Clinical trials

Acute lymphoblastic leukemia is the most common type of cancer in children diagnosed between the ages of two and five. After cancer treatment, children suffer from fatigue and exhaustion, and thus a decrease in daily physical activity. In addition, lack of physical activity and sports causes a decrease in strength and mobility and affects coordination of movements, proprioceptive perception and balance, which can lead to the occurrence of many injuries. In addition, physical inactivity in children who have survived cancer increases the risk of cardiovascular diseases or causes overweight and obesity. In addition, the separation of children with cancer from their peers harms social, emotional, physical and school indicators of quality of life. The aim of the project is to determine the impact of 12 weeks of buddy-movement therapy on the psychomotor and social development of pediatric cancer patients in remission. The investigators expect a significant improvement in the motor skills of pediatric oncology patients in remission, specifically in fine and gross motor skills, in coordination of both hands, in body coordination, in strength and dexterity. The investigators also assume that after the introduction of 12-week buddy-movement therapy, there will be a significant improvement in the quality of life of pediatric oncology patients in remission, specifically in emotional functioning, in social functioning, in physical functioning and in school functioning. Furthermore, it is anticipated that after the introduction of 12-week buddy-movement therapy, the study will notice significant differences in motor skills between the experimental and control groups. It is also assumed that after the introduction of 12-week buddy-movement therapy, significant differences in quality of life between the experimental and control groups will be observed. The research will involve pediatric oncology patients in remission aged 5 to 12 years with acute lymphoblastic leukemia - ALL, who are treated at the Department of Pediatric Hematology and Oncology of the National Institute of Children's Diseases (NÚDCH). The research participants will undergo an entry and exit examination, including body mass index (BMI; kg/m\^2) calculated from weight (kg), height (m), waist circumference (cm), hip circumference (cm), psychomotor examination using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, and quality of life measured by the Pediatric Quality of Life Inventory. They will be divided into a control and experimental group, with the experimental group undergoing a 12-week Buddy-movement therapy focused on the development of psychomotor skills and socialization of participants using Buddy peer support.

Total knee arthroplasty (TKA) often results in significant postoperative pain, which can hinder recovery despite advances in surgical and anesthetic techniques. Traditional pain management methods like femoral nerve blocks may impair motor function, delaying rehabilitation. The iPACK block, targeting the posterior knee without affecting motor control, offers a promising alternative. This study aims to compare the effectiveness of two iPACK block approaches-proximal (at the distal femoral shaft) and distal (between the femoral condyles)-in managing postoperative pain in TKA patients. In a double-blind, randomized controlled trial with 120 participants, pain scores, opioid use, and time to rescue analgesia will be assessed. The hypothesis is that the distal iPACK block provides superior pain relief, potentially improving patient outcomes and recovery.

Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder and has been increasingly recognized as a contributor to cognitive decline and a potential risk factor for neurodegeneration. Previous studies have identified several associated comorbidities, including vascular dysfunction, metabolic alterations, and neuroinflammatory changes. However, the impact and underlying interplay of these pathophysiological mechanisms remain poorly understood due to the lack of integrated, multidimensional assessment. This prospective, observational, longitudinal cohort study aims to investigate cognition and OSA-related physiological and pathophysiological processes in 100 adults newly diagnosed with OSA, who have no history of chronic diseases (except for overweight and obesity) and are not receiving chronic medication. A subgroup of patients with moderate to severe OSA indicated for positive airway pressure (PAP) therapy will be followed to evaluate its long-term effects on cognitive function and related mechanisms. All participants will undergo polysomnography (PSG), comprehensive neuropsychological assessment, brain MRI with volumetric analysis, biomarker profiling from blood and saliva, and evaluation of endothelial function, baroreflex sensitivity, and gut microbiome composition at baseline and after 12 months. PAP adherence will be continuously monitored. The primary objective of this study is to characterize the profile of cognitive impairment associated with OSA. Secondary exploratory analyses will focus on factors contributing to neurocognitive dysfunction in OSA.

This prospective phase II trial aims to evaluate the diagnostic performance of multi-cancer epitope diagnosis in monocyte (EDIM) based blood test PanTum detect test for early detection of individuals with pre-malignant or malignant lesion(s). The intervention in this trial is the PanTum detect test performed in two parallel groups of participants: Group A: Adult persons * with suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s) referred to FDG PET/CT * meeting the inclusion criteria and not-meeting the exclusion criteria * Expected number of participants: 67 Group B: Healthy adult persons * meeting inclusion criteria meeting the inclusion criteria and not-meeting the exclusion criteria * Expected number of participants: 67 Control method: uncontrolled Type of trial: evaluation of diagnostic performance of a diagnostic test with following Primary and Secondary objectives: Primary Objective 1\. To evaluate the sensitivity and specificity of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s) Secondary Objectives 1. To evaluate the positive and negative predictive value of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s) 2. To assess the concordance of result of PanTum Detect test with result of FDG PET/CT for macroscopic solid pre-malignant or malignant lesion(s) 3. To analyse the most frequent causes of false results of PanTum Detect test 4. To analyze the concordance rate of PanTum Detect test No1 and No2 5. To refine the interpretation criteria of PanTum Detect test 6. To analyse the subject´s willingness to participate on the trial 7. To analyse the subject´s experience with participation on the trial

The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC).

The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone.