ID

40357

Beschrijving

Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage; ODM derived from: https://clinicaltrials.gov/show/NCT01783717

Link

https://clinicaltrials.gov/show/NCT01783717

Trefwoorden

Versies (1)
  1. 12-04-20 12-04-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 april 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypothalamic Obesity NCT01783717

Engels

Eligibility Hypothalamic Obesity NCT01783717

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. be between 18 and 55 years old;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. greater than 6 months post-treatment (including surgery, radiotherapy or chemotherapy) of craniopharyngioma or other diseases in the hypothalamic region;
Beschrijving

Status post Timespan | Status post Operative Surgical Procedure Craniopharyngioma | Status post Therapeutic radiology procedure Craniopharyngioma | Status post Chemotherapy Craniopharyngioma | Status post Operative Surgical Procedure Hypothalamic Diseases | Status post Therapeutic radiology procedure Hypothalamic Diseases | Status post Chemotherapy Hypothalamic Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0872291
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0010276
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0010276
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C0010276
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0543467
UMLS CUI [5,3]
C0020655
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1522449
UMLS CUI [6,3]
C0020655
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C0392920
UMLS CUI [7,3]
C0020655
3. bmi≧28kg/m2 and/or diabetes mellitus;
Beschrijving

Body mass index | Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0011849
4. greater than 3 months after adequate replacement therapy for hypothalamic-pituitary-adrenal (hpa) axis and hypothalamic-pituitary-thyroid (hpt) axis;
Beschrijving

Status post Timespan | Status post Replacement Therapy HPA axis | Status post Replacement Therapy HPT axis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0872291
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0559956
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0597719
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0559956
UMLS CUI [3,3]
C0087111
UMLS CUI [3,4]
C0814031
5. sign informed consent document.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. less than 6 months post surgery or radiotherapy or chemotherapy for craniopharyngioma or other diseases in the hypothalamic region;
Beschrijving

Status post Timespan | Status post Operative Surgical Procedure Craniopharyngioma | Status post Therapeutic radiology procedure Craniopharyngioma | Status post Chemotherapy Craniopharyngioma | Status post Operative Surgical Procedure Hypothalamic Diseases | Status post Therapeutic radiology procedure Hypothalamic Diseases | Status post Chemotherapy Hypothalamic Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0872291
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0010276
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C0010276
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C0010276
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0543467
UMLS CUI [5,3]
C0020655
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1522449
UMLS CUI [6,3]
C0020655
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C0392920
UMLS CUI [7,3]
C0020655
2. inadequate replacement for the hpa axis and hpt axis or undertaking adjustments of the kind or dose of the substitutive medicine;
Beschrijving

Replacement Inadequate HPA axis | Replacement Inadequate HPT axis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0559956
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0597719
UMLS CUI [2,1]
C0559956
UMLS CUI [2,2]
C0205412
UMLS CUI [2,3]
C0814031
3. use of weight loss drugs or initiation of a weight loss program within past 3 months;
Beschrijving

Weight-Loss Agents | Initiation Weight Reduction Program

Datatype

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C3179079
4. use of glp-1 agonists or analogues or dipeptidyl peptidase iv (dpp-iv) inhibitors within past 3 months;
Beschrijving

GLP-1 Receptor Agonist | GLP-1 Mimetics | Dipeptidyl-Peptidase IV Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C3273809
UMLS CUI [3]
C1827106
5. history of bariatric surgery;
Beschrijving

Bariatric Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C1456587
6. diagnosed with simple obesity or diabetes mellitus prior to the hypothalamic disorders, and those diagnosed with type 1 diabetes mellitus;
Beschrijving

Simple obesity | Diabetes Mellitus | Status pre- Hypothalamic Diseases | Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0451819
UMLS CUI [2]
C0011849
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0020655
UMLS CUI [4]
C0011854
7. with end-stage-renal diseases or history of kidney transplant or complicated with acute/chronic kidney failure (gfr≦30ml/min);
Beschrijving

Kidney Failure, Chronic | Kidney Transplantation | Kidney Failure with Complication | Chronic Kidney Failure with Complication | Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0022671
UMLS CUI [3,1]
C0035078
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0009566
UMLS CUI [4,1]
C0022661
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C0009566
UMLS CUI [5]
C0017654
8. history of inflammatory bowel diseases or gastroparesis or other gastric mortility problems;
Beschrijving

Inflammatory Bowel Diseases | Gastroparesis | Abnormal gastric motility

Datatype

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0152020
UMLS CUI [3]
C0232574
9. history of pancreatitis or chronic cholecystitis;
Beschrijving

History of pancreatitis | Chronic cholecystitis

Datatype

boolean

Alias
UMLS CUI [1]
C3887021
UMLS CUI [2]
C0085694
10. history of allergic reaction to exenatide or other medication components;
Beschrijving

Allergic Reaction Exenatide | Allergic Reaction Pharmaceutical Preparation Component

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0167117
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1705248
11. undertaking warfarin;
Beschrijving

Warfarin

Datatype

boolean

Alias
UMLS CUI [1]
C0043031
12. pregnant or lactating women;
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. are participating in, or have participated in other drug clinical trials within past 3 months.
Beschrijving

Study Subject Participation Status | Clinical Trial | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
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Similar models

Eligibility Hypothalamic Obesity NCT01783717

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. be between 18 and 55 years old;
boolean
C0001779 (UMLS CUI [1])
Status post Timespan | Status post Operative Surgical Procedure Craniopharyngioma | Status post Therapeutic radiology procedure Craniopharyngioma | Status post Chemotherapy Craniopharyngioma | Status post Operative Surgical Procedure Hypothalamic Diseases | Status post Therapeutic radiology procedure Hypothalamic Diseases | Status post Chemotherapy Hypothalamic Diseases
Item
2. greater than 6 months post-treatment (including surgery, radiotherapy or chemotherapy) of craniopharyngioma or other diseases in the hypothalamic region;
boolean
C0231290 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0010276 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0010276 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0010276 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C0020655 (UMLS CUI [5,3])
C0231290 (UMLS CUI [6,1])
C1522449 (UMLS CUI [6,2])
C0020655 (UMLS CUI [6,3])
C0231290 (UMLS CUI [7,1])
C0392920 (UMLS CUI [7,2])
C0020655 (UMLS CUI [7,3])
Body mass index | Diabetes Mellitus
Item
3. bmi≧28kg/m2 and/or diabetes mellitus;
boolean
C1305855 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
Status post Timespan | Status post Replacement Therapy HPA axis | Status post Replacement Therapy HPT axis
Item
4. greater than 3 months after adequate replacement therapy for hypothalamic-pituitary-adrenal (hpa) axis and hypothalamic-pituitary-thyroid (hpt) axis;
boolean
C0231290 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0559956 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0597719 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C0559956 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0814031 (UMLS CUI [3,4])
Informed Consent
Item
5. sign informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Status post Timespan | Status post Operative Surgical Procedure Craniopharyngioma | Status post Therapeutic radiology procedure Craniopharyngioma | Status post Chemotherapy Craniopharyngioma | Status post Operative Surgical Procedure Hypothalamic Diseases | Status post Therapeutic radiology procedure Hypothalamic Diseases | Status post Chemotherapy Hypothalamic Diseases
Item
1. less than 6 months post surgery or radiotherapy or chemotherapy for craniopharyngioma or other diseases in the hypothalamic region;
boolean
C0231290 (UMLS CUI [1,1])
C0872291 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0010276 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0010276 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0010276 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C0020655 (UMLS CUI [5,3])
C0231290 (UMLS CUI [6,1])
C1522449 (UMLS CUI [6,2])
C0020655 (UMLS CUI [6,3])
C0231290 (UMLS CUI [7,1])
C0392920 (UMLS CUI [7,2])
C0020655 (UMLS CUI [7,3])
Replacement Inadequate HPA axis | Replacement Inadequate HPT axis
Item
2. inadequate replacement for the hpa axis and hpt axis or undertaking adjustments of the kind or dose of the substitutive medicine;
boolean
C0559956 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0597719 (UMLS CUI [1,3])
C0559956 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0814031 (UMLS CUI [2,3])
Weight-Loss Agents | Initiation Weight Reduction Program
Item
3. use of weight loss drugs or initiation of a weight loss program within past 3 months;
boolean
C0376606 (UMLS CUI [1])
C1704686 (UMLS CUI [2,1])
C3179079 (UMLS CUI [2,2])
GLP-1 Receptor Agonist | GLP-1 Mimetics | Dipeptidyl-Peptidase IV Inhibitors
Item
4. use of glp-1 agonists or analogues or dipeptidyl peptidase iv (dpp-iv) inhibitors within past 3 months;
boolean
C2917359 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C1827106 (UMLS CUI [3])
Bariatric Surgery
Item
5. history of bariatric surgery;
boolean
C1456587 (UMLS CUI [1])
Simple obesity | Diabetes Mellitus | Status pre- Hypothalamic Diseases | Diabetes Mellitus, Insulin-Dependent
Item
6. diagnosed with simple obesity or diabetes mellitus prior to the hypothalamic disorders, and those diagnosed with type 1 diabetes mellitus;
boolean
C0451819 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0332152 (UMLS CUI [3,1])
C0020655 (UMLS CUI [3,2])
C0011854 (UMLS CUI [4])
Kidney Failure, Chronic | Kidney Transplantation | Kidney Failure with Complication | Chronic Kidney Failure with Complication | Glomerular Filtration Rate
Item
7. with end-stage-renal diseases or history of kidney transplant or complicated with acute/chronic kidney failure (gfr≦30ml/min);
boolean
C0022661 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
C0035078 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0009566 (UMLS CUI [3,3])
C0022661 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C0009566 (UMLS CUI [4,3])
C0017654 (UMLS CUI [5])
Inflammatory Bowel Diseases | Gastroparesis | Abnormal gastric motility
Item
8. history of inflammatory bowel diseases or gastroparesis or other gastric mortility problems;
boolean
C0021390 (UMLS CUI [1])
C0152020 (UMLS CUI [2])
C0232574 (UMLS CUI [3])
History of pancreatitis | Chronic cholecystitis
Item
9. history of pancreatitis or chronic cholecystitis;
boolean
C3887021 (UMLS CUI [1])
C0085694 (UMLS CUI [2])
Allergic Reaction Exenatide | Allergic Reaction Pharmaceutical Preparation Component
Item
10. history of allergic reaction to exenatide or other medication components;
boolean
C1527304 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Warfarin
Item
11. undertaking warfarin;
boolean
C0043031 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
12. pregnant or lactating women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs
Item
13. are participating in, or have participated in other drug clinical trials within past 3 months.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
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