ANZCTR search results

This is a double-blind, placebo-controlled, First-In-Human Study of the safety, tolerability, pharmacokinetics of LW-1017 in Healthy Volunteers. Who is it for? You may be eligible for this study if you are aged between 18 to 55 years old and are in good general health without a clinically significant medical history. Study details Healthy volunteers will be randomly assigned to receive single oral doses of LW-1017 or matching placebo under three separate conditions starting on Day 1 (Period 1; under Regimen A fed condition), Day 8 (Period 2; under fasted conditions), and Day 15 (Period 3; under Regimen B fed condition) (3 doses total). Participants will undergo regular safety assessments, including vital signs, blood and urine tests, and other clinical evaluations. The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics of LW-1017 and to identify dose levels suitable for future clinical studies. If results are acceptable, subsequent studies may evaluate LW-1017 in patients with Alzheimer’s disease or Parkinson’s disease.

This trial aims to improve care for young people with obsessive–compulsive disorder (OCD) in community mental health services. It compares two evidence-based models of cognitive-behavioural therapy with exposure and response prevention (CBT-ERP): a standard approach and a stronger, more intensive approach that includes additional parent training and longer ERP sessions. Both models are expected to reduce OCD symptoms, with the stronger model leading to greater improvements for some young people. The study will also evaluate how well clinicians can learn, deliver, and sustain high-quality CBT-ERP after receiving tailored training and supervision. By improving the detection, assessment, and treatment of OCD, this project aims to increase access to effective care for young people and their families.

This feasibility study is aimed at testing the feasibility and acceptability of the ‘You-can-do-it: Successful Ageing’ Massive Open Online Course (MOOC). The MOOC has been developed at Curtin University in collaborations with researchers from Monash University, City University of New York and Boise State University. It was co-designed with partner organisations and consumers (including older adults and allied health students from Curtin University). This feasibility study will be followed by a wait-list randomised controlled trial where health literacy and ageism will be evaluated pre and post MOOC completion.

Research on dog-assisted reading programs in school settings mostly provide support; It has been shown that the greatest improvements in reading may occur with younger readers in earlier grades, greatest gains for children in special education, ESL, and children who struggle with reading (Kirnan et al., 2016) and with emotional disorders (Anderson & Olson, 2006). Existing research, however, shows mixed results as the methodology and designs vary and anecdotal supports are often subjectively positive (Kirnan et al., 2016; Stevenson et al., 2015). The aim of this research project is to evaluate the impact of a Dog Training Intervention on high school students using Seligman’s (2011) PERMA model of the five pillars of wellbeing: Positive emotion, Engagement, Relationships, Meaning, and Accomplishment. The EPOCH measure of adolescent well-being (Kern et al., (2016) is utlitised as an outcome measure as well as qualitative analysis of end of treatment focus groups with consenting adolescents. These methods will explore how the dog training intervention may have impacted on high school students’ engagement, perseverance, optimism, connectedness, and happiness as well as their experiences and perceptions of the intervention.

Pelvic pain is common, affecting about one in four women, typically starting in their teenage and young adult lives, critical times while they are studying, entering the workforce, developing relationships and considering a family, with pain continuing right up to menopause and beyond. The burden on the individual affects their physical and mental health, in turn affecting their work, study and relationships. Women living outside metropolitan areas usually experience significant barriers to access the specialised and interdisciplinary care they need. This study will design, deliver and evaluate an evidence-based interdisciplinary model of care to women living in a regional Victorian area. This small-scale study will assist the regional health service develop a sustainable and effective model of care that fits their local resources and context. The hypothesis is that an interdisciplinary model of care for pelvic pain will be feasible in a regional health service (NHW), when supported by specialised services from the RWH, a “hub and spoke model of care”.

This trial aims to compare four different radiotherapy treatment approaches for prostate cancer using a technique called "Stereotactic Body Radiotherapy" or SBRT to find out which has the best outcomes and least amount of side effects. The treatment approaches will look at two different schedules, either 5 treatments over 2 weeks or 2 treatments over 2 weeks, as well as whether a reduced radiotherapy dose can be used (called "de-escalated" treatment). Who is it for? You may be eligible for this trial is you are aged 18 years or older, have been diagnosed with prostate cancer that your doctor classifies as "intermediate risk" and are suitable for treatment with SBRT. Study details Participants who meet the eligibility criteria will be randomly assigned to one of the four treatment approaches. There is an equal chance of receiving each group. These include: Group 1: SBRT given in 5 treatments over 2 weeks with standard dose to the whole prostate Group 2: SBRT given in 5 treatments over 2 weeks with de-escalated dose to the prostate Group 3: SBRT given in 2 treatments over 2 weeks with standard dose to the whole prostate Group 4: SBRT given in 2 treatments over 2 weeks with de-escalated dose to the prostate During and after treatment for up to 5 years, participants will be asked to complete questionnaires about their quality of life related to prostate cancer as well as report on any side effects of treatment to the trial staff. The trial staff will also access participants' medical records to check whether there have been any signs the cancer has returned such as blood test results, imaging scan results and if any new treatment has been started. It is hoped that this trial will help to determine which radiotherapy approach is best for treating prostate cancer with the smallest amount of side effects. The results will help inform a future larger trial of these treatments that may definitively answer this question.

Deep brain stimulation (DBS) is an established efficacious treatment to reduce symptoms associated with neurological conditions such as Parkinson's disease. The success of DBS relies on accurate electrode lead implantation and optimised DBS stimulation. DBS stimulation includes several fitting parameters, including stimulation polarity. This study aims to explore the effects of DBS stimulation polarity on speech and gait outcomes in Parkinson’s disease.

The menstrual cycle may affect physical performance. However, existing evidence is inconsistent and often based on isolated testing timepoints rather than typical training conditions. By monitoring resistance training and quantifying kinematic outputs during exercise, practitioners can gain insight into how performance varies according to menstrual cycle phase, perceived symptoms, motivation, and readiness. This study aims to (1) investigate changes in kinematic outputs during resistance training across different menstrual cycle phases, and (2) examine whether symptoms and perceptions of motivation and readiness are associated with these changes across two mesocycles in resistance-trained females.

Excessive and unbalanced screen use is an increasing concern among Australian adolescents, with potential impacts on physical, psychological, and family well-being. The objective of this study is to evaluate the feasibility of a family-based intervention designed to promote healthy screen use among adolescents in Australia. The study will adopt a single-arm pre–post design conducted within secondary schools in South-East Queensland. The intervention will be delivered over approximately 2–3 weeks and will include interactive school-based sessions, short educational video modules, parent engagement activities, and home-based action strategies. Outcome data will be collected at baseline and immediately post-intervention to assess changes in screen use behaviours, related psychosocial measures, and implementation feasibility.

We are conducting this research study because in sick people requiring help with breathing, the insertion of a breathing tube with the assistance of an airway introducer is frequently done. Often the breathing tube (endotracheal tube or ETT) will catch on the voicebox as it goes into the windpipe, requiring extra steps. There are two designs of endotracheal tube in common use, one has the tip with a side facing bevel, and the other with a front to back facing bevel. It is theorised that the direction of the bevel at the end of the endotracheal tube influences the ease of insertion, making it less likely to ‘catch’ when an airway introducer is routinely used. There are no studies that show this is the case with the current available combinations. This trial will address this lack of knowledge, and assist our departments to decide which design of tube to use. Currently we use both designs.