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NCT ID: NCT03943550 Recruiting - Ulcerative Colitis Clinical Trials

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)

Start date: May 8, 2019
Phase: Phase 1
Study type: Interventional

The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in participants with active ulcerative colitis.

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: NCT03849599 Completed - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis

PULSE
Start date: February 21, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis. Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.

NCT ID: NCT03848234 Completed - Schizophrenia Clinical Trials

Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder

Start date: December 4, 2015
Phase: Phase 3
Study type: Interventional

To evaluate the effects of Estradiol patches vs placebo patches as add-on to antipsychotics on psychometric performance in patients with schizophrenia, schizoaffective or schizophreniform disorder

NCT ID: NCT03771170 Recruiting - Peritonitis Clinical Trials

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Peritonitis

Start date: January 10, 2018
Phase: Phase 4
Study type: Interventional

This study evaluates the efficacy and safety of Rheosorbilact®, solution for infusion ("Yuria-Pharm" LLC), in comparison with Ringer's Lactate, solution for infusion, in a complex therapy of peritonitis. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.

NCT ID: NCT03764085 Recruiting - Sepsis Clinical Trials

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Sepsis.

Start date: December 6, 2016
Phase: Phase 4
Study type: Interventional

This study evaluates the efficacy and safety of Rheosorbilact®, solution for infusion ("Yuria-Pharm" LLC), in comparison with Ringer's Lactate, solution for infusion, in a complex therapy of sepsis. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.

NCT ID: NCT03744637 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of Single Doses of MK -5475 on Pulmonary Vascular Resistance (MK-5475-002)

Start date: January 18, 2019
Phase: Phase 1
Study type: Interventional

This is a 2-part, 2-panel study of MK-5475 in participants with Group 1 pulmonary arterial hypertension (PAH). Part 1 is a double-blind, randomized, single-ascending dose assessment of the safety, tolerability and pharmacokinetics (PK) of inhaled MK-5475. Part 2 of this study is an open-label study and will assess the safety, tolerability, PK and pharmacodynamics of inhaled MK-5475 at dose determined by results of Part 1 of the study. There is no formal hypothesis to be tested.

NCT ID: NCT03719313 Recruiting - Clinical trials for Hepatitis Delta Virus

Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

D-LIVR
Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.

NCT ID: NCT03657784 Active, not recruiting - Healthy Volunteers Clinical Trials

Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function

Start date: October 13, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized, successive cohorts design, multicenter, single dose phase I study. The primary objectives are: - to evaluate the pharmacokinetics (plasma and urine) profile of P03277 following single intravenous injection (0.1 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference. - to assess dialysability of P03277 following a single intravenous injection (0.1 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.

NCT ID: NCT03559192 Recruiting - Clinical trials for Depressive Disorder, Major

A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression

Start date: July 16, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo when administered as adjunctive treatment in participants with Major Depressive Disorder (MDD) partially responsive to selective serotonin reuptake inhibitor/ serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.