ANZCTR search results

The prevalence of chronic diseases linked to inflammation has prompted a need for understanding its impact. Gum disease (GD), a chronic inflammatory condition affecting oral tissues, shares links with systemic inflammatory diseases. GD's effects aren't confined to the mouth; they can impact overall health and carry socio-economic burdens. GD's global prevalence, including a significant presence in Australia, emphasizes the need for investigation. GD offers an accessible model to study interventions for chronic inflammatory diseases due to its manageable accessibility, representation of both soft and hard tissues, and rapid inflammation response. GD's reversibility, ability to measure inflammatory markers, and its connection with systemic diseases further support its model suitability. Diet, a modifiable human aspect, plays a role in inflammation. Studies reveal dietary effects on GD, with low-fiber diets possibly contributing to higher GD prevalence. Dietary fibers, fermented by gut microbes, produce short chain fatty acids (SCFAs) like acetate, which inhibits pro-inflammatory responses. SCFAs such as butyrate and propionate also show potential anti-inflammatory effects. Despite this, many Australians fall short of recommended fiber intake. To address this, fiber supplementation becomes a potential solution. No comprehensive research on dietary fiber's impact on GD and SCFAs has been conducted. This project aims to test dietary fiber's effects on gum health, hypothesizing that reducing inflammation through fiber intake could improve gum health and potentially reduce the risk of inflammation-related chronic diseases. This research bridges nutritional immunology with oral health, holding implications for chronic diseases beyond gum health. The hypothesis suggests that increasing dietary fiber through a prebiotic supplement could lead to milder GD symptoms due to anti-inflammatory short chain fatty acids. The objective is to assess the effects of fiber supplementation on gum health using an experimental gum disease model in healthy individuals without existing gum disease.

Clinicians and patients require means by which they can share data related to their care and in turn have steps taken to redirect care when required in real-time, before and after surgery. This data includes physiological parameters of heart rate, body temperature, blood pressure, breathing rate and oxygen saturation levels, Our vision is to co-design a digital solution aimed at providing an efficacious, safe, effective, and equitable means of communication between patients and healthcare providers during the perioperative period. The Biobeat BB-613P device, a wireless wearable chest monitor, utilises photoplethysmography (PPG) technology, and has already been used in blood pressure validation studies in both the inpatient and outpatient setting, including the ICU. However, validation for use of this device in the immediate postoperative setting on surgical wards has not been previously conducted. As the PPG technology has the unique and novel ability for cuffless blood pressure monitoring, we aim to validate the accuracy and precision of this parameter in our clinical setting, in the Cardiopulmonary Exercise laboratory and in the theatre and early post-operative setting, using the approach described by the Institute of Electronics and Electronics Engineers (IEEE) Standard 1708a™-2019.

This research project is testing the safety and feasibility of delivering a treatment called transcranial Direct Current Stimulation (tDCS) to children with cerebral palsy in their home. This treatment has previously been used safely and feasibly in children with cerebral palsy in a laboratory. Our goal now is to expand the use of this technology into the home setting. The first step in establishing tDCS in the home is to test its safety and feasibility. Feasibility refers to how easily and conveniently the device can be used. For this study, we will also be capturing information on the safety of the device and reporting on the feedback from participants (both caregivers and children). Aim 1: To determine the safety and tolerability of at-home tDCS with remote supervision, activation and monitoring by a paediatric neurologist. Hypothesis 1: Children will tolerate the stimulation well with no serious adverse events. Hypothesis 2: The repeated and guided sessions will result in increased comfort and confidence reported by families in performing tDCS at home. Aim 2: To determine the feasibility of remotely-delivered tDCS. Hypothesis 1: Families will correctly and efficiently set-up the stimulation equipment, with the support of remote instruction. Hypothesis 2: Families will be able to initiate and successfully complete tDCS delivery over repeated sessions, with increasing quality of stimulation delivery (e.g., increased electrode contact quality).

MicroDep is an investigator-initiated trial evaluating the safety and efficacy of low doses of psilocybin as a treatment for depression of moderate severity. We aim to recruit 293 participants to a 6week randomised, placebo controlled trial comprising 11 dosing sessions. Participants will be assessed at baseline, at week 6, and at 1-week and 1-month followup. The primary outcome measure will be the GRID-Hamilton Depression Rating Scale. Secondary outcomes include psychological measures, neurophysiological measures, and omics-based biomarkers. There will be a neuroimaging substudy that will investigate markers of neuroplasticity in 80 participants. We hypothesise that low doses of psilocybin administered over a 6 week period will be superior to placebo in improving clinical outcomes in moderate depression. If we find evidence of efficacy in the main stage, participants randomised to the placebo condition will be offered the opportunity to repeat the intervention with the active drug.

This study will seek to explore potential benefits of meditation delivered via a virtual reality (VR) headset to people living with chronic or episodic migraine. It will also seek to identify avenues and challenges for further research in this area. A multiple baseline, replicated Single Case Experimental Design using an ABA (A-baseline, B-treatment, A-follow-up) procedure. A N=1 design comprising 12 participants will involve serial observations before, during and post intervention.

To test the addition of personally tailored medical nutrition therapy (MNT) telehealth counselling into Prima Health Solution’s current online Healthy Weight for Life™ (HWFL) program, on diet quality over 18-weeks while optimising weight loss.

The aim of this open-label, randomised, dose-comparison, pilot feasibility trial with two parallel arms is to determine the feasibility of using low and moderate doses of Curcutex (Meriva® Curcumin Phytosome®) for the management of EoE in adults. Primary Objective Evaluate the feasibility of using low and moderate doses of Curcutex (Meriva® Curcumin Phytosome®) for EoE in adults. Secondary Objectives 1. Ascertain whether Curcutex (Meriva® Curcumin Phytosome®) is safe in adults with EoE at low and moderate doses. 2. Assess whether Curcutex (Meriva® Curcumin Phytosome®) improves EoE-related symptoms in adults with EoE in low versus moderate doses. 3. Determine whether Curcutex (Meriva® Curcumin Phytosome®) improves Quality of Life in adults with EoE in low versus moderate doses. 4. Ascertain whether Curcutex (Meriva® Curcumin Phytosome®) reduces absolute eosinophil count in adults with EoE in low versus moderate doses. Current evidence suggests that orally administered Meriva®, at a dose of 500-1000 mg twice daily (or 1-2 g per day) for 12 weeks is safe and effective at reducing inflammation and pain in chronic inflammatory diseases such as EoE.

One of the major constituents of mammalian blood is haemoglobin. Haemoglobin is a protein complex bound to red blood cells, and is responsible for the delivery of oxygen to, and removal of carbon dioxide from the tissues. A shortage of haemoglobin is called ‘anaemia’. If a patient has anaemia before or after major surgery, they are more likely to develop a complication after their operation, and more likely to die. The worse the anaemia, the worse the risk. The prevention and treatment of anaemia is therefore of great importance to patients and their clinicians alike, especially patients who have required cardiac surgery, as the incidence of postoperative anaemia in these individuals is very high. However, anaemia is a symptom of a broader problem, not a diagnosis in and of itself. It has many, many potential causes, and while we suspect that anaemia after cardiac surgery is driven by a combination of blood loss and inflammation, this is yet to be proven. In general, the treatments that are available for anaemia that was present after an operation are effectively limited to blood transfusion. However, blood transfusion itself is associated with an increased risk of poor outcome. Because of the lack of treatment options, specialists have been generally incurious about what drives anaemia following an operation. However, over the last ten years, our understanding of the drivers of anaemia in general has improved markedly, which in turn has resulted in the development of several new therapies. Clinicians, therefore, have options that could be useful to treat anaemia after major surgery, including cardiac surgery. However, to apply these new treatments effectively, we must first understand what causes anaemia after cardiac surgery, and for how long this process lasts. The MOSAICS study has been designed with this conundrum in mind and will explore and define the many possible causes of anaemia after cardiac surgery. Volunteers having cardiac surgery at two hospitals will have their blood tested several times following their operation (both in hospital and for the first nine weeks after the operation) to examine the resolution of inflammation postoperatively, and to determine how this influences changes in the body’s handling of iron (a key component of haemoglobin), and the body’s ability to generate new haemoglobin to replace that which was lost during the operation. By determining the underlying cause of anaemia, we can design new studies that will target this cause. If successful, MOSAICS will provide important insights into the causes of postoperative anaemia and identify the best targets for novel treatments for this major problem, that continues to affect outcomes and quality of life for patients who are undergoing cardiac surgery.

The Affinity trial aims to assess the efficacy of an enhanced version of the moderated online social therapy (MOST) digital therapeutic social networking platform in reducing suicidal thoughts and behaviours in young people attending outpatient care. Participants randomized to the intervention condition will also have the option of participating in a fortnightly online psychosocial recovery group and to invite their caregivers to participate in caregiver online psychoeducation sessions. It is expected that the Affinity intervention condition will be faster at, and have greater maintained effects in, reducing levels of suicidal ideation than the treatment as usual condition. Effects of therapeutic mechanisms of action, as well as health economic aspects will also be assessed.

Dose CF Kids aims to characterise the pharmocokinetics (PK) and pharmacodynamics (PD) of the intravenous antibiotics used to treat pulmonary exacerbations requiring intensive therapy (PERIT) in children with CF. This information will help to clarify the optimal use of intravenous antibiotics in children with CF. Target therapeutic concentrations for IV antibiotic for PERITs in children with CF that are associated with maximal short- term improvement in lung function (measured by FEV1) will be determined. This will be used for modelling to inform optimal antibiotic dosing. It is hoped the data will allow development of an antibiotic dosing calculator. Dose CF Kids also aims to determine the specificity of novel kidney markers to detect drug- related kidney injury.