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.
The goal of the multicentric and interdisciplinary IMAGene project is to pursue early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile. The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients.
The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G). Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores.
The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia.
TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH. The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment.
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.
The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only.
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).
This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.