ID

42753

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00844194

Link

http://clinicaltrials.gov/show/NCT00844194

Stichworte

Versionen (2)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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    Eligibility NCT00844194 Diabetic Neuropathies

    Deutsch Englisch

    Eligibility

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

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

    age at least 18 Years

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
    Beschreibung

    Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0030193
    SNOMED CT 2011_0131
    22253000
    MedDRA 14.1
    10033371
    LOINC Version 232
    MTHU029813
    ICD-10-CM Version 2010
    R52
    ICD-9-CM Version 2011
    338-338.9
    CTCAE 1105E
    E11167
    UMLS CUI 2011AA
    CL420107
    UMLS CUI 2011AA
    C0238767
    SNOMED CT 2011_0131
    51440002
    UMLS CUI 2011AA
    C2673754
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0332290
    SNOMED CT 2011_0131
    385433004
    UMLS CUI 2011AA
    C1137110
    HL7 V3 2006_05
    I10
    To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
    Beschreibung

    To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514624
    UMLS CUI 2011AA
    C1269683
    SNOMED CT 2011_0131
    370143000
    MedDRA 14.1
    10057840
    ICD-10-CM Version 2010
    F32.9
    UMLS CUI 2011AA
    C0599755
    UMLS CUI 2011AA
    C1550543
    HL7 V3 2006_05
    FLFS
    UMLS CUI 2011AA
    C1137110
    HL7 V3 2006_05
    I10
    UMLS CUI 2011AA
    CL414621
    UMLS CUI 2011AA
    CL435026
    Male or female outpatients at least 18 years of age.
    Beschreibung

    Male or female outpatients at least 18 years of age.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0029921
    SNOMED CT 2011_0131
    373864002
    LOINC Version 232
    MTHU011902
    Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
    Beschreibung

    Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0430061
    SNOMED CT 2011_0131
    166435006
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0038288
    MedDRA 14.1
    10062116
    UMLS CUI 2011AA
    CL426201
    UMLS CUI 2011AA
    C0025274
    SNOMED CT 2011_0131
    20016009
    MedDRA 14.1
    10027182
    UMLS CUI 2011AA
    C0232970
    SNOMED CT 2011_0131
    76498008
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    C0009905
    SNOMED CT 2011_0131
    59261009
    UMLS CUI 2011AA
    C0065864
    SNOMED CT 2011_0131
    27707001
    UMLS CUI 2011AA
    C0420842
    SNOMED CT 2011_0131
    268457007
    UMLS CUI 2011AA
    C0042241
    SNOMED CT 2011_0131
    20359006
    UMLS CUI 2011AA
    C0493327
    SNOMED CT 2011_0131
    368441006
    MedDRA 14.1
    10007183
    UMLS CUI 2011AA
    C0677582
    UMLS CUI 2011AA
    C0021900
    SNOMED CT 2011_0131
    268460000
    MedDRA 14.1
    10022745
    UMLS CUI 2011AA
    CL425201
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
    Beschreibung

    Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0013658
    SNOMED CT 2011_0131
    105421008
    LOINC Version 232
    MTHU002635
    UMLS CUI 2011AA
    C1273101
    SNOMED CT 2011_0131
    395659009
    UMLS CUI 2011AA
    C0009452
    SNOMED CT 2011_0131
    263536004
    LOINC Version 232
    MTHU021752
    UMLS CUI 2011AA
    CL102947
    UMLS CUI 2011AA
    C1710220
    Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
    Beschreibung

    Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C1709747
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
    Beschreibung

    Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C2347662
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0011581
    SNOMED CT 2011_0131
    35489007
    MedDRA 14.1
    10012401
    ICD-10-CM Version 2010
    F32.9
    UMLS CUI 2011AA
    C2827774
    UMLS CUI 2011AA
    C0003289
    SNOMED CT 2011_0131
    372720008
    LOINC Version 232
    MTHU006782
    Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
    Beschreibung

    Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0030193
    SNOMED CT 2011_0131
    22253000
    MedDRA 14.1
    10033371
    LOINC Version 232
    MTHU029813
    ICD-10-CM Version 2010
    R52
    ICD-9-CM Version 2011
    338-338.9
    CTCAE 1105E
    E11167
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0442825
    SNOMED CT 2011_0131
    260409000
    UMLS CUI 2011AA
    C0348080
    SNOMED CT 2011_0131
    260905004
    HL7 V3 2006_05
    COND
    UMLS CUI 2011AA
    C0521102
    SNOMED CT 2011_0131
    78235001
    UMLS CUI 2011AA
    C0582103
    SNOMED CT 2011_0131
    225886003
    UMLS CUI 2011AA
    C1963916
    MedDRA 14.1
    10067547
    Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
    Beschreibung

    Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0332157
    SNOMED CT 2011_0131
    24932003
    UMLS CUI 2011AA
    C0013227
    UMLS CUI 2011AA
    C0205309
    SNOMED CT 2011_0131
    36692007
    UMLS CUI 2011AA
    C0678227
    SNOMED CT 2011_0131
    23981006
    UMLS CUI 2011AA
    C0442874
    SNOMED CT 2011_0131
    386033004
    MedDRA 14.1
    10029328
    Have previously been treated with duloxetine (for DPNP or MDD)
    Beschreibung

    Have previously been treated with duloxetine (for DPNP or MDD)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0245561
    SNOMED CT 2011_0131
    407033009
    LOINC Version 232
    MTHU021254
    UMLS CUI 2011AA
    C1963916
    MedDRA 14.1
    10067547
    UMLS CUI 2011AA
    C1269683
    SNOMED CT 2011_0131
    370143000
    MedDRA 14.1
    10057840
    ICD-10-CM Version 2010
    F32.9
    Are judged to be at suicidal risk by the clinical investigator or as defined by a score of >= 2 on question 9 of the Beck Depression Inventory-II (BDI-II).
    Beschreibung

    Are judged to be at suicidal risk by the clinical investigator or as defined by a score of >= 2 on question 9 of the Beck Depression Inventory-II (BDI-II).

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0235196
    SNOMED CT 2011_0131
    10042461
    UMLS CUI 2011AA
    C0022423
    SNOMED CT 2011_0131
    61254005
    UMLS CUI 2011AA
    CL102947
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C2960571
    SNOMED CT 2011_0131
    446053003
    Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
    Beschreibung

    Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0740858
    SNOMED CT 2011_0131
    66214007
    MedDRA 14.1
    10066169
    LOINC Version 232
    MTHU019364
    UMLS CUI 2011AA
    C0038580
    SNOMED CT 2011_0131
    2403008
    UMLS CUI 2011AA
    CL411789
    UMLS CUI 2011AA
    C0028040
    SNOMED CT 2011_0131
    68540007
    LOINC Version 232
    MTHU003222
    UMLS CUI 2011AA
    C0006644
    SNOMED CT 2011_0131
    255641001
    LOINC Version 232
    MTHU012263
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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)
    Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
    Item
    Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
    boolean
    C0030193 (UMLS CUI 2011AA)
    22253000 (SNOMED CT 2011_0131)
    10033371 (MedDRA 14.1)
    MTHU029813 (LOINC Version 232)
    R52 (ICD-10-CM Version 2010)
    338-338.9 (ICD-9-CM Version 2011)
    E11167 (CTCAE 1105E)
    CL420107 (UMLS CUI 2011AA)
    C0238767 (UMLS CUI 2011AA)
    51440002 (SNOMED CT 2011_0131)
    C2673754 (UMLS CUI 2011AA)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0332290 (UMLS CUI 2011AA)
    385433004 (SNOMED CT 2011_0131)
    C1137110 (UMLS CUI 2011AA)
    I10 (HL7 V3 2006_05)
    To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
    Item
    To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
    boolean
    C1514624 (UMLS CUI 2011AA)
    C1269683 (UMLS CUI 2011AA)
    370143000 (SNOMED CT 2011_0131)
    10057840 (MedDRA 14.1)
    F32.9 (ICD-10-CM Version 2010)
    C0599755 (UMLS CUI 2011AA)
    C1550543 (UMLS CUI 2011AA)
    FLFS (HL7 V3 2006_05)
    C1137110 (UMLS CUI 2011AA)
    I10 (HL7 V3 2006_05)
    CL414621 (UMLS CUI 2011AA)
    CL435026 (UMLS CUI 2011AA)
    Male or female outpatients at least 18 years of age.
    Item
    Male or female outpatients at least 18 years of age.
    boolean
    C0086582 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0029921 (UMLS CUI 2011AA)
    373864002 (SNOMED CT 2011_0131)
    MTHU011902 (LOINC Version 232)
    Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
    Item
    Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
    boolean
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0430061 (UMLS CUI 2011AA)
    166435006 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI 2011AA)
    C0038288 (UMLS CUI 2011AA)
    10062116 (MedDRA 14.1)
    CL426201 (UMLS CUI 2011AA)
    C0025274 (UMLS CUI 2011AA)
    20016009 (SNOMED CT 2011_0131)
    10027182 (MedDRA 14.1)
    C0232970 (UMLS CUI 2011AA)
    76498008 (SNOMED CT 2011_0131)
    C0680240 (UMLS CUI 2011AA)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    C0009905 (UMLS CUI 2011AA)
    59261009 (SNOMED CT 2011_0131)
    C0065864 (UMLS CUI 2011AA)
    27707001 (SNOMED CT 2011_0131)
    C0420842 (UMLS CUI 2011AA)
    268457007 (SNOMED CT 2011_0131)
    C0042241 (UMLS CUI 2011AA)
    20359006 (SNOMED CT 2011_0131)
    C0493327 (UMLS CUI 2011AA)
    368441006 (SNOMED CT 2011_0131)
    10007183 (MedDRA 14.1)
    C0677582 (UMLS CUI 2011AA)
    C0021900 (UMLS CUI 2011AA)
    268460000 (SNOMED CT 2011_0131)
    10022745 (MedDRA 14.1)
    CL425201 (UMLS CUI 2011AA)
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
    Item
    Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
    boolean
    C0013658 (UMLS CUI 2011AA)
    105421008 (SNOMED CT 2011_0131)
    MTHU002635 (LOINC Version 232)
    C1273101 (UMLS CUI 2011AA)
    395659009 (SNOMED CT 2011_0131)
    C0009452 (UMLS CUI 2011AA)
    263536004 (SNOMED CT 2011_0131)
    MTHU021752 (LOINC Version 232)
    CL102947 (UMLS CUI 2011AA)
    C1710220 (UMLS CUI 2011AA)
    Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
    Item
    Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
    boolean
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0680240 (UMLS CUI 2011AA)
    C1709747 (UMLS CUI 2011AA)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
    Item
    Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
    boolean
    C2347662 (UMLS CUI 2011AA)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0011581 (UMLS CUI 2011AA)
    35489007 (SNOMED CT 2011_0131)
    10012401 (MedDRA 14.1)
    F32.9 (ICD-10-CM Version 2010)
    C2827774 (UMLS CUI 2011AA)
    C0003289 (UMLS CUI 2011AA)
    372720008 (SNOMED CT 2011_0131)
    MTHU006782 (LOINC Version 232)
    Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
    Item
    Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
    boolean
    C0030193 (UMLS CUI 2011AA)
    22253000 (SNOMED CT 2011_0131)
    10033371 (MedDRA 14.1)
    MTHU029813 (LOINC Version 232)
    R52 (ICD-10-CM Version 2010)
    338-338.9 (ICD-9-CM Version 2011)
    E11167 (CTCAE 1105E)
    C1518422 (UMLS CUI 2011AA)
    C0442825 (UMLS CUI 2011AA)
    260409000 (SNOMED CT 2011_0131)
    C0348080 (UMLS CUI 2011AA)
    260905004 (SNOMED CT 2011_0131)
    COND (HL7 V3 2006_05)
    C0521102 (UMLS CUI 2011AA)
    78235001 (SNOMED CT 2011_0131)
    C0582103 (UMLS CUI 2011AA)
    225886003 (SNOMED CT 2011_0131)
    C1963916 (UMLS CUI 2011AA)
    10067547 (MedDRA 14.1)
    Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
    Item
    Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0332157 (UMLS CUI 2011AA)
    24932003 (SNOMED CT 2011_0131)
    C0013227 (UMLS CUI 2011AA)
    C0205309 (UMLS CUI 2011AA)
    36692007 (SNOMED CT 2011_0131)
    C0678227 (UMLS CUI 2011AA)
    23981006 (SNOMED CT 2011_0131)
    C0442874 (UMLS CUI 2011AA)
    386033004 (SNOMED CT 2011_0131)
    10029328 (MedDRA 14.1)
    Have previously been treated with duloxetine (for DPNP or MDD)
    Item
    Have previously been treated with duloxetine (for DPNP or MDD)
    boolean
    C1514463 (UMLS CUI 2011AA)
    C0245561 (UMLS CUI 2011AA)
    407033009 (SNOMED CT 2011_0131)
    MTHU021254 (LOINC Version 232)
    C1963916 (UMLS CUI 2011AA)
    10067547 (MedDRA 14.1)
    C1269683 (UMLS CUI 2011AA)
    370143000 (SNOMED CT 2011_0131)
    10057840 (MedDRA 14.1)
    F32.9 (ICD-10-CM Version 2010)
    Are judged to be at suicidal risk by the clinical investigator or as defined by a score of >= 2 on question 9 of the Beck Depression Inventory-II (BDI-II).
    Item
    Are judged to be at suicidal risk by the clinical investigator or as defined by a score of >= 2 on question 9 of the Beck Depression Inventory-II (BDI-II).
    boolean
    C0235196 (UMLS CUI 2011AA)
    10042461 (SNOMED CT 2011_0131)
    C0022423 (UMLS CUI 2011AA)
    61254005 (SNOMED CT 2011_0131)
    CL102947 (UMLS CUI 2011AA)
    C1704788 (UMLS CUI 2011AA)
    C2960571 (UMLS CUI 2011AA)
    446053003 (SNOMED CT 2011_0131)
    Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
    Item
    Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0740858 (UMLS CUI 2011AA)
    66214007 (SNOMED CT 2011_0131)
    10066169 (MedDRA 14.1)
    MTHU019364 (LOINC Version 232)
    C0038580 (UMLS CUI 2011AA)
    2403008 (SNOMED CT 2011_0131)
    CL411789 (UMLS CUI 2011AA)
    C0028040 (UMLS CUI 2011AA)
    68540007 (SNOMED CT 2011_0131)
    MTHU003222 (LOINC Version 232)
    C0006644 (UMLS CUI 2011AA)
    255641001 (SNOMED CT 2011_0131)
    MTHU012263 (LOINC Version 232)
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