ID

22037

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01393340

Nyckelord

Versioner (1)
  1. 2017-05-16 2017-05-16 -
Uppladdad den

16 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Nasal Polyposis NCT01393340

Engelsk

Eligibility Nasal Polyposis NCT01393340

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age | Racial group Any

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Upper Respiratory Infection Free of

Datatyp

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.
Beskrivning

Normal Laboratory Test Result

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Pregnancy | Breast Feeding | Premenarche

Datatyp

boolean

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

Age

Datatyp

boolean

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

Systemic Reaction Investigational New Drugs

Datatyp

boolean

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

Illicit Drugs | Washout Period Lacking

Datatyp

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.
Beskrivning

Acute sinusitis | Nasal infection | Upper Respiratory Infection

Datatyp

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.
Beskrivning

Cystic Fibrosis | Ciliary Motility Disorders | Kartagener Syndrome

Datatyp

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.
Beskrivning

Parasitic Disease

Datatyp

boolean

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

Malignant Neoplasm

Datatyp

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.
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C

Datatyp

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.
Beskrivning

Asthma attack Requirement Hospital admission | Emergency department patient visit Excluded

Datatyp

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.
Beskrivning

Immunotherapy Specific

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0205369
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Similar models

Eligibility Nasal Polyposis NCT01393340

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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