ID

41022

Description

Open-label Milnacipran for Persistent Knee Pain One Year After Total Knee Arthroplasty (TKA); ODM derived from: https://clinicaltrials.gov/show/NCT01780389

Link

https://clinicaltrials.gov/show/NCT01780389

Keywords

  1. 6/14/20 6/14/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 14, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Knee Pain After Total Knee Arthroplasty NCT01780389

Eligibility Knee Pain After Total Knee Arthroplasty NCT01780389

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject is a male or female adult outpatient age 18 or older at the time of consent.
Description

Adult | Outpatient | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0029921
UMLS CUI [3]
C0001779
2. subject has chronic persistent pain 1 year after tka without history of new injury, infection, or implant failure.
Description

Chronic pain Duration | Status post Knee Replacement Arthroplasty | Absence Injury New | Communicable Disease Absent | Failure of implant Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0150055
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0086511
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C3263723
UMLS CUI [3,3]
C0205314
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0854676
UMLS CUI [5,2]
C0332197
3. subject has vas > or = 40 mm at screen and baseline visits.
Description

Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1]
C0042815
4. subject has an understanding, ability and willingness to fully comply with study procedures and restrictions.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
5. subject has the ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the international conference on harmonisation (ich) good clinical practice (gcp) guideline e6 and applicable regulations, before completing any study-related procedures.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects unable to complete assessments due to language or cognitive impairment
Description

Assessment Completion Unable | Language Disorder | Impaired cognition

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0023015
UMLS CUI [3]
C0338656
2. subjects with a history of bipolar disorder or psychosis as confirmed by the mini international neuropsychiatric interview (mini).
Description

Bipolar Disorder | Psychotic Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0033975
3. subject currently has (or had a history within the last 6 months of) a drug dependence or substance abuse disorder according to diagnostic and statistical manual of mental disorders, fourth edition text revision (dsm-iv-tr) criteria (excluding nicotine).
Description

Drug Dependence | Substance Use Disorders | Exception Nicotine

Data type

boolean

Alias
UMLS CUI [1]
C1510472
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028040
4. subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or who has a prior history of or are currently demonstrating active suicidal ideation.
Description

At risk for suicide | Suicide attempt | Feeling suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C0038663
UMLS CUI [3]
C0424000
5. subject has any clinically significant ecg or clinically significant laboratory abnormality (including a positive urine drug screen) at screening.
Description

ECG Clinical Significance | Laboratory test result abnormal Clinical Significance | Urine drug screen positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2826293
UMLS CUI [3]
C0743300
6. subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. similarly, the subject will be excluded if he or she has any additional condition(s) that in the investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. this would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol.
Description

Comorbidity chronic | Comorbidity | Condition Interferes with Research results | Condition At risk Patient | Condition Preventing Completion of clinical trial | Condition Study Subject Participation Status Unfavorable | Illness Significant | Patient's condition unstable Protocol Compliance Difficult

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0009488
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0030705
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C2732579
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C3640815
UMLS CUI [7,1]
C0221423
UMLS CUI [7,2]
C0750502
UMLS CUI [8,1]
C0438114
UMLS CUI [8,2]
C0525058
UMLS CUI [8,3]
C0332218
7. subjects who do not agree to use adequate and reliable contraception throughout the study.
Description

Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
8. subject previously completed, discontinued or was withdrawn from this study.
Description

Study Subject Completion of clinical trial Previous | Study Subject Clinical Trial Discontinued | Patient withdrawn from trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C2732579
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C1444662
UMLS CUI [3]
C0422727
9. subject has taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
Description

Study Subject Participation Status | Investigational New Drugs | Clinical Trials

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0008976
10. subjects treated with antidepressant medication within 4 weeks of screening visit (6 weeks for fluoxetine).
Description

Antidepressant therapy | Fluoxetine

Data type

boolean

Alias
UMLS CUI [1]
C1096649
UMLS CUI [2]
C0016365
11. subjects with known sensitivity to milnacipran.
Description

Hypersensitivity Milnacipran

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1533126
12. subjects with liver disease or reduced liver function
Description

Liver disease | Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0086565
13. subjects with obstructive uropathies
Description

Urinary tract obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0178879
14. subjects who consume alcohol in amounts viewed by the investigator to be contraindicated
Description

Alcohol consumption Contraindicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C1444657
15. subjects taking monoamine oxidase inhibitors
Description

Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0026457
16. subjects with uncontrolled narrow angle glaucoma
Description

Angle Closure Glaucoma Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C0205318
17. subjects who are pregnant, may become pregnant, or who are nursing
Description

Pregnancy | Possible pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
UMLS CUI [3]
C0006147
18. subjects with seizure disorders
Description

Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0014544
19. subjects with bleeding disorders or use of other medications that may cause bleeding.
Description

Blood Coagulation Disorders | Pharmaceutical Preparations Causing Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0019080

Similar models

Eligibility Knee Pain After Total Knee Arthroplasty NCT01780389

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Outpatient | Age
Item
1. subject is a male or female adult outpatient age 18 or older at the time of consent.
boolean
C0001675 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Chronic pain Duration | Status post Knee Replacement Arthroplasty | Absence Injury New | Communicable Disease Absent | Failure of implant Absent
Item
2. subject has chronic persistent pain 1 year after tka without history of new injury, infection, or implant failure.
boolean
C0150055 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0086511 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C3263723 (UMLS CUI [3,2])
C0205314 (UMLS CUI [3,3])
C0009450 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0854676 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Visual Analog Pain Scale
Item
3. subject has vas > or = 40 mm at screen and baseline visits.
boolean
C0042815 (UMLS CUI [1])
Protocol Compliance
Item
4. subject has an understanding, ability and willingness to fully comply with study procedures and restrictions.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
5. subject has the ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the international conference on harmonisation (ich) good clinical practice (gcp) guideline e6 and applicable regulations, before completing any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Assessment Completion Unable | Language Disorder | Impaired cognition
Item
1. subjects unable to complete assessments due to language or cognitive impairment
boolean
C1516048 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0023015 (UMLS CUI [2])
C0338656 (UMLS CUI [3])
Bipolar Disorder | Psychotic Disorder
Item
2. subjects with a history of bipolar disorder or psychosis as confirmed by the mini international neuropsychiatric interview (mini).
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Drug Dependence | Substance Use Disorders | Exception Nicotine
Item
3. subject currently has (or had a history within the last 6 months of) a drug dependence or substance abuse disorder according to diagnostic and statistical manual of mental disorders, fourth edition text revision (dsm-iv-tr) criteria (excluding nicotine).
boolean
C1510472 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028040 (UMLS CUI [3,2])
At risk for suicide | Suicide attempt | Feeling suicidal
Item
4. subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or who has a prior history of or are currently demonstrating active suicidal ideation.
boolean
C0563664 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
C0424000 (UMLS CUI [3])
ECG Clinical Significance | Laboratory test result abnormal Clinical Significance | Urine drug screen positive
Item
5. subject has any clinically significant ecg or clinically significant laboratory abnormality (including a positive urine drug screen) at screening.
boolean
C1623258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0743300 (UMLS CUI [3])
Comorbidity chronic | Comorbidity | Condition Interferes with Research results | Condition At risk Patient | Condition Preventing Completion of clinical trial | Condition Study Subject Participation Status Unfavorable | Illness Significant | Patient's condition unstable Protocol Compliance Difficult
Item
6. subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. similarly, the subject will be excluded if he or she has any additional condition(s) that in the investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject. this would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol.
boolean
C0009488 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C2732579 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C3640815 (UMLS CUI [6,3])
C0221423 (UMLS CUI [7,1])
C0750502 (UMLS CUI [7,2])
C0438114 (UMLS CUI [8,1])
C0525058 (UMLS CUI [8,2])
C0332218 (UMLS CUI [8,3])
Contraceptive methods Unwilling
Item
7. subjects who do not agree to use adequate and reliable contraception throughout the study.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Study Subject Completion of clinical trial Previous | Study Subject Clinical Trial Discontinued | Patient withdrawn from trial
Item
8. subject previously completed, discontinued or was withdrawn from this study.
boolean
C0681850 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0422727 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Clinical Trials
Item
9. subject has taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0008976 (UMLS CUI [3])
Antidepressant therapy | Fluoxetine
Item
10. subjects treated with antidepressant medication within 4 weeks of screening visit (6 weeks for fluoxetine).
boolean
C1096649 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
Hypersensitivity Milnacipran
Item
11. subjects with known sensitivity to milnacipran.
boolean
C0020517 (UMLS CUI [1,1])
C1533126 (UMLS CUI [1,2])
Liver disease | Liver Dysfunction
Item
12. subjects with liver disease or reduced liver function
boolean
C0023895 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Urinary tract obstruction
Item
13. subjects with obstructive uropathies
boolean
C0178879 (UMLS CUI [1])
Alcohol consumption Contraindicated
Item
14. subjects who consume alcohol in amounts viewed by the investigator to be contraindicated
boolean
C0001948 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
Monoamine Oxidase Inhibitors
Item
15. subjects taking monoamine oxidase inhibitors
boolean
C0026457 (UMLS CUI [1])
Angle Closure Glaucoma Uncontrolled
Item
16. subjects with uncontrolled narrow angle glaucoma
boolean
C0017605 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Possible pregnancy | Breast Feeding
Item
17. subjects who are pregnant, may become pregnant, or who are nursing
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Epilepsy
Item
18. subjects with seizure disorders
boolean
C0014544 (UMLS CUI [1])
Blood Coagulation Disorders | Pharmaceutical Preparations Causing Hemorrhage
Item
19. subjects with bleeding disorders or use of other medications that may cause bleeding.
boolean
C0005779 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0019080 (UMLS CUI [2,3])

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