Clinical trials

The primary aim of the study is to identify clinical, laboratory, imaging, and pathohistological risk factors for the development of pancreatogenic diabetes after partial resection of the pancreas (PRP) and, based on these, to build a predictive model that would enable reliable and accurate identification of patients who will develop pancreatogenic diabetes. A review of the literature shows that there is currently no validated tool available in clinical practice for identifying patients at risk of this type of diabetes after PRP. Etiological differences between type 2 diabetes and pancreatogenic diabetes often lead to late diagnosis, limiting opportunities for timely intervention. The development of a comprehensive predictive model would contribute to a better understanding of the pathophysiology of pancreatogenic diabetes, enable the identification of patients at risk, facilitate tailored clinical monitoring, and allow the implementation of targeted preventive or therapeutic measures in the perioperative period. Based on a review of the literature and clinical observations, the investigators formulated the following hypotheses: H1: Clinical, laboratory, imaging, and pathohistological variables are independently associated with the development of pancreatogenic diabetes after partial pancreatic resection. H2: A predictive model that allows reliable and accurate identification of patients who will develop pancreatogenic diabetes can be build based on the identified variables (H1). H3: A comprehensive predictive model in the perioperative period allows more precise identification of patients who will develop pancreatogenic diabetes, and thus more effective risk stratification compared to the use of individual risk factors (variables). Based on the reviewed literature and our own clinical observations, this constitutes an original contribution to science. The investigators expect that the research will identify key clinical, laboratory, imaging, and pathohistological factors associated with the development of pancreatogenic diabetes after partial pancreatic resection. The development of a clinically useful predictive model that will allow individual risk assessment for the development of pancreatogenic diabetes in patients after partial pancreatic resection is anticipated. A similar comprehensive model has not yet been described in the accessible literature. The research will contribute to a better understanding of metabolic changes and will enable the identification of patients who will develop pancreatogenic diabetes after partial pancreatic resection. The results of the study could provide a basis for improved perioperative monitoring of these patients in the field of pancreatogenic diabetes.

This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins. Lowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins. Inclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels. In this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments. The main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.

This randomized crossover clinical trial will compare regional citrate anticoagulation (RCA) and standard heparin anticoagulation (HA) during postdilution hemodiafiltration (HDF) in chronic dialysis patients with end-stage kidney disease. The primary aim of the study is to evaluate biocompatibility during HDF by measuring markers of complement activation (C3a), platelet activation (PF4), and coagulation activation (thrombin-antithrombin complex, TAT). Secondary aims include comparison of solute removal efficiency, including beta-2 microglobulin, phosphate, and urea removal, as well as assessment of citrate, calcium, and magnesium kinetics during citrate anticoagulation. Twenty adult chronic dialysis patients will undergo two study HDF procedures in randomized order: one procedure using heparin anticoagulation and one procedure using regional citrate anticoagulation with a one-week interval between procedures. The study aims to improve understanding of the effects of anticoagulation methods on hemodiafiltration biocompatibility and dialysis efficiency and may contribute to optimization of citrate anticoagulation protocols in chronic hemodiafiltration patients.

The underlying mechanisms of microvascular dysfunction in Takotsubo cardiomyopathy remain incompletely understood. As CD34+ cells are essential to coronary microvascular homeostasis we will investigate the potential association between CD34+ cell count and changes in left ventricular function in patients with Takotsubo cardiomyopathy at baseline and 6-month follow-up.

The purpose of this study is to investigate the efficacy of dexamethasone in patients with tick-borne encephalitis.

The goal of this clinical trial is to learn if early combination with two antidiabetic drugs further improves blood glucose control compared to a single drug regimen in adults with short duration of type 2 diabetes. It will also learn about the effect of the combination treatment on body weight, body composition, blood lipids, oxidative stress, inflammation, metabolic control, insulin resistance and insulin secretion from pancreas, together with its safety profile. The main questions it aims to answer are: * Does early combination with two antidiabetic drugs improve blood glucose levels, determined by continuous glucose monitoring system? * Is early combination treatment as safe as treatment with a single antidiabetic drug? * Does early combination treatment reduces the need for rescue therapy? * Does early combination treatment reduces body weight and improves body composition? * Does early combination treatment improves blood lipid parameters, oxidative stress and inflammation? * Does early combination treatment improves metabolic parameters? * Does early combination treatment improves insulin resistance and insulin secretion? Researchers will compare early combination treatment with metformin and either peroral semaglutide or empagliflozin to a single drug regimen with only metformin to see if the combination treatment works to treat type 2 diabetes. Participants will: * Take the combination of two antidiabetic drugs or only metformin for every day for 26 weeks. * Visit the clinic four times during the study duration for checkups and tests. * Carry a continuous glucose monitoring sensor for 14 days prior to study visits.

This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are: * What is the management of complicated sinonasal infections in Ljubljana, Slovenia, * What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia, * What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia, * What is the management of complicated laryngeal infections in Ljubljana, Slovenia Participants will receive standard treatment according to the established evidence-based clinical practice.

This observational prospective clinical study aims to describe the epidemiology, management and outcome of patients with sinonasal and skull-base pathology (tumours and diseases with malignant clinical characteristics) in a tertiary otorhinolaryngology referral centre. The main questions it aims to answer are: * what is the caseload of patients with the included pathology in our centre * what are the results of management of these cases * what are the epidemiological characteristics of included patients * what is the quality of life of included patients.

The investigators will focus on pretreatment expectations of patients with early Lyme disease manifested as erythema migrans with the aim of assessing the association between pretreatment expectations quantified with a questionnaire and treatment outcome quantified with the presence of post-Lyme symptoms. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.

The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.

At birth, both the newborn and the mother experience adaptive stress, which can be measured using objective physiological methods. One of the possible methods is monitoring heart rate variability, which is an indirect indicator of the balance between the sympathetic and parasympathetic branches of the autonomic nervous system. The proposed study will monitor the effect of early skin-to-skin contact on heart rate variability in newborns delivered by cesarean section and their mothers. The researchers hypothesize that newborns and mothers who are provided with immediate direct skin-to-skin contact, compared to the control group receiving standard care, will exhibit higher heart beat-to-beat interval variability in the first hours after birth. This is expected to result from reduced stress and activation of the parasympathetic nervous system. The study will include 80 newborn-mother pairs with a gestational age of 39 weeks or more, delivered via planned cesarean section. Participants will be randomly assigned to a study group (skin-to-skin contact lasting at least 15 minutes after cesarean birth) and a control group (standard care), with 40 newborns in each group. Maternal and neonatal ECG will be monitored for 15 minutes following cesarean birth in both groups. In addition, neonatal ECG will be monitored at 6, 12 and 24 hours postpartum. Time-domain analyses of hearth rate variability will be performed.

The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.

The goal of this observational study is to determine how often orthostatic hypotension and postprandial hypotension occur in adults aged 65 years and older who are hospitalized in internal medicine departments. Orthostatic hypotension is defined as an excessive drop in blood pressure after standing up from a lying or sitting position. Postprandial hypotension is an excessive drop in blood pressure that occurs after eating a meal. These conditions can increase the risk of falls, fainting, loss of independence, and other health problems in older adults. The main questions this study aims to answer are: * How common orthostatic hypotension and postprandial hypotension are in hospitalized adults aged 65 years and older. * Whether these conditions are associated with medication use, chronic diseases, and geriatric syndromes (such as frailty, cognitive impairment, and functional decline). Participants will: * have blood pressure measured while lying down and standing * have blood pressure measured after a meal * undergo a comprehensive geriatric assessment, including evaluation of functional status, cognitive function, frailty, mobility, and nutritional status * provide information about medications and medical history * be followed for up to 12 months to record outcomes such as falls, syncope, hospitalization, and death

The goal of this observational study is to assess arterial stiffness and autonomic regulation of blood pressure and heart rate in healthy adults and people with arterial hypertension during orthostatic stress and graded physical exercise. The main objective is to analyze cardiovascular responses to exercise on a cycle ergometer in different subgroups of participants with hypertension. The study includes healthy young adults and older adults with hypertension. Participants undergo standardized assessments including orthostatic testing, graded exercise testing on a cycle ergometer, electrocardiography, and measurement of arterial stiffness parameters such as pulse wave velocity, as well as other vascular and hemodynamic parameters. The results of this study are expected to improve understanding of cardiovascular physiology and autonomic regulation in people with hypertension and may contribute to earlier recognition of autonomic dysfunction and improved clinical management.

The insertion of peripherally inserted central catheters (PICCs) represents a minimally invasive and safe method for establishing long-term central venous access in patients requiring prolonged intravenous therapy, including chemotherapy, parenteral nutrition, and long-term antibiotic treatment. Ultrasound-guided cannulation of peripheral arm veins improves procedural success, reduces complications, and increases patient comfort compared with centrally inserted central catheters.Accurate positioning of the catheter tip at the cavo-atrial junction is essential for optimal catheter function and safety. The Sherlock 3CG Tip Confirmation System combines electromagnetic tracking with intracavitary electrocardiography (ECG) to enable real-time catheter tip navigation and positioning.The aim of this prospective clinical study is to evaluate the accuracy and safety of ultrasound-guided PICC insertion using the Sherlock 3CG system, as well as to assess the impact of PICC placement on venous wall integrity. Ultrasound examination of the target vein will be performed before catheter insertion and after catheter removal to evaluate potential vascular wall changes associated with catheter use. A chest X-ray examination will be performed after each catheter insertion to confirm final catheter tip position and to assess the accuracy of the navigation system.Fluoroscopic guidance will be used only in selected cases, such as patients with anatomical anomalies, previously known difficult vascular access, or unsuccessful standard catheter advancement.A total of 80 adult patients with a clinical indication for PICC placement will be enrolled over a three-year study period.

The goal of this clinical trial is to investigate how vericiguat benefits adults with stable heart failure with reduced ejection fraction (HFrEF) who are already receiving guideline-directed medical therapy. The main questions are: * Does vericiguat improve right ventricular systolic function, measured by tricuspid annular plane systolic excursion (TAPSE)? * Does vericiguat favourably influence myocardial remodeling, fibrosis, angiogenesis, inflammation, metabolism, renal function, and hematologic balance? * Do genetic and oxidative stress profiles modify treatment response? Researchers will compare a group receiving vericiguat plus usual care with a group receiving usual care alone to assess structural, functional, and biomarker changes over 12 months. Participants will: * Have blood drawn at baseline and follow-up visits for biomarker, metabolomic, genetic, transcriptomic, and hematologic analyses, including platelet function testing * Perform oral glucose tolerance tests (OGTT) to assess insulin resistance * Undergo echocardiography, cardiac magnetic resonance imaging, and cardiac scintigraphy to evaluate heart structure, function, and perfusion * Attend follow-up visits at 1, 3, 6, and 12 months Open-label extension: After the 12-month randomized phase, participants originally assigned to usual care will be offered open-label vericiguat and followed for an additional 12 months. This exploratory extension will reassess study outcomes to evaluate the consistency and magnitude of response to vericiguat in the prior control cohort.

The goal of this study is to identify the molecular or genetic mechanisms that may predispose patients with bowel endometriosis to an increased risk of colorectal carcinoma. The study will include patients for whom surgical treatment of bowel endometriosis is clinically indicated. This research would represent a significant advancement in evaluating the necessity of surgical intervention in asymptomatic patients or those with mild symptoms. Furthermore, it would provide a broader insight into the systemic impact of endometriosis on other organ systems, ultimately improving risk assessment and preventive measures.

This study is evaluating whether a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, tirzepatide, can affect the function, structure and metabolism of skeletal muscles in adults with obesity. Participants, premenopausal females with obesity, will receive either tirzepatide or placebo over 24 weeks. Researchers will assess body weight, body composition, muscle strength and functional performance, neuromuscular function and will perform muscle biopsies before and after treatment to study molecular and histological changes following treatment. The goal of this study is to investigate the effects of tirzepatide on skeletal muscle function, quantity, quality and metabolism in adults with obesity as well as clarify the molecular and structural adaptations in skeletal muscle during tirzepatide-induced weight loss, addressing an important gap in understanding the impact of incretin-based therapies on muscle health.

The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.

Several drugs have been shown effective in the treatment of obesity, with concomitant favourable cardiovascular effects. Today, there are no studies on novel anti-obesity drugs in patients with adult congenital heart disease (ACHD). Therefore, the investigators aim to study the effects of the anti-obesity drug tirzepatide (Munjaro) on cardiovascular and metabolic factors in obese patients with ACHD. In a 24-week, randomized, open-label, placebo-controlled clinical trial the investigators will compare the effects of tirzepatide versus placebo in ACHD patients diagnosed with obesity. Patients will be randomized in a 1:1 ratio to either the intervention or placebo group. Participants will have monthly visits to monitor progress. At the beginning and end of the study, a full investigation protocol will be performed.

The goal of this clinical trial is to find out whether partly replacing aerobic interval training (AIT) with resistance training (RT) leads to greater improvements in physical fitness and muscle mass in women with coronary artery disease (CAD) during cardiac rehabilitation. The main questions this study aims to answer are: * Does combining RT (squats and pulling exercises with weights) with a reduced amount of AIT (cycling) improve aerobic fitness in the same way as AIT alone? * Does the combined training lead to greater improvements in muscle mass compared with AIT alone? * Does slow-speed RT (slower lowering phase) result in lower heart rate and blood pressure during exercise compared with normal-speed RT? Researchers will compare three exercise programs: * AIT only (control group), * AIT combined with normal-speed RT (1-second lifting, 2-second lowering), * AIT combined with slow-speed RT (1-second lifting, 5-second lowering). Participants will take part in a 12-week cardiac rehabilitation program and will train three times per week. At the start and end of the program, participants will complete a cycling fitness test, body composition assessment, blood sampling, two strength tests, and quality-of-life questionnaire.

This prospective, randomized study is designed to compare the efficacy and safety of three sedative-analgesic agents-intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine-for procedural sedation in children undergoing suture removal following cleft palate, alveolar ridge, or lip surgery. The study will include 60 children aged 6 months to 3 years, randomly assigned to one of three intervention groups. The primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs. All study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.

The goal of this randomized, double-blind, placebo-controlled clinical trial is to determine whether dapagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, can help prevent anthracycline-induced cardiotoxicity caused by anthracycline chemotherapy in adult women with breast cancer receiving (neo)adjuvant treatment. The main questions the study aims to answer are: i) Does dapagliflozin reduce the decline in left ventricular function (measured by LVEF, GLS, and myocardial work) during and after anthracycline therapy? ii) Does dapagliflozin lessen the deteriorating effect of chemotherapy on endothelial function and arterial stiffness? iii) Does dapagliflozin effect levels of cardiac injury and inflammation biomarkers (e.g., hs-troponin T, NT-proBNP, ST-2, GDF-15, galectin-3, IL-6, MPO)? Researchers will compare dapagliflozin 10 mg daily with placebo to see whether those receiving dapagliflozin experience less heart and vascular impairment during treatment. Participants will: * Take either dapagliflozin or placebo once daily during anthracycline chemotherapy. * Undergo heart and vascular ultrasound, and a 6-minute walk test before chemotherapy and again at 24 and 52 weeks. * Provide blood samples before, during and after chemotherapy to measure cardiac biomarkers. * Complete multiple questionnaires on quality of life.

This randomized controlled trial will evaluate the effectiveness of a structured four-week psychoeducation program for parents of adolescents diagnosed with anorexia nervosa (AN). The program aims to improve parental coping and improve adolescent treatment outcomes. Seventy adolescents with AN (ages 11-19) and their parents will be recruited at the University Medical Centre Ljubljana, Slovenia. Families will be randomly assigned to either an intervention group, receiving immediate psychoeducation, or a waitlist control group, receiving the program after one month. The psychoeducation program consists of four weekly 90-minute sessions covering eating disorder characteristics, maintaining factors, strategies for normal eating, and approaches for supporting change. Primary outcomes include change in adolescent body mass index (BMI) from baseline to post-intervention and three-month follow-up. Secondary outcomes include adolescent symptoms of eating disorders, anxiety, and depression, as well as parental anxiety, depression, stress, social support, and self-efficacy. The study will test whether early, structured parental involvement through psychoeducation improves both adolescent clinical outcomes and parental coping.

The aim of the Dragonfly study is to characterise and monitor the neurodevelopment of children and adults diagnosed with CTNNB1 syndrome through an international collaborative effort. Gaining comprehensive understanding of the mental, physical and social development of people with CTNNB1 neurodevelopmental syndrome and how their symptoms and abilities change over time will help improve and standardize care for these patients, as well as facilitate future research and clinical trials design.