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ID

36693

Beskrivning

Gastric Sleeve Pilot Study in Morbidly Obese Undergoing Liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT02068872

Länk

https://clinicaltrials.gov/show/NCT02068872

Nyckelord

Versioner (1)
  1. 2019-06-02 2019-06-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Obesity NCT02068872

    Engelsk

    Eligibility Obesity NCT02068872

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Obesity NCT02068872
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects must be willing to give written informed consent.
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    adult subjects 18-75 years of age of any race or gender who are listed for liver transplantation.
    Beskrivning

    Adult | Age | Racial group | Patient on waiting list Transplantation of liver

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C0034510
    UMLS CUI [4,1]
    C0422768
    UMLS CUI [4,2]
    C0023911
    for consideration of sleeve gastrectomy placement patients must meet the following criteria:
    Beskrivning

    Consideration Sleeve gastrectomy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0518609
    UMLS CUI [1,2]
    C3160799
    1. class iii obesity (bmi ≥ 40 kg/m2); or 2. class ii obesity (bmi 35-39.9 kg/m2 in conjunction with any of the following severe obesity related co-morbidities): i. obstructive sleep apnea defined as a formal sleep study consistent with this diagnosis with a) an epworth sleepiness scale ≥ 6 and b) polysomnography with respiratory disturbance index ≥ 10 and/or apneic episodes per hour of sleep; or ii. cardiovascular disease defined as prior history of stroke, myocardial infarction, stable or unstable angina pectoris, or prior coronary artery bypass); or iii. medically refractory hypertension defined as blood pressure greater than 140 mmhg systolic and/or 90 mmhg diastolic despite concurrent use of 3 anti-hypertensive agents of different classes iv. type 2 diabetes mellitus, defined as individuals taking insulin or oral hypoglycemic agents or who have a fasting glucose > 126 mg/dl
    Beskrivning

    Obesity Class | Body mass index | Comorbidity Relationship Severe Obesity | Sleep study Consistent with Obstructive Sleep Apnea | Epworth Sleepiness Scale Questionnaire | Polysomnography: respiratory disturbance index | Apneic episodes hour of sleep | Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Stable angina | Angina, Unstable | Coronary Artery Bypass Surgery | Refractory hypertension | Blood pressure determination | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity Class Different | Diabetes Mellitus, Non-Insulin-Dependent | Insulin | Oral hypoglycemic | Glucose measurement, fasting

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0028754
    UMLS CUI [1,2]
    C0456387
    UMLS CUI [2]
    C1305855
    UMLS CUI [3,1]
    C0009488
    UMLS CUI [3,2]
    C0439849
    UMLS CUI [3,3]
    C0028756
    UMLS CUI [4,1]
    C0162701
    UMLS CUI [4,2]
    C0332290
    UMLS CUI [4,3]
    C0520679
    UMLS CUI [5]
    C3541276
    UMLS CUI [6]
    C2111853
    UMLS CUI [7,1]
    C0003578
    UMLS CUI [7,2]
    C2937255
    UMLS CUI [8]
    C0007222
    UMLS CUI [9]
    C0038454
    UMLS CUI [10]
    C0027051
    UMLS CUI [11]
    C0340288
    UMLS CUI [12]
    C0002965
    UMLS CUI [13]
    C0010055
    UMLS CUI [14]
    C0860493
    UMLS CUI [15]
    C0005824
    UMLS CUI [16]
    C0871470
    UMLS CUI [17]
    C0428883
    UMLS CUI [18,1]
    C0003364
    UMLS CUI [18,2]
    C1265611
    UMLS CUI [18,3]
    C0456387
    UMLS CUI [18,4]
    C1705242
    UMLS CUI [19]
    C0011860
    UMLS CUI [20]
    C0021641
    UMLS CUI [21]
    C0359086
    UMLS CUI [22]
    C0202045
    2. have attempted (and failed) previous weight loss efforts over at least a three month period with diet, exercise, lifestyle changes or medications.
    Beskrivning

    Weight loss Effort Attempt | Weight loss Attempt failed | Diet therapy | Exercise | Lifestyle changes | Pharmaceutical Preparations

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1262477
    UMLS CUI [1,2]
    C0015264
    UMLS CUI [1,3]
    C1516084
    UMLS CUI [2,1]
    C1262477
    UMLS CUI [2,2]
    C1516084
    UMLS CUI [2,3]
    C0231175
    UMLS CUI [3]
    C0012159
    UMLS CUI [4]
    C0015259
    UMLS CUI [5]
    C0870811
    UMLS CUI [6]
    C0013227
    3. show understanding of the risks and benefits of surgery and side effects of the procedure.
    Beskrivning

    Comprehension Risks and Benefits Operative Surgical Procedures | Comprehension Side effects Procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C0687742
    UMLS CUI [1,3]
    C0543467
    UMLS CUI [2,1]
    C0162340
    UMLS CUI [2,2]
    C0879626
    UMLS CUI [2,3]
    C0184661
    4. be committed to lifestyle changes. all patients will be evaluated by the transplant psychologist as well as the bariatric surgery psychologist prior to consideration for study enrollment to ensure appropriate psychological motivation.
    Beskrivning

    Commitment Lifestyle changes

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0870312
    UMLS CUI [1,2]
    C0870811
    5. do not have any medical, psychiatric or emotional condition that would prohibit surgery (e.g. severe irreversible coronary artery disease, untreated schizophrenia, active substance abuse, and/or noncompliance with previous medical care)
    Beskrivning

    Absence Medical condition Preventing Operative Surgical Procedures | Absence Emotional or mental condition Preventing Operative Surgical Procedures | Coronary Artery Disease Severe | Schizophrenia untreated | Substance Use Disorders | Compliance behavior Lacking Medical care

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C3843040
    UMLS CUI [1,3]
    C1292733
    UMLS CUI [1,4]
    C0543467
    UMLS CUI [2,1]
    C0332197
    UMLS CUI [2,2]
    C3843038
    UMLS CUI [2,3]
    C1292733
    UMLS CUI [2,4]
    C0543467
    UMLS CUI [3,1]
    C1956346
    UMLS CUI [3,2]
    C0205082
    UMLS CUI [4,1]
    C0036341
    UMLS CUI [4,2]
    C0332155
    UMLS CUI [5]
    C0038586
    UMLS CUI [6,1]
    C1321605
    UMLS CUI [6,2]
    C0332268
    UMLS CUI [6,3]
    C0496675
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    status 1 listing (fulminant hepatic failure) for liver transplant
    Beskrivning

    Fulminant Liver Failure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0162557
    active drug abuse or alcohol use within six months
    Beskrivning

    Substance Use Disorders

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    positive urine pregnancy test (females)
    Beskrivning

    Urine pregnancy test positive

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0430059
    diagnosis of active malignancy
    Beskrivning

    Malignant Neoplasms

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    history of prior bariatric surgery
    Beskrivning

    Bariatric Surgery

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1456587
    failure to attend the initial patient information sessions or history of noncompliance
    Beskrivning

    Patient Information failed | Compliance behavior Lacking

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1955348
    UMLS CUI [1,2]
    C0231175
    UMLS CUI [2,1]
    C1321605
    UMLS CUI [2,2]
    C0332268
    failure to give consent for the study or to understand the proposed consent
    Beskrivning

    Informed Consent failed | Informed Consent Comprehension Unable

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0231175
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0162340
    UMLS CUI [2,3]
    C1299582
    failure of patient's insurance company to approve surgical intervention so as to avoid extensive cost burden on the patient
    Beskrivning

    Health Insurance failed

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021682
    UMLS CUI [1,2]
    C0231175
    Tillbaka till toppen

    Similar models

    Eligibility Obesity NCT02068872

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Obesity NCT02068872
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    subjects must be willing to give written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Adult | Age | Racial group | Patient on waiting list Transplantation of liver
    Item
    adult subjects 18-75 years of age of any race or gender who are listed for liver transplantation.
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0034510 (UMLS CUI [3])
    C0422768 (UMLS CUI [4,1])
    C0023911 (UMLS CUI [4,2])
    Consideration Sleeve gastrectomy
    Item
    for consideration of sleeve gastrectomy placement patients must meet the following criteria:
    boolean
    C0518609 (UMLS CUI [1,1])
    C3160799 (UMLS CUI [1,2])
    Obesity Class | Body mass index | Comorbidity Relationship Severe Obesity | Sleep study Consistent with Obstructive Sleep Apnea | Epworth Sleepiness Scale Questionnaire | Polysomnography: respiratory disturbance index | Apneic episodes hour of sleep | Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Stable angina | Angina, Unstable | Coronary Artery Bypass Surgery | Refractory hypertension | Blood pressure determination | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity Class Different | Diabetes Mellitus, Non-Insulin-Dependent | Insulin | Oral hypoglycemic | Glucose measurement, fasting
    Item
    1. class iii obesity (bmi ≥ 40 kg/m2); or 2. class ii obesity (bmi 35-39.9 kg/m2 in conjunction with any of the following severe obesity related co-morbidities): i. obstructive sleep apnea defined as a formal sleep study consistent with this diagnosis with a) an epworth sleepiness scale ≥ 6 and b) polysomnography with respiratory disturbance index ≥ 10 and/or apneic episodes per hour of sleep; or ii. cardiovascular disease defined as prior history of stroke, myocardial infarction, stable or unstable angina pectoris, or prior coronary artery bypass); or iii. medically refractory hypertension defined as blood pressure greater than 140 mmhg systolic and/or 90 mmhg diastolic despite concurrent use of 3 anti-hypertensive agents of different classes iv. type 2 diabetes mellitus, defined as individuals taking insulin or oral hypoglycemic agents or who have a fasting glucose > 126 mg/dl
    boolean
    C0028754 (UMLS CUI [1,1])
    C0456387 (UMLS CUI [1,2])
    C1305855 (UMLS CUI [2])
    C0009488 (UMLS CUI [3,1])
    C0439849 (UMLS CUI [3,2])
    C0028756 (UMLS CUI [3,3])
    C0162701 (UMLS CUI [4,1])
    C0332290 (UMLS CUI [4,2])
    C0520679 (UMLS CUI [4,3])
    C3541276 (UMLS CUI [5])
    C2111853 (UMLS CUI [6])
    C0003578 (UMLS CUI [7,1])
    C2937255 (UMLS CUI [7,2])
    C0007222 (UMLS CUI [8])
    C0038454 (UMLS CUI [9])
    C0027051 (UMLS CUI [10])
    C0340288 (UMLS CUI [11])
    C0002965 (UMLS CUI [12])
    C0010055 (UMLS CUI [13])
    C0860493 (UMLS CUI [14])
    C0005824 (UMLS CUI [15])
    C0871470 (UMLS CUI [16])
    C0428883 (UMLS CUI [17])
    C0003364 (UMLS CUI [18,1])
    C1265611 (UMLS CUI [18,2])
    C0456387 (UMLS CUI [18,3])
    C1705242 (UMLS CUI [18,4])
    C0011860 (UMLS CUI [19])
    C0021641 (UMLS CUI [20])
    C0359086 (UMLS CUI [21])
    C0202045 (UMLS CUI [22])
    Weight loss Effort Attempt | Weight loss Attempt failed | Diet therapy | Exercise | Lifestyle changes | Pharmaceutical Preparations
    Item
    2. have attempted (and failed) previous weight loss efforts over at least a three month period with diet, exercise, lifestyle changes or medications.
    boolean
    C1262477 (UMLS CUI [1,1])
    C0015264 (UMLS CUI [1,2])
    C1516084 (UMLS CUI [1,3])
    C1262477 (UMLS CUI [2,1])
    C1516084 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    C0012159 (UMLS CUI [3])
    C0015259 (UMLS CUI [4])
    C0870811 (UMLS CUI [5])
    C0013227 (UMLS CUI [6])
    Comprehension Risks and Benefits Operative Surgical Procedures | Comprehension Side effects Procedure
    Item
    3. show understanding of the risks and benefits of surgery and side effects of the procedure.
    boolean
    C0162340 (UMLS CUI [1,1])
    C0687742 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    C0162340 (UMLS CUI [2,1])
    C0879626 (UMLS CUI [2,2])
    C0184661 (UMLS CUI [2,3])
    Commitment Lifestyle changes
    Item
    4. be committed to lifestyle changes. all patients will be evaluated by the transplant psychologist as well as the bariatric surgery psychologist prior to consideration for study enrollment to ensure appropriate psychological motivation.
    boolean
    C0870312 (UMLS CUI [1,1])
    C0870811 (UMLS CUI [1,2])
    Absence Medical condition Preventing Operative Surgical Procedures | Absence Emotional or mental condition Preventing Operative Surgical Procedures | Coronary Artery Disease Severe | Schizophrenia untreated | Substance Use Disorders | Compliance behavior Lacking Medical care
    Item
    5. do not have any medical, psychiatric or emotional condition that would prohibit surgery (e.g. severe irreversible coronary artery disease, untreated schizophrenia, active substance abuse, and/or noncompliance with previous medical care)
    boolean
    C0332197 (UMLS CUI [1,1])
    C3843040 (UMLS CUI [1,2])
    C1292733 (UMLS CUI [1,3])
    C0543467 (UMLS CUI [1,4])
    C0332197 (UMLS CUI [2,1])
    C3843038 (UMLS CUI [2,2])
    C1292733 (UMLS CUI [2,3])
    C0543467 (UMLS CUI [2,4])
    C1956346 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C0036341 (UMLS CUI [4,1])
    C0332155 (UMLS CUI [4,2])
    C0038586 (UMLS CUI [5])
    C1321605 (UMLS CUI [6,1])
    C0332268 (UMLS CUI [6,2])
    C0496675 (UMLS CUI [6,3])
    Item Group
    C0680251 (UMLS CUI)
    Fulminant Liver Failure
    Item
    status 1 listing (fulminant hepatic failure) for liver transplant
    boolean
    C0162557 (UMLS CUI [1])
    Substance Use Disorders
    Item
    active drug abuse or alcohol use within six months
    boolean
    C0038586 (UMLS CUI [1])
    Urine pregnancy test positive
    Item
    positive urine pregnancy test (females)
    boolean
    C0430059 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    diagnosis of active malignancy
    boolean
    C0006826 (UMLS CUI [1])
    Bariatric Surgery
    Item
    history of prior bariatric surgery
    boolean
    C1456587 (UMLS CUI [1])
    Patient Information failed | Compliance behavior Lacking
    Item
    failure to attend the initial patient information sessions or history of noncompliance
    boolean
    C1955348 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    C1321605 (UMLS CUI [2,1])
    C0332268 (UMLS CUI [2,2])
    Informed Consent failed | Informed Consent Comprehension Unable
    Item
    failure to give consent for the study or to understand the proposed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C0162340 (UMLS CUI [2,2])
    C1299582 (UMLS CUI [2,3])
    Health Insurance failed
    Item
    failure of patient's insurance company to approve surgical intervention so as to avoid extensive cost burden on the patient
    boolean
    C0021682 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Tillbaka till toppen 

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