ANZCTR search results

MAPS is an online program which combines music/song writing and psychological therapies with a closed social networking group, for people living with younger-onset dementia (PLWYOD) and their spousal care-partners. The goals of the program are to improve well-being, social connections and coping, with a secondary goal of investigating whether non-cognitive symptoms related to dementia, called neuropsychiatric symptoms (NPS) might improve as part of the program.

This is an observational study investigating the use of the ResApp SleepCheck algorithms to determine the presence and severity of OSA in adult patients in a home setting. Breathing and snoring sounds recorded using a smartphone are analysed by the ResApp SleepCheck algorithms and compared to clinical diagnosis made via at-home polysomnography.

The study will assess the safety, antiviral activity, and immunogenicity of AB-729 followed by VTP-300 in virologically suppressed CHB participants. The study will enroll 62 stably NA-suppressed participants to receive AB-729 in addition to their NA for 24 weeks to lower HBsAg. Participants will then be randomized into one of two groups. Group A will receive active VTP-300 and Group B will receive VTP-300 placebo in addition to their NA. Participants will remain on their NA and be followed every 2-12 weeks for safety and efficacy assessments through Week 48. Group C an additional arm will assess if the addition of low dose nivolumab (0.3 mg/kg) to the MVA-HBV boost component of VTP-300 will further stimulate reduction of HBsAg after initial treatment with AB-729 followed by the ChAdOx1-HBV prime. If participants meet certain criteria (low ALT, low HBV-specific viral markers) at Week 48, they will stop their NA and be followed every 2-4 weeks for an additional 48 weeks to evaluate for functional cure. If participants do not meet these criteria they will stay on their NA and be followed every 12 weeks for 24 weeks. Participation will be for approximately 79-103 weeks, depending on whether NA discontinuation criteria are met. It is hoped that this study may lead to better understanding of host immune responses against HBV, and potentially facilitate immune control of HBV (functional cure).

Current national yearly data estimates 59,100 people aged 25 and over have a heart attack; around 162 events every day, including death. Despite advances in treatment, 15% of heart attack survivors have another heart attack, stroke or die within 12 months and 8.9% are unexpectedly readmitted to hospital within a year. The Secondary Prevention for All in Need (SPAN) trial will address the established evidence-practice gap that 7/10 heart attack survivors in Australia are not accessing guideline-advocated secondary prevention measures. Barriers to improving reach, completion and outcomes are complex and well-documented but can be addressed by studying more personalised ways of delivering prevention. This trial, where patients have an equal chance of receiving preventive treatment options, will evaluate the implementation of a published and flexible framework for improving secondary prevention amongst heart attack survivors; developed by three of the investigators. The SPAN trial involves comparing personalised rehabilitation with standard outpatient, group-based rehabilitation (or usual care). The SPAN framework offers a flexible, targeted and sustainable approach for risk factor control through shared decision-making and goal attainment. The trial will report on the differences between the two rehabilitation strategies in terms of completion defined as participation in greater than or equal to 80% of scheduled contacts as established at the initial engagement, and subsequently all admissions to hospital and death identified from administrative records at 1-year. We will determine if there is an absolute increase of at least 15% in the proportion of heart attack survivors that complete SPAN versus usual care; i.e. 65% vs 50% at medium three months, respectively. If successful this personalised rehabilitation strategy could be rapidly and widely implemented and would be expected to reduce the risk of recurrent cardiovascular events and unplanned readmissions to hospital nation-wide.

This project aims to undertake a multi-centre randomised controlled trial to evaluate the addition of the web-based health behaviour tool (FESS) to existing exercise physiology and exercise science services with the intention of improving health behaviours. The project is a 12-month, two-arm, randomised control trial with participants randomised into either the FESS intervention group or a control group. It is hypothesised that the FESS group will improve their health behaviours (as measured by the FESS questionnaire) in comparison to the control group. The FESS intervention group will have access to the online FESS Questionnaire for 12 months, which is completed daily (2-3 minutes in duration) in participants' own time. During the first three months of the intervention, participants in the FESS group will have adherence support from the research team. The control group will be simply directed to web-based government health behaviour information. The research team will then independently complete the eligibility screening and explain the study to participants at each location. Mixed evaluation methods will assess outcome measures at baseline, 3-month, 6-month and 12-month in both groups. FESS questionnaire adherence to the questionnaire will be evaluated in the FESS intervention group. Furthermore, accelerometers and questionnaires will be used in a sub-group of participants to validate the FESS survey against commonly accepted criterion measures.

The aim of this project is to examine the implementation of a new model of care. This model of care will involve giving intravenous therapy (IVT) to women with nausea and vomiting of pregnancy in their home. We aim to assess if the number of times women present to emergency departments is reduced by receiving IVT at home and to explore the acceptability, sustainability and feasibility of this model of care with both women who participate in the project and with clinicians and managers involved in delivery of hospital in the home care, midwifery and obstetrics.

Thromboembolic complications constitute significant causes of morbidity and mortality following hip fracture surgery. Ageing and obesity can independently increase the risk of thromboembolic complications. Patients at both extremes of BMI, both underweight and morbidly obese have the greatest risk of having fragility fractures. There is limited evidence on the cumulative effect of the two factors following orthopaedic surgery. Local reliable data on the extent of short- and long-term thromboembolic complications and VTE prophylaxis in this cohort are lacking. In addition, there has been extensive work on VTE following elective joint replacements; however, there is little literature on the role of BMI in postoperative thromboembolic outcomes in hip fracture patients. Our key research question is: What is the prevalence of thromboembolic complications in elderly patients undergoing hip fracture surgery and its association with clinicopathological factors including BMI. Our objective is to retrospectively review the incidence of short and long-term postoperative arterial and venous thromboembolic complications in patients at the Prince Charles Hospital before and after discharge and their association with BMI through database analysis and record linkage. For this data linkage study, details of the patients, 60 years and above that underwent hip fracture surgery at TPCH over a 10- year period (2010-2020) will be collected from Australian New Zealand Hip fracture registry (ANZ HFR), TPCH orthopaedic department data base as well as by individual chart review for missing or ambiguous details. We would exclude hip fracture patients that were not operated or those with co-existing fractures in other areas. Occurrence of complication will be retrieved from the orthopaedic database, from ANZ HFR from QH Statistical service branch (SSB) data linkage facility according to the data details and follow-up timepoints specified below. Diagnosis and complication codes are classified using the International Classification of Diseases, 10th Revision, Australian Modification (ICD-10-AM). Occurrence of postoperative complications will be retrieved from the orthopaedic database from regular follow up, ANZ HFR and QH Statistical service branch (SSB) data linkage facility for readmissions from QHAPDC (Queensland Hospital Admitted Patient Data Collection), representations from QNAPDC (Queensland Non-Admitted Patient Data Collection) and ED/clinic presentations, throughout the state and Mortality from Queensland Births Deaths and Marriages registry (QBDMR).

The purpose of this study is to investigate the safety of oral venetoclax treatment prior to fludarabine and cyclophosphamide non-myeloablative conditioning allogeneic stem cell transplantation for patients with haematological malignancies. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with with either acute leukaemia (myeloid and/or lymphoid, or biphenotypic), myelodysplastic syndrome, chronic lymphocytic leukaemia, B-cell non-Hodgkin lymphoma or plasma cell myeloma. Study details: All participants in thus study will undergo a short course of oral venetoclax between day -11 to -6 prior to fludarabine and cyclophosphamide conditioning allogeneic stem cell transplantation. The dose of venetoclax in this study will commence at 100mg daily for 5 days (total dose of 500mg), with subsequent groups increasing to a total dose of 1100mg over 5 days, 1900mg over 5 days and 2500mg over 5 days. Each participant will be assigned to received one dose level for the entire study. The safety of venetoclax treatment will be assessed by the incidence of side effects 30 days after starting the first dose of venetoclax. The study will determine the safest dose of venetoclax to be used prior to allogeneic stem cell transplantation for patients with haematological malignancies.

The study to evaluate the relative oral bioavailability, safety, and tolerability of EQ121 ER tablet formulations and an EQ121 IR capsule formulation in healthy volunteers. Part A: To evaluate the EQ121 IR capsule formulation and up to 10 different EQ121 ER tablet formulations under fasted conditions in adult healthy volunteers Part A will enroll up to approximately 40 adult healthy volunteers.

The study is to compare the remineralisation (repair) of early decay-like lesions in tooth after rinsing with two tooth crème/paste slurries prepared containing: (i) a major milk protein casein, combined with calcium and phosphate (CPP-ACP) and stannous (tin) fluoride (Treatment A); (ii) stannous fluoride alone (Treatment B) in a randomized, double-blind trial. All participants will wear palatal appliances for 14 consecutive days in each of the two treatment periods. This study hypothesis is that treatment A that contains 1% of CPP-ACP with 220ppm fluoride as stannous (tin) fluoride, will enhance remineralisation compared to Treatment B containing 220ppm fluoride as stannous (tin) fluoride alone.