ANZCTR search results

Brief Summary Cranial reconstruction using mesenchymal stromal cells and resorbable biomaterials, will result in the patient producing their own bone to fill the void which will reduce the risk of infection and resorption, lead to a better cosmetic result and obviate any long term consequence of having a synthetic material in vivo. Introduction: There are several reasons that parts of the skull may need to be removed: - After trauma to relieve brain swelling - During brain surgery (for brain cancer) - After trauma where the bone is so badly fractured/fragmented it needs to be removed. In all but the last case the bone flap is temporarily stored in a freezer and once the brain swelling has subsided it is reinserted. This procedure is called "autologous cranioplasty"; autologous, because it originally came from the patient and cranioplasty, referring to the repair. Although this is a straightforward procedure, there are a number of complications including infection and bone resorption that can occur. This study: Stromal cells have a proven ability to aid in bony healing. Furthermore stromal cells on a ceramic framework encased in a plastic scaffold have been shown in a small clinical trial to lead to healing of skull defects. In the present study, it is proposed to add stromal cells, either autologous or allogeneic, to a resorbable ceramic material and insert into the skull. The ceramic is designed to dissolve away over time as the body's own blood vessels and cells populate the construct and create the patient's new bone. It has been proven that without the encouragement of the cells and temporary scaffold materials, a hole in the skull will not heal. Given the incidence of bone resorption/infection and metal plate infection using traditional methods, it would seem prudent to provide a construct that will allow controlled replacement with the patient's own bone, thus negating any adverse long-term complications with synthetic materials that remain for life.

This study aims to evaluate the feasibility and safety of normal saline, compared to heparinised saline, for the prevention of occlusions (blockages) in central venous access devices (CVADs) in a paediatric oncology population. Who is it for? You or your child may be eligible to join this study if you/they are aged 0-18 years, have been diagnosed with an oncological or malignant haematological condition, and have a central venous access device (CVAD) in situ. CVADs are flexible tubes inserted in the chest, neck or upper arm veins, which enable the administration of anti-cancer drugs, collection of blood tests, and delivery of supportive therapies. Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will have their CVAD locked with 0.9% Sodium Chloride, whilst participants in the other group will have theirs locked with heparinised saline. Duration of study enrollment will be capped at six weeks. All participants will be monitored throughout their enrolment in the study to determine any CVAD blockages (known as occlusions), or other adverse events such as venous thrombosis and infection. We hope to determine whether a larger efficacy trial of these CVAD locking techniques is feasible and safe.

The aim of this study is to evaluate the effectiveness of different types of information leaflets on intention to undergo imaging for non-serious low back pain in patients with low back pain and the general public.

The ability of artificial tear supplements, that are commercially available ‘over-the-counter’, to improve tear film stability and reduce symptoms of dry eye will be evaluated. Specifically the clinical course of artificial tear supplement effects, including how quickly improvements in signs and symptoms occur and the time taken to reach maximal treatment effect will be assessed. The outcomes relative to dry eye subtype, such as those deficient in tear volume or those who exhibit poor tear quality at baseline, will be evaluated.

Obesity is one of the greatest health challenges facing today’s adolescents, who are now the largest global population segment (>25%). In Australia, over 30% of adolescents (13-18 years) are overweight or obese. Weight gain during adolescence is related to heart disease in later life. Implementing accessible obesity interventions could save our society $2.1B over the next 10 years. Hence, it is important we develop contemporary, low-cost, and engaging population-based obesity prevention solutions. Presently, Australian adolescents have limited access to age-appropriate obesity prevention services. There is a growing body of evidence indicating text messaging interventions are effective for secondary prevention of heart disease and our team has a successful program of related research. However, there is limited evidence for the role of text messages to engage adolescent populations in obesity prevention behaviours. In our preliminary work, through expert workshops and consumer testing, we have developed a bank of 300 evidence-based text messages that are acceptable and engaging for adolescents. In this randomised controlled trial, we aim to test the effectiveness of this healthy lifestyle text message program (TEXTBITES), with optional health counselling, compared to usual care in improving body mass index and lifestyle outcomes in overweight adolescents. Participants will be randomly assigned to the intervention program or standard care for 6-months. BMI and lifestyle outcomes will be assessed at the completion of the program, 6-months and all participants will be followed up 6-months later (12-months from baseline). There are no foreseen physical or psychological risks associated with participation in this study. For safety purposes, an independent, unblinded researcher will monitor all incoming text messages. This potentially scalable project will inform future practice and community initiatives to promote obesity prevention behaviours for adolescents.

The caesarean section (CS) rate has risen to the point where a third of all mothers in Australia give birth by this method [1]. CS is a major contributing factor to maternal mortality and morbidity following childbirth in developed countries and reducing the overall CS rate is a major policy goal for NSW Health [2]. The highest risk of adverse outcomes associated with CS occurs when it is performed during labour which is 40% of all CSs[1, 3]. Most of these are due to failure to progress (FTP) which accounts for around 8% of all births[3]. Induction of labour (IOL) reduces the risk of CS, particularly when there is a low risk of fetal distress [4, 5], but it is not feasible to offer this intervention to all women because given time, most women will labour naturally. To date, there is no method of prospectively identifying women who are most likely to benefit from IOL. Predictive models could identify women who might benefit from preventative measures such as induction of labour. We have created a model which will be used to screen for women at high risk of caesarean section in labour. This model incorporates maternal age, body mass index (BMI), height, gestational diabetes, estimated fetal weight, amniotic fluid index, and parity. We will be investigating if induction of labour compared with routine antenatal care at 39 weeks of gestation in women with a cephalic presenting fetus reduces the risk of caesarean section for abnormal progress in labour. References: 1.Hilder, L., et al., Australia's mothers and babies 2012. Perinatal statistics series no. 30. Canberra: AIHW, in Australia's mothers and babies 2012. 2. Health, N., Maternity - Towards normal birth in NSW, N. Ministry of Health, Editor. 2010. 3. Zhang, J., et al., Contemporary cesarean delivery practice in the United States. Am J Obstet Gynecol, 2010. 203(4): p. 326 e1-326 e10. 4. Gülmezoglu, A.M., et al., Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database of Systematic Reviews, 2012(6). 5. Boers, K.E., et al., Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ, 2010. 341: p. c7087.

This study will evaluate the effect of exercise on health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours in people with multiple myeloma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of multiple myeloma, and are free of any conditions that may prevent safe completion of the exercise demands of the study. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will immediately commence a 3 stage exercise program. The first stage will be gym-based and involves 2 x supervised sessions and 1 home-based session per week for 12 weeks. All supervised classes will be delivered by an Accredited Exercise Physiologist. Stage 2 is a 12 week home-based program (3 sessions/week) with weekly telephone support, with the option to attend one group-based class each week delivered by an Accredited Exercsie Physiologist. Stage 3 involves a maintenance home-based program for a further 6 months. The program will be individualised to the participants’ cardiorespiratory fitness and bone lesions, and will involve high-intensity aerobic exercise, resistance training and impact loading. Participants in the other group will receive the same program after a 12 week wait, during which time they will receive usual care. All participants will undergo a number of assessments at baseline, 12 weeks, 24 weeks, 36 weeks (group 2 only) 12 months (group 1 only) and 15 months (group 2 only) in order to evaluate health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours. The potential findings of this proposed research will ultimately influence the inclusion of exercise as part of standard care to improve the health and longevity of people with multiple myeloma.

The primary purpose of this trial is to evaluate the safety and efficacy of a combination treatment consisting of EDV's packaged with a chemotherapeutic targeted to cancer cells and an adjuvant therapy that is designed to boost the bodies own immune system to fight the cancer. In Phase I the study will enrol 5 evaluable patients per cohort. In Phase IIa the study, will enrol up to an additional 35 evaluable patients per cohort. Therefore up to 40 evaluable subjects per cohort will be enrolled in the study. Who is it for? You may be eligible to enrol in this trial if you are aged 18 years old or older and have either advanced pancreatic cancer or any solid tumour that has been treated with at least one prior treatment regime or where other standard therapies are not appropriate. Study details All participants enrolled in this trial will receive combination treatment with the following: 1. The EnGeneIC Dream Vector(TM) (EDV(TM)). The EDVs are very small particles known as nanocells, which are made from Salmonella bacteria. The type of Salmonella is one that does not cause disease. The EDV is the delivery vehicle used to transport the study drug directly to the site of the cancer. 2. The Cancer Treatment. The study drug is a type of chemotherapy. The study drug is packaged inside the EDVs (E-EDV-D682) and is targeted directly to the site of the tumour, rather than the body’s healthy cells and tissues. The EDVs will also be packaged with another substance that is designed to boost the immune system, called EDV-GC. 3. Bispecific antibody. The EDV delivery system works in 2 ways, as well as carrying the study drug, the EDV surface is also coated with a bispecific antibody. A bispecific antibody is two antibodies linked together, such that one can attach to the EDV and the other to cancer cells. Once attached, the EDVs are taken up inside the cancer cells, and the study drug is delivered directly inside the cell itself, causing the cancer cell to die. Treatment will be administered in 5-week cycles. The treatments are prepared in a syringe and administered into a vein (intravenous), over a period of 20 minutes using a special pump. Two doses of the treatment are given twice per week for the first 2 weeks, followed by weekly treatment for a further two weeks, with a treatment free week where a CT or MRI scanning is performed to evaluate the tumours response to treatment (Week 5). Treatment may continue until the patient or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the patients disease continues to grow. It is hoped that the findings from this trial will provide information on whether E-EDV-D682 and EDV-GC treatment may be safe and effective for the treatment of otherwise incurable pancreatic and other advanced solid tumours.

The current study aims to assess the efficacy, safety, and usability (i.e., clarity, efficiency, ease of navigation) of a new online psychological treatment for fears of death. We expect that this new treatment will result in reductions in fears of death and few adverse events, and will be seen seen as helpful and easy to use.

Peripheral Venous Catheters (PVC) are inserted for the administration of medications and fluid;. two billion are sold worldwide annually. While patient need for PVCs is high, up to 69% fail due to complications such as occlusion or phlebitis necessitating additional PVC insertions to complete treatment. PVC replacements increase healthcare costs (staff time/equipment) and some patients require higher risk central venous device, because they have run out of PVC insertion sites. Midline catheters (MCs) are an alternative to PVCs, increasingly used, but rarely in Queensland, Australia. On average 10cms long, they terminate at the axillary vein, not in the central venous circulation. As with any invasive device, leaking, infection and thrombosis can occur. Their rising popularity is due to concerns that patients’ veins are depleted by multiple consecutive PVCs. There have been no randomised controlled trials (RCTs) comparing these devices to guide practice. This pilot randomised control trial will test the feasibility of a large study comparing PVCs and MCs for patients with difficult vascular access and/or prolonged therapy.