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NCT ID: NCT05636176 Recruiting - Heart Failure Clinical Trials

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

HERMES
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

NCT ID: NCT05633459 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

A Study Evaluating the Safety and Tolerability of QRL-201 in ALS

Start date: December 16, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the safety and tolerability of multiple doses of QRL-201 in people living with ALS

NCT ID: NCT05617677 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

POETYK SLE-1
Start date: January 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

NCT ID: NCT05615272 Recruiting - Pain Clinical Trials

Treatment of Alveolar Osteitis: Traditional or Regenerative?

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Alveolar osteitis, commonly referred to as dry socket, is a common painful postoperative complication following tooth extraction. It is defined as pain in and around an extraction socket which increases at any time between one and three days following extraction, accompanied by partial or total loss of the blood clot from the socket, with or without halitosis (Blum, 2002). The incidence of the complication varies from 1-5% for routine extractions up to approximately 30% for third molar extractions. There are a variety of factors that contribute to the incidence of dry socket including tissue trauma, smoking in the early postoperative period and the oral contraceptive pill. Although it is a self- limiting condition, symptoms can be very debilitating for patients and therefore following diagnosis, immediate treatment should be provided to expedite resolution and to their improve quality of life during the healing period. Treatment options for dry socket vary from rinsing of the socket, regular analgesia and sometimes placement of an obtundent, sedative dressing such as Alveogyl or a zinc oxide eugenol alternative. This study will aim to compare two treatments for patients who present with alveolar osteitis (dry socket) to Dublin Dental University Hospital after tooth extraction. Following randomisation, one of two treatment modalities will be used, either a experimental treatment (Bio-PRF) or a positive control (Alveogyl). The results of this study will enable us to learn more about the efficacy of these treatment options for dry socket and how they affect patients.

NCT ID: NCT05611931 Recruiting - Endometrial Cancer Clinical Trials

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

XPORT-EC-042
Start date: April 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

NCT ID: NCT05608707 Recruiting - Aging Clinical Trials

APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults.

Start date: September 22, 2022
Phase: N/A
Study type: Interventional

The APPETITE Trial aims to investigate the efficacy of innovative plant protein fibre (PPF) products (developed in a previous workpackage) as part of a personalised diet with/out physical activity on appetite and incidence of undernutrition in older persons from three European countries at high risk of undernutrition.

NCT ID: NCT05608291 Recruiting - Melanoma Clinical Trials

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

Start date: January 16, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drugs. - How much study drug is in the blood at different times. - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. - How administering the study drugs might improve quality of life.

NCT ID: NCT05606770 Recruiting - Stroke Clinical Trials

The Adaptive Physical Activity Study for Stroke

TAPAS
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Despite recent advances in acute stroke intervention, secondary prevention strategies are lacking. Physical activity (PA) is the second largest predictor of stroke and the cornerstone of secondary prevention therapies. Adaptive interventions involve sequential treatments responsive to individuals' performance. Despite guidelines to adapt PA to individuals' needs, there is no evidence on the empirical development of adaptive PA interventions post-stroke. The evidence is dominated by standard trial designs, used to evaluate non-adaptive PA interventions. This trial will make original contributions to the literature by designing a first-in-class adaptive PA intervention using an innovative experimental design. This design will permit the delivery of optimal sequences of treatments to increase PA for individuals. Furthermore, by developing a user-informed smartphone application, this feasibility trial will lead to the design and evaluation of a highly-scalable definitive intervention to reduce the risk of recurrent stroke. Aim To use a Sequential Multiple-Assignment Randomised Trial (SMART) design to develop an adaptive, user-informed mobile health (mHealth) intervention to improve PA post-stroke. Subsequently this adaptive intervention will be evaluated against a treatment-as-usual control using a standard trial design in a definitive trial. Methods A co-design process was used to develop the technology platform for intervention delivery. There are two components which target increased PA in the current intervention: Structured Exercise and Lifestyle PA. The SMART will determine what sequence and/or combination of these intervention components produces the greatest increase in physical activity as measured by average daily step count. The primary outcome will be PA (steps/day), with clear feasibility and secondary clinical and cost outcomes. A SMART design will be used to evaluate the optimum adaptive PA intervention among people post-mild-to-moderate stroke.

NCT ID: NCT05598619 Recruiting - Quality of Life Clinical Trials

Effect of Colon Delivered Vitamin C on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Recent studies have shown that many vitamins, if consumed in high daily dosages or delivered to the colon, can modulate the gut microbiota and their metabolites. In parallel, gut microbiota imbalances are linked to diseases, e.g., obesity, type 2 diabetes, cardiovascular disease, autoimmune diseases, and intestinal inflammatory diseases. Therefore, vitamin administration could offer health benefits beyond those traditionally considered for these nutrients. Earlier, our group investigated the effect of colon-delivered vitamins A, B2, C, D, and E on the gut microbiota using a human clinical trial and showed that vitamin C, B2, and D modulates the human gut microbiome in terms of metabolic activity and bacterial composition. The most distinct effect was that of vitamin C, which significantly increased microbial alpha diversity and fecal short-chain fatty acids compared to the placebo. However, the dose-dependent and combined effect of colon-delivered vitamins on the microbial community and its subsequent impact on host health is unknown. This study will investigate the effect of colon-delivered vitamin C (three dosages) on the gut microbiome.

NCT ID: NCT05577065 Recruiting - Clinical trials for Upper Respiratory Tract Infections

A Study to Assess the Effect of a Probiotic on Upper Respiratory Tract Infections in Healthy Children

KLEENEX
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.