ANZCTR search results

This study aims to investigate effect of Nivolumab and Temozolomide vs Temozolomide alone on overall survival in newly diagnosed elderly patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 65 years or above, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery. Study details Participants will be allocated to either experimental or control group in a 2:1 ratio by chance (randomly). Patients assigned to the experimental group will receive a course of nivolumab via intravenous infusion (240 mg on days 1 and 15 every 28 days for cycles 1-4; then 480 mg day 1 every 28 days for cycles 5-6) in addition to the standard regimen of Temozolomide (TMZ) tablets and radiotherapy. Patients assigned to the control group will receive the standard treatment of adjuvant temozolomide (150-200mg/m2 days 1-5 every 28 days) for 6 cycles and standard radiotherapy treatment (40 Gy administered in 15 fractions). The study aims to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes for this patient population. The outcome of the study will help determine the most effective treatment for patients with glioblastoma in the future.

Shoulder range-of-motion measurement (ROM) in clinical settings is an integral component of physical examination to diagnose, evaluate treatment and quantify possible changes in people with shoulder pain. Compared to any other joint in the body, the shoulder has no fixed axis and produces the greatest ROM in the body. Hence, the reliability of measuring shoulder motion presents a challenge to clinicians. Advances in miniature devices and technology have led researchers to utilise wearable inertial sensors to capture human movement. Inertial sensors consisting of accelerometers, gyroscopes and magnetometers have the capability to measure joint angles, angular velocity and dynamic acceleration forces. The Microsoft Kinect (v2) is a low cost, portable, motion-sensing device capable of tracking up to six bodies within its field of view. The device features a depth sensor which provides full-body 3D motion capture capabilities. Up to 25 joint positions are extracted in three dimensions for each tracked body. The BioCap system (Sydney, Australia) combines two wireless inertial sensors worn on the wrists with an optical sensor (Kinect v2) to estimate human motion. Data is processed and merged to produce a full-body skeleton model of the subject. Measurements based on wearable sensors may potentially represent a well-balanced compromise between the practicality of questionnaires and the measurement precision and reliability of laboratory-based movement analysis (Pandyan et al 2002). It may in clinical practice help physicians in decision-making and clarify patients post-treatment expectations. However, before such technology can be used routinely, reliability and validity needs to be established to compare its performance to a gold standard. Thus, the purpose of this research is to determine the reliability and validity of a system that integrates inertial sensors with Kinect v2 to measure human shoulder joint angles. It is hypothesised that the BioCap system will be a highly reliable and valid tool to measure shoulder range-of-motion and kinematics in clinical practice.

The study aims to compare high intensity exercise to standard pre-operative preparation to improve cardiovascular fitness in major upper gastrointestinal cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo major upper gastrointestinal cancer surgery at John Hunter Hospital or Newcastle Private Hospital. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive standard pre-operative care, which consists of advice to improve fitness but no supervised or structured program. Participants in the other group will undertake prescribed, structured and supervised high intensity interval exercise over three sessions per week whilst on the wait list for major cancer surgery (approximately 30 days). This exercise will be primarily on a stationary bicycle with some walking sessions and tests for grip strength and walking distance within 6 minutes. All participants will undergo cardiovascular exercise testing upon enrolment and the week prior to surgery in order to assess any changes in fitness. A blood test will also be taken at the start and completion of the program, and a CT Scan used at the point of diagnosis and then 3 months following completion of the study. Participants will be followed for 90 days post-operatively in order to review any surgical complications, length of time in hospital, and other clinical outcomes. If the pre-operative fitness intervention is successful in this cancer population, and improved fitness relates to better outcomes, then borderline operative candidates may be able to undergo a similar program with a view to extending the option of curative surgery to a larger patient population.

The aim of this study is determine what benefits and costs are associated with integrating Reflectance confocal microscopy (RCM) imaging into dermatological clinical practice. Who is it for? You may be eligible to join this study if you have been identified during the routine dermatological appointment to require a skin biopsy of a lesion suspicious for either melanoma or basal cell carcinoma. Study details The study involves a one-off patient visit that will be incorporated within their standard dermatology visit. During the study visit reflectance confocal imaging will be performed on any lesion which has been identified as requiring a biopsy. Skin biopsy will be performed for every imaged lesion. Participants will also be asked to complete a questionnaire reflecting on their experience of both RCM imaging and having a biopsy, their previous skin cancer history and treatments and their willingness to pay for the service. Overseas centres have analysed the benefit of integrating RCM in clinical practice, however, to date there has not been a study done in Australia to assess this. As the Australian health system, and particularly the public dermatological service, differs from other countries, it will be beneficial to study the specific benefits of using RCM imaging within the clinical practice of a Queensland public hospital dermatology department.

Government policy on health care should seek to reflect the views of the community but current methods for community engagement are limited. Strategies such as opinion polling, community forums, and engaging consumer representatives on decision making panels may not be able to fully consider issues that are complex, require a greater understanding of potential benefits and harms, and may provide only a limited number of viewpoints from the community. A community jury is a deliberative process that can help to establish the community’s preferences and values on a particular topic. This research team has successfully conducted the first randomised controlled trial of a community jury process in health and demonstrated proof of concept that this form of public engagement could be potentially beneficial to health policy. Our findings demonstrated a community jury was capable of considering complex information on the harms and benefits of screening, and to distinguish individual from community choices. Our community jury also identified an innovative solution to the question being deliberated. Cognitive impairment ranges from mild impairment to severe dementia. It causes problems with memory, learning, and organising and mild cognitive impairment can be a precursor for dementia. The benefit evidence for case finding for dementia is scarce, the medication benefits not significant, and the nonpharmacological interventions mostly ineffective. We will conduct a community jury to consider the potential benefits and harms of case finding for dementia in primary care and ask the jury to propose a recommendation for the question, “Should the health system encourage GPs to practice ‘case finding’ of dementia in people over 50?”

CodaVax, the study drug being researched in this project, is an experimental vaccine being developed by Codagenix, Inc. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. CodaVax is a vaccine that is intended to prevent influenza. The primary objective of this study is to determine the safety and tolerability of CodaVax influenza vaccine compared to active and placebo controls when administered to healthy adults.

This study will investigate the role of dose in open-label placebo administration. Recent studies have found that open-label placebo treatments are effective in improving symptoms of IBS, depression, ADHD, and low-back and migraine pain. These findings suggest the possibility of generating a placebo effect without deception. Participants will be recruited to take part in a study investigating the effect of open-label placebo administration on well-being and randomly assigned to one of three conditions: no-treatment control, low dose (1 pill per day), or high dose (4 pills per day) placebo administration.

Despite the supports and treatments available to assist smoking cessation, relapse remains high amongst smokers who attempt to quit. An important factor that has been identified to contribute to relapse is difficulties with impulse control, also known as response inhibition. Smokers have been found to exhibit reduced response inhibition, that is, difficulties inhibiting an automatic response such as smoking, Difficulties with response inhibition has been hypothesised to be a predictor of relapse following a quit attempt. Therefore, it would be beneficial to target response inhibition during this time period to assist in achieving and maintaining abstinence. While response inhibition interventions have not yet been investigated in smokers, other studies have found it to be effective in changing unhealthy behaviours in heavy drinkers, dieters and overweight adults. This Randomised Controlled Trial aims to investigate whether response inhibition training is effective for reducing smoking in those who are dependent on nicotine, It will also examine how a number of mediators and moderators. Our research group is collaborating with Dr Natalia Lawrence to adapt her program which was developed and evaluated in the UK in relation to food inhibition training. Participants will be allocated to either a treatment group or an active control group. The response inhibition group will complete two weeks of the smoking response inhibition training program, while the control group will complete a general response inhibition training program. All participants will complete fourteen online training sessions over a two-week period and will provide follow-up data relating to their smoking status three time points after they have completed the training - post intervention, one and three month follow up.

The purpose of this study is to compare and contrast patient and nurse satisfaction with the Baxter(Registered Trademark) device and the Ambit(Registered Trademark) device for delivery of intravenous antibiotics in the home setting. The secondary aims are to examine any complications that occur with this these infusion pumps, the quantity of medication they deliver and the temperature during storage and use of these devices. The proposed research design is to allocate patients to receive home antibiotic infusion with one of two infusion devices for one week, then continue that treatment with the other device for one week. At the end of both periods the patients will be asked to fill in a questionnaire regarding their satisfaction with the device and any problems that arose. A survey will also be conducted of RDNS nursing staff that have provided home care to these patients to assess nurse satisfaction. In addition to the surveys, all infusion devices/bags will be weighed after their use to determine the quantity of any drug remaining. Each pump/bag will be equipped with a temperature sensor to determine the storage temperature of the drugs when kept in patients’ homes, as well as the ambient temperature during pump use. A temperature sensor will be placed on each patients arm to measure skin temperature during pump use, as this has an impact on elastomeric infusion pump accuracy. Patient case note data will also be monitored to collect statistics on infusion related complications, such as occlusions, disconnections, infections or repairs required.

The aim of this project is to demonstrate the effectiveness of using visual feedback to increase toe clearance during walking in people with stroke. This new intervention has the potential to improve walking safety and reduce the risk of trips and falls. One important gait variable in these types of trips is minimum toe clearance (MTC). Reduced MTC can increase the risk of tripping. 150 participants will be required to attend 16 sessions (two baseline assessments (one clinical assessment conducted by a Physiotherapist and practice walking on the treadmill, the other is biomechanical assessment to determine MTC), 10 gait training only, and 4 post-training assessments (one after completing the final training, and then 1 month, 3 months and 6 months post-training follow up session). Half of the participants (n=75) will be randomly assigned to an Experimental group who will receive treadmill-based gait training with toe clearance feedback and half will comprise a Control group who will undertake assessment and training trials exactly as the Experimental group but will NOT receive the corrective real time feedback. The ten training sessions will occur over a 5-6 week period, with at least one rest day between sessions. Six assessment sessions will be about 90 minutes duration. The training sessions will take approximately 60 minutes. At all sessions, participants will be required to walk on a treadmill for up to 10 minutes. They will wear a safety harness which will prevent them from falling. Participants will also have markers placed on their lower limbs, and a special camera (Optotrak) will record the movement of these markers while participants walk. Data will be recorded during assessment sessions, and additional clinical data will also be obtained. Participants will be asked some questions about their risk of falls. During the training sessions, data from markers will provide ‘real time’ feedback to Experimental participants about their affected leg toe clearance during the swing phase of walking. Using this information, participants will be asked to modify their walking pattern to match a “target” increased toe clearance. Feedback will be provided continuously for the first 6 sessions and then progressively reduced (faded) across the last 4 sessions.