ANZCTR search results

• Purpose: To test a new method of jaw reconstruction that uses a custom implant in combination with a thin layer of bone with its own blood supply (a flap). This small flap, in combination with the implant is designed to allow for new bone to grow. The implant is designed to dissolve over time as it is replaced by new bone. As this is a new method, the main purpose of this trial is to assess for safety and tolerability of the implant. • Who is Running It? The Plastic and Reconstructive Surgery Department at Princess Alexandra Hospital, under the sponsorship of Metro South Health • Where & How Long? The surgery as well as follow up appointments will take place at the Princess Alexandra Hospital over a total duration of three years. • Ethics Approval: Approved by the Metro South Human Research Ethics Committee.

Study Title: The NIKI-C Study - A study of pharmacokinetics of nebulized ketamine in post-operative cardiac surgery patients in intensive care unit: A phase 2, single site, prospective, interventional, open-label pharmacokinetic study. A minimum of 20 patients will be consented and enrolled to receive a single dose of nebulized ketamine 0.75mg/kg (ideal body weight). Over a 2 hour sampling period 8 blood and 2 urine samples will be collected. Assessments will be conducted to report feasibility, pain, tolerance, concomitant sedatives and analgesia as well as monitoring for study specific adverse events. The hypothesis of the study are that 1. Plasma blood levels of nebulized ketamine in ICU post-operative cardiac surgery patients is adequate to provide analgesia. 2. Nebulized ketamine is not associated with any serious adverse events in the ICU post-operative cardiac surgery patients.

Obesity is a known risk factor for developing MS and a known risk factor for increased disability in established MS. We know that a high proportion of the MS population is living with extra body weight which is a modifiable lifestyle factor. The evidence tells us that if we lose weight this will affect changes beyond body size alone. However, losing weight and maintaining it is difficult and needs the support of a healthcare team to aid behaviour change. We will use a tested randomised controlled trial design to help people living with relapsing-remitting MS to make positive changes to their eating patterns, exercise routine and overall self-management of their MS. Our lifestyle approach includes nutrition, exercise and psychology elements and compares them with usual care delivered by an MS nurse. All strategies will be provided via a telehealth platform. The main hypothesis is that a novel, interdisciplinary approach to an individualised lifestyle intervention will result in greater weight loss compared to usual care. We also hypothesise that the lifestyle approach will be both feasible, acceptable and result in greater improvements to symptoms of MS (tertiary outcome).

This is a prospetive, exploratory, randomised, controlled feeding study looking at whether an anti-inflammatory diet can augment treatment response to 5aminosalicylates (firs tline treatment) in ulcerative colitis. Diet may play a role in developing ulcerative colitis (UC) but we don’t know whether diet can be used to treat ulcerative colitis (UC). The aim of this study is to investigate whether the MAID diet can improve response to medications and quality of life for patients with UC. We will also look at whether diet can also help good gut bacteria, produce anti-inflammatory chemicals and reduce gut leakiness.

This is a Phase 1, four-part clinical trial in healthy adult participants to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SPT-320, an investigational oral prodrug of agomelatine. Part A involves a single dose of agomelatine to establish baseline pharmacokinetic data.

Dose could have a direct response on the engagement of participants with mHealth programs, however currently there is minimal evidence regarding the optimal dose of messages in a parent targeted mHealth (text-messaging) intervention. This study aims to explore how dose of text messages can influence the acceptability, engagement, effectiveness and cost of a parent targeted mHealth text messaging program, HB4HNEKids. We hypothesise that the higher dose of text messages will have a lower acceptability and engagement, similar effectiveness and higher cost compared with the lower dose text message arm.

Clinically significant obstructive sleep apnoea (OSA) affects approximately 30% of the middle-aged population and contributes to long term poor health. Four main physiological mechanisms cause OSA, but current treatments typically only address one of these mechanisms and they are not well tolerated. A pharmaceutical therapy for OSA is desired by patients and has the potential to treat more than one of the mechanisms causing it. This study will examine the effect of a commonly prescribed medicinal cannabis product (delta-9-tetrahydrocannabinol, THC) on the mechanisms that contribute to OSA, its impact on OSA severity and effects on psychomotor and cognitive function. We hypothesise that compared to placebo, 10mg of medicinal THC will decrease the severity of OSA and beneficially alter some of the mechanisms which cause OSA without having a detrimental effect on next-day psychomotor and cognitive function.

This study is a pilot trial testing two brief online interventions for young adults (18-25 years) with high concerns about their weight and body shape. The goal is to see if these single-session interventions (SSIs) are feasible and acceptable, and to explore their effects on mental health and help-seeking attitudes. Participants, who are first-year psychology students at Flinders University, will be randomly assigned to one of two interventions: a help-seeking SSI or a behavioural activation SSI. The help-seeking SSI provides participants with a better understanding of what negative body image is and motivational strategies to promote help-seeking, whereas the behavioural activation SSI aims to improve mood by emphasising the importance of positive action. Participants will complete baseline measures, followed by their allocated single session intervention and post-treatment measures straight after.

People with pulmonary fibrosis (PF) are 70% less active than healthy individuals. Low levels of physical activity increases fatigue and worsens breathlessness and quality of life. Pulmonary rehabilitation is a recommended intervention to improve physical function, breathlessness, and quality of life in people with PF. Finding strategies that prolong the benefits of pulmonary rehabilitation such as improving physical activity are needed. This study will explore whether a physical activity counselling session, combined with using a physical activity tracker can increase physical activity levels and make pulmonary rehabilitation benefits last longer in people with PF.

Aim: These studies aim to investigate the feasibility and acceptability of a novel music and text messaging intervention in individuals with endometriosis. It also aims to evaluate the efficacy of this intervention in improving pain, stress, depression, anxiety and and emotional health-related quality of life. Design: There are 2 phases of this study involving a co-development phase and pilot randomised controlled trial of the intervention. Participants: A total of 62 individuals living with endometriosis (5-6 for co-design of the intervention; and 56 for the pilot trial). Methods: Participants will be asked to listen to self-created music playlist every day for 28 days. Participants will also receive psychologically-focused text messages co-designed to improve management of symptoms/emotional wellbeing (Sherman et al., 2022, 2023, 2024). Participants will complete pre- and post-study surveys, as well as a brief 5-minute survey each day throughout the intervention. Outcome: Participants will perceive the EndoSMS x music intervention as acceptable and feasible.