ID

35748

Descrição

EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02464033

Link

https://clinicaltrials.gov/show/NCT02464033

Palavras-chave

Klinische Studie [Dokumenttyp]

D004704

Diabetes mellitus, Typ 1

Behandlungsbedürftigkeit, Begutachtung

20/03/2019 20/03/2019 -

Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de março de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 1 NCT02464033

model
Detalhes

Eligibility Diabetes Mellitus, Type 1 NCT02464033

1 Formulários

StudyEvent: Eligibility
1. Eligibility Diabetes Mellitus, Type 1 NCT02464033

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Item

1. informed consent given by patients and parent(s)/legal guardian(s)

boolean

C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])

Diabetes Mellitus, Insulin-Dependent

Item

2. type 1 diabetes according to the ada classification, diagnosed within the previous 100 days at the time of screening

boolean

C0011854 (UMLS CUI [1])

Age

Item

3. age 8.00 -17.99 years at time of screening

boolean

C0001779 (UMLS CUI [1])

Fasting C-peptide level

Item

4. fasting c-peptide at time of screening ≥0.12 nmol/l

boolean

C2208720 (UMLS CUI [1])

Anti-GAD antibody positive

Item

5. positive for gada but < 50 000 units

boolean

C1167896 (UMLS CUI [1])

Gender Menarche Avoidance Pregnancy | Gender Menarche Urine pregnancy test negative

Item

6. menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test

boolean

C0079399 (UMLS CUI [1,1])
C0025274 (UMLS CUI [1,2])
C0870186 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2,1])
C0025274 (UMLS CUI [2,2])
C0430057 (UMLS CUI [2,3])

Immunity Chickenpox | Communicable Disease Previous | Vaccination Previous

Item

7. immunity against varicella, either through previous infection or vaccination

boolean

C0020964 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0042196 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])

Adherence Vaccination Program Swedish

Item

8. patients must follow the swedish vaccination programme

boolean

C1510802 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C1710263 (UMLS CUI [1,4])

Childbearing Potential Sexually active Contraceptive methods

Item

9. patients of childbearing potential must agree to using adequate contraception, if sexually active, until 1 year after the last administration of gad-alum and etanercept. adequate contraception is as follows:

boolean

C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])

Gender Childbearing Potential

Item

for females of childbearing potential:

boolean

C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])

Item

1. oral (except low-dose gestagen (lynestrenol and norestisteron), injectable, or implanted hormonal contraceptives (females)

boolean

C0009907 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0033306 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0024321 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0028356 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
C1262153 (UMLS CUI [5,1])
C0458083 (UMLS CUI [5,2])
C1657106 (UMLS CUI [6,1])
C0458083 (UMLS CUI [6,2])

Intrauterine Devices

Item

2. intrauterine device (females)

boolean

C0021900 (UMLS CUI [1])

Intrauterine System | Contraceptive coil Progestin Releasing

Item

3. intrauterine system (for example, progestin-releasing coil) (females)

boolean

C4293370 (UMLS CUI [1])
C0419518 (UMLS CUI [2,1])
C0033306 (UMLS CUI [2,2])
C1283071 (UMLS CUI [2,3])

Vasectomy

Item

4. vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)

boolean

C0042387 (UMLS CUI [1])

Gender Childbearing Potential

Item

for males of childbearing potential:

boolean

C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])

Condoms, Male

Item

a. condom (male)

boolean

C0009653 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Immunosuppressant drug therapy | Topical Steroid Therapy Accepted | Inhaled steroids Accepted

Item

1. previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)

boolean

C1096650 (UMLS CUI [1])
C3897353 (UMLS CUI [2,1])
C1272684 (UMLS CUI [2,2])
C2065041 (UMLS CUI [3,1])
C1272684 (UMLS CUI [3,2])

Anti-Inflammatory Agents Continuous

Item

2. continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)

boolean

C0003209 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Antidiabetics Oral | Antidiabetics Injection | Hypoglycemic Agents | Exception Insulin

Item

3. treatment with any oral or injected anti-diabetic medications (especially hypoglycemic agents) other than insulin

boolean

C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0020616 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])

Vitamin D | Vitamin D Discontinue Unwilling

Item

4. treatment with vitamin d, marketed or not, or unwilling to abstain from such medication during the trial

boolean

C0042866 (UMLS CUI [1])
C0042866 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])

Hypercalcemia

Item

5. a history of hypercalcemia

boolean

C0020437 (UMLS CUI [1])

Anemia | Abnormal Hematology Test Result

Item

6. a history of anaemia or significantly abnormal haematology results at screening

boolean

C0002871 (UMLS CUI [1])
C1332130 (UMLS CUI [2])

Epilepsy | Craniocerebral Trauma | Cerebrovascular accident | Feature Continuous motor unit activity Proximal Muscle

Item

7. a history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles

boolean

C0014544 (UMLS CUI [1])
C0018674 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C2348519 (UMLS CUI [4,1])
C0429352 (UMLS CUI [4,2])
C2984223 (UMLS CUI [4,3])

Acute allergic reaction Vaccines | Drug Allergy

Item

8. clinically significant history of acute reaction to vaccines or other drugs in the past

boolean

C0413234 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2])

Vaccines | Vaccines Planned | Influenza vaccine

Item

9. treatment with any vaccine within 4 months prior to planned first administration of gad-alum or planned treatment with vaccine up to 4 months after the last injection with gad-alum, including influenza vaccine

boolean

C0042210 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0021403 (UMLS CUI [3])

Study Subject Participation Status | Investigational New Drugs

Item

10. participation in other clinical trials with a new chemical entity within the previous 3 months

boolean

C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])

Protocol Compliance Unable | Protocol Compliance Unwilling

Item

11. inability or unwillingness to comply with the provisions of this protocol

boolean

C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])

Substance Use Disorders

Item

12. a history of alcohol or drug abuse

boolean

C0038586 (UMLS CUI [1])

Illness Significant | Exception Diabetes Mellitus

Item

13. a significant illness other than diabetes within 2 weeks prior to first dosing

boolean

C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])

HIV Infection

Item

14. known human immunodeficiency virus (hiv)

boolean

C0019693 (UMLS CUI [1])

Hepatitis B | Hepatitis C

Item

15. prior or active viral hepatitis b or c infection

boolean

C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])

Breast Feeding | Pregnancy | Gender Menarche Urine pregnancy test Negative

Item

16. females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βhcg on-site within 24 hours prior to the gad-alum and etanercept administration, respectively)

boolean

C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0025274 (UMLS CUI [3,2])
C0430056 (UMLS CUI [3,3])
C1513916 (UMLS CUI [3,4])

Gender Sexually active | Contraceptive methods Unwilling

Item

17. males or females not willing to use adequate contraception, if sexually active, until 1 year after the last gad-alum and etanercept administration, respectively

boolean

C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])

Comorbidity Serious Excludes Subcutaneous Injection | Condition Serious Excludes Subcutaneous Injection | Skin Infection Excludes Subcutaneous Injection | Study Subject Participation Status Ineligible

Item

18. presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study.

boolean

C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0021499 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0021499 (UMLS CUI [2,4])
C0037278 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0021499 (UMLS CUI [3,3])
C2348568 (UMLS CUI [4,1])
C1512714 (UMLS CUI [4,2])

Protocol Compliance Unable

Item

19. deemed by the investigator not being able to follow instructions and/or follow the study protocol

boolean

C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

Item

20. active infection, including chronic and local infection or a history of previous tendency to serious infections, recent or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, or known infection with active ebv or cmv

boolean

C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C1400591 (UMLS CUI [3])
C0220898 (UMLS CUI [4,1])
C0009450 (UMLS CUI [4,2])
C0205404 (UMLS CUI [4,3])
C0004623 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0042769 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0026946 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0029118 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C0149678 (UMLS CUI [9])
C0010823 (UMLS CUI [10])

Hypersensitivity Enbrel Active ingredient | Hypersensitivity Etanercept | Hypersensitivity Enbrel Ingredient

Item

21. hypersensivity to the active substance in enbrel (etanercept) or other ingredients in enbrel

boolean

C0020517 (UMLS CUI [1,1])
C0720193 (UMLS CUI [1,2])
C1372955 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0717758 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0720193 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])

Tuberculosis | Latent Tuberculosis

Item

22. active or inactive (latent) tuberculosis (tbc) at screening

boolean

C0041296 (UMLS CUI [1])
C1609538 (UMLS CUI [2])

Malignant Neoplasms | Cardiovascular Disease

Item

23. history of malignancy or significant cardiovascular disease

boolean

C0006826 (UMLS CUI [1])
C0007222 (UMLS CUI [2])

Leukopenia | Anemia | Thrombocytopenia

Item

24. current or history of leukopenia, anemia and/or thrombocytopeni

boolean

C0023530 (UMLS CUI [1])
C0002871 (UMLS CUI [2])
C0040034 (UMLS CUI [3])

Liver diseases | Elevated liver enzymes

Item

25. liver disease (clinical or hepatic enzymes >3 times the upper limit of normal (uln))

boolean

C0023895 (UMLS CUI [1])
C0235996 (UMLS CUI [2])

Renal Insufficiency | Serum creatinine raised

Item

26. renal insufficiency (clinical or creatinine >3 times the upper limit of normal (uln))

boolean

C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])

Multiple Sclerosis | Condition Neurologic undefined | Lupus Erythematosus, Systemic | Anti-nuclear factor positive | Double stranded DNA antibody positive

Item

27. ms, undefined neurologic condition or known sle, or anti-nuclear or known doublestranded dna antibody positivity

boolean

C0026769 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0205494 (UMLS CUI [2,2])
C0750600 (UMLS CUI [2,3])
C0024141 (UMLS CUI [3])
C0151480 (UMLS CUI [4])
C2747922 (UMLS CUI [5])

Cardiac Arrhythmia

Item

28. arrhythmia

boolean

C0003811 (UMLS CUI [1])

Pancreatitis

Item

29. pancreatitis

boolean

C0030305 (UMLS CUI [1])

Serum vitamin D measurement

Item

30. vitamin d serum levels >100 nmol/l at screening

boolean

C0428586 (UMLS CUI [1])

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Eligibility Diabetes Mellitus, Type 1 NCT02464033

Eligibility Diabetes Mellitus, Type 1 NCT02464033

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