ANZCTR search results

We will conduct a 12-week feasibility and pilot randomised controlled trial of a personalised exercise and dietary intervention delivered via VIPAs in adults aged 50 to 75 years with oral hypoglycaemic agent-controlled type 2 diabetes mellitus (T2DM). Primary Aim: Our primary aim is to assess study processes including recruitment and retention rates, adherence to the exercise and nutrition intervention, acceptability and adverse events. Secondary Aim: Secondary aims are to compare changes in scores for the Diabetes Self-Management Questionnaire (DSMQ), objectively-assessed physical activity, self-reported fruit and vegetable intakes, health-related quality of life (EQ-5D-5L) and productivity, compared to a control group receiving general advice on physical activity and healthy eating via email. Hypotheses: Our primary hypothesis is that a 12-week home-based personalised exercise and dietary intervention delivered by VIPA will be feasible and acceptable, as evidenced by greater than or equal to 70% retention in the study, completion of greater than or equal to 66% of prescribed exercise and dietary advice, recruitment greater than or equal to 20% of eligible participants and overall themes of acceptability expressed. We also hypothesise that the VIPA group will demonstrate improvements in diabetes self-management, objectively-determined physical activity, health-related quality of life, self-reported fruit and vegetable intakes and direct and indirect productivity. We anticipate that these preliminary data will support the need for future studies to explore cost-effectiveness of this telehealth approach in Type 1 or 2 insulin dependent diabetes mellitus and gestational diabetes. This innovative model of service delivery has the potential to markedly reduce health care practitioner workloads and telehealth costs in type 2 diabetes management, while increasing empowerment and accessibility to evidence-based programs for patients most at need

Asthma is the most common chronic condition affecting children. Education is an important part of asthma management; however, multiple studies have shown it is poorly done by health professionals and 90% of people with asthma are still not using their medication or devices correctly. It is clear there is a need for innovative ways for education to be delivered. Augmented reality (AR) may provide a generation appropriate, engaging modality for this. This research is part of a larger study, which aims to investigate if AR is an effective educational tool for children with asthma. The aim of this phase of the study is to design an optimal, functional and suitable AR tool for educational use. An AR tool will be created for use via a smartphone or tablet to deliver education in an innovative way. Participants in this study will be asked to trial the tool, and interviews will be undertaken with participants to determine the usability and appropriateness, as well as any barriers of its use. Participants will include children and teenagers with asthma, their parents, and the health professionals involved in their care.

This is a prospective, open-labelled study in patients with pigment epithelial detachment (PED) secondary to neovascular macular degeneration. All subjects will receive 6.0mg of intravitreal brolucizumab every 4 weeks between baseline and week 8 (3 loading doses), and subsequently receive 6.0mg of intravitreal brolucizumab every 8 or 12 weeks for the remainder of the study period (weeks 52). Fifty five subjects who meet the inclusion/exclusion criteria will be recruited from Sydney Retina Clinic and followed up for 52 weeks. All assessments and treatments will be performed at Sydney Retina Clinic. All eligible subjects will initially receive 3 monthly loading doses of 6.0mg of intravitreal brolucizumab injection. Following these loading doses, a disease activity assessment will be performed at week 16. Disease Activity Criteria at Week 16: • Decrease in BCVA of greater than or equal to 5 letters compared with Baseline • Decrease in BCVA of greater than or equal to 3 letters and CSFT increase greater than 75µm compared with Week 12 • Decrease in BCVA of greater than or equal 5 letters due to neovascular AMD disease activity compared with Week 12 • New or worse intraretinal cysts (IRC) /intraretinal fluid (IRF) compared with Week 12 If a subject meet any of the above disease criteria at week 16, the subject will be assigned to receive injections every 8 weeks (q8w) thereafter, up to study exit (Week 16, 24, 32, 40 and 48). If a subject does not meet any of the above disease activity criteria, the subject will be injected every 12 weeks (q12w) up to study exit (week 20, 32 and 44).

Rib fractures account for a significant proportion of trauma presentations. Chest trauma alone is associated with significant morbidity and mortality; the mortality rate increases from 15% for 3-5 fractured ribs to 34% for 6 or more fractured ribs. The accepted approach involves multi-modal pharmacological therapies incorporating simple analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. But drug therapy has multiple side effects and is often insufficient. As such, there is growing interest in regional techniques in the management of these patients, such as chest wall catheter infusions of local anaesthesia. At Liverpool Hospital, referral to the Acute Pain Service to insert chest wall catheters was incorporated in the Rib Fracture Pathway for patient care in 2019. The implementation of chest wall catheter infusion techniques aims to reduce patient discomfort, reduce opioid requirement, reduce pulmonary complications and facilitate earlier discharge from ICU and hospital. This is a before-and-after quality improvement/assurance audit of a cohort of patients treated with traditional oral and intravenous analgesics, and comparing to the cohort of patients treated with traditional analgesics as well as the catheter infusion techniques. This is a retrospective study for both the control and interventional arms. We will collect pre-collected data on pain scores, analgesia requirements, ICU stay, length of stay, from Jan 2019 to March 2020.

This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy participants. The trial is split into three parts, starting with Part 1 (SAD) and then Parts 2 and 3 (MAD). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Parts 2 and 3 (MAD), participants receive 1 dose every day for 14 days.

TThis study aims to evaluate the efficacy and safety of VGT-309, a tumor-targeted imaging agent, when used intraoperatively in subjects scheduled for surgical resection or biopsy of suspicious or confirmed lung cancer. Who is it for? This study is for adult men and women aged 18 years and older who are scheduled to undergo surgical resection or excisional biopsy (as per standard care) of a lung nodule that is suspicious for, or confirmed to be, lung cancer. Study Details Eligible subjects will receive a single intravenous infusion of VGT-309, administered 36-96 hours preoperatively. Total participation will last approximately 35 days (excluding a 28-day screening period). During this time, subjects will undergo safety monitoring, including blood and urine sample collections, vital sign checks, physical examinations, and ECGs. This research aims to enable doctors to use VGT-309 as an intraoperative fluorescent imaging agent to differentiate lung cancer from surrounding normal tissue in the future.

Nutritional rehabilitation is integral in the treatment of anorexia nervosa (AN) . During nutritional rehabilitation, the provision of adequate nutrition to achieve weight restoration and medical stability must be balanced against managing the risks of refeeding syndrome (RS). Refeeding hypophosphatemia (RH) is commonly used to indicate the risk for the development of RS. The risk of developing RS is the greatest during the initial 72 hours following commencing nutritional rehabilitation. Current guidelines support an aggressive feeding model, however suggest restricting calories from carbohydrates and including foods rich in phosphate during nutritional rehabilitation in order to avoid RS. However, despite this suggestion, there have been few studies that have investigated the effect of nutrition composition, specifically carbohydrate intake, on the incidence of RH in patients with AN. The aim of this study was to compare a standard carbohydrate calorie matched aggressive feeding protocol with a low carbohydrate feeding protocol on the risk of refeeding syndrome (hypophosphatemia) in patients admitted to a child and adolescent eating disorder program. This study was a single centre randomised controlled trial. Consent was obtained from both the child or adolescent and their parent or guardian prior to participation in the study. The Paediatric and Adolescent Inpatient Unit at the Austin Hospital in Melbourne, Australia, provides tertiary level inpatient care for children and adolescents with eating disorders who require medical stabilisation. Whilst the preference is for outpatient treatment of the eating disorder, criteria for admission includes postural instability, bradycardia, dehydration, food refusal, rapid weight loss or being severely underweight (<75% expected body weight). Patients were randomly assigned via concealed allocation to either a low carbohydrate feeding plan which provided <40% of total energy from carbohydrate, as per current practice, or standard carbohydrate feeding plan which provided 50-60% of total energy from carbohydrate as per the Australian Guide to Healthy Eating recommendations. Calorie intake for both feeding plans was matched. Oral feeding was encouraged with oral bolus or enteral nutrition available if required. Patients were not prescribed any prophylactic nutrition supplementation during the admission, including multivitamin supplements. If phosphate levels were low, oral phosphate in the form of Sandoz phosphate was to be administered. The medical team monitored daily for any signs of RS and this was documented in the medical file. To our knowledge, there are limited studies that have investigated the link between carbohydrate intake and RH in orally fed children and adolescents. If carbohydrate intake doesn't need to be restricted in order to minimise the risks of RS, this may promote both an earlier and more normalised approach to eating and weight restoration.

This project aims to find out the impact of social and intrinsic factors that impact and influence the health outcomes of people with diabetic foot ulcers (DFU). We believe that determinants such as comorbidities, blood sugar control, and socioeconomic factors majorly impact host immune and bodily process pathways. We hope to identify markers that identify people who may develop chronic ulcers, infections, and predict poor health outcomes. These markers may allow us to develop targeted therapeutics, target resources, and make individualized treatment plans. The primary focus of the work is to improve patient care, quality of life and reduce the burden on DFUs.

Incorporating patient reported outcome measures (PROMs) into usual care in hospitals can improve safety, quality and patient satisfaction. The aims of this clinical trial are to: (i) understand barriers and enablers to ePROM implementation across nation-wide hospitals and to develop Australian ePROM implementation recommendations (entitled AusPROM); and (ii) test the feasibility and acceptability of the QoR-15 PROM for elective surgery day and overnight patients applying the early versions of the AusPROM implementation recommendations. There are two phases of this project. Phase I will identify barriers and facilitators to recommendations for the implementation of the AusPROM using a Delphi technique with health professional staff and will occur alongside Phase II. The Delphi technique will involve three separate 1 hour focus groups (vis videoconference) where barriers and enablers are discussed, and a consensus process is used to establish the AusPROM implementation recommendations. Following the first focus group, early versions of the implementation recommendations will be embedded into Phase II (feasibility testing) to test the implementation recommendations with feedback provided to the subsequent staff focus groups. Phase II will determine QoR-15 acceptability from an elective surgery patient perspective across 4 pilot hospitals, using the AusPROM implementation recommendations. For Phase II, patients will complete brief surveys, incorporating the QoR-15 and two acceptability questions, in the week prior to surgery, in the week following surgery and 4 weeks post-surgery. The primary endpoint will be 4 weeks post-surgery. The trial protocol has adopted the Guidelines for Inclusion of Patient Reported Outcomes in Clinical Trials Protocols (SPIRIT-PRO). The findings will highlight value of patient (acceptability domains) and health professional (Delphi technique) co-design to inform the AusPROM recommendations for the implementation of patient focused outcome measures. The trial will also illuminate the feasibility and value of using the QoR-15 to understand patient views about elective surgery outcomes.

This is a single-site study of people who are undergoing treatment for Treatment Resistant Depression (TRD). The study aims to understand the quality of life in people with TRD and to understand the clinical characteristics of patients as they present at a single time point (cross-sectional). Patients admitted as an inpatient to Albert Road Clinic will be invited to participate. Following consent participants will complete a quality of life questionnaire (AQoL-8D), participate in a short interview with the research team to complete a depression assessment (HAM-D) and obtain medical and treatment history. Participant hospital medical charts will be reviewed to obtain further information regarding medical and treatment history. The results of this study will be used to improve understanding of the burden of disease for people with TRD and to assess the feasibility for creating a registry of data in the future.