ANZCTR search results

This experimental study seeks to investigate the effect of different labels for high blood pressure (e.g. hypertension vs high normal blood pressure) on treatment decision-making and psychosocial outcomes (perceived severity; level of concern), compared to a control group where no label is given. It will also explore whether any effect is affected by a) sharing absolute risk information and b) health literacy. Australian adults aged 40-50 with a normal risk of hypertension will be sampled. Only those with an average risk profile will be included in the study, to be presented with a hypothetical diagnosis and asked a number of survey questions investigating health literacy, treatment decision making, risk perception and perceived self-efficacy.

The overall aim of this proposal is to explore the link between stress-related eating behavior and treatment outcomes in people undergoing treatment for obesity. Patients who have been referred for surgical treatment for obesity (sleeve gastrectomy) will be invited to participate in a study in which half of them will be randomly allocated to using a very-low-energy diet (VLED) for 2 months while waiting for surgery. Participants will complete questionnaires, and have a meal test (involving collection of blood samples prior to and for 2 hours after a liquid meal) at the beginning of the study, and three months after the intervention (VLED or surgery), and 12 months after surgery. We hypothesise that stress-related eating will improve after sleeve gastrectomy, and will be associated with one or more hormones involved in appetite regulation.

This study's purpose is to assess new bones lesion(s) in prostate cancer participants starting androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you have prostate cancer with a high risk of metastatic disease and your treating doctor recommends starting ADT and targeted radiotherapy. Study Details: Participants in this study will undergo a 68Ga-PSMA PET CT at study entry. Participants will have two additional 68Ga-PSMA PET CT at 6 and 12 months. Participants will be followed up per routine clinical care. Participants have the option of providing optional blood test. It is hoped that this research will provide insight in the incidence and mechanism of bone lesions in advanced prostate cancer.

The purpose of this study is to identify if introducing a protocol to standardise post-cardiac surgery fluid resuscitation can reduce the amount of intravenous fluid administered and potential patient harm. By using a protocol and the calculated mean systemic filling pressure analogue, the amount of intravenous fluid received post-cardiac surgery can be restricted.

NP202 has been shown to reduce rhythm disturbances in heart muscle in the ventricles, and it is compelling to discover if it similarly reduces rhythm disturbances in heart muscle in the atria. As AF is the most common rhythm disturbance in the atria, it is the most suitable target to investigate a benefit. This is a single-centre, randomised, double blind, placebo controlled study to assess the efficacy, safety and tolerability of NP202. Subjects will be screened during routine interrogation of their cardiac device. Eligible subjects will have a high burden of paroxysmal atrial fibrillation. They will be randomised and administered their first dose of investigational product (IP) on Study Day 1. Subjects will take their IP dose once a day for 1 month (30 days). During this treatment period they will return to the site for study visits at Week 2, and Months 1, 2, and 3. Month 3 is the end of the Treatment Period. Subject will return for follow up and the final study visit at Month 4. A Data Monitoring Committee (DMC) will review safety data at agreed recruitment and progression milestones to provide independent oversight of subject safety. Armaron Bio Pty Ltd has provided the study drug at no cost. They have not have provided any funding and the study investigators have full intellectual property and rights over the study data.

This aim of this study is to compare three breath hold techniques for radiotherapy in patients with liver, kidney, adrenal, pancreatic or lung tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are eligible for radiotherapy treatment to the liver, kidney, adrenal gland, pancreas or lung. Study details Non-lung cancer participants will undergo three breath hold techniques in a random order: exhale breath-hold (EBH); inhale breath-hold (IBH) and deep-inhale breath-hold (DIBH). Participants with lung cancer will undertake the DIBH technique only. The patient breathes through an Active Breathing Coordinator machine, which automatically stops air flow when the correct volume of air is measured. Exhale Breath Hold requires the patient to breathe out and hold their breath. Inhale Breath Hold requires the patient to breathe in and hold their breath. Deep Inhale Breath Hold requires the patient to take a deep breath in and hold their breath. X-Ray images will be taken while the patient holds their breath, to measure the stability and reproducibility of their tumour. Patients will also be asked to complete a questionnaire to assess their experience of the breath-hold technique(s). It is hoped that we can determine the best techniques to enable delivery of high dose radiation to the tumour, while minimising the radiation dose to healthy organs.

This single group trial aims to evaluate the effectiveness of a music engagement program in improving quality of life and depression in aged-care residents with Alzheimers disease and dementia. We hypothesise that residents' indicators of quality of life (including feelings of social connectedness to others and emotional mood) will improve from pre to post session. We also hypothesise that residents' symptoms of depression will improve from pre- to post-intervention (8 weeks).

The purpose of this study is to provide some preliminary data on the impact of different levels of compression on lymphoedema. Who is it for? You may be eligible for this study if you are over 18, have completed breast cancer therapy (except hormone treatments) at least 6 months ago and have been diagnosed with secondary arm lymphoedema. Study details Participants in this study will be randomised (by chance) into two groups. All participants will wear a compression garment for 12 hours a day for 6 months and will be a sleeve and gauntlet. You will be measured for these by a certified lymphoedema therapist. One group will wear a high compression garment, and the other will wear a low compression garment. Participants will have the garments checked after one week, two months and 4 months of wear; as well as have some scans, undergo some measurements and complete a questionnaire before and after the 6 month trial. It is hoped this research will provide important preliminary information as to what the optimal level of compression is for people with secondary arm lymphoedema.

This trial will test the effectiveness of a brief, video-based online program for reducing depression and anxiety in Australian adults (FitMindKit). Those with elevated psychological distress will be invited to participate and randomised to use either FitMindKit or a comparable general health online program (HealthWatch) for a period of 4 weeks. FitMindKit is an online program that uses brief therapeutic modules to reduce symptoms of common mental disorders (major depression, anxiety disorders, substance use disorders). The intervention consists of 12 modules adapted and abridged to encapsulate CBT-based therapeutic techniques, such as behavioural activation, cognitive reframing, problem solving, and mindfulness. Participants will complete brief pre- and post-program questionnaires, and will receive weekly e-mail reminders to use FitMindKit or HealthWatch. Outcome measures include depression and anxiety symptoms. It is hypothesised that those who receive the FitMindKit program will show significant reductions in depression and anxiety symptoms relative to those in the control condition post-intervention. It is also hypothesised that greater adherence to the intervention (number of modules completed) will be observed in the intervention group relative to the control group, and that greater adherence will be associated with greater reductions in depression and anxiety symptoms post-intervention among those who receive the FitMindKit program.

This dismantling study will examine the effectiveness of the three DBT skills modules - distress tolerance, emotion regulation and interpersonal effectiveness - on distress tolerance skills, emotion regulation skills, and interpersonal skills, in a sample of patients with Borderline Personality Disorder (BPD) in three adult mental health services in Queensland, Australia. It will further analyse the differential and combined effects of these modules on symptoms of BPD. We hypothesise that patients who participate in the skills modules will show specific improvements in the domains that the skills are designed to address.