There are about 1039 clinical studies being (or have been) conducted in Slovenia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The primary objective of the study is to investigate safety and efficacy of transendocardial CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and function, patient exercise capacity and clinical outcome. The safety end-points include serious adverse events (SAEs), defined as any serious event that may result in persistent or significant disability or incapacity and included death, heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation), and heart failure exacerbation requiring hospitalization.
Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide. We investigates short term interventions with low dose liraglutide in combination with metformin and high dose liraglutide alone influence on significant weight reduction in obese women with PCOS.
The purpose of this study is to determine whether there is potential benefits of prophylactic antibiotic treatment in comatose survivors of out-of-hospital cardiac arrest (OHCA) treated in intensive care unit with therapeutic hypothermia.
Prospective data will be collected in approximately 250 patients sustaining BCFx with or without any additional fracture(s) of the symphysis. Patients will be followed according to the standard (routine) at approximately 6 weeks and 3 months after the treatment. Data collection will include fracture details (i.e. classification, mechanism of injury), treatment details, functional and patient-reported outcomes, and anticipated or procedure-related adverse events (i.e. complications).
This is an open-label randomized phase II multicenter trial. An estimated 350 patients deemed to be in complete remission at month 3 after curative treatment are considered for this trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on dietary intervention in addition to standard recommendations and a control arm (arm B) including only standard recommendations. The intervention strategy is based on the AICR/WCRF recommendations for cancer and recurrences prevention and it is focused on decreasing inflammation, glycaemia and insulinaemia while promoting nutrient-rich diet. The reduction in the incidence of tumor recurrence will be analyzed comparing EFS curves between the two arms with the non-parametric Kaplan-Meier method. Secondary analyses will describe the time trend in the prevalence of side effects and quality of life, as assessed by the EORTC QLQ-H&N35 questionnaire. Translational analysis (cytokine, salivary and plasmatic miRNA) will be performed. The trial is coordinated by Istituto Nazionale Tumori, Milan and conducted in 6 European countries.
Given the data on the active ingredients of Totum-63, this research aims to evaluate the effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially on fasting plasma glucose in volunteers with abdominal obesity associated with impaired glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several glucose and lipid homeostasis related parameters since these data are still unknown for this specific dietary supplement formula. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.
The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic therapy on development of gut microbiota, functional gastrointestinal disorders of infancy, weight gain and body composition.
Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7 integrin which modulates lymphocyte trafficking in the gut. Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease (CD), respectively. Recent real life cohorts in adults support the effectiveness of VDZ in inducing and maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the use of VDZ besides two retrospective case series. Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults and practically non-existent in children. The investigators aim to prospectively explore the real life short and longer term outcomes of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment success based on VDZ trough levels and other clinical and laboratory variables.
The aim of the study is to compare the effect of water-based and land-based exercise training, and usual care (no exercise training) in patient with coronary artery disease, on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.
The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.