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ID

40438

Beschreibung

Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01707706

Link

https://clinicaltrials.gov/show/NCT01707706

Stichworte

Versionen (1)
  1. 21.04.20 21.04.20 -
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See clinicaltrials.gov

Hochgeladen am

21. April 2020

DOI

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Creative Commons BY 4.0
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    Eligibility Insomnia NCT01707706

    Englisch

    Eligibility Insomnia NCT01707706

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility Insomnia NCT01707706
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    aged 18 years or above
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    a previous diagnostic and statistical manual of mental disorders-iv major depressive disorder
    Beschreibung

    Major Depressive Disorder Previous

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1269683
    UMLS CUI [1,2]
    C0205156
    have a current diagnostic and statistical manual of mental disorders-iv diagnosis of insomnia disorder
    Beschreibung

    Sleeplessness

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0917801
    insomnia more than 3 nights per week for at least 3 months
    Beschreibung

    Sleeplessness Frequency Duration

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0917801
    UMLS CUI [1,2]
    C0439603
    UMLS CUI [1,3]
    C0449238
    insomnia severity scale (isi) total score higher than 15 at screening and baseline visit
    Beschreibung

    Insomnia Severity Index

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4545806
    use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
    Beschreibung

    Antidepressive Agents Dose Stable

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0003289
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0205360
    hypnotic dosage has not been increased in the last 4 weeks
    Beschreibung

    Hypnotics Dose Stable

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020591
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0205360
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    have a hamilton depression rating scale scores above 18
    Beschreibung

    Hamilton rating scale for depression

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0451203
    have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
    Beschreibung

    Sleep Apnea Polysomnography Overnight | Periodic limb movement sleep disorder Polysomnography Overnight

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0037315
    UMLS CUI [1,2]
    C0162701
    UMLS CUI [1,3]
    C0439583
    UMLS CUI [2,1]
    C1561887
    UMLS CUI [2,2]
    C0162701
    UMLS CUI [2,3]
    C0439583
    have suicidal risk as assessed by the hamilton depression rating scale suicidal risk item
    Beschreibung

    At risk for suicide Hamilton rating scale for depression

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0563664
    UMLS CUI [1,2]
    C0451203
    have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
    Beschreibung

    History of schizophrenia | History of psychotic disorder | Medical History Bipolar Disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0455502
    UMLS CUI [2]
    C3887134
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0005586
    have current alcohol or drug abuse and dependence
    Beschreibung

    Substance Use Disorders | Substance Dependence

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0038580
    pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
    Beschreibung

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0332197
    have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
    Beschreibung

    Communicable Disease Near Acupuncture Points | Abscess Near Acupuncture Points

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1706276
    UMLS CUI [1,3]
    C0001302
    UMLS CUI [2,1]
    C0000833
    UMLS CUI [2,2]
    C1706276
    UMLS CUI [2,3]
    C0001302
    taking chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
    Beschreibung

    Chinese Herbal Drugs Sleeplessness | Non-Prescription Drugs Sleeplessness

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013229
    UMLS CUI [1,2]
    C0917801
    UMLS CUI [2,1]
    C0013231
    UMLS CUI [2,2]
    C0917801
    any acupuncture treatment during the previous 12 months prior to baseline and
    Beschreibung

    Acupuncture

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0394664
    unstable medical conditions.
    Beschreibung

    Medical condition Unstable

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0443343
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Insomnia NCT01707706

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility Insomnia NCT01707706
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    aged 18 years or above
    boolean
    C0001779 (UMLS CUI [1])
    Major Depressive Disorder Previous
    Item
    a previous diagnostic and statistical manual of mental disorders-iv major depressive disorder
    boolean
    C1269683 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Sleeplessness
    Item
    have a current diagnostic and statistical manual of mental disorders-iv diagnosis of insomnia disorder
    boolean
    C0917801 (UMLS CUI [1])
    Sleeplessness Frequency Duration
    Item
    insomnia more than 3 nights per week for at least 3 months
    boolean
    C0917801 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [1,3])
    Insomnia Severity Index
    Item
    insomnia severity scale (isi) total score higher than 15 at screening and baseline visit
    boolean
    C4545806 (UMLS CUI [1])
    Antidepressive Agents Dose Stable
    Item
    use of antidepressants at the same dosage for at least 12 weeks prior to screening visit
    boolean
    C0003289 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Hypnotics Dose Stable
    Item
    hypnotic dosage has not been increased in the last 4 weeks
    boolean
    C0020591 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    Hamilton rating scale for depression
    Item
    have a hamilton depression rating scale scores above 18
    boolean
    C0451203 (UMLS CUI [1])
    Sleep Apnea Polysomnography Overnight | Periodic limb movement sleep disorder Polysomnography Overnight
    Item
    have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
    boolean
    C0037315 (UMLS CUI [1,1])
    C0162701 (UMLS CUI [1,2])
    C0439583 (UMLS CUI [1,3])
    C1561887 (UMLS CUI [2,1])
    C0162701 (UMLS CUI [2,2])
    C0439583 (UMLS CUI [2,3])
    At risk for suicide Hamilton rating scale for depression
    Item
    have suicidal risk as assessed by the hamilton depression rating scale suicidal risk item
    boolean
    C0563664 (UMLS CUI [1,1])
    C0451203 (UMLS CUI [1,2])
    History of schizophrenia | History of psychotic disorder | Medical History Bipolar Disorder
    Item
    have previous history of schizophrenia, other psychotic disorders, and bipolar disorder
    boolean
    C0455502 (UMLS CUI [1])
    C3887134 (UMLS CUI [2])
    C0262926 (UMLS CUI [3,1])
    C0005586 (UMLS CUI [3,2])
    Substance Use Disorders | Substance Dependence
    Item
    have current alcohol or drug abuse and dependence
    boolean
    C0038586 (UMLS CUI [1])
    C0038580 (UMLS CUI [2])
    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
    Item
    pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0332197 (UMLS CUI [3,3])
    Communicable Disease Near Acupuncture Points | Abscess Near Acupuncture Points
    Item
    have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
    boolean
    C0009450 (UMLS CUI [1,1])
    C1706276 (UMLS CUI [1,2])
    C0001302 (UMLS CUI [1,3])
    C0000833 (UMLS CUI [2,1])
    C1706276 (UMLS CUI [2,2])
    C0001302 (UMLS CUI [2,3])
    Chinese Herbal Drugs Sleeplessness | Non-Prescription Drugs Sleeplessness
    Item
    taking chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
    boolean
    C0013229 (UMLS CUI [1,1])
    C0917801 (UMLS CUI [1,2])
    C0013231 (UMLS CUI [2,1])
    C0917801 (UMLS CUI [2,2])
    Acupuncture
    Item
    any acupuncture treatment during the previous 12 months prior to baseline and
    boolean
    C0394664 (UMLS CUI [1])
    Medical condition Unstable
    Item
    unstable medical conditions.
    boolean
    C3843040 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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