ID

42753

Description

ODM derived from http://clinicaltrials.gov/show/NCT00844194

Link

http://clinicaltrials.gov/show/NCT00844194

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00844194 Diabetic Neuropathies

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
Description

Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).

Data type

boolean

Alias
UMLS CUI 2011AA
C0030193
SNOMED CT 2011_0131
22253000
MedDRA 14.1
10033371
LOINC Version 232
MTHU029813
ICD-10-CM Version 2010
R52
ICD-9-CM Version 2011
338-338.9
CTCAE 1105E
E11167
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0238767
SNOMED CT 2011_0131
51440002
UMLS CUI 2011AA
C2673754
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1137110
HL7 V3 2006_05
I10
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514624
UMLS CUI 2011AA
C1269683
SNOMED CT 2011_0131
370143000
MedDRA 14.1
10057840
ICD-10-CM Version 2010
F32.9
UMLS CUI 2011AA
C0599755
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C1137110
HL7 V3 2006_05
I10
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
CL435026
Male or female outpatients at least 18 years of age.
Description

Male or female outpatients at least 18 years of age.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0029921
SNOMED CT 2011_0131
373864002
LOINC Version 232
MTHU011902
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0038288
MedDRA 14.1
10062116
UMLS CUI 2011AA
CL426201
UMLS CUI 2011AA
C0025274
SNOMED CT 2011_0131
20016009
MedDRA 14.1
10027182
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0065864
SNOMED CT 2011_0131
27707001
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0493327
SNOMED CT 2011_0131
368441006
MedDRA 14.1
10007183
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
Description

Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.

Data type

boolean

Alias
UMLS CUI 2011AA
C0013658
SNOMED CT 2011_0131
105421008
LOINC Version 232
MTHU002635
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C0009452
SNOMED CT 2011_0131
263536004
LOINC Version 232
MTHU021752
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C1710220
Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Description

Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1709747
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
Description

Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011581
SNOMED CT 2011_0131
35489007
MedDRA 14.1
10012401
ICD-10-CM Version 2010
F32.9
UMLS CUI 2011AA
C2827774
UMLS CUI 2011AA
C0003289
SNOMED CT 2011_0131
372720008
LOINC Version 232
MTHU006782
Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
Description

Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.

Data type

boolean

Alias
UMLS CUI 2011AA
C0030193
SNOMED CT 2011_0131
22253000
MedDRA 14.1
10033371
LOINC Version 232
MTHU029813
ICD-10-CM Version 2010
R52
ICD-9-CM Version 2011
338-338.9
CTCAE 1105E
E11167
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0442825
SNOMED CT 2011_0131
260409000
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C1963916
MedDRA 14.1
10067547
Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
Description

Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0442874
SNOMED CT 2011_0131
386033004
MedDRA 14.1
10029328
Have previously been treated with duloxetine (for DPNP or MDD)
Description

Have previously been treated with duloxetine (for DPNP or MDD)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0245561
SNOMED CT 2011_0131
407033009
LOINC Version 232
MTHU021254
UMLS CUI 2011AA
C1963916
MedDRA 14.1
10067547
UMLS CUI 2011AA
C1269683
SNOMED CT 2011_0131
370143000
MedDRA 14.1
10057840
ICD-10-CM Version 2010
F32.9
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).
Description

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).

Data type

boolean

Alias
UMLS CUI 2011AA
C0235196
SNOMED CT 2011_0131
10042461
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C2960571
SNOMED CT 2011_0131
446053003
Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Description

Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
UMLS CUI 2011AA
C0038580
SNOMED CT 2011_0131
2403008
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0028040
SNOMED CT 2011_0131
68540007
LOINC Version 232
MTHU003222
UMLS CUI 2011AA
C0006644
SNOMED CT 2011_0131
255641001
LOINC Version 232
MTHU012263
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
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)
Item Group
Exclusion Criteria
CL425201 (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)
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