ANZCTR search results

Design: this is a randomised, double-blinded, placebo-controlled trial in patients with whiplash injury. it aims at testing whether a medicine we are trialling may reduce long term pain after a whiplash injury. Each group will include 20 participants, who will be recruited after presenting to the emergency department at JHC. Detailed information sheet will be supplied to all participants prior to asking them to consent for the trail. Participants will voluntarily enter the trial, have their rights of declining participation and terminating their participation explained to them in the first interview and provided to them in writing. All their data will be secured on a computer, not shared with anyone outside this research group. All their personal details will be destroyed once data analysis and journal submission is complete. You will be entering one of the groups by the order of chance using opaque sealed envelops. The investigators will have no prior knowledge which group you will fall into and no knowledge of which group you belong to during the phases of this study. If you are randomly selected into the treatment group, you will receive the active medicine, called low dose naltrexone. it is given as one tablet at bed time. If you are randomly selected into the 'placebo' group, you will be give a' sham' tablet to take daily at bed time. The study will run an observation period of 2 weeks, followed by a treatment period of 8 weeks, and a follow up visit at 6 months from the time you were randomised into a group. Observation phase: all participants will have daily numerical pain scale reported (0-100), zero equals no pain at all and a 100 means the worst imaginable pain, highest neck disability index (NDI) will be measured based on a validated questionnaire, Sensory testing (called QST) of your sensitivity to graded cold on specific sites of the body will be tested,. An assessment of your stress, anxiety and depression will be conducted using a specific questionnaire (DASS21), This will be done at same time points as the measures of neck disability and skin testing. A baseline blood test for inflammatory markers will obtained once from each participant. Treatment phase: placebo group will receive sham tablets at bed time for 8 weeks, treatment group will receive LDN at bed time for 8 weeks. All participants will record their NPS at the same time of taking the tablet. NDI, QST and DASS21 will be conducted at end of treatment period, and CRP will be tested once at end of the 8 weeks treatment period. Follow-up: at 6 months from entering a study group; we are planning to measure NPS, NDI, conduct QSTs, DASS21 and repeat the CRP test once per visit.

Alzheimer's disease (AD) has a long preclinical phase as characteristic brain changes accumulate before obvious symptoms and signs appear. The availability of a simple test to detect AD during this stage would have considerable value. Current tests or 'biomarkers' under evaluation for early AD detection are expensive (PIB PET imaging), invasive (CSF amyloid), or require a high level of skill and technology (MRI volumetric analyses). An inexpensive, ‘low tech’, minimally invasive, easily administered test for preclinical AD would therefore be especially valuable. We hypothesize that a small dose of an anticholinergic drug (atropine) given by 'nasal squirt' would reach the olfactory bulb (smell centre) and reduce -smell performance more in individuals with Alzheimer’s disease (AD), including those with early AD in whom poorer smell performance can also be expected, than in those without AD.

This is a project analysing three surgical approaches for the same orthopaedic procedure, total hip arthroplasty (THA). This study will be conducted as a pragmatic randomised controlled trial comparing three approaches to the hip joint for this procedure – anterior, posterior and direct lateral (Hardinge) approaches. The null hypothesis is there will be no difference in outcomes between three approaches in terms of patient satisfaction with the procedure. We will measure this via validated scores: patient reported outcome measures (PROMs).

Each year over 10 000 children attend Princess Margaret Hospital for Children (PMH) to have surgery under general anaesthesia, with many more children attending other hospitals at a state and national level. Respiratory complications are the most frequent problem under general anaesthesia, particularly in young children. Over one quarter of children visiting PMH for surgery have asthma or related breathing difficulties. These complications may have an impact on surgical outcomes, may lead to delays and cancelled surgeries as well as unplanned admissions to specialised wards. These respiratory complications can be minimised if children at risk are correctly identified preoperatively. Currently, anaesthetists rely on clinical histories to assess this risk. Symptoms such as asthma, wheezing, hay fever and a family history of allergies and asthma amongst others are all associated with a higher risk of respiratory complications under general anaesthesia. Over a series of studies, we have observed that children with active respiratory symptoms such as current asthma, wheeze or persistent dry nocturnal cough experience significantly more respiratory complications compared to children with other known risk factors (such as family history of asthma) or no risk factors. Our data suggests that these children have increased airway inflammation and lower lung function; in a previous study, we observed that 7 out of 10 children with active respiratory symptoms who had airway inflammation experienced respiratory complications during surgery. The use of new screening techniques that allow assessment of the risk for respiratory complications by measuring airway inflammation and changes in lung function would help anaesthetists to better assess this risk. This would then allow the anaesthetist to tailor a personalised anaesthesia management to minimise the risk for these complications. This pilot study aims to assess the feasibility of an innovative personalised approach, easily applicable to young children to significantly improve the prediction of respiratory complications prior to surgery. Males and females aged 4 to 10 years of age will be recruited after voluntary informed consent and will complete two tests prior to their surgery. Tests include measuring airway inflammation using the exhaled nitric oxide test and measuring lung mechanics using the forced oscillation technique. Strong evidence of successful use of these screening techniques will pave the way to dramatically change surgical and anaesthetic risk management prior to surgery and lead to improved health outcomes for children, their families and the broader health-care system.

This proposed study aims to investigate the association between a mixture of herb and how it could affect both body weight and depression in people who are on prescribed antidepressants. The mixture of herbs include red chili powder, black pepper, ginger, and turmeric . With the aid of DEXA scanning and SCID “a test to evaluate depression” this study will aim to examine if consuming the herbs mixture affects body weight or depression. It became a fact that people who are on prescribed antidepressants tend to gain weight. There are some studies in the past that attempted to create a remedy for the problem. None of them have proposed that herbs can be used together with antidepressants to reduce weight gain. Flyers and posters will be distributed to announce and recruit volunteers between 18 and 54 years old. Pages on on Facebook can be created to announce the trial. Clinical Trials Connect Database will be used as well to recruit with an in-built screening system. Women who are pregnant, people who are highly dependent on medical care, have a cognitive impairment, or intellectual disability will not be included in this study. However, our main target is people who are on antidepressants and suffering from depression. The duration of the study will be three months. During this time, the participants will be asked to use a mixture of four herb. The four herbs are Black pepper, Red chilli powder, Ginger, and Turmeric. The ability of these herbs to help with weight problems will be examined by using three groups of people. The first is the control group, which comprises of overweight but non-depressed subjects who take only the herb mixture. The second group comprises the depressed subjects who take only antidepressants with placebo. The third group "the main group" comprises of subjects who take the antidepressants together with the herb. Changes in body (weight/body-fat) and depression will be assessed using three main tests that will be repeated monthly; DEXA scanning to see changes in body fat, the Scale to test body weight, SCID to test depression, and Blood samples to see if there is an improvement in the blood inflammatory markers (C-reactive protein CRP).

Abdominal surgery is the most common surgery in Australia with over 130,000 operations annually. Complications are unfortunately common following upper abdominal surgery (UAS) and the most common type of complication is a post-operative pulmonary complication (PPC) with a reported incidence of up to 60% depending on the underlying risk characteristics of the patient and the surgery type. The leading cause of in-hospital death following UAS during is sepsis with a primary infective source of pneumonia. Preventing PPC is a key component of physiotherapy practice. Systematic reviews support the use of non-invasive ventilation (NIV) to prevent respiratory complications following abdominal surgery. NIV may reduce PPC risk by half, with a further sub-group effect specifically preventing pneumonia. Mechanically driven air-flow is delivered during inspiration via a sealed facemask or nasal interface until a predetermined positive airway pressure is obtained. This positive lung pressure increases lung volumes, reverses airway collapse, and improves gas exchange following abdominal surgery. Despite evidence supporting NIV, uptake in hospitals is poor and is utilised in just 3% of patients. If NIV has been shown to be superior to usual care in the prevention of PPC following abdominal surgery, why is it that this therapy is not widely provided as standard care? It could be because the perceived risk/negatives outweigh the benefit and the requirement for a dedicated skilled health professional to apply, titrate, and to monitor the use of NIV outside ICU. Unfortunately, this is conjecture as there is a paucity of cost-benefit and risk analysis evidence for NIV and requires investigating in detail. High flow nasal prongs (HFNP) have recently replaced standard oxygen therapy as standard care for surgical patients admitted to ICU. HFNP deliver heated and humidified gas flow via nasal prongs at a prescribed amount of oxygen with an increased flow of air which can provide a constant low level of positive airway pressure. HFNP may increase lung volumes and recruit collapsed alveoli. it is possible that HFNP could be a viable prophylactic modality preventing PPC and may be a more feasible option compared to NIV. This remains unproven as all NIV clinical trials investigating its prophylactic properties have only compared it to standard oxygen therapy. This trial aims to detect whether there is a possible signal towards reduction in PPC with the use of intermittent NIV in addition to continuous HFNP oxygen therapy following high-risk elective UAS and to measure the feasibility of providing these interventions. These findings will assist in designing and conducting future multi-centre trials.

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.