There are about 1030 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.
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.
Several high-altitude destinations recommend their visitors to avoid caffeine, theoretically due to the associated diuresis which could contribute to acute mountain sickness. There is however no direct evidence for this association. In fact, caffeine ingestion is known to improve exercise performance at sea level, and may therefore help mountaineers during expeditions. Sport science research is largely conducted in male participants, and the findings from these studies are assumed to apply to the female population. Given the known sex differences in body composition, hormones, and other physiological factors, this may not be appropriate. It is therefore important to conduct research in women, to allow for female-specific recommendations.
This study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in adults with diarrhea-predominant Irritable Bowel Syndrome (IBS-D).
The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question[s] it aims to answer are: - Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C/D) - Changes in liver function parameters compared to baseline. - Change in the estimated glomerular filtration rate (eGFR) compared to baseline. - To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage) - Incidence of acute graft rejection during the study - Incidence of BK and cytomegalovirus (CMV) infection during the study - To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D) - To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record. Participants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care
Urinary incontinence is becoming an increasingly common health, social and economic problem. The prevalence of urinary incontinence is estimated at 55% of the entire female population. Urgency urinary incontinence (UUI) is the least common subtype of urinary incontinence but has debilitating symptoms that lead to a decrease in quality of life. Ultimately, the urogynegology field does not have many successful types of treatments for this specific subtype. Extracorporeal magnetic stimulation of the pelvic floor is a type of conservative management that produces a magnetic field, which induces controlled depolarization of the nerves, resulting in pelvic muscle contraction and sacral S2-S4 roots neuromodulation. Therefore, it relieves symptoms of UUI and improves quality of life. There was no randomized, sham-controlled study published that researched the effectiveness of magnetic stimulation in the treatment of UUI that evaluated the success with subjective and objective methods, such as urodynamic studies. The aim of this study was to assess the efficacy of magnetic stimulation in the treatment of urgency urinary incontinence.
This is a multicenter, randomized, placebo-controlled, triple blind, phase II study to determine the efficacy and safety of xevinapant with radiotherapy in older patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of oral cavity, oropharynx, hypopharynx, or larynx. Upon confirmation of eligibility, subjects will be enrolled and randomized in a 1:1 ratio to: - Arm A: 3 cycles of xevinapant (200 mg/day from Day 1 to 14, per cycle) + intensive modulated radiotherapy (IMRT) followed by 3 cycles of xevinapant in monotherapy phase (200 mg/day from Day 1 to 14, per cycle) - Arm B: 3 cycles of placebo (from Day 1 to 14, per cycle) + IMRT followed by 3 cycles of placebo in monotherapy phase (from Day 1 to 14, per cycle). Patients will be stratified by institution, disease location/p16 status (p16 positive oropharyngeal cancer, versus others), G8 score. Three strata for the G8 will be used (>14, versus 11-14 versus <11). Patients will undergo imaging in week 20 and upon clinical suspicion of progression/recurrence. Clinical examination will take place every 12 weeks in the first 3 years.
Concomitant ablation is an effective treatment for patients with various types of atrial fibrillation undergoing heart surgery. However, recurrences of tachycardias after concomitant ablation can happen and seem to be mostly related to reentry mechanism resulting in atrial tachycardias. The aim of the study is to perform invasive re-mapping of ablated regions in the atria to assess durability of ablation lesions and prevalence of conduction gaps that can be targets for additional ablation to lower longterm arrhythmia recurrence.
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 or ORION-13 studies.
This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.
This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity.