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NCT ID: NCT05168709 Completed - COVID-19 Clinical Trials

Investigating COVID-19 Vaccine Immunity in Children in the Melbourne Infant Study of BCG for Allergy and Infection Reduction

COSI BAIR
Start date: January 20, 2022
Phase: Phase 4
Study type: Interventional

The COSI BAIR trial will involve approximately 60 children, aged 5 to 8 years old, comprising a subset of participants from the Melbourne Infant Study BCG for Allergy and Infection Reduction (MIS BAIR) randomised controlled trial. The overall aim of this trial is to investigate the specific and heterologous effects of COVID-19 vaccination on immunity in children. COSI BAIR will aim to recruit its participants from the MIS BAIR Bacillus Calmette-Guérin (BCG)-naïve group. These children will be followed up until 28 days after their final Coronavirus Disease 2019 (COVID-19) vaccination. Venous blood samples will be collected at two study visits, at Murdoch Children's Research Institute (MCRI): 1. Day 0 - baseline (day of COVID-19 vaccination #1), and 2. Day 84 (28 days after COVID-19 vaccination #2).

NCT ID: NCT05168202 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Start date: January 19, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.

NCT ID: NCT05166577 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC

Start date: October 8, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumors and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma

NCT ID: NCT05166161 Recruiting - Phenylketonuria Clinical Trials

A Long-Term Safety Study of PTC923 in Participants With Phenylketonuria

Start date: February 14, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the long-term safety of PTC923 in participants with phenylketonuria, and to evaluate the changes from baseline in dietary phenylalanine (Phe)/protein consumption.

NCT ID: NCT05165628 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers. The study will aim to recruit 15 participants per study group (30 participants in total). Participants will be randomly allocated to one of two treatment groups: - Group 1: CYP-006TK - Group 2: Standard care This will be an open label study with respect to treatment allocation. However, the person reviewing images of the study ulcers to assess healing will be blind to the participant's treatment allocation. Participants assigned to Group 1 will be treated with CYP-0006TK dressings on 8 occasions over 4 weeks. The dressings will be changed every 3 or 4 days. After the first 4 weeks, participants in Group 1 will revert to standard care for the rest of the study. Participants assigned to Group 2 will have their ulcer treated with standard care throughout the study. Participants will attend a total of 16 scheduled visits over 24 weeks. There will be a mixture of on-site (hospital/clinic) visits, and home visits. The study will end 24 weeks after the initiation of treatment, unless the study ulcer is completely headed before then.

NCT ID: NCT05164614 Completed - Healthy Volunteers Clinical Trials

Study Evaluating PK of PTH Administered Orally Via RaniPillâ„¢ Capsule

Start date: February 21, 2022
Phase: Phase 1
Study type: Interventional

A prospective, single-center, open-label, phase I study evaluating the pharmacokinetics (PK) of human parathyroid hormone (1-34) ("PTH") administered via the RaniPillâ„¢ capsule ("RT-102").

NCT ID: NCT05164328 Recruiting - Athlete Heart Clinical Trials

Prospective Athlete's Heart Study

Pro@Heart
Start date: June 23, 2015
Phase:
Study type: Observational

The Pro@Heart (Prospective Athlete's Heart) study is an international multicentre long-term prospective trial. The primary objective of the Pro@Heart study is to investigate the impact of training load (i.e. accurately evaluated in term of type, frequency, duration and intensity) and genotype on the variability of structural, functional and electrical exercise induced cardiac remodeling (EICR) in young competitive endurance athletes. The second objective is to determine how EICR, training load and genotype are associated with physical performance, health benefits and cardiac pathology (e.g. exercise-related cardiomyopathies and arrhythmias) during follow-up over several decades.

NCT ID: NCT05163314 Recruiting - Clinical trials for Dravet Syndrome (DS)

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

Start date: March 4, 2022
Phase: Phase 3
Study type: Interventional

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

NCT ID: NCT05163288 Active, not recruiting - Clinical trials for Niemann-Pick Disease, Type C

A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C

Start date: June 30, 2022
Phase: Phase 3
Study type: Interventional

A pivotal, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of Niemann Pick disease type C (NPC). The objective of this study is to evaluate the safety, tolerability and efficacy of N-acetyl-L-leucine (IB1001) compared to standard of care.

NCT ID: NCT05162768 Active, not recruiting - Clinical trials for Mitochondrial Diseases

Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)

NuPower
Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

SPIMD-301 is a 48-week, randomized, double-blind, parallel-group, placebo-controlled trial to assess efficacy and safety of single daily subcutaneous (SC) administration of elamipretide as a treatment for subjects with primary mitochondrial myopathy associated with nuclear DNA mutations (nPMD).