ANZCTR search results

This is a study to assess the efficacy and safety of cyclical testosterone and darolutamide in non-metastatic castration-resistant prostate cancer. Who is it for? You may be eligible for this study if you are an adult male with castrate resistant prostate cancer, with no evidence of metastatic disease (M0) on conventional imaging [Whole Body Bone Scan (WBBS) and Computed Tomography (CT) scan at screening] and prostate specific antigen (PSA) only progression on darolutamide. Study details Study participants will receive cyclical treatment with intramuscular (IM) testosterone, darolutamide and ongoing medical/surgical castration. This will be delivered in 56-day cycles until evidence of metastatic disease on conventional imaging unless treated beyond progression. Participants will be asked to provide blood samples, complete questionnaires and undergo scans during their treatment. It is hoped that findings from this study will help develop new treatment pathways for those with non-metastatic castration-resistant prostate cancer.

Spinal cord injury (SCI) is a life-changing severe injury resulting in substantial physical/psychological impairment. While significant research has investigated adjustment following SCI, very little is known about how co-morbid cognitive impairment impacts adjustment. It is believed around 50% of people with an SCI may have significant levels of cognitive impairment. The Project will employ a mixed methods approach (qualitative and quantitative) utilising implementation science to monitor the efficacy of the implementation and translation process for the 2023 version of the Psychosocial Guidelines (https://aci.health.nsw.gov.au/networks/spinal-cord-injury/resources/psychosocial-care), including guidelines for cognitive impairment, into the SCI Units in Sydney, NSW, Australia by exploring health care professionals and SCI patients’ perceptions towards the implementation of these guidelines. It is hypothesised that the intervention will promote the successful adoption, penetration, and sustainment of the 2023 version of the psychosocial guidelines in the SCI Units.

Whilst most patients are satisfied with their outcomes after a total knee replacement, moderate to severe persistent knee pain, defined as pain persisting beyond 3 post-operative months following surgery, can affect 25% of people at 6-months. NJ’s PhD studies have found associations of persistent high pain with reduced function, and reduced health related quality of life. Other studies have found that pain persisting after a knee replacement can interfere with walking, general activity and mood and reduced quality of life. A literature review conducted as part of NJ’s PhD (unpublished) found no rehabilitation programs addressing persistent pain after knee replacement. NJ, during his PhD studies, has designed a web-based, self-paced, pain rehabilitation program called Kneed to treat pain, reduced function and reduced quality of life for those with persistent pain after total knee replacement for osteoarthritis. The program consists of pain neuroscience education, exercise, motor imagery, desensitization techniques, relaxation, sleep and cognitive strategies such as goal setting. Educational and other strategies aim to normalize movement patterns (by reducing protective movements) and engage participants in functional activities by empowering behavior change. Kneed is being evaluated for the first time in a research study but has been used by patients under clinical supervision from Dr NJ (a Rehabilitation Physician) in a clinical practice. The potential benefit of Kneed as a digital health solution is to provide low-cost treatment to a broad audience, not limited by location (for example, rural areas and cities without pain management services). There are currently no evidence-based treatments available for this persistent pain condition, Kneed aims to provide one.

This study aims to use a Single-Case Experimental Design (SCED) in accordance with SCRIBE (Single-Case Reporting guideline In BEhavioural interventions) to investigate the efficacy of the RARE FINDS (Routine-based intervention, Activity and participation, Repetition and practice, Empowerment and education, Family centered, Individualised, Natural settings, Developmentally appropriate assessment, Start as early as possible) early intervention principles in improving gross motor function and goal attainment for young children living with or at risk of a rare disease (RD). Once the SCED has been completed, families involved in the study will be asked to participate in a 1/2 day workshop style co-design round table discussion which will form part of the qualitative review process of the study, aiming to refine the assessment and intervention components of the study for future studies.

To examine the feasibility and effect of the implementation of a descriptive glycaemic dashboard and proactive endocrinology consult service on glycaemia and glycaemic complications. Patients will be identified via an electronic dashboard with preset criteria of dysglycaemia and randomly assigned to 'standard of care', formal bedside consult, or a default entry on the electronic medical records. We hope to demonstrate that proactive intervention for patients with dysglycaemia will reduce hospital associated infections, as well as a number of other beneficial secondary outcomes.

Study hypothesis: Following an acute exposure to strength training exercise and nutritional supplementation with whey protein, limbs with a history of ACL injury will demonstrate increased activation of key molecular pathways underlying muscle growth, compared to a placebo-supplemented control group. A double-blinded two-conditions crossover design. Following an acute exposure to strength training exercise and nutritional supplementation with whey protein, limbs with a history of ACL injury will demonstrate increased activation of key molecular pathways underlying muscle growth, compared to a placebo-supplemented control group. Participants will be randomly assigned a trial order with each trial separated by a period of at least 5 days. All participants will first undergo magnetic resonance imaging (MRI) to assess quadriceps muscle size (i.e., volume) in both legs and preliminary resistance exercise testing to determine maximal strength of each leg. The design of the two experimental trials will follow the same format, with at least 5 days separating each. The evening prior to each experimental trial, participants will be provided a standardised meal to consume and be asked to arrive to the laboratory after an overnight fast (~8-10h). A small (i.e., ~150 mg) resting muscle biopsy sample will be obtained from the outer quadriceps (vastus lateralis) of the previously injured and contralateral (non-injured) limbs under local anaesthesia and sterile conditions. Additionally, a small blood sample (12mL each) will be collected pre, 1-hour and 3-hours post exercise for each of the two experimental trials, with a total of 6 blood samples collected over the entire study period. Immediately following the resting muscle biopsy collection, participants will consume approximately 0.4g/kg body weight whey protein isolate or an isocaloric placebo. After approximately 15 minutes of recovery after sample collection, participants will perform 6 sets of 8 unilateral leg-press repetitions with both limbs (90 second rest between sets) at a resistance equivalent to 80% of their unilateral maximum strength (determined for both legs independently). Participants will consume either a whey protein supplement or placebo immediately post exercise. 1 hour and 3 hours following completion of exercise, a subsequent biopsy will be obtained from the vastus lateralis muscle of each leg.

This study seeks to assess the effectiveness of an 18-month digital health intervention (Tiny Bites) targeting infant feeding practices, delivered to ECEC educators and primary caregivers of children aged between 4-12 months (inclusive) relative to a usual care control group. We hypothesise that children in the intervention group will have a 0.26 lower BMI zscore compared to those in the control group. We will recruit 60 early childhood education and care services and 540 carer/child dyads. Services will be randomly assigned to intervention or control in a 1:1 ratio. To improve infant feeding practices, services allocated to the intervention group will receive access to an online portal (which includes a self-assessment and webinars around infant nutrition) and support from health service staff. Parents in the intervention group will receive text messages tailored to their child's age around infant feeding. After delivering the intervention for 18 months, we will compare the BMI zscores of children in the intervention group to the control.

This study aims to assess the safety and efficacy of an Advanced closed-loop Android Artificial Pancreas System over an extended period of 12 months. All participants will continue with the equipment provided for the original study i.e. AAPS using a Ypsomed pump, Dexcom G6 CGM and an Android phone with an installed AAPS algorithm on the Lotus app. The advanced features and enhancements of the algorithm will be activated for all participants at the beginning of this extension trial. Those assigned to Advanced AAPS with announced meals in CLOSE IT will commence using the fully closed loop with no meal announcements. During this study, participants will have the choice of using either NovoRapid® or Fiasp® insulins. Participants will receive support from your usual clinical team in addition to our clinical research team as required. Assessments of HBA1C, weight and questionnaires will be completed at the start and after each 3-month period of the study.This trial is an extension of the original Close It trial ( ACTRN12622001401741).

This study is an audit of usual care physiotherapy for intensive care patients who have experienced mechanical ventilation of 5 days or longer duration. This audit will be conducted for a two-month period following appropriate ethics and governance approvals, or until a minimum of 100 participants have been recruited, to accurately capture the usual care in several hospitals around Australia. This audit is an essential first step prior to launching a multicentre study of a physiotherapy intervention (inspiratory muscle training) later in 2024. Due to the negligible risk to patients, and the need to capture usual care for patients who are unconscious, this observational study has obtained a waiver of consent. This multicentre study will be led by Canberra Hospital intensive care unit (ICU) researchers, but is overseen by a well-established group of expert researchers in ICU rehabilitation. The audit tool has been co-designed and tested by physiotherapists from various sites, with input from a consumer representative. This study will pave the way for high-quality Canberra-led multicentre research in 2024 and beyond.

Next day discharge after transcatheter aortic valve implantation (TAVI) has been shown to be safe and is now commonly implemented in clinical practice. A small number of studies have investigated same day discharge (SDD) after TAVI, but more studies are needed, particularly in self-expanding valves. This study will prospectively apply a locally derived discharge protocol to all consecutive patients undergoing elective, transfemoral TAVI procedures at our centres. The study aims to determine if the NORTH SHORE DAY-STAY TAVI clinical pathway effectively identifies patients who are at low risk of post-procedural complications and to evaluate if they can be safely discharged on the same day following transfemoral transcatheter aortic valve implantation (tf-TAVI). The project will measure endpoints including all-cause mortality, stroke, major bleeding, major vascular complication, new renal replacement therapy and high-grade AV block during index hospitalization and at 30-day follow up.