There are about 1560 clinical studies being (or have been) conducted in Serbia. 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 study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes. Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks). Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal. If blood sugar levels are normal after the first 26 weeks, participants will continue in a 5-week follow up period. In the second part of the study (intensification period-26 weeks), participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period. Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh, upper arm or stomach. The study will last for about 13 months. Participants will get a blood glucose meter to check blood sugar levels. In addition, participants will be asked to enter blood sugar levels in the study phone. In addition, Participants will be asked to enter selected few blood sugar values (three times during the study) in a paper diary that will be provided to participants. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
The goals of the study: 1. to investigate the frequency of Traditional, Complementary and Alternative Medicine use (TCAM) and intentional Non-adherence to medical recommendations (iNAR) in the general population in Serbia, as well as their mutual relations. 2. to examine the distribution of irrational beliefs in the general population; 3. to explore the relationships between TCAM and iNAR behaviors on the one hand and variables of personality, thinking styles and cognitive reflection on the other, with a major assumption that these relationships will be mediated by the domain of irrational beliefs and socio-political attitudes. Participants will respond to a battery of instruments assessing TCAM use and iNAR, as well as, sociodemographics and health-related variables (such as health status, chronic diseases, BMI, etc.), distal psychological (i.e. personality, thinking disposition and styles) and proximal psychological, variables, (i.e. the irrational mindset, as well as socio-political beliefs and attitudes). Data will be collected on the probabilistic household sample representative for the general population in Serbia (N=1043).
The goal of this clinical trial is to compare preemptive single-dose selective cyclooxygenase 2 (COX-2) inhibitor - etoricoxib and dexamethasone use in systemically healthy patients during the surgical extraction of impacted mandibular third molars. The main questions it aims to answer/evaluate are: - the level of inflammatory and early wound healing mediators in patients' saliva during early postoperative phase - clinical postoperative parameters such as pain, swelling and trismus - patient satisfaction with the treatment - rescue medication consumed during the postoperative period - incidence of adverse events Participants indicated for mandibular third molar surgery will be asked to: - take premedication (etoricoxib or dexamethasone) before surgical extraction - provide saliva samples before and following the surgery at regular check-ups - note the amount of rescue medication taken and pain intensity in different time points - perform clinical measurements of swelling and trismus at regular check-up visits - answer the questions about satisfaction and potential adverse events, if occur Researchers will compare preemptive single-dose etoricoxib, preemptive single-dose dexamethasone, and no premedication in impacted mandibular third molar surgery, to see if there are differences in inflammatory response and early wound healing, as well as in clinical postoperative parameters, patient satisfaction with the treatment and incidence of potential adverse events.
The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).
This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Procedure specific postoperative pain management (PROSPECT) guidelines for abdominal hysterectomy published in 2006 recommended laparoscopic or vaginal hysterectomy as a preferred surgical technique. Multimodal postoperative pain management plane includes cyclooxygenase-2 (COX-2) selective inhibitors, and/or conventional non-steroidal antiinflammatory drugs (NSAID) in combination with strong opioids for high-intensity pain or with weak opioids for moderate- or low-intensity pain. Paracetamol also was recommended in combination with COX-2 inhibitors or conventional NSAIDs. Epidural analgesia was recommended for high-risk patients. PROSPECT guidelines updated in 2018 discuss only perioperative approach for laparoscopic hysterectomy. However, hysterectomy technique has been switched from total abdominal to laparoscopic approach. In low resources settings, laparoscopic technique is nor well developed neither available to many patients. Furthermore, the majority of patients undergo total abdominal hysterectomy (TAH), that is very painful procedure. Quadratus lumborum block (QLB) is a regional analgesic technique described by Blanco in 2007. Society for Obstetric Anesthesiology and Perinatology (SOAP) and European Society for Regional Anaesthesia and Pain Therapy (ESRA) recommended QLB for post-Cesarean pain management in cases where intrathecal morphine could not be used or for breakthrough pain. Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. The effects of QLB for laparoscopic hysterectomy is controversial. We would like to see if QLB can provide analgesic benefits in multimodal pain management after TAH in our clinical settings.