ID

41135

Description

An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy; ODM derived from: https://clinicaltrials.gov/show/NCT00677313

Link

https://clinicaltrials.gov/show/NCT00677313

Keywords

Versions (1)
  1. 6/29/20 6/29/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 29, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Lipodystrophy NCT00677313

English

Eligibility Lipodystrophy NCT00677313

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
is male or female ≥5 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):
Description

Childbearing Potential | Perimenopausal state Menstrual period

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C3839366
UMLS CUI [2,2]
C0025329
1. not breastfeeding
Description

Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0332197
2. negative pregnancy test result
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
3. must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.)
Description

Contraceptive methods | Contraceptive implant | Injectable contraception | Contraceptives, Oral | Intrauterine Devices | Sexual Abstinence | Tubal Ligation | Partner had vasectomy | Barrier Contraception Double | Vaginal contraceptive diaphragm | Condoms, Male | Spermatocidal Agents

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C1657106
UMLS CUI [3]
C1262153
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0036899
UMLS CUI [7]
C0520483
UMLS CUI [8]
C0420842
UMLS CUI [9,1]
C0004764
UMLS CUI [9,2]
C0205173
UMLS CUI [10]
C0042241
UMLS CUI [11]
C0009653
UMLS CUI [12]
C0037862
has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation
Description

Lipodystrophy | Loss of body fat Generalized | Loss of body fat Partial

Data type

boolean

Alias
UMLS CUI [1]
C0023787
UMLS CUI [2,1]
C0424630
UMLS CUI [2,2]
C0205246
UMLS CUI [3,1]
C0424630
UMLS CUI [3,2]
C0728938
has been diagnosed with at least one of the following 2 metabolic disorders:
Description

Metabolic Disease Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C1265611
1. diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
2. hypertriglyceridemia as defined by fasting triglyceride concentrations >200 mg/dl
Description

Hypertriglyceridemia | Serum fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0020557
UMLS CUI [2]
C0582824
if ≥18 years of age, is able to read, understand, and sign the informed consent form (icf) and an authorization to use and disclose protected health information form, communicate with the investigator, and understand and comply with protocol requirements
Description

Age | Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0525058
if <18 years of age, has a parent or legal guardian to read and understand the icf and child assent form, communicate with the investigator, and understand and comply with protocol requirements. adolescent subjects must also read and understand the child assent form; if the child is too young or unable to read, then the child assent form must be explained to the child.
Description

Age | Informed Consent Parent | Informed Consent Guardian | Protocol Compliance Parent | Protocol Compliance Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0030551
UMLS CUI [5,1]
C0525058
UMLS CUI [5,2]
C1274041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has been diagnosed with hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
has known infectious liver disease
Description

Liver disorder due to infection

Data type

boolean

Alias
UMLS CUI [1]
C0400888
has known allergies to e. coli-derived proteins or hypersensitivity to any component of study treatment
Description

Hypersensitivity Escherichia coli Proteins | Hypersensitivity Component Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014834
UMLS CUI [1,3]
C0033684
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0949266
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Similar models

Eligibility Lipodystrophy NCT00677313

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
is male or female ≥5 years old
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential | Perimenopausal state Menstrual period
Item
if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):
boolean
C3831118 (UMLS CUI [1])
C3839366 (UMLS CUI [2,1])
C0025329 (UMLS CUI [2,2])
Breast Feeding Absent
Item
1. not breastfeeding
boolean
C0006147 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy test negative
Item
2. negative pregnancy test result
boolean
C0427780 (UMLS CUI [1])
Contraceptive methods | Contraceptive implant | Injectable contraception | Contraceptives, Oral | Intrauterine Devices | Sexual Abstinence | Tubal Ligation | Partner had vasectomy | Barrier Contraception Double | Vaginal contraceptive diaphragm | Condoms, Male | Spermatocidal Agents
Item
3. must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.)
boolean
C0700589 (UMLS CUI [1])
C1657106 (UMLS CUI [2])
C1262153 (UMLS CUI [3])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
C0520483 (UMLS CUI [7])
C0420842 (UMLS CUI [8])
C0004764 (UMLS CUI [9,1])
C0205173 (UMLS CUI [9,2])
C0042241 (UMLS CUI [10])
C0009653 (UMLS CUI [11])
C0037862 (UMLS CUI [12])
Lipodystrophy | Loss of body fat Generalized | Loss of body fat Partial
Item
has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation
boolean
C0023787 (UMLS CUI [1])
C0424630 (UMLS CUI [2,1])
C0205246 (UMLS CUI [2,2])
C0424630 (UMLS CUI [3,1])
C0728938 (UMLS CUI [3,2])
Metabolic Disease Quantity
Item
has been diagnosed with at least one of the following 2 metabolic disorders:
boolean
C0025517 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Diabetes Mellitus
Item
1. diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Hypertriglyceridemia | Serum fasting triglyceride measurement
Item
2. hypertriglyceridemia as defined by fasting triglyceride concentrations >200 mg/dl
boolean
C0020557 (UMLS CUI [1])
C0582824 (UMLS CUI [2])
Age | Informed Consent | Protocol Compliance
Item
if ≥18 years of age, is able to read, understand, and sign the informed consent form (icf) and an authorization to use and disclose protected health information form, communicate with the investigator, and understand and comply with protocol requirements
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Age | Informed Consent Parent | Informed Consent Guardian | Protocol Compliance Parent | Protocol Compliance Guardian
Item
if <18 years of age, has a parent or legal guardian to read and understand the icf and child assent form, communicate with the investigator, and understand and comply with protocol requirements. adolescent subjects must also read and understand the child assent form; if the child is too young or unable to read, then the child assent form must be explained to the child.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C0030551 (UMLS CUI [4,2])
C0525058 (UMLS CUI [5,1])
C1274041 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
HIV Infection
Item
has been diagnosed with hiv infection
boolean
C0019693 (UMLS CUI [1])
Liver disorder due to infection
Item
has known infectious liver disease
boolean
C0400888 (UMLS CUI [1])
Hypersensitivity Escherichia coli Proteins | Hypersensitivity Component Investigational Therapy
Item
has known allergies to e. coli-derived proteins or hypersensitivity to any component of study treatment
boolean
C0020517 (UMLS CUI [1,1])
C0014834 (UMLS CUI [1,2])
C0033684 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
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