ID

29482

Beskrivning

Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00957034

Länk

https://clinicaltrials.gov/show/NCT00957034

Nyckelord

Versioner (1)
  1. 2018-04-03 2018-04-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00957034

Engelsk

Eligibility Heart Failure NCT00957034

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female 50 years of age or older; post-menopausal (≥ 12 mo/ from last menstruation)
Beskrivning

Gender | Age | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
documented left ventricular ejection fraction (lvef) of 20-40% within 90 days prior to the baseline visit
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
history of hf for more than 90 days and a diagnosis of symptomatic hf (class iii nyha) for at least 30 days prior to the baseline visit
Beskrivning

Heart failure Disease length | Heart failure Symptomatic Disease length New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0872146
UMLS CUI [2,4]
C1275491
ambulatory (i.e., able to walk without assistance of another person or device such as cane or walker)
Beskrivning

Ambulatory | Able to walk Without Assistance

Datatyp

boolean

Alias
UMLS CUI [1]
C0439841
UMLS CUI [2,1]
C2712089
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C1269765
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
neuromuscular or rheumatologic conditions that limit the to their ability to improve walking distance
Beskrivning

Neuromuscular Diseases Distance of walking limitation | Rheumatism Distance of walking limitation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027868
UMLS CUI [1,2]
C2197730
UMLS CUI [2,1]
C0035435
UMLS CUI [2,2]
C2197730
pulmonary edema or multiorgan failure or cardiogenic shock within 30 days prior to the baseline visit
Beskrivning

Pulmonary Edema | Multiple Organ Failure | Shock, Cardiogenic

Datatyp

boolean

Alias
UMLS CUI [1]
C0034063
UMLS CUI [2]
C0026766
UMLS CUI [3]
C0036980
congenital heart disease, infiltrative myocardial disease
Beskrivning

Congenital heart disease | Cardiomyopathy Infiltrating

Datatyp

boolean

Alias
UMLS CUI [1]
C0152021
UMLS CUI [2,1]
C0878544
UMLS CUI [2,2]
C0332448
unstable angina or myocardial infarction within 30 days prior to the baseline visit
Beskrivning

Angina, Unstable | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
undiagnosed abnormal genital bleeding
Beskrivning

Genital hemorrhage Abnormal Undiagnosed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0854381
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C1408353
history of breast cancer, breast surgery, or breast disease contraindicating estrogen/hormone therapy
Beskrivning

Breast Carcinoma | Operation on breast | Breast Diseases | Oestrogen therapy Contraindicated | Hormone Therapy Contraindicated

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C3714726
UMLS CUI [3]
C0006145
UMLS CUI [4,1]
C0279494
UMLS CUI [4,2]
C1444657
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C1444657
polycystic ovary syndrome or any other condition known to be adversely affected by testosterone treatment
Beskrivning

Polycystic Ovary Syndrome | Condition Adverse reaction to testosterone

Datatyp

boolean

Alias
UMLS CUI [1]
C0032460
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0570247
resting heart rate > 120 bpm
Beskrivning

Resting Heart Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C1821417
systolic blood pressure > 180 mmhg or diastolic blood pressure > 100 mmhg
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
known or suspected hypersensitivity or allergy to any adhesive or to any of the components of the testosterone transdermal system (tts)
Beskrivning

Allergy to adhesive | Allergy to adhesive Suspected | Hypersensitivity Testosterone Transdermal System Component | Hypersensitivity Suspected Testosterone Transdermal System Component

Datatyp

boolean

Alias
UMLS CUI [1]
C1635164
UMLS CUI [2,1]
C1635164
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C4276340
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C4276340
UMLS CUI [4,4]
C1705248
use of serms, sarms, sprms, tibolone, testosterone, estrogen, progesterone agonists and antagonists or taking any prescription and over the counter medications/
Beskrivning

Selective Estrogen Receptor Modulators | Other Coding | Selective Progesterone Receptor Modulators | tibolone | Testosterone | Estrogens | Progesterone Agonists/Antagonists | Prescription Drugs | Drugs, Non-Prescription

Datatyp

boolean

Alias
UMLS CUI [1]
C0732611
UMLS CUI [2]
C3846158
UMLS CUI [3]
C3854078
UMLS CUI [4]
C0076660
UMLS CUI [5]
C0039601
UMLS CUI [6]
C0014939
UMLS CUI [7]
C4020604
UMLS CUI [8]
C0304227
UMLS CUI [9]
C0013231
nutraceuticals (eg, phyto-estrogens) that may have anabolic or steroid hormonal effects within 30 days prior to the baseline visit
Beskrivning

Nutraceuticals Resulting in Anabolic Effect | Nutraceuticals Resulting in Steroid hormone Effect | Phytoestrogens

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518478
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C3179309
UMLS CUI [2,1]
C1518478
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0301818
UMLS CUI [2,4]
C1280500
UMLS CUI [3]
C0071011
use of marketed or investigational oral, sub-lingual, topical, transdermal injectable, or vaginal androgen therapy including dehydroepiandrosterone (dhea) at any time within 3 months prior to the baseline visit
Beskrivning

Androgen therapy Oral | Androgen therapy Sublingual | Androgen therapy Topical | Androgen therapy Transdermal Injectable | Androgen therapy Vaginal | dehydroepiandrosterone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279493
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0279493
UMLS CUI [2,2]
C0001565
UMLS CUI [3,1]
C0279493
UMLS CUI [3,2]
C1522168
UMLS CUI [4,1]
C0279493
UMLS CUI [4,2]
C0040652
UMLS CUI [4,3]
C0086466
UMLS CUI [5,1]
C0279493
UMLS CUI [5,2]
C1522570
UMLS CUI [6]
C0011185
use of systemic corticosteroids within 30 days prior to the baseline visit (acute use for fewer than 7 days is acceptable)
Beskrivning

CORTICOSTEROIDS FOR SYSTEMIC USE

Datatyp

boolean

Alias
UMLS CUI [1]
C3653708
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Similar models

Eligibility Heart Failure NCT00957034

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Postmenopausal state
Item
female 50 years of age or older; post-menopausal (≥ 12 mo/ from last menstruation)
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Left ventricular ejection fraction
Item
documented left ventricular ejection fraction (lvef) of 20-40% within 90 days prior to the baseline visit
boolean
C0428772 (UMLS CUI [1])
Heart failure Disease length | Heart failure Symptomatic Disease length New York Heart Association Classification
Item
history of hf for more than 90 days and a diagnosis of symptomatic hf (class iii nyha) for at least 30 days prior to the baseline visit
boolean
C0018801 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0872146 (UMLS CUI [2,3])
C1275491 (UMLS CUI [2,4])
Ambulatory | Able to walk Without Assistance
Item
ambulatory (i.e., able to walk without assistance of another person or device such as cane or walker)
boolean
C0439841 (UMLS CUI [1])
C2712089 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C1269765 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Neuromuscular Diseases Distance of walking limitation | Rheumatism Distance of walking limitation
Item
neuromuscular or rheumatologic conditions that limit the to their ability to improve walking distance
boolean
C0027868 (UMLS CUI [1,1])
C2197730 (UMLS CUI [1,2])
C0035435 (UMLS CUI [2,1])
C2197730 (UMLS CUI [2,2])
Pulmonary Edema | Multiple Organ Failure | Shock, Cardiogenic
Item
pulmonary edema or multiorgan failure or cardiogenic shock within 30 days prior to the baseline visit
boolean
C0034063 (UMLS CUI [1])
C0026766 (UMLS CUI [2])
C0036980 (UMLS CUI [3])
Congenital heart disease | Cardiomyopathy Infiltrating
Item
congenital heart disease, infiltrative myocardial disease
boolean
C0152021 (UMLS CUI [1])
C0878544 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
Angina, Unstable | Myocardial Infarction
Item
unstable angina or myocardial infarction within 30 days prior to the baseline visit
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Genital hemorrhage Abnormal Undiagnosed
Item
undiagnosed abnormal genital bleeding
boolean
C0854381 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C1408353 (UMLS CUI [1,3])
Breast Carcinoma | Operation on breast | Breast Diseases | Oestrogen therapy Contraindicated | Hormone Therapy Contraindicated
Item
history of breast cancer, breast surgery, or breast disease contraindicating estrogen/hormone therapy
boolean
C0678222 (UMLS CUI [1])
C3714726 (UMLS CUI [2])
C0006145 (UMLS CUI [3])
C0279494 (UMLS CUI [4,1])
C1444657 (UMLS CUI [4,2])
C0279025 (UMLS CUI [5,1])
C1444657 (UMLS CUI [5,2])
Polycystic Ovary Syndrome | Condition Adverse reaction to testosterone
Item
polycystic ovary syndrome or any other condition known to be adversely affected by testosterone treatment
boolean
C0032460 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0570247 (UMLS CUI [2,2])
Resting Heart Rate
Item
resting heart rate > 120 bpm
boolean
C1821417 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure > 180 mmhg or diastolic blood pressure > 100 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Allergy to adhesive | Allergy to adhesive Suspected | Hypersensitivity Testosterone Transdermal System Component | Hypersensitivity Suspected Testosterone Transdermal System Component
Item
known or suspected hypersensitivity or allergy to any adhesive or to any of the components of the testosterone transdermal system (tts)
boolean
C1635164 (UMLS CUI [1])
C1635164 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C4276340 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C4276340 (UMLS CUI [4,3])
C1705248 (UMLS CUI [4,4])
Selective Estrogen Receptor Modulators | Other Coding | Selective Progesterone Receptor Modulators | tibolone | Testosterone | Estrogens | Progesterone Agonists/Antagonists | Prescription Drugs | Drugs, Non-Prescription
Item
use of serms, sarms, sprms, tibolone, testosterone, estrogen, progesterone agonists and antagonists or taking any prescription and over the counter medications/
boolean
C0732611 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C3854078 (UMLS CUI [3])
C0076660 (UMLS CUI [4])
C0039601 (UMLS CUI [5])
C0014939 (UMLS CUI [6])
C4020604 (UMLS CUI [7])
C0304227 (UMLS CUI [8])
C0013231 (UMLS CUI [9])
Nutraceuticals Resulting in Anabolic Effect | Nutraceuticals Resulting in Steroid hormone Effect | Phytoestrogens
Item
nutraceuticals (eg, phyto-estrogens) that may have anabolic or steroid hormonal effects within 30 days prior to the baseline visit
boolean
C1518478 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C3179309 (UMLS CUI [1,3])
C1518478 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0301818 (UMLS CUI [2,3])
C1280500 (UMLS CUI [2,4])
C0071011 (UMLS CUI [3])
Androgen therapy Oral | Androgen therapy Sublingual | Androgen therapy Topical | Androgen therapy Transdermal Injectable | Androgen therapy Vaginal | dehydroepiandrosterone
Item
use of marketed or investigational oral, sub-lingual, topical, transdermal injectable, or vaginal androgen therapy including dehydroepiandrosterone (dhea) at any time within 3 months prior to the baseline visit
boolean
C0279493 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0279493 (UMLS CUI [2,1])
C0001565 (UMLS CUI [2,2])
C0279493 (UMLS CUI [3,1])
C1522168 (UMLS CUI [3,2])
C0279493 (UMLS CUI [4,1])
C0040652 (UMLS CUI [4,2])
C0086466 (UMLS CUI [4,3])
C0279493 (UMLS CUI [5,1])
C1522570 (UMLS CUI [5,2])
C0011185 (UMLS CUI [6])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
use of systemic corticosteroids within 30 days prior to the baseline visit (acute use for fewer than 7 days is acceptable)
boolean
C3653708 (UMLS CUI [1])
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