ANZCTR search results

Dystonia is a movement disorder characterised by involuntary twisting movements and abnormal postures of the body. Cervical dystonia is the most common focal dystonia of younger adults, producing abnormal neck postures, twisting, shaking and turning movements of the neck, and pain in the neck and shoulders. How dystonia develops is not known. Treatment for cervical dystonia is predominantly with Botulinum toxin. There is compelling evidence for its benefit in reducing symptoms of head posturing and pain, however it requires repeated injections and does not always provide satisfactory outcomes. Botulinum toxin is known to interrupt neuro-muscular interaction, producing focal muscle weakness, however evidence for its use in migraine headache has implicated a direct effect on pain perception. Whether improvement in dystonia with botulinum toxin is related only to motor effects or has a longer term benefit on modulating the dystonia itself is not known. The experience of pain can alter sensory and motor processing related to direct interference with neuroplastic processes or compromised motor performance. Sensory testing has shown decreased sensory function in the affected compared with unaffected hand in people with hand dystonia. This type of sensory testing has not been performed in people with cervical dystonia. It is likely all dystonia arises from abnormal sensorimotor integration processes, though this process is currently incompletely understood. This project aims to measure peripheral sensory perception objectively in patients with cervical dystonia to determine if their sensation is abnormal, if this is a generalised or focal situation, and to determine if this sensation is altered by the administration of botulinum toxin which is effective in reducing the severity of the movements.

This study is evaluating the safety of a fluorescent marker (BLZ-100) used to visualise cancer cells in adults with skin cancer. Who is it for? You may be eligible to join this study if you are a male or female aged 18 years or above who has been diagnosed with non-melanotic skin cancer (e.g. non metastatic basal cell or squamous cell carcinomas or amelanotic melanoma) and are scheduled for surgical excision. Many types of cancer are primarily treated with surgery and the extent of surgical removal of the tumour is directly related to patient survival. However, it is often difficult for surgeons to distinguish tumour tissue from normal tissue or to detect tumour cells that have spread from the original tumour site. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumour to prevent adverse effects on function. In this study all participants will be administered BLZ-100 intravenously (i.e. directly into the vein) approximately 48 hours before scheduled excision of cancer lesions. BLZ-100 is a targeted fluorescent molecule that belongs to a class of products known as Tumor Paint (Trademark) bioconjugates designed to illuminate cancer cells to facilitate surgical resection. We hope that BLZ-100 will improve surgical outcomes by allowing surgeons to visualise the edges of the tumour and small groups of cancer cells in real-time, as they operate.

A combined palliative and nephrology, Renal Supportive Care clinic was established in March 2009. This research aims to describe the impact of a specialised palliative nephrology service on outcomes and will put this in context by also describing outcomes of patients who are managed in standard renal clinics (pre-dialysis clinic). The data collected is collected as part of standard medical care.

This research project is aimed at developing and assessing the feasibility and acceptability of an online program for men who have undergone treatment for testicular cancer. The program has been designed to reduce distress and address the needs of these men. Who is it for? You may be eligible to join this study if you are a male aged 18 years or more who has completed treatment for testicular cancer between 6 months to 5 years ago, and have no evidence of disease recurrence. You will need to have access to computer at least weekly for up to 10 weeks. Study details All participants in this study will receive an online intervention to address the specific unmet needs of testicular cancer survivors (such as for help with fear of cancer recurrence, body image and sexual issues, financial issues and re-establishing a sense of normal), as well as general anxiety and depression.The intervention involves completion of 6 online modules in 10 weeks. On completion of the intervention at 10 weeks, participants will be asked to complete a number of questionnaires about the feasibility, acceptability, utility, comprehensiveness, relevance, helpfulness, and simplicity of the intervention.

Participants are invited to take part in this research study to test a new treatment combination for prostate cancer. This is because they have cancer that started in the prostate and has spread to other parts of their body. This is known as metastatic prostate cancer. Current treatment for newly diagnosed metastatic prostate cancer involves androgen deprivation therapy(ADT). Androgen deprivation therapy has two components: 1. The main component is by stopping the release of androgen from the testicles. This is mainly done by using drugs that prevent the testicles from making androgens, and therefore reducing the levels of androgens in the body to low levels. These drugs are called luteinising hormone releasing hormone analogues (LHRHA). These drugs are given as injections. This is usually part of the standard initial treatment for men in your situation. The other way of reducing androgen production by the testicles is with a surgical operation to remove both testicles. This is not part of the trial. If participants have already had this surgical procedure or it is planned to be done, they will not need to be on LHRHA, but can still take part in this study. 2. The second component of ADT is to block the effects of androgens produced in other parts of the body with antiandrogen drugs. Antiandrogen drugs block testosterone and related androgens from attaching to molecules in the cancer cell called 'androgen receptors'. Blocking this attachment prevents androgens from having their effect. This might provide additional benefit in treating the cancer although this has not yet been proven. Several different types of antiandrogen drugs are available for use already. Enzalutamide is a new antiandrogen that is not yet approved for use in Australia. This study will compare the effectiveness of enzalutamide versus the currently available antiandrogen drugs when used on a background of treatment with a LHRHA (or surgical removal of the testicles). The main aim of the study is to see which of these combinations is best at improving the survival of men in this situation. Recent studies show promising results with the use of enzalutamide in participants who had been treated with androgen deprivation therapy and were no longer responding to the standard antiandrogens, this is known as castrate resistant prostate cancer (CRPC), which is a more advanced stage than the type of metastatic prostate cancer being studied here. With this stage of metastatic prostate cancer there is no evidence yet on which treatment is best to treat it. To do this, a total of 1100 participants will participate where half the participants on the study will receive enzalutamide with a LHRHA or surgical operation to remove both testicles and the other half (550 participants) will receive already available antiandrogens (but not enzalutamide) with a LHRHA or surgical operation to remove testicles. All participants on this study will receive active therapy and no placebo treatment will be used. The study is open label, meaning that both the participants and the investigators will know the treatment the participant will receive.

This study aims to determine if treatment for insomnia also reduces anxiety in school-aged children. Compared to children in the control group, we expect children in both treatment groups to show improvements in sleep and anxiety, with greatest improvements expected for the "moderate" treatment group.

Intervention for Developmental Coordination Disorder (DCD) has been shown to be better than no intervention, however there is scarce information on the delivery of all types of intervention. This study compares different personnel and environments in service delivery. Ninety-three children from 13 South Australian schools, aged five to eight years (at time of recruitment) were recruited to participate in this RCT. Participants received a group intervention running for 13 weeks, working on fine and gross motor skills. Schools were randomised using cluster randomisation to receive one of three modes of delivery. Group one schools received the program at school run by a school assistant, group two received the program in school run by a physiotherapist and group three received the intervention in a health clinic run by a physiotherapist. Group three was considered the control group for delivery as the literature concludes group programs run by health professionals in a health setting have success in treating children with DCD. Participants were assessed pre and post-intervention, and six months after the program completion. The Movement Assessment Battery for Children (MABC), Test of Gross Motor Development – Second Edition (TGMD-2), Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (PSPCSA) and the School Function Assessment (SFA) were used to assess participants, while parent and child questionnaires were used to gain information on more practical aspects of service delivery.

Heart artery disease (also known as coronary heart disease), which can lead to heart attacks, remains the leading cause of death in Australia. A significant proportion of heart attacks have been shown to be among those deemed ‘young’. This study aims to determine if siblings of young heart attack patients are likely to have significant coronary heart disease themselves even if they currently have no symptoms of it. If this were true then they maybe at an increased risk of suffering a heart attack or dying compared to the general population. This study will also explore whether currently available heart artery disease risk scoring tools are significantly less accurate in predicting the presence of CHD compared to computerised tomography (CT scan) of the heart arteries. If this is found to be true then it may establish CT as a screening test to allow early detection of coronary heart disease by visualising the heart arteries. Hence the aims are as follows: 1.To determine what proportion of siblings of young heart attack patients have coronary heart disease themselves. 2.To compare how accurate heart ultrasound scans during exercise (stress echo) are as compared to CT scans. 3.To investigate the accuracy of popular heart artery disease risk scoring tools: Framingham, Interheart and SCORE. 4.To determine the clinical outcomes of the participants who have coronary heart disease detected on their CT scans. Design and Methodology: We are aiming involve 50 siblings of young heart attack patients in this pilot study. All participants will undergo blood tests for cholesterol levels, stress echo and CT scans of the heart. Their probability of having coronary heart disease will be calculated using the aforementioned risk scoring tools. The reliability of these risk scoring tools will be compared with the findings of CT scan. The end point of the study will be two fold. Firstly, the findings of CT scan, stress echo and risk scoring tool will be compared and the proportion of participants with coronary heart disease (as detected by CT) will be determined. Secondly, participants will be followed with telephone calls for 30 days, 6 months and 12 months for any event of chest pain, hospitalisation for cardiac problem, heart attack or death. Their outcomes will be compared with their test results.

The combination of probiotics and prebiotics is known as ‘symbiotic’. This study aims to investigate whether daily consumption of symbiotic yoghurt can improve cholesterol levels and reduce blood pressure in hypercholesterolemic individuals over 8 weeks. A parallel, double-blind, randomised controlled trial involving 96 non- smoking, overweight or obese, aged 30-65 will be recruited and randomly assigned to 3 groups to consume 300g/day of either control, symbiotic or symbiotic yoghurt containing fresh pomegranate juice. Anthropometric measurements and fasting blood samples will be collected at the beginning of the study, week 4 and 8. Significance: Studies show that hypercholesteremia and hypertension are leading cause of morbidity and mortality in developed countries. Symbiotic food consumption may result in cholesterol and blood pressure reduction, thus reducing the chronic disease incidence. Previously the symbiotic effects have been investigated individually but not synergistically, and little is known about the mechanisms by which probiotics modulate hypocholesterolemic and anti-hypertensive effects. This is the first study examining the synergistic effect of this new symbiotic mixture in hypercholesteremic individuals. The findings will contribute in understanding the mechanisms of action of this symbiotic combination in improving health outcomes as well as new product development.

One of the most common types of anaesthetic used for caesarean section is a spinal anaesthetic. In order for women to be comfortable during the operation a large number of nerves are blocked. In addition to the pain nerves it is very common for other nerves to be affected, including those which are responsible for other types of sensation, movement in the legs and also those which normally help control blood pressure. Significantly low blood pressure in the mother may be associated with side-effects including nausea and vomiting, dizziness and possibly loss of consciousness and in extreme situations the baby may also receive a reduced blood supply from the placenta. For the anaesthetist to provide a safe anaesthetic it is very important to monitor these effects and especially any changes to blood pressure and how the woman’s body responds to it. This is particularly important during the first 5 to 10 minutes after the injection of the spinal anaesthetic. During this period it is usual to closely measure blood pressure, heart rate, the amount of oxygen in the blood and the electrical activity of the heart from an electrocardiogram. Recently, it has also become possible to directly observe the function of the heart relatively quickly and easily via a hand-held ultrasound probe placed on the chest – a transthoracic echocardiogram or TTE. These devices are very similar to those used for obtaining images of the baby during pregnancy. It is known from the use of these devices in other situations, including in pregnant women, that valuable information may be obtained about how the heart is performing. Until now this has not been done in healthy women having a spinal anaesthetic for an elective caesarean section. Hence, the purpose of our study is to document the effects of a standard spinal anaesthetic on the output of the heart by comparing measurements at approximately 10 minutes after the spinal injection with measurements taken immediately before the spinal using TTE. In keeping with usual practice, drugs will be given to help maintain normal blood pressure throughout. Information obtained from this study will be helpful in further understanding the impact of spinal anaesthetics on the cardiovascular system in pregnant women which is likely to help guide anaesthetists to reduce side effects and improve safety.