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ID

44304

Beskrivning

The Effect of Ketamine on Attentiveness; ODM derived from: https://clinicaltrials.gov/show/NCT01165294

Länk

https://clinicaltrials.gov/show/NCT01165294

Nyckelord

Versioner (3)
  1. 2018-10-24 2018-10-24 -
  2. 2018-10-24 2018-10-24 -
  3. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Schizophrenia NCT01165294

    Engelsk

    Eligibility Schizophrenia NCT01165294

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    normal ecg and safety assessments, or minor no-relevant deviations, at screening
    Beskrivning

    ECG normal | Safety Assessment Normal

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    UMLS CUI [2,1]
    C0549076
    UMLS CUI [2,2]
    C0205307
    vital signs: systolic between 100 and 140 mmhg and diastolic between 50 and 90 mmhg and heart rate between 45 and 90 beats/min
    Beskrivning

    Vital signs | Systolic Pressure | Diastolic blood pressure | Heart rate

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0518766
    UMLS CUI [2]
    C0871470
    UMLS CUI [3]
    C0428883
    UMLS CUI [4]
    C0018810
    no medication intake in the last four weeks
    Beskrivning

    Pharmaceutical Preparations Intake Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1512806
    UMLS CUI [1,3]
    C0332197
    volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to adhere to the prohibitions and restrictions specified in the protocol
    Beskrivning

    Informed Consent | Protocol Compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0525058
    negative drug screen
    Beskrivning

    Drug screen negative

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0919819
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    participation in another clinical trial in the last 3 months
    Beskrivning

    Study Subject Participation Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    significant allergies, allergic diathesis or known hypersensitivity for ketamine or its ingredients (ie, benzethonium chloride)
    Beskrivning

    Hypersensitivity | Diathesis allergic | Ketamine allergy | Hypersensitivity Ketamine Ingredient | Hypersensitivity Benzethonium Chloride

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020517
    UMLS CUI [2,1]
    C0012655
    UMLS CUI [2,2]
    C0700624
    UMLS CUI [3]
    C0570631
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C0022614
    UMLS CUI [4,3]
    C1550600
    UMLS CUI [5,1]
    C0020517
    UMLS CUI [5,2]
    C0079015
    history of or current significant respiratory disease, cardiovascular disease, endocrinological, gastrointestinal, neurological, glaucoma and known liver and kidney failure
    Beskrivning

    Respiration Disorder | Cardiovascular Disease | Endocrine System Diseases | Gastrointestinal Disease | Nervous system disorder | Glaucoma | Liver Failure | Kidney Failure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0035204
    UMLS CUI [2]
    C0007222
    UMLS CUI [3]
    C0014130
    UMLS CUI [4]
    C0017178
    UMLS CUI [5]
    C0027765
    UMLS CUI [6]
    C0017601
    UMLS CUI [7]
    C0085605
    UMLS CUI [8]
    C0035078
    contraindications for an mri being performed (claustrophobia, metal parts, pacemaker)
    Beskrivning

    Medical contraindication MRI | Claustrophobia | Parts Metallic | Artificial cardiac pacemaker

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0024485
    UMLS CUI [2]
    C0008909
    UMLS CUI [3,1]
    C0449719
    UMLS CUI [3,2]
    C2986473
    UMLS CUI [4]
    C0030163
    oxygen saturation po2 < 90 mmhg
    Beskrivning

    Oxygen saturation PO2 measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0369768
    UMLS CUI [1,2]
    C1283004
    clinically significant abnormalities in ecg or laboratory values
    Beskrivning

    ECG abnormality | Laboratory test result abnormal

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0522055
    UMLS CUI [2]
    C0438215
    recent history (within previous 6 months) of alcohol or drug abuse
    Beskrivning

    Substance Use Disorders

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    history of or current psychiatric diagnoses (dsm-iv, ii) or neurological disorders
    Beskrivning

    Mental disorders | Nervous system disorder

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    UMLS CUI [2]
    C0027765
    relatives in first or second degree with a schizophrenic disorder
    Beskrivning

    Schizophrenia First Degree Relative | Schizophrenia Second Degree Relative

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0036341
    UMLS CUI [1,2]
    C1517194
    UMLS CUI [2,1]
    C0036341
    UMLS CUI [2,2]
    C1519210
    serology positive for hepatitis b surface antigen, hepatitis c antibodies or hiv antibodies
    Beskrivning

    Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies | Serology positive HIV Antibodies

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0242089
    UMLS CUI [1,2]
    C0019168
    UMLS CUI [2,1]
    C0242089
    UMLS CUI [2,2]
    C0166049
    UMLS CUI [3,1]
    C0242089
    UMLS CUI [3,2]
    C0019683
    signs of hyperthyroidism based on the determination of t3, t4 and tsh
    Beskrivning

    Signs Hyperthyroidism | Triiodothyronine measurement | Thyroxine measurement | Thyroid stimulating hormone measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0311392
    UMLS CUI [1,2]
    C0020550
    UMLS CUI [2]
    C0428419
    UMLS CUI [3]
    C0202231
    UMLS CUI [4]
    C0202230
    Tillbaka till toppen

    Similar models

    Eligibility Schizophrenia NCT01165294

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ECG normal | Safety Assessment Normal
    Item
    normal ecg and safety assessments, or minor no-relevant deviations, at screening
    boolean
    C0522054 (UMLS CUI [1])
    C0549076 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    Vital signs | Systolic Pressure | Diastolic blood pressure | Heart rate
    Item
    vital signs: systolic between 100 and 140 mmhg and diastolic between 50 and 90 mmhg and heart rate between 45 and 90 beats/min
    boolean
    C0518766 (UMLS CUI [1])
    C0871470 (UMLS CUI [2])
    C0428883 (UMLS CUI [3])
    C0018810 (UMLS CUI [4])
    Pharmaceutical Preparations Intake Absent
    Item
    no medication intake in the last four weeks
    boolean
    C0013227 (UMLS CUI [1,1])
    C1512806 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    Informed Consent | Protocol Compliance
    Item
    volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to adhere to the prohibitions and restrictions specified in the protocol
    boolean
    C0021430 (UMLS CUI [1])
    C0525058 (UMLS CUI [2])
    Drug screen negative
    Item
    negative drug screen
    boolean
    C0919819 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status
    Item
    participation in another clinical trial in the last 3 months
    boolean
    C2348568 (UMLS CUI [1])
    Hypersensitivity | Diathesis allergic | Ketamine allergy | Hypersensitivity Ketamine Ingredient | Hypersensitivity Benzethonium Chloride
    Item
    significant allergies, allergic diathesis or known hypersensitivity for ketamine or its ingredients (ie, benzethonium chloride)
    boolean
    C0020517 (UMLS CUI [1])
    C0012655 (UMLS CUI [2,1])
    C0700624 (UMLS CUI [2,2])
    C0570631 (UMLS CUI [3])
    C0020517 (UMLS CUI [4,1])
    C0022614 (UMLS CUI [4,2])
    C1550600 (UMLS CUI [4,3])
    C0020517 (UMLS CUI [5,1])
    C0079015 (UMLS CUI [5,2])
    Respiration Disorder | Cardiovascular Disease | Endocrine System Diseases | Gastrointestinal Disease | Nervous system disorder | Glaucoma | Liver Failure | Kidney Failure
    Item
    history of or current significant respiratory disease, cardiovascular disease, endocrinological, gastrointestinal, neurological, glaucoma and known liver and kidney failure
    boolean
    C0035204 (UMLS CUI [1])
    C0007222 (UMLS CUI [2])
    C0014130 (UMLS CUI [3])
    C0017178 (UMLS CUI [4])
    C0027765 (UMLS CUI [5])
    C0017601 (UMLS CUI [6])
    C0085605 (UMLS CUI [7])
    C0035078 (UMLS CUI [8])
    Medical contraindication MRI | Claustrophobia | Parts Metallic | Artificial cardiac pacemaker
    Item
    contraindications for an mri being performed (claustrophobia, metal parts, pacemaker)
    boolean
    C1301624 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    C0008909 (UMLS CUI [2])
    C0449719 (UMLS CUI [3,1])
    C2986473 (UMLS CUI [3,2])
    C0030163 (UMLS CUI [4])
    Oxygen saturation PO2 measurement
    Item
    oxygen saturation po2 < 90 mmhg
    boolean
    C0369768 (UMLS CUI [1,1])
    C1283004 (UMLS CUI [1,2])
    ECG abnormality | Laboratory test result abnormal
    Item
    clinically significant abnormalities in ecg or laboratory values
    boolean
    C0522055 (UMLS CUI [1])
    C0438215 (UMLS CUI [2])
    Substance Use Disorders
    Item
    recent history (within previous 6 months) of alcohol or drug abuse
    boolean
    C0038586 (UMLS CUI [1])
    Mental disorders | Nervous system disorder
    Item
    history of or current psychiatric diagnoses (dsm-iv, ii) or neurological disorders
    boolean
    C0004936 (UMLS CUI [1])
    C0027765 (UMLS CUI [2])
    Schizophrenia First Degree Relative | Schizophrenia Second Degree Relative
    Item
    relatives in first or second degree with a schizophrenic disorder
    boolean
    C0036341 (UMLS CUI [1,1])
    C1517194 (UMLS CUI [1,2])
    C0036341 (UMLS CUI [2,1])
    C1519210 (UMLS CUI [2,2])
    Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies | Serology positive HIV Antibodies
    Item
    serology positive for hepatitis b surface antigen, hepatitis c antibodies or hiv antibodies
    boolean
    C0242089 (UMLS CUI [1,1])
    C0019168 (UMLS CUI [1,2])
    C0242089 (UMLS CUI [2,1])
    C0166049 (UMLS CUI [2,2])
    C0242089 (UMLS CUI [3,1])
    C0019683 (UMLS CUI [3,2])
    Signs Hyperthyroidism | Triiodothyronine measurement | Thyroxine measurement | Thyroid stimulating hormone measurement
    Item
    signs of hyperthyroidism based on the determination of t3, t4 and tsh
    boolean
    C0311392 (UMLS CUI [1,1])
    C0020550 (UMLS CUI [1,2])
    C0428419 (UMLS CUI [2])
    C0202231 (UMLS CUI [3])
    C0202230 (UMLS CUI [4])
    Tillbaka till toppen 

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