ANZCTR search results

The purpose of this study is to assess if the movement of the CPAP pressure meter while the participant is breathing can be used to determine the size of the breath. We will compare the movement to the amount of air your baby breathes, measured by the breathing monitor attached to the CPAP tubing. We currently do not have information about whether there is a link between the movement of the meter and the amount of air the participant is breathing, if there is this could be important information for babies who need breathing support at birth.

The prevalence of obesity in patients with T1D is increasing. The common consequences of obesity in individuals with T1D include, insulin resistance, increased insulin requirements and impaired glycaemic control, increasing the risk of diabetes-related complications in these individuals. Novel therapeutic strategies that reduce body weight and synergistically aid insulin therapy in improving glycaemic control are therefore needed to address this challenge and reduce their risk of life-threatening diabetic complications. Tirzepatide is an incretin-based therapy commonly used in patients with type 2 diabetes and/or obesity that has proven effective for reducing body weight and improving glycaemic control. Therefore, this study aims to evaluate the efficacy of tirzepatide in individuals with concurrent T1D and overweight or obesity who are receiving insulin therapy in a cross-over randomised study design. The aim is to evaluate if adjunctive insulin therapy with tirzepatide can lead to a reduction in body weight and improved metabolic outcomes compared to insulin treatment alone.

The lmmunoPET study aims to assess whether it is feasible to use 89Zr-durvalumab (89Zr-durva) as a PET tracer of PD-L1 (a cancer related protein) in patients with cancer. Who is it for? You may be eligible for this study if you are an adult with non-small cell lung cancer. Study details All participants will receive an injection in the arm containing the 89Zr-durva tracer about 3 days prior to completing a PET scan. Each PET scan will take approximately 30 minutes. This infusion will take place at three timepoints: before radiotherapy, 14 days after starting radiotherapy and approximately 42 days after radiotherapy treatment has finished. Blood tests will be taken at each of these PET scans. About 15 to 2oml of blood will be taken at each PET scan. It is hoped that this study will help determine if 89Zr-durvalumab (89Zr-durva) is a feasible option for use as a tracer of PD-L1.

Older adults often struggle to breathe deeply after breaking ribs because pain makes every breath hurt. This study will test whether adding an ultrasound-guided erector spinae plane (ESP) block—a small catheter that drips numb­ing medicine beside the spine—can improve breathing and comfort beyond what usual pain medicines alone achieve. Twenty patients aged 65 years or older with recent rib fractures will be randomly allocated to (1) ESP catheter + standard medicines or (2) standard medicines alone. Lung function metrics; FEV1, PEFR and FVC, will be checked with a hand-held spirometer before treatment and once daily for five days, and participants will be phoned at 30 days to discuss their recovery. Study hypothesis: patients who receive the ESP catheter will show a greater day-to-day improvement in lung function, report less pain, and need fewer opioids than those receiving standard care alone.

The MINI-MAP Trial is testing whether different blood pressure targets affect outcomes in critically ill patients who need medications called vasopressors to maintain their blood pressure. Patients will be randomly assigned to one of three minimum blood pressure targets (60, 65, or 70 mmHg) to determine which approach leads to better recovery and fewer complications. The study hypothesis is that using lower blood pressure targets will reduce the need for vasopressor medications and improve patient outcomes. This research aims to help doctors determine the safest and most effective blood pressure goals for patients in intensive care units.

Night-time muscle cramps affects about 1 in 3 adults. These cramps reduce quality of life and sleep, sometimes severely. A recent Cochrane review of non-drug therapies found some evidence of effectiveness of stretching in reducing the frequency of night-time calf cramps, though deficiencies in the stretching protocol and study designs reduce certainty of the evidence. Our previous research identifies a potential mechanism of benefit of stretching for muscle cramps, as well as other potentially effective, low cost and low risk educational interventions that align with the scientific understanding of cramp pathophysiology. We propose to undertake a randomised feasibility trial of lower limb stretching and cramps prevention education for night-time calf cramps. We will recruit 26 to 40 adults who experience night-time calf muscle cramp at least twice per week and who do not have known neurological disease. Approximately 13 to 20 people will be randomly assigned to a combination of calf and hamstring stretching plus receive cramps and cramps-prevention education. Approximately 13 to 20 people will be randomly assigned to sham stretching and cramps education (no cramps prevention education). Intervention duration will be 6 weeks. The primary outcome of the study is to determine the feasibility of conducting a full-scale RCT. The secondary outcome was to investigate limited efficacy testing of the effect of the intervention on cramp frequency and severity (as recorded in a cramp diary), quality of sleep, and quality of life.

The Women's Emotional Well-Being (WEB) Project aims to test via a randomised controlled trial, a primary care system model for women experiencing domestic and family violence (DFV) to improve women's mental health, safety, support and access to care. The project will recruit 24 general practice clinics (with at least 3 GPs/nurses) trained in delivering appropriate DFV first line responses. From these clinics, 864 women patients who are afraid of their partner, ex-partner and/or family member will be recruited before being randomised to an intervention or comparison group. Women in the intervention group will be offered a funded appointment to see the GP or nurse that includes an online safety assessment and planning, referrals to a peer support worker and DFV services. Women in the comparison group will receive usual care from their GP clinic. We hypothesise that the the intervention will decrease women's distress symptoms and increase helpful referrals, and their sense of empowerment, safety and support.

This study explores how daily physical activity affects sleep in people recovering from substance use disorders (SUD). Sleep problems are common during and after treatment for SUD and can make recovery harder. While physical activity is known to improve sleep in other populations, little is known about how it impacts sleep in people with SUD—especially over time and at different stages of recovery. We will follow people in three groups: those currently in residential treatment, those in ongoing recovery programs, and those in long-term recovery (over one year). Participants will wear activity and sleep monitoring devices and complete short daily surveys for one month. This will help us understand how day-to-day changes in physical activity relate to sleep and overall wellbeing. We will also compare two different sleep tracking devices to see how well they agree. The findings will provide a better understanding of how physical activity supports recovery, and may help tailor future treatments to each person’s unique needs.

Sleep Ninja® is a smartphone delivered program that targets poor sleep. It was previously evaluated in a randomized controlled trial which demonstrated an improvement in sleep and a reduction in depression symptoms relative to a control group. The app was made available to the public in Feb-2023 via the App Store and Google Play. This study sought a waiver of consent to access and examine data collected through the Sleep Ninja® app between Feb-2023 and July-2024. The aim of this study is to monitor whether the app, now released into a real-world setting, continued to generate the same positive benefits that were demonstrated in the randomized controlled trial. Specifically, the aim of this study is to: (1) Examine the characteristics (age, gender, location, sleep, mood, worry, quality of life) of individuals who use the Sleep Ninja® app. (2) Examine whether use of the Sleep Ninja® app is associated with improvements in sleep, depression, anxiety, and quality of life . (3) Examine the patterns of app use which are associated with the greatest clinical benefits.

This research aims to investigate the implementation of the evidence-based program, Tuning in to Kids (TIK) in rural early education services (TIK-REES). TIK has been adapted specifically for early childhood services, and provides professional training, resources, and supervision for early childhood educators to develop an understanding of emotion coaching skills, and how it can be practically applied to support children’s wellbeing and emotional development. The intervention also provides parents with an online parenting program that complements the early education intervention. TIK is a universal prevention program but is also especially useful where children have emotional or behavioural difficulties, including problems with separation anxiety. In particular, this study will seek to reduce separation anxiety for children in their experience of 4-year old kindergarten, reducing the risks that they will have school refusal during their first year at primary school. This study will be the first evaluation of TIK in Australian kindergartens, and focuses on an under-serviced, priority population in rural and remote areas of Victoria.