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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT03058328
Eligibility Criteria:
INCLUSION CRITERIA
* Diagnosed prostate disease who are scheduled for elective robot assisted prostate surgery (RALP) and who are otherwise healthy
* A body mass index (BMI) below 33
* Mini-mental state examination (MMSE) scoring \>23
EXCLUSION CRITERIA
Exclusion criteria are patients with:
* Neurodegenerative disease
* Significant psychiatric illness
* Previous stroke
* Pacemaker, myocardial infarction or cardiac arrhythmias,
* Known obstructive coronary artery disease, left ventricular hypertrophy or New York Heart Association (NYHA) class 2-4 heart failure
* Chronic pain or inflammatory disease such as rheumatoid arthritis, inflammatory bowel disease, SLE, psoriasis
* Steroidal therapy
* Statin medication
* Medication with ß-blockers, anti-cholinergic medication
* Poorly controlled diabetes mellitus or any other condition known to cause autonomic dysfunction
* Abuse of alcohol or drugs
* Previous splenectomy
* Presumed uncooperativeness or legal incapacity.
The patient should not have:
* undergone surgery the last 6 months
* been treated for cancer the last 12 months
* been treated for infectious disease the previous month.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03058328
Study Brief:
Protocol Section:
NCT03058328