clinical laboratory tests must be within normal limits or clinically acceptable for the investigator.
    boolean
    C0438214 (UMLS CUI [1])
    Childbearing Potential Contraceptive methods | Hormonal contraception | Combined Oral Contraceptives | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Partner had vasectomy | Condoms, Male | Childbearing Potential Sexually active Barrier Contraception | Female Sterilization | Postmenopausal state | Gender Urine pregnancy test negative | Gender Pregnancy Tests Monthly
    Item
    non-pregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. this includes: a) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); b) medically prescribed intra-uterine device (iud); c) condom in combination with a spermicide; d) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. they must have started this birth control method at least three months prior to screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for at least 3 months after last dosing. women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. women who are surgically sterilized or are at least one year postmenopausal are considered not to be of childbearing potential. however, all female subjects must have a urine pregnancy test prior to treatment, which must be negative. a monthly-control pregnancy test is requested.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C2985296 (UMLS CUI [2])
    C0009906 (UMLS CUI [3])
    C0021900 (UMLS CUI [4])
    C0221829 (UMLS CUI [5])
    C0087145 (UMLS CUI [6])
    C0420842 (UMLS CUI [7])
    C0009653 (UMLS CUI [8])
    C3831118 (UMLS CUI [9,1])
    C0241028 (UMLS CUI [9,2])
    C0004764 (UMLS CUI [9,3])
    C0015787 (UMLS CUI [10])
    C0232970 (UMLS CUI [11])
    C0079399 (UMLS CUI [12,1])
    C0430057 (UMLS CUI [12,2])
    C0079399 (UMLS CUI [13,1])
    C0032976 (UMLS CUI [13,2])
    C0332177 (UMLS CUI [13,3])
    Gender Contraceptive methods | Condoms, Male | Spermatocidal Agents | Heterosexual relationship Partner Contraceptive methods
    Item
    male subjects must agree to use an adequate form of birth control from first dosing to at least 3 months after last dosing. they must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described above.
    boolean
    C0079399 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0009653 (UMLS CUI [2])
    C0037862 (UMLS CUI [3])
    C0556476 (UMLS CUI [4,1])
    C0682323 (UMLS CUI [4,2])
    C0700589 (UMLS CUI [4,3])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding | Premenarche
    Item
    women must not be pregnant, breast feeding, or premenarcheal.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C2609149 (UMLS CUI [3])
    Age
    Item
    patients younger than 18 years old.
    boolean
    C0001779 (UMLS CUI [1])
    Systemic Reaction Investigational New Drugs
    Item
    subjects with history of systemic reactions to the study medication.
    boolean
    C1710276 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    Illicit Drugs | Washout Period Lacking
    Item
    subjects with prohibited medication at screening without full wash-out period.
    boolean
    C0086190 (UMLS CUI [1])
    C1710661 (UMLS CUI [2,1])
    C0332268 (UMLS CUI [2,2])
    Acute sinusitis | Nasal infection | Upper Respiratory Infection
    Item
    subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within two weeks of the inclusion are excluded.
    boolean
    C0149512 (UMLS CUI [1])
    C0555970 (UMLS CUI [2])
    C0041912 (UMLS CUI [3])
    Cystic Fibrosis | Ciliary Motility Disorders | Kartagener Syndrome
    Item
    subjects with cystic fibrosis, primary ciliary's dysfunction or kartagener's syndrome by history are excluded.
    boolean
    C0010674 (UMLS CUI [1])
    C0008780 (UMLS CUI [2])
    C0022521 (UMLS CUI [3])
    Parasitic Disease
    Item
    subjects must not have ever been diagnosed with a parasitic infection.
    boolean
    C0030499 (UMLS CUI [1])
    Malignant Neoplasm
    Item
    subjects must not have ever been diagnosed with cancer
    boolean
    C0006826 (UMLS CUI [1])
    HIV Infection | Hepatitis B | Hepatitis C
    Item
    subjects must not have a medical history of human immunodeficiency virus (hiv) or hepatitis b or c. testing will not be done at screening.
    boolean
    C0019693 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    Asthma attack Requirement Hospital admission | Emergency department patient visit Excluded
    Item
    subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency room visits which resulted in direct discharge without hospitalization) within the four weeks prior to screening.
    boolean
    C0347950 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0184666 (UMLS CUI [1,3])
    C0586082 (UMLS CUI [2,1])
    C2828389 (UMLS CUI [2,2])
    Immunotherapy Specific
    Item
    subjects must not have received specific immunotherapy within the previous three months.
    boolean
    C0021083 (UMLS CUI [1,1])
    C0205369 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

    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