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.
The purpose of this study is to examine patient's perspective of symptom control and impact of gastroesophageal reflux disease (GERD) on daily life.
Glycocyamine (guanidinoacetic acid - GAA) is the biochemical precursor of creatine, which is phosphorylated and plays an important role as a high-energy carrier in the muscle. Since GAA can be administered in liquid solutions, such as sports drinks, it could be hypothesised that GAA could easily enhance creatine biosynthesis with clear physiological effects yet to be determined. No single study has examined the influence of GAA on health, human performance or body composition indicators in healthy human subjects. Moreover, the most effective dose of GAA is yet to be find. Finally, the adverse effects of GAA supplementation in humans are not determined. The main aims of the present study will be to identify if the 6-weeks of GAA supplementation improves human performance and body composition, to determine most effective dose regimens of GAA, and to analyze adverse effects of GAA supplementation. Forty eight healthy, trained (> 2 yr training experience) male and female subjects (aged 20 to 25 years) will give their informed consent and volunteer to participate in the study, which will obtain the approval of the University's Ethical Advisory Commission. The subjects will be allocated to four randomly assigned trials: ingesting GAA (1.2, 2.4, 4.8 g of GAA in a single dose) or placebo (PLA) for 6 weeks in a double-blind design. All testing including blood and urine samples, body composition and muscle strength and exercise performance (both aerobic and anaerobic) will be conducted at presupplementation (baseline), at 1 week, at 2 weeks, at 4 weeks, at 6 weeks of supplementation and at 8 and 10 weeks (2 and 4 weeks after the end of supplementation) to analyze wash-out period. According to previous investigations, the investigators expect that ingestion of GAA will significantly increase both serum creatine and total homocystein. The investigators expect that ingestion of GAA will significantly improve muscle strength parameters and exercise performance results as compared to placebo in long term. The investigators also expect to find prevalence of side-effects (i.e. gastrointestinal distress, retention of fluid).
The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.
The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
The development of recombinant DNA technology, culminated in the introduction of the first recombinant human follicle stimulating hormone (r hFSH), Gonal-f, which further developed to become Gonal-f Filled-by-Mass (FbM) pen has been used in the fertility treatment since many years. It has been found that subjects using the pen found it less stressful, easier to use and more convenient than a conventional syringe and would recommend the prefilled pen to another woman considering gonadotropin treatment. However, the use of the Gonal-f (FbM) pen between Serbian subjects is on a very low level though the Gonal f vials with the 75 IU of follitropin alfa have been present in Serbian market since 2003. On the contrary from the clinical practice in European countries, Serbian subjects usually receive daily dose of injectable gonadotropins at the IVF clinics or by partner/family member. This open-label, multicentric, observational non-interventional study is designed with the aim to know the reason of Serbian subjects not injecting themselves with Gonal f and the quality of life (QoL) of Serbian women/couples with the infertility problem.
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period. The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2. Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study
The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.
Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)