0 Ratings
ID

25140

Description

Safety Study of Gleevec® in Children With Pulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00583115

Link

https://clinicaltrials.gov/show/NCT00583115

Keywords

Versions (1)
  1. 8/27/17 8/27/17 -
Uploaded on

August 27, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Pulmonary Hypertension NCT00583115

    English

    Eligibility Pulmonary Hypertension NCT00583115

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. male and female patients between the ages of 8 -18 years of age.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. diagnosis of idiopathic (or primary) pulmonary arterial hypertension according to the venice classification system (2003).54, 55
    Description

    Idiopathic pulmonary arterial hypertension | Primary pulmonary hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3203102
    UMLS CUI [2]
    C0152171
    3. functional classification of who class iii - iv.
    Description

    Pulmonary arterial hypertension WHO classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2973725
    UMLS CUI [1,2]
    C4267671
    4. pulmonary vascular resistance (pvr) >300 dynes / sec / cm5.
    Description

    Pulmonary Vascular Resistance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0456261
    5. ipah medications stable for at least 3 mo prior to baseline visit.
    Description

    IPAH Pharmaceutical Preparations Stable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0152171
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0205360
    6. female patients of child bearing potential who are sexually active must have negative pregnancy test within 7 days prior to initiation of study drug and use a double-barrier local contraception, i.e., intra-uterine device plus condom, or spermicidal gel plus condom up to the study completion visit.
    Description

    Childbearing Potential Sexually active Pregnancy test negative | Childbearing Potential Sexually active Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0241028
    UMLS CUI [1,3]
    C0427780
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0241028
    UMLS CUI [2,3]
    C0004764
    UMLS CUI [2,4]
    C0205173
    UMLS CUI [3]
    C0021900
    UMLS CUI [4]
    C0221829
    UMLS CUI [5]
    C0087145
    7. able to communicate well with the investigator, to understand and comply with the requirements of the study. able to verbalize understanding and sign the written informed assent.
    Description

    Protocol Compliance | Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    UMLS CUI [2]
    C0021430
    8. parents, or legal guardians, must be able to communicate well with the investigator, to understand and comply with the requirements of the study. they must verbalize understanding and sign the written informed consent statement.
    Description

    Protocol Compliance Parent | Informed Consent Parent | Protocol Compliance Legal Guardians | Informed Consent Legal Guardians

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0030551
    UMLS CUI [3,1]
    C0525058
    UMLS CUI [3,2]
    C0023226
    UMLS CUI [4,1]
    C0021430
    UMLS CUI [4,2]
    C0023226
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. pre-existing lung disease including parasitic diseases affecting lungs, bronchial asthma, congenital abnormalities of the lungs, thorax and diaphragm.
    Description

    Lung disease Pre-existing | Parasitic Diseases Affecting Lungs | Asthma | Congenital anomaly of lung | Congenital anomaly of thorax | Congenital anomaly of diaphragm

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024115
    UMLS CUI [1,2]
    C2347662
    UMLS CUI [2,1]
    C0030499
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0024109
    UMLS CUI [3]
    C0004096
    UMLS CUI [4]
    C0158644
    UMLS CUI [5]
    C1285210
    UMLS CUI [6]
    C0158782
    2. congenital heart disease, left ventricular failure, or left-sided obstructive lesion (pulmonary venous hypertension with pulmonary capillary wedge pressure > 12 mmhg) detected at right heart catheterization.
    Description

    Congenital heart disease | Left-Sided Heart Failure | Obstructive lesion Left sided | Pulmonary Hypertension Venous | Pulmonary Capillary Wedge Pressure | Catheterization of right heart

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0152021
    UMLS CUI [2]
    C0023212
    UMLS CUI [3,1]
    C3872566
    UMLS CUI [3,2]
    C0443246
    UMLS CUI [4,1]
    C0020542
    UMLS CUI [4,2]
    C0348013
    UMLS CUI [5]
    C0086879
    UMLS CUI [6]
    C0189896
    3. chronic thromboembolic pulmonary hypertension, congenital or acquired deficiencies of blood coagulation, deficient thrombocyte function, thrombocytopenia < 40,000/μl, or sickle cell anemia.
    Description

    Chronic thromboembolic pulmonary hypertension | Blood Coagulation Disorders, Inherited | Blood Coagulation Disorders Acquired | Blood Platelet Disorders | Thrombocytopenia | Anemia, Sickle Cell

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2363973
    UMLS CUI [2]
    C0852077
    UMLS CUI [3,1]
    C0005779
    UMLS CUI [3,2]
    C0439661
    UMLS CUI [4]
    C0005818
    UMLS CUI [5]
    C0040034
    UMLS CUI [6]
    C0002895
    4. pregnancy, breast feeding, or lack of safe contraception (hormonal contraception, iud, bilateral tubal ligation, hysterectomy) in premenopausal women.
    Description

    Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Lacking | Hormonal contraception | IUD | Bilateral tubal ligation | Hysterectomy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C0232969
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0332268
    UMLS CUI [4]
    C2985296
    UMLS CUI [5]
    C0021900
    UMLS CUI [6]
    C0589114
    UMLS CUI [7]
    C0020699
    5. hepatic insufficiency with transaminase levels >4-fold the upper limit of normal, or a bilirubin > 2-fold the upper limit of normal.
    Description

    Hepatic Insufficiency | Transaminases increased | Elevated total bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1306571
    UMLS CUI [2]
    C0438717
    UMLS CUI [3]
    C0741494
    6. renal insufficiency (serum creatinine > 200 μmol/l).
    Description

    Renal Insufficiency | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0201976
    7. history of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). a known hypersensitivity to the study drug, or drugs similar to the study drug.
    Description

    Drug Allergy | Atopy | Asthma | Urticaria | Eczema | Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013182
    UMLS CUI [2]
    C0392707
    UMLS CUI [3]
    C0004096
    UMLS CUI [4]
    C0042109
    UMLS CUI [5]
    C0013595
    UMLS CUI [6,1]
    C0020517
    UMLS CUI [6,2]
    C0013230
    UMLS CUI [7,1]
    C0020517
    UMLS CUI [7,2]
    C0013227
    UMLS CUI [7,3]
    C2348205
    8. previous therapeutic radiation of lungs or mediastinum.
    Description

    Radiotherapy to lung | Radiotherapy to mediastinum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948315
    UMLS CUI [2]
    C4049191
    9. participation in any treatment studies within 3 months prior to dosing, or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    Description

    Study Subject Participation Status | Participation Limitation Due to Regulation Local

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2,1]
    C0679823
    UMLS CUI [2,2]
    C0449295
    UMLS CUI [2,3]
    C0678226
    UMLS CUI [2,4]
    C0851285
    UMLS CUI [2,5]
    C0205276
    10. history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result, or a positive hepatitis b surface antigen (hbsag), or positive hepatitis c test result.
    Description

    Immunologic Deficiency Syndromes | HIV Seropositivity ELISA | HIV Seropositivity Western blot for HIV | Hepatitis B surface antigen positive | Hepatitis C test positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021051
    UMLS CUI [2,1]
    C0019699
    UMLS CUI [2,2]
    C0014441
    UMLS CUI [3,1]
    C0019699
    UMLS CUI [3,2]
    C0860963
    UMLS CUI [4]
    C0149709
    UMLS CUI [5]
    C1609517
    11. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, such as a history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding, or a history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
    Description

    Surgical aspects Changing Drug absorption | Surgical aspects Changing Drug distribution | Surgical aspects Changing Drug metabolism | Surgical aspects Changing Drug elimination | Medical condition Changing Drug absorption | Medical condition Changing Drug distribution | Medical condition Changing Drug metabolism | Medical condition Changing Drug elimination | Inflammatory Bowel Diseases | Gastritis | Ulcer | Gastrointestinal Hemorrhage | Rectal hemorrhage | Operation on gastrointestinal tract Major | Gastrectomy | Gastroenterostomy | Bowel resection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038895
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [1,3]
    C0678745
    UMLS CUI [2,1]
    C0038895
    UMLS CUI [2,2]
    C0392747
    UMLS CUI [2,3]
    C0699903
    UMLS CUI [3,1]
    C0038895
    UMLS CUI [3,2]
    C0392747
    UMLS CUI [3,3]
    C0683140
    UMLS CUI [4,1]
    C0038895
    UMLS CUI [4,2]
    C0392747
    UMLS CUI [4,3]
    C0683141
    UMLS CUI [5,1]
    C3843040
    UMLS CUI [5,2]
    C0392747
    UMLS CUI [5,3]
    C0678745
    UMLS CUI [6,1]
    C3843040
    UMLS CUI [6,2]
    C0392747
    UMLS CUI [6,3]
    C0699903
    UMLS CUI [7,1]
    C3843040
    UMLS CUI [7,2]
    C0392747
    UMLS CUI [7,3]
    C0683140
    UMLS CUI [8,1]
    C3843040
    UMLS CUI [8,2]
    C0392747
    UMLS CUI [8,3]
    C0683141
    UMLS CUI [9]
    C0021390
    UMLS CUI [10]
    C0017152
    UMLS CUI [11]
    C0041582
    UMLS CUI [12]
    C0017181
    UMLS CUI [13]
    C0267596
    UMLS CUI [14,1]
    C0399610
    UMLS CUI [14,2]
    C0205164
    UMLS CUI [15]
    C0017118
    UMLS CUI [16]
    C0017164
    UMLS CUI [17]
    C0741614
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    Eligibility Pulmonary Hypertension NCT00583115

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. male and female patients between the ages of 8 -18 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Idiopathic pulmonary arterial hypertension | Primary pulmonary hypertension
    Item
    2. diagnosis of idiopathic (or primary) pulmonary arterial hypertension according to the venice classification system (2003).54, 55
    boolean
    C3203102 (UMLS CUI [1])
    C0152171 (UMLS CUI [2])
    Pulmonary arterial hypertension WHO classification
    Item
    3. functional classification of who class iii - iv.
    boolean
    C2973725 (UMLS CUI [1,1])
    C4267671 (UMLS CUI [1,2])
    Pulmonary Vascular Resistance
    Item
    4. pulmonary vascular resistance (pvr) >300 dynes / sec / cm5.
    boolean
    C0456261 (UMLS CUI [1])
    IPAH Pharmaceutical Preparations Stable
    Item
    5. ipah medications stable for at least 3 mo prior to baseline visit.
    boolean
    C0152171 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Childbearing Potential Sexually active Pregnancy test negative | Childbearing Potential Sexually active Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides
    Item
    6. female patients of child bearing potential who are sexually active must have negative pregnancy test within 7 days prior to initiation of study drug and use a double-barrier local contraception, i.e., intra-uterine device plus condom, or spermicidal gel plus condom up to the study completion visit.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0241028 (UMLS CUI [1,2])
    C0427780 (UMLS CUI [1,3])
    C3831118 (UMLS CUI [2,1])
    C0241028 (UMLS CUI [2,2])
    C0004764 (UMLS CUI [2,3])
    C0205173 (UMLS CUI [2,4])
    C0021900 (UMLS CUI [3])
    C0221829 (UMLS CUI [4])
    C0087145 (UMLS CUI [5])
    Protocol Compliance | Informed Consent
    Item
    7. able to communicate well with the investigator, to understand and comply with the requirements of the study. able to verbalize understanding and sign the written informed assent.
    boolean
    C0525058 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Protocol Compliance Parent | Informed Consent Parent | Protocol Compliance Legal Guardians | Informed Consent Legal Guardians
    Item
    8. parents, or legal guardians, must be able to communicate well with the investigator, to understand and comply with the requirements of the study. they must verbalize understanding and sign the written informed consent statement.
    boolean
    C0525058 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C0030551 (UMLS CUI [2,2])
    C0525058 (UMLS CUI [3,1])
    C0023226 (UMLS CUI [3,2])
    C0021430 (UMLS CUI [4,1])
    C0023226 (UMLS CUI [4,2])
    Item Group
    C0680251 (UMLS CUI)
    Lung disease Pre-existing | Parasitic Diseases Affecting Lungs | Asthma | Congenital anomaly of lung | Congenital anomaly of thorax | Congenital anomaly of diaphragm
    Item
    1. pre-existing lung disease including parasitic diseases affecting lungs, bronchial asthma, congenital abnormalities of the lungs, thorax and diaphragm.
    boolean
    C0024115 (UMLS CUI [1,1])
    C2347662 (UMLS CUI [1,2])
    C0030499 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0024109 (UMLS CUI [2,3])
    C0004096 (UMLS CUI [3])
    C0158644 (UMLS CUI [4])
    C1285210 (UMLS CUI [5])
    C0158782 (UMLS CUI [6])
    Congenital heart disease | Left-Sided Heart Failure | Obstructive lesion Left sided | Pulmonary Hypertension Venous | Pulmonary Capillary Wedge Pressure | Catheterization of right heart
    Item
    2. congenital heart disease, left ventricular failure, or left-sided obstructive lesion (pulmonary venous hypertension with pulmonary capillary wedge pressure > 12 mmhg) detected at right heart catheterization.
    boolean
    C0152021 (UMLS CUI [1])
    C0023212 (UMLS CUI [2])
    C3872566 (UMLS CUI [3,1])
    C0443246 (UMLS CUI [3,2])
    C0020542 (UMLS CUI [4,1])
    C0348013 (UMLS CUI [4,2])
    C0086879 (UMLS CUI [5])
    C0189896 (UMLS CUI [6])
    Chronic thromboembolic pulmonary hypertension | Blood Coagulation Disorders, Inherited | Blood Coagulation Disorders Acquired | Blood Platelet Disorders | Thrombocytopenia | Anemia, Sickle Cell
    Item
    3. chronic thromboembolic pulmonary hypertension, congenital or acquired deficiencies of blood coagulation, deficient thrombocyte function, thrombocytopenia < 40,000/μl, or sickle cell anemia.
    boolean
    C2363973 (UMLS CUI [1])
    C0852077 (UMLS CUI [2])
    C0005779 (UMLS CUI [3,1])
    C0439661 (UMLS CUI [3,2])
    C0005818 (UMLS CUI [4])
    C0040034 (UMLS CUI [5])
    C0002895 (UMLS CUI [6])
    Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods Lacking | Hormonal contraception | IUD | Bilateral tubal ligation | Hysterectomy
    Item
    4. pregnancy, breast feeding, or lack of safe contraception (hormonal contraception, iud, bilateral tubal ligation, hysterectomy) in premenopausal women.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0232969 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0332268 (UMLS CUI [3,3])
    C2985296 (UMLS CUI [4])
    C0021900 (UMLS CUI [5])
    C0589114 (UMLS CUI [6])
    C0020699 (UMLS CUI [7])
    Hepatic Insufficiency | Transaminases increased | Elevated total bilirubin
    Item
    5. hepatic insufficiency with transaminase levels >4-fold the upper limit of normal, or a bilirubin > 2-fold the upper limit of normal.
    boolean
    C1306571 (UMLS CUI [1])
    C0438717 (UMLS CUI [2])
    C0741494 (UMLS CUI [3])
    Renal Insufficiency | Creatinine measurement, serum
    Item
    6. renal insufficiency (serum creatinine > 200 μmol/l).
    boolean
    C1565489 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Drug Allergy | Atopy | Asthma | Urticaria | Eczema | Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Similar
    Item
    7. history of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). a known hypersensitivity to the study drug, or drugs similar to the study drug.
    boolean
    C0013182 (UMLS CUI [1])
    C0392707 (UMLS CUI [2])
    C0004096 (UMLS CUI [3])
    C0042109 (UMLS CUI [4])
    C0013595 (UMLS CUI [5])
    C0020517 (UMLS CUI [6,1])
    C0013230 (UMLS CUI [6,2])
    C0020517 (UMLS CUI [7,1])
    C0013227 (UMLS CUI [7,2])
    C2348205 (UMLS CUI [7,3])
    Radiotherapy to lung | Radiotherapy to mediastinum
    Item
    8. previous therapeutic radiation of lungs or mediastinum.
    boolean
    C0948315 (UMLS CUI [1])
    C4049191 (UMLS CUI [2])
    Study Subject Participation Status | Participation Limitation Due to Regulation Local
    Item
    9. participation in any treatment studies within 3 months prior to dosing, or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    boolean
    C2348568 (UMLS CUI [1])
    C0679823 (UMLS CUI [2,1])
    C0449295 (UMLS CUI [2,2])
    C0678226 (UMLS CUI [2,3])
    C0851285 (UMLS CUI [2,4])
    C0205276 (UMLS CUI [2,5])
    Immunologic Deficiency Syndromes | HIV Seropositivity ELISA | HIV Seropositivity Western blot for HIV | Hepatitis B surface antigen positive | Hepatitis C test positive
    Item
    10. history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result, or a positive hepatitis b surface antigen (hbsag), or positive hepatitis c test result.
    boolean
    C0021051 (UMLS CUI [1])
    C0019699 (UMLS CUI [2,1])
    C0014441 (UMLS CUI [2,2])
    C0019699 (UMLS CUI [3,1])
    C0860963 (UMLS CUI [3,2])
    C0149709 (UMLS CUI [4])
    C1609517 (UMLS CUI [5])
    Surgical aspects Changing Drug absorption | Surgical aspects Changing Drug distribution | Surgical aspects Changing Drug metabolism | Surgical aspects Changing Drug elimination | Medical condition Changing Drug absorption | Medical condition Changing Drug distribution | Medical condition Changing Drug metabolism | Medical condition Changing Drug elimination | Inflammatory Bowel Diseases | Gastritis | Ulcer | Gastrointestinal Hemorrhage | Rectal hemorrhage | Operation on gastrointestinal tract Major | Gastrectomy | Gastroenterostomy | Bowel resection
    Item
    11. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, such as a history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding, or a history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
    boolean
    C0038895 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C0678745 (UMLS CUI [1,3])
    C0038895 (UMLS CUI [2,1])
    C0392747 (UMLS CUI [2,2])
    C0699903 (UMLS CUI [2,3])
    C0038895 (UMLS CUI [3,1])
    C0392747 (UMLS CUI [3,2])
    C0683140 (UMLS CUI [3,3])
    C0038895 (UMLS CUI [4,1])
    C0392747 (UMLS CUI [4,2])
    C0683141 (UMLS CUI [4,3])
    C3843040 (UMLS CUI [5,1])
    C0392747 (UMLS CUI [5,2])
    C0678745 (UMLS CUI [5,3])
    C3843040 (UMLS CUI [6,1])
    C0392747 (UMLS CUI [6,2])
    C0699903 (UMLS CUI [6,3])
    C3843040 (UMLS CUI [7,1])
    C0392747 (UMLS CUI [7,2])
    C0683140 (UMLS CUI [7,3])
    C3843040 (UMLS CUI [8,1])
    C0392747 (UMLS CUI [8,2])
    C0683141 (UMLS CUI [8,3])
    C0021390 (UMLS CUI [9])
    C0017152 (UMLS CUI [10])
    C0041582 (UMLS CUI [11])
    C0017181 (UMLS CUI [12])
    C0267596 (UMLS CUI [13])
    C0399610 (UMLS CUI [14,1])
    C0205164 (UMLS CUI [14,2])
    C0017118 (UMLS CUI [15])
    C0017164 (UMLS CUI [16])
    C0741614 (UMLS CUI [17])
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