ANZCTR search results

5 Fluorouracil (5fu) is administered in combination with leucovorin (LV) to enhance clinical activity. However, simultaneous administration is not possible because 5FU and LV are chemically incompatible. Collectively, these adverse events lead to poor patient outcomes due to treatment interruption and discontinuation. Deflexifol, an all in one formulation of 5FU/LV with cyclodextrin (HP-ß-CD 100mg/ml, 5FU 15mg/ml & LV 1mg/ml) at physiological pH, was developed as an alternative. This trial is to test the safety and efficacy of Deflexifol when given as a bolus or infusion to patients that have failed standard of care. The main outcome of this trial is to establish the safety and efficacy of Deflexifol and determine a suitable dose for further study in a phase II trial

The aim of the project is to evaluate the risk of antibodies to blood donor proteins developing after blood transfusions, Participants will be patients who are planned to undergo a transfusion of 1 or more units of red cells. Testing for antibodies to donor proteins will be done before and 6-8 weeks after the transfusion to look for the development of new antibodies. This will help researchers to find a way to give patients blood transfusions without the risk of them developing antibodies that could put later transplants at risk.

Endovascular aortic aneurysm repair (EVAR) is being performed at an increasing rate in both the elective and emergency settings. The lower immediate morbidity and mortality rates of EVAR have been influential in the rapid adoption of this technique. However, the need for ongoing monitoring and higher rates of subsequent re-intervention that are required remain a concern for Vascular surgeons. The ability to be able to identify and predict the patient group most likely to require such re-interventions would be highly beneficial to rationalising treatment for patients. Intra-operative pressure measurements of the aneurysm sac is one method that may be able to guide therapy and this study is an extension of the currently mixed evidence surrounding this area. The primary aim will be to assess if intra-sac pressure measurements (and changes in these measurements) can predict the development of intra-operative or persistent endoleaks or continued aneurysm sac enlargement. The intra-sac pressure measurements will be measured in terms of reduction in systolic and diastolic pressures as well as pulse pressure and as a ratio to the systemic circulation pressure. The progress of the aneurysm sac post-operatively will be monitored through the usual follow-up procedure of ultrasounds at regular intervals. If any persistent endoleaks are detected or there is continued sac enlargement then Computed Tomography (CT) with contrast injection or conventional angiography will be performed to further delineate the pathology.

A double-blind randomised controlled study to evaluate the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to ibuprofen for reducing pain severity and duration of headaches in healthy participants aged 18 years and older

The purpose of this trial is to investigate the impact of a school-based physical activity program (known as Burn 2 Learn), incorporating High Intensity Interval Training (HIIT), on the fitness and well-being of senior school students. We hypothesise that students participating in the Burn 2 Learn intervention will experience improved aerobic (primary outcome) and muscular fitness, and enhanced mental health (i.e., well-being and psychological distress), compared with a control group of students participating in usual practice (i.e., normal curricular lessons).

The aim of this project is to determine if ablation procedure will offer benefit over optimal medical management in people with paroxysmal/ persistant AF & HFpEF. We will also determine what changes are seen in the heart with AF and how it affects the heart’s structure & exercise capacity (Exercise RHC and VO2 peak). We will determine if these changes can improve with ablation.

This study aims to evaluate the effects of a coach-supported, individually-tailored online parenting program for parents of adolescents with anxiety or depression. The program is designed to provide parents with (1) personalised feedback about their current parenting, including what they are doing well and areas that they can improve in order to reduce their teen's levels of anxiety, depression and sleep problems; (2) specific modules of the online parenting intervention, recommended based on parents' identified areas for improvement; and, (3) e-coaching sessions to support parents in making changes in their parenting. and their relationship with their adolescent.

The aim of the study is to determine the effectiveness of a herbal combination capsule (Urox - Bedtime Buddy™), in the treating children aged 6-14 years who experience bed-wetting. It is hypothesised that the combination capsule will reduce the frequency of bed- wetting in children and therefore improve the physical, psycho social and social well being of the child. The trial aims to recruit 62 children in a randomised control trial where the child will receive either the active herbal combination capsule or a placebo. They will take the capsule daily for 8 weeks and record frequency of wet nights in a diary. The parent and child will also complete a validated questionnaire on the impact of bed-wetting on the child quality of life at various time-points in the trial. After the trial is completed follow up phone calls will measure frequency of nocturnal enuresis as well as day time continence questions at 16, 24 and 32 weeks.

Caesarean Section is a procedure commonly performed in Australia and worldwide. In Western Australia 34% of deliveries are performed by caesarean section. The procedure is performed under neuraxial anaesthesia for 98% of procedures in Western Australia. Pain following caesarean section is common with majority of patients requiring opiate analgesia. Despite being a procedure that is performed commonly there is a wide variety of both intraoperative and postoperative analgesia regimes. There has been conflicting evidence of the value of giving non-steroidal anti-inflammatory drugs (NSAIDs) on reducing post-operative analgesia requirements and whether non-selective NSAIDs are more effective than selective NSAIDs. The study will randomise the patient to receive either a non-selective or selective NSAID and assess whether there is any difference in pain scores. The null hypothesis is that there will be no difference in pain scores in the treatment groups.

The specific aim of this project is to evaluate a structured pharmacist-delivered minor ailment service, conducted in collaboration with general practitioners, in adult patients receiving care for certain ailments in Western Sydney primary health network region on clinical, humanistic and economic outcomes compared to usual care. The primary research questions are: 1. Is the new model of service delivery effective in improving appropriate medical referral? 2. Is the new model of service delivery effective in improving appropriate use of a non-prescription product? The secondary research questions are: 1. Is the new model of service delivery effective in improving symptom resolution? 2. Is the new model of service delivery effective in reducing re-consultation rates? 3. Is the new model of service delivery effective in improving quality of life? 4. Is the new model of service delivery cost effective?