ID

27618

Beschrijving

Role of Vitamin D in Secondary Prevention of Cardiovascular Events; ODM derived from: https://clinicaltrials.gov/show/NCT01018849

Link

https://clinicaltrials.gov/show/NCT01018849

Trefwoorden

Versies (1)
  1. 22-11-17 22-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 november 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Cardiovascular Disease NCT01018849

Engels

Eligibility Cardiovascular Disease NCT01018849

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female of age > 19 years at the time informed consent is signed.
Beschrijving

Age | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
subject with a diagnosis of unstable angina (with thrombolysis in myocardial infarction (timi) score of greater than or equal to 3) / nstemi or stemi,or documented coronary artery disease defined as at least one coronary artery with > 50% occlusion
Beschrijving

Angina, Unstable | TIMI Flow NSTEMI | TIMI Flow STEMI | Coronary Artery Disease | Coronary Occlusion Percentage Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C3272266
UMLS CUI [2,2]
C3537184
UMLS CUI [3,1]
C3272266
UMLS CUI [3,2]
C1536220
UMLS CUI [4]
C1956346
UMLS CUI [5,1]
C0151814
UMLS CUI [5,2]
C0439165
UMLS CUI [5,3]
C1265611
subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment.
Beschrijving

Patient Available Follow-up visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0589121
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin d deficiency).
Beschrijving

Phenytoin | Phenobarbital | orlistat

Datatype

boolean

Alias
UMLS CUI [1]
C0031507
UMLS CUI [2]
C0031412
UMLS CUI [3]
C0076275
subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin d metabolism).
Beschrijving

Comorbidity | Steroids Quantity per year Patient need for

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439508
UMLS CUI [2,4]
C0686904
subject is on an investigational drug, which is a new drug class and not part of standard acs protocol.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
subject is taking supplements of vitamin d with doses >400 iu/day.
Beschrijving

Vitamin D supplement Dose IU/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C3541352
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439465
subject has hypersensitivity to vitamin d products.
Beschrijving

Vitamin D allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0571828
subject has history of systemic lupus erythematosus (since vitamin d deficiency is common in this group27).
Beschrijving

Lupus Erythematosus, Systemic

Datatype

boolean

Alias
UMLS CUI [1]
C0024141
subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin d28)
Beschrijving

Sarcoidosis | Hypercalcemia | Increased vitamin D

Datatype

boolean

Alias
UMLS CUI [1]
C0036202
UMLS CUI [2]
C0020437
UMLS CUI [3]
C0919765
subject has history of renal stones.
Beschrijving

Kidney Calculi

Datatype

boolean

Alias
UMLS CUI [1]
C0022650
subject has hypercalcemia, which is defined as serum calcium levels >10.6 mg/dl, at the time of screening.
Beschrijving

Hypercalcemia | Serum Calcium Level

Datatype

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2]
C0036785
subject has end stage renal disease, defined as either chronic kidney disease stage v or requiring dialysis (since these patients have altered vitamin d and calcium metabolism).
Beschrijving

Kidney Failure, Chronic | Chronic Kidney Disease Staging | Dialysis Patient need for | Vitamin D metabolism altered | Calcium metabolism altered

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C1561643
UMLS CUI [2,2]
C0449385
UMLS CUI [3,1]
C0011946
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C1159433
UMLS CUI [4,2]
C0392747
UMLS CUI [5,1]
C0596236
UMLS CUI [5,2]
C0392747
subject has systemic disease (including terminal cancer, cirrhosis, end stage copd etc.,) with reduced (<12 months) life expectancy.
Beschrijving

Systemic disease | End stage cancer | Liver Cirrhosis | End stage COPD | Reduced life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0741884
UMLS CUI [3]
C0023890
UMLS CUI [4]
C4087491
UMLS CUI [5]
C1858274
subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study.
Beschrijving

Mental disorders Interfere with Protocol Compliance | Mental condition Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study.
Beschrijving

Condition Study Subject Participation Status At risk Unacceptable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C1883420
subject is pregnant.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
Terug naar het begin van de pagina

Similar models

Eligibility Cardiovascular Disease NCT01018849

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female of age > 19 years at the time informed consent is signed.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Angina, Unstable | TIMI Flow NSTEMI | TIMI Flow STEMI | Coronary Artery Disease | Coronary Occlusion Percentage Quantity
Item
subject with a diagnosis of unstable angina (with thrombolysis in myocardial infarction (timi) score of greater than or equal to 3) / nstemi or stemi,or documented coronary artery disease defined as at least one coronary artery with > 50% occlusion
boolean
C0002965 (UMLS CUI [1])
C3272266 (UMLS CUI [2,1])
C3537184 (UMLS CUI [2,2])
C3272266 (UMLS CUI [3,1])
C1536220 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4])
C0151814 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Patient Available Follow-up visit
Item
subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Phenytoin | Phenobarbital | orlistat
Item
subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin d deficiency).
boolean
C0031507 (UMLS CUI [1])
C0031412 (UMLS CUI [2])
C0076275 (UMLS CUI [3])
Comorbidity | Steroids Quantity per year Patient need for
Item
subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin d metabolism).
boolean
C0009488 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439508 (UMLS CUI [2,3])
C0686904 (UMLS CUI [2,4])
Investigational New Drugs
Item
subject is on an investigational drug, which is a new drug class and not part of standard acs protocol.
boolean
C0013230 (UMLS CUI [1])
Vitamin D supplement Dose IU/day
Item
subject is taking supplements of vitamin d with doses >400 iu/day.
boolean
C3541352 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439465 (UMLS CUI [1,3])
Vitamin D allergy
Item
subject has hypersensitivity to vitamin d products.
boolean
C0571828 (UMLS CUI [1])
Lupus Erythematosus, Systemic
Item
subject has history of systemic lupus erythematosus (since vitamin d deficiency is common in this group27).
boolean
C0024141 (UMLS CUI [1])
Sarcoidosis | Hypercalcemia | Increased vitamin D
Item
subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin d28)
boolean
C0036202 (UMLS CUI [1])
C0020437 (UMLS CUI [2])
C0919765 (UMLS CUI [3])
Kidney Calculi
Item
subject has history of renal stones.
boolean
C0022650 (UMLS CUI [1])
Hypercalcemia | Serum Calcium Level
Item
subject has hypercalcemia, which is defined as serum calcium levels >10.6 mg/dl, at the time of screening.
boolean
C0020437 (UMLS CUI [1])
C0036785 (UMLS CUI [2])
Kidney Failure, Chronic | Chronic Kidney Disease Staging | Dialysis Patient need for | Vitamin D metabolism altered | Calcium metabolism altered
Item
subject has end stage renal disease, defined as either chronic kidney disease stage v or requiring dialysis (since these patients have altered vitamin d and calcium metabolism).
boolean
C0022661 (UMLS CUI [1])
C1561643 (UMLS CUI [2,1])
C0449385 (UMLS CUI [2,2])
C0011946 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C1159433 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0596236 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
Systemic disease | End stage cancer | Liver Cirrhosis | End stage COPD | Reduced life expectancy
Item
subject has systemic disease (including terminal cancer, cirrhosis, end stage copd etc.,) with reduced (<12 months) life expectancy.
boolean
C0442893 (UMLS CUI [1])
C0741884 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C4087491 (UMLS CUI [4])
C1858274 (UMLS CUI [5])
Mental disorders Interfere with Protocol Compliance | Mental condition Interferes with Protocol Compliance
Item
subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study.
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Condition Study Subject Participation Status At risk Unacceptable
Item
subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1883420 (UMLS CUI [1,4])
Pregnancy
Item
subject is pregnant.
boolean
C0032961 (UMLS CUI [1])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial