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 study is designed as a parallel, randomized, double blind, three-arm single-center study exploring the efficacy and safety of 12-week once daily oral dosing of iron for correction of overall iron status in 150 otherwise healthy iron-deficient adults presenting with or without mild microcytic anemia. Three iron-containing preparations in the form of either Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, or >Your< Iron Forte Liquid will be tested. Potential study participants will be recruited from the general population of 18-50 year old adults. Participant eligibility will be determined by screening for hemoglobin and ferritin (in combination with C-reactive protein) levels in a sample of venous blood. Eligible individuals will be invited to participate in the study. Enrolled participants will be randomized into one of three intervention groups in a 1:1:1 ratio, receiving either Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, or >Your< Iron Forte Liquid. Efficacy and safety of the assigned interventions will be evaluated through analyses of relevant hematological (hemoglobin, red blood cell indices) and biochemical (ferritin, transferrin saturation) iron-related parameters and reported adverse events after the first 4 and after a total of 12 weeks of intervention.
A multicenter, intervention study will be conducted in all psychiatric hospitals in Slovenia. The purpose of the study is to evaluate the effect of verbal and non-verbal de-escalation techniques on the incidence and severity of aggressive behavior and on the incidence and duration of physical restraints. The proposed hypothesis is that de-escalation training and regular use of de-escalation can reduce aggressive incidents and the use of physical restraints in the acute psychiatric ward. In Slovenia, inpatient psychiatric treatment is provided by six psychiatric hospitals. There are two acute psychiatric wards in each hospital, one for male and one for female patients. All hospitals will be invited to participate in the study. The study will be carried out in two phases, a baseline period of five consecutive months and an intervention period of the same five consecutive months in the following year. At the end of the baseline period, hospitals will be randomly assigned to either the experimental or control group. The intervention will include training on verbal and nonverbal de-escalation techniques for staff teams in experimental wards. The first part of the education is based on theoretical backgrounds: aggressive behavior in a psychiatric patient, risk factors, communication, de-escalation. The second part is a practical workshop. The training will be 16-hour duration in total. A short handbook and a list of verbal and non-verbal approaches will be prepared for all staff members involved in the training. For the baseline and intervention phase, data on the number and severity of aggressive incidents, the number and duration of physical restraint episodes, and the number of aggressive or restrained patients will be obtained.
The aim of this study is to investigate the effect of cognitive training combined with physical exercise on cognitive function, physical performance and frailty indicators in the hemodialysis population.
Cerebral palsy (CP) is a permanent disorder of movement or posture due to non-progressive impairments of the developing brain. Current estimates indicate that as many as 30% of CP cases may be genetic in nature. In our study, the investigators will re-examine the data of children with CP, who are registered in the Slovenian National Registry of Cerebral Palsy. All children will be invited to the University Children's Hospital, University Medical Centre Ljubljana, where they will be re-examined by a neurologist. Blood for genetic testing will be taken. In the case of confirmed genetic ethiology of CP, the search for specific therapy will be possible.
A double-blind, randomized, placebo-controlled efficacy study in one period will include 34 participants divided into two groups. One group will receive a test product (n = 22; test group; multicomponent dietary supplement including MSM and several vitamins and minerals); the other group received placebo capsules (n = 12; placebo group; only modified starch). Volunteers will take two capsules / day orally continuously daily for 12 weeks to assess the effect of these substances on nail growth and condition and skin.
A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).
Tissue flossing involves wrapping a thick rubber band around a joint or muscle, which can partially occlude blood flow. In practice, it is often used while concomitantly performing a range of motion exercises (ROM) for 1 to 3 minutes in duration. The mechanisms involved in tissue flossing with a floss band may be similar to those involved in ischemic preconditioning. Previous results would support the use of tissue flossing on ROM, while there are no clear conclusions on post-activation effects on sports-related performance and muscle contractile properties. This may be attributed to the different methodologies used in the studies. Therefore, the time course associated with tissue flossing benefits remains to be investigated.
Electroporation provides non-viral gene delivery method for plasmid DNA. Its clinical application was already proven in preclinical and in clinical trial in treatment of melanoma skin metastases with plasmid coding IL-12, in USA. Intratumoral gene transfer of plasmid coding for IL-12 has proven safe end effective, having good local tumour control and some evidence indicates on abscopal effect. The EU directives recommend the use of plasmids without the gene for antibiotic resistance. For this purpose we constructed plasmid coding for IL-12 in accordance with the EU regulatory requirements. In the proposed study we intend to study the safety and tolerability of the constructed plasmid, phIL12, in treatment of basal cell carcinomas in patients with operable tumors in head and neck region. The study is designed as exploratory, dose escalating with the aim to determine the dose of plasmid that produces IL-12 expression in the tumours with best biological activity, infiltration of the immune cells and no toxicity.
Perioperative stress is associated with various influences before and after surgery. Instead of benzodiazepines, patients can be calmed by non-pharmacological methods. One of these is perioperative medical hypnosis, which has also other beneficial effects such as lower opioid consumption, better wound healing, shorter hospital stays. Acupuncture is used for analgesia. Is is effective for preventing and treating nausea and vomiting. Hypothesis of the study is that perioperative acupuncture reduces the consumption of analgesics and anaesthetics during surgery. The investigators will also study the impact of acupuncture on postoperative nausea and vomiting and analgesic consumption in the postoperative recovery unit and the occurrence of postoperative delirium.
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.