ID

44304

Description

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

Link

https://clinicaltrials.gov/show/NCT01165294

Keywords

Versions (3)
  1. 10/24/18 10/24/18 -
  2. 10/24/18 10/24/18 -
  3. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01165294

English

Eligibility Schizophrenia NCT01165294

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

ECG normal | Safety Assessment Normal

Data type

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
Description

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

Data type

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
Description

Pharmaceutical Preparations Intake Absent

Data type

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
Description

Informed Consent | Protocol Compliance

Data type

boolean

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

Drug screen negative

Data type

boolean

Alias
UMLS CUI [1]
C0919819
Exclusion Criteria
Description

Exclusion Criteria

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

Study Subject Participation Status

Data type

boolean

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

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

Data type

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
Description

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

Data type

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)
Description

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

Data type

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
Description

Oxygen saturation PO2 measurement

Data type

boolean

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

ECG abnormality | Laboratory test result abnormal

Data type

boolean

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

Substance Use Disorders

Data type

boolean

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

Mental disorders | Nervous system disorder

Data type

boolean

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

Schizophrenia First Degree Relative | Schizophrenia Second Degree Relative

Data type

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
Description

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

Data type

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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0020550
UMLS CUI [2]
C0428419
UMLS CUI [3]
C0202231
UMLS CUI [4]
C0202230
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Similar models

Eligibility Schizophrenia NCT01165294

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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