ID

29258

Beschreibung

Acetyl-L-Carnitine in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00984750

Link

https://clinicaltrials.gov/show/NCT00984750

Stichworte

Versionen (1)
  1. 13.03.18 13.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. März 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Type 2 NCT00984750

Englisch

Eligibility Diabetes Type 2 NCT00984750

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females >40 years old;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
high-risk subjects with type 2 diabetes (who criteria);
Beschreibung

Study Subject High risk | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332167
UMLS CUI [2]
C0011860
high blood pressure (systolic blood pressure >140 mmhg or with concomitant antihypertensive treatment stable since at least 3 months);
Beschreibung

Hypertensive disease | Systolic Pressure | Antihypertensive therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0585941
serum creatinine concentration <1.5 mg/dl;
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
patients legally able to give written informed consent to the trial (signed and dated by the patient);
Beschreibung

Ability Legal Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1301860
UMLS CUI [1,3]
C0021430
written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled diabetes (glycated hemoglobin >11%);
Beschreibung

Diabetic - poor control | Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0202054
acute cardiovascular events over the last 3 months;
Beschreibung

Cardiovascular event

Datentyp

boolean

Alias
UMLS CUI [1]
C1320716
specific contraindications or history of hypersensitivity to the study drugs;
Beschreibung

Medical contraindication Investigational New Drugs | Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;
Beschreibung

Hypersensitivity | Intolerance | Kidney Disease Immune system Mediated | Systemic disease Immune system Mediated | Malignant Neoplasms Immune system Mediated

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0231199
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0020962
UMLS CUI [3,3]
C0086597
UMLS CUI [4,1]
C0442893
UMLS CUI [4,2]
C0020962
UMLS CUI [4,3]
C0086597
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0020962
UMLS CUI [5,3]
C0086597
drug or alcohol abuse;
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
any chronic clinical conditions that may affect completion of the trial or confound data interpretation;
Beschreibung

Chronic disease Affecting Completion of clinical trial | Chronic disease Interferes with Interpretation Research data

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0681873
pregnancy or lactating;
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential without following a scientifically accepted form of contraception;
Beschreibung

Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
Beschreibung

Legal capacity Lacking | Comprehension Study Protocol Unable | Circumstances Comprehension Study Protocol Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0680082
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C2348563
UMLS CUI [3,4]
C1299582
evidence of an uncooperative attitude;
Beschreibung

Uncooperative attitude

Datentyp

boolean

Alias
UMLS CUI [1]
C2188045
any evidence that patient will not be able to complete the trial follow-up.
Beschreibung

Patient Completion of clinical trial Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C2732579
UMLS CUI [1,3]
C1299582
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Ähnliche Modelle

Eligibility Diabetes Type 2 NCT00984750

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females >40 years old;
boolean
C0001779 (UMLS CUI [1])
Study Subject High risk | Diabetes Mellitus, Non-Insulin-Dependent
Item
high-risk subjects with type 2 diabetes (who criteria);
boolean
C0681850 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
Hypertensive disease | Systolic Pressure | Antihypertensive therapy
Item
high blood pressure (systolic blood pressure >140 mmhg or with concomitant antihypertensive treatment stable since at least 3 months);
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
Creatinine measurement, serum
Item
serum creatinine concentration <1.5 mg/dl;
boolean
C0201976 (UMLS CUI [1])
Ability Legal Informed Consent
Item
patients legally able to give written informed consent to the trial (signed and dated by the patient);
boolean
C0085732 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetic - poor control | Glucohemoglobin measurement
Item
uncontrolled diabetes (glycated hemoglobin >11%);
boolean
C0421258 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Cardiovascular event
Item
acute cardiovascular events over the last 3 months;
boolean
C1320716 (UMLS CUI [1])
Medical contraindication Investigational New Drugs | Hypersensitivity Investigational New Drugs
Item
specific contraindications or history of hypersensitivity to the study drugs;
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Hypersensitivity | Intolerance | Kidney Disease Immune system Mediated | Systemic disease Immune system Mediated | Malignant Neoplasms Immune system Mediated
Item
previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;
boolean
C0020517 (UMLS CUI [1])
C0231199 (UMLS CUI [2])
C0022658 (UMLS CUI [3,1])
C0020962 (UMLS CUI [3,2])
C0086597 (UMLS CUI [3,3])
C0442893 (UMLS CUI [4,1])
C0020962 (UMLS CUI [4,2])
C0086597 (UMLS CUI [4,3])
C0006826 (UMLS CUI [5,1])
C0020962 (UMLS CUI [5,2])
C0086597 (UMLS CUI [5,3])
Substance Use Disorders
Item
drug or alcohol abuse;
boolean
C0038586 (UMLS CUI [1])
Chronic disease Affecting Completion of clinical trial | Chronic disease Interferes with Interpretation Research data
Item
any chronic clinical conditions that may affect completion of the trial or confound data interpretation;
boolean
C0008679 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnancy or lactating;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
women of childbearing potential without following a scientifically accepted form of contraception;
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Legal capacity Lacking | Comprehension Study Protocol Unable | Circumstances Comprehension Study Protocol Unable
Item
legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0680082 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
Uncooperative attitude
Item
evidence of an uncooperative attitude;
boolean
C2188045 (UMLS CUI [1])
Patient Completion of clinical trial Unable
Item
any evidence that patient will not be able to complete the trial follow-up.
boolean
C0030705 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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