Informatie: Dit is niet de actueelste versie van het datamodel. Een versieoverzicht vindt u links onder Versies. De actueelste versie vindt u hier.
Informatie:
Fout:
ID
15452
Beschrijving
Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT02366364
Link
https://clinicaltrials.gov/show/NCT02366364
Trefwoorden
Versies (2)
- 01-06-16 01-06-16 -
- 01-06-16 01-06-16 -
Geüploaded op
1 juni 2016
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility Major Depressive Disorder NCT02366364
Eligibility Major Depressive Disorder NCT02366364
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT02366364
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Gender
Item
male and female subjects
boolean
C0079399 (UMLS CUI [1])
Age
Item
aged 18 to 55 years
boolean
C0001779 (UMLS CUI [1])
Female Sterilization | Menopause | Contraceptive methods | Childbearing Potential pregnancy blood test Negative | Childbearing Potential Urine pregnancy test negative
Item
for female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control. if of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
boolean
C0015787 (UMLS CUI [1])
C0025320 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0850355 (UMLS CUI [4,2])
C0205160 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0430057 (UMLS CUI [5,2])
C0025320 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0850355 (UMLS CUI [4,2])
C0205160 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0430057 (UMLS CUI [5,2])
Laboratory Procedures | Upper Limit of Normal | Clinical Significance
Item
clinical laboratory values <2 times upper limit of normal (uln) or deemed not clinically significant by the investigator
boolean
C0022885 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
C2826293 (UMLS CUI [3])
C1519815 (UMLS CUI [2])
C2826293 (UMLS CUI [3])
Compliance behavior Study Protocol | Informed Consent
Item
ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
ID.6
Item
human immunodeficiency virus (hiv) infection, or hepatitis or other ongoing infectious disease.
boolean
ID.7
Item
current evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits), or in the option of the investigator that subject may be alcoholic.
boolean
ID.8
Item
current abuse of illicit substances, using the diagnostic and statistical manual (dsm) iv definition of drug abuse.
boolean
ID.9
Item
current smoker or use of other tobacco products.
boolean
ID.10
Item
currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
boolean
ID.11
Item
type i or type ii diabetes.
boolean
ID.12
Item
malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
boolean
ID.13
Item
currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
boolean
ID.14
Item
history of allergy, sensitivity, or intolerance to nmdar ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone or concomitant use of such agents.
boolean
ID.15
Item
received another investigational drug or device within 30 days of enrollment in this study.
boolean
ID.16
Item
previously participated in this study.
boolean
ID.17
Item
psychiatric disease including major depression, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug safety. 13) in the option of the investigator or the sponsor's study monitor, has a history of severe renal or hepatic impairment, severe active hepatic disease, or other clinically significant medical condition that may preclude safe study participation.
boolean