ANZCTR search results

This study aims to examine the effect of a medication called Ribociclib on human prostate cancer Who is it for? You may be eligible for this study if you are older than 18 years and have localised prostate cancer with a planned radical prostatectomy. Study details After the Protocol version 4.0 amendment implementation in August 2022, randomisation to the control group is stopped. All subsequent participants will be recruited to the experimental group. All new Participants post protocol version 4.0 implementation will be assigned to take a tablet of the study medication (in addition to the usual care) for the 21 days leading up to their prostatectomy. At each study visit participants will have various assessments such as blood testing, urine testing, scans, and questionnaire completion. A sample of prostate tissue will also taken during surgery. It is hoped this research will help demonstrate the activity of this medication against prostate cancers, and lay the groundwork for more trials using this drug.

Current best clinical practice for people in inpatient rehabilitation aims to increase physical, cognitive, and social stimulation for patients to promote recovery. The rehabilitation environment, that is, the physical building including the design and facilities/equipment available, and the models of care, potentially impact on people in rehabilitation’s engagement in activities that may potentially contribute to their recovery. This prospective observational study will examine the impact (if any) on patients’ levels of activity that may occur due to a change in physical environment and services when existing rehabilitation services are merged and will in the future be provided in a new rehabilitation facility. Data will be collected at two time points with different patient populations - 2018 at the existing inpatient rehabilitation services at The Canberra Hospital/Calvary Public Hospital and 2019 at the new rehabilitation facility University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research. This study aims to comprehensively describe the behaviour and activity of inpatients in these rehabilitation units so as to determine how much of the patient’s day is spent in activities that have the potential to contribute to their recovery, and how this may differ (if at all) between the rehabilitation units. Activity types and amounts will be determined through observation using behavioural mapping and accelerometers to measure the physical, cognitive and social activity of patients in patients receiving rehabilitation in inpatient rehabilitation units before and after the move. This research provides a unique opportunity to increase understanding of the potential impact, if any, of building design and models of care on patient activity within rehabilitation units and contribute towards future health service design.

This research project is being conducted to investigate the safety, tolerability, and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Dose of oral ETX0282 when administered alone and in combination with Cefpodoxime Proxetil in healthy adult subjects.

The 'Get Healthy!' program is a 12-week physical activity and nutrition intervention. It has been designed to encourage healthy lifestyle change for adults with intellectual disability. The goal of this pilot study is to assess the feasibility and impact of this program for participants with intellectual disability. The results of this study will be used to refine the "Get Healthy!" program for future use. The primary aim of the intervention is to assess the feasibility of implementing the 'Get Healthy! Physical Activity and Nutrition Program' with adults with intellectual disability. Secondary intervention aims are to determine what, if any, pre-post program changes occur across the following outcome measures: • Body Mass Index • Waist circumference • Cardiovascular fitness • Physical activity (amount and intensity) and sedentary behaviours • Blood pressure • Physical strength • Dietary intake (energy intake, food group consumption and diet quality) • Dietary and physical activity knowledge • Quality of life

Following our feasibility pilot, Sense© training was modified to increase suitability for a paediatric population of children with HCP. The principles of training remain the same and children progress through the same levels of graded somatosensory training as adults. To facilitate child engagement with the Sense© training, the principles of self-determination theory and family centred service were incorporated into the provision of Sense© for Kids training. To improve the relevance of Sense© for Kids training to children with HCP and their families further modifications were implemented following consumer engagement. Focus groups and interviews were conducted and feedback from children and their families were integrated into changes to Sense© for Kids training. A consumer representative also vetted all aspects of the study protocol and details of the intervention. These changes are aimed at reducing the scheduling demands on families and increasing the education provided to parents. Parent coaching will be used to facilitate maximal carryover of the benefits of therapy into everyday life following the completion of the formal intervention period. Our pilot work suggests that children improve in trained somatosensory domains, motor performance, and in trained occupational tasks. A qualitative investigation of parent and child engagement suggests that improvements were also observed in untrained tasks requiring bimanual function. Improvements following Sense© training were maintained six months after training ceased and warrant further investigation with a larger sample. In order to test the efficacy of the Sense© for Kids training, a “best practice” comparison intervention will be used to provide adequate control for ‘dosage’ and maintain the external validity of this trial. Further, it is considered unethical to withhold potentially effective interventions in controlled comparison conditions. Goal Directed Training delivered via Home Program is an evidence based intervention with a green light on the traffic light system of evidence for children with HCP. Because there are no evidence based somatosensory discrimination interventions for comparison, Goal Directed Training via Home Program will act as our control. Goal Directed Training is a motor learning approach which uses a child’s goals to allow problem solving and indirectly elicit movements needed to complete a task but does not include any direct somatosensory training: it is therefore a ‘best practice’ control intervention incorporating common features of Sense© for Kids training but no direct somatosensory training. Our primary objective is to determine whether Sense© for Kids training, a somatosensory discrimination intervention, is more effective than placebo (Goal Directed Training via Home Programs) in improving somatosensory discrimination in children with HCP.

Purpose The aim of this study is to evaluate the feasibility, acceptability and potential efficacy of a Technology-Mediated Professional Learning (TMPL) package delivered to Early Childhood Education and Care settings (ECECs) within one orgnisation in Tasmania. Hypotheses ECEC services where educators have participated in a TMPL programme will have better quality nutrition and physical activity environments and children who attend these services will participate in higher levels of physical activity compared with educators and children who attend services that have not participated in a TMPL programme

This research study aims to look at the effects of combining music therapy with functional electrical stimulation on arm and hand function after stroke. Functional electrical stimulation (FES) is an evidence-based therapy that is widely used in stroke rehabilitation of the arm and hand. Music therapy allows people to engage in music-based exercises, such as playing an instrument, as part of their rehabilitation and therapy. In iPad-based music therapy, the instrument that is used is in the form of an iPad application. In this project, we will use “ThumbJam”; a touch-sensitive iOS application in which instrumental sounds and scales (combinations of notes) can be programmed according to the preference of the user. This study will examine the effect of combining FES and iPad-based music therapy (“FES+iPad-based music therapy”) as an addition to usual treatment, in comparison to usual treatment alone. It is important to note that FES may or may not already be part of usual treatment. The primary aim of this research is to examine whether the addition of FES+iPad-based music therapy will further improve the functional activity of the affected arm and hand of stroke survivors. The secondary aim of this research is to examine the effect of the addition FES+iPad-based music therapy on wellbeing outcomes such as self-efficacy, depression, anxiety and stress, in comparison to usual treatment.

This project aims to determine whether infusing virus specific T cells from normal donors and frozen in liquid nitrogen is safe and effective therapy in patients at the first sign of virus infection after blood or bone marrow transplant. During the project a bank of frozen virus specific T cells will be created and if a blood or marrow transplant patient develops a virus infection that needs treatment, cells from the bank will be used early during the infection to see if they can recreate immunity to the infection and avoid the necessity for prolonged used of toxic antiviral drugs.

Osteoarthritis (OA) is degenerative disease effecting joints and is characterized by articular cartilage remodeling. It is one of the most common musculoskeletal disorders worldwide and affects an estimated 15% of Australians (3 million people) (Glyn-Jones et al., 2015). OA causes pain and eventual disability, and while not usually considered an inflammatory condition, there is associated inflammation of synovial tissue (Benito et al., 2005). The complex nature of the symbiotic relationship between the gastrointestinal microflora or microbiome and the health of the host has been elucidated in recent years. An unbalanced microbiome, dominated by certain species increases the risk of diverse systemic diseases, and inflammation, often low grade and chronic, is a common factor in many of these conditions. Evidence from animal and human trials suggest probiotics may be able to positively impact bone metabolism, reduce inflammation and pain attenuating inflammation via improving muscosal barrier health (Collins et al, 2015, Lei et al., 2014)) (Lei, 2014). The project aims to assess whether a three week course of probiotics is effective for reducing the pain associated with osteoarthritis in two participants diagnosed with osteoarthritis.This is an N-of-1 series, consisting of two double-blind placebo-controlled N-of-1 trials in otherwise healthy individuals. Each trial incorporates 3 randomised blocks, each consisting of 2 X 3-week period, which may comprise either the active or placebo supplement, designated A or B . Between each period there is a 2-week washout period. The primary outcome is self-reported pain, as measured by a 100mm Visual Analogue Scale. Secondary outcomes include the Patient Specific Functional Scale (PSFS) which consists of up to five self-nominated items that the participant perceives to most interfere with their daily functioning. The participant rates each item on a numerical scale 0 to 10 where 0 represents “no difficulties” and 10 represents “can’t do it at all”. This scale will be completed at the beginning and end of each 3-week intervention period. Usage of the preferred rescue medication (paracetamol) will be monitored throughout the 30-week duration of the study. The 2005-Complete Digestive Stool Analysis (CDSA) kit will be used to monitor the probiotic concentration on four occasions (Weeks 2, 5, 7 and 10).

Serum/plasma (blood) is routinely used for measurement of albumin/creatinine in the critically ill. However, point-of-care (POC) urinary albumin/creatinine testing in patients admitted to the Intensive Care Unit (ICU) may be advantageous due to the rapid availability of results. To date, the accuracy of POC urinary albumin/creatinine compared to laboratory analysis in this population has not been evaluated. The anticipated outcome of this project is that if agreement is detected between POC and laboratory analysis, then POC testing may be a valuable methodology for measuring urinary albumin/creatinine in critically ill patients. This could have useful applicability for rapid assessment of results, therefore predicting prognosis and mortality in this population.