There are about 3133 clinical studies being (or have been) conducted in Romania. 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 Phase 2 multicenter, double-blind, placebo-controlled, randomized, parallel-group trial to assess the efficacy and safety of 2 once-daily oral doses of IMU-838 (vidofludimus calcium), a small molecule inhibitor of dihydroorotate dehydrogenase (DHODH), 30 mg/day and 45 mg/day in the main study, cohort 1 (and 10 mg/day for the patients in the cohort 2 substudy), in patients with RRMS and evidence of active disease. The trial consists of a screening period, a blinded 24-week main treatment period, and an optional initially blinded, then open-label extended treatment period of up to 9.5 years. About 40 centers are planned to participate in Romania, Bulgaria, Ukraine, and Poland; potential additional centers in Hungary and Croatia were not used. The study started with 195 patients in the main group (cohort 1) planned to be randomized 1:1:1 to treatment with 30 mg/day or 45 mg/day IMU-838, or placebo (65 patients each) in the main treatment period. During the extended treatment period, patients were initially re-randomized so that patients previously on placebo were re-randomized 1:1 to treatment with 30 g/day or 45 mg/day IMU-838, all other patients were re-randomized to the same treatment they previously received. With approval of Protocol Version 3.0, a sub-study patient group (cohort 2) has been added with up to 60 patients, randomized to placebo or 10 mg IMU-838 for 24 weeks after which the option is available to continue into the extended treatment period and the recommended dose of 30 mg/day. However, based on discussion between investigator and patient 45 mg/day IMU-838/day may also be used.
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).
This study is being conducted in order to assess the need for dose adjustment for elafibranor in participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR<15mL/mn/1.73m^2) versus healthy participants after a single oral administration of elafibranor 120 mg
The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol
This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.
The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
VIABILITY study aims to investigate the link between systemic inflammation, pancoronary plaque vulnerability (referring to the plaque vulnerability within the entire coronary tree), myocardial viability and ventricular remodeling in patients who had suffered a recent ST-segment elevation acute myocardial infarction (STEMI). The level of systemic inflammation in the acute phase of the myocardial infarction and at 1 month will be assessed on the basis of serum levels of inflammatory biomarkers (hsCRP, matrix metalloproteinases, interleukin-6). Pancoronary plaque vulnerability will be assessed: (1) in the acute phase of the infarction, based on serum biomarkers known to be associated with increased plaque vulnerability, such as adhesion molecules (V-CAM or I-CAM) determined from the blood samples collected in the first day after STEMI; (2) at 1 month after infarction, based on computed tomographic angiography analysis of vulnerability features present in all coronary plaques. Myocardial viability and remodeling will be assessed based on: (1) 3D speckle tracking echocardiography associated with dobutamine infusion; (2) MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis and scar at the level of left atrium and left ventricle. At the same time, CT imaging features associated with systemic and local inflammation, such as global epicardial fat or local pericoronary epicardial fat will be quantified in order to investigate the impact of inflammatory-mediated plaque vulnerability on the extent of myocardial damage in acute myocardial infarction. All these parameters will be investigated in patients with successful primary revascularization performed in a timely manner for ST-segment elevation acute myocardial infarction, who will be divided into 2 groups: group 1 - patients who present persistence of an augmented inflammatory status defined as serum levels of hsCRP>3.0 mg/dl at discharge from the hospital or at 7 days postinfarction (whichever comes first), and group 2 - patients with no persistence of augmented inflammatory status (hsCRP<3.0 mg/dl). The primary endpoint of the study will be represented by the rate of post-infarction heart failure development, defined as the rate of re-admission in the hospital for heart failure or by a significant decrease in the ejection fraction (<45%). The secondary endpoints of the study will be: - rate of re-hospitalization - rate of repeated revascularization - rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)