ANZCTR search results

The study is evaluating the safety, tolerability, and immunogenicity of ABP 710 in healthy subjects compared with US Food and Drug Administration (FDA)-licensed Infliximab and European Union (EU)-authorized Infliximab. Who is it for? You may be eligible to join this study if you are a healthy male and female subjects 18 to 45 years of age, inclusive. Non-Japanese subjects will have a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Japanese subjects must be first- or second-generation Japanese and have a BMI of 18.0 to 25.0 kg/m2, inclusive. Trial details Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group will receive 5mg/kg of ABP 710 (100mg vial) intravenously once only. Participants in the second group will receive 5mg/kg2 of FDA-licensed Infliximab (100mg vial) intravenously. Participants in the third group will receive 5mg/kg2 of EU-authorised Infliximab (100mg vial) intravenously. All participants will be followed-up at 57 days post allocation to one of the three drugs used in this trial.

Spinal cord stimulation (SCS) is a minimally invasive procedure used for the treatment of persistent, refractory and neuropathic pain. Conventional SCS systems require regular manual adjustments of the level of electrical stimulation after initial programming. These adjustments are necessary because the level of the spinal cord stimulation is dependent on the distance between the spinal cord and the implanted electrodes, which changes with patient’s daily activity (e.g., standing, lying down, seating, etc.). When a patient changes body position, the movement of the spinal cord relative to the implanted lead may result in uncomfortable or inconsistent stimulation. This may lead to suboptimal pain control and significantly reduce the effectiveness of the SCS therapy, which may impact heavily on patient’s quality of life. For instance, one of the most important daily activities – sleep, may be significantly affected by the inconsistent stimulation. This may compromise effective treatment and lead to increase in the levels of dissatisfaction and pain. The RestoreSENSOR (Medtronic Inc, USA) is the first in its class implantable pulse generator for spinal cord stimulation that automatically changes stimulation settings in response to position changes and provides objective patient activity data. It achieves this thanks to the inbuilt acceleration sensor that enables continuous motion sensing. The Medtronic RestoreSENSOR neurostimulator also records and stores the frequency of patient’s posture and activity changes. These objective data can be used by the clinician to understand whether the patient’s individual stimulation requirements are changing over time. If the SCS therapy with RestoreSENSOR improves patients’ quality of sleep and activity levels in this study, this will demonstrate superior effectiveness of position-adaptive stimulation technology in providing pain relief and convenience to patients suffering from chronic pain. Improvement in quality of sleep and daily activity levels will serve as an indicator of efficacy of the treatment.

This research study is looking at a combination of four herbs, which are common components of a healthy diet, in men who have been treated for prostate cancer, and have rising prostate specific antigen (PSA). Who is it for? You may be eligible to join this study if you are a male aged 18 years or above whose PSA is rising at a slow or moderate rate after surgery or radiotherapy for prostate cancer (referred to as 'biochemically recurrent prostate cancer'). Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take a combination of tablets and capsules containing green tea (Camellia sinensis), turmeric (Curcuma longa), resveratrol (which commonly occurs in grapes and wine) from giant knotweed (Polygonum cuspidatum) and broccoli sprout extract (Brassica oleracea). All of these are readily available over-the-counter in herbal combination products, and have all been tested in humans before. Participants in the other group will instead receive a placebo (inactive treatment). All participants will be asked to take two tablets and two capsules twice daily for 12 weeks. Participants will not know to which group they have been allocated until after the study is completed. Participants will have their PSA doubling time assessed at 3 months to determine any effect of treatment. It is thought that the natural herbal treatments may slow the rate at which PSA rises, and may also help to reduce any lingering side-effects following treatment, and improve quality of life. This is an initial small (pilot) study that may form the basis of a larger trial in the future.

The aim of this study is to evaluate the efficacy of a novel treatment for problematic anger in Defence members who are also experiencing PTSD. It is hypothesised that the novel anger focused intervention for Defence members will result in the primary outcome of improved (reduced levels of) anger. Secondary outcomes which may be hypothesised include improved outcomes in associated mental symptomatology including depression, anxiety, alcohol use and symptoms of posttraumatic stress.

This research aims to identify the prevalence of foot pathologies in a female population of persistent high heel footwear users compared to those who do not regularly wear high heel footwear. We seek to identify if there is a correlation between the persistency of high heel footwear use (how many years, how many hours per day) against the severity and number of foot pathologies versus those who use non high heel footwear. We hypothesize that the prevalence of foot pathologies (such as hallux valgus, metatarsalgia, hyperkeratosis, neuroma, digital deformity) in a female population who are habitual high-heel wearers will be significantly higher compared to non-high heel wearers.

The purpose of the study is to see how effective the psychological intervention "EMDR" is in reducing binge eating, reducing weight, improving self-esteem, improving motivation to exercise, and decreasing mental health symptoms. It is hypothysized that this treatment can improve weight, binge eating and related symptoms in 10 sessions or less better than current conventional therapies.

The aim of this study is to assess whether, following a spinal anaesthetic for caesarean, transient maternal hip and knee flexion in the left lateral tilt supine position can allow caesarean section to commence earlier than traditional positioning with lower limbs straight. If this technique safely speeds up the onset of "adequate" surgical block suitable for the caesarean operation, it can potentially reduce the rate of caesarean sections requiring general anaesthetics. It is well established that in pregnant women requiring caesarean section most of the anaesthesia related risks have higher rate under general anaesthesia in comparison to spinal anaesthesia.

The primary purpose of this pilot project is to demonstrate the feasibility of a randomised controlled trial (RCT) investigating whether older people undergoing rehabilitation who receive feedback on activity levels are more active than patients who do not receive feedback. One of the main reasons older people are admitted for rehabilitation is to improve their mobility. There is increasing evidence indicating that mobility is improved by increasing physical activity. However, studies have shown that physical activity levels are very low in people undergoing rehabilitation. One difficulty for therapists is that to date there has been no way of easily measuring or monitoring activity levels in patients. It is therefore difficult to know how active a person really is, and whether their activity levels are improving during their rehabilitation stay. There are now devices available that can provide accurate feedback about activity levels, even in people who have very low levels of mobility and activity. One device is the SenseWear armband, which is the size of a watch and can measure even small changes in activity. The SenseWear armband has an optional display unit, which provides the person and their therapists with real time feedback about their level of activity. Studies in community dwelling groups have shown that feedback about activity levels can be used to improve activity. However, older people undergoing rehabilitation are typically more frail and dependent on staff to assist them be active. Hence, it is not known whether providing feedback to older people undergoing rehabilitation will lead to increased activity levels. Forty older people admitted for inpatient rehabilitation will be randomly allocated to either receive feedback and develop activity goals based on their activity level (intervention group) or monitoring of activity without feedback (control group). All participants will wear a Sensewear device for up to 3 weeks while undertaking inpatient rehabilitation. The results of the pilot will be utilised to inform the design and need for a future RCT. If we find that feedback provided by Sensewear device can promote activity, we shall further investigate if ongoing use can maximise activity level and mobility outcomes and reduce length of stay during inpatient rehabilitation.

Cognitive impairment is one complication of T2DM that has gained considerable recognition in the last decade. Pooled estimates from prospective studies of people with T2DM reveal a 60% increase risk for future dementia. Over 3 million Australian suffer or are at risk of T2DM and this number is projected to rise markedly in the next 20 years; thus increasing the prevalence of diabetes-related impairments including accelerated cognitive decline and dementia later in life. A postulated underlying mechanism of T2DM-related cognitive decline is endothelial dysfunction in the cerebral microvasculature. Transcranial Doppler (TCD) ultrasound offers an economical and non-invasive assessment of the dependence of cognition on cerebral perfusion, by measuring increases of blood flow velocity in the middle cerebral arteries (MCA), resulting from downstream dilatation of cerebral arterioles, which can occur in response to acute hypercapnia or cognitive stimulation. Hypercapnia is a condition of abnormally elevated carbon dioxide (CO2) levels in the blood This technique is known as cerebral vasodilator responsiveness (CVR). There are currently no studies characterizing the CVR to hypercapnia in the posterior cerebral arteries in adults with T2DM. There is increasing evidence that certain bioactive nutrients can act on endothelial cells to enhance vasodilator function. It is also evident that consumption of these sources of vasoactive nutrients may lead to enhanced cognitive performance, yet it is only recently that the concept that nutrients can deliver cognitive benefits by improving cerebral circulation has been recognized. This study aims to determine the most efficacious dose of resveratrol to improve cerebral vasodilator responsiveness (CVR) to hypercapnia in the anterior circulation (MCA) in adults with T2DM. An acute randomised, double-blind, placebo-controlled, crossover dietary intervention will be undertaken at the Clinical Nutrition Research Centre (CNRC) at the University of Newcastle. Interested participants will be sent a Participant Information Statement and Consent Form. Upon returning the signed Consent Form, the study coordinator will send the Health and Lifestyle Questionnaire. This will determine the participant’s suitability before visiting the CNRC for a screening visit. 40 non-insulin-dependent type 2 diabetes mellitus adults aged 40-80 years old will be selected. Suitable participants will be required to attend the CNRC five times at weekly intervals. Subjects will be provided with each dose on one occasion; this dose will be consumed in the clinic. The study will also assess the dose-response effects of resveratrol supplementation on neuropsychological test performance.

This study is intended to investigate the efficacy of intensive cognitive behavioural therapy for social anxiety disorder. The effect of this intervention will be analysed, and participants will be questioned about the acceptability of the intensive treatment format. The results of this study will hopefully inform us of any benefit of intensive individual CBT for the treatment of social anxiety disorder.