0 Ratings
ID

43487

Description

ODM derived from http://clinicaltrials.gov/show/NCT00856622

Link

http://clinicaltrials.gov/show/NCT00856622

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY 4.0
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    Eligibility NCT00856622 Ocular Hypertension

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age at least 18 Years
    Description

    age at least 18 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
    Description

    Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205092
    SNOMED CT 2011_0131
    66459002
    UMLS CUI 2011AA
    C0238767
    SNOMED CT 2011_0131
    51440002
    UMLS CUI 2011AA
    C0339573
    SNOMED CT 2011_0131
    77075001
    MedDRA 14.1
    10036719
    ICD-10-CM Version 2010
    H40.11
    ICD-9-CM Version 2011
    365.11
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0206368
    SNOMED CT 2011_0131
    111514006
    MedDRA 14.1
    10037118
    ICD-9-CM Version 2011
    365.52
    UMLS CUI 2011AA
    C1411998
    SNOMED CT 2011_0131
    46168003
    ICD-9-CM Version 2011
    365.13
    UMLS CUI 2011AA
    C0028840
    SNOMED CT 2011_0131
    4210003
    MedDRA 14.1
    10030043
    ICD-10-CM Version 2010
    H40.0
    ICD-9-CM Version 2011
    365.04
    Patients currently on IOP reducing therapy: IOP >= 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP >= 30mmHg (two IOP determinations at pre-study separated by at least one hour).
    Description

    Patients currently on IOP reducing therapy: IOP >= 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP >= 30mmHg (two IOP determinations at pre-study separated by at least one hour).

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0150312
    SNOMED CT 2011_0131
    52101004
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C0021888
    SNOMED CT 2011_0131
    41633001
    LOINC Version 232
    MTHU034775
    UMLS CUI 2011AA
    C0442797
    SNOMED CT 2011_0131
    260371004
    UMLS CUI 2011AA
    C0039798
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    History of acute angle closure or closed/barely open anterior chamber angle.
    Description

    History of acute angle closure or closed/barely open anterior chamber angle.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0205178
    SNOMED CT 2011_0131
    272118002
    UMLS CUI 2011AA
    C0429528
    SNOMED CT 2011_0131
    251726002
    UMLS CUI 2011AA
    C0429524
    SNOMED CT 2011_0131
    251722000
    Current use of contact lenses.
    Description

    Current use of contact lenses.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0009836
    SNOMED CT 2011_0131
    57368009
    LOINC Version 232
    MTHU013784
    Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
    Description

    Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1705869
    SNOMED CT 2011_0131
    422191005
    UMLS CUI 2011AA
    C1319234
    SNOMED CT 2011_0131
    404636007
    Ocular inflammation/infection occurring within three months prior to pre-study visit.
    Description

    Ocular inflammation/infection occurring within three months prior to pre-study visit.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0239429
    MedDRA 14.1
    10015943
    UMLS CUI 2011AA
    C0015403
    SNOMED CT 2011_0131
    128351009
    MedDRA 14.1
    10015929
    CTCAE 1105E
    E11391
    Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
    Description

    Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0005026
    SNOMED CT 2011_0131
    64686009
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C1705248
    UMLS CUI 2011AA
    C0304229
    SNOMED CT 2011_0131
    902003
    Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
    Description

    Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205161
    SNOMED CT 2011_0131
    263654008
    UMLS CUI 2011AA
    C1299003
    UMLS CUI 2011AA
    C0348080
    SNOMED CT 2011_0131
    260905004
    HL7 V3 2006_05
    COND
    UMLS CUI 2011AA
    CL411789
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
    Description

    Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0018801
    SNOMED CT 2011_0131
    155374007
    MedDRA 14.1
    10019279
    ICD-9-CM Version 2011
    428
    CTCAE 1105E
    E10124
    UMLS CUI 2011AA
    C0085610
    SNOMED CT 2011_0131
    49710005
    MedDRA 14.1
    10040741
    ICD-10-CM Version 2010
    R00.1
    CTCAE 1105E
    E10208
    UMLS CUI 2011AA
    C0264906
    SNOMED CT 2011_0131
    195042002
    MedDRA 14.1
    10003677
    ICD-10-CM Version 2010
    I44.1
    UMLS CUI 2011AA
    C0151517
    SNOMED CT 2011_0131
    27885002
    MedDRA 14.1
    10003673
    ICD-10-CM Version 2010
    I44.2
    ICD-9-CM Version 2011
    426.0
    CTCAE 1105E
    E10093
    Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
    Description

    Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0004096
    SNOMED CT 2011_0131
    195967001
    MedDRA 14.1
    10003553
    LOINC Version 232
    MTHU020815
    ICD-10-CM Version 2010
    J45
    ICD-9-CM Version 2011
    493
    UMLS CUI 2011AA
    C0024117
    SNOMED CT 2011_0131
    13645005
    MedDRA 14.1
    10009033
    ICD-10-CM Version 2010
    J44.9
    ICD-9-CM Version 2011
    496
    Pregnancy, Gestation
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0549206
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
    Description

    Women of childbearing potential who has not used adequate contraceptive methods during the last three months.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0420844
    SNOMED CT 2011_0131
    169450001
    Inability to adhere to treatment/visit plan.
    Description

    Inability to adhere to treatment/visit plan.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1299582
    SNOMED CT 2011_0131
    371151008
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C1512346
    HL7 V3 2006_05
    ENC
    UMLS CUI 2011AA
    C1301732
    SNOMED CT 2011_0131
    397943006
    Have participated in any other clinical study within one month prior to pre-study visit.
    Description

    Have participated in any other clinical study within one month prior to pre-study visit.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C2348558
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    age at least 18 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
    Item
    Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
    boolean
    C0205092 (UMLS CUI 2011AA)
    66459002 (SNOMED CT 2011_0131)
    C0238767 (UMLS CUI 2011AA)
    51440002 (SNOMED CT 2011_0131)
    C0339573 (UMLS CUI 2011AA)
    77075001 (SNOMED CT 2011_0131)
    10036719 (MedDRA 14.1)
    H40.11 (ICD-10-CM Version 2010)
    365.11 (ICD-9-CM Version 2011)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0206368 (UMLS CUI 2011AA)
    111514006 (SNOMED CT 2011_0131)
    10037118 (MedDRA 14.1)
    365.52 (ICD-9-CM Version 2011)
    C1411998 (UMLS CUI 2011AA)
    46168003 (SNOMED CT 2011_0131)
    365.13 (ICD-9-CM Version 2011)
    C0028840 (UMLS CUI 2011AA)
    4210003 (SNOMED CT 2011_0131)
    10030043 (MedDRA 14.1)
    H40.0 (ICD-10-CM Version 2010)
    365.04 (ICD-9-CM Version 2011)
    Patients currently on IOP reducing therapy: IOP >= 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP >= 30mmHg (two IOP determinations at pre-study separated by at least one hour).
    Item
    Patients currently on IOP reducing therapy: IOP >= 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP >= 30mmHg (two IOP determinations at pre-study separated by at least one hour).
    boolean
    C0150312 (UMLS CUI 2011AA)
    52101004 (SNOMED CT 2011_0131)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C0021888 (UMLS CUI 2011AA)
    41633001 (SNOMED CT 2011_0131)
    MTHU034775 (LOINC Version 232)
    C0442797 (UMLS CUI 2011AA)
    260371004 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    History of acute angle closure or closed/barely open anterior chamber angle.
    Item
    History of acute angle closure or closed/barely open anterior chamber angle.
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0205178 (UMLS CUI 2011AA)
    272118002 (SNOMED CT 2011_0131)
    C0429528 (UMLS CUI 2011AA)
    251726002 (SNOMED CT 2011_0131)
    C0429524 (UMLS CUI 2011AA)
    251722000 (SNOMED CT 2011_0131)
    Current use of contact lenses.
    Item
    Current use of contact lenses.
    boolean
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0009836 (UMLS CUI 2011AA)
    57368009 (SNOMED CT 2011_0131)
    MTHU013784 (LOINC Version 232)
    Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
    Item
    Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
    boolean
    C1705869 (UMLS CUI 2011AA)
    422191005 (SNOMED CT 2011_0131)
    C1319234 (UMLS CUI 2011AA)
    404636007 (SNOMED CT 2011_0131)
    Ocular inflammation/infection occurring within three months prior to pre-study visit.
    Item
    Ocular inflammation/infection occurring within three months prior to pre-study visit.
    boolean
    C0239429 (UMLS CUI 2011AA)
    10015943 (MedDRA 14.1)
    C0015403 (UMLS CUI 2011AA)
    128351009 (SNOMED CT 2011_0131)
    10015929 (MedDRA 14.1)
    E11391 (CTCAE 1105E)
    Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
    Item
    Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
    boolean
    C0020517 (UMLS CUI 2011AA)
    418634005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0005026 (UMLS CUI 2011AA)
    64686009 (SNOMED CT 2011_0131)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C1705248 (UMLS CUI 2011AA)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
    Item
    Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
    boolean
    C0205161 (UMLS CUI 2011AA)
    263654008 (SNOMED CT 2011_0131)
    C1299003 (UMLS CUI 2011AA)
    C0348080 (UMLS CUI 2011AA)
    260905004 (SNOMED CT 2011_0131)
    COND (HL7 V3 2006_05)
    CL411789 (UMLS CUI 2011AA)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
    Item
    Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
    boolean
    C0018801 (UMLS CUI 2011AA)
    155374007 (SNOMED CT 2011_0131)
    10019279 (MedDRA 14.1)
    428 (ICD-9-CM Version 2011)
    E10124 (CTCAE 1105E)
    C0085610 (UMLS CUI 2011AA)
    49710005 (SNOMED CT 2011_0131)
    10040741 (MedDRA 14.1)
    R00.1 (ICD-10-CM Version 2010)
    E10208 (CTCAE 1105E)
    C0264906 (UMLS CUI 2011AA)
    195042002 (SNOMED CT 2011_0131)
    10003677 (MedDRA 14.1)
    I44.1 (ICD-10-CM Version 2010)
    C0151517 (UMLS CUI 2011AA)
    27885002 (SNOMED CT 2011_0131)
    10003673 (MedDRA 14.1)
    I44.2 (ICD-10-CM Version 2010)
    426.0 (ICD-9-CM Version 2011)
    E10093 (CTCAE 1105E)
    Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
    Item
    Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0004096 (UMLS CUI 2011AA)
    195967001 (SNOMED CT 2011_0131)
    10003553 (MedDRA 14.1)
    MTHU020815 (LOINC Version 232)
    J45 (ICD-10-CM Version 2010)
    493 (ICD-9-CM Version 2011)
    C0024117 (UMLS CUI 2011AA)
    13645005 (SNOMED CT 2011_0131)
    10009033 (MedDRA 14.1)
    J44.9 (ICD-10-CM Version 2010)
    496 (ICD-9-CM Version 2011)
    Pregnancy
    Item
    Pregnancy, Gestation
    boolean
    C0549206 (UMLS CUI 2011AA)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
    Item
    Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0420844 (UMLS CUI 2011AA)
    169450001 (SNOMED CT 2011_0131)
    Inability to adhere to treatment/visit plan.
    Item
    Inability to adhere to treatment/visit plan.
    boolean
    C1299582 (UMLS CUI 2011AA)
    371151008 (SNOMED CT 2011_0131)
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C1512346 (UMLS CUI 2011AA)
    ENC (HL7 V3 2006_05)
    C1301732 (UMLS CUI 2011AA)
    397943006 (SNOMED CT 2011_0131)
    Have participated in any other clinical study within one month prior to pre-study visit.
    Item
    Have participated in any other clinical study within one month prior to pre-study visit.
    boolean
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C2348558 (UMLS CUI 2011AA)
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