ANZCTR search results

In this study, we aim to determine the relationship between clinical measures of early muscle activity in the affected lower limb and future walking speed for stroke survivors who were initially unable to walk. Our hypothesis is that muscle strength recovery will be a significant predictor of future walking speed. The muscle group we will measure include muscles that extend the hip and knees as well as the muscles that move the ankle joints. We will measure muscle strength manually and using surface electromyography to 'listen' for any muscle activity present. We will measure walking speed once the participant is able to walk independently. These measurements will be taken at 1,2,3,4,8,12 and 26 weeks post stroke.

Type 2 Diabetes (T2D) is a chronic condition characterised by high blood glucose levels brought about due to the inability of the body to produce and/or use insulin. Obesity and poor lifestyle choices are the dominant risk factors for developing T2D and its related complications. The current management of T2D relies heavily on the health care sector to prescribe and manage medication, under the premise that T2D is chronic and progressive. New research on T2D has shown that low carbohydrate diets and lifestyle modifications can lead to improvements in blood glucose levels, as well as weight loss, reduction in the use of medications, and over time effectively put T2D into “remission”. Over the last two decades, technological advances have led to the development of health-related applications (apps) including a high proportion dedicated to the management of diabetes. Given the rate of adoption of smart phone usage these apps provide enormous potential to support the management of T2D. At present there are only a limited number of studies providing evidence on the effectiveness of using an app for the management of T2D. This research project seeks to address the knowledge gap and discover if there is evidence to support a low carbohydrate diet and lifestyle intervention delivered via the Defeat Diabetes Application (DDA).

A prospective, non-dispensing study to assess the objective and subjective visual performance of ophthalmic prototypes. Up to 150 participants to be enrolled in the study, with a minimum of 10 participants included in the assessment of each prototype. The prototypes will be worn monocularly or binocularly, over the eye/s with best subjective vision with habitual correction or best-corrected subjective refraction, for a minimum of 20 minutes. In monocular measures, the non-measuring eye will be occluded during testing. Measures of visual acuity thresholds, visual function, and subjective vision gradings will be taken while wearing the prototypes. Each individual participant may test multiple prototypes and may test multiple prototypes at each study visit. All participants will undergo evaluation wearing relevant active and/or passive controls at the study visit.

The purpose of this research is to test a new online treatment for anxiety and depression. Many different treatment options are available to help people manage anxiety and depression. This new treatment is based on a psychological treatment called Acceptance and Commitment Therapy (ACT), which has proven to be effective in face-to-face treatment. In this study, we are interested in testing the acceptability, satisfaction, and outcomes from this therapy when delivered in an online delivery format. We’re also interesting in learning from participants how we can improve the ACT Course.

The primary objective is to study in vivo biofilm formation, growth, and undisturbed 3-dimensional architecture on different implant abutments restorative materials in an implant-supported biofilm device. The secondary objective is to analyse and compare the microbiological composition of this biofilm grown on different implant abutments restorative materials. Study Procedures - An implant-supported biofilm device will be fabricated using CAD-CAM and will be designed in a way where a disk can be inserted inside a chamber. The chamber will also consist of a channel that is directed and opens into the sulcular and marginal (interproximal) region in order to allow gingival crevicular fluid, saliva, and substrate to flow into the chamber. - Disks of five different restorative materials (titanium, zirconia, gold, dental ceramic, and polymeric material (Polymethylmethacrylate (PMMA) or Polyetheretherketone (PEEK)) will be fabricated and mounted in the chamber. - Biofilm will be allowed to grow on each material for 14-days in a cross-over design where the first disk will be removed and then the following one will be inserted and so on. The order in which the five materials are inserted into the five participants will be randomised. - Confocal laser microscopy will be used to analyse the architecture and viability of the biofilm grown on the disks. Next-generation sequencing will be performed to analyse and compare the bacterial composition of this chamber grown biofilm on the different implant abutments restorative materials

Surgery to remove solid tumours is the most commonly prescribed and effective treatment for most cancers of this presentation. However, major cancer surgery represents a stressor to the patient which results in a relative immunosuppression that can be seen in a reduction in the number and immune activity of natural killer cells. This study aims to assess the feasibility of boosting cancer patients' immunity prior to surgery through a combination of a pre-surgery flu vaccination and dietary supplements. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with an abdominal cancer requiring surgery, colorectal cancer, sarcoma, upper gastrointestinal cancer, liver or gallbladder cancer or genitourinary cancer (e.g. bladder/penile/cervical/uterine/ovarian cancers). Study details Participants who choose to enrol in this study will be allocated by computer randomisation to one of two treatment groups. The first group will be given a flu vaccine the day before on on the day of their scheduled surgery, and will be asked to take a dietary supplement (arginine) each day for the 5 days before and 5 days after their surgery. The second group will not receive a flu vaccine or the dietary supplement and will undergo their scheduled surgery only. The third group will have no intervention (control group). Participants in all groups will be asked to provide up to 5 blood samples for testing. It is hoped this research will determine whether it is practical to administer flu vaccines and dietary supplements to patients prior to a major abdominal cancer surgery. The preliminary results collected from this small study will also be used to determine whether it is worthwhile pursuing a larger clinical trial to investigate the effect of these strategies on immune activity in a larger population of cancer patients.

The project will evaluate the effectiveness of the Live Well intervention on people aged 65 and over who live in South Western Sydney (SWS). The Live Well intervention is based on the Fountain of Health project which has been effective in Canada. A minimum of 60 clinicians working in SWS will complete training to deliver Live Well. This includes clinicians working in Older People's Mental Health (OPMH), GPs and practice nurses in SWS. They will invite suitable clients to participate in the study. Consent will be obtained. During the Live Well intervention, participants will select one of six health and wellbeing domains to set a SMART goal. The six domains include physical activity, nutrition, social activity, brain activity, mental wellbeing and positive thinking. SMART goals contain the following characteristics: Specific, Measurable, Achievable, Realistic, Time-based. Pre and post measures will be taken on a Health and Wellbeing Questionnaire (HAWQ). Demographic and numerical data (from HAWQ) will be collected. It is anticipated that participants in the intervention will show improvements in one of the 6 health and wellbeing areas,

Paltusotine is an oral somatostain receptor 2 (sst2) agonist being developed for the treatment of acromegaly. This single cohort, 4 period study will evaluate the relative bioavailability of 60 mg paltusotine tablet, test formulation, compared to 60 mg paltusotine tablet, reference formulation, in healthy volunteers. The study will consist of 1 cohort in which participants will receive 1 dose of paltusotine (60 mg total), across 4 periods as follows: Period 1: Participants to receive 1 dose of 3×20 mg tablet, reference formulation, after overnight fast with meal at 4 hours postdose. Period 2: Participants to receive 1 dose of 1×60 mg tablet, test formulation, after overnight fast with meal at 4 hours postdose. Period 3: Participants to receive 1 dose of 1×60 mg tablet, test formulation, after overnight fast with meal at 1 hour postdose. Period 4: Participants to receive 1 dose of 1×60 mg tablet, test formulation, after overnight fast with meal at 4 hours postdose after pre-treatment with lansoprazole (orally disintegrating tablet, 15 mg twice daily) over 4 days. Participants will receive each dose with approximately 240 mL of water, after a 10 hour overnight fast. Participants will then fast for further 4 hours, or 1 hour for Period 3, after dosing. There will be 7 to 9 days between doses, except between Periods 3 and 4 there will be a 7-day washout. There will be up to 14 subjects enrolled in this study.

Concussion is the most common form of brain injury, making up 75-90% of all brain injuries. Concussions generally resolve within 7-10 days, however, up to 25% experience delayed recovery which may interfere with return to pre-injury activities (e.g. work) and cause significant stress for months and sometimes years after injury. Persisting concussion symptoms are thought to reflect a range of factors beyond the original injury to the brain including stress and anxiety and physical factors such as injury to the neck, visual and/or balance systems. Given that multiple factors may be contributing to the persistence of symptoms after concussion, an interdisciplinary approach to management is now recommended in clinical practice. Therefore, we aim to conduct a randomised controlled trial and evaluate an interdisciplinary intervention that incorporates expertise from psychology, physiotherapy, and medicine to target the primary factors thought to contribute to persisting concussion symptoms.

In settings of care for people who cannot breathe without support such as intensive care units (ICU), dyspnoea (the experience of difficulty breathing) is a frequent and terrifying problem. Recent reports indicate that dyspnoea in the ICU is just as commonly experienced as pain (47% report mod-severe dyspnoea vs 41% pain, n=138 ICU patients [Gentzler et al. 2019]), yet dyspnoea by comparison is poorly recognised, underassessed and under-treated. This results in increased length of ICU stay, poorer physical and long-term psychological outcomes; and occurs despite the availability of potentially suitable assessment tools and evidence-based effective interventions for dyspnoea in the ICU. Implementation of dyspnoea assessment and management in Australian ICUs is largely unexplored. This project aims to address explore this issue through two research questions: 1. What are the perceptions and beliefs of Australian ICU clinicians about dyspnoea assessment and management in patients in the ICU setting? 2. What is the experience of dyspnoea in people who have been cared for within an ICU environment? Methodology: The project will be conducted in two parts within an action research framework: 1. A cross-sectional national descriptive survey of medical, nursing and allied health clinicians working within Australian ICU’s, to explore attitudes and practices in dyspnoea assessment and management. 2. Semi-structured interviews with a purposive sample of ICU patients from a local facility, to explore the experience of breathlessness in people who have been cared for within the ICU environment. Significance: Internationally, addressing assessment and management of dyspnoea in ICU settings has been recognised as an ethical and moral imperative to lessen suffering, improve patient outcomes, and reduce health care costs associated with delayed time in the ICU and post-ICU morbidity. To date, there is no Australian data available on prevalence, assessment practices and management strategies on dyspnoea within the ICU setting. This study aims to gain an understanding of current Australian practice using a collaborative participatory action research approach to focus on patient and clinician-valued priorities and solutions. The findings from this study will provide a foundation for developing strategies to translate breathlessness science and evidence-based interventions into clinical practice in the ICU.