ANZCTR search results

The purpose of this trial is to evaluate the impact of the Burn 2 Learn (B2L) intervention on students' cardio-respiratory fitness and secondary outcomes (muscular fitness, body composition, vigorous physical activity, cognitive control, motivation, basic needs satisfaction and psychological health). Our primary hypothesis is that students allocated to the intervention condition will experience improved cardio-respiratory fitness relative to students allocated to the control condition by the primary study end point (14 weeks post-baseline). We aim to recruit 80 grade 11 students from two schools (x40 per school) who will be randomly allocated (by school) to received the B2L intervention or participate in usual practice (control group to receive the intervention after the final assessments). The B2L intervention will involve students participating in 2-3 sessions per week of High Intensity Interval Training (HIIT) for 14 weeks, delivered at school by peer leaders (trained grade 11 students). To facilitate the intervention, 2 x teachers will be recruited as school champions and will attend a one-day professional learning workshop. Peer leaders (x 5-10 students) will be identified and recruited from the intervention school. Peer leaders and students will participate in a 2 hour workshop delivered by the research team. The HIIT sessions will involve a variety of engaging exercises and will occur for 15-20 minutes at a time. The intervention school will receive an equipment pack (heart-rate monitors, iPad, Bluetooth speaker, exercise cards) to facilitate session delivery. To gain support from the home environment, parents of study participants will receive 2 x eNewsletters via Facebook or the Skoolbag app during the study period.

Many people with diabetes experience problems with their balance and walking, which can make day to day activities difficult and increase the chance of sustaining a fall. Nerve damage (a common complication of diabetes) can severely disrupt the quality of the signals transmitted from the feet to the brain, which provide vital cues about the ground we stand on and the relative position of our body above, to help people remain upright. Novel footwear devices are emerging as an attractive treatment option to help alleviate balance and walking problems and reduce the risk of falling in adults with diabetic peripheral neuropathy (nerve damage). Textured shoe insoles (comprising raised nodules) are designed to enhance the signals from foot skin receptors, which is important for good balance. This randomized controlled trial will be the first to explore whether use of different shoe insole surfaces (over 4-weeks) can improve balance and walking performance in adults with diabetic peripheral neuropathy. We will also investigate whether any alterations in balance or walking are associated with underlying changes in the amount of remaining feeling in participants’ feet (measures of foot sensation and foot position awareness). Additionally, we will explore whether wearing different shoe insole surfaces lead to improvements in physical activity levels or measures of self-reported foot heath and falls in adults with diabetic peripheral neuropathy. This study will bring new perspective to our understanding of the therapeutic role of footwear interventions, as a means to address deficient postural control in adults with neuropathic changes at the feet. The findings will be used to inform the development of new rehabilitative approaches that will help advance clinical guidelines and policy, and reduce the escalating personal, societal and economic burden of falls in people with diabetes.

Increasing energy expenditure to reverse obesity may be possible using beta-3 adrenergic receptor agonist drugs, however it was not until recently that such drugs have been available under prescription. These approved drugs were developed for purposes other than treatment of obesity, so they have never been studied in this context. In this proposal, we will conduct a pilot study to determine the effects of multiple doses (the highest prescription dose of 50 mg, plus 100, 150 and 200mg) of the beta-3 adrenergic receptor agonist, mirabegron, on whole body energy expenditure and cardiovascular responses. This will be a dose finding study for which the purpose is to obtain data in order to inform a larger trial which will be conducted subsequently. We aim to determine the highest dose which will maximise energy expenditure without effects on the cardiovascular system.

The aim of this study is to test if panitumumab is a potentially useful treatment for pancreatic cancers which do not have mutations in the KRAS gene. Panitumumab has been shown to be effective in colon cancer, but only in those patients with cancers that lack a mutation in the KRAS gene. The fact that 90% of patients with pancreatic cancer have a mutation in the KRAS gene may explain why panitumumab has not been found to be effective when it has been administered to all patients with pancreatic cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with locally advanced (unresectable) or metastatic pancreatic ductal adenocarcinoma (PDAC) which has progressed following first line chemotherapy. Study details Participants enrolled who have KRAS wild-type PDAC will be allocated to the treatment arm. These participants will receive panitumumab by injection, once every two weeks for up to 24 months, with chemotherapy started at 4 months if your treating doctor determines that this would be beneficial. Participants enrolled who have KRAS mutated PDAC will be allocated to the observation group. These participants will receive standard treatment as determined by their treating doctor, and will simply complete trial assessments. Assessments for all participants will include CT scans and blood tests to monitor cancer progression for up to two years. It is hoped that the findings from this trial will provide information on whether panitumumab is an effective therapy for KRAS wild-type PDAC.

The purpose of the intervention is to improve the social and communication skills of children with autism. We aim to do this by using children's everyday school context and their typically-developing class peers. We suspect, that both children with autism and their class peers will demonstrate signicant improvements in their social and communication skills following the intervention.

Incontinence associated dermatitis (lAD) is a preventable skin condition in the bottom and genital area due to exposure to moisture and other irritants. lt is characterised by patchy inflammation of the skin and eventually leads to skin erosion. The patient may experience itching or burning sensations and/or pain and can suffer a decrease quality of life. lAD results in complications including increased risk of developing a pressure injury or a skin infection. As a result, lAD associated complications can be expensive for healthcare services. This study intends to evaluate the effectiveness of 3M Cavil on TM Advanced Skin Protectant to prevent, delay and/or reduce the severity of lAD, in critically ill patients in the intensive care setting. This pilot study aims to enroll 30 eligible study participants who have been appropriately consented and screened. The interventional product will be administered three times a week, with the control product (standard treatment) administered daily whilst the participant is in the intensive care setting. Study participants will be assessed at baseline, Day 1 then daily or three times a week with evaluations including demographics, product application, skin assessment and completion of questionnaires. In addition the incidence and severity of adverse events and performance of the interventional product will be documented.

A prospective multi-center study of adult patients admitted to intensive care (ICU) or high dependency unit's across Victoria. Ethical approval will be sort through The Alfred Hospital, Monash University and the individual ethics boards for each participating site. This study aims to use anchor and distribution based methods to establish the minimal important difference (MID) of the ICU mobility scale (IMS) in a critically ill population. Anchor based: Where patients are treated by the same clinician physiotherapist within 24 hours of admission and discharge to ICU they will be asked two questions on the final assessment. “Has the patient’s mobility changed since admission to ICU?” and “If yes, how much have they changed?’ The rate of change will be scored as: 1- almost the same, hardly better at all, 2- a little better, 3- somewhat better, 4- moderately better, 5- a good deal better, 6- a great deal better and 7- a very great deal better. Similar assessments will be made for deterioration, substituting “worse” for “better”11. The IMS will also be independently collected at both time points by a clinical researcher. Distribution based: The patients’ IMS scores from ICU admission and discharge will be used to estimate the MID using two distribution based methods, the standard error of the mean and the effect size.

This clinical trial aims to evaluate the safety and tolerability of 2 different pirenzepine formulations after daily topical dose administrations in healthy subjects for 14 days and of an alternative dosing regimen in healthy subjects with 1 of the pirenzepine topical formulations. The secondary purposes of this trial are to evaluate the pharmacokinetics (PK) of pirenzepine and its desmethyl metabolite following single and multiple topical doses of 2 different pirenzepine formulations and to evaluate the PK of pirenzepine and its desmethyl metabolite following an alternative dosing regimen with 1 of the pirenzepine topical formulations.

The primary purpose of this trial is to evaluate the feasibility of implementing standardised early palliative (STEP) care for advanced breast, prostate and brain cancer patients. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with prostate cancer with metastases, breast cancer with at least one visceral metastasis or grade IV brain tumour/glioblastoma with recurrent disease or no cancer treatment prescribed, and their nominated carer. You must have been admitted to hospital for a stay lasting more than one day in the previous two weeks. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either standard care or to receive the STEP care intervention in addition to standard care. Participants allocated to the STEP care intervention will receive palliative care consultations (with their carer) at least once per month for three months. If the treating doctor/nurse determines that further palliative care would be beneficial then another three months of consultations may be provided. The palliative care is tailored to the needs of the person and their carer, but will include review and management of any symptoms of concern, referral for additional supports as required, review of informational needs, addressing illness understanding and discussion of prognosis, assistance with care planning, case conference with the person's GP. Researchers will monitor whether the implementation of this program, and whether recruitment into this trial are feasible, as well as asking all participants to complete a number of questionnaires to determine whether the STEP care intervention benefits patient and carer outcomes such quality of life, mood, and survival and reduces time spent in hospital. It is hoped that the results of this pilot trial will inform a future large scale trial to evaluate whether standardised early palliative care is beneficial for advanced cancer patients and their carers.

Test null hypothesis: there is no difference in pocket depth reduction, between one stage full mouth disinfection with and without the use of adjuvant systemic antimicrobial therapy (Azithromycin) against the alternative hypothesis of a difference. AIM :The purpose of this study will be to evaluate the use of systemically administered azithromycin as an adjuvant to OSFD (one stage full mouth disinfection) in the treatment of chronic periodontitis through clinical and microbiological periodontal parameters at baseline, 90 post therapy. SIGNIFICANCE OF THE RESEARCH - Although general consensus favours the use of systemic antibiotics in conjunction with conventional staged debridement therapy in treatment of advanced periodontal diseases, there are limited studies where systemic antimicrobials were used in conjunction with one stage full mouth disinfection. To the best of our knowledge, there are no studies that evaluated clinically or microbiologically the use of azithromycin as an adjuvant to the OSFMD. This trial could help provide evidence based guidelines for the use of azithromycin in conjunction with OSFMD in treatment of patients with chronic periodontitis.