ANZCTR search results

The primary objective of the proposed study is to test the mechanism of action of two pre-quit smoking cessation medications - varenicline and nicotine patch – in order to learn how best to optimize these pre-quit treatments.

Wernicke-Korsakoff syndrome (WKS), once thought to be a rare condition, is now known to be common in people with nutritional deficiencies or alcohol dependence. The primary cause of WKS is thiamine deficiency, and more than 90% of cases are reported in alcohol dependent patients because alcohol dependence predisposes to severe nutritional deficiency. WKS may lead to significant, long-term brain dysfunction with severe effects on work, personal and social function. Whilst effective treatment may greatly reduce severe disability and the human and social costs of this illness, almost no evidence exists on optimal dosing regimens. This project proposes to develop quality evidence for effective treatment of WKS in an Aboriginal setting. The need for evidence-based thiamine treatment protocols is of great clinical importance for two related reasons. First, in relation to acute symptomatic WKS, a failure to treat immediately or adequately may result in profound and often permanent cognitive and neurological disability. Secondly, the need for evidence-based treatment guidelines is greatly magnified when it is recognised that milder, subclinical WKS may be preventable with adequate thiamine treatment. The aims of this study are to determine the optimal thiamine dose required for: A. Treatment of acute symptomatic Wernicke-Korsakoff syndrome (WKS) among Aboriginal and non-Aboriginal alcohol-dependent patients. B. Reducing or preventing subclinical WKS-related brain damage in at-risk Aboriginal and non-Aboriginal alcohol-dependent patients. Primary Hypotheses 1. Among alcohol-dependent patients with acute symptomatic WKS, higher doses of parenteral thiamine (1500mg) will lead to greater improvements in specific cognition and neurological functions than lower doses (900mg or 300mg). 2. Among alcohol-dependent patients that are at high risk for subclinical WKS-related brain damage, higher doses of parenteral thiamine (900mg) will lead to greater improvements in specific cognition and neurological functions compared to lower doses (300mg or 100mg). Secondary Hypotheses 1. Thiamine deficient patients will show poorer performance on cognitive and neurological measures 2. Patients with concurrent magnesium deficiency will show greater impairment at baseline 3. Nutritional risk and alcohol frequency will correlate with thiamine pyrophosphate levels. 4. Number of previous admissions with thiamine supplementation in the past 3 months will correlate with thiamine pyrophosphate levels.

We aim to explore if the drug ‘denosumab’ is effective at reducing bone loss in the feet/foot in participants with Diabetes Mellitus and Charcot Foot. Bone loss or Osteoponia as it is referred to medically is a recognised feature of Charcot foot. If the bone loss process can be prevented then this may stop the Charcot process in a much quicker time frame.

In Australia, accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Recent research has shown that around 10-30% of young injured children will go on to develop chronic posttraumatic stress disorder (PTSD). Parents of injured children are also at risk of PTSD and this is associated with short and long-term consequences for their child’s physical and psychological recovery. PTSD is a complex and serious disorder that is associated with a range of adverse psychiatric and health outcomes; poorer adherence to medical treatment; reduced wound healing; diminished health-related quality of life; impaired parent-child relationships; and can significantly impact psychological, cognitive, social and neurobiological development. Despite the significance of this problem, to date, the mental health needs of injured young children have been neglected. One reason for this is due to the uncertainty and considerable debate around how to best provide early psychological intervention to traumatised children and adults. In particular, there are currently no published studies on early intervention for young traumatised children. The proposed research therefore aims to evaluate the effectiveness and feasibility of a screening and indicated prevention program for injured young children (1-6 years) and their parents. The study will employ a randomised control trial design and children who are screened as ‘high-risk’ for PTSD and their parents will be randomised to either (1) 2-session face-to-face child and family focused intervention or (2) treatment as usual. Assessment will be completed at baseline (2 weeks), 3 and 6 months post injury. The development, evaluation and dissemination of effective indicated prevention programs for young children and parents have the potential for enormous national and international benefit.

This study aims to examine whether feedback regarding mental health symptoms encourages increased help-seeking or service use. The research group will be initially running a national survey of an estimated 105,000 people. The survey will contain screening questionnaires for common mental health issues. At the end of this survey, participants will be asked whether they would like to be included in a randomised controlled trial (RCT). If yes, participants will be asked to provide their email addresses only. The national survey (already completed by participants) will serve as baseline data. They will then be randomised into one of two conditions: 'Feedback' or 'No Feedback' (control condition). Those who are randomised into the 'Feedback' condition will immediately be provided with feedback regarding their mental health symptomology, based on screening results . All RCT participants will then be assessed in a post-intervention survey, 3 months after the initial survey regarding their help-seeking or service use for mental health problems, quality of life, disability (days out of role) and mental health symptoms.

Fractures of the distal radius,: a randomised controlled trial comparing the volar locking plate and routine current surgical treatment

Fixation of the femoral stem and acetabular shell in their respective bones can be with cement, specialised coatings or a combination of the two (i.e. stem in cement, acetabulum with porous coating), known as hybrid fixation. The cemented Absolut hip stem with the non-cemented Global acetabular cup will be evaluated following primary total hip replacement surgery.

The aim of this study is to evaluate the efficacy of resistance exercise training and nutritional supplementation in prostate cancer survivors treated with androgen deprivation therapy. Who is it for? You may be eligible to join this study if you are a male aged 50-85 years and are currently undergoing treatment for prostate cancer with androgen deprivation therapy which is expected to continue for at least 52 weeks. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will participate in an individually tailored progressive resistance exercise training program three times a week and receive daily supplementation of calcium, vitamin D and protein over a period of 52 weeks. Participants in the other group will receive the usual care administered to men undergoing androgen deprivation therapy. Participants will be assessed at baseline, 26 weeks and 52 weeks in order to determine any changes in musculoskeletal health, cardiometabolic risk factors, and health-related quality of life. Assessment is by bone scans, blood tests, and questionnaires. The results of this study may contribute to the development of exercise and nutritional guidelines for optimising overall health in men treated with androgen deprivation therapy.

Using Randomised Controlled Trial methodology, this study investigates the effectiveness of a universal prevention intervention for depression in adolescents prior to the Higher School Certificate (HSC). Students in 30 schools across New South Wales (NSW) will be randomly allocated to receive an online, automated, preventative Cognitive Behavioral Therapy (CBT) program or an online control program focused on health and wellbeing. Students will participate in the intervention in February of Year 12, and will complete assessment measures pre- and post-intervention, approximately 6 months later (prior to the Trial HSC) and at 18-month follow-up. The primary outcome measure will be symptom levels of depression. Secondary outcomes include academic performance, incidence/recurrence of depression, suicidal ideation and behaviour. Cost effectiveness, as well as predictors of treatment response and adherence will also be measured. Additionally, the effect of the intervention on parental mental health and wellbeing will be examined.

Low back pain is one of the most common health problems and affects 80 – 85% of people over their life time. Low back-related leg pain or sciatica is a common variation of low back pain. Although the prognosis for sciatica is good in most patients, up to 30% of patients continue to have pain for 1 year or longer. People with sciatica may or may not present with signs of nerve damage and associated nerve-related pain (neuropathic pain). It is important to determine the presence of altered nerve function as this (i) may contribute to people having persistent pain and/or disability and both are associated with greater health costs and poorer patient outcomes; (ii) will help direct more targeted treatment for the underlying condition such as specific pharmaceutical intervention for the treatment of neuropathic pain or surgical intervention in case of nerve root compromise. Targeted treatment may prevent the transition to persistent pain and associated poorer health outcomes and greater health economic burden. This study will investigate responses to various sensory stimuli (to heat and cold, to light touch and pressure, to pin-prick and vibration) that can be used to assess nerve fibre dysfunction. We will explore the correspondence of quantitative laboratory sensory testing with simple bedside sensory testing in patients with sciatica and compare findings with a healthy population that is age and gender matched. Should the bedside examination findings match the laboratory findings, then bedside examination may potentially replace time-consuming laboratory testing in the future. We will also investigate if sensory examination findings may be associated with the persistency of pain and functional status at 3 and 12 months follow-up in patients with sciatica. It is anticipated that there will be sub-groups of patients with differing sensory profiles. Sensory profiles of enhanced pain sensitivity will be associated with pain persistency and functional status at 3 and 12 months follow-up. The outcome of the study will inform clinical pathways to optimise time and cost efficient health outcomes for this patient cohort.