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, multi-center, double-blind, randomized, controlled clinical trial aims to evaluate the efficacy of Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as treatments of Phantom Limb Pain (PLP). In PME, myoelectric pattern recognition (MPR) is used to predict motor volition and then use the decoded movements to control virtual and augmented reality environments (VR/AR), along with serious gaming (SG). The same device and VR/AR environments are used in PMI with the difference that subjects will imagine rather than execute phantom movements. Electromyography is used to monitor for no muscular activity in PMI.
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.
The primary purpose of this study is to describe the outcome of Immune Tolerance Induction (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with haemophilia A who have failed previous attempts at tolerization.
There are many existing treatments of female stress urinary incontinence such as the use of adult absorbent pads and diapers, behavioral training, including bladder training, pelvic muscle exercises, biofeedback, urethral plugs, intravaginal prosthesis, electrical stimulation, periurethral injections, and reconstructive surgery. However, there is still a lack of effective minimally invasive treatment options that are independent of patient compliance. One emerging approach of minimally invasive SUI therapy is pelvic floor reinforcement using laser therapy. The primary objective of this post-marketing study is to confirm the effectiveness and safety of the FotonaSmooth® device in the treatment of stress urinary incontinence (SUI) in a large number of females using objective and subjective methods. Patients with stress incontinence will be assigned to two groups, an active group, where the Fotona Dynamis Er:YAG Laser System will be used, and a sham group where a very low laser setting will be used, and parameter presentations will be masked. Participants will be adult females, 18 years old and older with clinical and urodynamic diagnosis of Stress Urinary Incontinence,who have had no significant improvement in urinary incontinence from at least one previous conservative treatment, such as behavioral measures, pelvic floor muscle training or the use of absorbent pads
PREPARE is an international, prospective, multi-center, open, randomized, cross-over implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes include, healthcare expenditure, process indicators for implementation and provider adoption of pharmacogenomics.
In our clinical controlled trial, patients with coronary heart disease will be randomly assigned into the exercise intervention (low intensity resistance training with vascular occlusion) or usual physical activity group (control group).
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks. The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. The patients will be enrolled in two different groups according to the protocol of the local anesthetic and saline administration: 1. group: continous infusion of the local anesthetic plus bolus on demand 2. group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.
The most common co-morbidity accompanying Chronic Kidney Disease (CKD) is hypertension, which appears in approximately 80% of all patients with renal dysfunction, whereas its prevalence in general population is remarkably lower appearing in approximately 30% of adults.Defining hypertension in ESRD patients under maintenance dialysis is a challenging procedure. Ambulatory blood pressure monitoring (ABPM) is considered the "gold standard" for the diagnosis of hypertension in hemodialysis patients over the last years. The major pathophysiologic mechanism underlying hypertension development in patients with ESRD under hemodialysis is water and sodium overload. Identifying an accurate and objective method of dry weight evaluation has been a matter of intensive nephrology research for more than two decades. Assessment of the water balance in hemodialysis patients on the basis of common clinical criteria (e.g. leg or face swelling or signs of lung congestion) is a subjective method with limited reliability, despite its widespread use. Recently, a novel technique has been developed to quantify water excess by conducting an ultrasound lung scan. Pilot studies have shown significant changes in lung water in hemodialysis patients according to body weight changes during interdialytic days and dialysis sessions. Moreover, results from previous studies indicate significant benefits from dry weight probing with regards to blood pressure (BP). The clinical application of a lung-ultrasound-based volume control strategy in hemodialysis patients is currently being tested by the randomized study entitled "Lung water by ultrasound guided treatment to prevent death and cardiovascular complications in high risk end stage renal disease patients with cardiomyopathy (The LUST Study)". This clinical trial aims at evaluating whether the use of the number of US-B lines could be used as a biomarker to guide a per-protocol intensification of ultrafiltration (UF) in order to reduce volume overload, improve cardiac function and prolong survival. Cardiovascular disease in patients with CKD is attributed to a spectrum of structural and functional alterations of the large and the small branches of the arterial tree. The most important process in patients with advanced CKD is that of arteriosclerosis, which is developed in parallel to atherosclerosis and is typically associated with impaired cushioning function of the aorta and the large conduit arteries. Accelerated arterial stiffening is involved in the development of isolated systolic hypertension, left ventricular hypertrophy (LVH) and congestive heart failure (CHF), which predispose to arrhythmias and sudden cardiac death. In the context of the phenomenon of "aortic-to-brachial BP amplification", systolic BP (SBP) and pulse pressure (PP) conventionally measured at the level of brachial artery are higher than the relevant pressures in the ascending aorta. Due to extreme elevation of arterial stiffness, BP amplification is disturbed in patients with ESRD. Prospective cohort studies have demonstrated that elevated central PP, wave reflections and arterial stiffness, as well as, reduced PP amplification represent strong and independent predictors of all-cause and cardiovascular mortality in hemodialysis patients. On this basis, estimation of central BP indices appears as an important tool towards optimisation of cardiovascular risk stratification in ESRD as well as in other diseased populations. Until recently, available devices for ABPM evaluated BP levels only at the level of brachial artery. The newly developed Mobil-O-Graph NG (IEM, Stolberg, Germany) provides the ability to monitor central aortic pressure and indices of vascular resistance, such as wave reflections (augmentation index, AIx) and arterial stiffness (pulse wave velocity, PWV).This device has recently been validated in hemodialysis patients and showed comparable performance with the widely used tonometric SphygmoCor device (ArtCor, Sydney, Australia). Accumulated evidence over central BP and PWV in hemodialysis patients derives mostly from studies that included only static pre-dialysis and post-dialysis measurements. However, variations of BP levels during intra- and interdialytic intervals combined with the superiority of aortic BP measurements, as analysed above, indicate that ambulatory monitoring of central BP is the best available method. This study aims for the first time to evaluate the outcome of a treatment strategy for dry weight probing, based on volume overload quantification with lung ultrasound, on 48-hour peripheral systolic BP, aortic BP and arterial stiffness in hemodialysis hypertensive patients. This is a Lust Sub-Study. Additional information can be found at: NCT02310061.
One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. One-leg standing and 10-meter walking tests will also be performed.