ID

21145

Descripción

Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis; ODM derived from: https://clinicaltrials.gov/show/NCT00639808

Link

https://clinicaltrials.gov/show/NCT00639808

Palabras clave

  1. 11/4/17 11/4/17 -
Subido en

11 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Gastroparesis NCT00639808

Eligibility Gastroparesis NCT00639808

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has type 1 or type 2 diabetes mellitus
Descripción

Diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
subject has documented diagnosis of gastroparesis by:
Descripción

Gastroparesis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0152020
delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
Descripción

Delayed gastric emptying

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0740411
a minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
Descripción

Chronic upper abdominal discomfort

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1868919
UMLS CUI [1,2]
C0205191
subject has normal upper endoscopy
Descripción

Endoscopy finding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438280
if female, must be permanently sterilized or postmenopausal.
Descripción

Gynaecological status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has received any investigational drug within the preceding 30 days
Descripción

Experimental drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0304229
patient is taking unstable doses of medication that affects gastric motility
Descripción

Pharmacotherapy affecting gastric motility

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0232572
patient has co-morbid condition
Descripción

Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
patient has a positive laboratory test result for hepatitis b, hepatitis c, hiv, or controlled substances.
Descripción

Hepatitis B, hepatitis C, HIV

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
Descripción

Psychiatric disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
patient has a recent,adult history of clinically significant hypersensitivity reaction(s) to any drug.
Descripción

Hypersensitivity to any drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1254351
patient has known history of alcoholism
Descripción

Substance Use Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586

Similar models

Eligibility Gastroparesis NCT00639808

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes mellitus
Item
subject has type 1 or type 2 diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Gastroparesis
Item
subject has documented diagnosis of gastroparesis by:
boolean
C0152020 (UMLS CUI [1])
Delayed gastric emptying
Item
delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
boolean
C0740411 (UMLS CUI [1])
Chronic upper abdominal discomfort
Item
a minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
boolean
C1868919 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Endoscopy finding
Item
subject has normal upper endoscopy
boolean
C0438280 (UMLS CUI [1])
Gynaecological status
Item
if female, must be permanently sterilized or postmenopausal.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Experimental drugs
Item
patient has received any investigational drug within the preceding 30 days
boolean
C0304229 (UMLS CUI [1])
Pharmacotherapy affecting gastric motility
Item
patient is taking unstable doses of medication that affects gastric motility
boolean
C0013216 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0232572 (UMLS CUI [1,3])
Comorbidity
Item
patient has co-morbid condition
boolean
C0009488 (UMLS CUI [1])
Hepatitis B, hepatitis C, HIV
Item
patient has a positive laboratory test result for hepatitis b, hepatitis c, hiv, or controlled substances.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Psychiatric disorder
Item
patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
boolean
C0004936 (UMLS CUI [1])
Hypersensitivity to any drug
Item
patient has a recent,adult history of clinically significant hypersensitivity reaction(s) to any drug.
boolean
C0020517 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
Substance Use Disorder
Item
patient has known history of alcoholism
boolean
C0038586 (UMLS CUI [1])

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