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NCT ID: NCT04911621 Active, not recruiting - High Grade Glioma Clinical Trials

Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma

ADDICT-pedGLIO
Start date: September 10, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Childhood aggressive gliomas are rare brain tumors with very poor prognosis. Due to the tumor's location and infiltrative nature, surgical removal is not always possible, and even when resection is performed and combined with chemo- and/or radiotherapy, tumor cells frequently persist, eventually giving rise to tumor recurrence. A promising strategy to eradicate persisting tumor cells is vaccination with dendritic cells (DC). DC are immune cells that play an important role in organizing the body's defense against cancer. The goal of DC vaccination is to activate these natural anti-tumor defense mechanisms to delay or prevent tumor progression or recurrence. Previous clinical studies have demonstrated that DC vaccination is well-tolerated, safe and capable of eliciting tumorspecific immunity. A clinical study including 10 pediatric patients (aged ≥ 12 months and < 18 years at the time of signing the informed consent) with brain (stem) tumors is initiated at the Antwerp University Hospital to investigate intradermal vaccination with WT1 mRNA-loaded autologous monocyte-derived DCs, either combined with first-line chemoradiation treatment or administered as adjuvant therapy following previous therapies. The general objective of this phase I/II clinical study is (1) to demonstrate that WT1-targeted DC vaccine production and administration in pediatric patients with HGG and DIPG, either combined with first-line chemoradiation treatment or administered as adjuvant therapy following previous therapies, is feasible and safe, (2) to study vaccine-induced immune responses, (3) to document patients' quality of life and clinical outcome for comparison with current patients' outcome allowing indication of the added value.

NCT ID: NCT04908189 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

Start date: July 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

NCT ID: NCT04904692 Active, not recruiting - COVID-19 Clinical Trials

Virological and Immunological Monitoring in Patients (Suspected of/Confirmed With) COVID-19

Co-Vim
Start date: March 23, 2020
Phase:
Study type: Observational

This study is a prospective, observational multicentric study. The study population entails adult patients hospitalized with a high clinical suspicion of COVID-19 and consists of two study arms (SARS-CoV2- vs. SARS-CoV2+).This combined fundamental research project has a dual goal: on the one hand assessing immunological predisposing factors for severe infection and investigating the immunological impact of SARS-CoV2 infection, on the other hand studying viral characteristics. Furthermore, a substudy will examine the pharmacokinetics and pharmacodynamics of hydroxychloroquine in patients receiving this antiviral treatment (REVIVE susbstudy). To answer these research questions, samples will be collected from patients with a high clinical suspicion of COVID-19, hospitalized at UZ Gent and 2 participating hospitals in Ghent (AZ Maria Middelares en AZ Jan Palfijn).

NCT ID: NCT04901195 Active, not recruiting - Clinical trials for Hidradenitis Suppurativa

A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

BE HEARD EXT
Start date: May 27, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

NCT ID: NCT04898153 Active, not recruiting - Clinical trials for End Stage Renal Disease

First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

aXess-FIH
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.

NCT ID: NCT04896008 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

ZENITH
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.

NCT ID: NCT04893317 Active, not recruiting - Clinical trials for Monomorphic Ventricular Tachycardia

Cryoablation for Monomorphic Ventricular Tachycardia (CryoCure-VT)

CryoCure-VT
Start date: May 26, 2021
Phase: N/A
Study type: Interventional

A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.

NCT ID: NCT04888702 Active, not recruiting - Clinical trials for Spinal Muscular Atrophy

Holter of Movement in Patients With SMA Undergoing Treatment.

Start date: August 8, 2018
Phase: N/A
Study type: Interventional

Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.

NCT ID: NCT04886596 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

NCT ID: NCT04886154 Active, not recruiting - Clinical trials for Infections, Meningococcal

A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

Start date: June 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, effectiveness and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study will be conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and will serve as a safety lead-in to the Phase II study. The Phase II part of the study will be conducted in 2 parts: The 'formulation and schedule-finding' part will follow in healthy adolescents and young adults and it is designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part will be conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.