Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01835457
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 and ≤35 yrs
* Male
* Healthy
* Travel insurance (for travel to Poland for the training in the concentration/meditation technique)
Exclusion Criteria:
* Use of any medication
* Smoking
* Use of recreational drugs within 21 days prior to endotoxemia experiment day
* Use of caffeine or alcohol within 1 day prior to endotoxemia experiment day
* Previous participation in a trial where LPS was administered
* Surgery or trauma with significant blood loss or blood donation within 3 months prior to endotoxemia experiment day
* Participation in another clinical trial within 3 months prior to endotoxemia experiment day.
* History, signs, or symptoms of cardiovascular disease
* History of frequent vaso-vagal collapse or of orthostatic hypotension
* History of atrial or ventricular arrhythmia
* Hypertension (RR systolic \>160 or RR diastolic \>90)
* Hypotension (RR systolic \<100 or RR diastolic \<50)
* Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
* Renal impairment: plasma creatinine \>120 µmol/L
* Liver function abnormality: alkaline phosphatase\>230 U/L and/or ALT\>90 U/L
* History of asthma
* Obvious disease associated with immune deficiency.
* CRP \> 20 mg/L, WBC \> 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01835457
Study Brief:
Protocol Section:
NCT01835457