ID

39295

Description

Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00902538

Link

https://clinicaltrials.gov/show/NCT00902538

Keywords

Versions (1)
  1. 12/17/19 12/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT00902538

English

Eligibility Essential Hypertension NCT00902538

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female aged 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
mean trough seated systolic blood pressure (sesbp) of ≥ 160/100 mmhg (sesbp of ≥ 160 mmhg and seated diastolic blood pressure (sedbp) ≥ 100 mmhg) at screening if not currently on antihypertensive medication (e.g. newly diagnosed subjects)
Description

Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough | Antihypertensive Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C0444506
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C0444506
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0332197
for subjects on monotherapy: mean trough sesbp of ≥ 150/95 mmhg (sesbp of ≥ 150 mmhg and sedbp ≥ 95 mmhg) at screening
Description

Study Subject Therapeutic procedure | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C0444506
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [3,3]
C0444506
for subjects on any combination of antihypertensive medications that includes either hydrochlorothiazide or amlodipine or olmesartan for a duration of at least four weeks: mean trough sesbp of ≥ 140/90 mmhg (sesbp of ≥ 140 mmhg and sedbp ≥ 90 mmhg) at screening
Description

Antihypertensive Agents Combination | Hydrochlorothiazide | Amlodipine | olmesartan | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0205195
UMLS CUI [2]
C0020261
UMLS CUI [3]
C0051696
UMLS CUI [4]
C1098320
UMLS CUI [5,1]
C1319893
UMLS CUI [5,2]
C0444504
UMLS CUI [5,3]
C0444506
UMLS CUI [6,1]
C1319894
UMLS CUI [6,2]
C0444504
UMLS CUI [6,3]
C0444506
for subjects on any other combination of antihypertensive medications that includes neither hydrochlorothiazide, amlodipine nor olmesartan: mean trough sesbp ≥ 160 mmhg, mean trough sedbp ≥ 100mmhg, at the end of the taper-off period
Description

Antihypertensive Agents Combination | Hydrochlorothiazide Absent | Amlodipine Absent | Olmesartan Absent | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0205195
UMLS CUI [2,1]
C0020261
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0051696
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1098320
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1319893
UMLS CUI [5,2]
C0444504
UMLS CUI [5,3]
C0444506
UMLS CUI [6,1]
C1319894
UMLS CUI [6,2]
C0444504
UMLS CUI [6,3]
C0444506
subject freely signs the informed consent form (icf) after the nature of the study and the disclosure of his/her data has been explained.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
female subjects of childbearing potential must be using adequate contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study [visit 1]). females taking oral contraceptives should have been on therapy for at least three months. adequate contraceptives include hormonal intra-uterine devices, hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. if a female becomes pregnant during the study, she has to be withdrawn immediately.
Description

Childbearing Potential Contraceptive methods | Postmenopausal state Absent | Female Sterilization Absent | Hysterectomy Absent | Contraceptives, Oral | Intrauterine Devices | Contraceptives, Oral, Hormonal | Depot contraceptive | Contraceptive patch | Injectable contraception | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | CONTRACEPTIVE SUPPLY, SPERMICIDE (E.G., FOAM, GEL)

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0020699
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0009905
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009907
UMLS CUI [8]
C0419531
UMLS CUI [9]
C2985284
UMLS CUI [10]
C1262153
UMLS CUI [11,1]
C0004764
UMLS CUI [11,2]
C0205173
UMLS CUI [12]
C0221829
UMLS CUI [13]
C0042241
UMLS CUI [14]
C1144908
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female subjects of childbearing potential who are pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of the investigational products, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological, and psychiatric diseases. the same applies for immunocompromised and/or neutropenic subjects.
Description

Disease Serious Limiting Evaluation | Cerebrovascular Disorders | Cardiovascular Diseases | Kidney Diseases | Respiration Disorders | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Metabolic Diseases | Hematological Disease | Malignant disease | Nervous system disorder | Mental disorders | Immunocompromised patient | Neutropenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C1261322
UMLS CUI [2]
C0007820
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0025517
UMLS CUI [10]
C0018939
UMLS CUI [11]
C0442867
UMLS CUI [12]
C0027765
UMLS CUI [13]
C0004936
UMLS CUI [14]
C0085393
UMLS CUI [15]
C0027947
subjects having a history of the following within the last six months: myocardial infarction (mi), unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischaemic attack.
Description

Myocardial Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Heart failure | Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0018801
UMLS CUI [5]
C0151620
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0007787
subjects with clinically significant abnormal laboratory values at screening, including subjects with one or more of the following:
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
aspartate aminotransferase (ast) > 3 times upper limit of normal (uln)
Description

Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
alanine aminotransferase (alt) > 3 times uln
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
gamma-glutamyltransferase (ggt) > 3 times uln
Description

Gamma-glutamyl transferase raised

Data type

boolean

Alias
UMLS CUI [1]
C0151662
potassium above uln (unless high value is due to haemolytic blood sample)
Description

Potassium increased | Exception Due to Blood specimen Hemolytic

Data type

boolean

Alias
UMLS CUI [1]
C0856882
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0178913
UMLS CUI [2,4]
C0312853
subjects with secondary hypertension of any aetiology such as renal disease, phaeochromocytoma, or cushing's syndrome.
Description

Secondary hypertension caused by Kidney Disease | Secondary hypertension caused by Pheochromocytoma | Secondary hypertension caused by Cushing Syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0022658
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0031511
UMLS CUI [3,1]
C0155616
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C0010481
subjects with contraindication to olmesartan, amlodipine, hydrochlorothiazide, or any of the excipients.
Description

Medical contraindication Olmesartan | Medical contraindication Amlodipine | Medical contraindication Hydrochlorothiazide | Medical contraindication Olmesartan Excipient | Medical contraindication Amlodipine Excipient | Medical contraindication Hydrochlorothiazide Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1098320
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0051696
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0020261
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C1098320
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0051696
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0020261
UMLS CUI [6,3]
C0015237
subjects with a mean sesbp > 200 mmhg or mean sedbp > 115 mmhg or bradycardia (heart rate < 50 beats/min at rest documented by mean radial pulse rate [pr] or electrocardiogram [ecg]) at screening (visit 1) or immediately before taking period i study medication (visit 2).
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Bradycardia | RESTING HEART RATE beats per minute | Radial pulse rate mean | Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3]
C0428977
UMLS CUI [4,1]
C1821417
UMLS CUI [4,2]
C0439385
UMLS CUI [5,1]
C0518831
UMLS CUI [5,2]
C0444504
UMLS CUI [6]
C1623258
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Similar models

Eligibility Essential Hypertension NCT00902538

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female aged 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough | Antihypertensive Agents Absent
Item
mean trough seated systolic blood pressure (sesbp) of ≥ 160/100 mmhg (sesbp of ≥ 160 mmhg and seated diastolic blood pressure (sedbp) ≥ 100 mmhg) at screening if not currently on antihypertensive medication (e.g. newly diagnosed subjects)
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,3])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0444506 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Study Subject Therapeutic procedure | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough
Item
for subjects on monotherapy: mean trough sesbp of ≥ 150/95 mmhg (sesbp of ≥ 150 mmhg and sedbp ≥ 95 mmhg) at screening
boolean
C0681850 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0444506 (UMLS CUI [2,3])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0444506 (UMLS CUI [3,3])
Antihypertensive Agents Combination | Hydrochlorothiazide | Amlodipine | olmesartan | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough
Item
for subjects on any combination of antihypertensive medications that includes either hydrochlorothiazide or amlodipine or olmesartan for a duration of at least four weeks: mean trough sesbp of ≥ 140/90 mmhg (sesbp of ≥ 140 mmhg and sedbp ≥ 90 mmhg) at screening
boolean
C0003364 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0020261 (UMLS CUI [2])
C0051696 (UMLS CUI [3])
C1098320 (UMLS CUI [4])
C1319893 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
C0444506 (UMLS CUI [5,3])
C1319894 (UMLS CUI [6,1])
C0444504 (UMLS CUI [6,2])
C0444506 (UMLS CUI [6,3])
Antihypertensive Agents Combination | Hydrochlorothiazide Absent | Amlodipine Absent | Olmesartan Absent | Sitting systolic blood pressure mean Trough | Sitting diastolic blood pressure mean Trough
Item
for subjects on any other combination of antihypertensive medications that includes neither hydrochlorothiazide, amlodipine nor olmesartan: mean trough sesbp ≥ 160 mmhg, mean trough sedbp ≥ 100mmhg, at the end of the taper-off period
boolean
C0003364 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0020261 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0051696 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1098320 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1319893 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
C0444506 (UMLS CUI [5,3])
C1319894 (UMLS CUI [6,1])
C0444504 (UMLS CUI [6,2])
C0444506 (UMLS CUI [6,3])
Informed Consent
Item
subject freely signs the informed consent form (icf) after the nature of the study and the disclosure of his/her data has been explained.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Postmenopausal state Absent | Female Sterilization Absent | Hysterectomy Absent | Contraceptives, Oral | Intrauterine Devices | Contraceptives, Oral, Hormonal | Depot contraceptive | Contraceptive patch | Injectable contraception | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | CONTRACEPTIVE SUPPLY, SPERMICIDE (E.G., FOAM, GEL)
Item
female subjects of childbearing potential must be using adequate contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study [visit 1]). females taking oral contraceptives should have been on therapy for at least three months. adequate contraceptives include hormonal intra-uterine devices, hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. if a female becomes pregnant during the study, she has to be withdrawn immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0020699 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009907 (UMLS CUI [7])
C0419531 (UMLS CUI [8])
C2985284 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C0004764 (UMLS CUI [11,1])
C0205173 (UMLS CUI [11,2])
C0221829 (UMLS CUI [12])
C0042241 (UMLS CUI [13])
C1144908 (UMLS CUI [14])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female subjects of childbearing potential who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Serious Limiting Evaluation | Cerebrovascular Disorders | Cardiovascular Diseases | Kidney Diseases | Respiration Disorders | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Metabolic Diseases | Hematological Disease | Malignant disease | Nervous system disorder | Mental disorders | Immunocompromised patient | Neutropenia
Item
subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of the investigational products, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological, and psychiatric diseases. the same applies for immunocompromised and/or neutropenic subjects.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0007820 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0442867 (UMLS CUI [11])
C0027765 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C0085393 (UMLS CUI [14])
C0027947 (UMLS CUI [15])
Myocardial Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Heart failure | Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack
Item
subjects having a history of the following within the last six months: myocardial infarction (mi), unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischaemic attack.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C0151620 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
Laboratory test result abnormal
Item
subjects with clinically significant abnormal laboratory values at screening, including subjects with one or more of the following:
boolean
C0438215 (UMLS CUI [1])
Aspartate aminotransferase increased
Item
aspartate aminotransferase (ast) > 3 times upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alanine aminotransferase (alt) > 3 times uln
boolean
C0151905 (UMLS CUI [1])
Gamma-glutamyl transferase raised
Item
gamma-glutamyltransferase (ggt) > 3 times uln
boolean
C0151662 (UMLS CUI [1])
Potassium increased | Exception Due to Blood specimen Hemolytic
Item
potassium above uln (unless high value is due to haemolytic blood sample)
boolean
C0856882 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0178913 (UMLS CUI [2,3])
C0312853 (UMLS CUI [2,4])
Secondary hypertension caused by Kidney Disease | Secondary hypertension caused by Pheochromocytoma | Secondary hypertension caused by Cushing Syndrome
Item
subjects with secondary hypertension of any aetiology such as renal disease, phaeochromocytoma, or cushing's syndrome.
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0022658 (UMLS CUI [1,3])
C0155616 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0031511 (UMLS CUI [2,3])
C0155616 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0010481 (UMLS CUI [3,3])
Medical contraindication Olmesartan | Medical contraindication Amlodipine | Medical contraindication Hydrochlorothiazide | Medical contraindication Olmesartan Excipient | Medical contraindication Amlodipine Excipient | Medical contraindication Hydrochlorothiazide Excipient
Item
subjects with contraindication to olmesartan, amlodipine, hydrochlorothiazide, or any of the excipients.
boolean
C1301624 (UMLS CUI [1,1])
C1098320 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0051696 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0020261 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C1098320 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0051696 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C1301624 (UMLS CUI [6,1])
C0020261 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean | Bradycardia | RESTING HEART RATE beats per minute | Radial pulse rate mean | Electrocardiography
Item
subjects with a mean sesbp > 200 mmhg or mean sedbp > 115 mmhg or bradycardia (heart rate < 50 beats/min at rest documented by mean radial pulse rate [pr] or electrocardiogram [ecg]) at screening (visit 1) or immediately before taking period i study medication (visit 2).
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0428977 (UMLS CUI [3])
C1821417 (UMLS CUI [4,1])
C0439385 (UMLS CUI [4,2])
C0518831 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
C1623258 (UMLS CUI [6])
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