ANZCTR search results

This study will develop the Skin Field Cancerisation Index (SFCI) using a Delphi method of experts who assess skin field photographs. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have photographs of skin fields including the face, upper limbs, lower limbs and torso. Study details This is a multi-site and multi-specialty initiative lead by Dermatologists with the primary outcome aim of validating the Skin Field Cancerisation Index (SFCI). Patient photography will be the primary method of data collection used for validating this score. Skin Fields that will be collected range from none to severe disease burden severity based on previous dermatological experience. Twenty medical specialists around Australia will assess up to 150 photographs to measure their perceptions of SFCI to identify reliability and validity of the instrument. This study will contribute to research in health care as the use of this score will provide consistency between observers and can potentially be used to assess efficacy of treatment interventions.

Insomnia is a highly prevalent chronic illness with approximately 30% of Australian adults classified as having insomnia or insomnia symptoms. To date, there is a paucity of research in insomnia treatments options in primary care, which is surprising considering the number of patients with insomnia who are managed by GPs. The current study will test the feasibility of a mobile application (SleepFix) delivering behavioural therapy for insomnia in primary care.

The LEISURE Study aims to assess the efficacy of a 12-week multimodal lifestyle intervention program incorporating exercise, diet, mindfulness and sleep compared to care-as-usual to reduce dementia risk in a group of healthy older adults. Participants’ risk profile will be assessed using novel biomarkers in conjunction with comprehensive neuropsychological and neuroimaging techniques. The rationale for the trial is founded upon a body of evidence that now suggests AD may be classified as an age-related metabolic neurodegenerative and vascular disease, wherein aberrant metabolic and inflammatory signalling leads to a cascade of neurotoxic changes that result in impaired cognitive function. Using this framework, each component of the multimodal lifestyle intervention has been chosen to target specific metabolic or vascular regulatory systems to promote neurogenesis, leading to improved cognitive function and reduced dementia risk. The LEISURE study aims to assess whether such multimodal lifestyle interventions are more efficacious than care-as-usual in reducing multiple risk factors implicated in the aetiology of dementia, particularly AD. The LEISURE study is unique in combining leading neuroimaging techniques with novel biomarker identification to develop a new model of dementia prevention through non-pharmacological lifestyle approaches. While the field of lifestyle interventions for dementia prevention is in its infancy, the LEISURE study will provide crucial insight into the biomolecular mechanisms underpinning healthy brain ageing.

RAFT is an SMS-based, brief contact intervention for people who have recently presented to hospital in suicidal crisis. RAFT sends a series of ‘caring contact’ messages with links to online therapeutic content. This trial will assess the benefits of linking participants with the RAFT online content relative to sending text messages alone and will also assess the benefit of sending information to a nominated support person. We hypothesise that linking participants with RAFT’s online content and including a nominated support person in the intervention will be associated with the greatest reduction in suicidal ideation.

Hip replacement demand continues to rise with the ageing population. There are several surgical approaches to perform hip replacement. The posterior approach is the most commonly performed approach, with several variations. Recently, there has been an increasing interest in the Direct Anterior Approach, due to the belief that it may result in decreased pain, faster recovery, improved hip stability and decreased risk of dislocation. Whilst some small early studies have reported decreased narcotic consumption, shorter length of stay and earlier independent mobilization; other have suggested increased rates of persistent pain, increased dislocation rates, component malposition and a comparable dislocation rate. Most studies already described in the medical literature are small numbers <50 patients and have short follow-up (<1year ) The aim of our study is to determine the long term patient outcomes and complication profile for the direct anterior approach in Total Hip Replacement using a large cohort. Hip function, hip pain, walking aid use, complications and patient satisfaction will be assessed by means of a patient survey completed 2 year and 5 year anniversary of their surgery. The survey will take approximately 10 minutes to complete and may be returned electronically or via reply paid envelope.

Obstructive sleep apnoea (OSA) is a surprisingly common disorder and occurs due to upper airway obstruction. OSA is characterised by repetitive periods of obstructed breathing during sleep and is an independent risk factor for coronary artery disease, affecting 40%-60% of cardiac patients. Furthermore, untreated moderate to severe obstructive sleep apnoea (OSA) in patients with established coronary disease is associated with increased cardiovascular morbidity and mortality. Therefore, treating OSA in isolation is key for cardiovascular risk reduction. The purpose of this trial is to determine whether optimized OSA therapy can be achieved in a cardiovascular population using best-practice compliance enhancement strategies including digital patient engagement tools. Furthermore, we will assess the impact of optimized OSA therapy on surrogate markers of cardiovascular health. Collectively, we hypothesise, that optimised OSA therapy will be accepted and treatment adherence can be optimised in patients with coronary artery disease and that treatment will improve surrogate markers of cardiovascular health.

Ventricular tachycardia (VT) is a life-threatening electrical disorder in patients with heart disease. Current methods treat VT by widespread ablation of damaged regions in the heart. We aim to test a strategy of focused ablation limited only to those areas that have electrical properties prone to facilitate VT. This will reduce procedural time and improve safety.

This study aims to evaluate the use of temozolomide in different regimes for Glioblastoma. The trial is testing two changes to the usual schedule of treatment. Who is it for? You may eligible for this study if you are a male or female aged 18 years or older, with newly diagnosed, histologically confirmed grade IV malignant glioblastoma. For the initial questions of interest, participants will be randomly allocated (50/50) chance to one of two treatment groups, to either QUESTION 1: Intervention Arm 1: After surgery, start temozolomide as soon as possible prior to chemoradiotherapy Control Arm 2: After surgery, start temozolomide at the same time as radiotherapy QUESTION 2: Intervention Arm 1: After chemoradiotherapy, take adjuvant temozolomide until disease progression Control Arm 2: After chemoradiotherapy, take adjuvant temozolomide for 6 cycles For participants that choose not to be randomly allocated treatment will be at patient/doctor discretion. All participants will be asked to have blood tests and scans as you would for usual treatment, the extra things requested are to fill out questionnaires and donate extra blood tests. It is hoped this research will help identify if starting temozolomide earlier than usual and/or continuing treatment with temozolomide for longer than usual will improve the outcomes of people with glioblastoma and assist development of future treatments.

A randomised controlled trial to evaluate whether osteopathic light touch manual therapy care has an impact on reducing crying time in infants (under 10 weeks old) with colic. The comparator arm is non-specific light touch. We will need to randomise 112 parent(s)/carers and their infants. Parents will be blinded to whether their infant receives the usual osteopathic therapy care or not. This study will provide information about the clinical and social relevance of osteopathic care for excessively crying, unsettled and distressed infants and their parents.

The purpose of this research is to determine the effectiveness of an individualised, fruit and vegetable rich diet on weight loss and on the changes in markers of inflammation that occur in response to a bout of exercise, as many people combine changes in diet and exercise for weight loss. Participants will receive individualised feedback on their diet and gain an increased understanding of how having a diet high in fruit and vegetables can be used for weight loss. Participants will also receive a weeks worth of fruit and vegetables at the commencement of the study to demonstrate target consumption.