ID

37771

Description

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Keywords

  1. 8/23/19 8/23/19 -
  2. 8/23/19 8/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 23, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

Screening - Prior Ovarian Cancer Treatment; Laboratory Tests; Lesion Assessment Record

Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Center Number
Description

Center Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1709561
Patient ID
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Prior Ovarian Cancer Treatment - Chemotherapy
Description

Prior Ovarian Cancer Treatment - Chemotherapy

Alias
UMLS CUI-1
C0029925
UMLS CUI-2
C0920425
UMLS CUI-3
C0392920
Line No.
Description

Line No.

Data type

integer

Alias
UMLS CUI [1]
C0750480
Chemo Agent
Description

Chemo Agent

Data type

text

Alias
UMLS CUI [1]
C0013216
Chemotherapy Start Date
Description

Chemotherapy Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0808070
Chemotherapy End Date
Description

Chemotherapy End Date

Data type

date

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0806020
Overall response
Description

Overall response

Data type

integer

Alias
UMLS CUI [1]
C3272903
Has the patient received radiotherapy?
Description

Has the patient received radiotherapy?

Alias
UMLS CUI-1
C1522449
Has the patient received radiotherapy?
Description

If "Yes", please specify below.

Data type

boolean

Alias
UMLS CUI [1]
C1522449
Prior Ovarian Cancer Treatment - Radiotherapy
Description

Prior Ovarian Cancer Treatment - Radiotherapy

Alias
UMLS CUI-1
C0029925
UMLS CUI-2
C0920425
UMLS CUI-3
C1522449
Line No.
Description

Line No.

Data type

integer

Alias
UMLS CUI [1]
C0750480
Radiotherapy - Specify Area
Description

Radiotherapy - Specify Area

Data type

text

Alias
UMLS CUI [1]
C1997599
Radiotherapy - Dose Received
Description

Radiotherapy - Dose Received

Data type

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C3174092
Radiotherapy - Date
Description

Radiotherapy - Date

Data type

date

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0011008
Has the patient received prior cancer-related surgery?
Description

Has the patient received prior cancer-related surgery?

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C0205156
UMLS CUI-3
C2826292
Has the patient received prior cancer-related surgery?
Description

If "Yes", please specify below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2826292
Prior Ovarian Cancer Treatment - Surgical Treatment
Description

Prior Ovarian Cancer Treatment - Surgical Treatment

Alias
UMLS CUI-1
C0029925
UMLS CUI-2
C0920425
UMLS CUI-3
C0543467
Line No.
Description

Line No.

Data type

integer

Alias
UMLS CUI [1]
C0750480
Surgery Type
Description

Surgery Type

Data type

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332307
Surgery Date
Description

Surgery Date

Data type

date

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0011008
Has the patient received other cancer-related treatments?
Description

Has the patient received other cancer-related treatments?

Alias
UMLS CUI-1
C0920425
UMLS CUI-2
C0205394
Has the patient received other cancer-related treatments?
Description

If "Yes", please specify below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
Other Cancer Related Treatments
Description

Other Cancer Related Treatments

Alias
UMLS CUI-1
C0920425
UMLS CUI-2
C0205394
Line No.
Description

Line No.

Data type

integer

Alias
UMLS CUI [1]
C0750480
Treatment
Description

Treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Treatment Start Date
Description

Treatment Start Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date
Description

Treatment End Date

Data type

date

Alias
UMLS CUI [1]
C1531784
Laboratory Tests (within 7 days prior to Day 1) - Haematology
Description

Laboratory Tests (within 7 days prior to Day 1) - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology - Sample Date
Description

Haematology - Sample Date

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0018941
Haematology - Laboratory Name
Description

Haematology - Laboratory Name

Data type

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0018941
Laboratory Tests (within 7 days prior to Day 1) - Haematology
Description

Laboratory Tests (within 7 days prior to Day 1) - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematology Test
Description

Haematology Test

Data type

integer

Alias
UMLS CUI [1]
C0018941
Haematology - No Result
Description

Haematology - No Result

Data type

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Haematology - Value
Description

Haematology - Value

Data type

text

Alias
UMLS CUI [1]
C0474523
Haematology - Value out of range and NOT clinically significant
Description

Haematology - Value out of range and NOT clinically significant

Data type

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C2826293
Haematology - Value out of range and clinically significant
Description

Haematology - Value out of range and clinically significant

Data type

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C2826293
Laboratory Tests (within 7 days prior to Day 1) - Chemistry
Description

Laboratory Tests (within 7 days prior to Day 1) - Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Chemistry - Sample Date
Description

Chemistry - Sample Date

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0008000
Chemistry - Laboratory Name
Description

Chemistry - Laboratory Name

Data type

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0008000
Laboratory Tests (within 7 days prior to Day 1) - Chemistry
Description

Laboratory Tests (within 7 days prior to Day 1) - Chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Chemistry - Test
Description

Chemistry - Test

Data type

integer

Alias
UMLS CUI [1]
C0525044
Chemistry - No Result
Description

Chemistry - No Result

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
Chemistry - Value
Description

Chemistry - Value

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
Chemistry - Value out of range and NOT clinically significant
Description

Chemistry - Value out of range and NOT clinically significant

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0438215
UMLS CUI [1,4]
C2826293
Chemistry - Value out of range and NOT clinically significant
Description

Chemistry - Value out of range and NOT clinically significant

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0438215
UMLS CUI [1,4]
C2826293
Lesion Assessment Record
Description

Lesion Assessment Record

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C1516048
Lesion No.
Description

Lesion No.

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0221198
Lesion Site Code
Description

Lesion Site Code

Data type

integer

Alias
UMLS CUI [1,1]
C0449695
UMLS CUI [1,2]
C0805701
Lesion Site Description
Description

Lesion Site Description

Data type

text

Alias
UMLS CUI [1,1]
C0449695
UMLS CUI [1,2]
C0678257
Lesion Measurement - Method Code
Description

Lesion Measurement - Method Code

Data type

integer

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C2911685
UMLS CUI [1,4]
C0805701
Lesion Measurement - Date Performed
Description

Lesion Measurement - Date Performed

Data type

date

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0011008
Measurable/ Non measurable Lesion Code
Description

Measurable/ Non measurable Lesion Code

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
UMLS CUI [2]
C1334988
Lesion Size - 1. Diameter (cm)
Description

Lesion Size - 1. Diameter (cm)

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C1301886
cm
Lesion Size - 2. Diameter (cm)
Description

Lesion Size - 2. Diameter (cm)

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C1301886
cm
Lesion Non-Evaluable
Description

Lesion Non-Evaluable

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1883425
Lesion Non-Evaluable - Lesion Measurement Method Code
Description

Lesion Non-Evaluable - Lesion Measurement Method Code

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1883425
UMLS CUI [1,3]
C1299991
UMLS CUI [1,4]
C0805701
Lesion Non-Evaluable - Date Performed
Description

Lesion Non-Evaluable - Date Performed

Data type

date

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1883425
UMLS CUI [1,3]
C0011008
Lesion Non-Evaluable Status
Description

Lesion Non-Evaluable Status

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1883425
UMLS CUI [1,3]
C0449438

Similar models

Screening - Prior Ovarian Cancer Treatment; Laboratory Tests; Lesion Assessment Record

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Center Number
Item
Center Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item Group
Prior Ovarian Cancer Treatment - Chemotherapy
C0029925 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C0392920 (UMLS CUI-3)
Line No.
Item
Line No.
integer
C0750480 (UMLS CUI [1])
Chemo Agent
Item
Chemo Agent
text
C0013216 (UMLS CUI [1])
Chemotherapy Start Date
Item
Chemotherapy Start Date
date
C0392920 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Chemotherapy End Date
Item
Chemotherapy End Date
date
C0392920 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Overall response
integer
C3272903 (UMLS CUI [1])
Code List
Overall response
CL Item
None —> If “None", patient is not eligible for this study.  (1)
CL Item
Partial Response  (2)
CL Item
Complete Response (3)
Item Group
Has the patient received radiotherapy?
C1522449 (UMLS CUI-1)
Has the patient received radiotherapy?
Item
Has the patient received radiotherapy?
boolean
C1522449 (UMLS CUI [1])
Item Group
Prior Ovarian Cancer Treatment - Radiotherapy
C0029925 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C1522449 (UMLS CUI-3)
Line No.
Item
Line No.
integer
C0750480 (UMLS CUI [1])
Radiotherapy - Specify Area
Item
Radiotherapy - Specify Area
text
C1997599 (UMLS CUI [1])
Radiotherapy - Dose Received
Item
Radiotherapy - Dose Received
text
C0392920 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Radiotherapy - Date
Item
Radiotherapy - Date
date
C0392920 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Has the patient received prior cancer-related surgery?
C0543467 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
C2826292 (UMLS CUI-3)
Has the patient received prior cancer-related surgery?
Item
Has the patient received prior cancer-related surgery?
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2826292 (UMLS CUI [1,3])
Item Group
Prior Ovarian Cancer Treatment - Surgical Treatment
C0029925 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C0543467 (UMLS CUI-3)
Line No.
Item
Line No.
integer
C0750480 (UMLS CUI [1])
Surgery Type
Item
Surgery Type
text
C0543467 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Surgery Date
Item
Surgery Date
date
C0543467 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Has the patient received other cancer-related treatments?
C0920425 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Has the patient received other cancer-related treatments?
Item
Has the patient received other cancer-related treatments?
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Other Cancer Related Treatments
C0920425 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Line No.
Item
Line No.
integer
C0750480 (UMLS CUI [1])
Treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Treatment Start Date
Item
Treatment Start Date
date
C3173309 (UMLS CUI [1])
Treatment End Date
Item
Treatment End Date
date
C1531784 (UMLS CUI [1])
Item Group
Laboratory Tests (within 7 days prior to Day 1) - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Haematology - Sample Date
Item
Haematology - Sample Date
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology - Laboratory Name
Item
Haematology - Laboratory Name
text
C3258037 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item Group
Laboratory Tests (within 7 days prior to Day 1) - Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematology Test
integer
C0018941 (UMLS CUI [1])
Code List
Haematology Test
CL Item
Hemoglobin  (1)
CL Item
Hematocrit  (2)
CL Item
RBC  (3)
CL Item
WBC  (4)
CL Item
Neutrophils  (5)
CL Item
Bands  (6)
CL Item
Lymphocytes  (7)
CL Item
Monocytes  (8)
CL Item
Eosinophils  (9)
CL Item
Basophils  (10)
CL Item
Platelets  (11)
CL Item
Granulocytes (12)
Item
Haematology - No Result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Haematology - No Result
CL Item
No Result (1)
Haematology - Value
Item
Haematology - Value
text
C0474523 (UMLS CUI [1])
Item
Haematology - Value out of range and NOT clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Code List
Haematology - Value out of range and NOT clinically significant
CL Item
Value out of range and NOT clinically significant (2)
Item
Haematology - Value out of range and clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Code List
Haematology - Value out of range and clinically significant
CL Item
Value out of range and clinically significant (3)
Item Group
Laboratory Tests (within 7 days prior to Day 1) - Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Chemistry - Sample Date
Item
Chemistry - Sample Date
date
C1302413 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Chemistry - Laboratory Name
Item
Chemistry - Laboratory Name
text
C3258037 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Item Group
Laboratory Tests (within 7 days prior to Day 1) - Chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Chemistry - Test
integer
C0525044 (UMLS CUI [1])
Code List
Chemistry - Test
CL Item
Total Protein  (1)
CL Item
Albumin  (2)
CL Item
Total Bilirubin  (3)
CL Item
SGPT (ALT)  (4)
CL Item
SGOT (AST)  (5)
CL Item
Alkaline Phosphatase  (6)
CL Item
Glucose  (7)
CL Item
LDH  (8)
CL Item
BUN  (9)
CL Item
Serum Creatinine  (10)
CL Item
Uric Acid  (11)
CL Item
Calcium  (12)
CL Item
Phosphorus  (13)
CL Item
Sodium  (14)
CL Item
Potassium  (15)
CL Item
Chloride  (16)
CL Item
Bicarbonate (17)
Item
Chemistry - No Result
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Chemistry - No Result
CL Item
No Result (1)
Chemistry - Value
Item
Chemistry - Value
text
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Chemistry - Value out of range and NOT clinically significant
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Code List
Chemistry - Value out of range and NOT clinically significant
CL Item
Value out of range and NOT clinically significant (2)
Item
Chemistry - Value out of range and NOT clinically significant
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Code List
Chemistry - Value out of range and NOT clinically significant
CL Item
Value out of range and clinically significant (3)
Item Group
Lesion Assessment Record
C0221198 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Lesion No.
Item
Lesion No.
integer
C0237753 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Lesion Site Code
integer
C0449695 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Code List
Lesion Site Code
CL Item
Abdominal/Pelvic  (01)
CL Item
Hepatic  (02)
CL Item
Pulmonary  (03)
CL Item
Lymph Node  (04)
CL Item
Chest Wall  (05)
CL Item
Other (99)
Lesion Site Description
Item
Lesion Site Description
text
C0449695 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Lesion Measurement - Method Code
integer
C1299991 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Code List
Lesion Measurement - Method Code
CL Item
Physical Measurement  (01)
CL Item
CT scan  (02)
CL Item
MRI scan  (03)
CL Item
Radiography  (04)
CL Item
Chest X-Ray  (05)
CL Item
Radionuclide scan  (06)
CL Item
Other (99)
Lesion Measurement - Date Performed
Item
Lesion Measurement - Date Performed
date
C1299991 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Measurable/ Non measurable Lesion Code
integer
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2])
Code List
Measurable/ Non measurable Lesion Code
CL Item
Measurable (1)
CL Item
Non-measurable (2)
Lesion Size - 1. Diameter (cm)
Item
Lesion Size - 1. Diameter (cm)
float
C0449453 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Lesion Size - 2. Diameter (cm)
Item
Lesion Size - 2. Diameter (cm)
float
C0449453 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Item
Lesion Non-Evaluable
integer
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
Code List
Lesion Non-Evaluable
CL Item
Ascites (1)
CL Item
Bone Metastases (2)
CL Item
Pleural Effusion (3)
Item
Lesion Non-Evaluable - Lesion Measurement Method Code
integer
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Code List
Lesion Non-Evaluable - Lesion Measurement Method Code
CL Item
Physical Measurement  (01)
CL Item
CT scan  (02)
CL Item
MRI scan (03)
CL Item
Radiography (04)
CL Item
Chest X-Ray  (05)
CL Item
Radionuclide scan  (06)
CL Item
Other (99)
Lesion Non-Evaluable - Date Performed
Item
Lesion Non-Evaluable - Date Performed
date
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Lesion Non-Evaluable Status
integer
C0221198 (UMLS CUI [1,1])
C1883425 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Code List
Lesion Non-Evaluable Status
CL Item
Not Done (1)
CL Item
Present (2)
CL Item
Absent (3)

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