ID

28876

Description

Nexalin Therapy for the Treatment of Depressive Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT00774813

Link

https://clinicaltrials.gov/show/NCT00774813

Keywords

Versions (1)
  1. 2/9/18 2/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00774813

English

Eligibility Depression NCT00774813

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00774813
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with mild to moderate depression episode, based on the ham-d21 rating scale (10-13 = mild; 14-17 = mild to moderate)
Description

Mild depressive episode Hamilton Depression Rating Scale 21-Item Questionnaire | Moderate depressive episode Hamilton Depression Rating Scale 21-Item Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0494397
UMLS CUI [1,2]
C3640518
UMLS CUI [2,1]
C0494398
UMLS CUI [2,2]
C3640518
diagnosed with mild to moderate depression episode based on icd-10 diagnostic guidelines
Description

Mild depressive episode ICD-10 | Moderate depressive episode ICD-10

Data type

boolean

Alias
UMLS CUI [1,1]
C0494397
UMLS CUI [1,2]
C1137110
UMLS CUI [2,1]
C0494398
UMLS CUI [2,2]
C1137110
is willing and able to spend 4 weeks as a hospital inpatient
Description

Hospital inpatient Duration Willing | Hospital inpatient Duration Able

Data type

boolean

Alias
UMLS CUI [1,1]
C0239966
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0239966
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C1299581
is willing and able to return to the clinic during follow-up period
Description

Follow-up Willing | Follow-up Able

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1299581
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a ham-d21 rating scale of <10 or >17
Description

Hamilton Depression Rating Scale 21-Item Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3640518
diagnosed outside of mild to moderate depression episode range based on the icd-10 diagnostic guidelines
Description

Mismatch Mild depressive episode ICD-10 | Mismatch Moderate depressive episode ICD-10

Data type

boolean

Alias
UMLS CUI [1,1]
C1881865
UMLS CUI [1,2]
C0494397
UMLS CUI [1,3]
C1137110
UMLS CUI [2,1]
C1881865
UMLS CUI [2,2]
C0494398
UMLS CUI [2,3]
C1137110
unable to complete wash-out interval without taking antidepressants or psychotropic medications
Description

Washout Period Complete Unable | Patient need for Antidepressive Agents | Patient need for Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0003289
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0033978
is pregnant or may be pregnant
Description

Pregnancy | Possible pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
sensitivity to electrodes and/or their conductive gels or adhesives
Description

Hypersensitivity Electrode | Hypersensitivity Electrode Conductive Gel | Hypersensitivity Electrode Adhesives

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013812
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013812
UMLS CUI [2,3]
C0180091
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013812
UMLS CUI [3,3]
C0001516
break in skin integrity at the areas of electrode placement
Description

Impaired skin integrity Area Implanted electrodes

Data type

boolean

Alias
UMLS CUI [1,1]
C4048181
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0013814
currently taking immune suppressing drugs or suspected use of narcotics
Description

Immunosuppressive Agents | Narcotics Use of Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0027415
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0750491
presence of any implanted electronic devices, cardiac stimulator, or pacemaker
Description

Implanted medical device Electronic | Stimulator cardiac | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C2735362
UMLS CUI [1,2]
C0013850
UMLS CUI [2,1]
C0175727
UMLS CUI [2,2]
C0018787
UMLS CUI [3]
C0030163
history of brain injury, including seizures, epilepsy, stroke, tumor of central nervous system, or hydrocephalus
Description

Brain Injuries | Seizures | Epilepsy | Cerebrovascular accident | Central Nervous System Tumor | Hydrocephalus

Data type

boolean

Alias
UMLS CUI [1]
C0270611
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0085136
UMLS CUI [6]
C0020255
history of heart attacks, congestive heart failure, or uncontrolled hypertension
Description

Myocardial Infarction | Congestive heart failure | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1868885
history of schizophrenia or manic-depressive syndrome
Description

Schizophrenia | Manic-depressive syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0005586
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Similar models

Eligibility Depression NCT00774813

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00774813
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mild depressive episode Hamilton Depression Rating Scale 21-Item Questionnaire | Moderate depressive episode Hamilton Depression Rating Scale 21-Item Questionnaire
Item
diagnosed with mild to moderate depression episode, based on the ham-d21 rating scale (10-13 = mild; 14-17 = mild to moderate)
boolean
C0494397 (UMLS CUI [1,1])
C3640518 (UMLS CUI [1,2])
C0494398 (UMLS CUI [2,1])
C3640518 (UMLS CUI [2,2])
Mild depressive episode ICD-10 | Moderate depressive episode ICD-10
Item
diagnosed with mild to moderate depression episode based on icd-10 diagnostic guidelines
boolean
C0494397 (UMLS CUI [1,1])
C1137110 (UMLS CUI [1,2])
C0494398 (UMLS CUI [2,1])
C1137110 (UMLS CUI [2,2])
Hospital inpatient Duration Willing | Hospital inpatient Duration Able
Item
is willing and able to spend 4 weeks as a hospital inpatient
boolean
C0239966 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0239966 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C1299581 (UMLS CUI [2,3])
Follow-up Willing | Follow-up Able
Item
is willing and able to return to the clinic during follow-up period
boolean
C3274571 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C1299581 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hamilton Depression Rating Scale 21-Item Questionnaire
Item
a ham-d21 rating scale of <10 or >17
boolean
C3640518 (UMLS CUI [1])
Mismatch Mild depressive episode ICD-10 | Mismatch Moderate depressive episode ICD-10
Item
diagnosed outside of mild to moderate depression episode range based on the icd-10 diagnostic guidelines
boolean
C1881865 (UMLS CUI [1,1])
C0494397 (UMLS CUI [1,2])
C1137110 (UMLS CUI [1,3])
C1881865 (UMLS CUI [2,1])
C0494398 (UMLS CUI [2,2])
C1137110 (UMLS CUI [2,3])
Washout Period Complete Unable | Patient need for Antidepressive Agents | Patient need for Psychotropic Drugs
Item
unable to complete wash-out interval without taking antidepressants or psychotropic medications
boolean
C1710661 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0003289 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0033978 (UMLS CUI [3,2])
Pregnancy | Possible pregnancy
Item
is pregnant or may be pregnant
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
Hypersensitivity Electrode | Hypersensitivity Electrode Conductive Gel | Hypersensitivity Electrode Adhesives
Item
sensitivity to electrodes and/or their conductive gels or adhesives
boolean
C0020517 (UMLS CUI [1,1])
C0013812 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013812 (UMLS CUI [2,2])
C0180091 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013812 (UMLS CUI [3,2])
C0001516 (UMLS CUI [3,3])
Impaired skin integrity Area Implanted electrodes
Item
break in skin integrity at the areas of electrode placement
boolean
C4048181 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0013814 (UMLS CUI [1,3])
Immunosuppressive Agents | Narcotics Use of Suspected
Item
currently taking immune suppressing drugs or suspected use of narcotics
boolean
C0021081 (UMLS CUI [1])
C0027415 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Implanted medical device Electronic | Stimulator cardiac | Artificial cardiac pacemaker
Item
presence of any implanted electronic devices, cardiac stimulator, or pacemaker
boolean
C2735362 (UMLS CUI [1,1])
C0013850 (UMLS CUI [1,2])
C0175727 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0030163 (UMLS CUI [3])
Brain Injuries | Seizures | Epilepsy | Cerebrovascular accident | Central Nervous System Tumor | Hydrocephalus
Item
history of brain injury, including seizures, epilepsy, stroke, tumor of central nervous system, or hydrocephalus
boolean
C0270611 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0085136 (UMLS CUI [5])
C0020255 (UMLS CUI [6])
Myocardial Infarction | Congestive heart failure | Uncontrolled hypertension
Item
history of heart attacks, congestive heart failure, or uncontrolled hypertension
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
Schizophrenia | Manic-depressive syndrome
Item
history of schizophrenia or manic-depressive syndrome
boolean
C0036341 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
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