ANZCTR search results

This study aims to evaluate the safety and effectiveness of a combination of veliparib with radiotherapy, followed by a combination of veliparib with temozolomide (a chemotherapy), to treat patients with newly diagnosed glioblastoma multiforme (a type of brain tumour). Who is it for? You can join this study if you are a person who is recently diagnosed with glioblastoma multiforme (brain tumour), underwent surgery (or have been scheduled to undergo surgery) for this diagnosis and are considered for further treatment with radiotherapy plus temozolomide treatment. Study details: If you like to join this study you will first be screened by your specialist to see if you meet the eligibility criteria to participate in this study. If you are deemed eligible to participate you will be randomly (by chance) assigned to one of two possible treatment groups: Group 1 will receive veliparib together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with a combination of temozolomide and veliparib. Group 2 will receive receive temozolomide together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with temozolomide. Your chance to receive the group 1 treatment is twice as high as to receive the group 2 treatment. Participants will be asked to attend clinic visits every 2-4 weeks during the treatment period and then two times more (1 month and 3 months after having received the last treatment). During these visits the specialist will assess the status of your glioblastoma and your physical and mental health, and ask you about your well-being. Participants will also be asked to undergo tests and procedures, such as blood testing, urine testing, scans, and questionnaire completion and to give tissue samples for laboratory research.

This is an open label study designed to assess the long term retention on treatment and long-term safety and tolerability of Triheptanoin in participants with drug-resistant epilepsy.

The primary purpose of the study is to evaluate the safety and performance of a novel, biodegradable dermal matrix for the treatment of patients with deep burns (deep-dermal/full-thickness injuries) involving 10-70% total body surface area (TBSA) requiring burn excision and significant skin grafting. Current standard of care for deep partial or full-thickness burns includes early excision of necrotic tissue and prompt coverage. This attenuates the postburn hypermetabolic response, decreases fluid loss, and ultimately improves survival. A full thickness autograft (skin transplant) is used to cover the debrided wound. However, if the extent of the burns is very severe, then this approach becomes impracticable, there is not enough healthy skin left to harvest and the patient is already too unwell to cope with another large wound. For moderate to large burn injuries in subjects, grafting at a second operation allows significant physiological recovery of the subject prior to graft harvest and application. Reducing the early surgical ‘insult’ to major burn injury sufferers is important in assisting patient survival and reduces the risk of loss of resources (such as harvested applied skin grafts and skin graft donor sites) secondary to physiological insufficiency or deterioration. The Biodegradable Temporising Matrix (BTM), manufactured and assembled by PolyNovo Biomaterials Pty Ltd has been designed specifically for use in extensive full thickness burn injuries, but its structure and properties make it suitable for other full thickness wounds where dermal reconstruction is necessary or desirable.

This project aims to determine the feasibility and acceptability of a brief, individualized and supervised exercise intervention to improve symptoms of depression, anxiety and stress among medical students. The project will also evaluate the effect of the intervention on key measures of physical health including weight, waist circumference, aerobic exercise capacity (fitness), muscle strength and sleep behavior. The project will randomly allocate participants to either one of three experimental groups aerobic exercise, resistance exercise or an active control condition where participants will receive a ‘Jawbone’ or similar physical activity monitor for a period of eight weeks.

Escherichia coli (“E. coli”) and Klebsiella are bacteria which are common causes of infections in your blood stream. Patients with bloodstream infections due to either E. coli or Klebsiella, can commonly be treated with antibiotics called third generation cephalosporins, such as the antibiotic ceftriaxone. When the blood stream infection is resistant to these antibiotics, the antibiotics meropenem and piperacillin/tazobactam have been shown to be effective alternatives for treatment. The purpose of this study is to work out whether these two other antibiotics, meropenem and piperacillin/tazobactam, are equally effective in the treatment of these antibiotic resistant bloodstream infections. These antibiotics have never been compared “head to head” in order to establish the best available treatment for these serious infections. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.

Researchers in allied health and primary care are partnering with Northern Sydney Medicare Local and the NSW State Falls Program (Clinical Excellence Commission) to establish a multi-disciplinary pathway model for fall prevention. The aim is to establish integrated processes and pathways at the levels of practitioner, practice, and program to identify older people at risk of falls and engage a whole of primary care approach to fall prevention. Few older people are asked by their general practitioner (GP) about falls or are offered interventions to prevent falls. For those that do, few base their falls prevention practice on recognised clinical guidelines. Primary care physicians report a number of barriers including time and educational materials. A major problem for evidence uptake is that studies which test fall interventions provided within a research context have much better outcomes than trials reflecting usual practice which rely on referral to usual health care providers. Studies have consistently shown that referral alone is not effective. This is because in reality few community-based organisations regularly offer evidence-based falls prevention services. We aim to form collaborative, information rich, working arrangements with GPs and allied health service providers. Our model aims to: improve access to appropriate fall prevention interventions for older people, ensure ongoing knowledge acquisition and sustainable action by healthcare professionals and organisations, using a multidisciplinary team approach to fall prevention that is integrated and translatable nationally. This cluster randomised trial is part of a hybrid translational project. The trial will evaluate if the intervention can change GP referral and management practices for falls prevention and if this will result in reducing falls for their older patients.

Sexuality and intimacy are key aspects of quality of life detrimentally affected by cancer, resulting in significant reductions in well-being for people with cancer and their partners However, health professionals rarely address this important health problem, and little is known about the factors which predict difficulties or re-negotiation of sexuality post-cancer This study will examine the experience and construction of intimacy and sexuality post-cancer, from the perspective of people with cancer, their partners, and health professionals, and elucidate pathways to difficulty or re-negotiation Based on these findings, programs of targeted couple interventions will be developed, and evaluated in a randomised controlled trial.

Chronic heart failure (CHF) is a complex medical condition characterised by recurrent exacerbations and a high rate of co-morbidities. An estimated 11,250 patients with CHF live within the South Metropolitan Health Service (SMHS) catchment area. The cost of CHF to the WA Health system is significant. According to the Epidemiology Branch, Department of Health (2011), from 2000 to 2010 (financial years from 2000/01-2009/10) CHF resulted in an average of 5,168 bed days per year in SMHS hospitals alone. A recent consensus statement by the National Heart Foundation and Cardiac Society of Australia and New Zealand conceded that outcomes for patients diagnosed with CHF “remain poor, often due to late diagnosis and inadequate disease management and support”. Many CHF patients are managed in primary care by their GP. However, there is currently limited support provided for GPs to conduct this challenging role, resulting in an overreliance on costly hospitalisations and use of tertiary health care when patients experience exacerbations. Moreover, in many cases, patients miss early warning signs and don’t engage GP care early when their changing condition can be managed effectively in a primary care setting. The aim of this study is to investigate a novel intervention that involves a community nursing model that is complemented by the use of telehealth to monitor patients remotely through online software. The core component of this approach will be a multifactorial telehealth intervention, facilitated by a CHF nurse. The telehealth intervention will be patient-centred, providing patients with education and support for self-management and have a strong focus on coordination of care through feedback of clinical information to GPs to help them implement timely medical follow up.

Excessive gestational weight gain (EGWG) or weight gain during pregnancy is associated with poor child and maternal health outcomes, including preeclampsia, gestational diabetes, complications with labour and delivery, and babies who are born either small or large for gestational age. There is also an increased likelihood of postpartum obesity in both mothers and their children, which in turn leads to an increased risk of chronic disease later in life. Estimates from one off studies indicate the prevalence of EGWG in Australia could lie between 38 and 67%. The NSW Get Healthy Service (GHS) is a telephone based coaching service available to all adults in NSW aged 18 years and over. The NSW Office of Preventive Health (OPH) and NSW Kids and Families have collaborated to develop a service enhancement or “module” for the GHS specifically aimed at supporting pregnant women to achieve appropriate gestational weight gain. An initial pilot phase for the module is proposed to assess effectiveness of the coaching program, through conduct of a randomised controlled trial. This RCT will compare the effectiveness of a telephone based coaching program versus provision of information alone in supporting pregnant women to achieve appropriate gestational weight gain and prevent postpartum weight retention. The hypothesis is that compared with participants who only receive information, pregnant women enrolled in the coaching program will be less likely to achieve excessive gestational weight, and be more likely to have returned to their prepregnancy weight 12 months after giving birth. A stratified cluster randomised design will be used, with stratification by prepregnancy BMI (normal and overweight/obese) and clustering by hospital. Four hospitals will be invited to participate, with two allocated to the control arm and two to the intervention arm. Pregnant women will be invited to participate in the trial on their first booking visit with a midwife, and allocated to an arm depending on the hospital they attend. Anthropometric (e.g. weight gain or retention) and behavioural (e.g. fruit and vegetable consumption) outcomes for each group will be compared at 36 weeks gestation and 12 months post birth. Additionally, qualitative feedback on the feasibility and acceptability of the module (information and coaching components) will be sought from participants and midwives.

This research project is aiming to determine the effects of 3 months supplementation with a proprietary spearmint extract, on cognitive functioning in healthy individuals. Participants will be required to complete 4 testing sessions and 1 screening session. During these sessions they will be asked to complete a variety of measures assessing cognitive function and general health. Participants will be asked to take one of the following treatments for a 90 day period: - Proprietary spearmint extract - Matched placebo