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.
This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's disease.
The primary aim of this research proposal is to examine whether this novel training program approach is capable to tackle excessive loss in muscle mass, function and contractile capacity with aging. Previous investigations have universally shown a dramatic loss in type II muscle fibers, while certain countermeasures in their follow-up studies were generally ineffective and limited to attenuate this phenomenon. Probably, they failed to meet recruitment threshold of larger motor units and subsequently innervate type II muscle fibers. Furthermore, previous investigations also failed to provide any data on specific blood markers that may provide additional insight into muscle fiber loss with aging. Muscle fibers type II play a crucial role in the human ability to produce as much as force as possible over a limited time-frame (e.g. 100-200 ms) to counteract unexpected perturbations during stair climbing for example and thus avoiding falls. Therefore, this data collection would be noteworthy in particular, especially for this population due to health-related outcomes and healthy aging process. Since age-related decline is accelerated already after short bouts of physical inactivity, with small recovery potential, any attempt to counteract age-related and disuse-related decline have high clinical significance. Based on the findings, data collected may aid in development of safety guidelines and protocols aimed at reducing health risks in this specific population. Importantly, in case the aforementioned hypotheses are confirmed, present findings may offer important information to the healthcare system, especially for reducing economic burden.
Evidence that supports using certain concentration of trisodium citrate as a locking solution for hemodialysis catheters has not yet been established. Higher concentrations of trisodium citrate are more effective in preventing thrombosis, formation of blood clots, preventing infections and biofilm formation, but due to potential side effects, their use is limited. The aim of the study is to compare the impact of two different concentrations of tri-sodium citrate solution (30% and 4%) on the formation of biofilms in hemodialysis single-volume jugular hemodialysis catheters and to determine the effectiveness of prevention of dysfunction of hemodialysis catheters.
The purpose of the study is to investigate utility and appropriateness of treatment interventions taking into account the presumed mechanisms of two main varieties of ulnar neuropathy at the elbow (UNE). The investigators hypothesize that in patients with UNE under the humeroulnar aponeurosis (HUA) surgical HUA release (simple decompression) is superior to conservative treatment. By contrast, in patients with UNE at the retroepicondylar (RTC) groove surgical HUA release (simple decompression) should not be superior to conservative treatment.
Introduction: Diabetes mellitus is characterized by impaired arterial function and high incidence of cardiovascular events. Metformin and most recent antidiabetic groups of drugs, SGLT2 inhibitors, were in previous studies shown to reduce cardiovascular events. Until now, direct effect of empagliflozin on arterial function and its comparison to metformin was not studied yet. Aim: The aim of the present study is to explore and compare potential direct effects of empagliflozin and metformin on arterial functional and structural arterial wall characteristics in patients with type 1 diabetes mellitus. Methods: Patients with type 1 diabetes mellitus are randomized into four groups: 1) empagliflozin (25 mg daily), 2) metformin (2000 mg daily), 3) combination (empagliflozin 25 mg daily and metformin 2000 mg daily) and 4) control (placebo). At inclusion and after 12 weeks treatment, arterial function is assessed: endothelial function (brachial artery flow-mediated dilation (FMD), reactive hyperemia index (RHI)) and arterial stiffness (carotid pulse wave velocity (PWV), carotid-femoral PWV (cfPWV) and common carotid artery stiffness (β-stiffness)).
Systematic reviews evaluating the effectiveness of supervised exercise therapies commonly conclude that, to date, there is no evidence to support the superiority of one form of exercise over another. Randomized controlled trials to date included mostly trunk strengthening exercises (e.g. bird dog, plank) and there is no evidence about supervised, individually graded integral movement therapy program for patients with chronic low back pain (CLBP). The research design is a randomized clinical trial with parallel-group design including two intervention groups: integral movement therapy and conventional local movement therapy. Participants in each group will receive 20 supervised sessions in a 10 week period, two times per week, with approximately 1 hour per session. Outcome assessments will occur at baseline and immediately post-intervention, follow up will take place at 6 months and 12 months after finishing the intervention. Pre specified analyses will evaluate the main effects of the treatment. This trial will use a novel, previously unexplored integral approach to CLBP through exercises. In contrast to commonly used exercise programs, the integral program does not include specific local strength exercises for hip and trunk flexors and extensors. However, learning dynamic trunk muscle control in various body positions with added limb movements could be beneficial because of the parallels to everyday work. The study will contribute to clinical practice by providing evidence to guide professionals when deciding for the proper and efficient treatment of patients with CLBP.
Abnormalities in lipid metabolism are present in 50-80% of patients with a kidney transplant and together with concurrent comorbidities and other associated cardiovascular risk factors put kidney transplant recipients at a high-risk for cardiovascular disease. First line lipid-lowering therapy in this population is pharmacological with 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), however there is a paucity of data on the efficacy of therapeutic lifestyle modification for cardiovascular risk management in kidney transplant recipients. The aim of the present study is to assess efficacy, safety and feasibility of a nutritional intervention for lowering cardiovascular risk factors in kidney transplant recipients. Investigators will conduct a randomized controlled trial on the effects of a low-fat, unrefined, plant-based diet compared to the currently recommended diet according to nutrition guidelines and based on the Mediterranean diet pattern to lower the primary end-point LDL-cholesterol and other secondary end-points validated as risk factors for cardiovascular events. Length of the intervention will be 6 weeks, with a late follow-up after additional 3 months. Stabile kidney transplant recipients with LDL-cholesterol >2.6 mmol/l and/or receiving lipid lowering treatment will be randomized in a 1:1 ratio to either interventional low-fat, unrefined, plant-based diet or to a control diet based on the Mediterranean dietary pattern. Both diets will be prescribed in the form of a weekly menu, both will be allowed to be eaten ad libitum (without prespecified calorie restriction) and in both groups study participants will be supported by tutor classes and counseling to maximise their adherence to prescribed dietary pattern.
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. The study has two parts: Part 1 to define the Recommended Phase 2 Dose, and Part 2 to evaluate safety and tolerability and efficacy of midostaurin. Both parts will consist of 2 induction blocks, 3 consolidation blocks, 12 cycles of post-consolidation consisting of continuous therapy with midostaurin, and a follow-up phase.
The study evaluates the effect of anaesthetic agents to depth of anaesthesia. An improved PK-PD model wil be developed that will provide the basis for understanding the mechanisms, simulating various scenarios and developing algorithms for better and safer administration of anaesthetic agents.