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])
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])