ANZCTR search results

Self-regulation, a type of self-management, takes an active learning approach to rehabilitation by enhancing the person’s self-awareness and encourages self-reflection to overcome problems. Mental imagery is when a person imagines every detail of the actions required to perform a task without actually physically moving to do the task. We postulate that self-regulation and mental imagery may enhance the self-awareness and attention developed and can enhance the everyday task performance, such as dressing and cooking for people with Parkinson's disease. Objectives of the study: 1. To pilot-test the self-regulation and mental imagery program to enhance performance of everyday activities, motor function, and cognitive function for people with Parkinson’s disease. 2. To evaluate the feasibility and acceptability of the SRII program.

The main purpose of this research project is to see if immunotherapy drug pembrolizumab may shrink the tumour prior to surgery and potentially reduce the requirement of subsequent treatment such as post-operative radiotherapy (PORT) in patients with Squamous Cell Carcinoma (SCC) of the skin. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a confirmed diagnosis of invasive SCC, and are a candidate for surgical resection and/or post-operative radiotherapy. Study details All participants will receive pembrolizumab intravenously once every 3 weeks for a total of 4 cycles prior to planned surgery. Depending on the effect of pembrolizumab, participants will either receive surgery, surgery and PORT, or neither, depending on the proportion of tumour cells seen on biopsy. All participants will subsequently have post-operative pembrolizumab for 12 months in three weekly visits. Your participation in this research project consists of: • A screening period of up to 28 days: After you sign this Participant informed consent form, testing will be done to determine if this research project is suitable for you. • A treatment period of approximately 64 weeks and • An end of treatment visit, approximately 30 days after the completion of the study drug treatment period. This may be because you have completed the treatment period, or you or your doctor has decided to stop you receiving the study treatment. • A post-treatment follow-up period of approximately up to 2 years or until your skin cancer returns or the study ends It is hoped that this study will help us understand whether pembrolizumab can shrink the tumour, in which patients this may be more likely to occur, and any side effects that may be experienced during this study. This may help to treat other patients with SCC of the skin in future and reduce the requirement for surgery or radiotherapy.

Currently, opioid dependency has been managed with methadone treatment per NSW Health Clinical guidelines treatment of opioid dependence. Patients are attending the clinic every day to get treatment. Methadone takes away doses creates a risk of injection and harming others. There is a need for a new medication to maintain opioid dependence and also provide takeaway doses safely. New medication will help to minimize intravenous methadone use and harming others. The Methadone Naloxone (M&Nx) has a potential medication to maintain opioid dependence and will be given as taking away doses in this study. The (M&Nx) has been tested in a patient group with opioid dependence. In this study, patients with opioid dependence were given M&Nx at different doses according to the patient’s condition and the Specialist Doctor's decision. M&Nx at 50:1 was tested for acceptability, safety, and tolerability at Drug Health Clinic and the medication was well tolerated. The clinical trial phases 1 a and 1 b for M&Nx were performed by applying multiple doses to the patients with opioid dependence. M&Nx medication needs to be investigated further to identify the utility of treatment in Drug Health clinical settings by Clinical trial phase 2a. This study aims to use M&Nx to increase the quality of patient life with enhanced harm reduction. Opioid prescribing has increased significantly, and diversion of prescribed opioids has become a major problem of drug misuse. Combining M&Nx treatment may reduce the attractiveness of selling, diverting, or injecting methadone. This trial intends to study M&Nx in the treatment of adult outpatients with opioid dependence to minimize infection transmission in the drug health clinic setting. The study aimed to promote a better approach for patients by offering potential advantages over methadone maintenance alone such as minimizing the risks of diversion, injection, and selling in the black market. Primary Objectives To compare feasibility and harm reduction of M&Nx to methadone alone standard of care in adult outpatients with opioid dependence. Secondary Objectives a)To assess patient satisfaction with treatment b) To assess treatment effects on illicit drug use other than opioids c) To assess treatment effects on quality of life and patient functioning

Kidney transplantation is the best form of treatment for patients with kidney failure, however transplant recipients are at risk of allograft rejection, because the recipient’s immune system recognises the transplanted organ as foreign. Up to 20% of kidney transplant recipients experience at least one episode of rejection. This remains a major cause of kidney transplant failure. Most episodes of rejection are diagnosed by performing a kidney biopsy on patients who have been found to have abnormalities on their blood test results. However, a significant proportion of patients have rejection despite not having abnormal blood test results. In order to detect these cases of “sub-clinical” rejection, the majority of transplant recipients are subjected to surveillance kidney biopsies at pre-determined time points, even in the absence of any clinical problems. Kidney transplant biopsies are invasive, uncomfortable and carry some risk, but remain the only reliable way of diagnosing rejection, especially sub-clinical rejection. Because surveillance biopsies are only performed at a few predetermined time points it is also possible for subclinical rejection to be present weeks or months before it is detected by such a biopsy or becomes clinically evident. Assessment of the pattern of proteins or protein fragments excreted into the urine of kidney transplant recipients may provide an alternative, non-invasive method of understanding the condition and health of the kidney. If a panel of urinary proteins that changes in the setting of kidney transplant rejection could be identified, it could potentially allow for the detection of patients with or at risk of subclinical rejection, therefore avoiding the need to subject large numbers of patients to surveillance biopsies. It might also allow earlier detection of subclinical rejection meaning that it can be treated with before damage is done to the kidney. This pilot study will be performed in collaboration between the Royal Melbourne Hospital and the Walter and Eliza Hall Institute of Medical Research . Kidney transplant recipients at the Royal Melbourne Hospital will have urine samples prospectively collected at pre-determined time points in the first year post-transplantation. These samples will be analysed at the Advanced Technology and Biology Division at the Walter and Eliza Hall Institute of Medical Research (WEHI). Urine protein patterns will be correlated with outcome data obtained in the course of routine clinical care in order to determine the existence of any patterns that correlate with rejection. Serial samples will be analysed to determine whether identification of these proteins at earlier time points can identify patients who ultimately develop rejection. Whether the lack of expression of these proteins can also identify patients who are not at risk of rejection (therefore not requiring surveillance biopsies will also be analysed.

Non-alcoholic liver disease (NAFLD) affects 20-30% of the population and significantly increases the risk of liver related all-cause mortality, transplant, cardiovascular disease and liver cancer. There are no proven safe or effective pharmacotherapies and current management targets weight loss. In the absence of optimal diet and exercise prescription effective management strategies for NAFLD require urgent attention. There are currently no established recommendations for diet or exercise prescription to achieve weight loss. Establishing an effective management strategy for NAFLD, in light of the high (~5.5 million Australians in 2021) and increasing prevalence of the condition, is a public health priority. Weight loss is the current recommendation for NAFLD and known to improve liver and cardiovascular outcomes. The Mediterranean Diet (MedDiet) is a promising intervention, improving body composition and metabolic risk factors in the absence of weight loss. These benefits are attributable to the MedDiet’s anti-inflammatory and antioxidant composition. Thus, developing a better understanding of the combined benefits of weight loss and MedDiet on body composition will facilitate the development of evidence-based interventions that can be translated into practice to improve outcomes for people with NAFLD. Rationale/Justification: The proposed research is significant as this innovative research will be the first worldwide to assess the feasibility of a web based hypocaloric MedDiet in NAFLD, in a non-Mediterranean cohort. A concept that would translate to an intervention that is novel yet simple, as well as cost effective, and can be integrated into practice.

We propose a prospective randomised clinical trial in patients with a fully recovered AF-mediated cardiomyopathy receiving ongoing heart failure therapy, given the paucity of data and the recognised reversible nature of this condition. Patients will be randomised to either staged withdrawal of neuro-hormonal therapies or their continuation and each group will crossover at 6 months for a total study duration of 12 months. Serial assessments will include cardiac imaging, exercise testing and symptom assessments throughout the study period.

Cirrhotic cardiomyopathy (CCM) is a specific type of cardiac dysfunction seen in liver cirrhosis without a primary cardiac cause. It is an important cause of morbidity and mortality before and after liver transplantation (LT). Despite its high prevalence, it is relatively understudied as the diagnosis often becomes clearer only under stressful conditions. The study aims to define early diagnosis of cirrhotic cardiomyopathy using advanced echocardiographic techniques and its clinical significance. In addition, the reversibility of cardiac dysfunction thus studied, will be assessed after LT. In a cohort of 80 consecutive cirrhotic patients, this will evaluate global myocardial work index (GWI)and global longitudinal strain (GLS) as markers of CCM under resting conditions and under pharmacologically induced stress when necessary. The study cohort will be followed-up for 12 months with respect to development of complications such as renal dysfunction, fluid overload, cardiac failure and death/ Lliver transplantation. It will provide the first ever description of GWI and GLS in the diagnosis of CCM in decompensated cirrhosis and its clinical correlation.

This study aims to compare a new form of image processing for endoscopy, called Texture and Colour Enhancement Imaging (TXI), with the existing image processing, white light endoscopy (WLE) and Narrow-Band Imaging (NBI) to determine if TXI is better able to detect early cancerous changes in the oesophagus of patients with Barrett's Oesophagus. Who is it for? You may be eligible for this study if you are between 18 and 80 years of age and you are undergoing a scheduled endoscopy for Barrett's oesophagus monitoring or you have been referred for further assessment of dysplasia/early cancer because of long term Barrett's oesophagus. Study details All participants who choose to enrol in this study will be randomly assigned by chance (similar to flipping a coin) to undergo either TXI followed by WLE and NBI imaging during their endoscopy, or to undergo WLE and NBI followed by TXI during their endoscopy. All participants will undergo both imaging processes, only the order will be randomly assigned. During the endoscopy, tissue biopsies will also be taken to check for cancerous or pre-cancerous cells within the oesophageal tissue. The endoscopy procedure is expected to take up to 15 minutes. It is hoped this research will determine whether the new TXI image process is able to detect more pre-cancerous cells than previous forms of endoscopic imaging. This new form of imaging may then be used to improve health outcomes of future patients with Barrett's oesophagus, by detecting potential cancers earlier so that treatment can be most effective.

This study will be a randomised controlled trial aiming to compare traditional Plaster of Paris (POP) cast versus synthetic cast for management of patients with simple wrist fractures who present to Monash Health emergency departments (ED). We hypothesize that if synthetic casts are applied in the ED in the first instance, although this material is more expensive than POP, this would eliminate the need for further cast changes at the Fracture Clinic review (usually 2/52 post injury). Therefore this intervention would reduce cost and time for the organisation overall. The primary outcome measure will be total number of cast changes until immobilisation by cast is no longer required. Secondary outcomes will include cost effectiveness and patient satisfaction. 110 participants will be recruited to the study between July 2021 to January 2022. Evidence gained from this study will contribute to future treatment of wrist fractures in the ED. It would reduce the cost to the healthcare system and demand on Fracture Clinic and also improve patient satisfaction and comfort. This practice may be translated into other health care networks in Australia and worldwide.

Background Artificial intelligence (AI) has become increasingly capable over the last decade. AI technologies are approaching or surpassing human abilities at complex tasks. Specifically, in healthcare, AI is approaching or surpassing human clinician ability in multiple narrow domains. Research on AI in medicine has been increasing worldwide and across almost all specialties. General public opinion has seen to be positive in several surveys, with the public expressing high hopes that AI could be used to improve healthcare. Interaction with AI technologies is likely to become an increasingly common aspect of healthcare for both patients and physicians. Despite these trends, there is no data regarding health consumers’ attitudes, and opinions towards the use of AI in emergency medicine and healthcare. Aim Assess health consumers’ attitudes towards the use of AI in emergency medicine and healthcare. Plan We will conduct voluntary semi-structured interviews with a representative sample of health consumers until thematic saturation is achieved. Health consumers will be recruited from consumer advocacy groups such as the Consumer and Community Involvement Program, and we will conduct the interview either in person or over the phone (at a time of their convenience). We will continue interviews as required until we achieve appropriate representation and theme saturation. We will undertake qualitative analysis on transcribed interviews to uncover attitudes and themes.