ANZCTR search results

The current pilot study study aims to: 1) examine the effectiveness of an 8-session, 2-hour group, CBT and mindfulness intervention in reducing psychological distress and improving quality of life, 2) compare the efficacy of intervention delivery method (group versus self-instruction) and 3) produce a CBT and mindfulness treatment protocol that is evidence-based and cost-effective for both practitioners and clients. Women aged 18 years or over, who experience symptoms of endometriosis, will choose to participate in one of three groups: Group, Self-Instruction or Care as Usual (Open Label design).

Primary healthcare services targeting Indigenous Australians, including Aboriginal Community Controlled Health Services (ACCHSs) have a unique role in providing accessible and appropriate health care. Yet there is wide variation in the extent to which such services provide the full range of treatments for unhealthy alcohol use (i.e. drinking above recommended limits or alcohol-use-disorders). This cluster randomised controlled trial examines the effectiveness of a model for whole-of-service support to increase uptake of evidence-based screening and treatment for unhealthy alcohol use among Aboriginal and Torres Strait Islander (Indigenous) Australians in primary care settings. We hypothesize that a collaborative, service-level intervention can result in improved rates of recommended screening and provision of treatment for unhealthy alcohol use.

The aim of this study is to examine reasons for re-presentation to emergency departments or admissions to hospital in a cohort of individuals with atrial fibrillation (AF). The use of treatment for AF, including rate and rhythm controlling strategies, and blood thinning medications (anticoagulation) to reduce the risk of stroke will also be explored. Factors associated with emergency department re-presentations and/or hospital admissions will also be examined.

Depression is one of the most prevalent and costly medical conditions worldwide (WHO, 2012). Although antidepressant medication is effective for many patients, up to 40% remain drug-resistant. Non invasive brain stimulation in the form of repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression with response rates of up to 60%. However, outcomes are variable both within and between individuals, suggesting that treatment protocols remain suboptimal. This variability is not surprising because non-invasive brain stimulation techniques were first developed in humans with no systematic “bench-to-bedside” evaluation of protocols, resulting in poorly defined clinical guidelines. Our lab has compared a range of brain stimulation protocols in a preclinical model of treatment resistant depression, and has shown that rTMS delivered at a 50mT intensity (at cortex) matches the behavioural effects obtained with rTMS delivered at 100% motor threshold equivalent to 1000mT intensity (currently used in human patients). However our 50mT protocol has additional benefits: it causes structural changes in the brain, leading to long lasting improvements in mood and cognition. This project will test efficacy of our low intensity protocol (50mT)as an add-on to the gold standard protocol (100%;1000mT) in a patient cohort (40 participants), using psychiatric assessment to evaluate changes in mood and cognition, and detection of two novel blood biomarkers for predictive ability. Significance: first pre clinically validated rTMS protocol for human treatment; establish a pipeline for translation of other rTMS protocols arising from basic research at the Perron Institute.

Endoscopic sleeve gastroplasty (ESG) is a procedure that facilitates weight loss by reducing the volume of the stomach. Instead of traditional weight loss surgery that involves skin incisions ESG is performed using an endoscope passed through the mouth, leading to reduced surgery-associated complications and recovery time. Non-alcoholic steato-hepatitis (NASH) fatty liver disease is a progressive liver disorder associated with obesity. This study will evaluate the effects of ESG on NASH liver disease, insulin resistance (or diabetic glycaemic control), weight loss and quality of life in ten adults with obesity and NASH fatty liver disease recruited through the NASH Fatty Liver Clinic at the Lyell McEwin Hospital Adelaide. The primary outcomes will be improvement in NASH liver disease (assessed on liver biopsy and blood tests), insulin resistance or diabetic glycaemic control, lipids, blood pressure and change in weight at 48 weeks following the procedure.

The purpose of this study is to compare ultrasound guided repeat fascia iliaca blocks delivered through a catheter to ultrasound guided single blocks delivered through a catheter with a saline control in emergency department hip fracture patients. The outcomes measured will be behavioural pain scores, verbal pain scores, opioid use, and incidence of delirium. Further a health economic component will analyse cost effectiveness of both interventions. We predict based on the literature and a pilot study that repeated boluses will be less painful, use less opioids, and have decreased incidences of delirium.

Effective treatments for complex perianal Crohn's disease remains an important unmet area of need in inflammatory bowel disease. Perianal fistulas affect over one third of Crohn's disease with severe cases requiring surgery and long-term immune-modifying treatments with side effects. Local injection of mesenchymal stem cells has been the only effective new treatment since the anti-tumour necrosis factor drugs over a decade ago. Fistula healing effects of stem cells have been shown last even at 1 year after treatment. Human amnion epithelial cells are a non-embryonic adult stem cell which is easily obtained from healthy human placentas (after delivery of a healthy baby) which would otherwise be discarded. Compared with mesenchymal stem cells, amnion stem cells are obtained much faster, produce much greater amounts and theoretically should be safer. This gives them a greater advantage. This study is a pilot study aiming to recruit 10 adults with complex perianal Crohn's fistulas who have previously failed one conventional treatment. Participants will receive one injection of amnion stem cells while undergoing examination under anaesthesia, which is a common procedure performed for those suffering this condition. The primary purpose of this study is to establish safety of the amnion stem cells with secondary goals to assess feasibility of treatment, effectiveness in fistula healing and improvement in quality of life. These will be measured at 24 weeks after treatment with stem cells. The total duration of the trial is approximately 28 weeks, however we would like to assess longer term with a final visit at 1 year. We hypothesise that human amnion epithelial cell therapy will be a safe, tolerable and effective treatment.

Background Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are the two most costly procedures performed in Australia. Venous thromboembolism (VTE) – pulmonary embolism (PE) or deep venous thrombosis (DVT) remain serious complications of THA and TKA and there is current uncertainty regarding which drugs should be used as chemoprophylaxis. Low molecular weight heparin (LMWH) is the most commonly recommended and used, but many surgeons use aspirin as it is a safe, efficacious, easy to administer and a low cost alternative. Study Aim This study aims to compare LMWH and aspirin in VTE prevention in patients undergoing THA or TKA at hospitals contributing data to the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). It is hypothesised that aspirin will be non-inferior to LMWH in preventing symptomatic 90-day VTE. Study Design and Intervention The study will use the AOANJRR to perform a registry-nested, cluster randomised crossover trial. The intervention will be aspirin given orally (once daily, 85-150mg) and the comparator will be LMWH (enoxaparin, 40mg subcutaneously), both given for 35 days after THA and for 14 days after TKA. Study Outcomes The primary outcome is verified symptomatic VTE within 90 days in patients undergoing primary THA or TKA for osteoarthritis. Secondary outcomes will include a cost-effectiveness analysis, efficacy for all THA or TKA (revision, primary, performed for any diagnosis) and non-VTE complications between the two groups (including wound ooze as a sub-study). Study Timeline Thirty-one institutions have commenced recruiting patients in 2019. Recruitment of patients for the CRISTAL trial will take at least 12 months for each treatment arm, yielding approximately 15,500 patients. It is estimated the study will take a further 12 months to complete for data analysis and manuscript preparation. This would provide a conservative estimate of 4 years for study completion.

This study will test whether it is feasible to collect information on quality of life in patients living with myeloma and provide this to treating clinicians in real-time at clinical visits. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have newly diagnosed multiple myeloma for which you have not received any prior treatment or are within 7 days of day 1 of treatment. Study details Participants will be randomly allocated (by chance) to one of two groups. Participants in one group will complete a quality of life questionnaire before 4 clinical visits and a summary of results of concern are provided to the treating clinician before the first 3 visits. The clinician is made aware that results from the questionnaire summary are to be taken into account in the patient's care. Participants in the other group will complete the same questionnaire before visits 1 and 4 only, and results are not provided to the treating clinician. Feasibility of the intervention will be assessed by patient and clinician evaluation surveys, clinician interviews and site study coordinator observations. Quality of life scores will also be compared between groups. The theory is that increasing clinicians' awareness of issues affecting patients quality of life could help to improve patient care.

This research study is being conducted in order to gather information about the overall clinical performance and ease-of-use of the DELTA Disposable Delivery System, an instrument used in cataract surgery to implant the intraocular lens (IOL) into the eye. Delivery systems are commonly used in cataract surgery, this study is simply testing a new type of delivery system. Intraocular lenses are implanted as part of routine cataract surgery to restore vision.