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 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT04532866
Eligibility Criteria:
Inclusion Criteria:
* Candidates who are professionals in the aerospace industry or related fields are eligible at a lower age limit of 28
* Height not to exceed 180 cm.
* Willing to be confined and isolated for up to 8 months.
* English and Russian verbal and written proficiency not lower than intermediate
* Absence of chronic disease or psychological deviations
Exclusion Criteria:
* Everybody who does not meet listed above requirements
* Past mental, cardiovascular, musculoskeletal and/or neurovestibular disorders or diseases
* Pronounced orthostatic intolerance or vestibular balance disorders (kinetosis)
* Abuses of drugs, medication or alcohol
* Claustrophobia
* Malnutrition up to 6 months before the start of the study
* Intake of anabolic steroids up to 6 months before study initiation
* Metal implants or other osteosynthesis materials
* Bisphosphonate therapy
* Taking medication that could influence the results of the examination.
* Taking hormonal contraceptives in the last 6 months before the start of the study
* Menstrual disorders
* Delivery up to 6 months before the start of studies
* clinically manifest abnormalities in the resting ECG that preclude participation in the study
* Hypertension (\> 130/85 mmHg)
* Increased risk of thrombosis
* Increased risk of stroke
* Infection with HIV or HBV
* HIV, hepatitis A, B, or tuberculosis infection
* clinically manifest changes in the differential blood count
* Clinically manifest changes according to the Comprehensive Metabolic Panel (CMP) (blood urea, uric acid, creatinine, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline Phosphatase (ALP), L-Lactate dehydrogenase (LDH), Glutamyltransferase (GGT), sodium, potassium, chloride, phosphorus, calcium, magnesium, CO2, total protein, albumin, globulin, fasting glucose (\< 100mg/dL)
* clinically manifest iron deficiency: \< 10 mg/L or \< 20 mg/L for women and men respectively
* clinically manifest lipid metabolism disorders
* clinically manifest vitamin D deficiency
* clinical manifest increase of C-reactive protein
* Tuberculosis infection
* Gastroesophageal reflux
* Ulcers
* Kidney disease and/or kidney stones
* Thyroid dysfunction
* Tinnitus
* Sensorineural hearing loss from 30 dB
* Pacemaker or internal defibrillator
* metallic implants (e.g. orthopaedic plates after bone fractures, joint replacement, surgical clips or staples, artificial heart valves, vein filters)
* metallic splinters (e.g. after an accident or because of war injury)
* non-removable braces
* Tattoos with unknown color composition
* Permanent Make-up
* Cochlear implant (implanted hearing aid)
* Medication pump
* Acupuncture needles
* Any other condition which, in the opinion of the investigator, renders the subject unfit for inclusion in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Years
Maximum Age:
55 Years
Study:
NCT04532866
Study Brief:
Protocol Section:
NCT04532866