ANZCTR search results

This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of multiple subcutaneous (into/under the skin) injections or single intravenous (IV) infusions (into the vein) of a new formulation of a drug called KZR-616.

The purposes of this study is to assess the urinary function of men undergoing a prostatectomy with and without a 'RoboSling', which is a thin piece of the patient's abdominal lining tissue that is stitched to the pubic bone during surgery to support the bladder. Who is it for? You may be eligible for this study if you are aged at least 18 years and are undergoing a prostatectomy for prostate cancer with one of the participating surgeons involved in this study. Study details Participants in this study will be randomised (by chance) into two groups. Both groups will undergo their planed prostatectomy procedure. One group will have a standard procedure, and the other group will have a standard procedure with the creating of a ‘RoboSling’ from their abdominal lining tissue during surgery. All participants will complete a number of questionnaires at 7 timepoints over the weeks and months just prior to and following their surgery. It is intended that this study will help to improve urinary continence in men after prostatectomy surgery in the future.

The aim of this study is to investigate the feasibility of delivering intensive meal preparation retraining using a group therapy model in a public health setting for people with a brain injury. The study will explore whether providing more intensive retraining in meal preparation in a group context provides equal or better outcomes for patients than current individual intervention (current usual practice). The participant will be randomly assigned to receive either group based meal preparation (breakfast group) or individual meal preparation retraining (usual practice). The breakfast group involves a 5 day per week (Monday to Friday) breakfast preparation group based program facilitated by a minimum of one occupational therapist and one occupational therapy assistant. Usual practice involves one to one therapist to patient sessions with frequency determined by the therapist based on capacity and outcomes of assessments completed. The participant will be asked to complete an assessment with an occupational therapist involving the participant completing a simple meal preparation task three times during the study: 1) before receiving the meal preparation intervention, 2) at the end of the intervention (four weeks) and 3) at the end of 12 weeks. The assessments include: the Perceive, Recall, Plan and Perform (PRPP) System of Task Analysis and the Functional Autonomy Measurement System (SMAF). The participant may also be invited to participate in a one hour individual interview with a member of the research team, about four weeks after commencing the intervention. This study will identify the feasibility of intensive group based breakfast preparation retraining in an inpatient setting. The impact of treatment mode and intensity on functional outcomes will provide opportunities for clinical recommendations and identification of patient satisfaction.

The ivaBRADine to reduce mICrovasculAR complications of type 2 DIAbetes mellitus (BRADICARDIA) study is a prospective randomised open blinded end-point (PROBE) design trial funded by a Heart Foundation Vanguard Grant. It will test the hypothesis that heart rate reduction improves (or reduces progression of) microvascular complications in type 2 diabetes mellitus. It will randomise 50 patients with type 2 diabetes mellitus 1:1 to ivabradine (in the intervention group) or no treatment/standard care (in the control group). Ivabradine works selectively on the sino-atrial node to slow heart rate without any other significant haemodynamic effects. The primary outcome will be change in urinary albumin creatinine ratio (UACR, the average of three first-void urine samples). The secondary outcomes will be change in retinal microvascular structure/pattern from retinal imaging and skin micro-vessel function using the laser Doppler and 3-D optical coherence tomography (OCT) techniques. These outcomes will be measured at baseline and at 90 days post intervention commencement.

Rurality and remoteness are associated with increased risk of diabetes-related foot ulcerations (sores) and lower limb amputation because people who live in rural areas are more likely to have diabetes and have reduced access to traditional preventative services. This study aims to assess the feasibility of using a short, face to face podiatrist-led intervention to support the adoption and utilisation of a smart-insole in a rural population. Ten people with diabetes-related nerve damage in the feet and two podiatrists will be recruited. An experienced health-coach will provide face to face training to the enrolled podiatrists in how to use health coaching strategies to support participants in using the SurroSense Rx smart-insole insole, which monitors foot pressure and weight bearing activity. Participants will wear the smart-insole in their shoes for four weeks, responding to alerts delivered via the associated smart-watch.

It is hypothesised that exposure to and engagement with creative activities increases mental wellness and reduce the symptoms of mental illness in young people, This research will examine whether exposure to common creative arts activities will help to enhance the mental wellness (such as mental resilience and mindfulness skills) and reduce symptoms of mental health problems in children from families where someone has a mental illness. This could be their parents (guardians), siblings and other close relatives.

The underlying principle of trials evaluating the effectiveness of pharmacological treatments is to compare a drug against a placebo. The difference in effectiveness is then attributed to the active ingredient of the drug. Typically, placebos are designed to resemble the drug as much as possible, but conventional placebos that only contain lactose fibres (or other inert substances) do not elicit side effects and therefore do not fully resemble all features of the drug. We therefore developed an active placebo that will elicit side effects, but otherwise has no effect on sleep. The main aim of this study is to test whether participants who are given a placebo under ‘double-blind’ conditions are more likely to believe that they are been given a real medication if they receive an active placebo eliciting side effects, compared with a benign placebo that only contains lactose fibres. Additionally, we will evaluate if side effects increase the effectiveness of an otherwise inactive placebo treatment. We hypothesise that active placebos demonstrate a larger placebo effect for sleep compared with conventional placebos.

Deep Brain Stimulation (DBS) in the nucleus accumbens (NAcc) for 10 patients with treatment-resistant severe and enduring anorexia nervosa (AN) patients. The primary aims of the study are to explore the safety, tolerability and efficacy of DBS in patients with treatment resistant AN. The secondary aims will look at the impact of the DBS using a number of measurements. Participants will be randomly allocated to two groups 'stimulation on' and 'stimulation off'. All participants will have devices switched on at month 4 post-op.

Infants with a family history of Autism Spectrum Disorder are at an increased risk of developing this disorder themselves. The provision of an early Acceptance and Commitment (ACT)-based therapy intervention aims to improve clinical outcomes for these infants by enriching parent-infant interactions, assisting with infant sleep, crying and fuss behaviours and supporting parental mental health. A randomised controlled trial will evaluate whether this intervention for parents of infants at risk of Autism Spectrum Disorder is effective, comparing this intervention with usual care. We expect that this intervention will improve the emotional availability of the parent-infant interaction, parental mental health as well as infant developmental outcomes.

Poor mental health has been identified as key factor in multiple risk behaviours that contribute to premature mortality and disability. Reducing liability to mental illness at the population level (e.g., universally), appears to be crucial to disrupting trajectories to mental disorder and related harms. For successful prevention, however, interventions need to be implemented early enough to effect real change. Yet, the majority of ‘early’ universal prevention research occurs in adolescence, in secondary schools, when mental illness is already rapidly increasing. As it is strongly empirically supported that mental illness has origins in childhood, intervening in early-to-mid childhood is likely to achieve significant preventative gains. Despite this, comparatively little evidence-based prevention occurs in this developmental period. We propose a small feasibility study to trial a universal prevention program in a mid-childhood cohort (the ‘Good Behaviour Game’ [GBG]). This program has been extensively evaluated, and been shown to significantly reduce conduct disorder, ASPD, anxiety and depression, drug and alcohol dependence, and suicide attempt, with effects sustained into early adulthood. Given its expected benefits, it is important to test whether the GBG can be delivered as intended in an Australian setting, and whether it is acceptable to schools. Such work will provide empirical justification for the next iteration, i.e., a full-scale trial. This trial focuses on establishing acceptability and feasibility of the program in Australian primary schools, and providing preliminary evidence for efficacy of the program in reducing emotional and behavioural problems.