Informações:
Falhas:
ID
28918
Descrição
Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00671515
Link
https://clinicaltrials.gov/show/NCT00671515
Palavras-chave
Versões (1)
- 15/02/2018 15/02/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
15 de fevereiro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00671515
Eligibility Depressive Disorder, Major NCT00671515
- StudyEvent: Eligibility
Similar models
Eligibility Depressive Disorder, Major NCT00671515
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
be male or female between the ages of 18 and 70
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
dsm-iv diagnosis of major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Depressed
Item
currently depressed as confirmed by the mini-plus at the screening visit
boolean
C0344315 (UMLS CUI [1])
Depressive Symptoms Score
Item
quick inventory of depressive symptomatology-self-report(qids-sr) score > 11 at study baseline
boolean
C0086132 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
Metabolic Syndrome
Item
meets criteria for the metabolic syndrome as defined by the ncep atp iii criteria
boolean
C0524620 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Illness Unstable | Illness Treated Inadequate
Item
unstable or inadequately treated medical illness as judged by the investigator
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0443343 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Personality Disorder Severe
Item
severe personality disorder
boolean
C0031212 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
At risk for suicide Serious | Depressive Symptoms Score
Item
serious suicidal risk as judged by the investigator or having a score > 2 on item 18 of the inventory of depressive symptomatology-clinician rated (ids-cr) scale
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0086132 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0205404 (UMLS CUI [1,2])
C0086132 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Intolerance to Pioglitazone | Hypersensitivity Pioglitazone
Item
known history of intolerance or hypersensitivity to pioglitazone
boolean
C1744706 (UMLS CUI [1,1])
C0071097 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0071097 (UMLS CUI [2,2])
C0071097 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0071097 (UMLS CUI [2,2])
Pioglitazone
Item
treatment with pioglitazone in the 3 months prior to randomization
boolean
C0071097 (UMLS CUI [1])
Antidiabetics | Hypoglycemic Agents | Insulin | rosiglitazone | Metformin | sitagliptin | Sulfonylurea | Glyburide | Glipizide | glimepiride | Other Coding | repaglinide | nateglinide | Incretins | exenatide | alpha-Glucosidase Inhibitors | Acarbose | miglitol
Item
currently taking an antidiabetic/glucose-lowering agent. antidiabetic agents that are prohibited include insulin, rosiglitazone, metformin, sitagliptin, sulfonylureas (e.g. glyburide, glipizide, glimepiride), non-sulfonylurea secretagogues (e.g. repaglinide, nateglinide), incretins (e.g. exenatide), and α-glucosidase inhibitors (e.g. acarbose, miglitol).
boolean
C0935929 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
C0289313 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C1565750 (UMLS CUI [6])
C0038766 (UMLS CUI [7])
C0017628 (UMLS CUI [8])
C0017642 (UMLS CUI [9])
C0061323 (UMLS CUI [10])
C3846158 (UMLS CUI [11])
C0246689 (UMLS CUI [12])
C0903898 (UMLS CUI [13])
C1562292 (UMLS CUI [14])
C0167117 (UMLS CUI [15])
C1299007 (UMLS CUI [16])
C0050393 (UMLS CUI [17])
C0066535 (UMLS CUI [18])
C0020616 (UMLS CUI [2])
C0021641 (UMLS CUI [3])
C0289313 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C1565750 (UMLS CUI [6])
C0038766 (UMLS CUI [7])
C0017628 (UMLS CUI [8])
C0017642 (UMLS CUI [9])
C0061323 (UMLS CUI [10])
C3846158 (UMLS CUI [11])
C0246689 (UMLS CUI [12])
C0903898 (UMLS CUI [13])
C1562292 (UMLS CUI [14])
C0167117 (UMLS CUI [15])
C1299007 (UMLS CUI [16])
C0050393 (UMLS CUI [17])
C0066535 (UMLS CUI [18])
Dementia
Item
diagnosed with dementia
boolean
C0497327 (UMLS CUI [1])
Heart failure
Item
diagnosed with heart failure
boolean
C0018801 (UMLS CUI [1])
Elevated serum transaminase levels
Item
transaminase elevation >2.5 times the upper limit of normal
boolean
C3808571 (UMLS CUI [1])
Renal Insufficiency
Item
presence of renal impairment
boolean
C1565489 (UMLS CUI [1])