ANZCTR search results

The purpose of this study is to evaluate the safety and tolerability of JNJ-95597528 after single and optional multiple ascending dose administration in healthy participants.

This pilot study aims to reveal the profiles of extracellular vesicles (EVs) in periodontal, peri-implant diseases (refers to diseased groups) before and after treatment follow-up (3, 6 and 12 months). EVs from periodontally healthy and peri-implant health patients (without follow-ups as no need to follow up) will be used as controls. Whole oral samples (saliva, GCF/PICF and plaque) will be used as controls. There are three general aims for this project: Aim 1: Diagnosis and prognosis values of EVs in periodontal disease groups Compare the differences in host and microbial derived EVs and their EV content expressions between periodontally health, periodontitis and periodontitis undergoing treatment over a 1-year observation period Aim 2: Diagnosis and prognosis values of EVs in peri-implant disease groups Compare the differences in host and microbial EVs and their EV content expressions between peri-implant health, peri-implant mucositis and peri-implantitis and peri-implant disease patients undergoing treatment over a 1-year observation period Aim 3: EV profiles after in vitro biofilm culture Examine the microbial EV microbiome and proteome profiles in samples from both healthy and diseased groups following in vitro biofilm culturing It is hypothesised that host and microbial EVs and EV content are differentially expressed in diseased patients compared with healthy or peri-implant health patients, and correlates with the severity of periodontitis or peri-implant disease. Furthermore, it is hypothesised that EVs will be positively correlated with improvements in clinical parameters after periodontal or peri-implant treatment.

This study is testing the safety, tolerability (if any side effects occur), pharmacokinetics (PK; the amount of experimental drug or any breakdown products in the blood), of a single dose/food effect of an experimental drug called Radiprodil in the presence or absence of food (food effect). This entry in the ANZCTR registry describes Part A: a single oral 15 mg dose of radiprodil SDD. Radiprodil is being developed as a potential new treatment of tuberous sclerosis complex (a rare genetic disease that causes non-cancerous tumours to grow in the brain and several other areas of the body) and focal cortical dysplasia (a malformation of neurons in a region of the brain called the cortex). Radiprodil is expected to reduce the risks of seizures and negative developmental outcomes that are characteristic in patients with these conditions. In patients with these disorders nearly all will have a form of epilepsy (seizures) from a very young age that does not respond to current treatments available. Seizures can affect the process of normal development and cognitive skills leading to behavioural issues and negative developmental outcomes. Radiprodil has the potential to normalise the pathways in the brain that are involved in seizures and therefore reduce the risks of seizures, negative developmental outcomes and other significant symptoms that are characteristic in patients with these conditions. The purpose of this study is to test the safety and tolerability of a new version of oral radiprodil called Sprayed Dried Dispersion (SDD) radioprodil when taken as a single dose either with or without food. The study will also assess the plasma pharmacokinetic profile (how a drug moves through the bloodstream over time) of the SDD radiprodil.

A study to test the use of a hydrogel containing 0.1%w/w mometasone furoate applied once a day in the treatment of chronic leg wounds. Adults meeting the study entry criteria will be identified and randomised to apply either the active product or a placebo over a period of 28 days, with follow-up after an additional 7 days. Hypothesis: A hydrogel containing 0.1%w/w mometasone furoate will shorten the healing time of chronic leg wounds in adult patients, as measured by reduced wound size and reduced inflammatory mediators.

This study will use EIT to define the patterns of tidal ventilation within the chest in infants undergoing inguinal hernia surgery with four different anaesthetic types, two where they are spontaneously breathing, and two where they are having a general anaesthetic with either spontaneous ventilation with laryngeal mask airway or mechanical ventilation. This study will determine whether mechanical ventilation during general anaesthesia increases the risk of lung inhomogeneity in neonates and small infants. We also hope to determine if there is a correlation between the degree of lung inhomogeneity and the four types of anaesthetic techniques.

This study will determine if there are any changes in sleep difficulties in relation to menopause, and other symptoms of menopause as well as looking at the rate of adverse events after using medicinal cannabis. This study will provide data for future clinical trials if potential benefits are found. We hypothesise that medicinal cannabis can improve sleep quality in relation to menopause, alongside other symptoms.

The aim of this project is to identify the most promising approach of improving diabetes risk factors for Indigenous Australians with type 2 diabetes using LibrePro continuous glucose monitoring and a 10-week intensive lifestyle program. Up to 90 participants who identify as Aboriginal and/or Torres Strait Islander, have been diagnosed with type 2 diabetes and have recently recorded a HbA1c >7.5% will be recruited from multiple locations. This study follows a basket trial methodology with 2 groups assessed at each stage: participants taking insulin &/- sulfonylureas and other diabetes medications; and participants on other diabetes medication (NOT taking insulin &/or sulfonylureas). Fifteen participants will be recruited for each group at each stage. It is expected that LibrePro continuous glucose monitoring and a 10-week intensive lifestyle program will be of sufficient promise to be taken forward to a Phase IIb-III trial and subsequent translation into clinical care. This will be based on the combination of efficacy, safety and feasibility with type 2 diabetes treated with insulin AND/OR sulfonylureas & other diabetes medications or treated with other diabetes medication (excluding Insulin AND/OR sulfonylureas) respectively.

This study investigates ongoing symptoms following COVID-19 and influenza infections in children and teenagers. Parents of children who have had COVID-19 or influenza will be invited to participate. Initially, cases will be identified through presentations at the Women's and Children's Hospital and will then expand to include statewide notifications. After providing consent, participants (or their parents) will complete surveys at the start of the study and then again at 3, 6, and 12 months after the viral infection. These surveys will help researchers monitor any persistent health issues over time. The primary goal of the study is to understand how common these ongoing health problems are in young people and how they impact their daily lives.

This study aims to evaluate whether local vibration therapy self-applied to the lower limbs can improve balance in older adults. Participants will use a handheld vibration device on their lower limbs daily for six weeks. Their balance will be measured using the Four-Square Step Test and what they feel their 'balance confidence' in would be when performing various activities will be measured with the Activities-specific Balance Confidence Scale. We hypothesise that this therapy will improve balance and increase confidence. The results could provide a simple, cost-effective method to help older adults improve their balance.

PReventing chronic pain after whiplash Road Traffic Injury (PRioRTI) is a randomised, double-blinded, placebo-controlled, multi-centre Phase III trial to evaluate the effectiveness of early (within 96 hours of injury) treatment with pregabalin vs placebo in development of chronic pain after whiplash injury. 258 male and female participants, aged between 18 and 70 years old will be recruited in Emergency Departments (EDs) across several sites in Australia (Qld, NSW). Follow-up assessments will be completed at 6 weeks, 3-, 6- and 12-months using Participant Reported Outcome Measures completed by participants online in REDCap. It is hypothesised that participants who receive the pregabalin treatment will report lower levels of neck pain at the follow up time points than participants who receive the inactive placebo treatment.