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.
Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI in children is limited by single center retrospective data and inconsistent diagnostic and stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a composite of early injury signs and risk of disease, will predict severe subsequent AKI in critically ill children and 2) the incorporation of urinary biomarkers into the renal angina scoring system will improve the prediction of the severe injury. The AWARE study is conducted to describe AKI epidemiology in a heterogeneous multinational cohort of critically ill children, characterize AKI risk factors and associated morbidity, and validate the KDIGO AKI criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national registry will create the largest ever repository of information available on AKI in children.
Transversus abdominis (TrA) and lumbar multifidus (LM) muscle have been proposed to play key role in stability of the lumbosacral spine. The muscles' functional and/or structural deficits have been linked to the low back pain (LBP) syndrome. Evaluation of the transversus abdominis and lumbar multifidus muscles' function in clinical practice is scarce and not well defined due to number of reasons. Surface electromyography of TrA and LM muscles, as a method of examining muscles function, is not involved in clinical routine. Rehabilitative Ultrasound Imaging (RUSI) of the TrA and LM, apart from providing information about their morphology, could be helpful in assessing their function. Since concentric muscle contraction results in the shortening and thickening of the muscle, evaluation of the potential association between muscle's morphometry, assessed by the ultrasound, and electromyography, may be of potential clinical interest. However, this potential relationship is context-dependant. Our aim was to establish the difference in the thickness change of the TrA and LM muscle during activation in subjects with and without low back pain, and to establish the possible correlation between electromyography and the thickness change of these muscles assessed by ultrasound in both groups of subjects.
Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully understood.Increased pain sensitivity in the primary area of pain (local pain) is considered a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is considered to present a more central phenomenon. It is suggested that pat ents with enhanced pain sensitivity report high level of disability. Despite fact that pain and disability are associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability is unknown. It has also been suggested that muscle function changes may be driven by pain. The possible role and contribution of trunk muscles function to pain and disability phenomena remain unknown. This study was aimed to estimate prevalence and possible correlation among pain hypersensitivity and functional and electromyography parameters of trunk muscles in patients reporting early phase of chronic LBP.
The purpose of the study is to test whether the health care provider access and training in CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness), would facilitate timely and error free best-practice delivery and minimize preventable death and costly complications in critically ill patients.
Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. Topical cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after laparoscopic cholecystectomy.
This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic receptor.
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.
Endovascular procedures already brought enormous revolution in the process of treatment of patient with abdominal aortic aneurysm (AAA). It is well defined that early mortality and morbidity is significantly reduced comparing to open repair. The persistent concern is long term durability of devices and their success of aneurysm exclusion in order to prevent rupture. At the moment the best armament to prevent rupture after endovascular exclusion is the watchful waiting and timely reintervention. The main complication that follows this procedure and causing catastrophic long term complications is endoleak. The ideal algorithm to follow up patients after aneurysm exclusion has not been found. In order to reveal endoleak ultrasound is used more than before, however frequent computerized tomography is wasting a lot of costs and exposing patients to irradiation and nephrotoxic contrast. Matrix metalloproteinase activity has been demonstrated in the process of aneurysm development. Imbalance between MMP and its inhibitors TIMP provokes collagenolytic and elastolytic activity that is inducing aneurysmatic degeneration of aortic wall. Due to the previously described connection between aneurysm and MMP activity, it was proved that serum level of MMP-9 is significantly higher in patients with abdominal aortic aneurysm (AAA). Also, higher levels of MMP-9 were discovered in patients with inadequate aneurysm exclusion after endovascular procedure suggesting that degradation of the aortic wall is still ongoing process, not being the case with successfully excluded aneurysm. There might be a potential role of MMP-9 serum level as a biomarker of present endoleak after endovascular aneurysm exclusion. All published trials have shown correlation between MMP 9 activity and presence of endoleak, however, no correlation was made between specific types of endoleak and necessity to reoperation (clinical significance). Additionally there were only four trials presented in the literature investigating low number of patients. Since there is possible value of MMP-9 serum level as biomarker of present endoleak, further studies are necessary. This why we are organizing multicentre trial, that will cover significant number of patients in order to define - Value of MMP-9 as a biomarker of successful initial exclusion - Value of MMP-9 level as predictor of aneurysm shrinkage - Value of MMP-9 level in patients with increased aneurysm diameter and no visible endoleak - Correlation of the MMP -9 serum level with different type of enoleak - Value of MMP-9 as biomarker of successful treatment of endoelak Material and methods Patient with AAA greater then 55 mm in diameter that are candidates for endovascular repair will be selected. Demographic, anatomical and data regarding the procedure will be gathered prospectively. Also serum levels of MMP-9 will be measured before procedure, during the first week before discharge, and after 1,6,12,18,24,36,48 months. On the same day of measuring MMP-9 level control MSCT and ultrasonography exam will be performed in order to collect data regarding the success of exclusion and presence of any endoleak with the accurate measurement of aneurysm diameter changes. Ultrasonography and MSCT exam will be performed by experienced physicians, also preoperative evaluation of anatomical data. In case of reintervention additional questionnaire will be filled regarding anatomical and procedure related data using pre and postoperative ultrasound and MSCT examination, while MMP-9 levels will be measured before procedure and after the procedure using the same protocol as for primary procedure. Statistical analysys Levels of MMP-9 in serum with presence of different types of endoleak will be correlated one week and 1,6,12,18,24,36 48 months after the procedure Anatomical data will be correlated with the decrease in MMP-9 level before and after procedure Levels of MMP-9 in serum after one week and one month will be correlated with further aneurysm shrinkage Level of MMP-9 in serum with type of endoleak will be correlated Level of MMP-9 before and after reoperation will be compared Level of MMp-9 in serum of patients with disappearing endoleaks will be followed Level of MMP-9 in serum of patients with new endoleaks will be followed
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.