age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
Item
Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
CL420107 (UMLS CUI 2011AA)
C0238767 (UMLS CUI 2011AA)
51440002 (SNOMED CT 2011_0131)
C2673754 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1137110 (UMLS CUI 2011AA)
I10 (HL7 V3 2006_05)
To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
Item
To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
boolean
C1514624 (UMLS CUI 2011AA)
C1269683 (UMLS CUI 2011AA)
370143000 (SNOMED CT 2011_0131)
10057840 (MedDRA 14.1)
F32.9 (ICD-10-CM Version 2010)
C0599755 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1137110 (UMLS CUI 2011AA)
I10 (HL7 V3 2006_05)
CL414621 (UMLS CUI 2011AA)
CL435026 (UMLS CUI 2011AA)
Male or female outpatients at least 18 years of age.
Item
Male or female outpatients at least 18 years of age.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0029921 (UMLS CUI 2011AA)
373864002 (SNOMED CT 2011_0131)
MTHU011902 (LOINC Version 232)
Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
Item
Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0038288 (UMLS CUI 2011AA)
10062116 (MedDRA 14.1)
CL426201 (UMLS CUI 2011AA)
C0025274 (UMLS CUI 2011AA)
20016009 (SNOMED CT 2011_0131)
10027182 (MedDRA 14.1)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0065864 (UMLS CUI 2011AA)
27707001 (SNOMED CT 2011_0131)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0493327 (UMLS CUI 2011AA)
368441006 (SNOMED CT 2011_0131)
10007183 (MedDRA 14.1)
C0677582 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
CL425201 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
Item
Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
boolean
C0013658 (UMLS CUI 2011AA)
105421008 (SNOMED CT 2011_0131)
MTHU002635 (LOINC Version 232)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
C1710220 (UMLS CUI 2011AA)
Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Item
Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
boolean
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
Item
Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
boolean
C2347662 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011581 (UMLS CUI 2011AA)
35489007 (SNOMED CT 2011_0131)
10012401 (MedDRA 14.1)
F32.9 (ICD-10-CM Version 2010)
C2827774 (UMLS CUI 2011AA)
C0003289 (UMLS CUI 2011AA)
372720008 (SNOMED CT 2011_0131)
MTHU006782 (LOINC Version 232)
Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
Item
Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
C1518422 (UMLS CUI 2011AA)
C0442825 (UMLS CUI 2011AA)
260409000 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C1963916 (UMLS CUI 2011AA)
10067547 (MedDRA 14.1)
Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
Item
Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0442874 (UMLS CUI 2011AA)
386033004 (SNOMED CT 2011_0131)
10029328 (MedDRA 14.1)
Have previously been treated with duloxetine (for DPNP or MDD)
Item
Have previously been treated with duloxetine (for DPNP or MDD)
boolean
C1514463 (UMLS CUI 2011AA)
C0245561 (UMLS CUI 2011AA)
407033009 (SNOMED CT 2011_0131)
MTHU021254 (LOINC Version 232)
C1963916 (UMLS CUI 2011AA)
10067547 (MedDRA 14.1)
C1269683 (UMLS CUI 2011AA)
370143000 (SNOMED CT 2011_0131)
10057840 (MedDRA 14.1)
F32.9 (ICD-10-CM Version 2010)
Are judged to be at suicidal risk by the clinical investigator or as defined by a score of >= 2 on question 9 of the Beck Depression Inventory-II (BDI-II).
Item
Are judged to be at suicidal risk by the clinical investigator or as defined by a score of >= 2 on question 9 of the Beck Depression Inventory-II (BDI-II).
boolean
C0235196 (UMLS CUI 2011AA)
10042461 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C2960571 (UMLS CUI 2011AA)
446053003 (SNOMED CT 2011_0131)
Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Item
Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0038580 (UMLS CUI 2011AA)
2403008 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0028040 (UMLS CUI 2011AA)
68540007 (SNOMED CT 2011_0131)
MTHU003222 (LOINC Version 232)
C0006644 (UMLS CUI 2011AA)
255641001 (SNOMED CT 2011_0131)
MTHU012263 (LOINC Version 232)