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Clinical Trials/NL-OMON43991
NL-OMON43991
Completed
Not Applicable

The effects of a psychological expectancy training directed at optimizing immune function - Psychological expectancy training

niversiteit Leiden0 sites60 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Het onderzoek wordt bij gezonde mensen uitgevoerd. Uitkomsten uit deze lijn van onderzoek bieden nieuwe handvatten voor verklaringsmodellen en therapeutische interventies voor gezonde mensen en patiënten met inflammatoire aandoeningen waarbij een verandering in de inflammatoire respons optreedt.
Sponsor
niversiteit Leiden
Enrollment
60
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversiteit Leiden

Eligibility Criteria

Inclusion Criteria

  • Healthy male adult volunteers between 18 and 35 years of age.
  • Good understanding of written and spoken Dutch.
  • Naive for tuberculosis.

Exclusion Criteria

  • History of inflammatory or cardiovascular diseases
  • Known hypersensitivity or allergy to any of the vaccine components
  • History exposure to open TB, (latent) TB disease or treatment
  • BCG vaccination at any time prior to entering the trial
  • Live vaccination (measles, mumps, rubella, oral polio, oral typhoid, varicella or yellow fever) 4 weeks or less prior to the BCG vaccination
  • Treatment with immune modulating drugs (systemic steroids, azathioprine, cyclosporine, anti\-TNFa, immunoglobulines, cytostatics) 3 months or less prior to enrolment
  • (History of) disease affecting the lymphoid organs (Hodgkin\*s disease, lymphoma, leukaemia, sarcoidosis)
  • Known congenital or acquired immune deficiencies (e.g. HIV)
  • Psychiatric (DSM\-V) or somatic conditions that interfere with the participant's safety and/or the study protocol (assessed during screening) such as personality disorders, schizophrenia, or haemophilia.
  • Professional sport player or extreme exercise (assessed during screening)

Outcomes

Primary Outcomes

Not specified

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