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 purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).
Objectives 1. To test the effectiveness and acceptability of an augmented internet-supported transdiagnostic intervention in Romania. 2. To assess the cost-effectiveness of the Internet version of the transdiagnostic program as compared to a standard treatment/usual care.
This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for the assessment of safety, tolerability and pharmacokinetics of single ascending doses of MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to severe atopic dermatitis.
Primary Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24. Secondary Objectives: Change From Baseline in HbA1c to Week 12 To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on: - Change in Fasting plasma glucose (FPG); - Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile; - Percentage of participants reaching HbA1c targets <7% or ≤6.5%; - Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia - Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia. To assess the safety in each treatment group. To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO). Percentage of participants requiring rescue therapy.
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.
Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: - Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). - To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).
The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation The secondary objective of the trial is to evaluate the adherence to product's administration in the enrolled children.