ANZCTR search results

This study involves the testing for eight weeks of a regulatory approved acne support supplement The research project is aiming to: • generate evidence-based advertising claims within the regulatory-permitted indications for the Acne Support product. • evaluate the product effectiveness on acne severity will be evaluated in an eight-week real-life direct-to participant setting, in people with mild-to-moderate facial acne. • assess the effectiveness of the treatment on other outcomes related to the condition and participants’ quality of life Patients will be recruited via a consumer panel or through social media or other virtual channels via an online screening survey. This study will be completed taking one oral tablet of the Acne Support product once daily for eight weeks.

The CONSOLE clinical trial aims to compare two schedules of radiotherapy in the treatment of painful cancer that has spread to bones not located in the spine. Who is it for? You may be eligible for this study if you are an adult over the age of 18 who has been diagnosed with cancer that has spread to your bones not located in the spine and is causing you pain. Study details Participants will be randomly assigned to one of two radiotherapy schedules as part of this study. In Arm A, called the conventional treatment or current standard of care, participants will be either given in one (1) treatment on a single day or five (5) treatments over a period of a maximum of seven (7) calendar days for each area which is painful. If you are having more than one area treated, all areas must be completed within 14 calendar days. Each treatment will go for around 15 to 30 minutes. . In Arm B, called Sterotactic Body Radiotherapy (SBRT), participants will be given in two (2) treatments with a minimum of one (1) and a maximum of three (3) days gap between treatments for each area which is painful. If you are having more than one area treated, all areas must be completed within 14 calendar days. radiotherapy which is given in two treatments. Each treatment will take around 30 to 45 minutes. Questionnaires and pain and medication diary will completed at the initial assessment, last day of treatment, 2 weeks after radiotherapy and at 3 and 6 months following the last treatment.

The aim of this study is to determine whether real-time feedback of patient-reported outcome measures (PROMs) to treating clinicians improves duration on treatment in patients with relapsed multiple myeloma receiving standard of care treatment, when compared to standard of care treatment alone. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of relapsed multiple myeloma, and have or are commencing a lenalidomide, carfilzomib, or daratumumab based treatment regimen. Study details Participants will be randomised (i.e. allocated by chance) to receive standard of care treatment plus real-time feedback of PROMs, or to receive standard of care treatment alone. Participants in the intervention group will be asked to complete a multiple myeloma-specific quality of life questionnaire (myPOS) within the week before each clinical visit using an online PROM collection system. Participants receiving daratumumab or carfilzomib based regimens will also complete additional questions regarding treatment-specific side effects at this time. The questionnaires will take approximately 10 minutes to complete, and will be completed prior to a total of 13 visits over a period of 12 months. A summary of the completed questionnaires with results of concern will be provided to your treating clinician before clinical visits, so that the results may be considered in your care. Participants in the standard of care alone group will not complete the MyPOS questionnaire prior to clinic visits. All participants will be asked to complete a quality of life questionnaire and a treatment satisfaction questionnaire every three months. Participants in the standard of care alone group, receiving daratumumab or carfilzomib based regimens, will also be asked to complete the additional questions regarding treatment-specific side effects every 3 months. After a period of 12 months, all participants will have data collected from their medical records on time to discontinuation of treatment, disease progression, and survival, and will complete questionnaires regarding quality of life, side effects, and treatment satisfaction. It is hoped that this study may show that real-time feedback of patient-reported outcome measures (PROMs) to treating clinicians at clinic visits improves duration on treatment and survival when compared to patients on standard of care alone.

The study is a feasibility trial using an uncontrolled pre-post design, which measures feasibility and performance before and after the intervention. This trial aims to examine whether intensive prehabilitation therapy can be safely and effectively delivered to people living with chronic spinal cord injury in Australia and who have undertaken minimal rehabilitation in the last two years. The feasibility trial will also test whether intensive prehabilitation improves overall health, social outcomes and functional recovery for people living with chronic spinal cord injury.

Derangements of serum phosphate concentrations, specifically hypophosphataemia, are common among ICU patients and our previous work has suggested this may be associated with worse clinical outcomes, including higher mortality and morbidity. Although replacement of phosphate through both intravenous and enteral routes is common in ICUs, the optimum threshold of serum phosphate at which to commence active replacement in critically ill patients is currently unknown, and the benefits have never been confirmed with an RCT. Resultantly, there are no consensus guidelines on phosphate replacement in ICU, with individual ICUs and clinicians self determining thresholds at which to replace phosphate. Such treatment comes at significant cost and there are potential adverse outcomes associated with phosphate replacement including hypocalcaemia (potentially precipitous and life-threatening), nausea, vomiting, diarrhoea and hypotension. Thus, ICU clinicians are left with substantial uncertainty about the optimal threshold at which to replace phosphate. Therefore, a clinical and ethical imperative exists to conduct a high-quality, investigator initiated, RCT to inform clinical practice with regards to phosphate replacement and its impacts on patient centred outcomes in critically ill patients. The PRICE-1 RCT will compare the use of a restrictive phosphate replacement protocol against a liberal phosphate replacement protocol for the management of serum phosphate levels in critically ill patients. The liberal protocol will start replacing phosphate when the serum concentration is below 0.80 mmol/L, whereas the restrictive protocol will start replacement when the serum phosphate concentration is below 0.50 mmol/L. The choice of oral versus intravenous phosphate administration is determined by the functioning of the patient's gastrointestinal tract. All other aspects of patient care will be determined by the treating clinicians as is appropriate for the condition/s with which the patients are admitted to the Intensive Care Unit. We hypothesise that use of a restrictive phosphate replacement protocol, compared to a liberal protocol, will result in reduced amount of phosphate replacement administered to critically ill patients in the Intensive Care Unit. Additionally, we hypothesise that the conduct of an electronic database-integrated cluster randomised trial will be feasible.

Aim/s, hypothesis and /or research question This is primarily a feasibility study to ascertain the achievability of larger scale studies involving the use of activity trackers in joint replacement (and potentially other operations) patients. Primary aim: 1. To investigate the association between PA and SB and postoperative outcomes (pain, function, quality of life, complications) and determine the composition of PA and SB (including the intensity of PA and time spent sitting, standing and sleeping) associated with better postoperative outcomes. Secondary aim: 1. Investigate the association between preoperative PA and SB and preoperative health status (pain, function, quality of life) 2. Characterise and compare PA and SB (including the intensity of PA and time spent sitting, standing, stepping, sleeping, number of sit-to-stand transitions per day, number of bouts of prolonged sitting >30 min) in patients undergoing hip or knee replacement in the preoperative, immediate-postoperative and 3-month postoperative stages Evidence gathered from the proposed study will be used to initiate a program of research to inform the design and implementation of larger multicentre observational and interventional studies with larger numbers of the participants and extended follow up periods. Primary hypothesis: Post-operative outcomes will be associated with PA and SB and will be influenced by the intensity of PA performed and the amount of sedentary time. Those with higher levels of pre-operative activity will be less likely to have post-operative complications, and the inverse relating to sedentary time.

Obesity is a leading contributor to preventable mortality in Australia. While the causes of obesity are multifaceted, epidemiological studies suggest that overconsumption of highly rewarding energy-dense and ultra-processed food is a leading driver of rising obesity rates. Our team has previously shown that obesity is associated with abnormal communication between the brain regions involved in reward responses to food (i.e., the medial prefrontal cortex [mPFC], striatum and insula), and those involved in energy regulation (i.e., the hypothalamus). These regions and their connections have also been linked to food cravings which are a known driver of overconsumption. Therefore, interventions that can modulate neural connectivity between cortico-striatal-hypothalamic regions are promising candidates to reduce food cravings in people with obesity. The connectivity between these brain regions can be modulated using non-invasive brain stimulation, namely a form of repetitive transcranial magnetic stimulation (rTMS) known as continuous theta burst stimulation (cTBS). rTMS is an FDA approved treatment for depression and is being trialled for multiple psychiatric and neurodegenerative diseases. In this trial we will test if rTMS-cTBS can reduce abnormally increased connections between brain regions involved in food reward responses in obesity. We expect that rTMS-cTBS over the mPFC will reduce abnormally increased connectivity (i.e. neural communication) between the mPFC and regions of the brain reward circuit involved in food cravings.

The purpose of this study is to assess the safety and immune system response to treatment with Tislelizumab in patients with Epstein-Barr virus (EBV)–positive diffuse large B-cell lymphoma (DLBCL). Who is it for? You may be eligible to join this study if you are aged 45 years or older and have been diagnosed with EBV-associated DLBCL, without immunosuppression. Study details All patients enrolled in this study will receive treatment based on 21-day cycles, with 4 stages: 1. "Induction" stage, involving intravenous Tislelizumab (200mg) and Rituximab (375mg/m2) on day 1 of each cycle over 3 cycles (9 weeks total). 2. "Combination" stage, involving Tislelizumab (200mg), Rituximab (375mg/m2), Cyclophosphamide (750mg/m2), Doxorubicin (50mg/m2), Vincristine (1.4mg/m2, up to a maximum of 2mg) on day 1 of each cycle; and oral tablet Prednisolone (100mg) daily on days 1 to 5 of each cycle. There are 6 cycles for this stage (18 weeks total). 3. "Cell Therapy" stage, involving intravenous Epstein-Barr Virus (EBV) virus specific T-cells (Auto-EBV-VST). Two infusions of 3x10^7/m2 each will be given a week apart. Six weeks after the 2nd infusion, patients will have a PET/CT scan to assess if the cancer has disappeared. If so, the patient will move to the next stage, "Maintenance". (However, if the cancer has not disappeared, the patient will be withdrawn from the treatment phase of this trial.) 4. "Maintenance" stage, involving intravenous Tislelizumab (400mg) on day 1 of every second cycle over 16 cycles (48 weeks total). Overall, the study will take 83 weeks. Other testing that will be performed includes serology, blood tests, bone marrow assessment and ECHO scans (at baseline and end of treatment). It is hoped that the research will provide evidence for the safety of this immune-based approach, and lead to better outcomes for EBV-associated DLBCL lymphoma patients.

This trial aims to determine the prevalence of vestibular dysfunction in patients admitted to a specialist rehabilitation unit. Who is it for? Patients aged 18 or above, current inpatients of BIRU or GARU wards at Princess Alexandra Hospital, Queensland Study details All participants will complete the Vestibular Screening Test and then complete objective vestibular testing. All participants from the same ward will be tested consecutively on the same day. It is hoped that this study will demonstrate the prevalence of vestibular dysfunction within patients of the specialised wards. It is also hoped that the outcomes of this project may have implications for physiotherapists working in subacute rehabilitation units to include vestibular screening as part of their standardised initial physiotherapy assessment on admission. A timely and routine vestibular screening assessment could be a worthwhile adjunct to the standard physiotherapy assessment to guide early and appropriate intervention and achieve optimal rehab outcomes.

Only 15% of cardiac rehabilitation attendees are achieving the physical activity guidelines. In people with heart disease, insufficient physical activity is an independent risk factor for all-causes of death. Within cardiac rehabilitation, people with heart disease are encouraged to meet the physical activity guidelines. Yet clearly, an innovative and effective physical activity intervention is needed in these programs. Our preliminary work has found that regular physical activity measurement by health professionals alone can drive physical activity adherence in insufficiently active adults. However, the optimum frequency of measurement in cardiac rehabilitation is unknown. ‘Measure It!’ is a very brief intervention, taking clinicians less than 5 minutes to complete. It includes a self-report and objective measure of physical activity (wearable activity tracker steps) plus physical activity advice. We will test two frequencies of physical activity measurement (2 and 5 measurements in total) by cardiac rehabilitation clinicians over 24-weeks. This hybrid effectiveness-implementation trial will recruit 190 insufficiently active cardiac rehabilitation attendees from 5 cardiac rehabilitation programs in the Australian Capital Territory and New South Wales. Daily minutes of accelerometer moderate-to-vigorous physical activity is the primary effectiveness outcome. Implementation outcomes will include acceptability, appropriateness, adoption, costs and sustainability. We hypothesize that 5 physical activity measurements over 24-weeks will result in increased accelerometer daily minutes of moderate-to-vigorous physical activity in insufficiently active cardiac rehabilitation attendees with heart disease compared with 2 physical activity measurements. If ‘Measure It!’ is successful, we will be able to recommend ways to incorporate this very brief intervention into cardiac rehabilitation service delivery. It will be a time and cost-effective approach to targeting physical activity within and beyond cardiac rehabilitation programs. Results will potentially drive changes in current practice, directly informing the development and implementation of cardiac rehabilitation services, leading to improved health for a large number of Australians with heart disease.