ANZCTR search results

The primary aim of our study is to test whether a psycho-educational intervention, comprising a tailored, psycho-educational booklet and individual, telephone-based psychological support, will reduce fear of melanoma recurrence, defined in this study as fear of a previous melanoma coming back somewhere else in the body as well as fear of developing a new melanoma on the skin. The secondary aims of our study are to assess the cost-effectiveness of the psycho-educational intervention, and to improve patient understanding of melanoma risk, doctor-patient communication about melanoma, melanoma-related health behaviours (e.g. skin self-examination) and unmet supportive care needs. Who is it for? To participate in the study, patients will be aged over 18 years, will have a previous melanoma diagnosed at stages 0 I or II, will be attending one of the melanoma high risk clinics in New South Wales, and have sufficient English language skills to read the booklet and complete the study questionnaires. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups – the ‘intervention’ group or the ‘standard care’ group. Four weeks before their full dermatological appointment at the high risk clinic (HRC), participants in the intervention group will receive two booklets: our newly developed psycho-educational booklet (called ‘Melanoma: Questions and answers’), and the freely-available Cancer Council booklet (called ‘Understanding Melanoma’). Participants in the intervention group (Group 1) will then have three individual telephone-based psychological support sessions (each up to 90 minutes duration) with a clinical psychologist. The first telephone session will occur about one week after participants receive the booklets (before their HRC appointment). The second telephone session will occur about one week after participants’ HRC appointment, and the third telephone session will occur about three weeks after participants’’ full HRC appointment. These telephone sessions aim to give participants the opportunity to raise questions or concerns they have after reading the melanoma booklet and after attending their clinical consultation. Their key goals are to assist participants: a) to have a point of contact; b) to use the newly developed melanoma psycho-educational booklet; c) to prioritise their goals; d) to use other available avenues of support Participants in the ‘standard care’ group will receive the Cancer Council ‘Understanding melanoma’ booklet and a blank notepad, four weeks before attending their clinic appointment. All participants will be asked to complete a questionnaire at baseline (6 weeks before their full dermatological consultation at the HRC), 2 weeks after their full dermatological consultation at the HRC, and again at 6 and 12 months, to evaluate the effect of the intervention on fear of melanoma recurrence, anxiety, stress, depression, quality of life, satisfaction with clinical care, melanoma risk knowledge, healthy behavioural adjustment to melanoma risk and unmet supportive care needs.

Every year, thousands of babies are born early (premature). Many premature babies need help to breathe for several days after birth, and sometimes for much longer. The most commonly used way of supporting the breathing of premature infants is with a technique called nasal continuous positive airway pressure (NCPAP). NCPAP uses large prongs snugly fitted into the baby’s nostrils, kept in place by a tight-fitting hat. The prongs supply air or oxygen under pressure to help keep the baby’s lungs open, making it easier to breathe. NCPAP is a well-tried and tested method of breathing support, but has some disadvantages: the hat and tubing can be quite bulky and cover most of the baby’s face, and the large prongs can rub on the baby’s nose and sometimes cause damage to the skin. A newer form of breathing support being used around the world, and in Australia, is called high flow nasal cannulae (HFNC). This method uses smaller prongs in the baby’s nose and does not require a hat to hold the prongs in place. Like NCPAP, HFNC also supplies air or oxygen under pressure to help support the baby’s breathing. Because the prongs are smaller and less bulky, HFNC may be more comfortable for babies than NCPAP, and it is easier to see the baby’s face. For these reasons, HFNC has become very popular as treatment for premature babies, and is being used around the world. However, HFNC has not been widely studied as a way of supporting breathing for babies soon after birth. The HIPSTER trial will compare the use of these two types of breathing support as treatment for premature babies who have breathing difficulties soon after they have been born. Premature babies born after 28 weeks’ and before 37 weeks’ gestation, who need breathing support in the first 24 hours of life, will be able to join this study. Babies who join the study will be chosen at random to receive either NCPAP or HFNC. The study will include a total of 612 babies, 306 will be treated with each type of breathing support. The main thing we are interested in is whether babies are successfully treated with the type of breathing support they are given. Babies who are given HFNC and are not improving can be switched over to have NCPAP, to see whether that helps. Information will be collected about the babies, such as how long the babies in each group need to carry on with breathing support, whether they need extra breathing help, whether they get any damage to their nose from the prongs, and how well they feed and grow. Basic information will also be collected about the mothers of the babies and the pregnancy.

This study aims to test the safety of multiple injections of the Dz13 (combined with DOPE and DOTAP) drug in patients with melanoma skin cancer. Dz13 is a small piece of DNA which binds to an mRNA molecule c-Jun and cuts it into two pieces disrupting the production of the c-Jun protein and can lead to a reduction in growth and spread of the tumour. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with dermal in-transit or satellite metastatic melanoma. You should have at least 3 measurable lesions at minimum distance of 5 cm from each other. Trial details: There will be 4 different cohorts (or groups) in this study, who are enrolled consecutively. Participants in the first group will receive 2 injections of the drug Dz13 into their tumour over a period of 1 week. Participants in the second group will receive twice weekly injections of Dz13 for two weeks, and group three for three weeks. Based on the findings of the first three groups, the fourth group will then receive twice weekly Dz13 injections for two or three weeks. All participants will be regularly assessed to determine safety and tolerability of treatment. The treated and pre-seelcted untreated tumours will be assessed by investigating the c-Jun levels within the tumour tissue and measuring tumour size. It is thought that Dz13 treatment may reduce the size of melanoma tumours in humans without significant toxicity.

Asthma is the most common serious medical problem to complicate pregnancies worldwide, with a prevalence between 8-13%, and affecting around 12% of pregnant women in Australia or 36,000 pregnancies each year. The health expenditure on asthma is significant and the economic burden of asthma is high. A recent meta-analysis demonstrated clear associations between asthma in pregnancies and adverse perinatal outcomes, with a 22-54% increased risk for low birth weight, small-for-gestational age, preterm delivery and pre-eclampsia. Previous work the laboratory also indicates asthma exacerbation contributes to poor outcomes including preterm delivery, growth restriction and stillbirth, and occurs in up to 55% of pregnancies. Oxidative stress is a potential mechanism driving the increased incidence of asthma exacerbation in pregnancy. Oxidative stress and inflammation manifest during pregnancy; however asthma in pregnancies further intensifies oxidative stress. We have previously identified that there are altered pathways regarding oxidant and antioxidant status in pregnant women with asthma, and consumption of antioxidant rich foods are beneficial for asthma control in non-pregnant adults with asthma. It has not been investigated whether antioxidant-rich foods can improve the elevated oxidative stress that occurs with asthma in pregnancies, thereby improving asthma control. We will reverse this oxidative burden through intervening with antioxidant-rich foods. We propose that 12 weeks of increased consumption of fruits, vegetables and wholegrains will modify the maternal biochemical profile of pregnancies complicated by asthma such that markers of oxidative stress will decrease and levels of antioxidants will increase. This novel approach will counteract the added oxidative stress caused by asthma during pregnancy and subsequently improve asthma control. No dietary guidelines exist for asthma management during pregnancy. Outcomes from our study will provide an avenue for which the development of new asthma management strategies can be devised.

The primary purpose of the study is to see if assisting 8 renal units to actively put certain clinical practice guideline recommendations into practice will result in fewer infections and a longer time to first infection in their peritoneal dialysis patients. The study hypothesis is that assisting nephrologists and renal nurses to follow infection prevention guidelines in their daily practice will lead to better patient outcomes in terms of less PD-related infections, better quality of life, less need to remove Tenckhoff catheters and less technique failure (and transfer to haemodialysis or withdrawal from dialysis altogether).

This is a double blind randomized trial post burn injury comparing groups receiving either intensive exercise or light exercise. Outcome measures will be levels of cortisol, lipids, resting energy expenditure, body composition, depression, post traumatic stress syndrome and generalized anxiety disorder.

This study is looking at the effect of Triamcinolone Hexacetonide, a long acting steroid (drug that decreases inflammation and pain) on the hip bone shape in children and adolescents with Perthes Disease. We will look to see if this drug is able to help improve range of movement, function, reduce pain and result in better overall outcomes for patients with Perthes disease. We also believe this drug may shorten the overall duration of the disease.

This study looks at treatment with a targeted biological therapy (Anti-Human Epidermal Growth Factor Receptor (Vectibix sequence) Targeted, Doxorubicin Loaded EnGeneIC Delivery Vehicles [VEDVsDox]) in people with recurrent Glioblastoma Multiforme (GBM). Who is it for? Patients may be able to join this study if they have recurrent WHO Grade IV advanced malignant GBM which expresses EGFR. Trial details The study will be conducted in two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion. Part 1 of the study is aimed at determining the maximum tolerated dose (MTD). It will commence dosing at 2x10^9 VEDVsDox and escalate to 5x10^9 VEDVsDox evaluating the safety and tolerability of VEDVsDox. The dose expansion phase (Part 2) will begin upon completion of the dose exploration (Part 1) and up to 46 subjects with recurrent GBM will be treated at the Recommended Phase Two Dose (RPTD) The treatment phase of both parts of the trial is divided into cycles. Each cycle is 8 weeks long and will require that the patient come to the hospital to receive the study treatment every week for 8 weeks. This will involve an intravenous injection (injection into a vein) of a 20mL of EDVs over a period of 20 minutes. The time spent at each hospital visit will vary and may be between 1 and 5 hours. During the treatment phase at various times the patient will have the following procedures performed: * An MRI scan every 8 weeks; * A physical examination, weight and a neurological examination; * Blood sample collection of 40ml (2 tablespoons) and urine sample collection and testing to assess overall health; *Electrocardiogram (ECG) to assess the health of the patients heart; *Vital signs including resting pulse, respiration, blood pressure, temperature will be measured; * Patients will be asked questions about quality of life and any side effects; * Blood sample collection of 9ml (1/2 tablespoon) for pharmacokinetic analysis in the first cycle only. The Patient may continue to receive cycles of study treatment for as long as the cancer remains stable or continues to reduce in size, and they are tolerating the treatment. When the patient has stopped treatment they will be asked to return to the hospital for a safety follow-up visit approximately 1 month after the last study treatment. This visit will be similar to the treatment visits.

The aim of this project is to assess the feasibility and effectiveness of an intervention, recently shown to have promise in the US, in Australia. The intervention targets depression by increasing nursing home residents’ involvement in simple, enjoyable activities. The pilot project will be conducted in two Brisbane Residential Aged Care (RAC) facilities and will involve working with residents and staff to increase resident involvement in enjoyable activities. The intervention is inexpensive and relatively simple to implement and will be assessed for effectiveness, feasibility and acceptability.

Given the range of observed (randomised controlled trials) and purported (anecdotal and epidemiological evidence) effects of both multivitamin and Omega-3 supplementation has upon mood and behaviour the general aim of the study is to investigate the combined effects of Omega-3 and multivitamin supplementation. The study will focus on the effects on mood, workplace stress and cardiovascular health in a workplace sample. More specifically, a three month supplementation with Healthy Body Vitamin Pack is expected to improve the experience of workplace stress, workplace variables, cardiovascular risk parameters and mood in conjunction with an improvement in biological measures such as antioxidant status and triglycerides.