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NCT ID: NCT03865485 Recruiting - Clinical trials for Child Mental Disorder

Prevention of Child Mental Health Problems in Southeastern Europe (RISE) - A Factorial Study (Phase 2 of MOST)

RISE
Start date: March 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03844555 Recruiting - Pharmacokinetics Clinical Trials

Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

Start date: February 28, 2019
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT03819491 Completed - Clinical trials for Male & Female Healthy Volunteers

Bioavailability Study of COQUN ORAL FORMULATION

Start date: June 22, 2018
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT03817580 Active, not recruiting - Clinical trials for Bacterial Microflora Reduction

Comparative Study of Antimicrobial Effectiveness

Start date: February 18, 2019
Phase: Phase 3
Study type: Interventional

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,

NCT ID: NCT03814785 Completed - Follicular Lymphoma Clinical Trials

GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

ASSIST_FL
Start date: December 1, 2011
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03814655 Not yet recruiting - Clinical trials for Partially Edentulous Mandible

Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software

DIGIMPLGD
Start date: March 15, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03813407 Not yet recruiting - Hyperkalaemia Clinical Trials

A Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Doses of Sodium Zirconium Cyclosilicate (SZC) for Correction of Hyperkalaemia and Effectiveness of Same Dose to Maintain Normokalaemia.

Start date: January 15, 2019
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03811431 Recruiting - Liver Diseases Clinical Trials

Contrast Enhanced Ultrasound Guidance Biopsy for the Diagnosis of Liver Tumors

ConCLUDe
Start date: January 1, 2011
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03807895 Recruiting - Clinical trials for Psychological Distress

REBT Intervention Program for Career Decision-making Difficulties in High School Pupils

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03805100 Not yet recruiting - Clinical trials for Macular Degeneration

Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

XPLORE
Start date: March 2019
Phase: Phase 3
Study type: Interventional

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).