There are about 2295 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 aim of this study is to optimize an adapted version of a parenting program, Parenting for Lifelong Health for Young Children (PLH), to meet the specific needs of families in three low- and middle-income countries in Southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova) using a cluster factorial experimental design to select the most efficacious, cost-effective, and scalable intervention components. This study is the second phase of a three-phase research project (www.rise-plh.eu). The cluster factorial experiment will examine the effectiveness, cost-effectiveness, and implementation of three selected components of the PLH for Children program to inform the selection of the most effective, cost-effective, and implementable components to include in a prevention package prior to testing it in a subsequent RCT. The cluster factorial experiment will be conducted across three Southeastern European country sites. Each site will recruit families with children aged two to nine years who have elevated levels of child behavior problems, including specifically high-risk groups, such as minorities (e.g. Roma families). Program facilitators will be recruited from local agencies and schools. The factorial experimental trial will randomize 16 clusters in each country to one of 8 experimental conditions which consist of any combination of the three components (program length: 5 sessions/10 sessions; engagement booster: high/low; fidelity booster: high supervision/low supervision). The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components. At the end of the cluster factorial experiment, we will develop an optimized version of the program by selecting components or component levels that have the highest level of effectiveness as based on effect size (rather than p-values). We will also take into consideration factors regarding cost-effectiveness and implementation outcomes when designing this optimized intervention package.
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 goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.
Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1ml Project X and Prevantics® Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations, ASTM International, West Conshohocken, PA, 2015,
The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.
The primary aim of the present study is to compare the accuracy of a full digital workflow for dental implants insertion to a partially digital workflow, for a limited edentulous space (1 to 3 dental units), in the maxilla or mandible.
Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children <18 years of age. Primary Objective:28-day maintenance phase (MP) primary objective:To compare the effect of SZC vs placebo on maintaining normokalaemia during the MP. Correction phase (CP) primary objective: To evaluate SZC dose levels on achieving normokalaemia during the CP. Overall design: Approximately 100 subjects will be enrolled at approximately 40 sites in locations including but not limited to Europe and North America for this study. This study will enrol males and females aged birth to <18 years with hyperkalaemia, except neonates with a gestational age less than 30 weeks or a birth weight less than 1500 g. All subjects are eligible for open-label treatment with SZC during the Correction Phase, and subjects aged 2 to <18 years who are eligible to participate in the Maintenance Phase will be randomised in a 1:1 ratio to double-blinded treatment with SZC or matching placebo comparator. Subjects aged <2 years who require continuing treatment will participate in an open-label Maintenance Phase. Only subjects aged 2 to <18 years may continue to the optional open-label Long-Term Maintenance Phase. Treatment will be stratified by the following age cohorts during the study: - 12 to <18 years of age - 6 to <12 years of age - 2 to <6 years of age - 0 to <2 years of age, except neonates with a gestational age less than 30 weeks or a birth weight less than 1500 g. During the dose escalation period in the CP, treatment will first be initiated in the oldest age cohort (12 to <18 years). The age cohort 6 to <12 years will start as soon as study drug is available. Dosing may then be started sequentially in the younger age cohorts, depending on the safety and efficacy data during the CP in the older cohorts. Data Monitoring Committee: An independent Data Monitoring Committee will be utilised for this study to evaluate emerging afety data during the dose escalation part of the study.
The main purpose of this study is to compare contrast-enhanced ultrasound guided liver biopsy (CEUS-LB) with conventional ultrasound guided liver biopsy (US-LB) in the diagnosis of liver tumors developed on a background of advanced chronic liver diseases. All patients referred to our department with a CT/MRI diagnosis of hepatic neoplasia will be randomly assigned to either CEUS-LB or US-LB. All LB will be performed by the same investigator. For the randomisation the flip coin technique will be used. One investigator without access to previous C/MRI/US report will do the randomization
Career decision-making difficulties are frequent problems for adolescents. Regular intervention or prevention programs mainly provide information for the students about themselves, about the world of work, about their interests and preferences etc. Rational emotive behavioral therapy (REBT), a form of Cognitive behavioral therapy (CBT) provides help for adolescents to efficiently cope with emotional problems (e.g., psychological distress) related to the career decision-making process. The present study aims to investigate the efficiency of an REBT career intervention program implemented in a school setting. School settings are appropriate to deliver group intervention for students. Classes from Romanian public high-schools will be randomized in either intervention or treatment as usual groups.
The objectives of this study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).