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ID

40758

Descrição

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Palavras-chave

Versões (4)
  1. 27/04/2020 27/04/2020 -
  2. 04/05/2020 04/05/2020 -
  3. 08/05/2020 08/05/2020 -
  4. 08/05/2020 08/05/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

8 mai 2020

DOI

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Licença

Creative Commons BY-NC 4.0
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    Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

    Inglês

    Predose Checklist; Las Visit Checklist

    1 Formulários  
    Administrative
    Descrição

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Descrição

    Patient Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Descrição

    Centre Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Date
    Descrição

    Visit Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Predose Checklist (Day 1)
    Descrição

    Predose Checklist (Day 1)

    Alias
    UMLS CUI-1
    C0439565
    UMLS CUI-2
    C1707357
    1. Has the patient washed out from their previous RLS medication for the appropiate length of time? (DAY 1)
    Descrição

    1. Has the patient washed out from their previous RLS medication for the appropiate length of time? (DAY 1)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1710661
    UMLS CUI [2,1]
    C0013216
    UMLS CUI [2,2]
    C0035258
    UMLS CUI [2,3]
    C0205156
    UMLS CUI [3]
    C0449238
    2. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Descrição

    2. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C1517741
    3. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    Descrição

    3. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [2]
    C0560579
    UMLS CUI [3]
    C0559430
    UMLS CUI [4]
    C0043188
    4. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    Descrição

    4. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1514989
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [2,1]
    C0008952
    UMLS CUI [2,2]
    C0332152
    5. Has the patient maintained their normal smoking practice?
    Descrição

    5. Has the patient maintained their normal smoking practice?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    6. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    Descrição

    6. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0279494
    UMLS CUI [1,2]
    C0678766
    UMLS CUI [1,3]
    C0231241
    UMLS CUI [1,4]
    C0282402
    UMLS CUI [2]
    C0029151
    7. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    Descrição

    7. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1290952
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0443288
    UMLS CUI [2]
    C2709201
    UMLS CUI [3]
    C0025125
    UMLS CUI [4,1]
    C0008952
    UMLS CUI [4,2]
    C0332152
    UMLS CUI [5,1]
    C0521102
    UMLS CUI [5,2]
    C2700391
    UMLS CUI [5,3]
    C0008972
    8. Has the patient washed out from any previous prohibited medication for the appropriate length of time?
    Descrição

    8. Has the patient washed out from any previous prohibited medication for the appropriate length of time?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1710661
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0683610
    UMLS CUI [1,4]
    C0205156
    UMLS CUI [2]
    C0449238
    9. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    Descrição

    9. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1827490
    UMLS CUI [2,1]
    C0207509
    UMLS CUI [2,2]
    C0178623
    UMLS CUI [3]
    C1827504
    UMLS CUI [4,1]
    C0178602
    UMLS CUI [4,2]
    C1948059
    UMLS CUI [5]
    C0282402
    10. Has the patient completed 2 consecutive nights of baseline actigraphy and ambulatory sleep EEG recordings at home?
    Descrição

    10. Has the patient completed 2 consecutive nights of baseline actigraphy and ambulatory sleep EEG recordings at home?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1442488
    UMLS CUI [2,1]
    C1171301
    UMLS CUI [2,2]
    C0013819
    UMLS CUI [2,3]
    C0037313
    UMLS CUI [3,1]
    C0013819
    UMLS CUI [3,2]
    C0037313
    UMLS CUI [3,3]
    C0439841
    11. Has the patient completed the St Mary’s Sleep Questionnaire at home?
    Descrição

    11. Has the patient completed the St Mary’s Sleep Questionnaire at home?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0034394
    UMLS CUI [1,2]
    C0037313
    Predose Checklist (Day 3; Extra Clinic Visit 1- 3)
    Descrição

    Predose Checklist (Day 3; Extra Clinic Visit 1- 3)

    Alias
    UMLS CUI-1
    C0439565
    UMLS CUI-2
    C1707357
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Descrição

    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C1517741
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    Descrição

    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [2]
    C0560579
    UMLS CUI [3]
    C0559430
    UMLS CUI [4]
    C0043188
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    Descrição

    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1514989
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [2,1]
    C0008952
    UMLS CUI [2,2]
    C0332152
    4. Has the patient maintained their normal smoking practice?
    Descrição

    4. Has the patient maintained their normal smoking practice?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    Descrição

    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0279494
    UMLS CUI [1,2]
    C0678766
    UMLS CUI [1,3]
    C0231241
    UMLS CUI [1,4]
    C0282402
    UMLS CUI [2]
    C0029151
    6. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    Descrição

    6. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1290952
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0443288
    UMLS CUI [2]
    C2709201
    UMLS CUI [3]
    C0025125
    UMLS CUI [4,1]
    C0008952
    UMLS CUI [4,2]
    C0332152
    UMLS CUI [5,1]
    C0521102
    UMLS CUI [5,2]
    C2700391
    UMLS CUI [5,3]
    C0008972
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    Descrição

    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1827490
    UMLS CUI [2,1]
    C0207509
    UMLS CUI [2,2]
    C0178623
    UMLS CUI [3]
    C1827504
    UMLS CUI [4,1]
    C0178602
    UMLS CUI [4,2]
    C1948059
    UMLS CUI [5]
    C0282402
    Predose Checklist (Day 15, Day 22, Day 29, Day 36, Day 43)
    Descrição

    Predose Checklist (Day 15, Day 22, Day 29, Day 36, Day 43)

    Alias
    UMLS CUI-1
    C0439565
    UMLS CUI-2
    C1707357
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Descrição

    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C1517741
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    Descrição

    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [2]
    C0560579
    UMLS CUI [3]
    C0559430
    UMLS CUI [4]
    C0043188
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    Descrição

    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1514989
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [2,1]
    C0008952
    UMLS CUI [2,2]
    C0332152
    4. Has the patient maintained their normal smoking practice?
    Descrição

    4. Has the patient maintained their normal smoking practice?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    Descrição

    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0279494
    UMLS CUI [1,2]
    C0678766
    UMLS CUI [1,3]
    C0231241
    UMLS CUI [1,4]
    C0282402
    UMLS CUI [2]
    C0029151
    6. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    Descrição

    6. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1290952
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0443288
    UMLS CUI [2]
    C2709201
    UMLS CUI [3]
    C0025125
    UMLS CUI [4,1]
    C0008952
    UMLS CUI [4,2]
    C0332152
    UMLS CUI [5,1]
    C0521102
    UMLS CUI [5,2]
    C2700391
    UMLS CUI [5,3]
    C0008972
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    Descrição

    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1827490
    UMLS CUI [2,1]
    C0207509
    UMLS CUI [2,2]
    C0178623
    UMLS CUI [3]
    C1827504
    UMLS CUI [4,1]
    C0178602
    UMLS CUI [4,2]
    C1948059
    UMLS CUI [5]
    C0282402
    8. Has the patient completed actigraphy and EEG recordings on 2 consecutive nights and completed the St Mary’s Sleep Questionnaire
    Descrição

    8. Has the patient completed actigraphy and EEG recordings on 2 consecutive nights and completed the St Mary’s Sleep Questionnaire

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1171301
    UMLS CUI [2]
    C0013819
    UMLS CUI [3,1]
    C0034394
    UMLS CUI [3,2]
    C0037313
    Last Visit Checklist
    Descrição

    Last Visit Checklist

    Alias
    UMLS CUI-1
    C1707357
    UMLS CUI-2
    C0545082
    UMLS CUI-3
    C1517741
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Descrição

    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C1517741
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    Descrição

    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [2]
    C0560579
    UMLS CUI [3]
    C0559430
    UMLS CUI [4]
    C0043188
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    Descrição

    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1514989
    UMLS CUI [1,2]
    C0443288
    UMLS CUI [2,1]
    C0008952
    UMLS CUI [2,2]
    C0332152
    4. Has the patient maintained their normal smoking practice?
    Descrição

    4. Has the patient maintained their normal smoking practice?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    Descrição

    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0279494
    UMLS CUI [1,2]
    C0678766
    UMLS CUI [1,3]
    C0231241
    UMLS CUI [1,4]
    C0282402
    UMLS CUI [2]
    C0029151
    6. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    Descrição

    6. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1290952
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0443288
    UMLS CUI [2]
    C2709201
    UMLS CUI [3]
    C0025125
    UMLS CUI [4,1]
    C0008952
    UMLS CUI [4,2]
    C0332152
    UMLS CUI [5,1]
    C0521102
    UMLS CUI [5,2]
    C2700391
    UMLS CUI [5,3]
    C0008972
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    Descrição

    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1827490
    UMLS CUI [2,1]
    C0207509
    UMLS CUI [2,2]
    C0178623
    UMLS CUI [3]
    C1827504
    UMLS CUI [4,1]
    C0178602
    UMLS CUI [4,2]
    C1948059
    UMLS CUI [5]
    C0282402
    8. Has the patient completed actigraphy and EEG recordings on 2 consecutive nights and completed the St Mary’s Sleep Questionnaire
    Descrição

    8. Has the patient completed actigraphy and EEG recordings on 2 consecutive nights and completed the St Mary’s Sleep Questionnaire

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1171301
    UMLS CUI [2]
    C0013819
    UMLS CUI [3,1]
    C0034394
    UMLS CUI [3,2]
    C0037313
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    Similar models

    Predose Checklist; Las Visit Checklist

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Predose Checklist (Day 1)
    C0439565 (UMLS CUI-1)
    C1707357 (UMLS CUI-2)
    1. Has the patient washed out from their previous RLS medication for the appropiate length of time? (DAY 1)
    Item
    1. Has the patient washed out from their previous RLS medication for the appropiate length of time? (DAY 1)
    boolean
    C1710661 (UMLS CUI [1])
    C0013216 (UMLS CUI [2,1])
    C0035258 (UMLS CUI [2,2])
    C0205156 (UMLS CUI [2,3])
    C0449238 (UMLS CUI [3])
    2. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Item
    2. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    boolean
    C0001948 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    3. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    Item
    3. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    boolean
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C0560579 (UMLS CUI [2])
    C0559430 (UMLS CUI [3])
    C0043188 (UMLS CUI [4])
    4. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    Item
    4. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    boolean
    C1514989 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C0008952 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    5. Has the patient maintained their normal smoking practice?
    Item
    5. Has the patient maintained their normal smoking practice?
    boolean
    C1519386 (UMLS CUI [1])
    6. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    Item
    6. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    boolean
    C0279494 (UMLS CUI [1,1])
    C0678766 (UMLS CUI [1,2])
    C0231241 (UMLS CUI [1,3])
    C0282402 (UMLS CUI [1,4])
    C0029151 (UMLS CUI [2])
    7. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research
    Item
    7. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    boolean
    C1290952 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    C2709201 (UMLS CUI [2])
    C0025125 (UMLS CUI [3])
    C0008952 (UMLS CUI [4,1])
    C0332152 (UMLS CUI [4,2])
    C0521102 (UMLS CUI [5,1])
    C2700391 (UMLS CUI [5,2])
    C0008972 (UMLS CUI [5,3])
    8. Has the patient washed out from any previous prohibited medication for the appropriate length of time?
    Item
    8. Has the patient washed out from any previous prohibited medication for the appropriate length of time?
    boolean
    C1710661 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0683610 (UMLS CUI [1,3])
    C0205156 (UMLS CUI [1,4])
    C0449238 (UMLS CUI [2])
    9. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant
    Item
    9. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    boolean
    C2347852 (UMLS CUI [1,1])
    C1827490 (UMLS CUI [1,2])
    C0207509 (UMLS CUI [2,1])
    C0178623 (UMLS CUI [2,2])
    C1827504 (UMLS CUI [3])
    C0178602 (UMLS CUI [4,1])
    C1948059 (UMLS CUI [4,2])
    C0282402 (UMLS CUI [5])
    10. Has the patient completed 2 consecutive nights of baseline actigraphy and ambulatory sleep EEG recordings at home?
    Item
    10. Has the patient completed 2 consecutive nights of baseline actigraphy and ambulatory sleep EEG recordings at home?
    boolean
    C1442488 (UMLS CUI [1])
    C1171301 (UMLS CUI [2,1])
    C0013819 (UMLS CUI [2,2])
    C0037313 (UMLS CUI [2,3])
    C0013819 (UMLS CUI [3,1])
    C0037313 (UMLS CUI [3,2])
    C0439841 (UMLS CUI [3,3])
    11. Has the patient completed the St Mary’s Sleep Questionnaire at home?
    Item
    11. Has the patient completed the St Mary’s Sleep Questionnaire at home?
    boolean
    C0034394 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    Item Group
    Predose Checklist (Day 3; Extra Clinic Visit 1- 3)
    C0439565 (UMLS CUI-1)
    C1707357 (UMLS CUI-2)
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Item
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    boolean
    C0001948 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women?
    Item
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    boolean
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C0560579 (UMLS CUI [2])
    C0559430 (UMLS CUI [3])
    C0043188 (UMLS CUI [4])
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    Item
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    boolean
    C1514989 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C0008952 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    4. Has the patient maintained their normal smoking practice?
    Item
    4. Has the patient maintained their normal smoking practice?
    boolean
    C1519386 (UMLS CUI [1])
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    Item
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    boolean
    C0279494 (UMLS CUI [1,1])
    C0678766 (UMLS CUI [1,2])
    C0231241 (UMLS CUI [1,3])
    C0282402 (UMLS CUI [1,4])
    C0029151 (UMLS CUI [2])
    6. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research
    Item
    6. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    boolean
    C1290952 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    C2709201 (UMLS CUI [2])
    C0025125 (UMLS CUI [3])
    C0008952 (UMLS CUI [4,1])
    C0332152 (UMLS CUI [4,2])
    C0521102 (UMLS CUI [5,1])
    C2700391 (UMLS CUI [5,2])
    C0008972 (UMLS CUI [5,3])
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    Item
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    boolean
    C2347852 (UMLS CUI [1,1])
    C1827490 (UMLS CUI [1,2])
    C0207509 (UMLS CUI [2,1])
    C0178623 (UMLS CUI [2,2])
    C1827504 (UMLS CUI [3])
    C0178602 (UMLS CUI [4,1])
    C1948059 (UMLS CUI [4,2])
    C0282402 (UMLS CUI [5])
    Item Group
    Predose Checklist (Day 15, Day 22, Day 29, Day 36, Day 43)
    C0439565 (UMLS CUI-1)
    C1707357 (UMLS CUI-2)
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Item
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    boolean
    C0001948 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women?
    Item
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    boolean
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C0560579 (UMLS CUI [2])
    C0559430 (UMLS CUI [3])
    C0043188 (UMLS CUI [4])
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    Item
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    boolean
    C1514989 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C0008952 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    4. Has the patient maintained their normal smoking practice?
    Item
    4. Has the patient maintained their normal smoking practice?
    boolean
    C1519386 (UMLS CUI [1])
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    Item
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    boolean
    C0279494 (UMLS CUI [1,1])
    C0678766 (UMLS CUI [1,2])
    C0231241 (UMLS CUI [1,3])
    C0282402 (UMLS CUI [1,4])
    C0029151 (UMLS CUI [2])
    6. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research
    Item
    6. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    boolean
    C1290952 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    C2709201 (UMLS CUI [2])
    C0025125 (UMLS CUI [3])
    C0008952 (UMLS CUI [4,1])
    C0332152 (UMLS CUI [4,2])
    C0521102 (UMLS CUI [5,1])
    C2700391 (UMLS CUI [5,2])
    C0008972 (UMLS CUI [5,3])
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    Item
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    boolean
    C2347852 (UMLS CUI [1,1])
    C1827490 (UMLS CUI [1,2])
    C0207509 (UMLS CUI [2,1])
    C0178623 (UMLS CUI [2,2])
    C1827504 (UMLS CUI [3])
    C0178602 (UMLS CUI [4,1])
    C1948059 (UMLS CUI [4,2])
    C0282402 (UMLS CUI [5])
    8. Has the patient completed actigraphy and EEG recordings on 2 consecutive nights and completed the St Mary’s Sleep Questionnaire
    Item
    8. Has the patient completed actigraphy and EEG recordings on 2 consecutive nights and completed the St Mary’s Sleep Questionnaire
    boolean
    C1171301 (UMLS CUI [1])
    C0013819 (UMLS CUI [2])
    C0034394 (UMLS CUI [3,1])
    C0037313 (UMLS CUI [3,2])
    Item Group
    Last Visit Checklist
    C1707357 (UMLS CUI-1)
    C0545082 (UMLS CUI-2)
    C1517741 (UMLS CUI-3)
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    Item
    1. Has the patient refrained from consuming alcohol for 24 hours prior to the clinic visit?
    boolean
    C0001948 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women?
    Item
    2. Has the patient limited their daily alcohol consumption to no more than 3 units for men and 2 units for women? (1 unit is equivalent to 1 beer, one measure of sprits or 1 small glass of wine.)
    boolean
    C0001948 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C0560579 (UMLS CUI [2])
    C0559430 (UMLS CUI [3])
    C0043188 (UMLS CUI [4])
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    Item
    3. Has the patient refrained from strenuous exercise (outside of normal routine) from 48 hours before the clinic visit?
    boolean
    C1514989 (UMLS CUI [1,1])
    C0443288 (UMLS CUI [1,2])
    C0008952 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    4. Has the patient maintained their normal smoking practice?
    Item
    4. Has the patient maintained their normal smoking practice?
    boolean
    C1519386 (UMLS CUI [1])
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    Item
    5. Has the patient refrained from fluctuating dose of oestrogen ie. in hormone replacement therapy (HRT) or oral contraceptives?
    boolean
    C0279494 (UMLS CUI [1,1])
    C0678766 (UMLS CUI [1,2])
    C0231241 (UMLS CUI [1,3])
    C0282402 (UMLS CUI [1,4])
    C0029151 (UMLS CUI [2])
    6. Taking medication (activity); Other; Restricted | OTC - Over The Counter | Medicinal Herbs | Clinic Visits; Before | Interferes with; Procedure (set of actions); Clinical Research
    Item
    6. Has the patient refrained from taking other medication (OTC or herbal remedies) for 48 hours prior to the clinic visit? Patients who have taken OTC medication may still be able to continue in the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety.
    boolean
    C1290952 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0443288 (UMLS CUI [1,3])
    C2709201 (UMLS CUI [2])
    C0025125 (UMLS CUI [3])
    C0008952 (UMLS CUI [4,1])
    C0332152 (UMLS CUI [4,2])
    C0521102 (UMLS CUI [5,1])
    C2700391 (UMLS CUI [5,2])
    C0008972 (UMLS CUI [5,3])
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    Item
    7. For the concomitant medications which are CYP1A2 inducers, substrates or inhibitors, has the patient kept the dose constant? (this includes women taking hormone replacement therapy (HRT) or oestrogen containing medications)
    boolean
    C2347852 (UMLS CUI [1,1])
    C1827490 (UMLS CUI [1,2])
    C0207509 (UMLS CUI [2,1])
    C0178623 (UMLS CUI [2,2])
    C1827504 (UMLS CUI [3])
    C0178602 (UMLS CUI [4,1])
    C1948059 (UMLS CUI [4,2])
    C0282402 (UMLS CUI [5])
    8. Has the patient completed actigraphy and EEG recordings on 2 consecutive nights and completed the St Mary’s Sleep Questionnaire
    Item
    8. Has the patient completed actigraphy and EEG recordings on 2 consecutive nights and completed the St Mary’s Sleep Questionnaire
    boolean
    C1171301 (UMLS CUI [1])
    C0013819 (UMLS CUI [2])
    C0034394 (UMLS CUI [3,1])
    C0037313 (UMLS CUI [3,2])
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