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NCT ID: NCT03920267 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus

Start date: March 26, 2019
Phase: Phase 2
Study type: Interventional

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE)

NCT ID: NCT03917550 Recruiting - Depression Clinical Trials

RECOVERY: A Transdiagnostic Intervention for Anxiety and Depression

RECOVERY
Start date: March 18, 2019
Phase: N/A
Study type: Interventional

To investigate the efficacy and acceptability of a guided internet delivered transdiagnostic intervention, targeting mild to moderate clinical symptoms of anxiety and depression and emphasizing the changes taking place at the level of the structures of the self.

NCT ID: NCT03915964 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

RA-BRIDGE
Start date: April 22, 2019
Phase: Phase 4
Study type: Interventional

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.

NCT ID: NCT03912753 Recruiting - Clinical trials for Human Immunodeficiency Virus

Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings

Start date: May 2019
Phase: N/A
Study type: Interventional

This project is designed to remedy unaddressed and interlocking HIV-prevention and mental health needs among gay and bisexual men (GBM) in the Central Eastern European country of Romania, and their underpinning stigma-related mechanisms. Rampant stigma contributes to the increasing prevalence of HIV among Romanian GBM (from under 10% in 2009 to close to 20% in 2014, by best available estimates) and keeps GBM out-of-reach of HIV-prevention services. An mHealth pilot intervention (titled "Despre Mine. Despre Noi." [DMDN] translated as "About Me. About Us."), which reduced Romanian GBM's risk for HIV infection while also reducing depression and alcohol abuse in an initial pre-post trial, is now ready for testing in a randomized controlled trial with a large national sample in the current study, entitled Comunică (translation: Communicate). The Comunică intervention entails eight 60-minute live chat sessions delivered by trained counselors on a mobile study platform using motivational interviewing (MI) and cognitive-behavioral skills training (CBST). First, during pre-trial (mos 1-5), in collaboration with a community advisory board consisting of GBM community members, GBM-affirmative physical and mental health providers, and a technical developer, the investigators will fine-tune the Comunică intervention based on the investigators' pilot findings and evaluation interviews, and expand the original DMDN education materials for an education attention condition (EAC) that will serve as control. Second, during the intervention phase (mos 6-45), the investigators will recruit, screen, assess, and randomize GBM at risk for HIV infection and alcohol abuse to either the Comunică intervention (n=163) or EAC (n=163). The conditions are content matched, and both are hosted on the study platform. While Comunică will consist of eight weekly mHealth live chat sessions, EAC will consist of eight self-administered educational modules. Third, during the follow-up phase (mos 8-55), the investigators will assess at 4, 8, and 12 months post-baseline, in a mobile fashion identical to the baseline, the primary outcome of condomless anal sex with male partners and secondary outcomes of alcohol abuse, depression, biologic HIV/STI infection, HIV/STI testing, and psychosocial mechanisms rooted in the Information-Motivation-Behavioral Skills (IMB) model (e.g., HIV/STI knowledge, condom use self-efficacy) and minority stress theory (e.g., identity concealment, internalized homophobia).

NCT ID: NCT03902886 Completed - Cerebral Palsy Clinical Trials

Independent Walking Onset of Children With Cerebral Palsy

BB-AQM
Start date: September 5, 2018
Phase:
Study type: Observational

This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.

NCT ID: NCT03884933 Enrolling by invitation - Clinical trials for Mental Disorders, Severe

Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe

RECOVER-E
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

RECOVER-E's main purpose is to ensure well-functioning community mental health teams in five countries in Europe; these teams will serve as the central node for the coordination and provision of care for people with severe mental illness (SMI). At present, specialist teams providing comprehensive, evidence-based mental health care are not available or functional in many countries in Eastern Europe, and the care pathways and evidence-based treatment protocols for community-based and recovery-oriented mental healthcare have not been defined or tailored to local situations and therefore, are not being implemented. This project aims to implement and study community-based initiatives to narrow this gap. These efforts will emphasize the development of human resource capacity and care pathways that can be distilled in a comprehensive pathway to scale for regional and national decision-makers for potential project expansion and replication after the project period.

NCT ID: NCT03882970 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

SURPASS-3
Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 59 weeks and may include up to 22 visits.

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 1, 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: NCT03843125 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

SLE-BRAVE-X
Start date: August 30, 2019
Phase: Phase 3
Study type: Interventional

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).