There are about 1447 clinical studies being (or have been) conducted in Croatia. 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 is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.
The GLOBAL study is an international multi-center, prospective study designed to enroll up to 10,000 consecutive eligible subjects who are clinically referred for coronary CT angiography for assessment of suspected coronary artery disease (CAD). The purpose of the study is to perform extensive biomarker analysis of atherosclerosis in patients phenotyped using advanced imaging modalities of atherosclerosis.
An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives are to perform an external prospective validation of this scoring system, to evaluate its potential impact on therapeutic strategy and to test its reproducibility. This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard. Reference standard: Reference standard will be surgical procedure with histology or standard clinical follow-up depending on most appropriate routine practice. Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a different PPV. It would thus be necessary to have at least 569 patients classified as SCORE 2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming 6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340 patients will be included in this study to insure a probability of at least 95% to obtain the aforementioned number of patients in each score category. The inclusion period will last 18 months (extension for a period of 12 months) and monitoring will continue for 2 years. Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system for Adnexal Masses. Radiology 2013, May;267(2):432-43.
This will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis. Patients who complete study SPM-005 will be enrolled in this study at the time of the last visit of the preceding study.
Bispectral Index Monitoring (BIS) has been proven to be effective in preventing awareness. Optimizing anesthesia level using BIS monitoring, neither to light nor to deep will probably help to shorten recovery time and reduce drug consumption. The aim of the study was to investigate the effect of BIS monitoring on extubation and recovery time, and intraoperative anesthesia consumption.
The purpose of this study is to evaluate the safety and efficacy of NU100 in patients with relapsing remitting multiple sclerosis (RRMS) as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions (CALs; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU100 to placebo and the non-inferiority of NU100 to Betaferon®, respectively.
The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.