There are about 1029 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.
Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.
Periodontal disease is an oral disease characterized by microbially associated, host-mediated inflammation of the periodontium. In the treatment of periodontal disease, conventional periodontal therapy includes both surgical and non-surgical approaches. Non-surgical therapy (i.e. scaling and root planing - SRP) remains an essential part of periodontal therapy. Here, diseased root surface debridement utilizing different hand and ultrasonic instrumentation is performed to facilitate periodontal re-attachment and to reduce the bacterial mass in the periodontal pocket. In the last decade, the use of lasers (light amplification by stimulated emission of radiation) has occupied part of the dialogue within periodontology due to several proposed advantages. In the arena of periodontology, laser use, as an adjunct to non-surgical therapy, was demonstrated to enhance periodontal healing; however, it is still the matter of debate. Among laser applications, low-level laser therapy is recommended for its pain-reducing, woundhealing and anti-inflammatory effects. Hyaluronic acid is a non-sulfated glycosaminoglycan and a major component of the extracellular matrix. It is found in various body fluids, such as gingival crevicular fluid, saliva, serum and synovial fluid. Anti-inflammatory, anti-edematous and anti-bacterial activities of hyaluronic acid have been investigated in dentistry, specially in periodontology.
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.
Background: Immunotherapy has been successful in treating advanced melanoma, but a large proportion of patients do not respond to the treatment with immune checkpoint inhibitors (ICIs). Preclinical and small cohort studies suggest biomarkers from the primary tumor, stool and body fluids as markers of response. This prospective study will evaluate gastrointestinal microbiome (bacterial spices and virome) composition and exosomal mRNA expression of PD-L1 and IFNγ correlation with radiological response rates to ICIs treatment of advanced melanoma patients. Methods: Patients treated with immune checkpoint inhibitors as a first line treatment for metastatic melanoma are recruted to the study. Stool samples are submitted before the start of treatment, at the 12 (+/-2) week and 28 (+/-4) week, and at the event ( such as, suspected disease progression/hyperprogressio, immune related adverse event (irAE), etc). Peripheral venous blood samples are taken additionaly at the same time points for cytologic and molecular tests. Histological material from the tumor tissue is obtained before the start of immunotherapy treatment. Primary objectives are to determine whether human gastrointestinal microbiome (bacterial and viral) and exosomal mRNA expression of PD-L1 and IFNγ predict response to treatment with PD-1 and CTLA-4 inhibitors and are associated with occurrence of irAE in patients with metastatic melanoma at different time points. Response is evaluated radiologically with imaging methods in accordance with the irRECIST criteria. Conclussion: Despite the great success of the treatment of metastatic melanoma with immunotherapy, there remains a significant proportion of patients who do not respond to treatment or who develop severe adverse events during treatment. Identification of novel predictive and prognostic biomarkers for immunotherapy treatment response is therefore necessary. This study is the first to combine and investigate multiple potential predictive and prognostic biomarkers and its dynamics. The results could serve for a better and multi-level understanding of the various factors influencing immunotherapy treatment.
The goal of this study is to learn about the effectiveness of TAP block for pain relief after vascular surgery on the abdominal aorta. The main question the investigators are looking to answer is whether the TAP block lowers the dose of opioid required after abdominal aortic surgery.
The epidemiology of H. pylori infection among children in Slovenia has not been investigated. Therefore, we are conducting a study to examine the epidemiology of H. pylori and associated risk factors among children in Slovenia.
FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis. After a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 IU/kg once-weekly for 24 months (additional preventive dose not permitted). An activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study. The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24. Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.
This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.
The aim of the study is to investigate whether a serious smartphone game (called MOBI-CPR game) used in the home environment has an impact on the retention of adult basic life support knowledge and skills.
In the proposed study, three objectives will be pursued: 1. To develop a method to identify more effectively the acute and long-term risk of adolescents with the most threatening self-harm behaviours. 2. To identify the factors that influence the risk of self-harm behaviours and the success of treatment/treatment of these behaviours in the most at-risk adolescents (changes in these factors). 3. Develop guidelines for more effective treatment of the most at-risk adolescents. For this purpose, a sample of approximately 200 young people who will be hospitalised for suicide risk (the most at risk in Slovenia) and an approximately equal number of healthy adolescents will be included. At inclusion, the presence of several factors will be assessed by reviewing demographic data, clinical diagnosis, self-assessment questionnaires and clinical psychological tests (CSSRS, B-NSSI-AT, ISAS, LPFS-BF2.0, BPFSC-11, TSCC, PAI, ECR-RS, DASA-YV, ASHRS), social assessment, and blood sampling for genetic analyses (DNA isolation, sequencing, nucleotide sequence recognition, quantification and evaluation of short tandem repeats, identification of methylation sites). Longitudinal tracking of autoaggressive events and heteroaggressive events during hospitalisation will be performed and recorded on an ongoing basis. The risk and protective factors of the adolescents most at risk will be compared with a control group of adolescents. The same factors will be reassessed in the most at-risk adolescents after 6 and 18 months of treatment as usual. The data will be collected in a data entry and storage system that will ensure the privacy of the data entered in accordance with the GDPR. This will allow the investigators to identify young people at particular risk of severe self-harm behaviour more reliably, to target them for more intensive and effective treatment, and thus to improve their safety, quality of life and prognosis in the short and long term.