ANZCTR search results

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.

This pilot trial will explore the feasibility and efficacy of an interprofessional outpatient treatment for anorexia nervosa and atypical anorexia nervosa. Interprofessional Enhanced Cognitive Behaviour Therapy (CBT-IE) is an adaptation of one of the leading outpatient eating disorder treatment models in which a dietitian and mental health professional deliver treatment collaboratively rather than being solely delivered by a mental health professional. Feasibility will be evaluated with regards to recruitment, retention, and attrition. Efficacy will be investigated with regards to weight restoration, eating disorder psychopathology, dietary intake, relationship to food, psychosocial functioning and team collaboration.

Obesity is the cause of profound health, psychosocial, and economic burden for affected individuals and the community (Wang, McPherson, Marsh, Gortmaker, & Brown, 2011). However, weight loss is notoriously challenging. Even the most intensive evidence-based programs often fall short in enabling people to sustain weight loss long term, with weight re-gain the most common pattern (Butryn et al., 2011). Several psychosocial barriers have been identified that make it particularly challenging for people with obesity to effectively achieve and sustain weight loss. These are: (1) substantial and pervasive weight stigma targeted at higher weight people (Haynes et al., 2018; Wu & Berry, 2018), (2) unsupportive social networks among people with obesity, both in general and for health behaviour change specifically (Puhl et al., 2021; Zwickert & Rieger, 2014), and (3) secondary to stigma and poor social networks, people with obesity are more likely to experience loneliness, and (4) mental ill-health (Jung & Luck-Sikorski, 2019), each of which exacerbate disordered eating (Levine, 2012). GROUPS 4 HEALTH (G4H) is uniquely suited to addressing these psychosocial barriers in order to facilitate weight loss and maintenance. Our study is a pilot trial of G4H to test its effectiveness in reducing these psychosocial barriers to health behaviour change and improving well-being among higher weight people (BMI 30+). The primary outcomes used to assess intervention effectiveness include loneliness, general mental well-being, and self-efficacy to achieve health goals. Secondary outcomes include social support, disordered eating behaviour, self-efficacy for physical activity, healthy eating and weight management, collective efficacy of therapy group to achieve health goals, depression and anxiety symptoms, self-esteem, social phobia, multiple group memberships, and social identification with therapy group, facilitators, and weight-related groups, and internalised weight stigma. We expect that participants who complete the G4H program will experience benefits in these outcomes that will be apparent immediately following program completion and at 2-months post intervention completion.

People who complete mindfulness or exercise programs tend to report improvements in mental health such as a reduction in psychological stress and an increase in wellbeing. The aim of this research project is to evaluate a newly developed mindfulness and aerobic exercise program and its effects on mental health (and on factors related to mental health) when compared to doing nothing at all. This program may go on to be used as a health and wellbeing program in the broader community.

Who is it for? You may be eligible for this study if you are 18 years or older, and have been diagnosed with locally advanced pancreatic cancer (LAPC), Purpose of the study To investigate the safety of an active implantable (radiological) medical device called OncoSil, when implanted into patients with pancreatic cancer who are receiving standard chemotherapy, and to evaluate the response on the tumour after implantation. This will be compared to those who receive standard chemotherapy alone. Allocation to receive OncoSil treatment will be at the discretion of the investigator of the study, and your treating physician and oncologist. Study Details Participants that will receive the OncoSil treatment will undergo an Endoscopic Ultrasound, to accurately visualise the pancreas and assess tumour size. This will be performed under sedation and you are not likely to feel any pain during the process. The doctor guides the endoscope down the oesophagus, through the stomach and into the first part of the small intestine. The ultrasound is used to image the tumour in the pancreas. A fine needle is extended from the end of the endoscope into the pancreas and into the middle of the tumour. Once this needle is in an appropriate position within the tumour, a doctor will attach a syringe filled with OncoSil to the other end of the needle. The doctor will slowly depress the plunger of the syringe so that the contents of the syringe are implanted into the tumour, the OncoSil syringe is removed. Another syringe containing a small amount of saline (salt water solution) is attached to the needle. This will flush any remaining OncoSil from the needle into the tumour. The saline syringe is removed. The endoscope is removed by carefully pulling it back up the oesophagus and out of your mouth. Following implantation, you will be observed for a minimum of four hours and, if stable and pain-free, you may be discharged the same day. You will be required to attend two follow up visits with you study doctor, which will occur 4 weeks and 12 weeks after the OncoSil procedure. We hope this research will help provide further information on the safety and usefulness of this form of treatment for LAPC, and the results support further evaluation with larger trials.