ANZCTR search results

This study aims to assess the effect of combining two different cancer treatments, Lu-PSMA and capecitabine, for the treatment of castration-resistant metastatic prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with castration-resistant metastatic prostate cancer and you meet additional health criteria that will be determined by a blood test. Study details This study will be conducted in two parts. Participants who choose to enrol in the first part - dose escalation - will be allocated into one of four capecitabine dosing groups. Participants will attend their cancer treatment centre and receive twice daily doses of capecitabine for 14 days. On the 10th day, participants will also receive a dose of Lu-PSMA. Treatment will be administered to a maximum of 6 cycles, at an interval of 6 weeks (42 days). Participants will be enrolled firstly into the lowest dose group, if there are no serious side effects noted then enrolment into the higher dosing groups will occur. Once the maximum tolerated dose is determined, the second part will begin enrolling participants. Participants who choose to enrol in the second part - dose expansion - will all receive the maximum tolerated dose of capecitabine twice daily for 14 days. On the 10th day, participants will also receive a dose of Lu-PSMA. Treatment will be administered to a maximum of 6 cycles, at an interval of 6 weeks (42 days). Participants who choose to enrol in either the first or second part will be asked to undergo routine blood tests and CT imaging to determine any impact the combined treatments may be having on their cancer. Overall participation is not expected to exceed 12 months.. It is hoped this research will determine the maximum safest dose of capcitabine that can be administered to prostate cancer patients together with Lu-PSMA. Once a safe dose has been determined, a larger trial enrolling more cancer patients may be undertaken to further assess the efficacy of the combined treatments.

The result of injury in humans is scar formation. In the case of burn injuries, particularly larger surface area and deeper burn injuries, extensive scar formation has a significant physical and psychosocial impact on patients after recovery. Scar formation after injury is driven initially by the inflammatory response but subsequently by matrix producing cells (fibroblasts) that generate excess collagen. This collagen is organized in parallel bundles and the excess collagen as well as organization of collagen underpins the poor appearance and physical properties of scar. A family of 5 lysyl oxidase (LOX, LOXL1-4) enzymes are involved in a process of cross-linking collagen. This cross-linking is increased in scars. This study will test an inhibitor of these enzymes, PXS 5505, in burn patients with moderate burn injuries and that require surgery. The study will test the safety of PXS-5505 when given to burn patients after their surgery and also measure the scarring after their recovery. The study will be a double-blind and randomised controlled trial with 60 patients randomised 2:1 to PXS-5505 or placebo.

The REPAIRS pilot trial aims to investigate the feasibility and acceptability of a randomised controlled trial comparing a ‘standard’ regimen of opioid pain medicines to a ‘reduced’ regimen of opioid pain medicines prescribed upon discharge after total hip or knee replacement. Both groups will also receive the same robust regimen of non-opioid pain medicines. The pilot trial will be open label to prescribers and participants, however the researchers conducting the surveys and statistical analysis will be blinded to treatment allocation. We will recruit ~50 participants to test outcomes such as recruitment per screening rate, adherence to medication regimens, acceptability of surveys. There will also be an inbuilt process evaluation where we will interview all participants, and ~ 10 key staff members to qualitatively investigate the acceptability of the trial interventions and processes. Participants will be followed up for 6 weeks from hospital discharge.

Many trades (e.g. infantry, special operations) within the Australian Army require individuals to perform consecutive days of prolonged (>10 h), physically demanding work in the heat, as part of multi-day training exercises and operations. These conditions can cause dangerous rises in body core temperature, cardiovascular strain and fluid depletion over the course of the day, which can cause carry-over effects that may exacerbate exertional heat illness (EHI) risk on the following day. For example, recent epidemiological data from the US Armed forces indicate that the odds of developing EHI on a given day is exacerbated when training is conducted in hot weather on the preceding day. Further, several field- and laboratory-based studies have demonstrated that this elevated EHI risk may be related to exacerbated increases in body core temperature and cardiovascular strain on the second of consecutive days of work in the heat. While the mechanism(s) explaining these impairments in thermoregulatory and cardiovascular strain remain unclear, there is recent evidence to indicate that these carry-over effects may progressively worsen over two or more days. Despite the potentially deleterious effects of multi-day exercise in the heat on physiological strain, there are major gaps in our understanding of the factors (e.g. aerobic fitness, environment, work intensity) that may exacerbate the magnitude of these effects. For example, recent work has demonstrated that increasing age may worsen the next-day effects of a prolonged workday in the heat on thermoregulatory function. There also exists shortcomings in our knowledge of the impact of multi-day exercises in the heat on cognitive function and fatigue, which may reduce task performance and increase the risk of errors and risk taking behaviour. This makes it difficult to develop interventions to mitigate risk of decrements in performance and improve safety. The overarching aim of this project is to investigate the cumulative physiological effects of consecutive days of physical work in hot conditions.

Depression is a common mental illness, and it is one of the leading causes of disease burden worldwide. Fortunately, there are many effective treatments available for depression, including lifestyle changes, psychological treatments, and medications such as antidepressants. However, not all patients will respond to the first treatment prescribed. Some patients may only experience a 'partial response', where a few treatments help their depression somewhat, but they do not achieve a full recovery. Currently, the reasons why some patients do not respond, or only experience a partial response to an antidepressant, is not fully understood. Recently, researchers have been investigating new medications that may help patients recover from depression. One of these new medications is Esketamine, which is a relatively new molecule derived from a drug called Ketamine - an anaesthetic that has been used medically for decades. Researchers have been investigating the antidepressant properties of Ketamine for a long time. It is thought that Ketamine, and its derivative, Esketamine, help to treat depression for a number of reasons. However, it is not yet known which patients benefit most from Esketamine when used in conjunction with conventional antidepressants. In addition, we do not yet understand how the effect of Esketamine is impacted by other treatments that a patient may be taking for their depression. Finally, it has not yet been investigated how patients with a partial response to an antidepressant will benefit from adding Esketamine to their therapeutic regimen without switching to a new baseline antidepressant. Therefore, there are two principle aims of this study 1) to investigate whether Esketamine is effective when added to ongoing antidepressant treatment and 2) to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice. In patients that improve with the addition of Esketamine to their current antidepressant treatment, we hypothesize that their improvement will be determined by their personal characteristics and/or the type of treatment they are already receiving.

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.