ANZCTR search results

Eligible patients will randomly assigned (50/50 chance) to receive both the propagermanium and placebo in different orders as follows, either: 1. Treatment Period 1: Propagermanium capsule twice a day for 12 weeks Treatment Period 2: Placebo capsule twice a day for 12 weeks. OR 2. Treatment Period 1: Placebo capsule twice a day for 12 weeks Treatment Period 2: Propagermanium capsule twice a day for 12 weeks. This study will determine how safe and effective propagermanium is in the treatment of paients with DKD by: • monitoring symptoms that patients may experience while on the study • measuring levels of protein in patients urine and kidney function during the course of the study. • measuring the levels of propagermanium and irbesartan that enters into patients urine and blood • comparing the propagermanium result to patients' pre-study and placebo results

The aim of this study is to determine if an evidence-based parenting program which also teaches skills to cope with everyday stress (Enhanced Stepping Stones Triple P) is more effective than a parenting program alone (Stepping Stones Triple P) in improving the mental wellbeing of both parents and children who experience mental health challenges. For adults, mental health challenges include symptoms of depression, anxiety, hyperactivity, and substance abuse. For children, mental health challenges may include symptoms of depression and anxiety as well as developmental issues including symptoms of attention deficit/hyperactivity, autistic traits and conduct problems.

This study aims to assess the accuracy of continuous interstitial glucose monitoring using two different blood glucose monitoring systems and compare results to conventional methods (finger prick test) in women requiring betamethasone treatment for preterm birth. In usual practice only finger prick testing will occur. In this study the two devices are used on abdomen and upper arm, and an IV cannula is inserted for measurement of blood ketones.

Adverse drug events (ADEs) cause around 2–3% of all Australian hospital admissions at a cost of about AUD$1.2 billion annually, and are the focus of this proposal. Older people are at high risk of ADEs, and we have shown that exposure to medicines that might harm them is very common in older people and can have important clinical consequences. The problem is hard to identify. Many older people may benefit from taking fewer medicines, but doctors rarely stop medicines in older people, even those close to death. There is now good evidence that some medicines can be stopped safely in older people, and that reducing unnecessary medicines has survival benefits for older people. The barriers and enablers to stopping medicines are now well described. However an important gap persists in translating what we know about problem medicines use to inform doctors and patients’ shared decision making around this issue. We have designed the present study to systematically address the known barriers to deprescribing. We will evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) framework to address multiple medicines use in older inpatients taking 5 or more medicines. This randomised controlled trial will compare the AusTAPER intervention to usual care. Addressing multiple medicines use in older people may reduce adverse events and save money. There is evidence to suggest that there will be cost benefits by both reduced medicines costs, and reduced adverse events leading to reduced health service utilisation.

Older people are at high risk of adverse drug reactions. We have shown exposure to potentially harmful medicines is very common in older people, can have substantial clinical consequences, but is problematic to identify. Older people with multiple comorbidities have rarely been included in clinical trials and there is genuine clinical equipoise as to the risks and benefits of many medicines in older people. In addition, there is uncertainty about the validity of the default practice of extrapolating from trial data in younger groups when prescribing to older people. Many older people may benefit from taking fewer medicines, but doctors rarely cease medicines in older people, even those close to death. There is now substantial evidence some medicines can be safely and carefully ceased in older people, with reduction in polypharmacy having survival benefits for older people. The barriers and enablers to deprescribing are now well described. However, an important gap persists in translating the evidence about the benefits of more appropriate prescribing and safety of deprescribing into everyday clinical practice. Currently this body of evidence is not being used enough to inform GPs and patients’ shared decision making around this issue. The present pilot study is designed to investigate the feasibility of an approach to systematically address the known barriers to deprescribing and evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) in addressing polypharmacy. The AusTAPER intervention integrates patient priorities and decision support tools to electronically flag potentially inappropriate medicines, and provides a clinical pathway for structured assessment and follow-up by GPs and community pharmacists in a web-based system. The ‘Team’ in this intervention model refers to the patient (‘participant’), study pharmacist and GP.

This is a study evaluating the safety and maximum tolerated dose of HLX20, a Human Monoclonal Antibody, in participants with advanced or metastatic solid tumours. Who is it for? You may be eligible for this study if you are aged at least 18 years old and have a confirmed advanced or metastatic tumour, for which treatment has failed or not tolerated. Study details All participants in the study will receive intravenous treatment with the study drug HLX20. The dose may vary depending on when the participant joins the study. Blood and tissue samples will be collected for safety analysis, efficacy and tolerability of HLX20. Additionally, patients may also undergo imaging/scans and a biopsy if archival tissue sample is unavailable. There is no guarantee that you will receive any benefits from this study, and taking part in this study may or may not cause your health to improve. Information from this study may help doctors learn more about HLX20 on the treatment of your cancer

Background: Infection in orthopaedic surgery can be catastrophic. Increased perspiration from theatre staff has been associated with higher rates of wound contamination. Wearing lead safety gowns, which is often done during surgery to allow the use of image intensifier, may result in heavy perspiration. Aim: We aimed to determine feasibility of wearing a neck cooling device during surgery and whether it reduced surgeons’ perspiration levels and decreased the negative impact on surgeons’ comfort levels during orthopaedic procedures requiring the use of lead gowns. Method: A pilot randomised control trial was conducted. Surgeons were randomised to either wearing the neck cooling device (intervention) or not wearing the device (control). Procedure duration, theatre temperature, humidity and perceived technical difficulty of operation were recorded. After the procedure, surgeons completed a questionnaire documenting how the temperature and humidity had a negative effect on their comfort and perceived level of perspiration. Multilevel mixed effects linear regression with random effects, adjusting for potential confounders was performed.

This is a preliminary study which will provide information on whether it is possible to conduct a larger clinical trial on acupuncture or ear acupuncture for weight loss in Polycystic Ovary Syndrome (PCOS). We are recruiting adult women with PCOS aged up to 45 years old who have a BMI of over 25. All women will receive 3 months of telephone-based health coaching. Women will be randomly allocated to receive either health coaching alone; acupuncture and health coaching; or ear acupuncture and health coaching. The aim of this study is to see if acupuncture may be effective, whether it is possible (feasible) to conduct a larger study, and whether our proposed treatment is acceptable to women in the community with PCOS. We will be collecting data on weight, insulin and glucose tolerance, testosterone levels, and other symptoms and signs of PCOS as well as measuring heart rate variability.

This study aims to evaluate the feasibility, acceptability and efficacy of a new cognitive behavioral intervention designed to help children with epilepsy improve their social competence. The new intervention uses a number of non-invasive, child friendly techniques previously used with children with developmental disorders and typically developing children to teach children with epilepsy how to respond in social situations. The intervention is focused on development of perspective taking, which means understanding what another person is thinking (cognitive perspective taking) and feeling (affective perspective taking); also called theory of mind. We decided to focus our intervention on perspective taking, as it is a core social cognitive skill that is important for socialisation. Also, research has shown that children with epilepsy have marked difficulties perspective taking about thoughts and feelings of others, which affects their ability to respond in social situations. Children with epilepsy also have difficulty identifying and labelling their own thoughts and feelings, which is a precursor for knowing about the thoughts and feelings of others. This is the first intervention that addresses this critical area of clinical need. Social difficulties are frequent in children with epilepsy and have significant clinical implications including increased risk of anxiety, depression and ongoing social and emotional difficulties as adolescents and adults. This feasibility study will involve four face-to-face groups led by registered psychologists. The groups will involve role-plays, videos, social stories, group discussions, and paper and pen tasks. The groups will be held in clinical rooms designed for child and family therapy. The study will also involve four one-to-one assessments with a psychologist (15 to 35 minutes each) that will take place at baseline (4 to 6 weeks before the first day of the intervention), pre-treatment (first day of the intervention) post-treatment (last day of the intervention), and follow-up (4 to 6 weeks after the intervention has been completed). The assessments will involve paper and pen and computerized tasks. All tasks are similar to those that would be completed in a normal clinical setting. At no point during the study will children be exposed to activities that will pose undue physical or psychological strain. However, in the unlikely event a child becomes distressed, this will be sensitively managed by the psychologists running the groups.

The primary purpose of this study is to conduct a series of Single Case Experimental Designs (SCEDs) that compare the effectiveness of conservative multimodal physiotherapy in reducing daily neck pain and improving self-efficacy whilst performing daily activities in individuals with Chronic Whiplash Disorder (WAD), in 3 individuals with Post Traumatic Stress Symptoms (PTSS) and 3 individuals without PTSS. The hypothesis is that multimodal conservative physiotherapy when performed in individuals without PTSS will be more effective in reducing daily neck pain intensity and improving self-efficacy whilst performing daily activities when compared to individuals with PTSS. This multiple baseline design study has several dependent variables that are measure simultaneously - including the Neck Disability Index, the Depression Anxiety and Stress Scale, EQ-5D-5L, the Pain Catastrophising scale, patient specific questions based on a self efficacy questionnaire and the Global Impression of Change scale. The intervention is introduced in a staggered sequence. Thus, at different stages of the study some tiers will be in the baseline (A) phase and others will be in the intervention (B) phase. This study will utilise an A1-B-A2 design to measure the effectiveness of a standard multimodal conservative physiotherapy intervention across the three phases: a baseline phase with no intervention (A1), intervention phase (B) and lastly a no intervention phase with follow-up (A2). The onset of the intervention start point will be randomly allocated, with two participants starting at day 5, another two on day 8 and the last two on day 11. During this 4 week intervention period, participants will have 8 one hour sessions of physiotherapy treatment. Afterwards, there will be a 4 week follow-up phase where the participants will have no contact with the intervention personnel, in order to determine the possible duration of improvement post intervention.