ANZCTR search results

Outcomes for child anxiety treatment are suboptimal. Exposure therapy is the key technique to reduce anxiety, and involves facing the feared situation to learn that it is safe (i.e., safety learning). However safety learning can be forgotten, and fears come back. This clinical trial will assess whether adjunctive memory rehearsal after exposure therapy enhances outcomes and prevents relapse. Results will advance understanding of treatment mechanisms and optimise child anxiety treatment.

The aim of this study is to test the feasibility, efficacy, and acceptability of a co-designed digital body image intervention, a website, intended to provide non-clinical adult women with cognitive behavioural, psychoeducational, and media and health literacy activities. We hypothesise that relative to pre-intervention, participants in the treatment group would report decreased body dissatisfaction and ideal internalisations, and higher body acceptance and health confidence at post-intervention. We hypothesise sustained effects at one -month follow-up, compared to a wait list control group. We also aimed to learn more about how treatment group participants would rate the website in acceptability, and how the website could be improved. By evaluating the efficacy of the present co-designed website, there is potential to address the gap in scalable, user-centred body image interventions that are suitable for preventative and early care.

Delirium is a clinical condition characterized by an acute disturbance in a person's attention, cognition, and awareness. It can occur in any age group but is more common in older adults. It can be caused by the combined effect of hospital admissions, certain medications, and underlying medical conditions. Delirium is associated with poor outcomes for patients, with increased postoperative complications, delayed functional recovery, and prolonged hospital stays, and increased risk of death. Healthcare providers face difficulties in identifying or diagnosing delirium and providing high standard care for patients experiencing delirium. In this project, we will evaluate a comprehensive approach involving data from wearable devices and clinical records of patients to develop a predictive model to detect the onset of delirium and to classify the hypoactive and hyperactive states of delirium. The wearable device, which is a smartwatch designed for clinical trials, can monitor physical activity and physiological parameters in older adults, and the clinical records can provide valuable patient health information. This project aims to develop Artificial Intelligence (AI)-based predictive and diagnostic applications using the data collected from the wearable device worn by inpatients along with their clinical records to predict and classify delirium. This will help in timely identification and management of the underlying causes and risk factors, which are crucial in preventing the development of delirium and understanding its symptoms. The developed predictive and diagnostic applications could assist healthcare providers in enhancing health outcomes for older adults admitted to hospitals.

This study will investigate whether smartwatches can be used to diagnose heart problems early. Participants will use their smartwatches to record 12-lead electrocardiograms (ECG) similar to those done in hospitals and clinics, and also provide a snapshot of their daily physical activity for the preceding year. The purpose of this research is to see if self-recorded heart data and activity data can help in the early detection of heart disease and provide a better understanding of how physical activity affects heart health. We hypothesize that using smartwatch ECG technology for at-home heart check can lead to earlier identification of cardiovascular risks. ECG Heart Age, as a marker of increased cardiovascular risk, has the advantage of being easily understood by the patient and may provide strong incentives for life-style changes or compliance to medication. If ECG Heart Age can be obtained without the use of conventional ECG machines, but instead applied by non-health care professionals at their own home, impact may be even greater. WHO identified the need for more research on the dose-response relationship between volume and/or intensity of physical activity and health outcomes. However, accurately measuring activity volume and intensity in the general public is challenging. Whilst there are many benefits to wearable devices, there are potential confounders to measuring activity in trials and extrapolating to general exercise levels. A potential solution to this issue is through collection of objectively measured physical activity in individuals who own a smartwatch or an activity monitor.

This study is a Phase 1, randomized, single-masked, multiple ascending dose (MAD) study designed to evaluate the safety, tolerability, and preliminary efficacy of pregabalin (PRG) ophthalmic solution in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The study will be conducted at up to 3 clinical sites and will include up to 32 participants, divided into 4 escalating dose cohorts. The study will employ a single-masked design, meaning that the evaluating investigator and subjects will remain unaware of the treatment allocation, while other study personnel, including the sponsor, Safety Review Committee (SRC), and medical monitor, will be unmasked. The comparator arm will use XALATAN (latanoprost ophthalmic solution), a well-established drug used for lowering intraocular pressure (IOP). This study aims to determine the safety profile of pregabalin eye drops and to explore its effects on IOP and corneal sensitivity over a three-day treatment period.

This research study is to compare the user experience with Omnipod 5 and ‘usual care’ in people living with type 1 diabetes. This study will be unique in that it will assess the user experience with automated insulin delivery (AID) enabled pod therapy across the lifespan of those with T1D from young children, through adolescence to adulthood and older adulthood, using closely aligned methodology. We hypothesise that Omnipod 5 use will be associated with a positive user experience and improved quality of life and other psychosocial measures compared to ‘usual care’ with multiple daily injections and tubed insulin pumps.

Obesity is a growing health issue, and current treatments are often expensive or not widely available. This study is testing whether dexamphetamine, an older and affordable medication, can safely and effectively help people lose weight when combined with diet and lifestyle changes. Participants in the study will either receive dexamphetamine or a lookalike placebo for six months, with regular check-ins to monitor health and support lifestyle habits. The medication dose will be carefully adjusted based on individual response and safety, and participants will be followed for two years after treatment ends. If successful, this research could lead to a more accessible and cost-effective way to manage obesity in everyday healthcare settings.

This study aims to examine the neurobiological underpinning of body image dissatisfaction in women aged 18-35 years old, and whether Eye Movement Desensitization and Reprocessing (EMDR) therapy is effective and acceptable in reducing body image dissatisfaction in this population. Through accessing secondary data from individuals with low levels of body dissatisfaction, we will compare neurological responses to images of self and other to a high body dissatisfaction group collected as part of this study, It is hypothesised that there will be neurobiological differences in those with high and low body image dissatisfaction. Further, it is hypothesised that EMDR will be effective at reducing distress associated with body image memories.

This study aims to assess the ProtonPetal Alpha One’s ability to track potassium levels at rest, when compared to current on market PoC reference measurement devices. Findings from this trial will guide future clinical evaluations and device refinement.

The aim of this study is to compare outcomes between two splints used after surgical repair of flexor tendon injury, namely the forearm-based dorsal blocking splint and Manchester short splint. Outcomes will include patient-reported hand function and quality of life, and clinician-reported range of motion and grip strength.