ANZCTR search results

Intravenous (IV) antibiotic therapy is a very common reason for inpatient admissions. Traditionally a short peripheral intravenous cannula (PIVC) (<4 cms) has been the ‘default’ device for short term (1-14 days) antibiotic therapy however 33 – 54% of short-PIVCs fail during treatment, resulting in delayed antibiotic administration and repetitive insertion procedures. Interruption to antibiotic treatment has been linked to re-emergence of infectious disease, increased hospital stays, and antimicrobial resistant organisms. Recently, longer peripheral IV devices (4.5 -6.4 cms) have been introduced for short-term peripherally-compatible IV therapy. While observational data appears to suggest that long-PIVCs (with a greater catheter length within the vein) out-perform short-PIVCs, this has not been evaluated in a randomised controlled trial (RCT). We will conduct a single centre, two-arm, parallel RCT whereby initially 70 patients will be randomised to receive either a short-PIVC (control) or long-PIVC (intervention) for antibiotic administration. Should feasibility criteria be met a total 192 will be randomised to a fully powered study. We the investigators hypothesise that long-PIVCs will result in less antibiotic therapy interruption, with patients requiring fewer subsequent PIVC insertions.

This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment for metastatic colorectal cancer. Who is it for? You may be eligible for this trial if you are aged 18 years or over, have metastatic colorectal adenocarcinoma, have between more than 3 lesions, and are receiving first-line systemic treatment. Study details Participants will receive metastasis-directed LAT such as surgery, radiotherapy, microwave or thermal ablation following 3-6 months of initial standard first-line systemic treatment, Those receiving LAT will return to systemic treatment 16 weeks after enrolment only if they did not complete 6 months of first-line treatment prior to enrolment. Information on progression-free survival and treatment outcomes will be collected. Data from this study will inform investigators of the potential benefit of local ablative therapy in the therapeutic setting for metastatic colorectal cancer.

This study aims to observe acute muscle loss in patients with an acute severe traumatic brain injury over the first 28 days. To date acute muscle loss following the first 7 days following traumatic brain injury has not been reported. This study will assist to determine if there is an association between acute muscle wasting and functional impairments following a severe traumatic brain injury. The study will also determine if enteral or parenteral nutritional intake whilst admitted to intensive care (energy and protein) is associated with acute muscle wasting. This observational study is expected to lay the foundation for future interventional studies to assess the effect of exercise or nutrition (or a combination of both) on muscle loss and functional recovery following a severe traumatic brain injury.

This study will compare treatment satisfaction with Omnipod-DASH insulin pump with usual care with insulin pump therapy without sensor or multiple daily insulin injections in adults with Type 1 diabetes. We hypothesize that adults with Type 1 diabetes will report a more positive experience using Omnipod-DASH compared with their usual care.

Autism is a lifelong neurodevelopmental disorder characterised by differences in social communication, repetitive and restricted behaviours and sensitivities to sensory input (Diagnostic and Statistical Manual of Mental Disorders 5th ed: DSM-5; APA, 2013). Along with autism symptomology, autism is linked to a greater incidence of insomnia, with the prevalence estimated at 60- 86% in school aged children, compared to 5-30% among their non-autistic peers (Paine & Gradisar, 2011; Papadopoulos et al., 2019; Liu et al., 2006). Consequences of poor sleep include behavioural problems, impaired adaptive behaviour, psychopathology and exacerbated autism symptomology (Paine & Gradisar, 2011; Papadopoulos et al., 2019). Resultingly, effective treatment for insomnia is imperative in order to reduce negative consequences. Cognitive Behavioural Therapy for insomnia (CBTi) is recommended as a primary treatment for insomnia (American Academy of Sleep, 2005) and has demonstrated efficacious outcomes (Quaseem et al., 2016). However, there is scant research on CBTi as a treatment for insomnia among individuals with autism, with the majority of studies focusing on pharmaceutical options (Cortesi et al., 2012). Therefore, the present study aims to establish the efficacy of Cognitive Behaviour Therapy for Insomnia (CBTi) in children aged 7-12 with autism, compared to a waitlist control group of children aged 7-12 with autism. Hypotheses Children who receive CBTi will have significantly greater improvements in sleep parameters including sleep onset latency, wake after sleep onset, sleep duration and sleep efficiency compared to a waitlist controlled autistic group. Additionally, children who receive CBTi will have significantly greater improvements in anxiety, depression and daytime sleepiness compared to the waitlist controlled autistic group.

Following bowel resection due to cancer, up to 80% of patients will experience variable and unpredictable bowel function and symptoms termed as Low Anterior Resection Syndrome (LARS). The exact mechanism of LARS remains unclear and currently there is no standard treatment. Research shows that the gut microbiome, also known as gut bacteria, is changed in patents following bowel cancer and may be linked with LARS and the changes in bowel function and symptoms experienced. This program of research therefore aims to examine the effect of Faecal Microbiota Transplantation in LARS symptoms, the gut microbiome and quality-of-life. Who is it for? You may be eligible for this study if you are aged 19 years or older, have had an ileostomy reversed with a background of low anterior resection or ultra-low anterior resection due to adenocarcinoma of the colon or rectum, and are experiencing symptoms of minor or major LARS. Study details Participants will be randomised (i.e. allocated by chance) to receive one of two different doses of faecal microbiota transplant, or standard care. Faecal microbiota transplant involves administering faecal matter via a syringe using colonoscopy, which requires insertion of a flexible tube into the rectum, and will take an addition of approximately 5 minutes to your routine colonoscopy to complete. Participants allocated to standard care will not receive a faecal microbiota transplant. All participants will answer a number of questionnaires about bowel function and quality of life, and will provide a stool sample for analysis at baseline and week 4 of the study. Participants will also provide a blood sample to assess their immune response and signs of inflammation at baseline and week 4 of study. It is hoped that this research will show that faecal microbiota transplant is an effective treatment for reducing symptoms of LARS and improving quality of life in patients who have undergone a low anterior resection.

This intervention program aims to boost well being and engagement among people aged 65 years and older. The primary intervention uses a behavioural activation approach to support participants to plan and do personally meaningful and enjoyable activities to lead a more rewarding life. This approach has been demonstrated to help people become happier in studies around the world and is also a very effective treatment for depression and has undergone pilot testing (see ACTRN12620000126910). This approach will be compared to a multi-component positive psychology intervention, where participants will be taught a variety of different strategies that use cognitive reframing strategies to build positive emotion and wellbeing. Our goal in this study is to test whether a tailored version of a well-established behavioural activation intervention increases engagement, valued activity, health, and wellbeing in an older adult population, when compared to another wellbeing program that is matched for time, effort, and contact.

A major source of sleep disruption in older adults is obstructive sleep apnoea (OSA), a disorder characterised by frequent pauses in breathing due to partial or complete airway closure during sleep. These events result in sleep disturbance and oxygen deprivation, which previous studies have shown to be associated with an increased risk of dementia. Therefore, there is an imperative to establish definitively whether treatment of sleep apnoea can prevent dementia. This multi-site feasibility randomised-controlled trial aims to determine whether it is feasible to deploy a targeted intervention to treat sleep apnoea in participants with subjective memory complaints and determine the magnitude of effect on memory decline. Participants will be randomised to the intervention or control group for 2 years. Participants in the intervention group will receive treatment for their OSA following an algorithm and incorporating key principles of goal setting and behavioural sleep management. Participants in the control group will have their screening results sent to their referring medical practitioner, with recommendations for further investigation. Further, 90 participants will undergo a 25 min MRI at the study center during their standard visit at baseline and 24 months. For the MRI scan, participants will be selected based on participant choice and willingness to participate, as well as, if they pass the MRI safety questionnaire and consent. The primary outcome is the feasibility of the trial. The stop-go criteria to determine feasibility will depend on meeting the acceptability, hypoxic burden, and tolerability criteria. The secondary outcomes listed are primary being collected for the propose of showing feasibility of collection rather than serious intension of showing efficacy.

TDAY is a pilot open-label randomised control study comparing two different forms of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Major Depressive Disorder (MDD) in adolescents and young adults. Participants with MDD will be randomised to one of two rTMS treatment groups. In both groups a magnetic coil will be applied to L) side of the scalp, in which the coil generates an electrical impulse to the stimulate the underlying brain tissue, No anaesthetic is required. Group 1 will receive what is considered a standard 10Hz treatment protocol while Group 2 will receive a more novel, intensive intermittent thetaburst (iTBS) treatment protocol. Treatments will be administered Monday - Friday for 4 weeks. All participants will be engaged with their treating doctor for the duration of the trial, and will continue their current treatment regimen (i.e., either maintain a stable dose of antidepressant medication, or continue without antidepressant treatment). The primary outcome measures of safety and tolerability will be assessed continually across the study by monitoring adverse events and dropout rates. The secondary outcome measure (change in depression score) will be assessed at the end of week 2 and week 4, with a further assessment at week 8 to ascertain if any improvements have been maintained, and if some participants have a delayed response to treatment. The study hypothesis is that the acceptability and safety/tolerability of the more novel intensive iTBS treatment protocol (Group 2) will similar or greater than that of the standard rTMS treatment protocol (Group 1).

The primary purpose of this trial is to evaluate whether FDG PET is helpful for clinicians treating men with newly diagnosed aggressive prostate cancer (according to tissue histology) and staged with PSMA PET. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with aggressive prostate cancer (high risk features) and have not had treatment to date, but you may be planning to undergo surgery, radiotherapy or other treatments. Study details: All participants enrolled in this trial will undergo a FDG PET/CT scan. The results of the scan will be made available to your doctors to help them to plan the most suitable treatment course. The accuracy of the PET scans will be determined according to follow-up information available up to 12 months after entering the study. The findings of the scans will be investigated for their ability to predict future cancer outcomes. Patient reported outcomes (PROs) as to how the scans and subsequent treatment affect enrolled participants will also be assessed.