Clinical trials

An open-label, one-arm, single-center clinical study tested safety and efficacy of one hour daily dosage of H2 gas in a form of inhalation. Dosage is administered during morning hours every working day according to detailed instructions to study participants. Primary objective: To verify the safety of hydrogen gas inhalation on a sample of patients with mild cognitive impairment (according to the objective opinion of the physician) and diagnosed mild to moderate form of dementia, as well as to verify cognitive abilities via tests from prof. MUDr. Aleš Bartoš, Ph.D. - ALBA (Amnesia Light and Brief Assessment) and POBAV (Naming of pictures and their equipment). Secondary objective: To assess the effect on specific health indicators (e.g. inflammation, antioxidant capacity, metabolism) by blood sampling as well as blood pressure/pulse measurement and BMI. Primary endpoint: Inhalation Safety, Questionnaire - Subjective Assessment (ALBA and POBAV). Secondary endpoints: Biochemical indicators (e.g. inflammation, antioxidant status), blood analysis and BP/Pulse + BMI. Study population: 50-80 years old participants with mild cognitive declin in overall good health condition. Inclusion criteria: * patients diagnosed with mild cognitive impairment (MCI) with an overall good health condition * generally good health, with the ability to perform daily * activities independently (modified Rankin score 0-2, Barthel index minimum 70 points) * age between 50 and 80 years, ensuring inclusion of individuals within the typical risk range for cognitive decline * a reliable study partner or caregiver who can provide accurate information about the participant's cognitive and functional abilities throughout the study * stable medical condition, without major fluctuations in health status that could interfere with cognitive assessments * signed informed consent, ensuring that participants understand the study protocol and potential risks Exclusion criteria: * pregnancy or lactation, as the safety of hydrogen inhalation therapy in these populations has not been established * use of medications or investigational treatments that could significantly affect cognitive function or interfere with study outcomes * history of severe psychiatric disorders such as major depression, bipolar disorder, or schizophrenia, which may independently influence cognitive performance * history of cerebrovascular events, including recent stroke or transient ischemic attack, which may confound cognitive outcomes * severe cardiovascular diseases, including uncontrolled hypertension, recent myocardial infarction, or heart failure, that could pose additional risks during the study * chronic kidney disease (stage 3 or higher), as impaired renal function may alter systemic metabolism and affect the study's findings * significant respiratory disorders, such as severe chronic obstructive pulmonary disease (COPD) or restrictive lung diseases, that could impact the safety of hydrogen inhalation * known hypersensitivity or allergic reactions to materials used in the hydrogen delivery system, such as nasal cannulas or facial masks * recent participation in another clinical trial within the past 90 days, to prevent potential interactions and ensure unbiased study results Duration of the study for each participant: 24 weeks (12 weeks of hydrogen inhalation + 12 weeks withou hydrogen inhalation) This pilot study is not designed for formal hypothesis testing; its purpose is to gather descriptive safety data and estimate effect sizes for future research. We will enroll 30 participants to gather enough information on safety, tolerability, and feasibility. The primary analysis will concentrate on the frequency and severity of adverse events (AEs/SAEs) and ALBA + POBAV scores to evaluate cognitive changes. Descriptive statistics will summarize adverse events, vital signs, and lab results. In the secondary analysis, we will assess variations in biochemical markers (inflammation, antioxidant capacity, metabolism) and physiological metrics (blood pressure, pulse, BMI) using paired t-tests or Wilcoxon signed-rank tests, depending on how the data is distributed. Any missing safety data will be conservatively imputed, and multiple imputation techniques will be utilized for efficacy measurements. While there is no formal interim analysis planned, continuous safety monitoring will be carried out. Results will be shared through summary statistics, tables, and appropriate graphical representations, offering preliminary insights into the feasibility and potential advantages of molecular hydrogen inhalation therapy.

Tooth extraction leads to a substantial reduction in alveolar bone volume, with up to 25% loss within the first year and up to 40-60% within three years. This prospective randomized clinical study aims to compare four commonly used methods of alveolar ridge preservation, evaluating their effectiveness in maintaining bone volume for later prosthetic or implant rehabilitation. Alveolar dimensions will be measured using calibrated CBCT imaging pre-extraction and at six months post-extraction.

A carotid web (CaW) is a shelf-like, thin, triangular endoluminal projection typically arising from the posterior wall of the internal carotid artery (ICA) bulb. CaW is considered by many to be an intimal variant of fibromuscular dysplasia and is associated with an increased risk of ischemic stroke in otherwise low-risk, younger patients. The CaWY study is a cross-sectional, multicenter, population-based sonographic survey with blinded central image adjudication, reported in accordance with STROBE guidelines for cross-sectional studies, aimed at estimating the prevalence of CaW detected by duplex sonography in the general population aged 15-25 years.

In an effort to replicate metabolic surgery's durable results in metabolic disease while minimizing its risks, two innovative methods has been created. Two surgical methods to create a bowel-to-bowel anastomosis, similar to the type used in current metabolic surgeries. It be to create a jejuno-ileal, side-to-side anastomosis and jejunocolic side-to-side anastomosis. The side-to-side jejuno-ileal anastomosis and side-to-side jejunocolic anastomosis provides two routes for ingested food. The new, shorter route has a malabsorptive effect similar to that seen in Roux en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) - procedures which leads to weight loss. Additionally, delivery of non-absorbed macronutrients to the distal ileum, or transverse colon can enhance incretin effect and improve Type 2 Diabetes Mellitus parameters. However, the native route is also preserved, which theoretically reduces the risk of malnutrition, diarrhea, and metabolic derangements seen in other metabolic surgeries.The side-to-side jejuno-ileal anastomosis was already tested in the Pilot Study of the GI Windows Self-Forming Magnetic (SFM) Anastomosis Device for Creation of an Incisionless Small Bowel Bypass for Treatment of Obesity and Diabetes in year 2015 (15). The results of this study demonstrated the safety of this approach without serious adverse events. This non-surgical approach resulted in significant weight loss, favorable changes in insulin and incretin responses to a mixed meal and significant improvement in HbA1c in T2DM (16).In summary, metabolic diseases are a growing pandemic with suboptimal clinical solutions. The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represents a new class of therapy that may produce durable clinical results generally associated with surgery while minimizing its attendant risks.

Delirium is a frequent and serious problem in hospitalized patients; it is associated with multiple hospital-acquired complications. There is evidence that the incidence of deliri-um may be minimized by multimodal interventions (pain management, shortening the duration of mechanical ventilation, light sedation, avoiding benzodiazepines, routine delirium monitoring, and early mobilization). Even though a clear association between sleep and delirium has not been established, many studies suggest that sleep disturban-ces may be a key risk factor for the development of delirium. Therefore, sleep promoti-on is becoming an integral part of clinical care. The project support the hypothesis that non-pharmacological preventive interventions promoting sleep (sleep protocol) positive-ly influence the quality of sleep and reduce the incidence of delirium in hospitalized patients. This will be verified by qualitative and quantitative research methods, with the quantitative study being divided into three prospective cross-sectional studies and one interventional study. Data will be obtained from 3240 hospitalized patients by combi-ning subjective methods (questionnaire surveys) and objective measurements (acti-graphy). The project outcomes will allow better understanding of the relationship betwe-en sleep and delirium. A set of non-pharmacological preventive interventions promoting sleep will be developed, with a subsidiary aim to potentially reduce the incidence of delirium in hospitalized patients.