ANZCTR search results

This study is evaluating how well six different types of ultrasound enhanced breast biopsy markers can be visualised using ultrasound on the day of surgery to act as a target for preoperative ultrasound guided lesion localisation with hook wire for surgical removal. Who is it for? You may be eligible to join this study if you have a mammographic abnormality requiring stereotactic vacuum assisted core biopsy. Trial details Following vacuum assisted core biopsy of one (or more) breast lesions, a participant will have one marker randomly (by chance) selected from six different marker types inserted into the biopsy site. Each participant may have more than one breast lesion that requires a biopsy in which case the next marker on the list will be used to ensure a different marker is used for each lesion. The performance of each marker (how visible it is on ultrasound and whether it stays at the biopsy site) will be assessed and compared to determine if any of these markers can be reliably used for preoperative lesion localisation using ultrasound guided hook wire insertion.

Menopause is the point in time when a woman’s menstrual periods stop. The years leading up to a woman’s final period is referred to as the “menopausal transition” and, on average, lasts 4 to 7 years. Previous research has found that about 1 in every 4 women experience symptoms of depression during this transition period. Some women may also notice changes that include: irregular menstrual periods, hot flushes, sleep disruption, night sweats, vaginal and urinary problems and low libido. Fortunately, the most bothersome features of the menopausal transition can be managed successfully, including the changes in mood. What we would now like to find out is if we can prevent changes in mood occurring altogether by addressing relevant risk factors for depression that might be present during the menopausal transition. This project requires the participation of midlife women who are experiencing symptoms consistent with the lead up to menopause. Eligible participants will be randomly assigned into one of two groups: Standard Medical Care or Standard Medical Care and a Health Coaching Program Women allocated to the health coaching program will have access to a health coach for a minimum of 8 telephone coaching sessions. The health coach will offer informational material on menopausal transition, depression and healthy lifestyle behaviours in addition to providing problem solving skills based training. A series of validated self-report measures will be mailed to all study participants at four time points (Baseline and at 8 weeks, 26 weeks and 52 weeks). These measures will collect demographic, lifestyle and clinical information. The primary outcome of this study is the diagnosis of depression (major depressive episode or dysthymia) according to DSM IV at follow up. We will test the following hypothesis: women randomly assigned to health coaching program will have a lower 12 month prevalence of depression than women randomly assigned to standard care.

The current study will evaluate an integrative internet-based approach to prevent mental health and substance use problems in adolescence. The intervention is known as Climate Schools Combined (CSC), and comprises of a twelve-lesson substance use course, and a six-lesson mental health course. Together the CSC program simultaneously targets alcohol, cannabis, depressive and anxiety disorders with the aim of reducing substance use and decreasing anxiety and depressive symptoms. The study is being run in 71 schools across QLD, NSW and WA. The CSC intervention will be compared to the individual Climate Schools Substance Use intervention, the Climate Schools Mental Health intervention, and the control condition. The RCT will be conducted over three years, with the delivery of the Substance Use course in Year 8 (except QLD students whom will receive the course in Year 9) and the Mental Health course in Year 9 (Year 10 for QLD). This study will be the first time such an intervention has been trialed, and is the first intervention designed to fit within the school syllabus to concurrently target substance use and mental health. Long term follow up: The approved extended long-term follow up will provide the first ever evaluation of the long-term effectiveness of combining universal approaches to the prevention of substance use, anxiety and depression and will examine the durability of intervention effects into the longer-term, over a 7-year period from adolescence to early adulthood.

Any missed injuries in trauma can cause prolonged hospital stay due to change in medical/surgical therapy, immobilisation, increase morbidity and mortality and increase cost of care. Trauma patients are referred to the physiotherapist for acute rehabilitation and ongoing care in the community when discharged from hospital. The aim of this study is to compare a medical tertiary survey and physiotherapy tertiary survey in identifying missed musculoskeletal extremity injuries after trauma admission. The patient recruitment period will be 12 months. When the eligible trauma patient is recruited to the study, the assessing physiotherapist will perform a tertiary survey as a part of an initial assessment to a physiotherapy treatment. Tertiary survey filled out by the physiotherapist will be compared with the treating trauma team. There will be 2 outcome groups in this study. Patients whose tertiary survey performed by physiotherapists prior to the admitting trauma team will be in P group. Patients whose tertiary survey performed by admitting trauma team prior to physiotherapists will be in T group. The outcomes of this study are: 1. Number of missed musculoskeletal injuries identified by physiotherapist and admitting trauma team 2. Comparison of new or missed and types of musculoskeletal injuries identified by physiotherapists 3. Number of tertiary surveys completed by physiotherapists earlier than the admitting trauma team.

The aim of this study is to assess the effectiveness and safety of using Eltrombopag in patients with early refractory ITP. Early refractory ITP is when the ITP is not responding to standard therapy within 6 months of diagnosis. Eltrombopag is approved in Australia to treat severe chronic ITP however it is not approved for use in early refractory ITP. Personal experience provided by doctors who have used this medication indicate that as well as being effective in treating patients with chronic severe ITP, it might also be effective when treating patients in the earlier stages of ITP when initial steroid therapy is no longer adequately working. This is an open label study, all patients will receive an oral tablet dose daily of eltrombopag based on their platelet count and ethnicity (patients from Japan have been shown to have an increased eltrombopag serum level by approximately 80% compared to Caucasian patients). All patients will receive the study drug for 12 weeks and assessed for bleeding episodes and platelet count. Patients deemed to have responded will stay on eltrombopag with the opportunity to dose reduce to the lowest possible dose whilst maintaining a response over time. The study will run for 130 weeks (2 1/2 years) for those who continue to respond and there will be availability of the medication to patients beyond that. Overall response will be assessed at week 12 and defined as the achievement of CR, PR and MR. Time to response and duration of response and alternative treatment free survival will also be assessed. Therapeutic response will be assessed at week 26.

Endoscopic management of large colonic polyps is an increasingly utilised and accepted alternative to surgery. Complete polyp removal after a single treatment session is high with a recent prospective study reporting first-time success in 84% of patients presenting for endoscopic management. The success rate of first time complete polypectomy is significantly lower when the lesion cannot be fully excised utilising a standard injection and snare technique. This is more common in large rectal polyps, polyps that have undergone partial or incomplete resection, and polyps that have been marked with SPOT tattoo. All these scenarios result in submucosal fibrosis and therefore failed lift with standard submucosal injection. In this setting the traditional approach has been to resort to ablative techniques such as argon plasma coagulation (APC) and snare tip coagulation (STC), however the use of APC has been identified as a risk factor for residual adenoma at follow-up colonoscopy with a recent study showing an increase in residual adenoma at follow-up from 17.5 to 39.5% (RR 2.25; 1.45-3.50, p=0.002). Recently, the use of hot avulsion (HA) has been shown in a prospective pilot study, to be a safe and highly effective technique for dealing with difficult non-lifting polyps (NLP). Currently there is no published literature to guide effective management of the NLP. The proposed study design is a randomised clinical trial comparing HA to APC (the current standard of care) for the management of polyps that fail removal using a standard snare resection technique. We postulate that HA will result in a significantly higher rate of complete polyp removal of the non-lifting polyp when compared to standard therapy. Patients undergoing colonoscopy for removal of large polyps (>20mm), polyps that have failed previous resection, polyps that have previously been injected with SPOT tattoo or patients presenting for follow-up of previously removed large polyps will be approach for inclusion in the study. Following commencement of polypectomy, if the endoscopist fails to remove the polyp entirely using standard snare techniques, they will be randomised to either HA or standard of care (APC). The primary outcome measure of this study is the rate of macroscopic and histologic eradication of neoplasia at the first follow up colonoscopy which is routinely performed at 4 months. The outcome variable is dichotomous (residual or no residual) and will be expressed as a proportion. If patients fail removal at first follow-up, a second treatment will be attempted. If at the second follow-up there is persistent polyp, this will be considered a treatment failure and the treating physician will then be able to either cross arms or refer the patient for surgical management.

The current study aims to examine the effects of protein and fat ‘preloads’ of RYGB on GE or SI transit, appetite-related and incretin hormones, GI symptoms and haemodynamics. We hypothesized that when given before a mixed meal, (A) a fat ‘preload’ has no effect on GE but slows SI transit, increases the GLP-1 and PYY responses, reduces glycaemic and insulin responses and attenuates the fall in BP and rises in HR/SMA blood flow, as well as symptoms; and (B) a protein ‘preload’ has no effect on GE but slows SI transit, increases GLP-1 and PYY responses, reduces the glycaemic but increases the insulin response and attenuates the fall in BP and rises in HR/SMA flow and symptoms.

Resveratrol, which is a nutritional supplement derived from certain plant foods including red grapes, has the potential to improve blood sugar levels in patients with type 2 diabetes by uncertain mechanisms. In this study, we aim to identify the effects of resveratrol on the rate of gastric emptying, blood sugar levels and blood levels of hormones produced by the intestines

Less than half of all people at highest risk of a cardiovascular disease (CVD) event are receiving and adhering to best practice recommendations to lower their risk. In this project we examine the role of an e-health assisted consumer strategy as a means of overcoming such health system inefficiencies. With the implementation of the Personally Controlled E-Health Record (PCEHR) for all Australians in 2012, consumer focussed e-health is set to become a key component of the health system. Despite the scale of this initiative, few people even know of its existence and there is little research on the factors that will support its uptake. Innovative strategies that are practical to implement and support negotiation of care between consumers and care providers are therefore urgently needed.

The main aim is to investigate the efficacy and safety of methoxyflurane as a patient controlled analgesia in colonoscopic procedures, as compared to the traditional endoscopist provided analgesia/sedation. Hypothesis Methoxyflurane is as effective and safe in providing adequate analgesia for patients undergoing colonoscopic procedures as conventional intravenous sedative/analgesia with midazolam and fentanyl. Patients prefer patient controlled analgesia, compared with endoscopist administered analgesia.